[Congressional Record Volume 141, Number 194 (Thursday, December 7, 1995)]
[Senate]
[Pages S18183-S18228]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                     PARTIAL-BIRTH ABORTION BAN ACT

  The PRESIDING OFFICER. Under the previous order, the Senate will now 
resume the consideration of H.R. 1833, which the clerk will now report.
  The legislative clerk read as follows:

       A bill (H.R. 1833) to amend title 18, United States Code, 
     to ban partial-birth abortions.

  The Senate resumed the consideration of the bill.

       Pending:
       Smith amendment No. 3080, to provide a life-of-the-mother 
     exception.
       Dole amendment No. 3081 (to amendment No. 3080), of a 
     perfecting nature.
       Pryor amendment No. 3082, to clarify certain provisions of 
     law with respect to the approval and marketing of certain 
     prescription drugs.
       Boxer amendment No. 3083 (to amendment No. 3082), to 
     clarify the application of certain provisions with respect to 
     abortions where necessary to preserve the life or health of 
     the woman.
       Brown amendment No. 3085, to limit the ability of dead beat 
     fathers and those who consent to the mother receiving a 
     partial-birth abortion to collect relief.


  Amendment No. 3083 to Amendment No. 3082, and Amendment No. 3081 to 
                           Amendment No. 3080

  The PRESIDING OFFICER. Under the previous order, there will now be 60 
minutes equally divided for debate on amendments by Senators Dole and 
Boxer.
  The Senate will be in order.
  Who seeks recognition?
  Mr. KENNEDY addressed the Chair.
  The PRESIDING OFFICER. The Senator from Massachusetts.
  Mr. KENNEDY. Mr. President, I ask the Senator from California for 5 
minutes, when the Senate is in order.
  Mrs. BOXER. Mr. President, if you will bring the Senate to order?
  The PRESIDING OFFICER. The Senator from Massachusetts has asked for 5 
minutes from the Senator from California.
  Mrs. BOXER. Yes, as soon as the Senate is in order. I do not believe 
we should start the clock running until the Senate is in order. Mr. 
President, this is a very serious difficult debate. Members on both 
sides feel very strongly. I will be happy to yield 5 minutes to the 
Senator from Massachusetts when the Chair believes the Senate is in 
order.
  The PRESIDING OFFICER. The Senator will begin debate when there is 
order.
  The Senator from Massachusetts.
  Mr. KENNEDY. Mr. President I yield myself 4 minutes and 15 second and 
ask to be notified at that time.
  Mr. President, I oppose the pending bill and strongly support the 
Boxer amendment to protect the lives and health of women. I came away 
from the November 17 Judiciary Committee hearing more convinced than 
ever that this bill is an unwise, unconstitutional----
  Mrs. BOXER. Mr. President, if I could ask the Senator to yield, the 
Senate is not in order.
  The PRESIDING OFFICER. Will the Senators to the left of me take their 
conversations off the floor?
  The Senator from Massachusetts.
  Mr. KENNEDY. Mr. President, I oppose the pending bill to outlaw 
medically necessary abortions, and I strongly support the Boxer 
amendment to protect the lives and health of women.
  The Senate began to debate H.R. 1833 last month, a mere 6 days after 
the bill had passed the House. At first, the bill's Senate sponsors 
even refused the reasonable request that hearings be held. But a strong 
bipartisan majority of the Senate rejected that unacceptable approach. 
The bill was committed to the Judiciary Committee for a hearing. But 
there was no committee markup and the Senate does not have the benefit 
of a committee report.
  The haste with which this bill is being pushed through the Senate is 
unseemly. Obviously, its proponents don't want their proposal examined 
too closely. They'd rather have the Senate vote on emotion, not on the 
facts.
  I attended the November 17 hearing, and I came away from it more 
convinced than ever that this bill is an unwise, unconstitutional, and 
dangerous proposal.
  The hallmark of good legislation is clarity. But the November 17 
hearing revealed that this bill is unacceptable vague. In criminal 
legislation like this, that's unconstitutional, and it's quite likely 
that the courts will throw out this bill under the void for vagueness 
doctrine.
  The problem is obvious. The Judiciary Committee heard from a panel of 
medical experts who could not even agree among themselves on the 
medical meaning of the legislative language, or on which procedures 
might be banned. Dr. Courtland Robinson of Johns Hopkins University 
called the language ``vague, not medically substantiated, and just not 
medically correct . . . the name [partial-birth abortion] did not exist 
until someone who wanted to ban an abortion procedure made up this 
erroneous, inflammatory term.''
  The bill's very vagueness itself threatens the lives and health of 
American women. In the absence of a clear definition of what is 
outlawed, doctors will decline to perform any abortion that a 
prosecutor or jury might later find objectionable.
  Prof. Louis Michael Seidman of Georgetown Law Center testified: ``If 
I were a lawyer advising a physician who performed abortions, I would 
tell him to stop, because there is just no way to tell whether the 
procedure will [violate this law].''
  Dr. Robinson, who has practiced medicine for over 40 years, expressed 
the fear that if doctors are unwilling to perform needed abortions, 
women will resort to the back-alley methods that were used before safe, 
legal abortions became available. He testified:

       In the 1950's in New York, I watched women die from 
     abortions that were improperly done. By banning this 
     technique, you would, in practice, ban most later abortions 
     altogether by making them virtually unavailable. And that 
     means that women will probably die. I know. I've seen it 
     happen.

  Despite the bill's apparently deliberate vagueness, the one activity 
it clearly bans is a procedure known as ``intact dilation and 
extraction'' or ``D&E'' surgery. There are perhaps 450 such operations 
performed in the United States each year, and they involve ``wanted 
pregnancies gone tragically awry,'' according to Dr. Mary Campbell of 
Planned Parenthood, who testified at the hearing. Dr. Campbell 
explained that when emergency conditions threaten the life or health of 
the pregnant woman, this procedure is safer than any other abortion 
method, such as induced labor or caesarean section.
  Depending upon the position of the fetus in the womb, a woman is 14 
times as likely to die from a C-section as from a D&E, and twice as 
likely to die from induced labor as from a D&E, according to Dr. 
Campbell. C-sections create an increased risk of rupture of the uterus 
in future pregnancies.
  The bill's supporters ignore this compelling medical testimony and 
the scholarly articles that support it. They rely instead on a single 
quotation from a single doctor to the effect that 80 percent of these 
abortions he performs are ``elective.'' But proponents of the bill are 
grossly distorting what that doctor said. They never complete the 
quotation--the doctor stated that he is referring to abortions before 
the sixth month of pregnancy.
  The Supreme Court has made plain that in the case of such pre-
viability abortions, a woman may elect to terminate her pregnancy 
without the undue interference from the Government. After viability, of 
course, there are no elective abortions. As Dr. Campbell noted 
emphatically, ``third trimester abortion for healthy babies is not 
available in this country.* * * Occasionally, someone comes to see me 
who thinks she is 10 weeks pregnant; it turns out she is 32 weeks 
pregnant. I don't say, `where can we get you a third-trimester 
abortion.' I say, `You will be having a baby.' ''
  The Judiciary Committee heard the facts about the D&E procedure from 
doctors. We also heard moving testimony from two women who needed and 
obtained this surgery to avoid serious health consequences.
  Coreen Costello is a pro-life Republican. She learned that the fetus 
she 

[[Page S 18184]]
was carrying had ``a lethal neurological disorder. * * * Due to 
swelling, her head was already larger than that of a full-term baby. 
Natural birth or an induced labor were impossible.'' The D&E procedure, 
she said, ``greatly lowered the risk of my death. * * * There was no 
reason to risk leaving my children motherless if there was no hope of 
saving [my baby].''
  Vicki Wilson testified about an equally tragic pregnancy. As she told 
the committee, ``approximately 2/3 of my daughter's brain had formed on 
the outside of her skull. * * * Because of the size of her anomaly, the 
doctors feared that my uterus would rupture in the birthing process, 
most likely rendering me sterile.'' She pleaded with the committee: 
``There will be families in the future faced with this tragedy because 
prenatal testing is not infallible. I urge you, please don't take away 
the safest procedure available. This issue isn't about choice, it's 
about medical necessity.''
  The bill's supporters obviously cannot deal with the force of this 
first-hand testimony. So what do they do? They now suggest that the 
surgical procedures that saved Coreen Costello and Viki Wilson were not 
``partial-birth abortions.''
  That devious retreat speaks volumes about the vagueness of this bill, 
and the uncertainty it is designed to create. Even its sponsors don't 
know what it means. But let there be absolutely no mistake. The 
procedure that these two witnesses underwent was an intact D&E. It was 
the procedure depicted on Senator Smith's charts. It is the procedure 
that the bill's proponents say they object to. It is the procedure that 
saved the lives and health of Coreen Costello and Vicki Wilson. And now 
the bill's supporters pretend the bill wouldn't apply to those cases. 
If it doesn't apply to those cases, it will not apply to any cases.
  These two brave women do not stand alone. Five other women submitted 
testimony for the record describing similar cases. Thousands of women 
owe their lives or their health to the availability of a surgical 
procedure that the U.S. Senate is on the verge of outlawing and sending 
any doctor to prison who performs it.
  On its face, this bill is an unprecedented intrusion by Congress into 
the practice of medicine. Its passage would represent the first time in 
American history that Congress has outlawed a specific medical 
procedure and imposed criminal penalties on doctors for treating their 
patients. As Dr. Robinson told the Judiciary Committee: ``With all due 
respect, the Congress of the United States is not qualified to stand 
over my shoulder in the operating room and tell me how to treat my 
patients.''
  This political excursion into the practice of medicine is plainly 
inappropriate. So why is it before the Senate today? The answer is 
simple. The right-to-life movement has brought this bill to Congress in 
the hope that its passage will advance their goal of discrediting Roe 
versus Wade and eventually outlawing all abortions. The bill's 
supporters in the House boasted of such a strategy. At least one 
witness at the committee hearing spoke frankly of this broader agenda. 
Helen Alvare of the Catholic Conference testified in support of the 
bill. She responded to questioning by Senator Feingold that she 
absolutely favored criminal penalties for all abortion procedures. As 
she said, ``If abortion proponents are afraid that somehow this [bill] 
opens the public mind to considering abortion further, they are 
certainly right.''

  That is why supporters of this bill do not mind its vagueness. They 
do not really want to imprison the doctors who perform this procedure. 
They want to intimidate all doctors into refusing to perform any 
abortions at all.
  Before we head down that dangerous road, we should remember that Roe 
versus Wade and the subsequent Supreme Court decisions affirming a 
woman's right to choose are based squarely on the Constitution. The 
constitutional basis of the decision has been reaffirmed by the Supreme 
Court in case after case since 1973. In its decision in Planned 
Parenthood versus Danforth, the Supreme Court specifically invalidated 
a Missouri law that banned a particular abortion procedure. The Court 
held that the Missouri law might force ``a woman and her physician to 
terminate her pregnancy by methods more dangerous to her health than 
the method outlawed.''
  This bill is a frontal assault on settled Supreme Court law. 
Basically, it asks the Supreme Court to overrule Roe versus Wade.
  At the hearing, Professor Seidman of Georgetown Law Center identified 
a half dozen independent reasons why the bill is unconstitutional. The 
most disturbing of all the reasons is the bill's failure to permit 
abortions that are necessarily to preserve the life of the woman or to 
protect her from serious adverse health consequences.
  The Boxer amendment would at least remedy this most glaring defect. 
It states clearly that the criminal prohibition in the bill will not 
apply in the case of pre-viability abortions, or in the case of 
abortions that in the medical judgment of the attending physician are 
necessary to preserve the life of the mother or avoid serious, adverse 
health consequences.
  Every Member of the Senate who supports Roe versus Wade should 
support the Boxer amendment. So should every Member of the Senate who 
wants to protect the lives and health of American women.
  In contrast, the Smith/Dole version of the exception is grossly 
inadequate. It fails to address the situation where an abortion is 
necessary to avoid serious adverse health consequences. The Boxer 
amendment protects both the life and the health of the woman. The 
Smith/Dole amendment protects only the woman's life.
  Senator Smith and Senator Dole know how to write a genuine life-of-
the-mother exception. The model is obvious--the long-standing Hyde 
amendment in Medicaid, which allows Medicaid to pay for abortions in 
cases where it is necessary to save the life of the mother.
  But Senator Smith and Senator Dole don't want a real exception for 
the life of the mother. In fact, their language does not even protect a 
woman's life. It contains two gaping loopholes, and these loopholes 
make it meaningless.
  First, the Smith/Dole amendment limits the types of life-threatening 
situations in which the exception applies. Only threats to a woman's 
life that arise from ``a physical disorder, illness or injury'' are 
covered. It does not cover the threat to a woman's life that may arise 
from the pregnancy itself, since pregnancy is not a ``physical 
disorder, illness or injury.'' Coreen Costello, for example, did not 
have an illness like cancer or diabetes that threatened her life. The 
threat to her life arose from her pregnancy itself, and would not be 
covered by the Smith/Dole exception.
  Second, the Smith/Dole exception is conditioned on whether ``any 
other medical procedure would suffice'' to save the woman's life. This 
proviso is an outrageous example of second-guessing a doctor's 
judgment. Doctors who had literally saved a patient's life could find 
themselves in a Federal prison because a prosecutor and a jury 
concluded after the fact that the patient's life could also have been 
saved using a different medical procedure that offended Congress' 
sensibilities less.

  What doctor would take that chance? None. The Smith/Dole exception is 
a sham. It provides no significant additional protection to doctors who 
want to save the life of the woman.
  Few aspects of the lives of citizens are as sensitive and as 
deserving of privacy as the relationship between patients and their 
physicians. Several years ago, we debated a proposal to gag physicians 
and prevent them from counseling women about abortion. But this bill 
makes the gag rule debate pale by comparison. It puts the Federal 
Government--indeed, Federal law enforcement officers--directly into the 
doctor's office in the most intrusive way.
  The procedure involved in this case is extremely rare. It involves 
tragic circumstances late in pregnancy where the mother's life or 
health is in danger. The Federal Government has no business intruding 
into these family decisions at all, and certainly not in so misguided a 
fashion.
  The laws in 41 States already regulate post-viability abortions. The 
appropriations of medical practices is overseen by state and local 
health departments, medical societies, hospital ethical boards, and 
other organizations. The Federal criminal law is a preposterous means 
of regulating the highly personal, individual decisions 

[[Page S 18185]]
facing families with tragic pregnancies.
  Coreen Costello told the Judiciary Committee: ``We are the families 
that ache to hold our babies, to raise them, to love and nurture them. 
We are the families who will forever have a hole in our hearts. We are 
the families that had to choose how our babies would die. Each one of 
you should be grateful that you and your families have not had to face 
such a choice. I pray that no one you love ever does. Please put a stop 
to this terrible bill.
  I join Coreen Costello in urging the Senate to defeat this bill. The 
test for every male Senator in this Chamber is very simple--would you 
deny this procedure to your wife or daughter if it's needed to save her 
life or health? Would you send her doctor who performed it to jail?
  This bill is medical malpractice. The Senate should stop practicing 
medicine without a license. This bill should be defeated.
  The PRESIDING OFFICER. Who seeks recognition?
  Mr. GRAMM addressed the Chair.
  The PRESIDING OFFICER. The Senator from Texas.
  Mr. GRAMM. Mr. President, I yield as much time as he might require to 
the distinguished Senator from Indiana, Senator Coats.
  The PRESIDING OFFICER. The Senator from Indiana is recognized.
  Mr. COATS. Mr. President, Americans have honest disagreements over 
the subject of abortion. Strong convictions often lead to strident 
rhetoric, at times straining the bounds of civil discourse. Labels and 
name calling too easily substitute for persuasion as a means of winning 
the hearts and minds of fellow citizens. Extremism and fanaticism are 
served up as daily fare, often being dismissively attached to those 
with strong pro-life views.
  And yet there are times when strong words are necessary, when truth, 
raw and exposed, merits an apt label. There is only one issue at stake 
here: It is an affront to humanity and justice to kill a kicking infant 
with scissors as it emerges from its mother.
  This legislation is not the expression of extremism. Only the 
procedure itself is extreme--extreme in its violence, extreme in its 
disregard for human life and dignity.
  We have listened to the words of an eyewitness to this procedure. So 
we know what the procedure is. A pro-choice nurse who assisted an 
abortionist in this procedure described the procedure. I do not like to 
describe the procedure on this floor. I do not like to read the 
procedure. But I know one thing. I cannot condone or support this 
procedure. And, if we are going to vote with a clear understanding of 
what it is we are dealing with, we need to understand the procedure.
  I quote from this pro-choice nurse who assisted an abortionist in 
this procedure.
       What I saw is branded on my mind forever . . . Dr. Haskell 
     went in with forceps and grabbed the baby's legs and pulled 
     them down into the birth canal. Then he delivered the baby's 
     body and the arms--everything but the head. The doctor kept 
     the head right inside the uterus. . . .
       The baby's little fingers were clasping and unclasping, and 
     his little feet were kicking. Then the doctor stuck the 
     scissors in the back of his head, and the baby's arms jerked 
     out, like a startled reaction, like a flinch, like a baby 
     does when he thinks he is going to fall.
       The Doctor opened up the scissors, stuck a high-powered 
     suction tube into the opening, and sucked the baby's brains 
     out. Now the baby went completely limp.
       I was really completely unprepared for what I was seeing. I 
     almost threw up as I watched Dr. Haskell doing these things.
       Next, Dr. Haskell delivered the baby's head. He cut the 
     umbilical cord and delivered the placenta. He threw the baby 
     into a pan, along with the placenta and the instruments he 
     had just used. I saw the baby move in the pan. I asked 
     another nurse, and she said it was just ``reflexes.''
       I had been a nurse for a long time, and I have seen a lot 
     of death--people maimed in accidents, gunshot wounds, you 
     name it. I have seen surgical procedures of every sort. But 
     in all my professional years, I had never witnessed anything 
     like this.
       The woman wanted to see her baby, so they cleaned up the 
     baby and put it in a blanked and handed it to her. She cried 
     the whole time. She kept saying, ``I am so sorry, please 
     forgive me.'' I was crying, too. I couldn't take it. That 
     baby boy had the most perfect angelic face I think I have 
     ever seen in my life.

  The only possible way to defend this procedure is with evasion and 
misrepresentation.
  It is said that this procedure is rare. But we are safely talking 
about hundreds of these abortions annually. And as a matter of 
unalienable human rights, it should not only be rare, it should be 
nonexistent.
  I suggest, if we are talking about 1 abortion with this procedure 
rather than 600, the issue is exactly the same.
  It is said that the child feels nothing. But we know that a mother's 
anesthesia does not eliminate her child's pain. And we know that a 
child killed in this procedure feels exactly what a preemie would feel 
if its doctors decided to kill it in its nursery.
  It is said that this procedure is done to save the life of the 
mother. But we know that this procedure is not without substantial risk 
for the mother. And, in fact, its primary purpose is the convenience of 
the abortionist.
  It is said that partial birth abortions are part of the mainstream of 
medicine. But we know that the AMA Council on Legislation stated that 
this practice is not a ``recognized medical technique'' and that the 
``procedure is basically repulsive.''
  I am quoting. The AMA Council on Legislation said that this procedure 
is ``basically repulsive.'' I think anyone who understands the 
procedure and knows the description of the procedure can come to no 
other conclusion.
  It is said that only prolife fanatics support this legislation. But 
how could this possibly apply to Members of the House like Patrick 
Kennedy, Susan Molinari, and John Dingell? One pro-choice Member of the 
House commented, ``It undermines the credibility of the pro-choice 
movement to be defending such an indefensible procedure.''
  When we strip away all these arguments, we are left an uncomfortable 
truth: This procedure is not the practice of medicine, it is an act of 
violence.
  It is hard to clearly confront reality in this matter, because 
clarity causes such anguish. But that reality is simple and terrible: 
The death of a child with the most perfect angelic face I think I have 
ever seen in my life. That face should haunt us and shame us as a 
society. It should cause us to grieve--but more than that, it should 
cause us to turn back from this path to barbarism.
  Mr. President, I ask unanimous consent to have printed in the Record 
an article written by George Will called, ``Fanatics For `Choice.' 
Partial-birth abortions, sonogram photos and `the idea that the fetus 
means nothing.' ''
  There being no objection, the article was ordered to be printed in 
the Record, as follows:

                        Fanatics For ``Choice''

                          (By George F. Will)

       Americans are beginning to recoil against the fanaticism 
     that has helped to produce this fact: more than a quarter of 
     all American pregnancies are ended by abortions. Abundant 
     media attention has been given to the extremism that has 
     tainted the right-to-life movement. Now events are exposing 
     the extraordinary moral evasions and callousness 
     characteristic of fanaticism, prevalent in the abortion-
     rights lobby.
       Begin with ``partial-birth abortions.'' Pro-abortion 
     extremists object to that name, preferring ``intact dilation 
     and evacuation,'' for the same reason the pro-abortion 
     movement prefers to be called ``pro-choice.'' What is 
     ``intact'' is a baby. During the debate that led to House 
     passage of a ban on partial-birth abortions, the right-to-
     life movement was criticized for the sensationalism of its 
     print advertisements featuring a Dayton nurse's description 
     of such an abortion:
       ``The mother was six months pregnant. The baby's heartbeat 
     was clearly visible on the ultrasound screen. The doctor went 
     in with forceps and grabbed the baby's legs and pulled them 
     down into the birth canal. Then he delivered the baby's body 
     and the arms--everthing but the head. The doctor kept the 
     baby's head just inside the uterus. The baby's little fingers 
     were clasping and unclasping and his feet were kicking. Then 
     the doctor stuck the scissors through the back of his head, 
     and the baby's arms jerked out in a flinch, a startle 
     reaction, like a baby does when he thinks that he might fall. 
     The doctor opened up the scissors, stuck a high-powered 
     suction tube into the opening and sucked the baby's brains 
     out.''
       To object to this as sensationalism is to say that 
     discomforting truths should be suppressed. But increasingly 
     the language of pro-abortion people betrays a flinching from 
     facts. In a woman's story about her chemical abortion, 
     published last year in Mother Jones magazine, she quotes her 
     doctor as saying, ``By Sunday you won't see on the monitor 
     what we call the heartbeat.'' ``What we call''? In partial-
     birth abortions the birth is kept (just barely) partial to 
     preserve the legal fiction that a baby (what some pro-

[[Page S 18186]]
     abortion people call ``fetal material'') is not being killed. An 
     abortionist has told The New York Times that some mothers 
     find such abortions comforting because after the killing, the 
     small body can be ``dressed and held'' so the (if pro-
     abortionists will pardon the expression) mother can ``say 
     goodbye.'' The New York Times reports, ``Most of the doctors 
     interviewed said they saw no moral difference between 
     dismembering the fetus within the uterus and partially 
     delivering it, intact, before killing it.'' Yes.
       Opponents of a ban on partial-birth abortions say almost 
     all such abortions are medically necessary. However, an 
     abortionist at the Dayton clinic is quoted as saying 80 
     percent are elective. Opponents of a ban on such abortions 
     assert that the baby is killed before the procedure, by 
     the anesthesia given to the mother. (The baby ``undergoes 
     demise,'' in the mincing words of Kate Michelman of the 
     National Abortion and Reproductive Rights Action League. 
     Does Michelman say herbicides cause the crab grass in her 
     lawn to ``undergo demise''? Such Orwellian language is a 
     sure sign of squeamishness.) However, the president of the 
     American Society of Anesthesiologists says this 
     ``misinformation'' has ``absolutely no basis in scientific 
     fact'' and might endanger pregnant women's health by 
     deterring them from receiving treatment that is safe.
       Opponents of a ban say there are only about 600 such 
     procedures a year. Let us suppose, as not everyone does, the 
     number 600 is accurate concerning the more than 13,000 
     abortions performed after 21 weeks of gestation. Still, 600 
     is a lot. Think of two crashes of jumbo airliners. Opponents 
     of the ban darkly warn that it would be the first step toward 
     repeal of all abortion rights. Columnist John Leo of U.S. 
     News & World Report says that is akin to the gun lobby's 
     argument that a ban on assault weapons must lead to repeal of 
     the Second Amendment.
       In a prophecy born of hope, many pundits have been 
     predicting that the right-to-life ``extremists'' would 
     drastically divide the Republican Party. But 73 House 
     Democrats voted to ban partial-birth abortions; only 15 
     Republicans opposed the ban. If the ban survives the Senate, 
     President Clinton will probably veto it. The convention that 
     nominated him refused to allow the Democratic governor of 
     Pennsylvania, Bob Casey, who is pro-life, to speak. Pro-
     choice speakers addressed the 1992 Republican Convention. The 
     two presidential candidates who hoped that a pro-choice 
     stance would resonate among Republicans--Gov. Pete Wilson, 
     Sen. Arlen Specter--have become the first two candidates to 
     fold their tents.
       In October in The New Republic, Naomi Wolf, a feminist and 
     pro-choice writer, argued that by resorting to abortion 
     rhetoric that recognizes neither life nor death, pro-choice 
     people ``risk becoming precisely what our critics charge us 
     with being: callous, selfish and casually destructive men and 
     women who share a cheapened view of human life.'' Other 
     consequences of a ``lexicon of dehumanization'' about the 
     unborn are ``hardness of heart, lying and political 
     failure.'' Wolf said that the ``fetus means nothing'' stance 
     of the pro-choice movement is refuted by common current 
     practices of parents-to-be who have framed sonogram photos 
     and fetal heartbeat stethoscopes in their homes. Young 
     upscale adults of child-bearing age are a solidly pro-choice 
     demographic group. But they enjoy watching their unborn 
     babies on sonograms, responding to outside stimuli, and they 
     read ``The Well Baby Book,'' which says: ``Increasing 
     knowledge is increasing the awe and respect we have for the 
     unborn baby and is causing us to regard the unborn baby as a 
     real person long before birth . . .''
       Wolf argued for keeping abortion legal but treating it as a 
     matter of moral gravity because ``grief and respect are the 
     proper tones for all discussions about choosing to endanger 
     or destroy a manifestation of life.'' This temperate judgment 
     drew from Jane Johnson, interim president of Planned 
     Parenthood, a denunciation of the ``view that there are good 
     and bad reasons for abortion.'' So, who now are the fanatics?

  Mr. COATS. With that, Mr. President, I yield the floor.
  The PRESIDING OFFICER. Who yields time?
  Mrs. BOXER. Mr. President, I yield myself 2 minutes, and then I will 
yield directly to Senator Specter.
  I wish to put a face to the women in this debate, so night after 
night as Senator Smith and I have debated this issue, I have shown the 
faces of different families who have had to face this tragedy who are 
never shown on the posters that the other side has used during this 
debate. Those are the faces that I think are very, very crucial and 
very, very important.
  This is Coreen Costello about whom Senator Kennedy commented. This is 
a woman who describes herself as a pro-life Republican who underwent 
this procedure so she could live to see her other children grow.
  Why on Earth would we in the Senate, knowing nothing about medicine, 
ban a procedure that some doctors testified before us at the Judiciary 
Committee saves lives like this and gives these children a mother.
  I would say that as Senator Coats read the quote from the nurse, what 
he failed to say is she had worked for 3 days in this clinic in a 
temporary capacity. The fact is that her supervisor wrote the 
following, and I would place it in the Record:
  Miss Pratt--
  This nurse--
  Absolutely could not have witnessed fetal movement as she describes. 
We do not train temporary nurses in second trimester dilation and 
extractions since it is highly technical and would not be performed by 
someone in a temporary capacity.
  He also failed to mention that the American Nurses Association, which 
represents 2.2 million nurses, who learn to save lives, strongly 
opposes this legislation. They do not believe it is humane to deprive 
women such as Coreen Costello and their beautiful families of a chance 
to live. So we will be talking about that.
  And now I would yield 4 minutes to the Senator from Pennsylvania, Mr. 
Specter.
  The PRESIDING OFFICER. The Senator from Pennsylvania.
  Mr. SPECTER. Mr. President, I thank the distinguished Senator from 
California.
  Mr. President, I support both of the pending amendments, the 
amendment offered by the distinguished majority leader, Senator Dole, 
and the amendment offered by the distinguished Senator from California, 
Mrs. Boxer.
  I believe that the broader amendment, the Boxer amendment, is the 
preferable one because it articulates the basic constitutional standard 
which was setforth in Row v. Wade and upheld in Casey v. Planned 
Parenthood in 1992, an opinion written by three Justices appointed by 
Presidents Reagan and Bush.
  When you talk about the life of the mother and the health of the 
mother, conditioning the health on ``serious adverse health 
consequences,'' that is the constitutionally protected doctrine. When 
you talk about the language of the Dole amendment, which I intend to 
support, it is not in the blanket terms of life of the mother as in the 
Hyde amendment or the traditional amendments which are offered on 
appropriations bills which make an exception for life of the mother but 
instead talks about ``saving the life of the mother whose life is 
endangered by a physical disorder, illness or injury, provided that no 
other medical procedure would suffice for that purpose.''
  That language is hard to interpret at best, and I do believe would 
place substantial doubt in the minds of many doctors who would be 
called upon to try to figure out what it means.
  This is a medical procedure which is chilling beyond any question, 
and we do at the present time have a line drawn as to when there is 
someone alive protected by the laws against homicide and infanticide 
and the constitutional protections which apply on the medical procedure 
of abortions.

  We had only 1 day of hearings on this matter. The day we had was 
certainly preferable to having no hearings at all, but we were unable 
to get on relatively short notice, because we had a very limited time 
span, the doctors who were really familiar with these procedures. The 
fact is that those who are familiar were reluctant to step forward and 
offer medical judgments. But we heard very profound testimony from 
physicians who expressed the concern about having legislation in this 
field where it is very difficult to start to draw lines about what 
medical practices and what medical procedures ought to be.
  There is so much to be said for the proposition that it is between 
the doctor and the patient as to what is necessary for the life of a 
mother, which is at least the most restrictive standard which ought to 
be adopted in clearcut terms and really is not by the amendment offered 
by the distinguished majority leader but really ought to be extended 
life of the mother or health of the mother which has been established 
by the constitutional parameters by the Supreme Court of the United 
States.
  We have legislation which is very profound in its import, which had 
one limited hearing in the House, one limited hearing in the Senate, 
and which we will be legislating upon which will leave many, many open 
questions and many doubts on a very, very serious medical procedure.
  So, at a minimum, Mr. President, I hope that the Boxer amendment 
would 

[[Page S 18187]]
be adopted as well as the Dole amendment.
  The PRESIDING OFFICER. The 4 minutes yielded to the Senator from 
Pennsylvania have expired.
  The Senator from New Hampshire.
  Mr. SMITH. Mr. President, how much time is available on our side.
  The PRESIDING OFFICER. There are 22 minutes, 14 seconds.
  Mr. SMITH. And the other side?
  The PRESIDING OFFICER. There are 19 minutes exactly.
  Mr. SMITH. I will yield 5 minutes to the Senator from Texas, Mr. 
Gramm.
  The PRESIDING OFFICER. The Senator from Texas.
  Mr. GRAMM. Mr. President, I wish to begin by congratulating our dear 
colleague from New Hampshire. First of all, I wish to congratulate him 
for his leadership on this issue. I wish to congratulate him for the 
way that he has handled the issue. I hope that we are successful today 
in ending this procedure which I believe no civilized society can 
condone.
  This is not an issue that I had heard discussed before on the Senate 
floor until one day I came over to the floor to speak on another 
subject, and the distinguished Senator from New Hampshire was 
describing this procedure. Questions were raised as to whether someone 
might be offended by the description. I rose simply to make the point 
that if we are offended by the description of the procedure, surely we 
have to be offended by the fact that the procedure is occurring in 
America today.
  I joined the distinguished Senator from New Hampshire as his original 
cosponsor when he introduced the bill. There were only two of us to 
begin with on the bill. That number has grown.
  I do not know that I can add much to this debate. But let me try to 
sum up my feelings on the issue. The Dole amendment, which is now 
pending, removes any doubt about the fact that the life of the mother 
and any threat to the life of the mother is a defense for using this 
procedure. If the mother's life is in danger, this procedure can be 
used.
  So the question really boils down to whether a civilized society can 
condone this procedure when the life of the mother is not at risk. And 
I submit this: We have heard the description. We have heard testimony 
of a nurse who witnessed this procedure first-hand. It really boils 
down to this. This procedure is almost always used with a late-term 
baby, which is generally viable outside the womb. And when the baby is 
3 inches away from the full protection of the Constitution, the baby's 
life is terminated in a violent manner that I think is objectionable in 
a civilized society.
  The question is, Are we going to stop it? I remind my colleagues, 
this is a vote about banning a procedure when the mother's life is not 
in danger. The child is delivered feet first, and when only the head of 
the child remains in the womb, its life is terminated--just 3 inches 
away from the full protection of the Constitution.
  This amendment bans no other type of abortion. It simply bans this 
procedure, which I believe is offensive, and which I believe is 
unacceptable in a civilized society.
  I hope our colleagues will vote for the Dole amendment because it 
formalizes what those of us who were for the Smith proposal to begin 
with understood, and that is, the life of the mother exception was 
included to begin with. This further clarifies it for someone who is 
concerned about that. And I think it is a legitimate concern, though I 
was satisfied with the original language. But with the Dole amendment 
adopted, I think we have a clear-cut choice. I hope our colleagues will 
vote for the Dole amendment, against the Boxer amendment, and then vote 
for the Smith proposal.
  I think it is the right thing to do. I am very proud to associate 
myself with the distinguished Senator from New Hampshire on this issue. 
I reserve the remainder of our time.
  Mrs. BOXER addressed the Chair.
  The PRESIDING OFFICER. The Senator from California.
  Mrs. BOXER. I plan to yield to the Senator from Maine, Senator Snowe, 
in a moment.
  I wanted to answer a couple points made by my friend from Texas. 
First, he did describe the usual life-of-the-mother exception, which we 
voted on many times in the Senate, which is usually the Hyde language. 
That is not the language in the Dole amendment. The language in the 
Dole amendment, although described as life-of-the-mother, relates to a 
woman with a preexisting condition, not to situations that we are 
talking about where the woman's life is in danger due to the pregnancy 
itself.
  So the only real life-of-the-mother exception is the Boxer amendment. 
But we will support both Dole and Boxer because under the Dole 
amendment two or three women may be saved a year. Under the Boxer 
amendment you will save more women like Coreen and others. So we would 
advise Senators to vote for both.

  I want to say that I am very proud that we reached across the aisle 
here and the Boxer amendment is supported by Senator Brown, Senator 
Specter, Senator Snowe, and also on our side, Senators Murray, Moseley-
Braun, and Lautenberg.
  At this time I yield 4 minutes to the Senator from Maine, Senator 
Snowe.
  Ms. SNOWE. I thank the Senator for yielding.
  Mr. President, Members of the Senate, I rise in support of the 
amendment that has been offered by my colleague from California, 
Senator Boxer. I think there is no question in light of the testimony 
that was presented to the Judiciary Committee during a hearing on this 
legislation, when many of us advocated that this legislation go to 
committee so that we would have a chance to hear first hand from those 
women who would be affected by this kind of legislation, that without a 
doubt this amendment becomes even more important, more crucial, more 
vital to women's health.
  Twenty-two years ago the Supreme Court handed down the Roe versus 
Wade decision. It said that the woman's interest and decisions in 
reproductive matters should remain paramount. It also said the States 
could ban abortion in the last trimester. But they also had to include 
exceptions for when the life and health of the mother is in danger--let 
me repeat--as long as they allowed exceptions for cases in which a 
woman's life and health is endangered.
  The Supreme Court has reaffirmed that decision time and time again. 
Forty-one States ban abortion in the last trimester, but they provide 
exceptions for the life and health of the mother, as is 
constitutionally required by the Roe versus Wade decision. That is what 
the Boxer amendment does. It upholds that decision providing for the 
life and health of the mother. The Supreme Court recognized, in its 
wisdom, that there would be certain limiting, exceptional, tragic 
circumstances that may require an abortion in the final trimester. That 
is a decision that has to be made between the doctor and his patient.
  Without such an exception, without providing for life and health 
exceptions, innocent women are harmed. I have been somewhat amazed by 
some of the discussion that has taken place here on the floor. These 
are not casual decisions. These are not decisions that are made 
lightly. This procedure is not performed for sex selection.
  These are tragic and compelling circumstances under which a woman has 
to make this decision. That was verified and reinforced by the 
testimony presented by so many women before the Judiciary Committee 
recently. It was compelling testimony. These are heart-wrenching 
decisions and very difficult ones. These are procedures that are rarely 
performed, seldom performed. But there are times in which they have to 
be performed to save the life of the mother or to prevent drastic 
consequences to her health. Those are the facts.

  There have been 450 such procedures performed annually. They are so 
rare that they amount to 0.04 percent in the last trimester. Now we are 
talking about criminalizing a procedure that can save the life and the 
health of the mother. Now we are saying that political judgment will 
override medical judgment.
  I cannot imagine that any doctor, under the language in this 
legislation, if this amendment is not accepted, would be willing to 
take an action that is the safest and the most appropriate course, 
given the criminal prosecution involved in this legislation, unless we 

[[Page S 18188]]
accept the Boxer amendment that provides for the exception in cases of 
life and health.
  One doctor was quoted in the New York Times recently. He said, ``I 
don't want to make medical decisions based on congressional language. I 
don't want to be that vulnerable. It's not what I want for my 
patients.''
  The PRESIDING OFFICER. The Senator's time has expired.
  Mrs. BOXER. I yield the Senator an additional 60 seconds.
  The PRESIDING OFFICER. The Senator is recognized for an additional 60 
seconds.
  Ms. SNOWE. Another doctor, Dr. Robinson, an OB-GYN at Johns Hopkins, 
testified before the Judiciary Committee:

       Telling a doctor that it is illegal for him or her to 
     perform a procedure that is safest for a patient is 
     tantamount to legislating malpractice.

  So what we are doing under this legislation if we do not accept the 
Boxer amendment is saying to doctors, we want you to perform more 
dangerous, more traumatic procedures for the woman, even if it is 
against their best medical advice; for example, caesarean sections, 
that would require four times the risk of death as vaginal delivery. In 
fact, a woman is 14 times more likely to die from a caesarean section 
than from the procedure that this legislation seeks to outlaw.
  Induced labor carries a potentially life-threatening risk and 
threatens the future fertility of women by potentially causing cervical 
lacerations and hysterectomies which leave women often unable to have 
children for the remainder of their lives.
  As one professor said during the hearing, the only thing that this 
procedure does is to channel women from one less risky abortion 
procedure to another more risky abortion procedure. That is what we are 
doing here. He said that the Government does not have a legitimate 
interest in trying to discourage that.
  I hope that we will not throw women's lives and women's health into 
limbo by rejecting this legislation. I hope that they support the Boxer 
amendment.
  The PRESIDING OFFICER. The Senator from California.
  Mrs. BOXER. Mr. President, I do not need time at this point.
  The PRESIDING OFFICER. The Senator from New Hampshire.
  Mr. SMITH. I yield 5 minutes to the Senator from Pennsylvania.
  The PRESIDING OFFICER. The Senator from Pennsylvania.
  Mr. SANTORUM. Mr. President, I thank the Senator from New Hampshire 
for yielding. I want to congratulate him on the work he has done. He 
has been here many, many days and many, many hours debating a very 
difficult, emotional issue.
  I have been in the U.S. Senate and the House of Representatives now 
for 5 years. I have never spoken on the floor of either body on the 
issue of abortion. I never felt in my heart comfortable coming to the 
floor and talking about legislating the issue of abortion.
  I thought, as do many folks who vote pro-life here, that the issue is 
one that we have to educate and we have to change hearts and we have to 
go out to the public and sensitize the public to the horrors of 
abortion in this country. I say that as someone who is pro-life, but I 
think there are people who are pro-choice who believe also that 
abortion is wrong, it should be minimized in this country. So I always 
felt uncomfortable talking about legislating abortion.
  I have to say, I felt compelled to come up and talk about this. This 
is not about pro-life or pro-choice. This is about a horrific procedure 
that should shock the conscience of anyone who has heard how this 
procedure is done.
  The Senator from Maine just said, ``Well, you are going to take folks 
and force them from one risky procedure to another risky procedure. 
That may be true, but this risky procedure shocks the conscience of 
anyone who has heard it described. This is so horrific. There is some 
sort of moral code in this country. To see a baby three-quarters born 
have scissors stuck in the back of their brain--where have we come as a 
country when we say, ``Well, we need a statute to prohibit that,''--
this is wrong.
  I do not even think we should be having debate about it. One of the 
problems I think many of us have who are pro-life, who are conservative 
is that we tend to argue facts and figures. I was ready to read you 
that of the two doctors who performed the majority of these abortions, 
half of the babies who were born were perfectly healthy. One doctor 
testified to that effect and nine of the flawed babies had cleft 
palate. Flawed babies.
  We had Dr. Haskell, the other abortionist who does this, saying 80 
percent of the abortions were purely elective abortions. So do not try 
to sell a bill of goods. Those are facts and figures.
  I think what we have trouble with sometimes, as Republicans, is we 
put up charts, graphs, and numbers, and people just sort of glaze over. 
On the other side, they are much smarter. There is Senator Boxer with 
pictures of happy faces. There are no facts and figures.
  There is no medical evidence to support that partial birth abortion 
is the right thing to do, this is the moral thing to do, that this is 
what our society should stand for. No, you put up pictures of happy, 
smiling faces. You pull at the heartstrings on the other side and hope 
that all the truth just gets pushed in the background.
  There is an obvious truth here. There is an obvious truth here. You 
have a baby, not what they like to refer to as, ``an intact dilation 
and extraction.'' That is the way they describe this. An intact 
procedure. This intact thing is a baby, and it is three-quarters of the 
way delivered through the birth canal. It is not terminated, it is 
killed.
  Whether you are for abortions or against abortions, you cannot be for 
doing this. It shocks the conscience of a society and should not--
should not--be a procedure that is sanctioned by this body.
  I yield back the remainder of my time.
  Mrs. BOXER addressed the Chair.
  The PRESIDING OFFICER. The Senator from California.
  Mrs. BOXER. Mr. President, I yield myself 4 minutes, and I am glad 
the Senator from Pennsylvania is staying here because his remarks about 
this family are the most outrageous thing I have ever heard.
  The reason this family is smiling is because Coreen Costello was 
pregnant with her daughter, Katherine Grace, and the dad's hand is on 
her stomach, and they are so excited about having this baby, their 
third child.
  This is a woman who is pro-life who found out that Katherine Grace 
had a lethal neurological disorder and had been unable to move for 2 
weeks.
  Do you want facts? I will give you facts, sir.
  The movements that Coreen had been feeling were not the healthy 
kicking of her baby. They were nothing more than bubbles in amniotic 
fluid which had puddled in her uterus rather than flowing through the 
baby. The baby had not been able to move for months--not her eyelids, 
not her tongue, nothing. The baby's chest cavity was unable to rise and 
fall to stretch her lungs to prepare them for air. Her lungs and her 
chest were left severely undeveloped, almost to the point of 
nonexistence. Her vital organs were atrophying.
  The doctors told Coreen and her husband the baby was not going to 
survive, and they recommended terminating the pregnancy. She did not 
have an option. Her doctor told her if she did not use this procedure, 
which you will vote to outlaw today, she would probably not live.
  So when you stand up here and you talk about happy faces and you try 
to demean the other side, you ought to know your facts and, sir----
  Mr. SANTORUM. If the Senator from California will yield.
  Mrs. BOXER. I have no time to yield on my time. I will be glad to 
yield on your time.
  Mr. SANTORUM. Thirty seconds. You cannot have it both ways, Senator. 
You cannot have it both ways. You cannot have a life-of-the-mother 
exception, claim her life is in jeopardy and say our bill does not take 
care of that. If you are going to claim life-of-the-mother in her case, 
our bill covers that.
  If you are going to claim that she had alternative procedures, like a 
cesarean or other kinds of procedures where she could have had an 
alternative, you cannot argue both sides of the story, Senator. You 
have to argue the facts, just one side at a time. 

[[Page S 18189]]

  Mrs. BOXER. Mr. President, if I may reclaim my time.
  The PRESIDING OFFICER. The Senator from California has the floor.
  Mrs. BOXER. Mr. President, I have read you the facts of the case. The 
doctor said her life might be in danger. The doctor said for sure she 
could suffer infertility. That is not excepted in your bill. As a 
matter of fact, sir, when your bill was written, there was no exception 
at all, and the exception that is now in your bill would not cover her 
particular case in any event because your exception only covers a 
preexisting condition. Therefore, the Boxer-Brown language is 
absolutely essential to cover this particular case.
  I will give you more facts, I say to my friend from Pennsylvania. The 
American College of Obstetricians and Gynecologists represents 35,000 
physicians. They opposes this bill. They think it is dangerous.
  The American Nurses Association, representing 2.2 million nurses, 
oppose this bill. So those are just some of the facts.
  Mr. President, I ask unanimous consent to add Senator Mikulski as a 
cosponsor of the Boxer-Brown amendment.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mrs. BOXER. I yield the floor and reserve the remainder of my time.
  The PRESIDING OFFICER. Who yields time?
  Ms. MIKULSKI. Mr. President, I rise in opposition to H.R. 1833. I 
oppose it because it is a direct assault upon women's reproductive 
rights.
  But let me first thank Senator Smith for agreeing to support the 
motion which the Senate adopted on November 8. This motion called on 
the Judiciary Committee to hold a hearing on H.R. 1833, the so-called 
partial-birth abortion ban.
  As my colleagues know, the committee held that hearing on November 
17. I believe the hearing process was very important. The issues raised 
by this bill are complex and sensitive. It is vital they be thoroughly 
explored before the Senate votes on this legislation.
  I believe both proponents and opponents of H.R. 1833 found the 
hearing most helpful. I think all would agree Senator Hatch conducted a 
fair and informative hearing. We heard from medical professionals, 
legal and constitutional experts, and from the women themselves who 
courageously shared their compelling and heartrending stories.
  After reviewing all of the testimony, I am more convinced than ever 
that Congress should not pass the bill before us. I heard nothing to 
change my mind, and much to reinforce my deep concerns.
  Let me tell you why I oppose this bill.
  First, it intrudes on the doctor/patient relationship, by 
criminalizing a specific medical procedure.
  Second, it is poorly drafted. The bill's vague language will have a 
chilling effect on physicians who provide abortions.
  Third, it provides no exceptions for cases involving threats to the 
life and health of the woman.
  Fourth, most significantly, it is a direct assault on Roe versus 
Wade. In my view, the bill is part of a concerted effort to ban all 
abortions.
  I oppose this bill because it is a dangerous and unwarranted 
intrusion on the doctor/patient relationship. It has an impact far 
beyond the issue of abortion. For the first time, Congress would be 
deciding what medical procedures a doctor can and cannot provide. This 
bill substitutes political reasoning for medical judgment. Congress, 
not medical experts, would pass judgment on a medical procedure.
  H.R. 1833 makes criminals of doctors, doing their best to serve the 
patient's needs, who perform the procedure banned by the bill. It makes 
criminals of doctors even when in their expert opinion, the procedure 
is medically necessary to save a woman's life or prevent serious, 
adverse consequences to her health.
  At the November 17 hearing, medical experts had very different views 
on what the procedure involves, on what the medical alternatives would 
be, and on what is best to safeguard a woman's life and health. If they 
cannot agree on this medical issue, how can we expect to legislate in 
this area? This is reason enough why Congress should not intervene in 
decisions on medical procedure.
  I oppose this bill because it provides no true exception for the life 
and health needs of the woman. At the hearing, very compelling 
testimony was offered by women who have faced the difficult decision to 
have a late term abortion to save their lives or their health. These 
were women who eagerly awaited the birth of their child.
  Then a medical emergency occurred--one that threatened their lives or 
posed serious consequences to their health. Congress should not tell 
these women, and others who face this most tragic and personal of 
decisions, that they cannot have the medical procedure their physician 
recommends to save their life, or their health, or their ability to 
have a child in the future. Congress should not tell them that it knows 
better than their doctor what medical care they should be provided.
  Senator Smith has offered an amendment to provide an exception for 
cases where the woman's life is at risk. I have some concerns about 
this amendment. I fear it may not cover all situations where the life 
of the woman is threatened by continuing her pregnancy. And I am 
concerned that, under his amendment, the burden of proof will still be 
placed upon the physician. However, I will support his amendment. If it 
will save even a few women who need a late term abortion to save their 
lives, I cannot oppose it.
  But I believe it is absolutely essential that we pass the amendment 
offered by Senator Boxer. Her amendment provides clear, direct 
language. It will enable physicians to use their expert medical 
judgment to act to preserve the life of the woman or to avert serious, 
adverse consequences to her health.
  Senator Boxer's amendment makes it clear that when a woman must 
choose abortion late in pregnancy, she must have access to the safest 
possible procedure. And, physicians, not Senators, should make that 
decision.
  The Boxer amendment lets doctors be doctors. It trusts them to do 
what is right for their patients. It ensures that women's lives and 
health are not put at risk. I strongly urge my colleagues to vote for 
this essential amendment.
  I oppose this bill because it is poorly drafted. It is filled with 
vague, nonmedical terminology. Much of the Judiciary Committee hearing 
was spent debating what the bill meant. Witnesses and committee members 
alike could not agree on such basic questions as: How is the procedure 
in question actually performed? What procedure is the bill describing 
at all? What does partial birth mean?
  If Congress passes H.R. 1833, and it is signed into law, I guarantee 
you will open the door to endless litigation in an effort to sort out 
what the bill does and does not do.
  The bill's vagueness creates a further problem, whether intentionally 
or not is unclear. This lack of clarity would have a chilling effect on 
abortion providers, who are trying to make the best decision for their 
patients. Physicians who are trying to do their duty to protect life or 
health, now will have to guess whether their decision might violate 
Federal law.
  How many doctors will continue to perform this type of late term 
abortion, or any abortions at all, if faced with possible criminal or 
civil liability. There is already a tremendous shortage of abortion 
providers. The bill will make this shortage even greater. And, of 
course, that is part of the plan--to scare doctors from the field.
  Doctors who provide abortion services already face death threats, 
firebombings, and harassment at work and home. Now they will have to 
look over their shoulder in fear of arrest. Who will be willing to 
provide abortion services in that climate? And who will pay the price? 
Women will pay the price, women trying to exercise their right to a 
legal medical procedure.
  Finally, Mr. President, I oppose this bill because it is a direct 
assault on Roe versus Wade. In Roe and all its subsequent rulings, the 
Supreme Court has consistently upheld the right of doctors to perform 
late term abortions to protect life or health. The Court has allowed 
States to ban post-viability abortions, but only when an exception for 
life or health is provided.
  The Court has maintained that a doctor's first duty is to the woman. 
Her 

[[Page S 18190]]
life and health must be the doctor's paramount concern. The doctor 
cannot trade off her life for the life of the fetus.
  So, this bill, by ignoring the Court's requirement of a life and 
health exception is a direct challenge to Roe. And not the last 
challenge. Proponents of this bill have made clear they want to ban all 
abortions, one procedure at a time, one woman at a time.
  If they succeed in passing this bill, what procedure will they target 
next? Which women will next be denied their right to choose? If we 
allow this bill to pass, even with the amendments which I hope will be 
adopted, Congress will have struck a major blow against reproductive 
rights.
  Mr. President, the basic question is not what is decided, but who 
decides. And the answer is, women and their doctors should decide, not 
politicians. Women must have the right to make their own decisions on 
reproductive matters, in consultation with their physicians. That is 
what it means to be pro-choice, and that is why I will oppose this 
bill.
  Mrs. MURRAY. Mr. President, let me just say at the outset that I 
think it is incredible that we are here today debating this bill. There 
are unfinished appropriations bills, and an unresolved Federal budget 
situation that demand our full attention. I believe the American people 
would prefer us to address the real issues of the day--issues that 
affect our hard-working families--and not this kind of divisive, 
inflammatory legislation.
  Of course, the reality is that we are here and we are considering 
this so-called partial-birth abortion ban, and there are a few things 
that I want to say regarding the bill, and also to talk briefly about 
the amendment offered by my friend, Senator Boxer.
  Mr. President, I have listened carefully to this debate and I am 
increasingly convinced that it is far from being a clear and narrowly 
defined piece of legislation, as the proponents of the bill keep 
claiming it to be. I find it to be a vaguely written and dangerous 
attempt to ban not just a single procedure. Rather, I see it as a way 
to instill fear and confusion in the doctors who perform abortions, and 
to deter them from performing a procedure that may help save a woman 
whose life is in danger.
  It seems clear to me this bill is about families who are faced with a 
terrible tragedy, and it is about the doctors who must make an expert 
decision based on what they believe to be in the best interest of the 
mother. Frankly, this bill is about Congress muscling its way into the 
doctor's office. It is not only presumptuous, it is unprecedented and 
it is dangerous. We are proposing to criminalize doctors, and I want to 
caution each and every one of my colleagues to stop this legislation. 
Like Senator Boxer has said, this is a slippery slope we do not want to 
start down.
  But, unfortunately, it looks like there are Senators who are intent 
on pressing on with this bill, and so we, at least, have to try and do 
what our colleagues in the House failed to do--to include an exception 
for cases to save the life and health of the mother. Mr. President. The 
Senator from New Hampshire has offered an amendment which he claims 
provides a life of the mother exception. Well, I will vote for his 
amendment, because it is at least a step in the right direction.
  But let's be honest. The amendment makes no room for instances where, 
in the medical judgment of the attending physician, the procedure would 
be necessary to avert serious health consequences to the woman--
consequences such as severe hemorrhaging or paralysis.
  Only the Boxer amendment can be considered a true life exception. 
Only the Boxer amendment takes the health of women into account. Only 
the Boxer amendment sends the right message to the families of this 
Nation, to the women who are faced with an unimaginable tragedy. We 
hear, over and over again, graphic depictions of this procedure, but 
what of the vivid descriptions of the pain and torment these mothers 
have gone through? Of the horror of losing a much wanted child? Of the 
fear that she will never again have a chance to have a baby?
  Is there anyone here who honestly believes these women are choosing 
to have a late-term abortion? This insinuation is an affront to the 
women of this Nation. The small number of women who have late-term 
abortions do so because their doctors have determined it to be 
medically necessary to save their lives and their health. End of story.
  The Boxer amendment says: We respect you and will leave this 
difficult decision where it belongs--between you, your doctor, and your 
God. We think it is important to allow families to choose the procedure 
that is best for them, to best protect the health of the woman and to 
best safeguard her chances of being able to conceive again.
  Without this amendment we send the women of this country the message: 
``We don't care about you, we don't respect your or your doctors. The 
U.S. Congress and the Federal Government know best.
  Well, I don't believe Congress know best. We should leave this 
difficult decision to the experts and to the families who are faced 
with this tragedy. Congress has no place telling doctors what 
procedures they can and cannot perform--we have never even considered 
getting involved in the lives of physicians, and we shouldn't start 
now. Not this way.
  There is too much at stake, and I appeal to the common sense and 
humanity of each Member of this Chamber: If you must pass this 
reprehensible bill, at least vote to include this critical 
modification, and allow for exceptions in cases where women's health 
and lives are at stake.
  Mr. LEVIN. Mr. President, the Supreme Court has held in Roe versus 
Wade and reaffirmed in Planned Parenthood versus Casey, that States can 
ban late-term abortions except when necessary to preserve a woman's 
life or health. Forty-one States have established postviability bans on 
abortion with exceptions to preserve a woman's life or health. Only one 
State has banned the intact D&E abortion procedure which is the 
apparent subject of the bill before the Senate and that ban is being 
challenged in the courts.
  Forty-nine States have not banned this procedure. If the bill before 
the Senate becomes law, the Federal Government would dictate the 
regulation of abortion by banning a specific abortion procedure. This 
Federal ban in this bill would even apply to abortions performed 
previability, that is, in the second trimester and the bill does not 
contain the exception required by Roe, to preserve a woman's health.
  Some physicians believe the intact D&E abortion procedure represents 
the safest late-term abortion option. Others disagree. Politicians are 
not equipped to make decisions banning specific medical procedures when 
the medical community itself cannot even reach agreement on these 
decisions. We should not be voting to criminalize a specific medical 
procedure when doctors themselves are divided on the matter.
  If a physician is engaged in any inappropriate medical practice, the 
medical establishment has systems of peer and professional review in 
every State to deal with it. These systems of review include State 
medical boards and peer review on hospital review boards that police 
their membership. They should be the ones to ban a procedure if they 
determine it to be inappropriate.
  But physicians and their review processes have not banned this 
procedure. In fact, the American College of Obstetricians and 
Gynecologists, an organization representing more than 35,000 physicians 
that specialize in this area of medicine, oppose the bill before us. It 
wrote, in a letter to majority leader Dole, that:

       The College finds very disturbing that Congress would take 
     any action that would supersede the medical judgment of 
     trained physicians and criminalize medical procedures that 
     may be necessary to save the life of a woman.

  The American Medical Women's Association, Inc., representing 13,000 
woman physicians, has also said of the bill:

       This legislation represents a serious impingement on the 
     rights of physicians to determine appropriate medical 
     management for individual patients.

  In addition, the American Nurses Association, the only full-service 
professional organization representing the Nation's 2.2 million 
registered nurses through its 53 constituent associations, oppose the 
bill. Their letter states:

       It is the view of the American Nurses Association that this 
     proposal would involve an 

[[Page S 18191]]
     inappropriate intrusion of the federal government into a therapeutic 
     decision that should be left in the hands of a pregnant woman 
     and her health care provider.

  I also received letters from physicians in Michigan familiar with 
this field of medicine opposing the proposed ban of the intact D&E 
abortion procedure. I ask unanimous consent to insert those letters in 
the Record.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  [See exhibit 1.]
  Mr. SIMPSON. This bill would criminalize a so-called partial birth 
abortion which is defined by the bill as, ``an abortion in which the 
person performing the abortion partially vaginally delivers a living 
fetus before killing the fetus and completing the delivery.'' Senator 
Hatch referred to a statement by Dr. Haskell, a physician who has 
performed many intact D&E abortion procedures, that only about one-
third of the fetuses he extracted using the procedure were dead.
  My question is, in the one-third of the intact D&E abortion 
procedures he performed where the fetuses were dead, did Dr. Haskell 
know before beginning the procedure if those fetuses were dead? If he, 
and any other physicians in this situation, did not, they were taking a 
risk by beginning a procedure that could be a criminal act under the 
terms of this bill.
  The Senator from New Hampshire and others have said that Coreen 
Costello's abortion was not a partial birth abortion, presumably 
because she said the ``fetus passed away peacefully in the womb.''
  Did the physician know when he began the procedure whether the fetus 
was alive or dead? If a physician doesn't know for sure before 
beginning an abortion procedure whether the fetus is alive or dead, 
wouldn't the physician who starts down the path of performing the 
procedure be facing the possibility of criminal prosecution under the 
terms of this bill?
  In addition, the physician who performed the intact D&E procedure on 
Mrs. Costello might not be sure when he began the procedure if the 
fetus would be alive or dead when extracted since there is a range of 
fetal response to the anesthesia administered in an intact D&E 
abortion, the procedure that Mrs. Costello underwent.
  The performance of that procedure might then be considered an attempt 
at committing a crime even if the fetus turned out to be dead upon 
delivery. The procedure Mrs. Costello underwent thus could be covered 
by this bill and the physician that performed it subject to Federal 
criminal prosecution even if the fetus turned out to be dead when 
delivered.
  While banning one abortion procedure, this bill leaves legal other 
abortion procedures which can be used in later-term pregnancies. Are 
those other procedures as safe for the mother? Are they any less 
destructive to the fetus? Why are the other procedures left legal when 
some have argued they are less safe for the mother, while this one 
procedure, which some physicians believe is the safest for the mother, 
is made criminal?
  These other procedures that are left legal under this bill include 
inducing labor and delivery with drugs despite evidence of risk to the 
woman. A caesarean operation called a hysterotomy, which could result 
in severe bleeding, infection and even death for the woman, is also 
left legal, even in the third trimester to preserve the woman's life. 
Another procedure that would be left legal under this bill is called 
standard D&E which is performed in the second trimester and does not 
deliver the fetus intact, but removes the fetus from the uterus piece 
by piece.
  In conclusion, the Supreme Court has held that States can ban late-
term abortions except when necessary to protect a woman's life or 
health. Forty-one States have done that. But only one State has banned 
the intact D&E abortion procedure, and that ban is being challenged in 
the courts.
  Forty-nine States have not acted to ban intact D&E. The medical 
profession's own self-regulating system has also not acted to ban 
intact D&E. The U.S. Senate is not equipped to make this technical 
medical decision.
  The bill under consideration today would ban abortions using this 
procedure even in the second trimester and it does not allow for an 
exception required by Roe, to preserve a woman's health.
  Finally, this bill establishes Federal criminal penalties for a 
specific abortion procedure which may be the safest alternative for the 
mother while permitting other abortion procedures that could be less 
safe for the mother. We should leave this issue to the medical 
profession and the State legislatures, where it now and where it 
belongs.

                               Exhibit 1

                                           The American College of


                              Obstetricians and Gynecologists,

                                 Washington, DC, November 6, 1995.
     Hon. Robert Dole,
     Majority Leader,
     Washington, DC.
       Dear Majority Leader Dole: The American College of 
     Obstetricians and Gynecologists (ACOG), an organization 
     representing more than 35,000 physicians dedicated to 
     improving women's health care, does not support HR 1833, the 
     Partial-Birth Abortion Ban Act of 1995. The College finds 
     very disturbing that Congress would take any action that 
     would supersede the medical judgment of trained physicians 
     and criminalize medical procedures that may be necessary to 
     save the life of a woman. Moreover, in defining what medical 
     procedures doctors may or may not perform, HR 1833 employs 
     terminology that is not even recognized in the medical 
     community--demonstrating why Congressional opinion should 
     never be substituted for professional medical judgment.
       Thank you for considering our views on this important 
     matter.
           Sincerely,
                                              Ralph W. Hale, M.D.,
     Executive Director.
                                                                    ____

                                                  American Medical


                                    Women's Association, Inc.,

                                 Alexandria, VA, November 5, 1995.
     Hon. ------ ------,
     U.S. Senate,
     Washington, DC.
       Dear Senator ------: On behalf of the 13,000 women 
     physician members of The American Medical Women's 
     Association, I write to express AMWA's concern regarding 
     Senate bill S. 939, ``The Partial-Birth Abortion Ban''.
       It is the position of the American Medical Women's 
     Association that this legislation represents a serious 
     impingement on the rights of physicians to determine 
     appropriate medical management for individual patients. AMWA 
     recently passed resolution 15, which opposes federal 
     legislation banning this or any other medical procedure 
     determined to be of benefit to patients, at its annual House 
     of Delegates Meeting.
       AMWA urges the Senate to carefully consider the 
     implications that its support of this legislation will have 
     on the practice of medicine. We encourage the Senate to 
     actively oppose S. 939 as legislation which unduly interferes 
     with the physician-patient relationship.
           Sincerely,
                                      Jean L. Fourcroy, MD, Ph.D.,
     President.
                                                                    ____



                                  American Nurses Association,

                                 Washington, DC, November 8, 1995.
     Hon. Carl M. Levin,
     U.S. Senate,
     Washington, DC.
       Dear Senator Levin: I am writing to express the opposition 
     of the American Nurses Association to H.R. 1833, the 
     ``Partial-Birth Abortion Ban Act of 1995'', which is 
     scheduled to be considered by the Senate this week. This 
     legislation would impose Federal criminal penalties and 
     provide for civil actions against health care providers who 
     perform certain late-term abortions.
       It is the view of the American Nurses Association that this 
     proposal would involve an inappropriate intrusion of the 
     federal government into a therapeutic decision that should be 
     left in the hands of a pregnant woman and her health care 
     provider. ANA has long supported freedom of choice and 
     equitable access of all women to basic health services, 
     including services related to reproductive health. This 
     legislation would impose a significant barrier to those 
     principles.
       Furthermore, very few of those late-term abortions are 
     performed each year and they are usually necessary either to 
     protect the life of the mother or because of severe fetal 
     abnormalities. It is inappropriate for Congress to mandate a 
     course of action for a woman who is already faced with an 
     intensely personal and difficult decision. This procedure can 
     mean the difference between life and death for a woman.
       The American Nurses Association is the only full-service 
     professional organization representing the nation's 2.2 
     million Registered Nurses through its 53 constituent 
     associations. ANA advances the nursing profession by 
     fostering high standards of nursing practice, promoting the 
     economic and general welfare of nurses in the workplace, 
     projecting a positive and realistic view of nursing, and by 
     lobbying the Congress and regulatory agencies on health care 
     issues affecting nurses and the public.
       The American Nurses Association respectfully urges you to 
     vote against H.R. 1833 when it is brought before the Senate.
           Sincerely,
                                            Geri Marullo, MSN, RN,
     Executive Director.
                                                                    ____

                                  
[[Page S 18192]]

                                  Roseville, MI, December 7, 1995.
     Hon. Carl Levin,
     Washington, DC.
       Dear Senator Levin: I am writing you with concerns about 
     the S.B. 939, the D&X Abortion Procedure Ban. I am absolutely 
     opposed to political intervention in the practice of 
     medicine.
       As a practicing OB-Gyn, I cannot begin to cite the 
     ramifications of such a bill. If passed, it will prevent me 
     from providing the best possible care for my patients in 
     emergency situations. The D&X procedure is the safest option 
     for many women faced with medical emergencies during 
     pregnancy. It is done only in extreme situations, such as 
     when a woman's life is in danger or when a fetus has severe 
     abnormalities that are incompatible with life. This bill 
     endangers the lives of women, who are already making 
     heartwrenching decisions.
       I find it very disturbing that the Senate would take any 
     action that would overrule the judgment of trained 
     physicians. As a physician, I and others like myself, would 
     find it frightening that my government would prevent me from 
     providing the best possible care for my patients. Please do 
     not lot this happen.
           Sincerely,
     Samuel Edwin, M.D.
                                                                    ____

                                        Department of Dermatology,


                                          Henry Ford Hospital,

                                    Detroit, MI, November 6, 1995.
     Re Bills to limit physician abortion procedures.

     Senator Carl Levin,
     U.S. Senate,
     Washington, DC.
       Dear Senator Levin: I am very upset to hear proposed 
     legislation to make criminal various surgical procedures 
     performed by physicians. I realize the legislation is being 
     introduced as a method to limit abortion. However I am 
     incensed that non-physicians are trying to limit the scope of 
     medical practice, and make it criminal as well!
       Personally I feel it is the woman's right to choose, and as 
     men, we should not interfere. But as a physician it is a 
     slippery slope for non-physicians to limit our practices 
     especially for political means.
       Please block this legislation!
           Sincerely,
                                               Tor Shwayder, M.D.,
         Director, Pediatric Dermatology; Fellow, American 
           Academies of Pediatrics & Dermatology.
                                                                    ____

  Mr. FEINGOLD. Mr. President, I rise in opposition to H.R. 1833.
  I do so because this legislation raises serious policy, legal and 
medical issues.
  H.R. 1833 seeks to impose criminal sanctions upon physicians who 
perform certain types of late term abortions.
  It is important, Mr. President, to understand that very few late term 
abortions take place in this country, under any circumstances. It is 
estimated that there are approximately 600 abortions annually performed 
in the third trimester of pregnancy, with about 450 done by what is 
called an intact D&E procedure. The procedure which would be banned 
under this legislation is a form of an intact D&E procedure. Late-term 
abortions take place under the most tragic of circumstances, where 
something has gone wrong with the pregnancy. Late-term abortions are 
physically difficult and emotionally devastating to the women involved 
and their families. Several women who were forced to have such an 
abortion testified at the Senate Judiciary Committee hearing about the 
pain and anguish they and their families had experienced.
  This bill would place the Federal Government into the role of 
deciding what procedures a physician can or cannot use in performing a 
late-term abortion. It would substitute the judgment of Congress for 
the judgment of the individual physician performing an abortion.
  I believe that such legislation is bad policy. The American people 
have repeatedly said that they want less government interference in 
their lives. This bill moves in exactly the wrong direction.
  Since the beginning of the 104th Congress, there has been a great 
deal of rhetoric about how we need to restrain the Federal Government, 
about how the Federal Government has usurped the powers of State and 
local government entities, and about how the Federal Government has 
intervened in areas beyond its primary realm of responsibility. We have 
heard repeatedly that we need fewer Federal mandates and fewer Federal 
regulations.
  Mr. President, let me say that I agree with a good deal of those 
sentiments. I believe that the Federal Government has gone too far in 
many areas. That is one reason why I voted against last year's Federal 
crime bill and this year's terrorism bill. In each instance, I saw 
examples of the Federal Government overzealously reaching into areas of 
law which have traditionally been within the jurisdiction of State and 
local law enforcement agencies.
  I voted for the unfunded mandate legislation because I agree that the 
Federal Government needs to exercise restraint in forcing the States to 
comply with Federal mandates. I support many aspects of the regulatory 
reform drive because we do need greater flexibility and less Federal 
micromanagement in many areas.
  But now, Mr. President, we are presented with legislation that places 
the Federal Government in the role of deciding what specific procedures 
a physician should use or not use when faced with a problem pregnancy 
and a woman's desire to terminate that pregnancy.
  Mr. President, there are many reasons why this is a dangerous area 
for Federal Government intervention. One of the physicians said it well 
during the Judiciary Committee hearing on November 17. Dr. J. Courtland 
Robinson testified:

       Sometimes, as any doctor will tell you, you begin a 
     surgical procedure expecting it to go one way, only to 
     discover that the unique demands of the case require that you 
     do something different. Telling a physician that it is 
     illegal for him or her to adapt his or her surgical methods 
     for the safety of the patient . . . flies in the face of 
     standards for quality medical care.

  Dr. Robinson also pointed out in his testimony that many physicians 
would not undertake a surgery at all if they were legally prohibited 
from completing it in the safest, most effective way, according to 
their professional judgment.
  Mr. President, I want to reiterate that the measure under 
consideration would insert the Federal Government into one of the most 
intensely private and personal areas. This bill would have Congress 
override the decisions made by a woman and her physician in an area 
that literally involves life or death.
  It is ironic that many of the same individuals who strongly 
challenged the ability of the Federal Government to handle 
comprehensive health care reform are among the foremost proponents of 
this effort to insert the Federal Government into a physician's 
decisions in the operating room.
  For example, during last year's health care debate, the distinguished 
Senator from North Carolina (Mr. Helms) asked:

       Do you want the Federal Government, the Government that 
     operates your postal system to decide whether you should have 
     an operation or not? With this kind of government 
     intervention, what is left for the doctor and the patient to 
     decide?

  Yet, that is precisely the kind of intervention that is being 
proposed by this legislation. This measure says that a physician who 
determines that a specific procedure is necessary to protect the life 
or health of his or her patient may face a Federal criminal prosecution 
for exercising his professional judgment.
  Mr. President, it is also important to note that the language of this 
bill is so vague that a number of physicians have indicated that they 
would simply stop performing late-term abortions rather than run the 
risk of criminal prosecution or endangering the life or health of their 
patient. Dr. Robinson told the committee:

       For many physicians, this law would amount to a ban on a 
     D&E [procedure] entirely the law is so vague and based on 
     erroneous assumptions, it would leave doctors wondering if 
     they were open to prosecution or not each time they 
     performed a late abortion. That means that by banning this 
     technique, you would in practice ban most later abortions 
     altogether by making them virtually unavailable. And that 
     means that women will probably die.

  Dr. Robinson, incidently, is a former Presbyterian missionary who has 
practiced medicine for more than 40 years. He described for the 
committee his exposure to the consequences of illegal abortions prior 
to the Roe decision. He testified that over a period of five years on 
the staff of a hospital in New York, he watched women die from 
abortions that were improperly performed. His concerns about the 
consequences of legislation that would make certain types of abortions 
illegal and deny women access to the safest abortion procedure for 
their individual circumstances were clearly an outgrowth of his 
familiarity with what happens when Government treads too 

[[Page S 18193]]
far into what should be a decision made by a woman and her physician.
  Mr. President, that brings me to a second policy concern regarding 
this legislation. On its face, H.R. 1833 seeks to criminalize the 
performance of a particular type of abortion. Yet, Mr. President, there 
is little doubt that the purpose behind this legislation is to begin 
the process of curtailing and ultimately denying all access to legal 
abortion.
  When pressed, many of the proponents of H.R. 1833 will admit the 
truth of this assertion.
  One of the major House proponents, Congressman Chris Smith (R. N.J.) 
stated in a November 9, 1995, USA Today article, `` We will begin to 
focus on the methods [of abortion] and declare them to be illegal.''
  At the Judiciary Committee hearing on this measure, I asked one of 
the proponents, Helen Alvare, Director of Planning and Information, 
Secretariat for Pro-Life Activities of the National Conference of 
Catholic Bishops, whether all methods of abortion should be 
criminalized. The response I received was very clear. Ms. Alvare stated 
her view that ``every single kind of procedure that takes an unborn 
life'' should be outlawed.
  Mr. President, I specifically asked whether that included nonsurgical 
forms of abortion, such as the use of a drug like RU-486 which leads to 
the termination of a pregnancy in the very early stages, the first few 
weeks. The answer was yes, and Ms. Alvare was very clear that she found 
the use of an abortifacient drug at the earliest stages of a pregnancy 
to be as objectionable as the procedure under discussion.
  Mr. President, I think the record should also note that in the past 
there have been efforts to ban other methods of abortion which the 
proponents of this legislation now point to as remaining available 
should this ban be enacted into law. For example, in 1976, in Planned 
Parenthood versus Danforth, the Supreme Court struck down a Missouri 
statute which would have prohibited saline abortion procedures after 
the first 12 weeks of pregnancy.
  It is clear that this legislation is part of a calculated plan to 
make abortion more difficult for women and their physicians. It is part 
of a calculated plan to limit and erode a woman's ability to exercise 
her constitutionally protected rights. We cannot lose sight of the fact 
that Dr. Robinson's memories of a time when abortion was illegal and 
women died from illegal abortions might become a reality again if these 
efforts are successful.
  Mr. President, I want to focus now upon an important aspect of the 
Judiciary Committee hearings dealing with why this particular procedure 
might, in the judgment of a woman's attending physician, be the most 
appropriate in light of her individual circumstances.
  Mr. President, throughout this debate, different physicians who 
testified at the Judiciary Committee hearing will be quoted as to their 
view regarding whether the procedure under discussion is more or less 
safe for a woman than other procedures, whether the procedure may be 
necessary in a particular situation to protect a woman's future ability 
to bear children, and precisely what the procedure is that would be 
banned under this legislation.
  What occurred at the hearing, Mr. President, was a professional 
disagreement among members of the medical community on the efficacy and 
risks associated with various abortion procedures. That members of the 
medical community have different opinions on these issues is both 
understandable and expected.
  It is also precisely the reason why trained physicians and their 
patients, not members of the Congress, should make the decisions about 
what course of treatment is appropriate in individual situations.
  The ability to choose between alternative courses of medical 
treatment and the ability to choose between physicians who favor one 
procedure over another is something that we often take for granted.
  Physicians who themselves do not choose to perform the type of 
procedure at issue have also made it clear that they do not believe 
Congress should be legislating in this area. In particular, Dr. Warren 
M. Hern of Boulder, Colorado, a physician who performs late-term 
abortions has been quoted by proponents of H.R. 1833 as having 
reservations about this particular procedure. However, in his testimony 
submitted to the Senate Judiciary Committee on November 17, 1995, he 
outlined the possible advantages of using the intact D&E procedure, 
including a reduction of the risk of perforation of the uterus and 
reducing the risk of embolism of cerebral tissue into the woman's blood 
stream. He concluded by stating:

       While I may choose a different method of performing a late 
     abortion, I support the right of my medical colleagues to use 
     whatever methods they deem appropriate to protect the woman's 
     safety during this difficult procedure. It is simply not 
     possible for others to second guess the surgeon's judgment 
     in the operating room. That would be dangerous and 
     unacceptable.

  Mr. President, I am not sure that it is appropriate for Members of 
Congress to even try to resolve a matter that is the subject of debate 
between physicians as to whether there are situations where this 
procedure is preferable to another procedure. It is clear from the 
testimony at the Judiciary hearing that there are respectable 
differences of opinion in this area.
  For example, Dr. Mary Campbell, medical director of Planned 
Parenthood of Washington, DC, testified there were a number of 
situations where alternative abortion procedures such as induction or 
cesarean section are considered less safe than an intact D&E procedure. 
For example, Dr. Campbell testified that ``a woman is twice as likely 
to die'' with an induction procedure, an alternative abortion procedure 
in a late-term pregnancy. She further testified that a cesarean section 
was another option, but that a woman was 14 times as likely to die with 
a Cesarean hysterotomy as with a D&E procedure.
  Dr. Campbell outlined her views as to why the intact D&E procedure 
was preferable in certain cases. According to Dr. Campbell, the 
procedure requires less dilation of the cervix and thus markedly 
decreases the chances of cervical lacerations and cervical incompetence 
which can adversely affect future pregnancies. She also testified that 
the uterine scar, especially from the kind of vertical incision most 
often used in cesarean sections involving abnormal preterm fetuses, 
creates an increased risk of uterine rupture in future pregnancies.
  Dr. Robinson testified with the same concerns about the risks posed 
by alternative procedures. In response to my question, Dr. Robinson 
testified that a vertical scar in the uterus resulting from such a 
cesarean was definitely an increased hazard when a woman has a 
subsequent pregnancy.
  Included in the hearing record are letters from Dr. Elaine Carlson of 
Cedars-Sinai Medical Center in Los Angeles indicating that alternative 
procedures can cause a traumatic stretching of the cervix that then 
increases a woman's changes for infertility in the future and from Dr. 
George Henry of Denver, CO, indicating similar concerns. Dr. Henry, in 
a subsequent letter to me elaborated on the risks to both a woman's 
life and her future ability to bear children from a cesarean section 
type of surgical approach. ``Such a surgery,'' Dr. Henry wrote, 
``exposes the patient herself to much greater medical risk immediately 
and also increases the need for repeat C- sections in future 
pregnancies as well as the risk of uterine rupture in future 
pregnancies because of the uterine scar--and even the potential loss of 
the uterus if emergency hysterectomy is required.''
  Other witnesses, proponents of this legislation, disagreed and stated 
their view that the intact D&E procedure was more risky than the other 
procedures, and that there were no circumstances where they would 
consider this procedure necessary to protect the life or health of the 
woman.
  Mr. President, what this debate told me is that there is room for 
disagreement between physicians about specific medical procedures; it 
is not for Congress to determine which side of this debate is right or 
wrong. These are medical questions which ought to be decided by medical 
professionals, not Members of Congress. Congress ought not to tie the 
hands of a physician trying to make the best decision for his or her 
patient. As Dr. Robinson testified, ``The physician needs to be able to 
decide, in consultation with the patient and based upon her specific 
physical 

[[Page S 18194]]
and emotional needs, what is the appropriate method. The practice of 
medicine by committee or legislature is not good for patients or for 
medicine in general.''
  Mr. President, the reasons why Congress ought to stay out of this 
decisionmaking process was also eloquently made by several women who 
had made the difficult choice of choosing this procedure when a much 
wanted pregnancy has turned into a tragedy.
  Coreen Costello testified:

       It deeply saddens me that you are making a decision having 
     never walked in our shoes. When families like ours are given 
     this kind of tragic news, the last people we want to seek 
     advise from are politicians. We talk to our doctors, lots of 
     doctors. We talk to our families and other loved ones, and we 
     ponder long and hard into the night with God.

  Mr. President, we ought to heed those words. These decisions are 
private, personal decisions to be made by the families involved, guided 
by their physicians. The Federal Government ought to leave these 
decisions with the people involved.
  Finally, Mr. President, let me briefly address the Constitutional 
issues raised by this legislation.
  H.R. 1833, in my view, is fatally flawed because it fails to 
adequately provide protections for procedures necessary to preserve or 
protect a woman's life or health. Roe vs. Wade, and the cases that have 
followed including Casey, have made it clear that States have the 
authority to restrict and even ban abortions after fetal viability 
except where necessary to protect a woman's life or health. H.R. 1833 
as originally proposed included an utterly inadequate provision 
allowing only an affirmative defense to be asserted by the physician 
that the procedure was necessary to protect a woman's life. In other 
words, a physician who performs this procedure in order to save a 
woman's life could be hauled into a Federal court and prosecuted for 
violating this statute. The physician would only be able to raise as a 
defense that the procedure was performed to save a woman's life. It is 
only after extensive debate that the proponents of H.R. 1833 proposed 
to change their language to provide an explicit exception from the 
statute's coverage for a procedure necessary to preserve a woman's 
life. However, the amendment they have offered contains limitations 
upon the life of the mother exception which also raise questions as to 
whether it comports with the standard set forth in Roe v. Wade.

  Moreover, the proponents have failed to even acknowledge the 
requirement that an exception be provided where the procedure is 
necessary to protect a woman's health, including her future ability to 
bear children. The proponents argue that such an exception is 
unnecessary because alternative procedures are available. Those 
arguments fail to acknowledge the medical disagreement over whether 
such alternative procedures pose greater risks to the woman's health. 
The proponents of this legislation seem to take the view that even if 
an alternative procedure would result in a woman being unable to bear a 
child in the future, that is an adequate alternative.
  Mr. President, I find this to be a particularly harsh judgement to be 
imposed upon families who have experienced the tragic end to a much-
sought pregnancy. To tell a woman and her family that Congress will not 
allow her doctor to use a procedure which will allow her a greater 
chance to be able to have another pregnancy and bear a child in the 
future is cruel and unconscionable.
  Mr. President, let me conclude by reiterating again that this 
legislation would insert the Federal Government into one of the most 
private, personal decisions a woman and her family and her physician 
must face. The American people have said time and again they want less 
Government intrusion into their lives, not more. This bill is in every 
way an inappropriate extension of power by the Federal Government into 
the lives of individual Americans at a very traumatic and emotion 
point. It ought to be rejected.
  Mr. PELL. Mr. President. A month ago, the Senate chose to refer to 
the Senate Judiciary Committee a bill which would ban from use a 
medical procedure currently used to terminate late-term pregnancies. I 
supported that referral because it was unclear what all of the 
ramifications of such a ban were and the Senate deserved the 
opportunity to have a complete record upon which to make an informed 
decision regarding this complex and controversial issue.
  Today, we have that record before us. I thank the members of the 
committee for their thorough and detailed work in exploring this 
difficult matter and based on that record, I have come to the 
conclusion that I will oppose this legislation.
  I do so because I believe that the bill goes too far in its virtual 
ban of the use of this procedure, despite the fact that in many cases 
medical professionals believe that it is the safest means to terminate 
troubled and tragic late-term pregnancies. I believe that medical 
doctors, following the constitutional guidelines under which abortion 
is legal and following consultation with a woman and her family, should 
be able to choose the medical procedure he or she deems most 
appropriate to terminate a pregnancy without facing criminal or civil 
penalties. Indeed, criminalizing a medical procedure in the manner 
proposed in the bill would be the first such time we have done so in 
our country's history.
  I do not come to this position lightly. I, and I believe virtually 
all Americans, am disturbed with the harsh realities that this issue 
forces our human conscience to acknowledge. In the end, however, I 
believe that it is not the place of Congress to interject itself in 
this manner into the tragic personal decisions that women and families 
must face. I do believe it should be a rarely used procedure and in 
that regard have been informed that there is no recollection of it 
being used in my State of Rhode Island. Indeed, there are only a 
handful of practices throughout the country that utilize it and the 
total number of cases amount to less than one-tenth of 1 percent of 
total abortions. I also believe that the heightened scrutiny that this 
procedure has received will reduce those occasions when it is used 
inappropriately. In the end, however, I believe that it should remain 
an option available to doctors when they deem it medically necessary in 
order to terminate a pregnancy.
  By way of conclusion, I ask unanimous consent to have printed in the 
Record an article from the New York Times written by a woman who went 
through this procedure. I believe it eloquently makes the case that it 
would be wrong to enact the outright ban contained in this bill for 
this procedure and, accordingly, that this option should remain 
available to women and families of this country.
  There being no objection, the article was ordered to be printed in 
the Record, as follows:

              [From the New York Times, November 29, 1995]

                           Giving Up My Baby

                          (By Coreen Costello)

       Those who want Congress to ban a controversial late-term 
     abortion technique might think I would be an ally. I was 
     raised in a conservative, religious family. My parents are 
     Rush Limbaugh fans. I'm a Republican who always believed that 
     abortion was wrong.
       Then I had one.
       It wasn't supposed to be that way. My little girl, 
     Katherine Grace, was supposed to have been born in the 
     summer. The births of my two other children had been easy, 
     and my husband and I planned a home delivery.
       But disaster struck in my seventh month. Ultrasound testing 
     showed that something was terribly wrong with my baby. 
     Because of a lethal neuromuscular disease, her body had 
     stiffened up inside my uterus. She hadn't been able to move 
     any part of her tiny self for at least two months. Her lungs 
     had been unable to stretch to prepare them for air.
       Our doctors told us that Katherine Grace could not survive, 
     and that her condition made giving birth dangerous for me--
     possibly even life-threatening. Because she could not absorb 
     amniotic fluid, it had gathered in my uterus to such 
     dangerous levels that I weighed as much as if I were at full 
     term.
       I carried my daughter for two more agonizing weeks. If I 
     couldn't save her life, how could I spare her pain? How could 
     I make her passing peaceful and dignified? At first I wanted 
     the doctors to induce labor, but they told me that Katherine 
     was wedged so tightly in my pelvis that there was a good 
     chance my uterus would rupture. We talked about a Caesarean 
     section. But they said that this, too, would have been too 
     dangerous for me.
       Finally we confronted the painful reality: our only real 
     option was to terminate the pregnancy. Geneticists at Cedars-
     Sinai Medical Center in Los Angeles referred us to a doctor 
     who specialized in cases like ours. He knew how much pain we 
     were going through, and said he would help us end Katherine's 


[[Page S 18195]]
     pain in the way that would be safest for me and allow me to have more 
     children.
       That's just what happened. For two days, my cervix was 
     dilated until the doctor could bring Katherine out without 
     injuring me. Her heart was barely beating. As I was placed 
     under anesthesia, it stopped. She simply went to sleep and 
     did not wake up. The doctor then used a needle to remove 
     fluid from the baby's head so she could fit through the 
     cervix.
       When it was over, they brought Katherine in to us. She was 
     wrapped in a blanket. My husband and I held her and sobbed. 
     She was absolutely beautiful. Giving her back was the hardest 
     thing I've ever done.
       After Katherine, I didn't think I would have more children. 
     I couldn't imaging living with the worry for nine months, 
     imagining all the things that could go wrong. But my doctor 
     changed that. ``You're a great mother,'' he told me. ``If you 
     want more kids, you should have them.'' I'm pregnant again, 
     due in June.
       I still have mixed feelings about abortion. But I have no 
     mixed feelings about the bill, already passed by the House 
     and being considered in the Senate, that would ban the 
     surgical procedure I had, called intact dilation and 
     evacuation. As I watched the Senate debate on C-Span this 
     month, I was sick at heart. Senator after senator talked 
     about the procedure I underwent as if they had seen one, and 
     senator after senator got it wrong. Katherine was not 
     cavalierly pulled halfway out and stabbed with scissors, as 
     some senators described the process.
       I had one of the safest, gentlest, most compassionate ways 
     of ending a pregnancy that had no hope. I will probably never 
     have to go through such an ordeal again. But other women, 
     other families, will receive devastating news and have to 
     make decisions like mine. Congress has no place in our 
     tragedies.

  Mr. SMITH. Mr. President, how much time do I have remaining?
  The PRESIDING OFFICER (Mr. Abraham). The Senator from New Hampshire 
has 12 minutes and 15 seconds remaining.
  Mr. SMITH. Mr. President, I hope my colleagues are listening 
carefully at this stage of the debate, because we are down now to where 
we are about to vote on two very important amendments related to this 
bill.
  Senator Boxer has taken the time to go through two very compelling 
cases, very tragic cases. Both of those women testified before the 
Judiciary Committee, and that was heart-rending testimony.
  I viewed the testimony. I have read it. There is only one problem, 
and I have said it, Senator DeWine has said it and others have said 
it: These women did not have partial-birth abortions. I will repeat, 
these women did not have partial-birth abortions. Coreen Costello and 
Viki Wilson did not have partial-birth abortions. Senator Boxer knows 
that, and both of the young women know that. A partial-birth abortion 
specifically is killing a child who is 90 percent born through the 
birth canal by the use of the catheter and the scissors.

  Now, let me read from the testimony of Coreen Costello:

       When I was put under anesthesia, Katherine's heart stopped. 
     She was able to pass away peacefully inside my womb, which 
     was the most comfortable place for her to be. When I awoke a 
     few hours later, she was brought to us. She was beautiful. 
     She was not missing any part of her brain. She had not been 
     stabbed in the head with scissors. She looked peaceful.

  Mr. President, that is my point.
  Mr. SANTORUM. If the Senator will yield, that picture is not factual, 
right? That picture is not factual, is it?
  Mr. SMITH. The Senator is correct.
  Mrs. BOXER. Will the Senator yield to me on my own time?
  Mr. SMITH. Yes.
  Mrs. BOXER. I will place in the Record a letter from these women, and 
I will read it later, which completely makes the statement that this 
particular procedure that they underwent is, in fact, the procedure 
that would be outlawed. And, in fact, the doctor that was vilified in 
this debate--by name, Dr. McMahon--and was summoned before the House 
committee is the doctor that performed the intact dilation and 
evacuation procedure. These women are completely upset, and here is a 
quote from the first sentence:

       We are shocked and outraged--

  This is to Senator Smith.

     --at attempts by you and other Members of the Senate to 
     dismiss our significance as witnesses against the partial-
     birth abortion ban.

  I have to tell you Senators, you can fight this and you may well have 
the votes. But do not demean these women. I have to say, Viki Wilson, 
who you said yesterday did not have this procedure, had Dr. McMahon as 
a doctor. She is a registered nurse. Her husband is a physician in an 
emergency room. They both know this bill. They say what Viki underwent 
is exactly what is described in the bill.
  So if we are going to have an argument every time I bring out another 
family, and you are going to say they are excepted, are we going to 
write legislation like that?
  I reserve the remainder of my time.
  Mr. SMITH. Reclaiming my time, Mr. President, when you look out the 
window and it is raining, and the person sitting next to you says it is 
not raining--I mean, you can argue this, but facts are facts. I am not 
demeaning the testimony of Viki Wilson or Coreen Costello. They were 
very, very moving stories. This Senator was very moved by those 
stories. But they are not partial-birth abortions.
  This Senator's bill, and all the amendments we are talking about on 
the bill, does not stop the procedure that Viki Wilson and Coreen 
Costello had.
  I will now repeat and read verbatim from the testimony of Viki 
Wilson. Please listen carefully and make your own judgment.
  Viki Wilson said:

       My daughter died with dignity inside my womb. She was not 
     stabbed in the back of the head with scissors. No one dragged 
     her out half alive and killed her. We would never have 
     allowed that.

  Mr. SANTORUM. If the Senator will yield. So the second picture the 
Senator from California has up there is also not factual, is that true?
  Mr. SMITH. It is a fact that that is the family, but it is not a fact 
that they had a partial-birth abortion.
  Mr. SANTORUM. So we are going to continue to throw pictures up, and 
that is how we are going to deal with facts.
  Mr. SMITH. Yes. This bill is very clear and specific, and it outlines 
this procedure in the birth canal. That is all this allows. I say that 
in sincerity to the Senator because I know he feels very strongly. I 
must say to him, that is the fact.
  Why Senators would come down here and testify to things that are not 
accurate, you will have to ask them. Listen, here is the exact language 
of my bill:

       The term partial-birth abortion means an abortion in which 
     the person performing the abortion partially, vaginally 
     delivers a living fetus before killing the fetus and 
     completing the delivery.

  When I read the testimony of the two women, both of them said their 
child died in their womb peacefully. Now, dying in womb peacefully--
does that say ``an abortion in which the person performing the abortion 
partially, vaginally delivers a living fetus before killing the fetus 
and completing the delivery''? That is what this bill stops. That is 
all it stops. That is all it says. That is exactly what it says.
  I say to my colleagues, no matter how you feel on the issue, please, 
at least accept facts as being facts. This is the floor of the U.S. 
Senate. We have an obligation to tell the truth. That is not the truth, 
what Senator Boxer is saying. Whether it is meant to be or thought to 
be is another issue. But it is not fact. I know what my bill says. That 
is what it says. I just read it to you.

  How much time is remaining?
  The PRESIDING OFFICER. Six minutes thirty seconds.
  Mr. SMITH. I yield 2 minutes to myself and ask to be notified when 
the 2 minutes are up.
  Let me just say that this Dole-Smith amendment provides a life-of-
the-mother exception. We had an affirmative defense in the bill. 
Members came to me and said, ``We want it a little more clarified.'' I 
said, ``Fine,'' and we clarified it because I think Senators sincerely 
had a concern about that--even though there have been no witnesses to 
testify that the mother's life was ever a problem. Let me just say that 
this applies to any situation in which a pregnant woman's life is 
physically threatened by any pregnancy, complication, or other 
disorder, and a partial-birth abortion is the only means by which her 
life can be saved. That is the life-of-the-mother exception. It is very 
clear. There is no question about it.
  If we go to the Boxer partial-birth abortion on demand amendment, it 
allows partial-birth abortions on demand throughout the full 9 months 
of the pregnancy. If a woman has any health 

[[Page S 18196]]
problem that she so indicates, then any child could be aborted for any 
reason. That is a fact.
  We voted on this before on the floor of the Senate, and we voted it 
down. I hope that we will vote it down now and have a true life-of-the-
mother exception, as we have tried to do.
  I remember in the debate when the Senator from California, and 
others, made a big case here on the floor to please have the life-of-
the-mother exception, have it clarified. We have done that. In fact, I 
voted to send the bill back to committee to have time to do that and to 
hear the testimony of the witnesses.
  I will conclude on this point, Mr. President. We had no doctors who 
performed partial-birth abortions testifying and no women who had them 
testifying. So I am not sure what the committee hearing produced.
  Thank you, Mr. President.
  Mrs. BOXER. Mr. President, how much time remains on my side?
  The PRESIDING OFFICER. Seven minutes, 30 seconds.
  Mrs. BOXER. I ask that I be notified when I have used 3 minutes.
  Mr. President, I will tell you, this debate is one of the most 
fascinating I have ever been in. I will hold up picture after picture 
of people who know that this bill applies to the procedure they had, 
and my colleague, who thinks he might perhaps be a doctor, and his 
friends think that, in fact, they do not know what they are doing 
because they are U.S. Senators. After all, they know more than the 
families that went through this what happened. Again, here is the 
letter I read part of, dated December 7--and that is today. This was 
raised yesterday as a red herring, that these people that I held up did 
not know what they were talking about.
  These women and families wrote us. Seven of them said this, and I 
will quote--this is to Senator Smith:

       We are shocked and outraged by attempts by you to dismiss 
     our significance as witnesses against the partial-birth 
     abortion bill.

  Then they say:

       Your rhetoric vilifies our physician, Dr. McMahon, who is 
     the Nation's leading developer and practitioner of this 
     technique for third-trimester abortions, and you claim 
     simultaneously that we did not undergo the procedure in 
     question. But we definitely had intact dilation and 
     evacuation procedures, and it is definite that no doctor who 
     wants to stay out of prison will perform that procedure, or 
     any surgery that remotely resembles it, if your bill is 
     passed.

  They write this:

       If your bill passes, families with tragedies like ours will 
     have added misery and pain because the surgical procedure 
     that helped us will be unavailable. Please stop pushing this 
     awful bill and please stop pretending that we are 
     irrelevant.

  Of course, Senators will continue to say that these people, religious 
families, loving families, simply do not know what they are talking 
about and do not know what was done to the body of their incredibly 
important family member.
  Now, this is Viki Wilson. She testified to the Judiciary Committee as 
follows. These are facts, facts from her mouth.

       I am a practicing Catholic and I couldn't help but believe 
     that God had some reason for giving us such a burden, and 
     then I found out about this legislation. I knew then and 
     there that Abigail's life had special meaning.
       I think God knew I would be strong enough to come here and 
     tell you my story, to try to stop this legislation from 
     passing and causing incredible devastation for other families 
     like ours, because there will be other families in our 
     situation, because prenatal testing is not infallible and I 
     urge you please do not take away the safest method known.

  The PRESIDING OFFICER. There are 4 minutes 30 seconds remaining.
  Mrs. BOXER. I will take an additional 30 seconds, and I will retain 
the time for my colleague from New Jersey.
  Coreen Costello says, ``I hope you can put aside your political 
differences, your positions on abortion, your party affiliation''--this 
is a picture of Coreen--``and just try to remember us. We are the ones 
who know. We are the families that ache to hold our babies, to love 
them, to nurture them. We are the families who will forever have a hole 
in our hearts.''
  I say to any Senator that tries to demean these families and tell 
them they do not know what went on in these families should think 
again. We were elected to be Senators, not doctors, and not God.
  I retain the remainder of my time.
  Mr. SMITH. Mr. President, how much time remains?
  The PRESIDING OFFICER. Four minutes twenty-two seconds.
  Mr. SMITH. I yield myself 3 minutes 22 seconds.
  Mr. President, it is very frustrating. Again, I will just repeat for 
emphasis for those, I hope, who are listening to the debate: Viki 
Wilson in her testimony not only indicated that she did not have a 
partial-birth abortion, she said she would not have one. So these are 
not partial-birth abortions. But again I will not continue to debate 
it.
  Any reasonable person, hopefully, who is watching the debate would 
understand the definition is very clear. A partial-birth abortion is 
when a child is killed in the birth canal. These two women in the 
horrible circumstances they went through lost their children in the 
womb. This amendment would not prevent what happened to them.
  Since I have been accused of not being a doctor, which is a fair 
accusation, let me offer into the Record a sample of the 200 
unsolicited letters from ob-gyn's from all over America. I 
ask unanimous consent that all of these be printed in the Record after 
this debate.

  The PRESIDING OFFICER. Without objection, it is so ordered.
  (See exhibit No. 1.)
  Mr. SMITH. I will quote from a letter from a Dr. Dorothy Czarnecki, 
an ob-gyn from Philadelphia. She says:

       Dear Senator Smith: I appreciate your efforts on behalf of 
     the ``partial-birth abortion'' controversy. In no way are 
     these done only on abnormal infants. This is just another 
     brutal way to destroy life. This procedure is not necessary 
     to protect the life or health of women in this country.

  Another one from Dr. Lauri Scott, M.D., assistant professor of 
maternal-fetal medicine in Dallas, TX.

       I am a specialist in maternal-fetal medicine and on faculty 
     in the Department of Obstetrics and Gynecology at the 
     University of Texas, Southwestern Medical Center. It is the 
     nature of my specialty that I deal with high-risk pregnancies 
     and would be the consultant called to deal with issues 
     regarding the ``life-of-the-mother.''
       I can tell you unequivocally there is no maternal medical 
     reason for ``late-term abortions.'' In situations where the 
     life of the mother is at stake, we simply deliver the infants 
     and the baby takes its chances in the nursery.

  ``Dear Senator Smith,'' Mary Davenport, Oakland, CA:

       I am writing to you in support of the partial-birth 
     abortion bill. There is no medical indication for this 
     procedure, and the performance of this operation is totally 
     in opposition to 2,000 years of Hippocratic medical ethics. 
     Please do your best to eliminate this procedure. It is not 
     done in any other nation of the world.

  Margaret Nordell, M.D., caring for women of all ages, Minot, ND:

       I am a member of the DakotaCare Physicians Association. I 
     believe that this procedure is unnecessary to protect either 
     the life or health of women in this country.

  Dr. Karin Shinn, Coney Island Hospital:

       Dear Senator Smith: I am a practicing ob-gyn on the staff 
     of Coney Island Hospital. It is my professional opinion that 
     the partial-birth abortion procedure is very dangerous and 
     absolutely unnecessary to protect either the life or the 
     health of the women in America.

  Letter after letter after letter, Mr. President, all over the 
country. To say that somehow the U.S. Senator who stands here on the 
floor, quoting from doctors about a medical procedure, to taking the 
``slam'' that somehow we cannot vote for something or talk about 
something because we are not doctors--we send troops into Bosnia, that 
will happen. And I assure you that every Senator who votes to send them 
there has never served in combat and probably never been there. That is 
for sure. We vote on Medicare and we vote on Medicaid and not everybody 
here is a senior citizen.
  The argument is absolutely ludicrous and frankly insulting. I hope my 
colleagues will defeat the Boxer amendment and support the Smith-Dole 
amendment.

                               Exhibit 1


                                             Philadelphia, PA,

                                                November 28, 1995.
     Hon. Robert Smith,
     U.S. Senate,
     Washington, DC.
       Dear Senator Smith: I appreciate your efforts on behalf of 
     the ``partial birth abortion'' controversy. In no way are 
     these done only on abnormal infants. This is just another 
     brutal way to destroy life. This procedure is not necessary 
     to protect the life or health of women in this country.
     
[[Page S 18197]]

       Thank you again and keep up the fight to protect our 
     children.
           Sincerely,
     Dorothy Czarnecki, M.D.
                                                                    ____



                                                   Dallas, TX,

                                                 November 7, 1995.
     Re late term abortions.
     Hon. Robert Smith,
     U.S. Senator, Washington, DC.
       Dear Senator Smith: I am a specialist in Maternal-Fetal 
     Medicine and on faculty in the Department of Obstetrics and 
     Gynecology at the University of Texas Southwestern Medical 
     Center. It is the nature of my specialty that I deal with 
     high risk pregnancies, and thus would be the consultant 
     called to deal with issues regarding ``the life of the 
     mother''. Prenatal diagnosis is also part of my specialty, 
     and I am the one who breaks the news of fetal abnormalities 
     and helps to plan how best to manage the rest of the 
     pregnancy.
       I can tell you unequivocally that there is no maternal 
     medical indication for ``late term abortions.'' In situations 
     where the life of the mother is at stake, we simply deliver 
     the infant and the baby takes its chances in the nursery. In 
     our nursery, 50% of the infants born at 24 weeks gestation 
     will survive, most without significant problems. Prior to 24 
     weeks we recognize that the baby will generally die due to 
     extreme prematurity, but we perform no procedures to ensure 
     its death; there is no medical reason for this when the 
     concern is with the life of the mother. ``Late term 
     abortions'' are no safer, and may be more dangerous for the 
     mother, than simple induction of labor.
       The only reason for a ``late term abortion'' is to ensure 
     that the late second trimester and third trimester fetus is 
     born dead. The only possible medical indication would be a 
     situation in which the fetus has abnormalities incompatible 
     life. However, in most of these situations, the infant would 
     die shortly after birth anyway and terminating the pregnancy 
     in the late 2nd or 3rd trimester carries the same 
     complications as allowing the pregnancy to go to term and end 
     naturally.
       This procedure has no place in modern obstetrics and only 
     serves to destroy lives that might otherwise survive. I 
     suspect that the women who made such tragic decisions for 
     medical reasons chose this procedure without truly informed 
     consent or full knowledge of their options. It should never 
     be performed as an elective procedure. Please support 
     legislation banning this procedure.
           Sincerely,

                                        L. Laurie Scott, M.D.,

                                              Assistant Professor,
     Maternal-Fetal Medicine.
                                                                    ____



                                                  Oakland, CA,

                                                 December 1, 1995.
       Dear Senator Smith: I am writing to you in support of the 
     partial birth abortion bill. There is NO medical indication 
     for this procedure, and the performance of this operation is 
     totally in opposition to 2000 years of Hippocratic medical 
     ethics. Please do your best to eliminate this procedure. It 
     is not done in any other nation of the world.
           Sincerely yours,
     Mary L. Davenport, M.D.
                                                                    ____



                                                    Minot, ND,

                                                November 28, 1995.
     Senator Robert Smith,
     U.S. Senate,
     Washington, DC.
       Dear Mr. Smith: I, Margaret Nordell, a medical doctor of 
     obstetrics and gynecology am supporting Senator Robert Smith 
     in the ban against ``partial birth abortion''. I am a member 
     of the DakotaCare Physicians Association. I believe that this 
     procedure is unnecessary to protect either the life or the 
     health of women in this country.
           Sincerely,
     Margaret Nordell, M.D.
                                                                    ____

                                            Coney Island Hospital,


                                          Department of OBGYN,

                                  Brooklyn, NY, November 26, 1995.
     Hon. Robert Smith,
     U.S. Senate,
     Washington, DC.
       Dear Senator Smith: I am a practicing OBGYN on the staff of 
     Coney Island Hospital in Brooklyn, New York. It is my 
     professional opinion that the partial birth abortion 
     procedure is very dangerous and absolutely unnecessary to 
     protect either the life or the health of women in America. 
     Therefore, I whole heartedly support the partial birth 
     abortion ban bill to be passed and become officially law. 
     Thank you.
           Sincerely,
                                             Karin E. Shinn, D.O.,
                                              Assistant attending.

  The PRESIDING OFFICER. The Senator from California has 3 minutes 52 
seconds.
  Mrs. BOXER. I yield 2 minutes to the Senator from New Jersey.
  Mr. LAUTENBERG. Mr. President, first, let me commend my colleague 
from California for speaking so forthrightly about an issue that does 
not belong in the kind of debate that we have heard from the other side 
from the proponents of this amendment.
  Strangely enough, and I speak now as a father and a grandfather, as a 
father of four. We lost a couple because of health problems with my 
wife, and every one of those pregnancies that was lost was a terrible 
experience for us.
  When my youngest daughter lost a fetus, lost a pregnancy that was in 
its 7th month because the baby was entangled in the cord, it was very 
painful, very painful. We did not know whether we had a healthy baby or 
not, but we were torn by this experience, to have her go to the 
hospital, spend 8 hours in labor to deliver the fetus.
  The interesting thing to me, Mr. President, is I have not heard one 
woman speak for that side. It is the men who speak on what women ought 
to do, tell them how to conduct their lives, tell them what to do with 
their bodies, describe the pain that they will never feel. It is quite 
interesting. They want to tell everybody what the moral right is.
  I just heard one of our Senators say something that to me is so 
preposterous. He says those who will vote to send troops to Bosnia will 
never serve in combat. Who is he that knows all this information? What 
a silly thing to say. It is the same thing we are talking about here.
  What this is is license for the Government to participate in the 
operating room when a doctor does a procedure, when a doctor decides to 
perform a procedure that the woman carrying the fetus wants to have 
done because she feels that it is essential or the doctor feels it is 
essential for her health.
  These abortions, these procedures are rarely done when someone was 
making that choice simply to rid themselves of that pregnancy.
  This is a sad day, I think, Mr. President.
  Mr. President, the bill before us is extremely dangerous and I 
strongly oppose it.
  This bill is poorly titled for many reasons. It would more 
appropriately be called The Big Government Intrusion into the Doctor-
Patient Relationship Act.
  Under this bill, we will literally have FBI agents snooping around 
examining rooms. Let me repeat this. This legislation authorizes the 
FBI to go wandering around doctors' offices looking at patients and 
what doctors are doing to them.
  Furthermore, this bill does not include a life and health of the 
mother exemption.
  This bill will send a chilling signal to doctors in this country. And 
they will leave the practice of reproductive health care in droves.
  And women could die in waiting rooms while doctors are on the phone, 
consulting with defense and constitutional lawyers, about what they can 
or cannot do to treat their patients.
  Mr. President, one reason I am opposing this bill is because I 
believe doctors and patients can make proper decisions about which 
health care treatment is most appropriate.
  Mr. President, one of the most extreme elements of this bill is its 
failure to include an exception to deal with situations in which the 
life or health of the mother is at risk. The pending Boxer amendment 
seeks to make this bill a little less extreme. The Boxer amendment 
would create a real health and life-of-the-mother exception.
  Under the bill, as originally presented, if a doctor thought it 
likely that a woman would become permanently disabled if she carried a 
fetus to term, the doctor would still be prohibited from performing 
this procedure. Can you imagine that? A doctor would have to feel 
certain that carrying a fetus to term would endanger the life of the 
mother in order to do what is medically required for treatment.
  Otherwise, the doctor could not perform this procedure even though 
the woman could suffer severe, permanent health damage without the 
procedure.
  Mr. President, this bill will affect real people. Real women and 
families who have had to go through this procedure.
  One such woman is Viki Wilson, a nurse, who 18 months ago was 
expecting her first child. Early tests showed the child to be normal 
but an 8-month ultrasound revealed that the fetus had a fatal 
condition--two thirds of the brain had formed outside the skull.
  Carrying the pregnancy to term would have imperiled Viki's life and 
health. In consultation with her doctor, Viki and her husband Bill made 
the heartbreaking decision to undergo this procedure. This bill would 
make this practice illegal.

[[Page S 18198]]

  Mr. President, I would like to quote Viki at this point. She stated 
``I strongly believe that this decision should be left within the 
intimacy of the family unit.''
  So do I Mr. President.
  While this bill is really extreme, the Boxer amendment would make it 
a little less extreme. At a minimum, we ought to adopt the amendment, 
which would establish a meaningful exception in cases where the life 
and health of the mother is at stake.
  I urge my colleagues to adopt the Boxer amendment and I yield the 
floor.
  The PRESIDING OFFICER. The time of the Senator has expired.
  Mr. LAUTENBERG. I yield the floor and hope that my colleagues will 
support the amendment that is proposed by Senator Boxer.
  Mrs. BOXER. Mr. President, I retain the remainder of my time.
  The PRESIDING OFFICER. The Senator has no other time.
  Mrs. BOXER. I thought I saved some time.
  The PRESIDING OFFICER. They have no time.
  Mrs. BOXER. How much time do I have remaining?
  The PRESIDING OFFICER. The Senator has 1 minute.
  Mrs. BOXER. Mr. President, this has been a tough debate so far. We 
have gone through it for 3 days. Maybe this is the 4th day, Senator 
Smith.
  I have to say, it is emotional. Why is it emotional? Because what we 
are doing impacts real people. We have seen these families night after 
night. We have seen charts of part of a woman's body, as if she had no 
face. I have to say to my colleagues, if they really think about it, if 
their daughter came to them and said, ``Dad, I have been told the most 
horrible news. If I do not terminate this pregnancy, even though it is 
so late term, I could die. I could be infertile. And the only procedure 
is this procedure,'' I really do believe, if Senators are honest, male 
or female, they would fall to their knees and pray to God and go ahead 
and have that procedure.
  Why would we want to risk that woman's life? Please vote ``yes'' for 
Dole and ``yes'' for Boxer-Brown.


                       Vote on Amendment No. 3081

  The PRESIDING OFFICER. The question now occurs on amendment No. 3081, 
offered by the majority leader, Mr. Dole.
  The yeas and nays have been ordered. The clerk will call the roll.
  The assistant legislative clerk called the roll.
  Mr. FORD. I announce that the Senator from New York [Mr. Moynihan] is 
necessarily absent.
  The PRESIDING OFFICER. Are there any other Senators in the Chamber 
who desire to vote?
  The result was announced--yeas 98, nays 0, as follows:

                      [Rollcall Vote No. 592 Leg.]

                                YEAS--98

     Abraham
     Akaka
     Ashcroft
     Baucus
     Bennett
     Biden
     Bingaman
     Bond
     Boxer
     Bradley
     Breaux
     Brown
     Bryan
     Bumpers
     Burns
     Byrd
     Campbell
     Chafee
     Coats
     Cochran
     Cohen
     Conrad
     Coverdell
     Craig
     D'Amato
     Daschle
     DeWine
     Dodd
     Dole
     Domenici
     Dorgan
     Exon
     Faircloth
     Feingold
     Feinstein
     Ford
     Frist
     Glenn
     Gorton
     Graham
     Gramm
     Grams
     Grassley
     Gregg
     Harkin
     Hatch
     Hatfield
     Heflin
     Helms
     Hollings
     Hutchison
     Inhofe
     Inouye
     Jeffords
     Johnston
     Kassebaum
     Kempthorne
     Kennedy
     Kerrey
     Kerry
     Kohl
     Kyl
     Lautenberg
     Leahy
     Levin
     Lieberman
     Lott
     Lugar
     Mack
     McCain
     McConnell
     Mikulski
     Moseley-Braun
     Murkowski
     Murray
     Nickles
     Nunn
     Pell
     Pressler
     Pryor
     Reid
     Robb
     Rockefeller
     Roth
     Santorum
     Sarbanes
     Shelby
     Simon
     Simpson
     Smith
     Snowe
     Specter
     Stevens
     Thomas
     Thompson
     Thurmond
     Warner
     Wellstone

                             NOT VOTING--1

       
     Moynihan
       
  So the amendment (No. 3081) was agreed to.
  Mr. COHEN. Mr. President, I move to reconsider the vote.
  Mr. GRAMM. I move to lay that motion on the table.
  The motion to lay on the table was agreed to.
  The PRESIDING OFFICER. Under the previous order, the underlying 
amendment, No. 3080, as amended, is agreed to.


                       vote on amendment no. 3080

  The PRESIDING OFFICER. The question now is on agreeing to amendment 
No. 3083 offered by the Senator from California. The yeas and nays have 
been ordered. The clerk will call the roll.
  The legislative clerk called the roll.
  Mr. FORD. I announce that the Senator from New York [Mr. Moynihan] is 
necessarily absent.
  The PRESIDING OFFICER (Mr. Bennett). Are there any other Senators in 
the Chamber who desire to vote?
  The result was announced--yeas 47, nays 51, as follows:

                      [Rollcall Vote No. 593 Leg.]

                                YEAS--47

     Akaka
     Baucus
     Biden
     Bingaman
     Boxer
     Bradley
     Brown
     Bryan
     Bumpers
     Byrd
     Campbell
     Chafee
     Cohen
     Daschle
     Dodd
     Dorgan
     Feingold
     Feinstein
     Glenn
     Graham
     Harkin
     Hollings
     Inouye
     Jeffords
     Kassebaum
     Kennedy
     Kerrey
     Kerry
     Kohl
     Lautenberg
     Leahy
     Levin
     Lieberman
     Mikulski
     Moseley-Braun
     Murray
     Nunn
     Pell
     Pryor
     Robb
     Rockefeller
     Sarbanes
     Simon
     Simpson
     Snowe
     Specter
     Wellstone

                                NAYS--51

     Abraham
     Ashcroft
     Bennett
     Bond
     Breaux
     Burns
     Coats
     Cochran
     Conrad
     Coverdell
     Craig
     D'Amato
     DeWine
     Dole
     Domenici
     Exon
     Faircloth
     Ford
     Frist
     Gorton
     Gramm
     Grams
     Grassley
     Gregg
     Hatch
     Hatfield
     Heflin
     Helms
     Hutchison
     Inhofe
     Johnston
     Kempthorne
     Kyl
     Lott
     Lugar
     Mack
     McCain
     McConnell
     Murkowski
     Nickles
     Pressler
     Reid
     Roth
     Santorum
     Shelby
     Smith
     Stevens
     Thomas
     Thompson
     Thurmond
     Warner

                             NOT VOTING--1

       
     Moynihan
       
  So the amendment (No. 3083) was rejected.
  Mr. SMITH. Mr. President, I move to reconsider the vote.
  Mr. DOLE. I move to lay that motion on the table.
  The motion to lay on the table was agreed to.
  The PRESIDING OFFICER. Under the previous order, the Senator from New 
Hampshire is recognized.


                Amendment No. 3088 to Amendment No. 3082

 (Purpose: To express the sense of the Senate that the Senate should, 
through the Committee on the Judiciary, conduct hearings to investigate 
  the effect of the new patent provisions of title 35, United States 
Code, (as amended by the Uruguay Round Agreements Act) on the approval 
                           of generic drugs)

  Mr. SMITH. Mr. President, I send a second-degree amendment to the 
desk and ask for its immediate consideration.
  The PRESIDING OFFICER. The clerk will report.
  The assistant legislative clerk read as follows:

       The Senator from New Hampshire [Mr. Smith], for Mr. DeWine 
     and Mr. Dodd, proposes an amendment numbered 3088 to 
     amendment No. 3082.

  Mr. SMITH. Mr. President, I ask unanimous consent that reading of the 
amendment be dispensed with.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  The amendment is as follows:

       Beginning on page 1, line 3, strike ``APPROVAL'' and all 
     that follows through line 22 on page 3 and insert the 
     following: ``SENSE OF THE SENATE.
       ``It is the sense of the Senate that the Senate should, 
     through the Committee on the Judiciary, conduct hearings to 
     investigate the effect of the new patent provisions of title 
     35, United States Code (as amended by subtitle C of title V 
     of the Uruguay Round Agreements Act (Public Law 103-465; 108 
     Stat. 4982)), on the approval of generic drugs under section 
     505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
     355).''.

  Mr. SMITH. Mr. President, I will try to explain the amendment.
  First, I yield to the majority leader.


                                Schedule

  Mr. DOLE. Mr. President, I have been asked to indicate what may be in 
store for the rest of the evening. It is not certain that these are all 
the amendments, but we have an amendment by Senator Bingaman on 
shutting down the Government; an amendment by Senator Feinstein which, 
as I understand it, is similar to the Boxer amendment just disposed of; 
a Brown amendment on deadbeat dads; then we have 

[[Page S 18199]]
the pending amendment of Senator Pryor, which Senator Smith will 
second-degree. There may be additional amendments. I think it is safe 
to say there will be votes well into the evening.
  I yield the floor.
  Mr. CHAFEE. I wonder if the majority leader has any indication, if 
this is disposed of this evening, what would happen tomorrow?
  Mr. DOLE. We have a cloture vote scheduled on the constitutional 
amendment on the desecration of the flag. That could be resolved if we 
get an agreement on State Department reorganization. If we do that, 
then we can vitiate the vote on cloture and probably have debate only 
tomorrow on the flag amendment, but no final disposition.
  Mr. JOHNSTON. Does the majority leader expect we will have a small 
window where we might get home to get a bite to eat?
  Mr. DOLE. How close are you?
  Mr. JOHNSTON. About 20, 25 minutes.
  Mr. DOLE. You are not going to New Orleans, are you? I think we may 
have a vote in the next few minutes, and then we can probably arrange 
at least an hour.
  Mr. JOHNSTON. I thank the majority leader.
  The PRESIDING OFFICER. The Senator from New Hampshire is recognized.
  Mr. SMITH. Mr. President, let me just say, for the benefit of my 
colleagues, I am not going to prolong the debate on this second-degree 
amendment. I know Senator Pryor has some comments and Senator DeWine 
wants to speak. I do not know of any others. But if others are going to 
speak, hopefully, they will come to the floor and we can expedite this 
matter as quickly as possible.
  This amendment requires hearings on the relationship between GATT 
patent laws and the FDA Hatch-Waxman law relating to prescription 
drugs. At the outset, let me say I would have preferred not to have 
this bill, become a Christmas tree for nongermane amendments. It was 
hopeful that we would not have nongermane amendments. But the 
underlying Pryor amendment dealing with pharmaceutical products, GATT, 
and patent protections has nothing to do with partial-birth abortion. 
However, I recognize the right my colleague has to offer such an 
amendment, and I respect that. I hope that we will not spend a lot of 
time on this and delay this bill. We saw the same tactic a few weeks 
ago, and it seems to me that maybe there is some reluctance to face the 
issue at hand.
  Mr. President, this second-degree amendment calls for hearings in the 
Judiciary Committee to look into this issue. I say to my colleague from 
Arkansas that it is an important issue and deserves a hearing, and I 
recognize that. I recognize that the Senator has a legitimate interest 
in this. I hope that it will not delay a vote on the bill, as other 
Senators have expressed interest to me--or have asked me whether or not 
there would be a vote tonight on final passage of the partial-birth 
bill. I am prepared to do that at any time. I do not know specifically 
of other amendments, but you never know.
  If this second-degree amendment fails or if any other Senators are 
going to try to load the bill up, we will have to be offering second-
degree amendments on all kinds of things from sex selection to Down's 
syndrome, and Lord knows what. Let's hope we do not get into all that.
  Hopefully, Mr. President, why don't we just vote and move on and see 
where the votes fall on this bill.
  If we want to talk about patent protections, come to the hearing and 
testify about patent protections. Then when the Senate is ready to vote 
on that, when we can come down and debate it.
  It is a very complicated issue, patents and trade. I don't think it 
ought to go through the Senate in a hurry without having an opportunity 
to hear from both sides. The Senator from Arkansas voted a couple weeks 
ago to have a hearing on partial-birth abortion, and we did. I was not 
originally in favor of it, I admit, but we did have the hearing.
  I did reconsider my views and allowed it to be sent to the committee. 
I hope the Senator from Arkansas will do the same.
  I urge my colleagues if there is a vote to vote for the Smith 
amendment so we can have a full hearing under this issue of patent 
protection. I yield the floor.
  Mrs. BOXER. Before my colleague from Arkansas speaks on this 
particular subject which he has been such a leader on, I wanted to make 
a comment that President Clinton has long believed that it is important 
to protect the life and the health of a mother, of a woman.
  We know he will, in fact, veto this bill because the Senate now voted 
this down. A very close vote. I want to thank my colleagues who stood 
with Senator Brown, with me, and with those who feel so strongly about 
this, that we must put a woman's face on this debate.
  I am very moved by the vote that we had. It sends a very strong 
signal to the President of the United States: That 47 Senators, 
notwithstanding incredible organized phone banks, et cetera, stood up 
for the life and the health of the women in this country. I am proud 
that you stood with me. I am proud that you stood with women.
  I want to particularly thank in that context every one of my 
colleagues that spoke on this. Senator Moseley-Braun spoke so 
eloquently yesterday and she made the point that the women of America 
will have to wake up to what is happening to their rights. She did that 
in the most beautiful fashion. I urge everyone to read the Record, 
because this assault on a woman's right to choose has begun in earnest.
  When people do go to the polls they will have to decide where they 
stand. Could they stand with a Government that wants to get right into 
the hospital room with your family, right into your bedroom with your 
family, or do they believe that the families in our country with their 
God and with their conscience can make those kind of decisions?
  I am very moved by the vote that we had. I will certainly vote 
against the final passage of this bill. Senator Feinstein will be 
offering us an excellent substitute which basically restates the law of 
the land that says in the late term of a pregnancy the States control 
what happens in these late-term abortions.
  I think everyone was very surprised by this vote. I was moved by the 
vote. I hope colleagues will vote ``no'' on final passage, since there 
is no exception for the life of the mother. The Senate voted for a 
partial exception, and therefore it makes it a very, I think, weak 
bill, and the President has said he would veto it. I applaud that.
  I yield the floor.
  Mr. PRYOR. Mr. President, I thank the Chair for recognizing me. Mr. 
President, the day before yesterday I introduced an amendment on behalf 
of myself and my very good friend from Rhode Island, Senator Chafee, 
and our good friend from Colorado, Senator Brown.
  Mr. President, I ask unanimous consent that Senator Robert Byrd of 
West Virginia be added as an original cosponsor of this amendment.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mr. PRYOR. Mr. President, what we are seeing here tonight on the 
second-degree amendment, and I say this in all due respect to my 
colleagues who have offered this second-degree amendment to this 
principal amendment, this is merely an attempt to kill the Pryor-
Chafee-Brown-Byrd amendment. That is it, pure and simple.
  First, it is a sense-of-the-Senate resolution which all of us know in 
this body has no force of law. It has no real meaning. It has no 
traction, as we say around here. Beyond that, it does not require any 
Committee to hold any hearing at any specific time.
  It merely says that the Judiciary Committee would conduct hearings to 
investigate the effect of the new patent provisions of title 35 U.S. 
code as amending subtitle C. of title 5 of the Uruguay Round 
agreements.
  Mr. President, this amendment would probably end up in the 
wastebasket. There is no date certain for a hearing. Additionally, the 
amendment sends instructions for a hearing, under this sense-of-the-
Senate amendment, to the Judiciary Committee. It would not be sent to 
the Labor Committee that has jurisdiction over food and drug issues. It 
is being sent to the Judiciary Committee of the U.S. Senate.
  Once again, there is no date certain for when a hearing might be held 
on 

[[Page S 18200]]
the effect of the proposal that we are discussing this evening in the 
U.S. Senate.
  Make no mistake, what this amendment is all about is an attempt to 
kill the Pryor-Chafee-Brown-Byrd amendment. It is a tactic to delay. It 
is a motion to protect one of the greatest windfalls that we have ever 
created in the history of our entire Government.
  Now, Mr. President, I have several things I want to say during the 
course of this debate. I see my very good colleague, Senator Chafee, my 
colleague on the Finance Committee, who has been so loyal as a friend 
and as a supporter in trying to close this loophole that we created 
when we did not conform the food, drug and cosmetic law to the GATT 
treaty and its provisions.
  Mr. President, I also see my friend from Colorado, Senator Brown, an 
original cosponsor of our amendment.
  Mr. President, expecting that my colleagues might have something to 
say on this issue, for the moment I yield the floor and I reserve the 
opportunity to address this issue further.
  Mr. CHAFEE. Mr. President, I want to take a moment to discuss the 
pending amendment. This is really a very simple issue.
  Under the Uruguay Round the nations agreed to boost protection of 
patents significantly. This was an historic step. Indeed, this was the 
first time that in these multilateral trade agreements such as this, 
the GATT, we became involved with so-called intellectual property.
  In order to implement the provisions of the commitment to increase 
the protection for patents, the Congress changed the U.S. patent law 
from 17 years from approval to 20 years from filing date. This was a 
change to conform with GATT.
  To be fair to existing patent holders, Congress gave those existing 
patent holders the option of taking the longer term. As a result, those 
holding patents as of June 1985 received an extension of up to 3 years.
  However, granting this extension affected generic drug manufacturers 
who had been preparing to go to market after the original patents 
expired. To be fair to them, too, Congress made a compromise: 
manufacturers who had already made a substantial investment preparing 
to go into the market, would be allowed to proceed--but they would be 
required to pay a royalty to the holder of the patents. This was a 
carefully worked out compromise.
  This transition was made available to all manufacturers, not just 
generic manufacturers of drugs. There are generic manufacturers of blue 
jeans and every other patent. Wherever there is a patent involved 
someone is waiting for the patent to expire and then come forward with 
their own product.
  The product is called a generic product--not just a generic drug, but 
generic blue jeans, or whatever it might be. However, Congress made an 
error. It is not the first error Congress has ever made, but it was a 
costly one. We failed to consider a conforming amendment to the patent 
provisions of the Food, Drug and Cosmetic Act, which Senator Pryor 
previously alluded to.
  The consequence of this oversight is that one group of generic 
manufacturers--in other words, those coming on with a substitute 
product--had been denied the benefits of this transition provision. 
These were the generic pharmaceutical manufacturers. So, while the 
manufacturers, that is the manufacturers who had the patent of these 
branded pharmaceutical products, got an extra 3 years, the generic drug 
manufacturers were cut out altogether from transition remedies--from 
doing anything.
  This oversight, if left uncorrected, I must say, is a wonderful 
windfall for the pharmaceutical manufacturers who are protected by it, 
who got this windfall which was never planned for. This windfall is in 
the area of billions of dollars--not millions, but billions. So, quite 
understandably, they are very enthusiastic to prevent anything from 
happening around here, to prevent the Pryor amendment from going into 
effect. Obviously, others can give illustrations of this.
  What will be the effect of the passage of the Chafee-Brown-Pryor-Byrd 
amendment? First, it will level the playing field by making the GATT 
transition provision available to generic drug manufacturers like it is 
to generic blue jeans manufacturers, or whoever it might be. This is 
what we intended. Second, it will stop the unintended, and therefore 
unfair, windfall. And, third, it will save consumers, insurers, and, I 
might say, the Government--because the Government will benefit greatly 
from getting their Medicaid prescription drugs at a far lower price 
than otherwise would be true.
  There are two counterpoints that opponents of this will make. Some 
have warned that this amendment would negate or otherwise affect the 
hard-won gains that came about through GATT and the intellectual 
property protections. That is a red herring. The STR, the Special Trade 
Representative, has assured us that our amendment will not in any way 
interfere with the GATT intellectual property protection rights. In 
fact, the USTR supports this amendment, for they say the conforming 
amendment--namely, the Pryor effort--should have been included in the 
GATT bill but was overlooked inadvertently.
  Now, as to the argument that our amendment would upset the delicate 
balance of the Hatch-Waxman Act, that also is a red herring. This is 
not about Hatch-Waxman; this is about GATT. Officials of the Food and 
Drug Administration have assured us that our amendment absolutely would 
not disturb the so-called Hatch-Waxman Act. Let me say, if this were 
interfering with GATT in some way, the intellectual property 
provisions, I would not be for this amendment.
  This is what we might call a ``good Government'' amendment. It seeks 
to close a loophole which was unintentionally created. We made a 
mistake, and now we are trying to correct it. Does it have any support 
outside of those of us here? Certainly a broad coalition of senior 
citizens and consumer groups support it. Furthermore, it is the right 
thing to do. Occasionally we do the right thing around here.
  I certainly hope that this amendment of the Senator from Utah, to 
send this back, and the Senator from New Hampshire, would not prevail. 
I hope it will not prevail because, if it does prevail, that does in 
the Pryor effort here.
  Could I ask the Senator from Arkansas, does this amendment provide 
for a date that the hearing must be completed?
  Mr. PRYOR. Mr. President, I respond to my colleague from Rhode 
Island, there is absolutely no date set forth in the sense-of-the-
Senate resolution to require the Judiciary Committee, or any other 
committee of the Senate, to hold a hearing. It is totally open ended. 
Again, there is no date specified in the sense-of-the-Senate 
resolution.
  Mr. CHAFEE. I have a question for the distinguished Senator from New 
Hampshire. He mentioned the sending of his bill back to committee for a 
study. I guess the Senator from New Hampshire supported that in the 
end, reluctantly.
  My question is this: Did that amendment, that sent the Senator's bill 
back to committee, have a date at which the committee must report back? 
As I recall, it did. I may be mistaken.
  Mr. SMITH. I believe it was 17 days, I say to my colleague, Senator 
Chafee. But I need to check that.
  Mr. CHAFEE. I certainly would abide by whatever the Senator says, and 
if he wishes to correct it later, that is fine. But, as I recall, when 
that was sent, Senator Smith's bill which came up here, say, a month 
ago, when that was sent back to committee, that was sent back with a 
time limit to it, a definite period. Whether it was 17 days or 3 weeks 
or whatever it was, I am not sure. But I remember, to the best of my 
recollection, there was a time certain. Yet, in this case, the Senator 
from New Hampshire, in his amendment, has not provided for a date 
certain. What does the Senator from Arkansas suggest on that? Would 
this be more palatable if there was a time limit?
  Mr. PRYOR. Let me respond, Mr. President, to my friend from Rhode 
Island once again. It would certainly be more palatable if we had an 
imminent date for the Judiciary Committee to hold such a hearing. But, 
to be honest, I do not think a Judiciary Committee hearing is going to 
give us any more facts than we know today. We pretty well have the 
facts. Those facts are that the Congress made an mistake. We created an 
error in the GATT legislation. We opened a loophole, and now we have an 
opportunity to fix it.
  As the Senator from Rhode Island just stated, this is really a very, 
very 

[[Page S 18201]]
simple matter. It becomes dramatic because of all the dollars involved: 
All the dollars that appeared unexpectedly in a windfall that goes to a 
small handful of drug companies that had no idea a year ago that this 
windfall would occur and that these billions of dollars would basically 
be falling out of the trees into their bank accounts.
  So I say, even if there were a day certain, we are about to leave for 
Christmas. If we even set a day certain of 10 days from now, perhaps 
the Senate and the House will not even be in session. We do not know 
when we are coming back in session next year. So I say once again, this 
is an attempt to kill the original Pryor-Chafee-Brown-Byrd amendment.
  Mr. CHAFEE. I would ask the Senator from Arkansas another question. 
It seems to me that this is an odd provision, in that it is referred to 
the Judiciary Committee, yet the jurisdiction of the Food and Drug 
Administration is in the Labor Committee.
  Mr. PRYOR. The Senator is absolutely correct.
  Mr. CHAFEE. So, why is this being sent to the Judiciary Committee?
  Mr. PRYOR. I believe the distinguished Senator from New Hampshire is 
the author of this amendment. Perhaps he could advise us as to why the 
amendment is being sent to the Judiciary Committee.
  Mr. SMITH. The Senator from New Hampshire is not the sponsor of the 
amendment. The Senator from New Hampshire offered the amendment.
  Mr. HATCH. If the Senator will yield, I will be happy to answer that. 
I will be happy to answer that. It is because it involves a hallowed 
and important element in the history of this country and in the world, 
and that is patents. We happen to handle patents. It involves 
intellectual property. It also involves an international intellectual 
property agreement which we better be careful of here, because there 
are a lot countries out there that do not honor intellectual property.
  There are a lot of countries out there that do not believe in 
patents. Or, if they do not believe in patent terms--if, after a 
multiyear negotiated agreement in international relations, intricate, 
negotiated every line of that agreement--it is bunk to say that this 
was a mistake. We then retrench on patent terms the first time out of 
the blocks when we have gone all over the world talking about 
intellectual property, respect for intellectual property, and for other 
countries to treat American products fairly. And right out of the 
blocks we say we have to do away with that, you send a message that we 
are going to wreck the world window on the rest of our lives. We have 
taken years to get to this point.
  I am going to have a lot to say on why there are two sides to this 
thing, and that it is more important to uphold the international 
treaty, uphold the international patent protection, than it is to 
demagogue on this particular issue.
  I will make my points afterwards. But the reason it is sent to the 
Judiciary Committee is because it involves the most important aspects 
of the patent law and intellectual property law. That is what is 
involved here.
  Mr. CHAFEE. Mr. President, first of all, if it involves treaties, 
then, of course, it goes to the Finance Committee. The last place in 
the world it should go is the Judiciary Committee.
  Mr. HATCH. Not if it involves patents.
  Mr. CHAFEE. If you want time, you can have time after I finish.
  We have a letter from Mickey Kantor, U.S. Trade Representative, 
September 25, 1995:

       The extension of the section 1534(c)--that is what we are 
     doing here to pharmaceutical property products--would not 
     undermine ongoing U.S. efforts to seek high levels of 
     intellectual property protection around the world.

  So there is no problem here with patents. That does not have anything 
to do with it. The fact of the matter is that this reference, if indeed 
it should be made--I do not think it should--but if it should, it 
should go to one of two places: The Finance Committee, which deals with 
trade, or the Labor Committee, which deals with FDA. I would be far 
happier to see it go there than to the place suggested.
  Mr. PRYOR. Mr. President, if the Senator from Rhode Island will 
yield--then I want to hear, and I know we all do, our friend from 
Colorado, Senator Brown--I'd like to ask if in the history of the 
Judiciary Committee has that committee held hearings on the Food, Drug 
and Cosmetic Act? That committee does not have jurisdiction over this 
act, yet that is where we are about to dump this issue.
  The second point I would like to raise is my friend from Utah, 
Senator Hatch, has talked about, ``Oh, this is relating to patents. We 
have to protect these patent rights.'' That seems ironic, since on June 
7, 1995 the United States Patent Office ruled--the Patent Office ruled, 
Mr. President--that they determined the expiration dates of the patents 
in question. They are in force on June 8, 1995 and, therefore, are 
entered into the greater of the term of 20 years from their relevant 
filing days, or 17 years from grant. In other words, they held in our 
favor. The Patent Office held in our favor that the generics could in 
fact come in and compete with the brand-name companies. Of course, the 
brand-name companies with all of their high-powered lawyers, money, et 
cetera, moved on to the courts. And because the courts interpreted 
literally our mistake as being the intent of Congress, and I must say 
that I think they made a mistake, Glaxo and other major pharmaceutical 
companies won out.
  I would like to make one more point, and then I am going to sit down 
for a spell.
  The PRESIDING OFFICER. The Senator from Rhode Island controls the 
floor.
  Mr. CHAFEE. I would certainly like to hear the Senator make that 
explanation, if he might.
  Mr. PRYOR. I would like to just say, if we allow this situation to 
persist and refuse to close this loophole, let us for a moment look at 
what is going to happen to one pharmaceutical company that has 
inherited this windfall. Let us look at Glaxo. They make Zantac. Here 
is some Zantac. It cost $170 a bottle. You can go over to Canada, by 
the way, and buy this for about $70 a bottle. Or, if in our country we 
had the competition for Zantac on the shelves today, as we should have 
occurred earlier this week, it would cost about half of what this $170 
bottle of Zantac cost.
  But, if we go forward, let us say even for an additional 30 days and 
allow this windfall to continue, or let us say just to Christmas day--
and Christmas day is just a few days away, Mr. President--Glaxo is 
going to make another $115 million. If we hold a hearing in the 
Judiciary Committee, say next November, and then keep this thing in 
effect, maybe until 1996, a year from Christmas and do not correct it 
until a year from this Christmas, this one company--because of our 
mistake and because of our refusal to correct that mistake--will have 
made an extra $2.328 billion.
  Do we want our patent law in this country to be based upon an error, 
to be based on a mistake that we made, and refuse to correct? I do not 
think so, Mr. President.
  I look forward to hearing some of the comments from other colleagues 
who feel, I believe, as strongly about this issue as I do.
  Mr. CHAFEE. Mr. President, I would like to ask the Senator from 
Arkansas one more question. I understand that these substantial amounts 
will be made by the companies that they would not otherwise make, if we 
corrected this. My question is: But, if we correct it sometime in the 
future, then is there a refund in some type that occurs? Does it undo 
itself, or everything is just prospective?
  Mr. PRYOR. The way that I understand the law, I say to my friend, if 
a generic company has been out there and has made what we call a 
substantial investment where they are ready to come into the market at 
the end of the 17-year patent protection period, then the generic would 
be allowed to go on the shelves, to go on the market, to be advertised, 
to be marketed, selling for one-half of what the brand name sells these 
drugs for today. At that time a royalty for this time that was 
unexpired--like for 600 additional days for Glaxo and Zantac--a royalty 
would be paid even to the Glaxo company by the competing generic drug 
company. The amount of that royalty would be established in a court of 
law, and there is a system whereby that amount would be established.
  I think that is the question the Senator from Rhode Island is asking.
  Mr. CHAFEE. I understand that. But now my question is: But, let us 
assume 

[[Page S 18202]]
that this is referred back to this committee--the wrong committee, as 
it turns out, but nonetheless it is referred back--nothing happens, and 
finally let us say in March we straighten out the law, then 
retroactively is there some compensation that takes place?
  Mr. PRYOR. Mr. President, I apologize to my friend from Rhode Island. 
I did not understand his original question. I do now.
  In other words, if we were to correct this, even in March or April, 
whenever, and admit we made a mistake, which we did and we all agree 
that we did, then the company gets to keep all of that money. There is 
no refund. The Medicaid programs have continued to pay the highest 
price for these drugs. The Veterans Administration has continued to pay 
the highest price for these drugs. The consumers get no rebate. The 
consumers get no relief. The only benefit accrues to a very few drug 
companies that we failed to include in the coverage of the new law in 
the GATT treaty. They get to keep all of these excess profits. And that 
is what this fight is all about. Every time, every day that these drug 
companies get to keep this amount of money, these exorbitant profits, 
this windfall, it comes out of the pocketbooks of the consumer, the 
veterans, the Medicaid programs, and every citizen of this land.
  Mr. CHAFEE. I thank the Senator. I thank the Chair.
  Mr. BROWN addressed the Chair.
  The PRESIDING OFFICER. The Senator from Colorado.
  Mr. BROWN. Mr. President, I appreciate the thought. I wish to assure 
my good friend from Ohio that I will not be long.
  I hope Members, as they vote on this, will consider a couple of 
points. I don't think these are in dispute. If they are, I know my good 
friends will correct me. But I think every Member ought to be aware 
that this amendment is very important and would have a significant 
impact on the Treasury of the United States. The estimates are that 
this will save the taxpayers in the neighborhood of $150 million. It 
may be more than that, but CBO has come forward with that figure. So 
one of the things Members ought to think about is the dramatic, 
significant increase in revenue and reduction of the deficit that this 
amendment can have if it is passed.
  Second, many Members may have read the Newark Star Ledger's editorial 
of October 26. Let me quote it:

       Thanks to a gigantic loophole resulting in the GATT, 
     consumers may wind up paying as much as $6 billion more for 
     higher priced brand name drugs.

  Mr. President, I do not know if the $6 billion figure is correct or 
not. That is an estimate by the paper. I must say my own estimate is 
less than that. But there is no question this is big, big, big money, 
and it comes right out of the pockets of the consumers of this country.
  So the two things that I think are really without question here are 
first that the amendment offered by the distinguished Senator from 
Arkansas is a friend of the taxpayers of this country. It has a 
significant impact in a positive way on reducing the deficit.
  Second, this amendment is very much a friend of the consumers in this 
country. It saves the consumers of this country literally billions of 
dollars. Is it the $6 billion the Newark paper talked about? My guess 
is it is less than that. But it is a huge amount. If you are concerned 
about the consumers of this country, you ought to be in favor of it.
  Two other points have been raised, and I think they merit addressing. 
One is, is this fair? Is it fair to adjust the rules? Well, let us take 
a look at it. When the patent for this medicine was granted, it 
extended 17 years from the time of filing. Is that diminished in any 
way if this amendment passes? The answer is no. The answer is 
absolutely no. The drug company gets exactly what they thought they 
were getting when they filed for the patent. They do not lose in any 
way. They get exactly what they were offered at the time they developed 
the product, at the time they marketed the product, at the time they 
put the factory together to produce the product. Nothing has changed.
  What do they lose? They lose the windfall that came from the treaty.
  If you are on the subject of what is fair, let us ask ourselves, what 
if you were a different firm? What if you were a firm that was aware of 
the drug and aware of the law and got geared up to produce a 
competitive product in reliance on the laws of this Nation, and the 
laws of this Nation said the exclusivity ends after 17 years.
  For this particular drug, there are competing companies. There are 
companies that relied on the law. There are companies that made 
investments. They put together a plant to produce this, and they geared 
up to produce it and sell it on the market. If you are concerned about 
fairness, you should not be concerned about Glaxo. They got exactly 
what they invested for. You ought to be concerned about the companies, 
honest people who invested in facilities and plants and processes in 
reliance on our law and had the product taken away from them after they 
made that big investment. Now, if you are concerned about fairness, you 
ought to be in favor of the amendment, not against it.
  Last, Mr. President, let me simply add one other thing that I think 
is important. It has been suggested on this floor by a number of people 
that doing this somehow will be inconsistent with our treaties under 
GATT, and the very distinguished chairman of the Judiciary Committee 
has just pointed out what a great investment we have in intellectual 
property. He is absolutely right.
  I might say, Mr. President, from my point of view, if you were going 
to send this to a committee, I would think the Judiciary Committee 
would be a great committee. It has some of the brightest, most able 
Members, and the most modest, too, in the Senate. But the point is this 
should not go to committee at all. The point is if you send it to the 
committee, what you do is you cost consumers hundreds of millions of 
dollars just by the delay, and you cost the taxpayers some money, too.
  I think the last point that deserves addressing is this one. Are we 
doing something, with the Pryor amendment are we doing something that 
violates the GATT treaty? We do have--and I acknowledge it--a vested 
interest in making sure that treaty is honored.
  For that point I wish to draw Members' attention to some information. 
It is the treaty itself. I know a lot of Members did not get a chance 
to read it, and having tried to read it myself I understand why. But 
there are some interesting things you find out. I wish to read you the 
precise words of the agreement itself because it relates specifically 
to this point. And I am talking about part VII. This is under article 
70. The title is: ``Protection of Existing Subject Matter.'' In 
paragraph 4, there are the following words:

       . . . or in respect of which a significant investment was 
     made, before the date of acceptance of the WTO Agreement by 
     that Member, any Member may provide--

  By ``Member'' they are referring to a country--

     for a limitation of the remedies available to the right 
     holder as to the continued performance of such acts after the 
     date of application of this Agreement for that Member. In 
     such cases the Member shall, however, at least provide for 
     the payment of equitable remuneration.

  Mr. President, the treaty itself anticipates exactly this kind of 
legislation. Let me repeat it. This amendment in no way is at odds with 
the treaty. It in no way violates the treaty. As a matter of fact, the 
exact words of the treaty anticipate this very action.
  Now, to suggest that we somehow are jeopardizing our intellectual 
property rights by taking this action, I do not believe conforms with 
either the spirit of the treaty or the precise words of the treaty. The 
reality is if someone has made a substantial investment relying on our 
current law, we have a right under the treaty, in specific terms, to do 
this.
  Mr. President, there are two editorials at this point I would like to 
enter into the Record because they make the point very well. One is by 
the Des Moines Register and the other is by the Washington Post. I ask 
unanimous consent that they be printed in the Record.
  There being no objection, the editorials were ordered to be printed 
in the Record, as follows:

             [From the Des Moines Register, Nov. 27, 1995]

  A Costly Oversight--Fine Print in GATT Law Could Cost Zantac Users 
                                Millions

       The nation's prescription drug makers are at war again, 
     with a $1 billion-plus purse 

[[Page S 18203]]
     going to the winner. If the brand-name drug manufacturers win, the 
     losers will include the millions of Americans who suffer from 
     ulcers or heartburn, and take the drug Zantac regularly to 
     combat the problem. It's going to cost each of them about 
     $1,600.
       Zantac is made by Glaxo Wellcome, the biggest in the 
     business.
       Here's what started the current war:
       When a new prescription drug hits the market, generic drug 
     manufacturers await the patent expiration so they can enter 
     the market with the same drug. They offer it for sale without 
     the brand name, usually at a fraction of the brand-name 
     price.
       The new international GATT treaty signed by the United 
     States and 122 other countries sets the life of a patent at 
     20 years from the date of application. Former U.S. law 
     provided patent protection for pharmaceuticals for 17 years 
     from the date of approval. Because the difference could have 
     a significant impact on the number of years a firm could 
     market its patented drug without competition. Congress made 
     special provisions for drugs under patent at the time GATT 
     was approved last summer.
       But when the legal beagles got done reading all the fine 
     print, it turned out that Zantac was granted a 19-month 
     extension of its patent life--and it is such a hugely popular 
     drug that that translates into a multimillion-dollar 
     windfall.
       Generic drug makers call the windfall a congressional 
     oversight, and estimate the difference is worth $2.2 billion 
     to Glaxo, because the generics can't enter the market for 19 
     more months. Glaxo counters that Congress made no mistake, 
     that the extension was part of the compromise with generics. 
     It won't wash. Nothing in the GATT treaty was intended to 
     further enrich the happy handful of brand-name drug makers 
     who hold lucrative patents--or to penalize the users of the 
     drugs.
       A month's supply of Zantac ordinarily sells for around 
     $115; the generic price--meaning the same drug without the 
     Zantac label--would be around $35, the generic makers 
     contend. Unless Congress changes the wording of the law 
     regarding transition to GATT provisions, Zantac users will 
     pay the difference for 19 months longer.
       Some generic drug manufacturers had already spent a bundle 
     preparing to enter the market before the GATT treaty took 
     effect. They lose. So do taxpayers, who pay for Medicaid 
     prescriptions. The Generic Drug Equity Coalition estimates 
     that the higher cost of Zantac and some other drugs affected 
     by the mistake (such as Capoten, for high blood pressure) 
     will cost Iowa Medicaid $3.5 million. Further, say the 
     generic drug makers, it will tack another $1.2 million onto 
     the cost of health-insurance premiums for Iowa state 
     employees.
       Glaxo's political-action committee has doubled its 
     contributions to Congress in recent months. Glaxo wants the 
     mistake to stay in the law. Generic drug manufacturers want 
     it out.
       So should ulcer sufferers. So should taxpayers. So should 
     Congress.
                                                                    ____


                [From the Washington Post, Dec. 4, 1995]

                          The Zantac Windfall

       All for lack of a technical conforming clause in a trade 
     bill, full patent protection for a drug called Zantac will 
     run 19 months beyond its original expiration date. Zantac, 
     used to treat ulcers, is the world's most widely prescribed 
     drug, and its sales in this country run to more than $2 
     billion a year. The patent extension postpones the date at 
     which generic products can begin to compete with it and pull 
     the price down. That provides a great windfall to Zantac's 
     maker, Glaxo Wellcome Inc.
       It's a cast study in legislation and high-powered lobbying. 
     When Congress enacted the big Uruguay Round trade bill a year 
     ago, it changed the terms of American patents to a new 
     worldwide standard. The effect was to lengthen existing 
     patents, usually by a year or two. But Congress had heard 
     from companies that were counting on the expiration of 
     competitors' patents. It responded by writing into the trade 
     bill a transitional provision. Any company that had already 
     invested in facilities to manufacture a knock-off, it said, 
     could pay a royalty to the patent-holder and go into 
     production on the patent's original expiration date.
       But Congress neglected to add a clause amending a crucial 
     paragraph in the drug laws. The result is that the 
     transitional clause now applies to every industry but drugs. 
     That set off a huge lobbying and public relations war with 
     the generic manufacturers enlisting the support of consumers' 
     organizations and Glaxo Wellcome invoking the sacred 
     inviolability of an American patent.
       Mickey Kantor, the president's trade representative, who 
     managed the trade bill for the administration, says that the 
     omission was an error, pure and simple. But it has created a 
     rich benefit for one company in particular. A small band of 
     senators led by David Pryor (D-Ark.) has been trying to right 
     this by enacting the missing clause, but so far it hasn't got 
     far. Glaxo Wellcome and the other defenders of drug patents 
     are winning. Other drugs are also involved, incidentally, 
     although Zantac is by far the most important in financial 
     terms.
       Drug prices are a particularly sensitive area of health 
     economics because Medicare does not, in most cases, cover 
     drugs. The money spent on Zantac is only a small fraction of 
     the $80 billion a year that Americans spend on all 
     prescription drugs. Especially for the elderly, the cost of 
     drugs can be a terrifying burden. That makes it doubly 
     difficult to understand why the Senate refuses to do anything 
     about a windfall that, as far as the administration is 
     concerned, is based on nothing more than an error of 
     omission.

  Mr. BROWN. Mr. President, let me simply conclude this way. If you are 
concerned about the taxpayers, you ought to like the Pryor amendment 
because the CBO says it brings us in $150 million, or saves it. If you 
are concerned about the consumers of this country, you ought to be in 
favor of the Pryor amendment because it is going to save them $6 
billion, if you believe some estimates, or a little less if you believe 
my estimate.
  If you are concerned about fairness, you ought to be in favor of the 
Pryor amendment because people have invested money in plant and process 
and production capability to comply with our laws and they are simply 
out by this windfall.
  Last, Mr. President, if you are concerned about the integrity of our 
protection of intellectual property, you ought to be for the Pryor 
amendment because this is precisely and exactly what the treaty 
anticipated.
  I yield the floor.
  Mr. BRYAN. Mr. President, I have come to the Senate floor a number of 
times to talk about prescription drug pricing, and to support Senator 
Pryor's efforts to control the costs of drugs. Today I am pleased to 
cosponsor Senator Pryor's amendment to correct the GATT treaty loophole 
that creates a windfall profit for certain prescription drug companies.
  The GATT treaty, voted on by Congress, included two important 
provisions that affected every product, company, and industry in the 
country. One, provided that all patents would be extended from 17 to 20 
years; an additional 3 years of protection. Two, provided that a 
generic company, in any industry, would be permitted to go to the 
marketplace and compete on the 17-year expiration date, if the generic 
company had made a substantial investment, and was willing to pay a 
royalty.
  An unintended loophole was created, however, when the prescription 
drug industry was accidently excluded from the generic competition 
provision. The loophole means that prescription drug companies have a 3 
year longer patent period, without any competition during that time 
extension from generic companies. This loophole has created a 
multimillion dollar windfall for certain drug companies that must be 
corrected.
  Seniors use prescription drugs more than any other age group. For 
them, this loophole means they will pay higher drug prices for 3 years 
because of a mistake. Without the ability of generic drug companies to 
compete, drug prices will remain artificially high during that 3-year 
period. There is no reason why seniors should suffer because of an 
unintended mistake that can be corrected today.
  What drugs are involved here? More than 100 drugs would be protected 
from generic drug competition. The world's best-selling ulcer drug, 
Zantac, would cost twice as much as it should because of the loophole. 
The hypertension drug, Capoten, will cost 40 percent more than it 
should because of the loophole. Additionally such drugs as Mevacor for 
lowering cholesterol, Prilosec for ulcers, and Diflucan, an antifungal 
agent are affected.
  This loophole will also affect the drug prices paid by the Medicaid 
Program. Medicaid already faces deep cuts in its funding. If this 
loophole is not corrected, Medicaid will be forced to pay higher drug 
prices during the 3-year period, further straining its ability to 
provide medical care for the most vulnerable in our country.
  Veterans will also suffer as the Veterans Affairs Administration will 
be forced to pay higher drug prices. People using public health 
services will also be affected. The bottomline is that taxpayers will 
pay more for the drugs used by these programs than they should, because 
competitive generic alternatives will not be available.
  There is no reason to allow some prescription drug companies an 
unintended windfall profit to the detriment of all Americans who depend 
on drugs for their continued health. Seniors, veterans, and the most 
vulnerable in our country particularly deserve our protection from 
unnecessarily high 

[[Page S 18204]]
drug prices. I hope my colleagues will see this loophole for the 
mistake it is, and support this amendment to correct it.
  Ms. MOSELEY-BRAUN. Mr. President, I would like to take this 
opportunity to express my support for the Dodd-DeWine amendment. This 
amendment would require the Judiciary Committee to hold hearings on the 
GATT patent extension provisions. The GATT issue is a complex one and 
requires full disclosure. The Pryor amendment has no place on the 
partial birth abortion bill. Hearings are appropriate and, in my 
opinion, critical to ensure that the members of this body fully 
understand the issue and the implications of any action to modify the 
GATT agreement.
  The Pryor amendment would modify the current General Agreement on 
Tariffs and Trade [GATT] as it applies to patent protections for 
pharmaceutical products. This amendment, which was voted down in the 
Finance Committee, has been portrayed as a technical correction to the 
General Agreement on Tariffs and Trade [GATT] agreement. It is not. 
This amendment opens up an international agreement on trade to resolve 
a domestic intra-industry dispute. It is shortsighted, 
counterproductive and will impede the availability of life saving drugs 
and therapies for all of us.
  Before, I discuss substantively the issue at hand, I would like to 
state unequivocally that I firmly believe that all persons who are sick 
should have access to affordable, comprehensive health care services. 
In 1992, I campaigned on the issue of health care reform and I remain 
firmly committed to that goal. My views on the GATT patent extension 
issue are in no way inconsistent with my support for reform. In fact, I 
believe present attempts to undo and reopen GATT could have an adverse 
impact on the development of state of the art medicines and treatments, 
which in turn deny all of us the benefit of advances in medical 
science.
  At question, is a provision, in the newly adopted agreement, that 
provides additional patent protection to pharmaceutical products. GATT 
provides 20 year patent protection to all products and industries 
covered by the agreement--there are over 1 million patent holders in 
the United States who will receive extended patent protection. This 
change, which extends U.S. patent protection from the current 17 years 
from the date the patent is granted to 20 years from the date of 
filing, conforms U.S. patent law to the international standards agreed 
to under GATT. The agreement, including the patent provisions, was 
overwhelmingly approved by Congress last November. The Pryor amendment 
would repeal the patent extension provisions as they apply to 
pharmaceutical products. Some of my colleagues believe this amendment 
is needed because they believe the patent extension provisions were a 
mistake and that an inadvertent windfall to a handful of pharmaceutical 
companies was created. I do not believe this assertion is fair or 
accurate.
  The GATT law was very clear. The implementing legislation provided 
that, in certain circumstances, individuals or organizations that had 
relied on the shorter expiration term could use the patented technology 
during the extension period, although they must pay a royalty to the 
patent holder to do so. Section 102 of the GATT, however, states that 
``Nothing in this Act shall be construed . . . to amend or modify any 
law of the United States . . . unless specifically provided for in this 
Act.'' GATT changed many areas of patent law, but it did not change 
current Federal law that prohibits the FDA from granting approval for 
the manufacture of generic drugs until the patent term on the original 
product has expired. On May 25, the FDA ruled that nothing in the GATT 
explicitly overrules this provision and on November 1, the court of 
appeals for the Federal circuit also upheld the patent extension 
provisions in GATT.
  The actions by the FDA and the Federal circuit court of appeals 
underscore the purpose of the GATT treaty which is to make trade laws 
more uniform and consistent. Uniformity is needed to prevent countries 
from passing laws that are favorable to their own domestic companies; 
110 countries worked for over 7 years to complete negotiations on GATT. 
The intellectual property issues were among the most contentious. The 
essential goal of patent protections are to allow companies and 
individuals to invest freely and securely in the development of 
important and needed products. If companies are provided exclusive 
protection over an innovation, they are more likely to invest the 
necessary resources into developing a safe and effective product. This 
kind of market stability and security are vital with respect to 
pharmaceutical products, which require enormous R & D resources. 
Achieving better protection of intellectual property was a major 
victory for the United States as U.S. manufactured products, 
trademarks, and services are increasingly counterfeited abroad. The 
agreement is final and cannot be renegotiated without putting these 
hard fought, and hard won, protections at risk.

  The patent language in GATT gives the United States greater assurance 
that innovations that originate here will not be pirated by foreign 
firms. The benefits of the provisions cannot be overstated. First, it 
will provide American companies the economic and intellectual security 
needed to develop safe and effective new products; second, it will 
ensure stability in the U.S. pharmaceutical market. This will not only 
stabilize the U.S. market, but also protect U.S. jobs. Third, it will 
ensure research and investment by U.S. companies on products that are 
needed to treat fatal disease. To change this international agreement 
now, because of an intra-industry dispute, invites retaliation from 
other countries eager to undo our gains.
  One of my main concerns is that if the United States is seen as 
hesitant about implementing this part of the new GATT, a number of 
countries that have been reluctant to prevent their firms from pirating 
United States products would have the excuse they need to go slow in 
implementing the agreement, or to avoid implementing it at all. That 
would result in the destabilization of the U.S. market, a loss of U.S. 
exports and U.S. jobs, have a letter here, that I would like to place 
in the Record from Sir Leon Brittan, Vice President of the European 
Commission, that comments on a proposed changes to the patent extension 
provisions in GATT. Brittan states that ``this threat causes serious 
concern to the European research-based pharmaceutical industry and to 
the Commission, and it seems to be in contradiction with the long-
standing U.S. policy of providing strong protection for research-based, 
intellectual property right both home and abroad.'' Brittan also notes 
that changes to the GATT law in the area of patent extension will set 
back hard-won improvements in universally agreed upon patent 
protections.
  Finally, I would like to return to my first concern--consumer 
interest. On average it takes 12 years and $360 million to bring a new 
drug to market. Research-based, pharmaceutical firms spend nearly $18 
billion annually on research and development. This emphasis on R&D has 
produced treatments not only for common conditions and ailments, but 
also for life-threatening diseases. The United States invests more than 
any other nation on research. I have received numerous letters from 
patient groups that are very concerned that modifications to GATT will 
adversely impact research and development, particularly on orphan 
diseases for which there is little or no ability to recoup the up-
front, financial investment. At the close of my statement I will insert 
several of these letters for the Record. We must continue to increase 
our investment if we are to discover cures and effective treatments for 
diseases that continue to plague millions of Americans like AIDS, 
Alzheimers, Parkinson's disease, and cancer.
  Some have maintained that repealing the patent-extension provisions, 
as they apply to pharmaceutical products, is appropriate, because it 
would make available cheaper versions of a limited number of name-brand 
drugs a few months earlier than they would otherwise be available. I 
believe there is a more compelling issue regarding the balance of trade 
and the larger consumer interest. Increased patent protection ensures 
that research and development will continue in, not only, the medical 
field, but also in all areas of innovation. This country leads the 
world in research and innovation; it 

[[Page S 18205]]
contributes to the public good both here and abroad, and every American 
benefits from our leadership. Changes to the GATT agreement that seek 
to repeal patent extensions for only one class of innovations are, in 
my opinion, shortsighted. Such changes will decrease private sector 
revenues for research and development, compromise U.S. leadership on 
intellectual property protection, and adversely impact the 
competitiveness of U.S. companies in relation to their foreign 
counterparts.
  The competitiveness of U.S. industries is of great concern to me 
since I became a Member of this body 3 years ago. This is because of 
the inextricable linkage between competitive industries and the growth 
and maintenance of U.S. jobs. This is why I supported legislation such 
as NAFTA, GATT, product liability reform. I have given careful 
consideration to all of the these issues. I am convinced that these 
measures will increase the ability of U.S. industries to compete and 
lead to a more viable job market. The patent-extension issue is a 
complex one, and I believe, any action by Congress to modify the GATT 
agreement should only be undertaken after a thoughtful and thorough 
review of the long-term implications of such action. It is for these 
reasons that I must oppose the Pryor amendment.
  I ask unanimous consent that the letters referred to earlier be 
printed in the Record.
  There being no objection, the letters were ordered to be printed in 
the Record, as follows:

                                      United Patients' Association


                             for Pulmonary Hypertension, Inc.,

                                                     Speedway, IN.
     Hon. Carol Moseley-Braun,
     Hart Senate Office Building,
     U.S. Senate,
     Washington, DC.
       Dear Senator Moseley-Braun: I'm writing to you on behalf of 
     400-500 Americans who suffer from a very rare and very deadly 
     disease known as Primary Pulmonary Hypertension (PPH). Until 
     recently, the best hope for long-term survival from PPH was 
     through a lung or heart/lung transplant. However, today, 
     thanks to research which dates back to the 1970's, a new drug 
     was recently approved to treat PPH which not only is 
     extending these patients' lives but is allowing them to live 
     full, active and productive lives.
       I have learned that some generic companies are now trying 
     to change the law so that they can gain financially by 
     bringing their products to market before the patents on the 
     pioneering companies' products expire. I can attest to the 
     value that research-based companies bring to patients as a 
     result of strong patent protection, and I urge you to oppose 
     these efforts.
       While I appreciate the cost savings that generic drugs can 
     offer in the short term, I also know that innovative new 
     therapies for complex, life-threatening diseases will come 
     only from research-based pharmaceutical companies. When it 
     comes to serving patients suffering from deadly orphan 
     diseases like PPH, it is the research-based companies that 
     give us hope.
       Glaxo Wellcome recently received approval to market the 
     first medicine that will significantly extend the life, 
     greatly improve the quality of life, and help avoid complex, 
     risky surgery for people suffering from PPH. I know of no 
     generic drug company that would commit the millions of 
     dollars or many, many years of research to discover or 
     develop such a medicine, and it is unlikely that they will 
     ever produce a generic version for a patient population so 
     small. There are many other similar patient populations who 
     depend on the research-based companies to bring these new 
     medicines to market.
       The purpose of the General Agreement on Tariffs and Trade 
     (GATT) was to strengthen intellectual property law around the 
     world and bring U.S. intellectual property law into 
     compliance with other industrialized countries. If the GATT 
     resulted in longer patent protection for a few medicines--all 
     of which already face competition from other therapies--that 
     in my view is a benefit for our society.
       Our patients have experienced the direct benefits of the 
     tremendous investments that the pharmaceutical industry has 
     made in research and development. Research-based companies 
     need and deserve the incentives provided by strong 
     intellectual property protection. Please do nothing to weaken 
     them.
           Sincerely,
                                                   Judith Simpson,
     R.N., Ed. S., President, UPAPH.
                                                                    ____



                                          Fibrosis Foundation,

                                   Bethesda, MD, November 8, 1995.
     Hon. Carol Moseley-Braun,
     U.S. Senate, Hart Senate Office Building,
     Washington, DC.
       Dear Senator Moseley-Braun: I understand Senators Pryor and 
     Chafee are attempting to amend the Hatch-Waxman Act to 
     eliminate extensions for existing pharmaceutical patents 
     granted by GATT. I urge you not to vote for that amendment, 
     but instead to protect existing legislation that preserves 
     incentives for research and development.
       As President and Chief Executive Officer of the Cystic 
     Fibrosis Foundation, I have personally witnessed the great 
     suffering endured by patients and their families in their 
     fight against cystic fibrosis (CF). There are 30,000 young 
     individuals in this country with CF, a fatal genetic disease; 
     more than 900 live in Illinois. I have also witnessed how, 
     for many patients, modern medicines have brought hope, relief 
     from suffering, and even a return to health--a miracle made 
     possible by biomedical research.
       By rewarding ingenuity and encouraging innovation, patent 
     protection makes possible the investment of hundreds of 
     millions of dollars and years of time and effort in medical 
     research, all the while with no guarantee of success. Because 
     of the discoveries born of these investments, the patients we 
     come in contact with every day benefit through saved lives 
     and improved quality of life. Our health care system benefits 
     from a reduction in the overall cost of care.
       While we certainly support patient access to lower cost 
     treatments for disease, that short-term benefit pales if it 
     comes at the long-term expense of finding cures to life-
     threatening illnesses. The current law governing 
     pharmaceutical patents is fair and in the long-term best 
     interest of patients.
       On behalf of those patients who still await a cure or 
     effective treatment to alleviate their suffering, I again 
     urge you not to undercut the patent protection that underlies 
     America's best hope for new and better answers to disease.
           Sincerely,
                                                  Robert J. Beall,
     President and Chief Executive Officer.
                                                                    ____



                                  National Kidney Association,

                                  Evanston, IL, November 22, 1995.
     Hon. Carol Moseley-Braun,
     Senate Hart Office Building,
     Washington, DC.
       Dear Senator Moseley-Braun: I am writing you as both a 
     constituent, and as the President of the National Kidney 
     Cancer Association. Thank you for your recent vote in support 
     of the enforcement of the General Agreement on Tariffs and 
     Trade (GATT) provision regarding drug patents.
       Your action will allow significant pharmaceutical research 
     to continue on numerous diseases, including kidney cancer. As 
     you may be aware, kidney cancer afflicts thousands of 
     individuals each year and at the present time, no cure exists 
     for this disease.
       Our greatest hope for a cure is innovative pharmaceutical 
     and biotechnology products, derived from private sector 
     efforts. To find this cure, millions of dollars will have to 
     be spent. It is imperative that Congress provide steadfast 
     support for scientific discovery and strong patent protection 
     for new drugs and therapies. My view is that this new GATT 
     law will encourage further investment in research and 
     development, and make new medicines possible. This new law 
     gives hope to millions around the world, including kidney 
     cancer patients, who currently have no options.
       I applaud your courage in opposing efforts to weaken the 
     GATT patent provisions. Keep up the important battle to 
     support research and development of new drugs. Thank you for 
     your determination and insightful leadership.
           Sincerely,
                                              Eugene P. Schonfeld,
     President and Chief Executive Officer.
                                                                    ____

                                      The National Organization on


                                       Fetal Alcohol Syndrome,

                                 Washington, DC, November 8, 1995.
     Hon. Carol Moseley-Braun,
     Hart Senate Office Building,
     Washington, DC.
       Dear Senator Moseley-Braun: It has come to my attention 
     that, through an effort by Senator Pryor, Congress is 
     considering changes to existing law that would chip away at 
     patent protections in the United States, and possibly around 
     the world. I ask you to reject that effort.
       This nation has sought to protect and foster innovation 
     since its very beginnings, primarily through our system of 
     patent protections. Most recently, as a result of the General 
     Agreements on Tariffs and Trade, the U.S. changed its patent 
     terms to bring them in line with international standards. Yet 
     Congress is now considering weakening that agreement.
       As a member of the National Organization on Fetal Alcohol 
     Syndrome, I find that possibility very disturbing. Patients 
     afflicted with disease book to biomedical research, 
     especially research taking place in America's pharmaceutical 
     industry, for new and better treatments to restore them to 
     health. But this country's huge investments in research and 
     development cannot be maintained without the assurance of 
     strong patent protection, not only in the U.S., but also in 
     other markets around the world.
       If Congress begins chipping away at patent protection in 
     the U.S., it begins chipping away at the foundations of a 
     system that has made this country Number One in the world in 
     the discovery of new medicines. It also begins to undermine 
     patent protection standards around the world. And it begins 
     the process of deflating the hopes of millions of patients in 
     this country who depend on medical research to find a cure.
       Please, cast your vote in favor of innovation, and against 
     any effort to undermine 

[[Page S 18206]]
     patent protection in this or any other country around the world.
           Sincerely,
                                                     Patti Munter,
     President.
                                                                    ____



                                   Alliance for Aging Research

                                 Washington, DC, November 9, 1995.
     Hon. Carol Moseley-Braun,
     U.S. Senate, Washington, DC.
       Dear Senator Moseley-Braun: It has come to my attention 
     that, in connection with a proposal sponsored by Senator 
     David Pryor, Congress is considering changes to existing 
     patent law that would erode patent protection in the United 
     States. I am pleased to see that you are opposed to that 
     effort.
       America has always sought to protect and foster innovation 
     primarily through our system of patent protection and patent-
     term restoration. Recently in accordance with its 
     multilateral obligations under the Agreement on Trade-Related 
     Aspects of Intellectual Property Rights negotiated during the 
     Uruguay Round of GATT, Congress amended the Patent Code to 
     harmonize its provisions with international standards. As a 
     result, patent terms for certain eligible products--in all 
     industries--were extended. Under the Pryor proposal, however, 
     Congress would weaken our implementation of GATT patent 
     provisions.
       As the Executive Director of the Alliance for Aging 
     Research, I am concerned by any proposal that would have such 
     as effect. Patent rights are the cornerstone of America's 
     biomedical research enterprise. Patents provide a critical 
     incentive for all companies, particularly pioneer 
     pharmaceutical manufacturers, to conduct ground breaking 
     biomedical research. Patients and their physicians depend 
     upon access to the fruits of biomedical research--access 
     which can only occur if there are adequate incentives for the 
     research to be conducted in the first place. Congress cannot 
     expect the private sector to continue making high-risk 
     investments in research and development if there is no 
     assurance of strong patient protection (and if there is no 
     assurance that the United States will meet its multilateral 
     obligations to provide such protection).
       This is a particularly critical issue for the aging 
     Americans represented by the Alliance. Clearly, the 
     curtailment of biomedical R&D will lead to a downturn in the 
     rate at which biomedical innovations will become available to 
     the public. New incentives for research and innovation such 
     as those provided by GATT must be maintained. Otherwise, 
     Congress will erode the foundations of a system that has made 
     America the leader in the discovery of new medicines.
       I thank you for supporting innovation and research for new 
     treatments that will benefit America's elderly.
           Best regards,
                                                     Daniel Perry,
                                               Executive Director.

                      GATT AND PRESCRIPTION DRUGS

  Mr. LEAHY. Mr. President, I have worked for many years with Senator 
Pryor on trying to keep prescription drugs affordable for Americans. 
High prices for prescription drugs force some elderly and low-income 
Vermonters to choose between buying food or fuel for heat and paying 
for their medication.
  In this continuing effort, I am very pleased to join Senator Pryor as 
a cosponsor of S. 1277, the Prescription Drug Equity Act of 1995. This 
bill corrects a loophole in the GATT Treaty that gives a handful of 
drug companies as much as a $6 billion windfall at the expense of 
seniors, the poor and all consumers. This bill would allow generic drug 
companies to sell some of the world's most frequently prescribed drugs 
at half the cost that they are available at today.
  Here is an opportunity for the Congress to lower out-of-pocket health 
care costs. It is an opportunity that comes at a time when Congress is 
discussing multibillion dollar cuts in Medicare and Medicaid that will 
increase health care costs for seniors and low-income Americans.
  Today, seniors who rely on Medicare for their health insurance do not 
receive assistance for the cost of prescription drugs. Even if a senior 
also has private health insurance, there is no guarantee that it will 
cover prescription drug bills. Seniors on fixed incomes depend on money 
saving generic drugs.
  Seniors need the savings on prescription drugs now more than ever. So 
do the over 40 million Americans with no health insurance whatsoever.
  Prescription drugs and the research devoted to developing new drugs 
are vital to meet the health care needs of many Americans. While the 
manufacturers that take risks and invest in the development of new 
drugs have a right to a return on their research investment, we must 
not allow prohibitive costs to jeopardize consumer access to these 
drugs. There must be a balance.
  If the GATT loophole is closed, Medicaid will save $150 million over 
5 years and consumers will save up to $2 billion. In my home State of 
Vermont alone, the savings in Medicaid are estimated to be almost $1 
million. And, Vermont consumers are expected to save as much as $6.8 
million in prescription drug costs.
  Opponents of the Pryor legislation argue that it will prevent drug 
companies from conducting research and development on new drugs. Under 
the Pryor legislation, however, these companies still would have had 
more than the full 17 year protection they expected to have when they 
introduced their products, to gain a return on their research 
investment. In addition, drug companies will continue to receive 
royalties from the generic companies who market competing prescription 
drug products.
  Drug firms pocket almost $6 million each day that the GATT loophole 
is in effect. These companies will go to no end to protect their 
windfall. They have launched a multimillion dollar effort to lobby 
Congress. They even went as far as misrepresenting a statement by 
former Surgeon General, C. Everett Koop, by portraying him as a strong 
supporter of their billion dollar windfall.
  We in Congress have a responsibility to protect consumers against 
these drug company giants. I urge my colleagues to support the 
Prescription Drug Equity Act of 1995 and pass this legislation as soon 
as possible.
  Mr. GRASSLEY. Mr. President, I would like to say a few words about 
the amendment offered by my colleague, for though it is well 
intentioned, it does have important potential adverse effects on our 
international trade agreements.
  This legislation would deny innovator pharmaceutical products the 
full statutory term of patent protection that was provided under GATT 
and the Uruguay Round Agreements Act [URAA]. There is a requirement in 
the GATT Intellectual Property Agreement [TRIPS], found in article 
70:2, that WTO members provide TRIPS level patent protection for 
existing subject matter on the date of application of the agreement for 
the country in question. This requirement will greatly benefit U.S. 
industries across a broad range of intellectual property elements; not 
just those industries concerned about pharmaceutical patents. It is in 
the U.S. interest that countries with weak patent protection provide 
the shortest possible transition periods. This is the clear objective 
of the TRIPS agreement and, in particular, article 70:2.
  To meet this key objective of the TRIPS agreement, I believe the FDA 
interpretation of the Hatch/Waxman Act must prevail. Article 70:2 was 
specifically inserted in the TRIPS agreement to prevent WTO members 
from delaying the application of the stronger protection found in the 
TRIPS agreement to existing patents, most of which we can safely say 
will be held by U.S. rightholders.
  I strongly believe that U.S. commercial interests in WTO countries 
that currently provide weak protection will be dealt a severe blow 
should this amendment pass. We need look no further than Argentina, 
whose patent protection laws are bad and getting worse, as an example 
of what might happen if the United States pursues a policy that 
minimizes GATT mandated improvements in patent rights. And there are 
other countries whose patent regimes offer no protection to the makers 
of patented pharmaceutical products, costing billions of dollars that 
would otherwise go into research for new breakthrough drugs.
  I should also point out that the courts have had a chance to render 
judgment on this issue, and they have upheld the current interpretation 
of the Hatch-Waxman Act that this amendment would overturn. So I urge 
my colleagues to vote against this amendment and for the motion to send 
this to the Judiciary Committee.
  Mr. BYRD. Mr. President, the Pryor amendment would correct an 
unintended loophole created in the legislation implementing the General 
Agreement on Tariffs and Trade [GATT]. This loophole will cost 
consumers billions and give a windfall profit to certain drug 
companies. Congress must take the responsible course of action and 
correct its mistake by passing the Pryor amendment. Omissions and 
errors are more likely to happen when large, complex bills are taken up 
under 

[[Page S 18207]]
limited time constraints. Such is the case with GATT, which was 
considered under fast track procedure and was rushed through Congress. 
I believe this is an ill-advised way to conduct Senate business. It is 
the responsibility of the Congress to correct its unintended oversights 
and omissions.
  How did this loophole come about? When Congress enacted the Uruguay 
Round Agreements Act [URAA], the legislation implementing the General 
Agreement on Tariffs and Trade [GATT], which I opposed, it extended all 
patent terms from 17 years from date of approval to 20 years from the 
filing date. In addition, the legislation allowed generic companies to 
market their products as of the 17 year expiration date if they had 
made a substantial investment and would pay a royalty to the patent 
holder. The carefully constructed transition rules were meant to apply 
to all industries. However, because conforming language to the Federal 
Food, Drug, and Cosmetic Act was inadvertently omitted, this provision 
does not apply to the generic pharmaceutical industry. The drug 
industry is the only industry that is shielded from generic competition 
under GATT during the extended patent term.
  The U.S. negotiators have indicated that it was not their intent to 
exclude the pharmaceutical industry from this provision, and that the 
omission of the conforming language was an oversight. According to U.S. 
Trade Representative Mickey Kantor in a letter to Senator Chafee,

       This provision--the transition rules--was written neutrally 
     because it was intended to apply to all types of patentable 
     subject matter, including pharmaceutical products. Conforming 
     amendments should have been made to the Federal Food, Drug, 
     and Cosmetic Act and Section 271 of the Patent Act, but were 
     inadvertently overlooked.

  This oversight means consumers will pay more for their drugs than 
would otherwise have been the case. If generic drug companies cannot 
bring their versions of drugs to market under the transition rules, 
consumers will be forced to pay more for their prescriptions. 
Nationwide, it is estimated this may cost consumers $2.5 billion. West 
Virginians and the West Virginia State government will pay an 
additional $43 million in drug costs. Those who will likely be impacted 
greatly by this Congressional oversight are senior citizens. Although 
seniors comprise 12 percent of the population, they use one third of 
prescription drugs. At the same time, seniors live on fixed incomes and 
oftentimes experience difficulty in affording their prescriptions. it 
is outrageous that Congress would worsen their situation by failing to 
enact legislation to correct this Congressional oversight.
  Mr. President, this situation can easily be remedied by adopting the 
Pryor amendment. I urge my colleagues to support the Pryor amendment, 
and I would like to be added as a cosponsor of this amendment.
  Mr. PELL. Mr. President, today the Senate considered an amendment 
authored by my friends and colleagues, Senators Pryor and Chafee meant 
to clarify confusion that has resulted from the implementing 
legislation Congress wrote following approval of the GATT Treaty last 
year. Specifically, the issue involves when the patent terms on 
domestic pharmaceutical products expire and when generic companies can 
begin to market copies of those products to the general public.
  Since this issue has been brought to public attention, many 
contradictory charges have been levelled which have served to create a 
sense of confusion over whether or not certain entities are receiving 
unfair advantage over the other. Unclear are such issues as: What was 
the intent of our GATT negotiators, and did this intent change as the 
negotiations went on? What was the intent of Congress on this matter 
or, as the Federal courts have found, was there no intent expressed at 
all? How do our trading partners feel about our addressing this issue 
now, long after we approved the implementing legislation approving 
GATT? Who benefits and is that benefit justified or fair?
  The answers to these questions are not clear at present. And given 
the enormous stakes on both sides, I find that reaching a satisfactory 
conclusion difficult given the incomplete record. Moreover, this is not 
an abstract policy issue for me as a Senator from the State of Rhode 
Island, where Glaxo-Wellcome, one of the pharmaceutical companies with 
much at stake here, has a manufacturing facility. Prior to making a 
decision that could affect so many Rhode Islanders, I feel that a clear 
airing of the ramifications of this proposal is required. Given the 
assurances that these hearings will occur within 120 days, I feel 
confident that this issue will be addressed and when it does, we will 
have an adequate record on which to base our decisions.
  I do wish to note that by supporting the effort to refer this to the 
Judiciary Committee for hearings, I am not stating my opposition to the 
proposal per se. I will wait to come to the conclusion once the 
hearings have been completed and when the full weight of the proposal 
is more clear.
  Mr. COHEN. Mr. President, I rise to support the Pryor generic drug 
amendment which will correct an oversight in the General Agreement on 
Tariffs and Trade [GATT] implementing legislation that has 
unintentionally postponed the date at which certain generic 
prescription drugs can enter the market. While this delay only affects 
a handful of drug products, consumers who take these drugs are paying a 
big price for this technical mistake.
  This amendment would clarify the intent of transition rules in the 
trade bill allowing manufacturers who had made substantial investment 
in product development, based on pre-GATT patent expiration dates, to 
go to market as planned once they pay the patent-holder the required 
royalty. This correction is needed because certain provisions in the 
Hatch/Waxman Act, dealing with drug development, have had the 
unintended consequence of prohibiting generic companies from using the 
GATT transition rules. Pharmaceuticals are the only industry unable to 
use these rules.
  Under GATT, new pharmaceuticals are given patent protection for the 
longer of 20 years from the filing date or 17 years from the patent 
issuance. Transition rules were enacted to provide fairness to all 
industries and parties--patentee and competitor--during transition to 
the new patent-term law. We must correct this rather technical error in 
the trade bill to ensure these rules are available to all industries.
  Both Mickey Kantor, U.S. Trade Representative, and David Kessler, FDA 
Commissioner, agree with this interpretation and believe a legislative 
fix is needed to allow generic companies to go forward. This amendment 
is tightly constructed and would have no impact on other trade issues 
included in the GATT.
  While I am aware that this amendment will dip into the profits of a 
few pioneer drug companies, I believe this error has already given them 
an unintended windfall. If left uncorrected, it is estimated that the 
delay of several generic medications could cost consumers and 
government health programs nearly $2 billion.
  We have a responsibility to pass this amendment and help consumers 
gain access to more affordable medications. For millions of Americans, 
especially senior citizens, prescription drugs represent their largest 
out-of-pocket health expense. Many life-sustaining drugs are already 
out of their reach. We can not let the desire of a few drug companies 
to let this error go uncorrected place an even greater burden on 
consumers who struggle daily to pay for their prescription drugs.
  Mr. SPECTER. Mr. President, I support the intent of Senator Pryor to 
remedy what was apparently an unintended omission when the Senate 
ratified the implementing legislation for the General Agreement on 
Tariffs and Trade (GATT) in the 103d Congress. However, I remain 
concerned with ambiguities in the Pryor amendment with respect to the 
definition of substantial investment.
  When the GATT implementing legislation was approved last year, it 
contained a provision harmonizing U.S. patent law with the rest of the 
world by changing patent terms to 20 years from the initial patent 
application rather than 17 years after granting of the patent. In order 
to be fair to existing patent holders, the legislation gave them the 
option of utilizing the longer of the pre-GATT and post-GATT patent 
terms.
  However, because the legislation affected many generic manufacturers 
who had been preparing to go to market with competing products upon the 


[[Page S 18208]]
expiration of the original patent term, Congress agreed to allow 
generic manufacturers who had already made a substantial investment in 
that product to utilize the original patent expiration date and 
commence marketing, upon paying of a royalty to the patentee.
  Some have argued that the courts can interpret the definition of 
substantial investment, and consequently, there is no need for 
legislative guidance on that definition. I disagree. By retaining this 
legislative ambiguity, we are ceding the legislative role to the 
courts. We are also creating considerable costly litigation because of 
this ambiguity which should be made clear in the statute. These are 
resources which could be better devoted to developing new products and 
making them available to the public.
  I have discussed with Senator Pryor my willingness to work with him 
to correct this ambiguity and then accomplish his intended remedy.
  Mr. HATCH addressed the Chair.
  The PRESIDING OFFICER. The Senator from Utah.
  Mr. HATCH. Mr. President, I take a tremendous interest in this 
subject, in part because I chair the Judiciary Committee, which handles 
all patents, copyrights and trademark legislation and problems. Since 
the amendment would made changes in the patent code, the matter would 
come before the Judiciary Committee as it has in the past.
  In addition, I want to point out that my colleague from Arkansas was 
mistaken when he said the Judiciary Committee has never handled 
anything regarding FDA matters. In fact, I think he said, if I am 
correct, that the Judiciary Committee never looked at the Food, Drug 
and Cosmetic Act.
  Perhaps he was not aware that the 1962 Drug Amendments, which 
established the safety and efficacy standards for drugs reviewed by the 
FDA, were written in the Judiciary Committee.
  This is a result of the Kefauver hearings, which led to adoption of 
new amendments providing the efficacy standards which are often 
heralded as the model standards for the world.
  If there is any one thing you can point to at the FDA that protects 
human beings and makes sure that the medical products Americans use are 
safe and efficacious, it comes from work done by the Judiciary 
Committee. But that is not the point.
  Before I go to the broader policy issue, which is much more important 
than I think my colleagues would acknowledge, let me just call their 
attention to other Judiciary Committee work on the GATT intellectual 
property provisions. I am referring to a joint hearing in the 103d 
Congress before the House Judiciary Subcommittee on Intellectual 
Property and Judicial Administration and the Senate Judiciary 
Subcommittee on Patents, Copyrights and Trademarks.
  Pharmaceutical industry representatives, including those representing 
biotech organizations, and academic researchers appeared before these 
two combined committees.
  I do not want to take too long on this, but let me just take a moment 
or two to read from this very important joint hearing transcript.
  Representative William Hughes, who then was the chairman of the House 
Subcommittee said to Mr. Bruce Lehman, Commissioner of Patents and 
Trademarks:

       There have been some concerns raised particularly by the 
     biotech industry, that grants of patents will be delayed 
     because of unreasonable requests from the PTO for human 
     trials which, as you well know, could take years for some 
     biotechnology products to prove utility, a requirement of 
     patentability. Is that a legitimate concern on their part?

  PTO Commissioner Lehman said:

       Well, to the extent that that is a legitimate concern, Mr. 
     Chairman, I think that is addressed in the Patents Term 
     Restoration and Drug Price Competition Act that extends 
     patent terms specifically to deal with regulatory delay. 
     Perhaps that act should be adjusted if it is not addressing 
     the concerns of industry.

  By the way, the Drug Price Competition and Patent Term Restoration 
Act happens to be the bill that Representative Henry Waxman and I wrote 
back in 1984, which is considered to be one of the finest pieces of 
consumer legislation in the last 30 years, if not in the entire history 
of the country.
  I am very proud of that law.
  It is one of the reasons why I am saying this is not a question of 
whether somebody is going to get a windfall profit or not.
  This issue has very broad policy considerations. It is not just 
something that can be couched in terms of ``gouging the consumers,'' 
because there are two sides of this issue.
  The Drug Price Competition and Patent Term Restoration Act, the 
Hatch-Waxman bill, brought the two sides together.
  I know it. It was negotiated in my office over a 2-week period, 18 
hours a day. One reason I remember it so well is because I had a root 
canal during that time, and by the time we got near the end I 
threatened to kill everybody in the room if they did get together and 
get it done.
  We finally did.
  It was a tense time. It was a tough time. When we got it done, almost 
everybody agreed that this is one of the finest pieces of consumer 
legislation ever.
  It has saved an average of $1 billion a year to consumers every year 
since its enactment in 1984, as we predicted it would.
  So, naturally, I am concerned when I hear that that act is going to 
be amended in an unwise fashion.
  If the USA, whose officials have asked heads of states all over the 
world to live up to these hard-won international intellectual property 
agreements, changes this major treaty right off the bat by reducing 
patent terms just because we think some companies may benefit, then all 
the intellectual property work we have done over all these years is 
going to go down the drain.
  But let me talk again about the Hatch-Waxman bill.
  There were two sides to it. There were those who were spending 
billions of critical dollars in research that is going to help bring 
down health care costs. These manufacturers are putting their money 
where their mouths are in order to find these breakthrough drugs that 
will reduce the costs of medicine over the long run and help to relieve 
some human misery.
  But one of the problems these research-based companies face is that 
the FDA approval process has taken so long. The agency is supposed to 
approve drugs in 180 days, according to the statute.
  That has not happened in fact. It has taken so long that the patent 
terms are eaten up by the delays.
  So, there were those on the side of the research companies who said--
and I was one of them--that what we must do is restore some of the 
patent term lost through unnecessary regulatory delays. The other side 
consisted of those representing the interests of the generic drug 
industry.
  I understand that those who support the Pryor amendment do so because 
they are worried about consumer costs. What their arguments neglect 
however, are two simple questions:
  What are consumers going to consume if we do not put money into 
research?
  And what will consumers consume if there are not the incentives to 
produce the products they need?
  The thing that has made the United States the greatest research 
country in the world is that we protect patents as a property right in 
the Constitution itself.
  This, again, is another Judiciary Committee concern for those who do 
not seem to appreciate that point.
  There are those on the consumer side who legitimately asked why it 
takes so long to get generic drugs approved after the innovator drugs 
come off patent. They suggested the availability of an abbreviated new 
drug application so they did not have to go through the whole safety 
and efficacy process.
  It would have taken them 2 to 3 years to take a product like Zantac--
which I mention since that product has been attacked here--and 
duplicate it so that they can reduce the price for the benefit of 
consumers.
  So what did we do? We worked hard to enable those generic companies 
to be able to do what would be called infringement in any other 
industry.
  As a consequence of this change, these generic manufacturing 
companies were able to borrow from the work of the research-based 
companies who are spending as much as half a billion dollars to produce 
one marketable drug, and produce a bioequivalent of a 

[[Page S 18209]]
drug such as Zantac that becomes effective the day Zantac comes off the 
patent.
  Or a better illustration might be Valium. When Valium's patent 
expired, the Hatch-Waxman bill provided that all kinds of generic 
companies were able to produce their version of Valium that very day, 
rather than be delayed the 2 or 3 years through the whole process 
again.
  That is important, because what we did is bring both sides together 
to create the generic industry as we know it today. In fact, I am proud 
to have been called on occasion ``the father of the generic drug 
industry.''
  So I have a tremendous interest in making sure that the generic 
industry is solid and producing lower-cost drugs.
  But I also have a tremendous interest in seeing that research 
companies are given fair deals on their patents.
  Now, when we came up with the Hatch-Waxman bill we knew there would 
be winners and losers.
  Both sides knew this.
  They were willing to make trade-offs in order to accomplish a greater 
goal.
  We knew there were winners and losers with the Waxman-Hatch bill, and 
we also knew that when GATT was finalized there would be winners and 
losers.
  Now, I think Dr. Koop's position has been misrepresented by the other 
side, some of whom do not think he understands what really went on. 
There seems to be some confusion about Dr. Koop, our former Surgeon 
General, who is probably the leading doctor in the history of this 
country.
  I think Dr. Koop has a pretty good reputation in the field of public 
health. He was a most outstanding Surgeon General. I did not always 
agree with him, but I always respect his views.
  Dr. Koop wrote a letter to clarify that those on the other side could 
not misrepresent his position any more.
  That letter is printed in today's issue of Roll Call. It makes, I 
believe, an eloquent case against the Pryor amendment.
  I will submit for my colleagues' consideration this letter to Morton 
Kondracke, Executive Editor of Roll Call, from Dr. C. Everett Koop, 
former Surgeon General of the United States. I ask unanimous consent 
that the full letter be printed in the Record at this point.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

                        Koop on Pharmaceuticals

       To the Editor:
       In your Food & Drug Policy Briefing (Oct. 9), an article 
     appeared concerning patent protection under the General 
     Agreement on Tariffs and Trade. I am of the firm belief that 
     any action on the part of the Senate to weaken the hard-
     fought patent protections of GATT would imperil the future of 
     intellectual property rights and undermine the research 
     activities of pioneering pharmaceutical companies.
       The right to claim ideas as property allows innovators to 
     invest their time and money bringing those ides to fruition. 
     It is the basis of our patent system that allowed American 
     ingenuity to prosper throughout the Industrial Age. Today, we 
     are at the dawn of an Information Age and now, more than 
     ever, the rights of intellectual property holders must be 
     protected.
       Consider the enormous investment in time, money, and 
     brainpower required to bring a single new medicine to 
     patients: 12 years and more than $350 million is the average 
     investment. Only 20 percent of new compounds tested in a 
     laboratory ever find their way onto pharmacy shelves. Only a 
     third of those ever earns a return on the colossal investment 
     made to discover it.
       Though risky and expensive, this process works. The U.S. is 
     the world leader in the development of innovative new 
     medicines. Proceeds from the sales of these medicines support 
     the work and research invested in new successful drugs, as 
     well as the thousands of drugs that never make it out of the 
     lab.
       Patent protection makes that investment in research 
     worthwhile--and possible. Recently, patent protection around 
     the world was strengthened and harmonized by GATT, which 
     required changes that equalized intellectual property 
     protection in all participating countries. These changes are 
     important to encourage the risky, expensive research 
     necessary to provide new medicines to fulfill unmet medical 
     needs.
       Now, some generic drug companies are challenging GATT's 
     advance in intellectual property protection. They are urging 
     Congress to amend the 1984 Hatch-Waxman Act to give them an 
     advantage under GATT that no other industry enjoys.
       A key provision of the Hatch-Waxman Act gives generic drug 
     companies a jump-start on marketing by allowing them to use a 
     patented product for development and testing before the 
     patent expires. This special exemption from patent law is not 
     allowed for any other industry.
       In return for these special benefits, the Hatch-Waxman Act 
     requires generic drug companies to wait until the expiration 
     of the research companies' patents before they can begin 
     marketing their drugs. Now, the generic drug industry is 
     asking Congress to give it a special exemption from that 
     restriction as well.
       In my opinion, that would be unwise. Treatment discovery 
     has already slowed; we should reverse that process, not 
     ensure it.
       Generic drugs play an important role in helping lower the 
     cost of medicines. But it is the pharmaceutical research 
     industry that discovers and develops those medicines in the 
     first place, investing billions of dollars in research and 
     development that can span decades without any guarantee of 
     success--an investment made possible by our system of patent 
     protection.
  Mr. HATCH. Preserve patent protection and you preserve the 
opportunity for the discovery of future cures and treatment for 
disease. Undercut that protection and you undercut America's hope for 
new and better answers to our health care needs.
  It is for this reason that I must rise tonight in opposition to the 
amendment offered by Senators Pryor, Chafee, and Brown.
  Whenever Senator Pryor and I join in debate over pharmaceutical 
issues, I am sure some of our colleagues want to say, ``Here we go 
again.''
  Well, here we go again.
  Mr. President, I oppose this amendment because the current statutory 
framework, as interpreted by several recent court decisions, reflects 
sound policy and should not be disturbed.
  I am glad we are having this debate today, as I welcome the 
opportunity to put the issue in better perspective.
  This is a debate that cuts across party lines.
  Reasonable people may disagree about the best course of action to 
take on this amendment, but it is still the same debate: Who is going 
to benefit, the research companies or the generic companies?
  The generics have benefited greatly from what I have personally done 
for them, and so have the research companies.
  But our overriding goal here must be to make sure we keep in place 
the incentives necessary for America to continue as the world leader in 
developing innovative medical technologies that can be delivered at 
competitive prices. The bottom line is that the Pryor amendment would 
undermine that goal.
  At the end of this debate, I am hopeful that my colleagues will share 
my strong conviction that two relevant laws--the Drug Price Competition 
and Patent Term Restoration Act, sometimes known as Waxman-Hatch or 
Hatch-Waxman and the GATT Treaty--act together to advance important 
public health and trade policies.
  I believe it is clear that the Senate must reject the Pryor amendment 
if we are to maintain that balance.
  Let me summarize my three basic objections to this amendment:
  First, many experts in international trade believe that the adoption 
of this amendment would send precisely the wrong signal to our trading 
partners, some of whom have had notorious track records of being 
patent-unfriendly.
  A major gain we made with GATT was to win international harmonization 
with a 2-year patent term. Adoption of the Pryor amendment could cause 
backsliding on the part of foreign countries required to implement and 
enforce their obligations under GATT. Let us not steal defeat from the 
jaws of victory.
  Second, the Waxman-Hatch Act achieved a careful balance between the 
generic and innovator sectors of the pharmaceutical industry.
  The proponents of the Pryor amendment urge that only one industry is 
singled out for different treatment under the GATT implementing 
legislation.
  What is absent from that line of argument is the fact that only one 
industry, the generic drug industry, is permitted by current law to 
engage in activities that in any other industry would constitute patent 
infringement, as I have said before.
  A recent Federal district court reviewed the relevant provisions of 
law and concluded, ``This was no more a windfall to the * * * [pioneer 
firms] * * * than the windfall which benefited many patent holders when 
the seventeen year term of patents was extended to twenty years.'' 

[[Page S 18210]]

  Third, if the Pryor amendment is adopted, it may run afoul of the 
takings clause of the fifth amendment to the Constitution. Patents are 
recognized and protected by American courts and by our Constitution as 
property.
  By repealing patent extensions granted under the GATT legislation and 
reducing vested patent terms, the Pryor amendment could trigger the 
guarantee that affected property holders receive just compensation.
  I ask unanimous consent that a copy of an October 24 ``Dear 
Colleague'' letter signed by a bipartisan group of 11 Senators, and a 
December 6 ``Dear Colleague'' letter discussing these issues be printed 
in the Record at this point.
  There being no objection, the letters were ordered to be printed in 
the Record, as follows:

                                                  U.S. Senate,

                                 Washington, DC, October 24, 1995.
       Dear Colleague: We are writing to indicate our bipartisan 
     opposition to an amendment which may be offered during Senate 
     consideration of S. 1357, the Balanced Budget Reconciliation 
     Act of 1995. That amendment would deny U.S. innovator 
     pharmaceutical manufacturers international patent protections 
     provided under key provisions of the GATT implementing 
     legislation.
       The Uruguay Round Agreements Act (URAA) implemented the 
     United States' obligations under GATT by providing that the 
     term of any patent in force on June 8, 1995, be the greater 
     of 20 years from the applicable filing date or 17 years from 
     the date of grant. These critically-important patent 
     provisions benefit all industries and all patent holders.
       Nevertheless, a handful of generic drug companies have 
     urged Congress to rewrite the law in effect to eliminate the 
     20-year term for certain prescription drug patents by 
     allowing generic companies to sidestep existing statutory 
     provisions under the Drug Price Competition and Patent Term 
     Restoration Act of 1984 (``Hatch-Waxman'') that preclude the 
     generic from entering the market until the full term of the 
     pioneer's patent has expired.
       Repealing this provision of the URAA would: weaken the U.S. 
     position in negotiating and enforcing strong international 
     patent protection which was a major achievement of the GATT; 
     have a chilling effect on biomedical research in the 
     pharmaceutical industry; and be subject to legal challenge as 
     an unconstitutional taking of property.
       It is inappropriate to consider a change of this magnitude 
     in the context of budget reconciliation. Both Hatch-Waxman 
     and the Uruguay Round were hard-won compromises which were 
     negotiated very carefully. The amendment has both trade and 
     intellectual property implications, as well as substantial 
     implications for food and drug law. Furthermore, this issue 
     is now before the Federal courts in ongoing litigation and 
     any action at this time would be premature.
       For these reasons, as discussed in detail in the 
     attachments, we urge you to oppose consideration of the GATT 
     patent amendment during debate on budget reconciliation.
           Sincerely,
         Christopher J. Dodd; Orrin G. Hatch; Joseph I. Lieberman; 
           Alfonse M. D'Amato; Charles E. Gressley; Lauch 
           Faircloth; Mike DeWine; Carol Mosely-Braun; Ernest F. 
           Hollings; Jesse Helms; Dan Coats.


      the gatt amendment would undermine america's trade position

       Intellectual property rights were addressed on a 
     multilateral trade basis for the first time in the history of 
     GATT during the Uruguay Round. As a result of hard-fought 
     compromises, worldwide standards for protecting and enforcing 
     intellectual property rights were established, and 
     intellectual property protection was significantly improved.
       The decision to tackle patent rights during the Uruguay 
     Round, despite the reluctance of some developing countries, 
     reflects the complexity of international trade and the 
     international significance of patent rights.
       As the principal source of inventive activity, the U.S. 
     stands to gain substantially from the Agreement on Trade-
     Related Aspects of Intellectual Property (TRIPs) improvements 
     in patent protection worldwide. In countries that previously 
     provided limited patent protection, a minimum 20-year patent 
     term must be granted immediately upon their acceptance of the 
     TRIPs obligations. Enhanced patent protection overseas will 
     have a significant impact on the commercial interests of the 
     United States and the resulting economic gains and job 
     creation in the United States will be considerable.
       The Uruguay Round agreement was a landmark achievement, but 
     the real test comes when countries implement their 
     multilateral obligations under GATT. Since the U.S. insisted 
     on the inclusion of enhanced patent protections in the 
     Uruguay Round agreements and historically has been the 
     leading international advocate for broadening patent rights, 
     it is essential that the U.S. be a world leader on GATT 
     implementation.
       Enhanced patent protection will be diminished abroad if the 
     United States itself violates the patent term embodied in 
     TRIPs. It is almost certain that such an action would provide 
     foreign-based pirates and patent infringers with potent 
     ammunition in seeking to have their domestic governments 
     devise measures that are inconsistent with TRIPs--thereby 
     denying U.S. patent holders their rights secured by TRIPs.
       A report just released by two American Enterprise Institute 
     (AEI) analysts concludes that such ``weaken[ing] [of] the 
     patent system during this critical period of implementing the 
     TRIPs agreement could well give developing countries a 
     pretext for backing away from their GATT commitments to 
     strengthen the protection of intellectual property.'' They 
     point out several developing nations, including India, 
     Singapore, and Thailand, which are already attempting ``to 
     dilute and evade'' the patent protection commitments they 
     accepted during the Uruguay Round.
       It is clear that, in this patent-unfriendly context, the 
     proposed amendment would be interpreted internationally as 
     encouraging a minimalist's interpretation of GATT's 
     improvements in patent protection. As the AEI analysts 
     conclude, America's trading partners will construe the 
     amendment as a green light to act inconsistently with GATT: 
     ``Thus, any signal that the United States itself is 
     contemplating weakening its TRIPs obligations will 
     undoubtedly be seized upon by these countries as a pretext to 
     resist pressure to put in place strong intellectual property 
     protections.'' Having redefined patent terms domestically in 
     order to secure enhanced patent rights overseas, it would be 
     imprudent for this Congress to send any such signal.
       The international trade ramifications extend beyond 
     questions of intellectual property protection. The positions 
     advocated by proponents of this amendment ``are likely to be 
     turned against the United States in future trade 
     negotiations,'' according to the AEI analysts. The AEI report 
     concludes that arguments advanced in support of the amendment 
     ``will come to haunt U.S. negotiators'' and ``play rights 
     into the hands of developing countries who still maintain and 
     defend compulsory licensing.''
       For all of these reasons, the AEI analysts conclude that 
     USTR Kantor's contention that the amendment would not 
     undermine America's position in international trade 
     negotiations ``would seem to come under the heading of `` 
     `whistling in the wind.' ''
       Significantly, USTR Kantor's position has been strongly 
     countered by his predecessors, former-Ambassadors Clayton 
     Yeutter and Bill Brock. Ambassador Brock asserts that nations 
     which in the past have denied American investors patent 
     protection ``will see this retreat on our part as a ready 
     excuse to implement their own minimalist versions of 
     intellectual property protection.'' Thus, Ambassador Brock 
     concludes, we would be unable ``to force other nations to 
     adhere to the TRIPs agreement if we set this unfortunate 
     precedent.''
       Similarly, the Emergency Committee for American Trade 
     (ECAT) concludes, ``A U.S. retreat from its own commitments 
     to increased intellectual property protection for all 
     patented products would be a destructive precedent that could 
     lead to an unraveling of hard-won gains.''
       The European Community (EC) has expressed similar ``serious 
     concerns'' about any such precedent. The Vice-President of 
     the European Commission believes the amendment ``would 
     contradict our mutual aim of providing a reasonably high and 
     secure protection for the huge investments made by EC and US 
     research-based pharmaceutical companies'' and ``send a 
     negative and highly visible signal to those numerous 
     countries which are still in the process of preparing new 
     legislation on the protection of pharmaceutical inventions.''
       As America's trading partners implement GATT, it is vital 
     that the U.S. be in a position to demand that they adopt 
     legislation consistent with the requirements embodied in the 
     Uruguay Round agreements. In order to do so, we cannot be 
     childed into adopting an ill-considered amendment that 
     vitiates patent protection for American patent holders.


    the gatt patent amendment will chill r&d in research-intensive 
                               industries

       Intellectual property rights are critical to all American 
     industries and should not be lightly disregarded. They are 
     particularly important to the pharmaceutical industry because 
     they fuel the engine that drives the biomedical research 
     enterprise and result in numerous therapeutic advances.
       An amendment that eliminates the GATT patent benefits for 
     pharmaceutical products would undermine a critically 
     important incentive for research and development.
       As with other research-incentive industries in the United 
     States, the pioneer pharmaceutical industry has benefited 
     significantly from America's patent system. Due to the high 
     costs and significant risks associated with developing and 
     marketing prescription drugs, patents have allowed 
     pharmaceutical manufacturers to attract the risk capital 
     necessary to develop and clinically test innovative new 
     therapies.
       The results of such ground breaking biomedical research 
     flows directly to patients who have access to drugs for 
     complex and life-threatening diseases which are developed 
     only by pioneer pharmaceutical companies. We should continue 
     to reward their ingenuity and encourage their innovation.
       If Congress encourages a curtailment of biomedical R&D by 
     limiting incentives, it inevitably will cause a downturn in 
     the rate at which biomedical inventions will become available 
     to the public. For this reason, an array of patient and 
     research groups--including the American Association for 
     Cancer Research, the Alliance for Aging Research, the Cystic 
     Fibrosis Foundation, the Allergy and 

[[Page S 18211]]
     Asthma Network/Mothers of Asthmatics, and the Autism Society--oppose 
     the amendment.


 the gatt patent amendment could effect an unconstitutional taking of 
                                property

       Legal analysis supports the view that the proposed GATT 
     amendment ``would clearly deprive the patent holders of their 
     property rights. . . .'' Patents have traditionally been 
     recognized and protected by American courts as property.
       Based upon existing precedents, it can be argued that any 
     legislation affecting either the exclusive use of a product 
     to which a patent holder is entitled, or the time during 
     which the patent holder is entitled to that exclusive use, 
     affects core elements of the property right represented by a 
     patent.
       By repealing patent extensions granted under the URAA, and 
     reducing vested patent terms to which existing patent holders 
     are currently entitled, this amendment could trigger the 
     Fifth Amendment guarantee that the property holders receive 
     just compensation.
       In this era of fiscal constraints, and particularly in the 
     context of the budget reconciliation debate, it would be 
     ironic indeed for Congress to impose such financial 
     obligations on an already-strained federal budget. We should 
     carefully consider whether the amendment would have such an 
     effect.


   it is inappropriate to consider the gatt patent amendment during 
                             reconciliation

       Regardless of one's views about its merits, it is clear 
     that a GATT patent amendment would be inappropriate at this 
     point.
       The proposed amendment is not a technical amendment as it 
     has been characterized by its proponents, who suggest they 
     are simply trying to correct a ``simple mistake in 
     legislative drafting'' that resulted in a ``legal loophole'' 
     in the URAA. The facts are quite different.
       The amendment would result in substantial changes in two 
     statutes--the URAA and the 1984 Hatch-Waxman Act. The Hatch-
     Waxman Act represents a careful balance between the interests 
     of innovator manufacturers and generic drug companies. It has 
     worked well for over 10 years and should not be amended 
     lightly. Even minor changes to Hatch-Waxman could have 
     profound effects on all segments of the pharmaceutical 
     industry.
       Under Hatch-Waxman, generic drug companies are already 
     given significant advantages. They are allowed to begin 
     development of their generic drugs while the pioneer's patent 
     remains in effect, and they can rely on the safety and 
     efficacy data developed by the innovator. The proposed GATT 
     amendment would negate a complementary provision in the 
     Hatch-Waxman Act; that provision requires generic companies 
     to respect the pioneer's full patent term, and thereby upset 
     the balance codified in that statute.
       The dramatic changes that would result from the proposed 
     amendment would occur without the benefit of prior 
     congressional consideration. The proposed amendment would 
     have a direct and significant effect on patent rights, which 
     fall squarely within the jurisdiction of the Judiciary 
     Committee.
       We should not rush to legislate in this area before all 
     Committees of relevant jurisdiction have had a reasonable 
     opportunity to hold hearings and give careful consideration 
     to all of the proposed amendment's potential ramifications.
       Finally, questions relating to implementation of the URAA 
     are currently in litigation. One lawsuit addressing the 
     precise issue covered by the proposed amendment has been 
     expedited for consideration by the U.S. Court of Appeals for 
     the Federal Circuit (CAFC). The CAFC heard arguments in that 
     case just two weeks ago. An amendment on this issue would be 
     premature at this time.
                                                                    ____



                                                  U.S. Senate,

                                 Washington, DC, December 6, 1995.
       Dear Colleague: We are writing to urge your opposition to 
     the Pryor amendment to H.R. 1833, the partial birth abortion 
     ban bill. This amendment would deny the benefits of GATT to 
     U.S. innovator pharmaceutical companies.
       The Pryor amendment is bad policy. It undermines the 
     purposes of GATT, and it fundamentally upsets the delicate 
     balance we forged in 1984 upon adoption of the Drug Price 
     Competition and Patent Term Restoration Act (``Hatch-
     Waxman''). That Act was designed to ensure that innovator 
     companies continue to have sufficient incentive to invest the 
     billions of dollars necessary to produce new medicines while 
     at the same time allowing generic companies a quick and 
     inexpensive way to get their versions of the drugs on the 
     market after the patent has expired.
       The Hatch-Waxman Act also gave generic drug companies an 
     advantage possessed by no other industry in either the United 
     States or the industrialized world. It specifically repealed 
     those provisions of patent and case law that forbade any 
     testing, plant construction, or investment in something which 
     is still under patent, thus enabling the generic industry to 
     conduct its bioequivalency tests and even produce a drug 
     before the patent expires. It is generally agreed that this 
     reduces the effective life of a drug patent about three 
     years. This is in addition to the fact that Hatch-Waxman 
     allows generics to avoid the lengthy, multiyear approval 
     process by using the safety and efficacy testing data of the 
     innovator company. This is estimated to save the generics 
     between $350 million and $500 million per drug.
       We are enclosing a previous dear colleague letter which 
     provides you with information on this subject, as well as a 
     letter to the editor that will appear in tomorrow's Roll Call 
     from Dr. C. Everett Koop, the former Surgeon General of the 
     United States. We urge you to read this letter carefully as 
     it eloquently and persuasively argues our case. We are also 
     including a collection of statements from various patient 
     groups who also oppose the Pryor amendment because these 
     individuals know first-hand that intellectual property is the 
     key to new discoveries which mean life or death for millions 
     of people.
       We urge you to join us in opposing the Pryor amendment.
           Sincerely,
     Christopher J. Dodd,
                                            United States Senator.
     Orrin G. Hatch,
     United States Senator.
                                                                    ____

                                                November 30, 1995.
     Mr. Morton Kondracke,
     Executive Editor,
     Roll Call, Washington, DC.
       In your special supplement on the FDA (October 9, 1995), an 
     article appeared concerning patent protection under the 
     General Agreement on Tariffs and Trade (GATT). I am of the 
     firm belief that any action on the part of the U.S. Senate to 
     weaken the hard-fought patent protections of the GATT would 
     imperil the future of intellectual property rights and 
     undermine the research activities of pioneering 
     pharmaceutical companies.
       A little-known revolution has taken place in my lifetime. 
     When I started practicing medicine, only a fraction of the 
     drugs that we now take for granted existed. Over the years, I 
     have witnessed great suffering endured by patients and their 
     families that, just a few years later, could have been eased 
     because of the advent of the latest ``miracle drug.'' These 
     breakthrough treatments have brought hope and, in many cases, 
     renewed health to thousands of patients. They are the product 
     of an increasingly important concept: the sanctity of 
     intellectual property.
       The right to claim ideas as property allows innovators to 
     invest their time and money bringing those ideas to fruition. 
     it is the basis of our patent system that allowed American 
     ingenuity to prosper throughout the Industrial Age. Today, we 
     are at the dawn of an Information Age and now, more than 
     ever, the rights of intellectual property holders must be 
     protected.
       Consider the enormous investment in time, money, and brain 
     power required to bring a single new medicine to patients: 12 
     years and more than $350 million is the average investment. 
     Only 20% of new compounds tested in a laboratory ever find 
     their way onto pharmacy shelves. Only a third of those ever 
     earns a return on the colossal investment made to discover 
     it.
       Though risky and expensive, this process works. the U.S. is 
     the world leader in the development of innovative new 
     medicines. proceeds from the sales of these medicines support 
     the work and research invested in new successful drugs, as 
     well as the thousands of drugs that never make it out of the 
     lab.
       Patent protection makes that investment in research 
     worthwhile--and possible. Recently, patent protection around 
     the world was strengthened and harmonized by the GATT, which 
     required changes that equalized intellectual property 
     protection in all participating countries. These changes are 
     important to encourage the risky, expensive research 
     necessary to provide new medicines to fulfill unmet medical 
     needs.
       Now, some generic drug companies are challenging the GATT's 
     advance in intellectual property protection. They are urging 
     Congress to amend the 1984 Hatch-Waxman Act to give them an 
     advantage under the GATT that no other industry enjoys.
       A key provision of the Hatch-Waxman Act gives generic drug 
     companies a jump start on marketing by allowing them to use a 
     patented product for development and testing before the 
     patent expires. This special exemption from patent law is not 
     allowed for any other industry. For example, a television 
     manufacturer who wants to market or use its own version of a 
     patented component must wait until the patent expires; 
     otherwise, it risks liability for patent infringement.
       in return for these special benefits, the Hatch-Waxman Act 
     requires generic drug companies to wait until the expiration 
     of the research companies' patents before they can begin 
     marketing their drugs. Now, the generic drug industry is 
     asking Congress to give it a special exemption from that 
     restriction as well.
       In my opinion, that would be unwise. Treatment discovery 
     has already slowed; we should reverse that process, not 
     ensure it.
       While the generic drug industry continues to prosper as a 
     result of the benefits received in the 1984 Act, medical 
     research has continued to become more complex, more costly, 
     and more time consuming, further limiting the effective 
     market life for patented products.
       Generic drugs play an important role in helping lower the 
     cost of medicines. But it is the pharmaceutical research 
     industry that discovers and develops those medicines in the 
     first place, investing billions of dollars in research and 
     development that can span decades without any guarantee of 
     success--an investment made possible by our system of patent 
     protection. Preserve protection and 

[[Page S 18212]]
     you preserve the opportunity for the discovery of future cures and 
     treatments for disease. undercut that protection, and you 
     undercut America's hope for new and better answers to our 
     health care needs.
           Sincerely yours,
     C. Everett Koop, M.D.
                                                                    ____


  Patient Advocates Oppose Efforts to Weaken Strong Patent Protection

       ``At a time when health care delivery, research and 
     development are evolving faster than anyone can accurately 
     monitor, Senator Pryor's efforts to lead Congress down a road 
     that chips away at patent protections for U.S. pharmaceutical 
     products will dig a health care grave for Americans.''--Nancy 
     Sander, President, Allergy and Asthma Network/Mothers of 
     Asthmatics, Inc.
       ``Congress cannot expect the private sector to continue 
     making high-risk investments in research and development if 
     there is no assurance of strong patent protection . . .''--
     Daniel Perry, Executive Director, Alliance for Aging 
     Research.
       ``The risk of supporting [Senator Pryor's] legislation 
     would be to weaken the incentives for innovation in academia, 
     research institutions, and medical research-based companies. 
     We believe that this will impede our capacity to address the 
     growing epidemic of cancer.''--Joseph R. Bertino, M.D., 
     President, American Association for Cancer Research, Inc.
       ``The ASTMH members have dedicated their lives to easing 
     the suffering of patients under their care and returning them 
     to health whenever possible. In this effort, modern medicines 
     are among our most effective tools. Congress' steadfast 
     support of strong patent protection has encouraged the 
     investments in research and development that make these 
     medicines possible.''--Carole A. Long, Ph.D., President, 
     American Society of Tropical Medicine and Hygiene.
       ``While we certainly support patient access to lower cost 
     treatments for disease and disability rehabilitation, that 
     short-term benefit pales if it comes at the long-term expense 
     of finding cures to life-threatening illnesses.''--Sandra H. 
     Kownacki, President, Autism Society of America.
       ``Because of the discoveries born of these investments [in 
     pharmaceutical research], the patients we come in contact 
     with every day benefit through saved lives and improved 
     quality of life.''--Robert J. Beall, Ph.D., President and 
     CEO, Cystic Fibrosis Foundation.
       ``Patients afflicted with disease look to biomedical 
     research, especially research taking place in America's 
     pharmaceutical industry, for new and better treatments to 
     restore them to health.''--Patti Munter, President, The 
     National Organization on Fetal Alcohol Syndrome.
       ``Our patients have experienced the direct benefits of the 
     tremendous investments that the pharmaceutical industry has 
     made in research and development. Research-based companies 
     need and deserve the incentives provided by strong 
     intellectual property protection.''--Judith Simpson, R.N., 
     Ed.S., President, United Patients' Association for Pulmonary 
     Hypertension, Inc.
                                                                    ____

  Mr. HATCH. As the ``Dear Colleague'' letters point out, what is at 
stake here is not just the patent status of a few drugs, but also our 
international trade posture and the complex set of incentives and 
regulations that govern our Nation's biomedical research and 
development network.
  Let me turn to a more detailed explanation of my position.
  As my colleagues are aware, the Uruguay Round Agreement Act--the 
URAA--is the statute that implements the GATT Treaty.
  Some have said today that the GATT patent amendment merely corrects a 
simple oversight made in drafting the GATT implementation bill.
  This is simply not true.
  And wishing will not make it so.
  Negotiations on the GATT Treaty were exceedingly detailed and 
complex. They took place over many years--in fact, across the terms of 
four American Presidents.
  Given the ample opportunity for this issue to have arisen previously, 
it seems to me that those who argue we should adopt this after-the-fact 
technical correction amendment should face a heavy burden.
  Their case is, and should be, severely undercut by the fact that the 
Congress made changes in the very sections of the relevant laws that we 
are now being told were not amended as a simple matter of oversight.
  One of the chief benefits that the GATT Treaty can achieve for the 
American people is to increase international protection of intellectual 
property.
  These important agreements are set forth in the Agreement on Trade-
Related Aspects of Intellectual Property, the so-called TRIPS 
provisions. A key aspect of TRIPS was to require that all 123 GATT 
signatory countries adopt a minimum 20-year patent term, measured from 
the date that a patent application is filed.
  Strengthening international recognition of intellectual property 
rights such as patents was one of the most important gains we made in 
the adoption of the GATT Treaty. These rights act to protect innovative 
American firms, which all to often have been the victims of 
unscrupulous behavior by foreign competitors who have expropriated 
American know-how.
  Obviously, all World Trade Organization member countries must take 
seriously their obligations to respect intellectual property rights 
under the GATT Treaty and ensure that there will be no back sliding.
  It is vital that America must also be perceived as honoring its 
obligation as a World Trade Organization member.
  I recognize that Ambassador Kantor has been identified as one who is 
supportive of this type of Pryor amendment.
  In a September 18 letter to Senator Pryor, Mr. Kantor takes a view 
that the approach advocated by the Pryor amendment does not weaken the 
campaign for stronger patent protection abroad and reflects the intent 
of the drafters of the URAA. I disagree with him, and I disagree with 
Senator Pryor on both scores.
  First, I would like to point out that two former U.S. Trade 
Representatives, William Brock and Clayton Yeutter, have stated that 
the recently adopted GATT Treaty is a major improvement that benefits 
the American public.
  They have explained that changing the implementing legislation now 
sends exactly the wrong message.
  Mr. President, both of these international trade experts were active 
participants in the TRIPS negotiations during their respective 
stewardships at the U.S. Trade Representatives' Office as U.S. Trade 
Representatives.
  As Mr. Yeutter wrote to the Finance Committee in September of this 
year:

       In the Uruguay Round, one of the principal objectives of 
     the United States was to strengthen international protection 
     of patents, trademarks, copyrights, trade secrets, and 
     semiconductor lay-outs. The United States leads the world in 
     ideas and innovation, particularly in cutting-edge 
     technologies such as pharmaceuticals and biotechnology. Thus, 
     . . . TRIPS . . . was a major breakthrough for the United 
     States.

  He goes on to say:

       In my view, adding further preferential exceptions to the 
     Uruguay Round's 20-year minimum patent term, for the generic 
     drug industry or anyone else, would set an unfortunate 
     precedent and seriously undermine U.S. efforts to secure 
     stronger International IPR disciplines. Many developing 
     countries have long opposed effective patent protection for 
     pharmaceuticals and agricultural chemicals in order to 
     protect domestic industries engaged in illicitly copying 
     American products.

  As Mr. Yeutter clearly indicates, there are strong trade policy 
arguments for standing firmly behind this new 20-year rule. These 
concerns were also shared by another former U.S. Trade Representative, 
William Brock.
  In a recent letter, Senator Brock explained the significance of the 
GATT intellectual property provisions:

       When I first proposed international agreements to extend 
     intellectual property protection worldwide under the GATT, no 
     one believed it could be done. Yet it was the crowning 
     achievement of the recently successful Uruguay Round. . . Now 
     I hear that some pending proposals could imperil the 
     implementation of that agreement. I refer specifically to 
     legislation recently introduced by David Pryor. . . .
       Proponents suggest that this legislation is only a 
     ``technical'' correction to the . . . URAA . . . and neither 
     weakens patent protection . . . nor diminishes the United 
     States' ability to fight for stronger international patent 
     protection. I disagree!

  Senator Brock goes on to say as former Trade Representative:

       It will be difficult, if not impossible for the United 
     States to force other nations to adhere to the TRIPS 
     agreement if we set this unfortunate precedent.
       In sum, in exchange for the hope of short term savings, the 
     Pryor proposal could cost all U.S. firms and workers the 
     enormous long term gains we worked so hard to achieve in the 
     Uruguay Round. That is penny wise and pound foolish.

  When the comments of these two former U.S. Trade Representatives are 
contrasted with the views of Mr. Kantor, and my friend from Arkansas, 
Senator Pryor, it is clear that this is the type of issue upon which 
reasonable and honorable people may disagree.
  I understand that the proponents of this amendment are motivated by 
good intentions, but I think they are on the 

[[Page S 18213]]
wrong side of both the law and the policy on this issue.
  In further support of my viewpoint I point out that Ambassador 
Kantor's counterpart at the European Commission finds the Pryor 
approach extremely troublesome. Now, if you know the British, when they 
say ``extremely troublesome,'' that is about as strong a statement as 
they can make.
  Sir Leon Brittan has informed the current U.S. Trade Representative:

       I am therefore concerned that the adoption of these 
     proposals (or for that matter, any other bill which aims at 
     achieving the same objectives) would send a negative and 
     highly visible signal to those numerous countries which are 
     still in the process of preparing new legislation on the 
     protection of pharmaceutical innovation.

  This information should dispel the myth that there are no important 
trade implications at stake in this debate.
  It should dispel the myth that the Pryor amendment has no potential 
negative impact on our efforts to enhance international respect for 
intellectual property laws.
  I ask unanimous consent that the remarks of Clayton Yeutter, Bill 
Brock, and Sir Leon Brittan be printed in the Record.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

         The Right Honourable Sir Leon Brittan, oc, Vice-President 
           of the European Commission,
                              Brussels, Belgium, October 20, 1995.
     Hon. Mickey Kantor,
     U.S. Trade Representative,
     Washington, DC.
       Dear Mickey: My attention has been drawn to draft 
     legislation recently introduced in the United States Senate 
     (S. 1191 and S. 1277), concerning the marketing of generic 
     pharmaceutical products. As I understand it, the effect of 
     these Bills would be to deprive the owner of a pharmaceutical 
     patent of the full benefits of the patent term provided for 
     in the TRIPs Agreement of the Uruguay Round.
       This threat causes serious concern to the European 
     research-based pharmaceutical industry and to the Commission, 
     and seems to be in contradiction with the long-standing US 
     policy of providing strong protection for research-based 
     intellectual property rights, both at home and abroad.
       The United States and the European Community combined their 
     forces during the Uruguay Round on patent questions. We 
     fought successfully together, for example, for the principle 
     that existing subject matter should benefit fully from the 
     reinforced standards included in the TRIPs Agreement. The 
     unqualified adoption of these provisions by our trading 
     partners, especially in the developing countries, is of great 
     importance for American and European industry alike. Any 
     deviation from these principles should therefore be treated 
     with utmost care. This also applies to the use of the 
     exceptions clause contained in Article 70(4) of the TRIPs 
     Agreement. In my view, these proposals have several 
     significant shortcomings, and the basic philosophy which they 
     translate into legislative language would contradict our 
     mutual aim of providing a reasonably high and secure 
     protection for the huge investments made by EC and US 
     research-based pharmaceutical companies.
       I am therefore very much concerned with the potential 
     impact of the adoption of such legislation on third counties. 
     For several years both the US and the Community have made 
     major efforts, jointly in the GATT but also in the context of 
     our respective bilateral negotiations with third countries, 
     to improve the protection of intellectual property rights. 
     This effort has been successful, both in the GATT where the 
     TRIPs Agreement has now been adopted as part of the Uruguay 
     Round, but also in our relations with many third countries. 
     This includes not only significant improvements with respect 
     to the adoption of higher substantive standards for patent 
     protection but also so-called pipeline protection for 
     pharmaceutical and agro-chemical product inventions. 
     Nevertheless, there is still a long way to go before the 
     TRIPs Agreement is implemented by our WTO partners, and we 
     both have further objectives to pursue at the bilateral level 
     in terms of improved protection of our intellectual property 
     rights. I am therefore concerned that the adoption of these 
     proposals (or, for that matter, any other bill which aims at 
     achieving the same objective) would send a negative and 
     highly visible signal to those numerous countries which are 
     still in the process of preparing new legislation on the 
     protection of pharmaceutical inventions.
       I very much hope that you share my worries and the United 
     States Administration will convey these concerns to the 
     United States Congress.
           Sincerely,
     Leon.
                                                                    ____



                                       Hogan & Hartson L.L.P.,

                               Washington, DC, September 26, 1995.
     Re amendment to shorten pharmaceutical patent terms under 
       Uruguay Round Agreements Act.

     Hon. William V. Roth, Jr.,
     Chairman, Committee on Finance,
     U.S. Senate, Washington, DC.
       Dear Mr. Chairman: I am writing at the request of Glaxo-
     Wellcome, Inc. to offer my views on the application of the 
     Uruguay Round Agreements Act (``URAA'') to certain 
     pharmaceutical patents. As I understand it, an amendment may 
     be offered by Senator Pryor in the Finance Committee to 
     extend the transition rules of Section 532(a)(1) of the URAA 
     to generic drug manufacturers that already receive 
     preferential treatment under the Hatch-Waxman Act. The Pryor 
     Amendment (S. 1191) would in effect shorten the terms of 
     these patents in order to safeguard the activities of generic 
     drug manufacturers that would otherwise be deemed to be 
     infringing under U.S. law.
       In the Uruguay Round, one of the principal objectives of 
     the United States was to strengthen international protection 
     of patents, trademarks, copyrights, trade secrets, and 
     semiconductor lay-outs. As you will recall, we fought long 
     and hard even to get this issue on the Uruguay Round agenda. 
     The United States leads the world in ideas and innovation, 
     particularly in cutting-edge technologies such as 
     pharmaceuticals and biotechnology. Thus, the Agreement on 
     Trade-Related Intellectual Property Rights (``TRIPS''), which 
     established effective legal protection for patents (including 
     a minimum 20 year patent term), was a major breakthrough for 
     the United States.
       In my view, adding further preferential exceptions to the 
     Uruguay Round's 20 year minimum patent term, for the generic 
     drug industry or anyone else, would set an unfortunate 
     precedent and seriously undermine U.S. efforts to secure 
     stronger international IPR disciplines. Many developing 
     countries have long opposed effective patent protection for 
     pharmaceuticals and agricultural chemicals in order to 
     protect domestic industries engaged in illicitly copying 
     American products. This is one reason the United States 
     finally agreed to extremely long transition periods in TRIPS. 
     The proposed amendment would provide further aid and comfort 
     to foreign pirates that want to continue infringing American 
     patents. It would be thrown back at U.S. trade negotiators 
     every time they complain that a foreign government is not 
     adhering to its TRIPS obligations.
       In Section 532(a)(1) of the URAA, Congress made the right 
     choice by rejecting proposals to in effect shorten the 20 
     year minimum patent term established in TRIPS. To reconsider 
     that decision now would be a mistake; the proposed amendment 
     would clearly undercut future U.S. efforts to enforce strong 
     international IPR disciplines.
           Sincerely,
     Clayton Yeutter.
                                                                    ____



                                        The Brock Group, Ltd.,

                               Washington, DC, September 20, 1995.
     Senator William V. Roth, Jr.,
     Hart Senate Office Building,
     Washington, DC.
       Dear Senator Roth: When I first proposed international 
     agreements to extend intellectual property protection 
     worldwide under the GATT, no one believed it could be done. 
     Yet it was the crowning achievement of the recently 
     successful Uruguay Round--thanks almost solely to the 
     persistent and active support of the U.S. business community 
     and U.S. governmental leaders.
       Now I hear that some pending proposals could imperil the 
     implementation of that agreement. I refer specifically to 
     legislation recently introduced by David Pryor, called the 
     Consumer Access to Prescription Drugs Act (S. 1191). S. 1191 
     creates special rules so that the generic pharmaceutical 
     manufacturers can take advantage of preferential treatment 
     under the Drug Price competition and Patent Term Restoration 
     Act of 1984 (``Hatch/Waxman Act'') without adhering to the 20 
     year patent term negotiated during the GATT Uruguay Round 
     negotiations.
       Proponents suggest that this legislation is only a 
     ``technical'' correction to the Uruguay Round Agreements Act 
     (URAA) and neither weakens patent protection under URAA nor 
     diminishes the United States' ability to fight for stronger 
     international patent protection. I disagree! This issue is 
     far too important to risk on the basis of hoped-for ``good 
     intentions'' in nations which have never favored intellectual 
     property protection.
       Countries around the world are still in the process of 
     implementing the Uruguay Round Agreement. A number have 
     withheld their own action to wait and see what we do. We all 
     know those whose prior actions have cost American inventors 
     and entrepreneurs billions. The will see this retreat on our 
     part as a ready excuse to implement their own minimalist 
     versions of intellectual property protection. It will be 
     difficult, if not impossible for the United States to force 
     other nations to adhere to the TRIPS agreement if we set this 
     unfortunate precedent.
       In sum, in exchange for the hope of short term savings, the 
     Pryor proposal could cost all U.S. firms and workers the 
     enormous long term gains we worked so hard to achieve in the 
     Uruguay Round. That is penny wise and pound foolish. The 
     United States must continue to be a leader on full 
     implementation of every aspect of the agreement on 
     intellectual property in both substance and in form.
       One final additional point. Domestically, this legislation 
     would upset the delicate balance provided for in the Hatch/
     Waxman Act, which already grants generic pharmaceutical 

[[Page S 18214]]
     firms special treatment in the area of patents not available to other 
     industries. S. 1191 would further the bias against pioneer 
     pharmaceutical firms.
       Please give careful consideration to the negative impact 
     this legislation would have. I would be delighted to give you 
     additional specifics if it would be helpful.
           Sincerely,
                                                 William E. Brock.

  Mr. HATCH. I also take exception to those such as Senator Pryor and 
Ambassador Kantor who suggest this amendment achieves a result clearly 
intended by the URAA.
  This is the position that was taken in a September 27 letter from the 
FDA Deputy Commissioner for Policy, William Schultz.
  I must highlight with great skepticism the portion of the FDA letter 
that states in part: ``the URAA does not address the effect of the URAA 
patent term extensions on the drug approval process under the Federal 
Food, Drug, and Cosmetic Act * * *''
  It may be true that the URAA does not address the question in a way 
the FDA and proponents of the Pryor amendment would like, but let us be 
crystal clear that the relevant statutes do, in fact, address this 
question.
  I find the characterization in the September FDA letter particularly 
interesting in light of the earlier May 25, 1995 FDA response to a 
citizen petition filed by several innovator drug firms.
  The May FDA statement of policy is quite explicit on what the law 
addresses. In that statement, the FDA acknowledged that the Supreme 
Court's 1984 Chevron decision provides guidance in the area of 
statutory construction. In Chevron, the Supreme Court instructed ``If 
the intent of Congress is clear, that is the end of the matter; for the 
court, as well as the agency, must give effect to the unambiguously 
expressed intent of Congress.''
  Consider the following five direct quotes from the May FDA statement 
signed by Deputy Commissioner Schultz:
  No. 1:

       The agency believes that interpretation of the 
     interrelationship between the transitional provisions of 
     section 532(a)(1) of the URAA and 35 U.S.C. is governed by 
     the plain language of the URAA.

  The second direct quote from the FDA May statement signed by the very 
same Deputy Commissioner Schultz:

       The URAA is not `silent or ambiguous' on the question of 
     applying the transitional provision to the generic drug 
     approval process.

  Let me give you the third:

       Moreover, this apparently is not an example of Congress 
     having overlooked a statutory provision that might have been 
     changed had it been aware of its existence . . .

  No. 4:

       . . . the agency does not believe that it can assert that 
     Congress was unaware of the existence of these remedies for 
     infringement of patents on drug products, and, therefore, did 
     not include them among the unavailable remedies. . . of the 
     URAA.

  And finally, No. 5:

       In the present matter, therefore, the plain meaning of the 
     URAA is dispositive.

  This is quite a contrast from the recent letter from Mr. Shultz which 
can be called nothing less than political.
  In the May letter, this FDA official makes some very compelling and 
categorical findings which support my arguments about the proper 
interpretation of the relevant statutes. A number of courts have issued 
rulings consistent with this interpretation.
  For example, on August 8, 1995 the United States Court of Appeals for 
the Federal Circuit issued a ruling in the case of DuPont Merck 
Pharmaceutical Company versus Bristol-Myers Squibb.
  Upon reviewing the relevant statutes the court found that, ``* * * 
the URAA does not clash with the Hatch-Waxman Act,'' and precluded the 
generic manufacturers from entering the market via the Waxman-Hatch 
route until the expiration of the affected patent. Likewise, as I 
stated earlier, on October 16, the United States District Court for the 
Eastern District of Virginia issued an opinion in a group of four 
consolidated cases that raised similar but not identical URAA/Hatch-
Waxman issues.
  In this case, Merck versus Kessler, the court was unpersuaded by the 
arguments made by the generic drug industry and stated ``This was no 
more a windfall * * * than the windfall which benefited many patent 
holders when the 17-year term of patents was extend to 20 years.''
  I think the District Court got the law on the windfall issue exactly 
right.
  Finally, I would note that on November 1, the Federal Circuit, the 
court that handles patents, copyrights, and trademark issues, 
overturned a decision rendered by the United States District Court for 
the Southern District of Florida in the case of Bristol-Myers Squibb 
versus Royce Labs.
  Although, as I have laid out, various officials in the current 
administration and the proponents of the amendments now flatly assert 
that Congress clearly intended the result they wish to achieve, it is 
instructive that the Federal Circuit ruling--this is last November 1, 
just a little over a month ago--noted:

       The parties have not pointed to, and we have not 
     discovered, any legislative history on the intent of 
     Congress, at the time of passage of the URAA, regarding the 
     interplay between the URAA and the Hatch-Waxman Act. 
     Therefore, we limit our inquiry to the wording of the 
     statute.

  I wonder what tangible information that Ambassador Kantor and the FDA 
possess on this issue of intent and why neither the litigants nor the 
Federal Circuit appear to have it at their disposal?
  In finding against the generic manufacturer the Federal Circuit makes 
a number of points in the Bristol-Myers Squibb versus Royce Labs case 
that I wish to bring to my colleagues' attention:
  1. The decision notes the unique treatment afforded to new drugs by 
the 1984 law. The Federal Circuit said:

       Yet, as the Supreme Court stated in Eli Lilly Co. v. 
     Medtronic Inc., the Hatch-Waxman Act created an important new 
     mechanism designed to guard against infringement of patents 
     relating to pioneer drugs, with enforcement provisions that 
     apply only to drugs and not to other products.

  2. The Court also observed, citing as authority the 1990 Federal 
Circuit decision in the VE Holding Corp. case: ``We presume `that 
Congress is knowledgeable about existing law pertinent to legislation 
it enacts.' ''
  3. The Court went on to say that:

       We believe that if Congress had intended that the URAA 
     affect the Hatch-Waxman Act's finely crafted ANDA approval 
     process in the manner urged by [generic manufacturers], at 
     the very least it would have referred to 21 U.S.C. 355(j) and 
     35 U.S.C. 271(e) in the URAA.

  4. Finally, the Federal Circuit boiled down the situation as follows:

       The statutory scheme does not say, as [the generic 
     manufacturer] argues . . ., ``If normally you would infringe, 
     you do not infringe during the Delta period.'' Rather, it 
     says, ``If normally you would infringe, you also infringe 
     during the Delta period.''

  So let there be no doubt in anyone's mind about the clarity of the 
law or the intent of Congress in this area.
  Having discussed the trade policy argument and the ``it-is-merely-an-
unintended-technical- oversight'' argument, I would like next to 
address this windfall issue since it goes to the heart of the argument 
advanced by those behind this amendment.

  Let me say to my colleagues that my involvement in the Hatch-Waxman 
Act of 1984 compelled me to think carefully about the need for 
balancing incentives.
  The American public should enjoy the benefits both of low-cost 
generic medications and breakthrough products developed by R&D-based 
firms. I have worked hard to see that both sides are taken care of. Let 
me repeat that: Both lower-cost generic drugs and breakthrough drugs 
ought to be available to American consumers.
  The challenge is to devise incentives that foster the availability of 
both breakthrough and generic drugs. That is precisely what Hatch-
Waxman attempts to do and has done.
  Let there be no doubt that I am a supporter of both the generic and 
the innovator sectors of the pharmaceutical industry. One of my great 
regrets is that neither sector has as large a presence in my State of 
Utah as they do in many other States across the Nation. But both are 
there.
  Nevertheless, both of these players in the pharmaceutical market 
produce products that have enormous benefit for citizens in Utah and 
everywhere. It is for that reason that we must weigh heavily any 
legislation that would adversely affect their ability to deliver these 
products to the public.
  The fact that I oppose this particular amendment does not change the 
fact that I am, and will remain, a devoted supporter of the generic 
drug industry. Unlike my colleagues proposing this 

[[Page S 18215]]
amendment, however, I am convinced that it would be unwise to adopt 
this measure.
  The proponents of the Pryor amendment urge that only one industry is 
singled out in current law for different treatment under the URAA 
transition rules. What is absent from this line of reasoning is the 
fact that only one industry, the generic drug industry, is permitted by 
current law to engage in activities that would ordinarily constitute 
patent infringement--and I am one of the people who helped them get 
there.
  Mr. President, I remind my colleagues that before we so hastily throw 
around the terms ``windfall'' and ``unjust enrichment'' let us clearly 
understand the laws and policies at issue and how they affect 
incentives for biomedical research.
  One of the centerpieces of this debate is the operation of the so-
called ``Bolar Amendment'' contained in the Hatch-Waxman Act and 
codified at 35 U.S.C., section 271.
  In the 1984 Roche versus Bolar case, the Federal Circuit held that 
the manufacture or use of a patented product for the development of 
data to submit to FDA constituted patent infringement.
  It is this provision of the Hatch-Waxman Act that treats generic drug 
manufacturers differently from every other industry in our economy.
  Under the Hatch-Waxman Act generic drug firms may legally use a 
pioneer product to help secure FDA approval and can gear up production 
to go on the market before the pioneer product patent expires. Normally 
such activities would constitute patent infringement, clear and simple.
  There is nothing similar to the special treatment afforded the 
generic industry elsewhere in the patent code. This unique status is 
sufficient to justify treating generic drug products differently 
treatment under the URAA transition rules.
  One of the things that I find troubling about this amendment today, 
like the previous amendment offered at the Finance Committee mark-up, 
is that the Senate floor--when debating a bill to ban partial-birth 
abortions--may not present the best time or place to reconsider the 
details of such carefully crafted bills such as the URAA and the Hatch-
Waxman Act.
  The FDA policy statement issued in May states:

       The 1984 Waxman-Hatch Amendments to the Federal Food, Drug, 
     and Cosmetic Act represent a careful balance between the 
     policies of fostering the availability of generic drugs and 
     of providing sufficient incentives for research on 
     breakthrough drugs . . . There is certainly a strong argument 
     to be made that such a compromise should not be upset without 
     hearings and careful deliberation as to the impact on the 
     twin interests served by the Waxman-Hatch Amendments.

  As Chairman of the Judiciary Committee, I can say that the Committee 
has an interest in any legislation, such as Senator Pryor's, that 
affects patent rights. As one of the authors of Waxman-Hatch and as an 
advocate for both the generic and pioneer sectors of the industry, I 
have a special interest in the legislation under debate.
  But since this debate is taking place now, I believe that I have a 
responsibility to provide perspective on some of the changing pressures 
on the biomedical research and development that have occurred since the 
passage of Hatch-Waxman back in 1984.
  Let me turn to some charts which I believe illustrate this, and I 
will do this to try to move along. However, this is an important issue, 
which should not just be tossed aside. Nor should we act like this is 
just a simple little issue between consumers and gouging drug 
companies.
  Let me turn now to some charts which I believe illustrate the broader 
context in which this amendment must be evaluated.
  There are a number of complex factors that shape the environment of 
the biomedical research enterprise in this country.
  By placing their sole focus at the back end of the R&D pipeline and 
on those few products that are successfully commercialized, the 
proponents of the amendment do not take into account the nature of the 
risks involved in conducting the necessary research leading to 
development of new drugs.
  If the United States is to remain the world's leader in health care 
technology and our citizens are to continue to receive the latest in 
medical advances, it seems to me that the Senate has a responsibility 
to look at the factors that influence participation in the front end of 
the development pipeline.
  In my view, it is critical that we work to create the incentives 
necessary to attract trained personnel and resources into biomedical 
research and development.
  This first chart shows pharmaceutical research and development as a 
percentage of sales. As you can see, the electrical products industry 
spends 2.5 percent on research and development as a percentage of 
sales, the telecommunications industry 3.7 percent, the aerospace 
industry 4.2 percent, the scientific instruments industry 5.4 percent, 
and the office/computer machinery industry 8.0 percent. On the other 
hand, in 1993 the pharmaceutical research and development companies 
spent 18.3 percent of their total sale on research and development.
  That is what is involved here--research, research, research--the hope 
for the future that we might solve some of these immense medical 
problems.
  As you can see, the ratio of R&D investment as a percentage of 
product sales is significantly higher than for other representative R&D 
industries such as electronics, computers, aerospace, and 
telecommunications.
  As a result of this investment, the United States still enjoys a 
positive balance of trade in the area of pharmaceuticals. Between 1989 
and 1994, the sum of these annual positive balances was over $5.2 
billion.
  Maybe if other industries would invest as much in R&D as the drug 
industry, the United States could once again have a favorable overall 
balance of trade.
  A favorable balance of trade means jobs for Americans, and that is an 
important consideration in today's economic climate.
  Let me go to the next chart. This next chart shows how many research 
misses it takes for pharmaceutical companies to find a hit that is 
commercially viable. This shows how many chemically synthesized drugs 
there are. The reason we have the break here is because the poster is 
not large enough to show how high this bar would really go--5,000 drugs 
identified. Of those 5,000, only 500 were tested in organ preparations. 
Of those, only 250 were tested in animals, 5 in human clinical studies, 
and only one was eventually approved for use in humans by the FDA. One 
out of 5,000 tries becomes a hit--one.
  These companies take tremendous risks in trying to come up with a 
marketable drug, one that will return what it costs for the research 
and development to develop it.
  As you can see, for every successful drug that emerges out of the 
pipeline, 5,000 potential products drop by the wayside.
  One other fact to note as we go from activity to activity across the 
bottom of this chart is that these activities get costlier as we move 
from test tube to the patient's bedside.
  Let me go to the next chart because these are things you should not 
ignore. This chart shows that this is a bigger policy issue than the 
belief by some that these companies are gouging.
  This next chart shows the drug development cost rising over time. In 
1986, the cost to develop a new drug was $151 million. In 1990, the 
average cost for the approval of a new drug was $359 million.
  As you can see, it costs a lot of money to bring a new drug to 
market. In addition, these costs have risen since the passage of the 
Hatch-Waxman law in 1986. And these costs continue to rise today.
  Clinical and preclinical tests are costly. They are difficult. And 
they are highly regulated activities.
  As you can see, a significant amount in gross sales must be generated 
by each one of these research companies, like any one of the ones they 
are complaining about here, to recover the huge drug development costs. 
There has to be in the billions of dollars of sales to recuperate their 
research and development companies.
  If they do not recuperate those moneys at least a part of the time--
and they do not a lot of the time--they are not going to stay in 
business. If this happens, we will not have these blockbuster drugs, 
and we will not have the 

[[Page S 18216]]
life-saving pharmaceuticals that are saving people's lives every day.
  We will not have a cure for AIDS, and we will not have a cure for 
Alzheimer's disease or any other number of diseases.
  The next chart shows that there is a public/private partnership in 
drug research and development.
  Mr. CHAFEE. Mr. President, I wonder if I might ask the Senator a 
question, if it is possible to reach a time agreement on this?
  Mr. HATCH. There sure is. I will be through in a few minutes. I do 
not think that I will have any more to say, unless somebody asks 
questions. I am happy to reach a time agreement.
  Mr. CHAFEE. I ask the sponsor. We are all here. Can we arrive at a 
time agreement?
  Mr. HATCH. Why don't you get your side together, let me finish my 
remarks and then we will agree on a time agreement?
  Mr. CHAFEE. You are in such flying form. You have all of your engines 
running.
  Mr. HATCH. That is why I want to finish my remarks. This is an 
important issue. As the author of the Hatch-Waxman Act, I am very 
concerned about it. However, I do not intend to take too much longer. 
We are going through the salient points.
  This particular chart shows R&D expenditures. NIH expenditures are 
the blue bars. The private sector expenditures are the green bars. The 
private sector means the pharmaceutical research company.
  In 1985 we spent more on research and development in the NIH --$4.8 
billion--than was spent by the pharmaceutical companies --$4.1 billion 
on R&D.
  In 1988, R&D for the pharmaceutical companies started to surpass 
NIH--$6.3 billion for NIH, and $6.5 billion for the pharmaceutical 
companies.
  In 1991, the NIH spent $7.7 billion, and the pharmaceutical companies 
jumped to $9.7 billion.
  In 1995, the NIH will spend $11.3 billion on research and 
development. The pharmaceutical companies will spend almost $15 
billion.
  Pharmaceutical companies are doing the job. Do not undercut them. 
This amendment undercuts them. This amendment appears to be a populist 
amendment. It seems to have appeal to those who think they are on the 
consumer side. But the consumer really is on both sides--one side would 
lead to lower drug costs on the short run, our side would lead to 
continued support of the research and development of drugs for the long 
term.
  Research and development benefit the generic companies because if 
they do not get to blockbuster drugs, the generic companies will not be 
able to copy them.
  I have already shown that the drug industry spends a relatively large 
proportion of its earnings in R&D and that the cost of bringing the 
successful drug to market is high and rising.
  That chart shows one of the most significant developments in the 
biomedical research enterprise since the passage of Hatch-Waxman in 
1984.
  The R&D expenditures by pioneer drug companies now--for the first 
time in recent history--exceeds the funding of the National Institutes 
of Health.
  One of the major reasons that the United States is the world's 
recognized leader in biomedical research is the public investment made 
in NIH since World War II.
  American citizens have enjoyed the benefits of the close partnership 
that has developed among pharmaceutical and medical device firms, 
academic medical centers, and the NIH.
  The basic research conducted at and supported by the NIH is 
complemented by the private sector R&D efforts.
  This is the type of public-private partnership that we can all take 
pride in and should fight to retain in the future.
  We do not want to take away the incentives of R&D. That is what this 
amendment does.
  We all know of too many instances in which our foreign competitors 
have exploited their close linkages between Government and industry to 
wrest away U.S. industrial leadership. If we Americans leverage 
together our public and private sector resources, we can compete 
against anyone in the world.
  As we tighten our budget belt to put the Nation's fiscal house in 
order, I do not think it is realistic to expect that we will continue 
to see the growth rate in the NIH budget that is represented on this 
chart.
  But I want to see this growth rate of the research companies 
continue.
  Since 1988, the NIH budget has almost doubled.
  If we are to retain our world leadership in biomedical research it 
will be important to retain the incentives that will encourage drug 
firms and the capital markets to invest their resources in this 
research.
  This chart shows that industry is stepping up to the plate.
  American citizens and families around the world will benefit from 
this research.
  What is the difference between the regulatory review requirements for 
generic versus pioneer drugs?
  Let me show the difference for those of you who may not have a 
knowledge of FDA law. These are the steps to establish safety and 
efficacy for innovator drugs for these research companies, which take 
12 years to complete. In 1990, this process cost $359 million. Lab and 
animal studies, 3.5 years; phase one safety studies, 1 year; phase 2, 
testing effectiveness of studies, 2 years; phase 3, extensive clinical 
testing, 3 years; FDA review, 2.5 years.
  Under Hatch-Waxman, look at how the generic benefit. We provide a 
shortcut for generic drugs. All they have to do to take their drug to 
market is to complete a bioequivalency test and establish that their 
drug is bioequivalent. That takes 10 to 18 weeks.
  That takes 10 to 18 weeks, and an abbreviated new drug process which 
is 6 months. That is all they have to do. They do not have to spend 
$359 million. They can copy that drug the minute it comes off patent 
and eliminate the costs. This has made and built the whole generic 
industry and has benefited consumers through saving billions and 
billions of dollars since 1984.
  Are we going to just make it even more difficult for these companies 
that have made this whole industry by now, under Hatch-Waxman, and let 
them just take these drugs and run with them? I fought to get this 
done. I believe in generics. I think this ought to continue. Let us be 
very, very clear about it. This is a privilege that we give no one else 
in patent law, and we do it for consumers.
  Now, are we going to now to make it very, very difficult to produce 
the drugs that these people have to have to be able to survive? I hope 
not.
  A study by the Tufts University Center for the Study of Drug 
Development estimated that it takes on average $359 million and 12 
years to get a new drug approved by the Food and Drug Administration. I 
know that is insane, but that is what it takes.
  A lot of time elapses in the laboratory just determining the best 
drug candidates through test tube and animal studies. Three complex and 
time-consuming phases of human clinical trials are required to develop 
the necessary safety and efficacy data that must be submitted to the 
FDA. This testing takes time and money.
  It is essential in this debate to understand that the generic drug 
manufacturers are not required to undertake any of this extensive and 
expensive testing.
  Let no one undervalue the importance that this testing process has 
for the health and safety of every American.
  In contrast to the rigorous safety and efficacy requirements placed 
on the pioneer drug firms--these up here that takes 12 years and $359 
million to develop a drug,--the Hatch-Waxman law provides for a much 
simpler and easier approval standard for generic drugs.
  Generic drug manufacturers can rely upon the safety and efficacy data 
of pioneer firms and must only show that their product is bioequivalent 
to the pioneer product. That can be done in a matter of weeks, not 
years, at a fraction of the cost and none of the risks that are faced 
by these pioneer firms.
  According to a 1992 Frost & Sullivan study, after the passage of the 
Hatch-Waxman Act, the average cost for a generic drug company to 
prepare and file an abbreviated new drug application is ``well below 
the million mark.''
  A large part of the reason why generic drugs can be sold for less 
than brand-name products is that the generic companies do not have to 
perform the extensive research and clinical 

[[Page S 18217]]
trials required of innovator drug companies. Nor do generic drug firms 
have to finance all the products that fall by the wayside.
  Generic drug companies piggyback on the fruits of the pioneer's 
research. We permit that. We want that to occur. But we should not 
ignore what a great thing the pioneer companies do for us.
  There is a tremendous amount of appeal to an amendment which appears 
to provide consumers with the opportunity to greater access to lower-
cost drugs. If Senator Pryor's proposal were that simple, I would be 
for it. It is easy to get up and make it look like your approach is the 
only approach for consumers.
  But if the companies that go through these 12 years, $359 million, 
5,000 tries to get one drug are undercut, we are all undercut, and the 
generics will not have any drugs to copy so that they can keep their 
industry going.
  It is penny-wise and pound-foolish to treat this like it is some 
simple little consumer versus gouger issue. It is a lot more than that.
  Senator Pryor's proposal is not that simple. You cannot accept it on 
face value. You have to delve into all the facts and the case law. 
Failure to examine this information about the nature of these two 
industries would be shortsighted at best.

  In fact, there could be some short-term financial gains for some if 
we did not provide full patent term for a whole range of products. By 
that logic, however, we ought to just make everything generic--generic 
appliances, automobiles, electronics, everything. It would save the 
consumers all kinds of money.
  It would also dry up all research and development, all technology, 
all the investment in quality and efficient production, including jobs 
and the vast array of choices Americans have as consumers.
  We would no longer have breakthrough drugs which are improving and 
saving the lives of so many millions of Americans.
  As I have said, I have a tremendous affection for both the brand name 
and generic industries. They are both important to our Nation's health 
care.
  In my view, it is clearly in the best interests of consumers that 
both pioneer and generic drug companies exist harmoniously in our 
competitive drug and medical marketplace.
  It serves neither the public nor this body well for us to berate 
continually the R&D-based pharmaceutical industry which is doing so 
much good in this world and ironically is the industry upon which the 
generic companies themselves rely.
  I believe we have to defeat this amendment. I understand the 
distinguished Senator from Ohio has an amendment to this amendment. My 
personal preference would be to defeat this amendment and to stand up 
for American trade, American technology, American research and 
development, for the right to keep these products coming to these 
generic companies, for the right of all Americans to have access to 
reasonable and good and lifesaving drugs and to have the incentives to 
get us there.
  By the way, just to choose Zantac as an illustration, Zantac is a 
therapeutically important drug. It is one of the best antiulcer 
medications in the world today. Of course, there are other drugs of 
this class. Tagamet, for instance, is already subject to generic 
competition. It just so happened that the company that makes Zantac, 
Glaxo, had gone through this long, expensive research and development 
process, and they were left with an effective patent term of around 
12\1/2\ years after FDA approved this product. The URAA will extend its 
patent life for an additional 20 months or thereabouts.
  The fact is that the drug Zantac came out in 1983, 1 year before the 
Hatch-Waxman bill, and therefore had it been approved 1 year later it 
would have qualified for, as I understand it, 2 full years of further 
patent protection under the transition rules of Hatch-Waxman.
  In fact, Zantac was a loser under Hatch-Waxman. Well, it happens to 
be a winner under the GATT Treaty and Uruguay Round Agreement, and if 
we undercut that, yes, you might be able to say, well, they are going 
to make some additional revenues--I see your chart here--$3 billion, 
but let me tell you something. They spent millions of dollars 
developing this product, and they lost a substantial time of their 
patent term before the product was approved. Even with the time it 
receives under the URAA, it still does not get a full 17-year patent 
term.
  There is another side to the coin. I do not want anybody to get an 
unfair windfall, but it is hardly a windfall when firms are investing 
billions of dollars in research annually. I have to say that there were 
winners and losers under Hatch-Waxman, and there will be winners and 
losers under the GATT Treaty.
  But the bigger policy concern is how not to undercut the treaty and 
send the wrong message to the rest of the world. Undercutting 
intellectual property protection would be injurious to the whole world, 
or at least the 123 nations that agreed to GATT, and not undermining 
the incentives for pharmaceutical research that enables our country to 
be the leader in the world in this important endeavor.
  I do not think there is any reason for the generic companies to come 
in here and complain since their whole industry was created by the very 
bill that they are now trying to amend and take even further advantage 
when, in fact, they have a tremendous advantage today and will have 
every year that the Hatch-Waxman bill is in effect. So this is not some 
simple little gouging issue or some simple little equity issue.
  Mr. President, I have a number of concerns relating to the manner in 
which the language of the amendment is drafted. These concerns include: 
On substantive grounds, as I have argued earlier, I am opposed to the 
manner in which sections (a) and (b) of the amendment, respectively, 
act to overturn the 17 year from grant/20 year from filing choice of 
the URAA transition rules and the elimination of section 271(e) of 
title 35, United States Code, as the sole and unique remedy provided by 
the Hatch-Waxman Act.
  I am also concerned about the operation of the equitable remuneration 
provisions contained in section (c) of the proposed amendment. It 
appears to me that this provision puts the cart before the horse. Under 
the Hatch-Waxman law patent rights are carefully determined before a 
generic drug product may be approved for marketing.
  Section (c) of the amendment appears to reverse the operation of the 
URAA transition rules. Specifically, the amendment seems to allow a 
generic drug manufacturer to infringe and only allows a patent holder 
to seek equitable remuneration after the infringement has taken place. 
This is opposite of current law which makes a potentially patent-
infringing ANDA applicant subject to an infringement action and an 
equitable remuneration determination prior to the commission of any 
infringing act.
  I also will seek clarification of whether this amendment would permit 
the marketing of generic versions of products that vary slightly from 
innovator products without triggering the equitable remuneration 
provisions. Specifically, I will seek clarification of whether the 
phrase in section (c), ``an approved drug that is the subject of an 
application described in subsection (a)'', refers to the innovator drug 
or the generic copy.
  I am also concerned about the lack of guidance on the question of 
what constitutes a ``substantial investment'' under this amendment and 
whether an innovator firm may contest such an assertion made be a 
generic firm. In addition, I will seek a better understanding of what 
standards a court should apply when reviewing the apparently unilateral 
finding on the part of a generic manufacturer that it has made a 
substantial investment.
  So, there are many technical questions that can be raised about this 
amendment.
  At this point, I hope I have made the case for this side, and I 
personally hope that Senators will defeat the Pryor amendment and that 
we go about keeping the industry going the way it has been going in 
both areas for the benefit of all mankind.
  I yield the floor.
  Mr. CHAFEE addressed the Chair.
  The PRESIDING OFFICER. The Senator from Rhode Island.
  Mr. CHAFEE. Mr. President, with the principals in the Chamber here, I 
wonder if it would be possible to set a specific time that we might 
vote.
  I know a lot of Senators are out, so I do not think we are in the 
position 

[[Page S 18218]]
where we can go immediately to a vote in 15 minutes or so. I would 
offer the suggestion that we agree to vote at 8:30, while allowing time 
for the Senator from Ohio and others to speak.
  I defer to the Senator from New Hampshire.
  Mr. SMITH. I would say to the Senator from Rhode Island, we are 
working on that. We are very close. We are not quite there. We need to 
confer with Senator Hatch for a few moments. We may very well be able 
to come up with an agreement very similar to what the Senator just 
indicated, if he could give us a few more minutes.
  Mr. CHAFEE. Fine. I am just I suppose a catalyst here. But I do know 
that people are away, so that as much notice as can be given the 
better.
  Mr. DeWINE addressed the Chair.
  The PRESIDING OFFICER. The Senator from Ohio.
  Mr. DeWINE. Mr. President, Senator Dodd and my second-degree 
amendment to the Pryor amendment expresses the sense of the Senate that 
the Senate should, through the Committee on the Judiciary, conduct 
hearings to investigate the effect of these new patent provisions in 
title 35. I think it makes eminent sense to do this. Let me just, while 
I see my colleague from Utah on the floor, get his attention for a 
moment and ask him if he could respond to a question.
  Mr. HATCH. Sure.
  Mr. DeWINE. The second-degree amendment Senator Dodd and I have 
offered provides that this issue would be referred to the Judiciary 
Committee for hearings. And as chairman of the Judiciary Committee, I 
wonder if the Senator could give the Members of the Senate some 
indication of how he intends to conduct the hearing or what time there 
would be in that event. There have been some questions on the floor. 
And I think we should respond to the Members before the voting in 
regard to that.
  Mr. HATCH. I am not adverse to hearings. I think this is that 
important. In fact, I think it is an appropriate way to proceed. I have 
to tell the Senator that we have about all we can handle for the rest 
of the year on the Judiciary Committee. I do not think anybody doubts 
that. We have the judges, the matters on the floor, and hearings 
scheduled.
  So I would be very happy to agree to some sort of date certain, at 
least within a time period. I think you ought to give us, I would say, 
at least 120 days in which to hold a hearing. But I will try to hold it 
as expeditiously as possible within that period. We will be fair to 
both sides, because I think both sides need to be fully aired on this 
matter.
  If we hold such a hearing, if the Senator prevails on his amendment, 
I would do that expeditiously. It would probably be some time after the 
first of the year, but hopefully within 120 days.
  The hearing will give both sides a real airing of this. We will treat 
this issue--not like some demagoged issue, but treat it like it should 
be treated, that is, as one of the most important issues in the history 
of trade negotiations.
  So it is up to the Senator. It is his amendment. But I will be happy 
to put it within a certain timeframe. If the Senator will tell me what 
he wants, I will be happy to try to do that. If the majority leader 
tells me, I will be happy to do that.
  Mr. DeWINE. It would be my understanding, from the statement made by 
the chairman, that he would be willing to hold these hearings, and 
Members of the Senate could be advised these hearings would take place 
sometime within the next 120 days. Is that correct?
  Mr. HATCH. If I understand the distinguished Senator, I would be 
willing to set it within 120 days, and notify all Members when it will 
occur, of course. I have no problem with that. I will give advance 
notice about it.
  Mr. DeWINE. I thank the Senator very much.
  (Mrs. HUTCHISON assumed the chair.)
  Mr. DeWINE. Madam President, let me continue briefly in regard to 
this matter.
  Madam President, I think it is abundantly clear after we have 
listened to this debate--my colleague from Rhode Island, my colleague 
from Arkansas, both have been very, very eloquent in regard to this 
issue--I think it is clear, after listening to my colleague from Utah, 
the chairman of the Judiciary Committee, that there are two sides to 
this issue, that there is a very complicated, a very serious issue, and 
it is the type of issue, quite frankly, that we should have hearings.
  We should, as the chairman of the Judiciary Committee just said, hold 
those expeditiously. We should hear from both sides of the particular 
issue. And then I believe we will be in a much better position for this 
Senate to take a position and to actually hold a vote.
  I think as we listen to this debate it is just abundantly clear that 
there are legitimate issues, arguments on both sides of the debate and 
that we should examine those. Frankly, the only way this Senate has to 
examine them at length is not just by debate on this floor, but it is 
also by actual hearings. So I think Members of the Senate should 
understand that the vote in favor of the DeWine-Dodd amendment would, 
in fact, guarantee that these hearings would take place and the Senate 
would have the opportunity to have the benefit of hearings.
  There are two sides to this. On the one hand opponents of the Pryor 
amendment argue that shortening the patent term contained in the 
agreement on trade related aspects of intellectual property rights, 
that provision in the Uruguay round of GATT would have detrimental 
effects on both the development of new and innovative medicines and 
also the global patent protections gained for United States 
manufacturers in Uruguay.
  In fact, Madam President, according to former Surgeon General Dr. C. 
Everett Koop, who my colleague from Utah has already quoted, to bring a 
new single medicine to patients requires on the average an investment 
of 12 years and $350 million. Of the components tested in a laboratory, 
only 20 percent ever make it onto pharmacy shelves, and only a third of 
those ever earn a return on the investment made through the discovery.
  Madam President, if we weaken patent protections on these products, 
we will stifle innovation, and slow down further the discovery of new 
treatments for diseases such as possibly AIDS or cancer.
  Two former U.S. Trade Representatives, Clayton Yeutter and William 
Brock, argue that passage of the Pryor amendment would set a bad 
precedent. It would cost all U.S. firms and workers the enormous long-
term gains that the Trade Representatives worked so hard for in 
Uruguay. It would do this by making it nearly impossible for the United 
States to force other nations to adhere to the intellectual property 
protections of this agreement.
  Robert L. McNeill, executive vice Chairman of the Emergency Committee 
of American Trade, said the following:

       . . . enhanced protection of intellectual property rights 
     will be diminished abroad if the United States itself 
     violates the patent term contained in the [intellectual 
     property rights protections] agreement. It is almost certain 
     that such an action would provide foreign-based pirates and 
     patent infringers with potent ammunition in seeking to have 
     their domestic governments devise measures that are 
     inconsistent with [these protections.]

  Madam President, on the other hand, supporters of the Pryor amendment 
argue that failure to amend the Hatch-Waxman Act would place a 
substantial burden on consumers. Moreover, according to U.S. Trade 
Representative Kantor, amending the act would ``in no way increase the 
ability of our trading partners to justify their failure to provide * * 
* consistent patent protection [for intellectual property rights.]''
  So clearly, Madam President, this amendment is not as 
straightforward--the underlying amendment by my colleague from Arkansas 
is not as straightforward as it might appear on the surface. This is 
legislation that should be debated fully and not thrown in as an 
amendment to the partial-birth abortion bill.
  Madam President, I yield the floor.
  Mr. DODD. Regardless of one's view about the merits of the issue, an 
abortion bill is not the appropriate place to take up the GATT patent 
issue. This amendment is complicated, involving issues of patent law, 
trade, innovation and new drug therapies. This issue needs a full 
hearing, so that we can get past demagoguery and really look at the 
issues carefully.
  That is why Senator DeWine and I are suggesting that we hold at least 
one hearing on the issue before adopting an amendment that would deny 
the 

[[Page S 18219]]
benefits of GATT to U.S. innovator pharmaceutical companies.
  The underlying amendment would result in substantial changes in two 
statutes--the GATT implementing statute and the 1984 Hatch-Waxman Act. 
The first is a trade treaty that we negotiated in good faith with many 
other countries who are relying on our commitment to abide by the 
strong international patent protections that were a major achievement 
of GATT. The Hatch-Waxman Act provided special rules for generic drugs 
that give the generic drug industry an advantage possessed by no other 
industry in the United States or the industrialized world. These two 
statutes were developed carefully to ensure that this country continues 
to lead the world in innovative drugs and new therapies.
  These are not issues to be treated lightly. The proposed Pryor 
amendment is not a technical amendment to the GATT law, though that's 
how its been characterized. The GATT language was carefully negotiated 
and should not be amended without careful thought and consideration of 
the implications.
  The Hatch-Waxman Act represents a careful balance between the 
interests of innovator manufacturers and generic drug companies. It has 
worked well for more than 10 years and should not be amended lightly.
  The proposed amendment also would have a direct and significant 
effect on patent rights, which fall squarely within the jurisdiction of 
the Judiciary Committee. The dramatic changes that would result from 
the proposed amendment would occur without the benefit of prior 
congressional consideration.
  We should not rush to legislate in this area before we hold hearings 
and give careful consideration to all of the proposed amendment's 
potential ramifications. I urge my colleagues to support holding a 
hearing on this issue before voting on a measure that could send a very 
dangerous signal to our trading partners
  Mr. PRYOR. Madam President, I now ask for the yeas and nays on the 
second-degree amendment.
  The PRESIDING OFFICER. Is there a sufficient second?
  There appears to be. The yeas and nays are ordered.
  The yeas and nays were ordered.
  The PRESIDING OFFICER. Is there further debate?
  Mr. PRYOR. Madam President, do I have the floor at this time?
  The PRESIDING OFFICER. You have been recognized.
  Mr. PRYOR. Madam President, I do not know where the time agreement 
stands. We have been negotiating during the course of the evening. I 
know Members of the Senate are at home for dinner and need at least 30 
minutes notification.
  I would like to say, and I think I can speak for Senator Chafee, that 
we are reaching a point where we are ready to determine a time certain 
to vote. I would strongly encourage that. I do not know of any other 
speakers we have on our side. I have a few more comments I would like 
to make about this subject. I wonder if the Senator from New Hampshire, 
the manager of the bill, might have any comments on a time agreement, 
or a time certain?
  Mr. SMITH. Mr. President, I believe everyone on our side has spoken 
who wishes to speak. How much time does the Senator wish?
  Mr. PRYOR. I might suggest that we vote at 8:35. If there are no 
speakers on the other side, I would like to take the remaining time.
  Mr. BIDEN. If the Senator will yield, is it possible to consider--I 
guess it is a leadership decision--starting the vote at 8:25 and let 
the vote extend, so that those of us who are trying to get 
transportation out of the city on an 8:30 train could make the train? I 
will not insist on that, but if it is possible, that would be nice--
since no one else wants to speak and we are worried about getting 
people in here to vote. A couple of us want to get out of here. Is it 
possible to do that?
  Mr. SMITH. Did the Senator say 8:30?
  Mr. BIDEN. I only need 7 minutes to make it to the train.
  Mr. SMITH. That depends on whether or not the Senator wants to miss 
the vote.
  Mr. BIDEN. No.
  Mr. PRYOR. I think, more importantly, is the Senator going to vote?
  Mr. BIDEN. Yes.
  Mr. SMITH. The Senator from Arkansas asked for how much time?
  Mr. PRYOR. Here is what our policy committee has requested. We think 
it is going to take at least 30 minutes to get our Members here. 
Therefore, I would like to respectfully suggest that we vote at 8:45 on 
the motion to table the second-degree amendment.
  Mr. HATCH. If the Senator will yield, can we protect a few minutes on 
this side? I understand Senator Helms may want to speak. I might want 
to say one or two things.
  Mr. PRYOR. If we can divide the time equally, we can have 15 minutes 
and you could have 15 minutes.
  Mr. HATCH. We may yield back subsequent to that time if it helps our 
colleagues.
  Mr. SMITH. I will propound a unanimous consent request.
  I ask unanimous consent that a vote occur on or in relation to the 
Smith amendment at 8:45 and the time between now and 8:45 be equally 
divided between the two sides.
  The PRESIDING OFFICER. Is there objection?
  Without objection, it is so ordered.
  Mr. PRYOR. Madam President, I think this has been a very educational 
debate, to say the least. During the course of the evening, it has been 
proposed that we try to have a time certain placed on the sense-of-the-
Senate resolution offered by the Senator from Ohio and others. It has 
further been proposed that if this issue goes before the Senate 
Judiciary Committee, there might be, for example, a 120-day period when 
the report from the committee comes back to the floor of the Senate.
  Madam President, with all due respect to that idea, let us just look 
for a moment at what that would do. We have done a little calculation 
here. If we extend 120 days of protection to Glaxo for Zantac alone--
and this does not include the other dozen or so drug companies under 
this umbrella-- 120 days of not resolving this problem will give them 
unlimited opportunities to charge the highest price for their drug. 
They will have unlimited protection from any generic that wants to come 
to the market. Simply put, we are going to be depositing $720 million 
to the bank account of Glaxo, because by next Christmas of 1996, which 
is just about 12\1/2\ months from now, Glaxo will have made an extra 
$2.328 billion if we fail to close this loophole.
  Madam President, I, as a U.S. Senator, am not a stockbroker. I will 
never advise anybody to buy any stock or make investment because I have 
never been very successful at that myself. But if we extend this for 
120 days, or even another 30 days, without closing this loophole, I 
suggest that we all go out in the morning and buy Glaxo stock because 
they are going to continue receiving an enormous windfall that they had 
no idea they would receive.
  Madam President, second, I ask unanimous consent to add three 
additional original cosponsors: Senator Bryan, Senator Leahy, and 
Senator Dorgan.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mr. PRYOR. Next, Madam President, there has been a discussion this 
evening and quotes by my friend from Ohio, Senator DeWine, and from 
Senator Hatch of Utah, about Dr. Koop. Well, Dr. Koop got drawn into 
this issue in a very interesting way, and it appears to me, after 
talking to Dr. Koop some days ago, that Dr. Koop may not have been 
aware of--or the Glaxo people may not have presented the true case to--
Dr. Koop when they had him sign a particular advertisement which 
appeared in The Hill newspaper. It also appeared earlier in the 
Washington Post. This is the advertisement that Dr. Koop signed on 
October 25, 1995. The advertisement appears to have been purchased by 
Dr. Koop to say that ``Senator Pryor's bill would weaken the patent 
protection needed for the next generation of pharmaceuticals.''
  I called him up and I said, ``Dr. Koop, I am probably your No. 1 fan 
in this country. I have supported you, I have revered you, and now you 
have signed this advertisement in all these papers saying that you are 
opposed to my amendment.'' He says, ``What amendment?'' I said, ``The 
amendment with which we are trying to close this loophole.'' He said, 
``I did not know that was what it was all about.'' 

[[Page S 18220]]

  Well, on December 3, a Journal of Commerce appeared about Dr. Koop. 
``In a brief interview, Dr. Koop said he did not know the details of 
the lobbying campaign by Glaxo-Wellcome when he agreed to lend his name 
to what was described to him as an effort to preserve patent drugs from 
foreign piracy.'' In fact, the lobbying was an effort by a British drug 
company to retain an inadvertent million-dollar loophole in last year's 
trade bill at the expense of generic drug companies. Dr. Koop said he 
was unaware that a general statement he had made on patent rights would 
be used in the Glaxo campaign. When asked by a reporter if he had been 
done a disservice by Glaxo officials, Dr. Koop responded, ``I would 
have to say I was,'' and expressed regret that he had ever been 
involved in the fight over Glaxo's loophole.

  Madam President, I have heard my very good friend from Utah talking 
about all of the research dollars that are being expended to find all 
of these cures for all of the problems and ailments and diseases that 
we have today. I want to compliment the pharmaceutical companies for 
doing a wonderful job. They are second to none in the world.
  But, Madam President, I do not think we need to shed any crocodile 
tears for the company Glaxo. One, it is the biggest drug company in the 
world, and when the Glaxo research was done on Zantac alone, which was 
over two decades ago--and they have had patent protection, no 
competition whatever for a period of 17 years, no competition, Madam 
President--when that research was done, not only was most of it done by 
NIH and farmed out to universities throughout the educational system 
across the land, but taxpayers' dollars helped dramatically in finding 
the research and the answers that this particular drug/pharmaceutical 
was intended to cure.
  Let's don't shed too many crocodile tears when we are talking about 
research. First, Glaxo is probably much like the other drug companies. 
They are spending more today to market and advertise their drugs than 
they are to research the new--as they say, blockbuster--drug 
breakthroughs. They are spending more now for marketing than they are 
for research.
  Let's look at Glaxo itself, and at the pretax profits for the last 12 
months: $3.3 billion--not millions of dollars, but $3.3 billion. And 
much of this came from the best-selling drug in the world today, 
Zantac, which, unless we close this loophole, we are going to provide 
further protection from competition.
  Madam President, we have also heard a lot of discussion about patent 
rights and intellectual property rights. Let me once again refer, as I 
have in the past and as Senator Chafee has, to a letter that I 
received, or actually Senator Chafee received.
  I think I received an identical letter, dated September 25, in which 
our U.S. Trade Representative, Ambassador Mickey Kantor, said, ``This 
provision [the transition rules] were written neutrally because it was 
intended to apply to all types of patentable subject matter, including 
pharmaceutical products. Conforming amendments should have been made to 
the Federal Food, Drug, and Cosmetic Act and section 271 of the Patent 
Act, but were inadvertently overlooked.''
  That is a direct statement, Madam President, from our trade 
Ambassador who negotiated the GATT Treaty and who is there to protect 
not only our patent rights but also our intellectual property rights.
  Madam President, I am going to reserve the balance of my time. I look 
forward to hearing additional statements from my colleagues.
  Mr. SMITH. I yield whatever time the Senator from Utah consumes.
  Mr. HATCH. I do not know why some on the other side said that Dr. 
Koop said he was sorry he was ever involved. Dr. Koop's letter, dated 
November 30, makes it very clear he wants to be involved, that this is 
an important issue. Here is the letter he wrote.
  I know Dr. Koop as well, if not better, than anybody in this body. I 
was the one who, as ranking member on the Labor and Human Resources 
Committee, fought for his nomination through a full 9 months, if my 
recollection serves me correctly. I am very close to him.
  I did not ask Dr. Koop to write this letter. He voluntarily wrote the 
letter. Anybody who reads that letter and thinks there is an argument 
on the other side, just does not enjoy good reason. Dr. Koop is 
extremely clear. I think he probably would not appreciate being 
misrepresented.
  Now, with regard to congressional intent, the Federal Circuit Court 
of Appeals backs my position. It says:

       The parties have not pointed to and we have not discovered 
     any legislative history on the intent of Congress at the time 
     of passage of the URAA regarding the interplay between the 
     URAA and the Hatch-Waxman Act. Therefore, we limit our 
     inquiry to the actual wording of the statute.

  That is a Federal Circuit Court of Appeals, the court that has the 
expertise to decide these issues. I do not think anybody can doubt for 
a minute that the arguments I have made do not have legal backing, 
legislative backing, and good, commonsense backing, because they do.
  Recently, a Federal district court, as I mentioned before, reviewed 
the relevant provisions of law and concluded, ``This was no more a 
windfall to the''--and he names the pioneer firms which include Glaxo--
``then the windfall that benefited many patent holders when the 17-year 
term of patents was extended to 20 years.'' No more of a windfall now 
than that was then.
  I might add that it is not a windfall because, in all honesty, the 
generic drugs will benefit greatly and have benefited greatly from the 
pioneer companies' development of these blockbuster drugs like Zantac.
  Many believe this debate is prompted by the patent status of one 
drug, Zantac. I do not know if that is true or not. It has certainly 
been a tremendously successful drug which has literally helped millions 
of people and would not have been developed if the logic of the other 
side had been adopted years ago.
  One of the facts that has been obscured in this debate is that, 
ironically, this patent has never been extended. Let me give the facts 
on this drug. Keep in mind it takes up to 12 years, between $359 
million and a half billion dollars to put a drug like Zantac through.
  Here are the facts: the patent application for Zantac was submitted 
July 5, 1977. That patent was issued December 5, 1978 and an 
investigational new drug application was filed with FDA on December 3, 
1979. On June 9, 1983, 3\1/2\ years after initial submission to FDA, 
more than 6 years after the patent application was made, the drug was 
approved.
  Upon approval, this product only had an effective patent term of 
about 12.5 years on the day that FDA approved this product.
  Now, the concern that the regulatory review period at FDA was eating 
substantially into the patents of new drugs was a major motivating 
force behind the Waxman-Hatch Act.
  The Food, Drug and Cosmetic Act specifies that the drug review period 
is 180 days. But this, as in the case of Zantac, is virtually never met 
by the FDA. In fact, to the contrary, it takes years to get these drugs 
through, at a tremendous cost.
  Only because Zantac was approved about a year earlier than the Hatch-
Waxman law was passed, it was not eligible for the patent term 
extension part of the bill.
  In other words, it was an unfortunate fact that it did not benefit 
from the Hatch-Waxman bill. Had Zantac been approved after Hatch-Waxman 
was enacted, it could have been qualified for patent extensions that 
this law calls for and provides.
  So, Zantac, a loser under Hatch-Waxman because it could not qualify 
for the patent extensions that have been routinely granted as a matter 
of congressional policy since 1984, is now under sharp criticism for 
trying to take advantage of the same benefit that millions of patent 
holders were accorded under GATT.
  Not only is this ironic, it does not strike me as fair, that a 
product with only 12.5 years of effective patent life, which expected 
to have 17 years upon FDA approval, is being castigated as somehow 
``unfairly'' manipulating the patent system.
  Even under the GATT transition rules, Zantac will receive much less 
than the 17-year patent life that it was supposed to receive.
  Yet, here we face suggestions that it is greedy for a patent holder 
to want to take full advantage of its patent. 

[[Page S 18221]]

  The proponents of the amendments are circulating talking points that 
state:

       But the Waxman-Hatch amendments did a second thing: They 
     gave brand companies a 5-year patent extension. In other 
     words, Glaxo can receive up to 25 years of patent protection 
     under current law. And now this company receives the GATT 
     patent protection as well. It is trying to block the generic 
     competition Congress calls for in the GATT treaty.

  Now, let us just be honest about it.
  That information has been sent out to people here in Congress as 
though it were true.
  In fact, the statement is misleading in several ways.
  First, let us be clear that Zantac, as a pre-Hatch-Waxman product, 
did not qualify for any of the benefits of Hatch-Waxman.
  Second, to suggest that a company can receive up to 25 years of 
patent protection under current law is not only misleading, it is 
false.
  It would seem to me that the normal patent term will have to be a 
period of something less than 20 years, unless you make the unlikely 
assumption that the Patent Office approves the patent on the day the 
application is submitted.
  Also, since Hatch-Waxman time is only calculated after a patent 
issues, I do not see how you can ever reach 25 years, even 
hypothetically.
  I would welcome an explanation of this 25-year period. I think every 
patent lawyer in the country would be just fascinated with it, if it 
could be given.
  It is also the case that many believe the biotechnology patents are 
among those that might actually routinely lose time under the new 20-
year-from-time-of-filing rule established by GATT.
  This is because these products often present difficult, novel issues 
of patentability.
  I cite with particularity that joint hearing between the two 
intellectual property committees of the House and Senate, where Lita 
Nelsen, Director of the Technology Licensing Office of the 
Massachusetts Institute of Technology, said:

       The 20-year-from-filing change proposed in the current bill 
     runs the risk of substantially reducing the patent protection 
     available for companies investing in university technology.

  She goes on to say:

       Any shortening of patent life most seriously impacts the 
     most forward-thinking technologies, which are the very types 
     of technologies which universities should specialize in and 
     which we believe will most benefit the country's future 
     technical and economic development.
       The 20-year-from-initial-filing rule currently being 
     proposed offers a significant danger of shortening the time 
     available for patent protection and therefore may have a 
     detrimental effect on development of university technologies.

  She also goes on to say:

       Also, leading-edge technology patents, such as those in 
     biotechnology, software and microelectronics usually take 
     significantly longer than the so-called average patent to 
     issue.

  She concludes:

       Finally, no one should be led to believe the 20-year-from-
     filing rule will lengthen effective patent life. Most of the 
     time, for high technology patents, it will shorten the life 
     and, more importantly, will shorten the remaining life of 
     patent protection after the long development period is 
     finally over and products are on the market.

  The fact is this. Zantac has never had a patent extension until the 
GATT transition rules, because it did not--it simply did not--qualify 
under the Hatch-Waxman statute.
  So, to indicate that it is going to reap the benefits of some sort of 
windfall is not only a misrepresentation, but it ignores several 
significant facts. It ignores all of the research costs which go into 
the pharmaceuticals we use. It ignores all of the incentives for 
research which must be a part of our intellectual property laws. It 
ignores all of the balancing we did in the 1984 law in order to 
accommodate the interests of these two great industries.
  At the same time, it attacks our international agreements for which 
we fought so hard for decades, as reflected in the GATT agreement and 
Uruguay Round agreement. It does this in a way that sends a signal to 
all those countries that do not believe in patents or have difficulties 
with our position on patents that they do not have to honor it. It 
shows that the United States is not serious about this agreement 
either.
  The fact of the matter is this: There are winners, there are losers 
in the Hatch-Waxman Act. There are winners and there are losers in 
GATT, and everybody knew it.
  Now we have one industry that has been given special privileges, 
privileges that I personally have helped them to get, coming in and 
saying we want more special privileges and we want to amend the very 
act that benefited them and created their industry.
  Frankly, I do not think that what specific company benefits and what 
company does not should be our focus here. Our focus should be on the 
right thing to do, which is to uphold GATT and vote down the Pryor 
amendment.
  I reserve the remainder of our time.
  The PRESIDING OFFICER. Who yields time?
  Mr. SMITH. Madam President, I suggest the absence of a quorum.
  The PRESIDING OFFICER. The time of the quorum would be charged to 
both sides equally? Without objection, it is so ordered.
  The clerk will call the roll.
  The legislative clerk proceeded to call the roll.
  Mr. PRYOR. Madam President, I ask unanimous consent that the order 
for the quorum call be rescinded.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mr. PRYOR. Madam President, may I inquire as to how many minutes I 
have left?
  The PRESIDING OFFICER. The Senator has 5 minutes 43 seconds.
  Mr. PRYOR. Thank you, Madam President.
  Madam President, this debate is coming to conclusion at long last. We 
are about to make a tentative decision on this matter.
  Let me say to my colleagues, Madam President, that somehow or 
another, sooner or later, we have to correct this problem. We have to 
close this loophole. If we fail to table the second-degree amendment, 
sometime or another I am going to be back. I want my colleagues to know 
that this is not the last they will hear of this amendment and this 
issue, because I think it is so absolutely atrocious that this could 
happen, is happening, and that we have yet not closed this loophole. 
Like MacArthur, Madam President, I shall return.
  This has been a fascinating debate. It has lasted 2\1/2\ hours, about 
as long as a typical Senate hearing would last. And now, at the end, we 
see the facts have not changed. They have not changed at all. Those 
facts are as follows: the Congress made a mistake and we have a very 
rare opportunity to correct that mistake.
  Let us look now at who is on the side who thinks that we made a 
mistake and who believes that we should rectify that mistake.
  First, our U.S. Trade Representative, Mickey Kantor, said that 
Congress made a mistake, that it was never intended that these drug 
companies would be given this extra amount of unearned protection to 
market without any competition. The Food and Drug Administration said 
the Congress made a mistake. FDA tried to rectify the situation but 
they failed, and it is too bad that they did. Our U.S. Patent Office 
said that a mistake has been made by implication, and their decision 
was taken to court. Because of the technical aspects of the language, 
the Patent Office was overruled.
  If we review the Congressional Record we will find that at no time 
during the debate on the issue of the GATT Treaty, leading to the 
adoption of the GATT Treaty, at no place do we find reference to this 
issue by anyone--not by any of the drafters or the debaters, nor by 
those opposed to or in favor of that treaty. At no time did anyone even 
hint that we were going to carve out a special exception for a few drug 
companies in order to give them extra monopolistic opportunities to 
compete unfairly in the marketplace, and to keep generic drugs from 
competing.
  The State Medicaid directors, Madam President, have written in 
support of our efforts. They say that unless we correct this loophole, 
the Medicaid programs in each of the 50 States are going to continue to 
suffer and pay the highest price for these particular drugs, especially 
Zantac, and will be kept from buying generic drugs for the poorest of 
the poor population. 

[[Page S 18222]]

  The elderly, the consumers--none will benefit from the efforts of the 
generic drug companies to reduce the cost of drugs like Zantac by as 
much as 50 percent or 60 percent. Yet, we may be about to vote and say 
that we are going to continue to give these enormous profits, these 
windfall profits, to a few pharmaceutical companies, and to take those 
profits, to give them those profits at the expense of taking those 
dollars from the consumer and the taxpayers of America.
  This amendment that we are about to vote on is very simple. It is an 
attempt to kill our desire to close this loophole. That is what it is.
  I respect my colleagues who offer it. I realize that some may believe 
that this particular issue is complex. But I must say, as my colleagues 
have said, that this is, in fact, a very simple issue. We have made a 
mistake. And now it is time to rectify it.
  Madam President, I have frequently used the following analogy: You 
are walking down the street on the sidewalk, or wherever, and find a 
billfold, and you open that billfold up. And there is a $100 bill in 
there, and there is also the name of the owner. Do you take that 
billfold and the $100 to the owner? Do you try to find the lawful and 
rightful owner of that billfold that contains the $100, or, do you put 
it in your pocket?
  In this case, these drug companies have found a billfold. It has a 
lot of money in it. Rather than returning it to the rightful owner--the 
taxpayer and the consumer, in this case--Madam President, they are 
taking that billfold, they are taking the money, and they are putting 
it right in their pocket.
  I urge the defeat of the second-degree amendment.
  Mr. HATCH. Madam President, if we want a cure for Alzheimer's, or for 
AIDS, or for so many other dreaded diseases, we had better not undercut 
the patent process.
  We had better not undercut the GATT process.
  If we want free and fair trade throughout this world, we had better 
make sure that we do not undercut something we fought to obtain for so 
many years.
  If we want to keep America's medical research base premier among 
world nations, and continue to bring forth promising technologies which 
help our senior citizens and so many others, this body should vote down 
the Pryor amendment.
  It would send our world trading partners the wrong message, and in 
the end put a huge dent in what is already a well-functioning system 
that benefits both the research company and the generic companies in a 
fair way.
  That is what is involved here.
  Let me just say one other thing.
  I commit here and now that we will hold hearings on this should the 
amendment of the Senators from New Hampshire and Ohio pass.
  We will hold hearings on this issue before the end of 120 days. I 
will commit to that as chairman of the Judiciary Committee, and I do 
not think anybody doubts in this body that I will not live up to that 
commitment, because I will.
  I think that is the way we should handle it and I hope my colleagues 
will vote against the motion to table.
  Mr. SMITH. Madam President, is there any time remaining?
  The PRESIDING OFFICER. There are 29 seconds.
  Mr. SMITH. Madam President, let me just say that no matter what the 
pros and cons are of this amendment it is irrelevant to the issue at 
hand. Regardless of how you feel about GATT or the patent protections, 
let us not load this historic bill up with this controversial unrelated 
amendment.
  I urge my colleagues to vote ``no'' on the motion to table.
  Mr. PRYOR. Madam President, I ask unanimous consent that Senator 
Daschle, Senator Leahy, Senator Bryan, and Senator Feinstein be added 
as original cosponsors of my amendment.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mr. PRYOR. Madam President, I move to table the pending amendment, 
the second-degree amendment, and I ask for the yeas and nays.
  The PRESIDING OFFICER. Is there a sufficient second?
  There is a sufficient second.
  The yeas and nays were ordered.
  The PRESIDING OFFICER. The question is on agreeing to the motion of 
the Senator from Arkansas to lay on the table the amendment of the 
Senator from Ohio. On this question, the yeas and nays have been 
ordered, and the clerk will call the roll.
  The bill clerk called the roll.
  Mr. SIMPSON (when his name was called). Present.
  Mr. FORD. I announce that the Senator from New York [Mr. Moynihan] is 
necessarily absent.
  The result was announced--yeas 48, nays 49, as follows:

                      [Rollcall Vote No. 594 Leg.]

                                YEAS--48

     Akaka
     Baucus
     Bingaman
     Bond
     Boxer
     Bradley
     Breaux
     Brown
     Bryan
     Bumpers
     Byrd
     Chafee
     Cohen
     Conrad
     Daschle
     Dorgan
     Exon
     Feingold
     Feinstein
     Ford
     Glenn
     Graham
     Hatfield
     Heflin
     Inouye
     Jeffords
     Kassebaum
     Kennedy
     Kerrey
     Kerry
     Kohl
     Leahy
     Levin
     Lugar
     McCain
     Mikulski
     Murray
     Nunn
     Pressler
     Pryor
     Reid
     Robb
     Rockefeller
     Roth
     Sarbanes
     Simon
     Snowe
     Wellstone

                                NAYS--49

     Abraham
     Ashcroft
     Bennett
     Biden
     Burns
     Campbell
     Coats
     Cochran
     Coverdell
     Craig
     D'Amato
     DeWine
     Dodd
     Dole
     Domenici
     Faircloth
     Frist
     Gorton
     Gramm
     Grams
     Grassley
     Gregg
     Harkin
     Hatch
     Helms
     Hollings
     Hutchison
     Inhofe
     Johnston
     Kempthorne
     Kyl
     Lautenberg
     Lieberman
     Lott
     Mack
     McConnell
     Moseley-Braun
     Murkowski
     Nickles
     Pell
     Santorum
     Shelby
     Smith
     Specter
     Stevens
     Thomas
     Thompson
     Thurmond
     Warner

                        ANSWERED ``PRESENT''--1

       
     Simpson
       

                             NOT VOTING--1

       
     Moynihan
       
  So the motion to lay on the table the amendment (No. 3088) was 
rejected.


                      Amendment No. 3082 withdrawn

  Mr. PRYOR. Mr. President, if I may have just a few seconds, I know 
this was a very hard vote, a very close vote. I want to compliment 
those on the opposing side. They made a very, very strong argument, and 
they prevailed this evening. But I will make it possible for the Senate 
to revisit this issue in the very, very near future, Mr. President. I 
want to thank those who supported us, and at this time I withdraw my 
amendment.


                           Amendment No. 3085

  The PRESIDING OFFICER (Mr. Santorum). The question recurs on the 
Brown amendment No. 3085.
  Mr. BROWN. Mr. President, may we have order.
  The PRESIDING OFFICER. The Senate will please come to order.
  Mr. SMITH. Will the Senator yield for a unanimous-consent request?
  Mr. BROWN. Yes.


                      unanimous-consent Agreement

  Mr. SMITH. Mr. President, I have a unanimous-consent request here, 
and I think Members will be interested in hearing it.
  Mr. President, I ask unanimous consent that following the disposition 
of the Pryor amendment, the following be the only amendments remaining 
in order and limited to the following time restraints: The Brown 
amendment No. 3085, 5 minutes equally divided; a Feinstein amendment, 
supporting current law, 35 minutes, 20 minutes under the control of 
Senator Feinstein, 15 minutes under the control of Senator Smith; a 
Brown limiting liability amendment, 15 minutes equally divided; a Smith 
affirmative defense amendment, 5 minutes equally divided.
  I further ask that the votes be stacked to occur on or in relation to 
the above-listed amendments at the conclusion or yielding back of all 
time, and that prior to the votes, there be 4 minutes equally divided 
for closing remarks on the bill, with the votes occurring in the order 
in which they were debated, and following disposition of the 
amendments, the bill be advanced to third reading, and final passage 
occur, all without further action or debate.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mr. SMITH. Mr. President, to recap for all Members, we expect two 
additional votes to occur within the next 40 minutes. That is the 
essence of it. 

[[Page S 18223]]



                           Amendment No. 3085

  Mr. BROWN. Mr. President, the bill as it is now drafted creates a new 
cause of action and allows a variety of parties to bring suit against 
those who have been involved in the restricted prohibited abortion 
practice.
  Among those allowed to bring suit is the father. Unfortunately, the 
bill does not now restrict which father can bring suit. Literally, 
someone who is the father of the fetus but has not acknowledged the 
child, has not married the woman, and has not supported the child in 
any way or any process can bring legal action and get a bonanza by 
suing the physician.
  In my mind, to provide a financial benefit to someone who has 
fathered a child and not acknowledged it nor married the woman is a 
mistake. I don't think we ought to be about providing a new avenue of 
financial reward for a man who does not live up to his 
responsibilities.
  The amendment is very simple. It restricts the fathers who can bring 
legal actions in this case to ones who have married the mother.
  Mr. President, I think it is a pretty straightforward amendment. I 
yield the floor. I believe this has been cleared on both sides. I think 
a voice vote may well be appropriate.
  Mr. SMITH. The Senator from Colorado is correct. As far as I know, 
there is no objection on this side, and I do not believe there are any 
objections on the other side.
  Mrs. BOXER. Mr. President, that is right. I applaud the Senator for 
this amendment.
  The PRESIDING OFFICER. The question is on agreeing to the amendment.
  The amendment (No. 3085) was agreed to.
  Mr. BROWN. I move to reconsider the vote.
  Mr. SMITH. I move to table the motion.
  The motion to lay on the table was agreed to.


                           Amendment No. 3090

(Purpose: To limit liability under this act to the physician performing 
                        the procedure involved)

  Mr. BROWN. Mr. President, I rise to offer an amendment and ask for 
its immediate consideration
  The PRESIDING OFFICER. The clerk will report.
  The assistant legislative clerk read as follows:

       The Senator from Colorado [Mr. Brown] proposes an amendment 
     numbered 3090.

  Mr. BROWN. Mr. President, I ask unanimous consent that reading of the 
amendment be dispensed with.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  The amendment is as follows:

       On page 2, line 6, strike ``Whoever'' and insert ``Any 
     physician who''.
       On page 2, line 10 strike ``As'' and insert ``(1) As''.
       On page 2, between lines 13 and 14, insert the following:
       ``(2) As used in this section, the term `physician' means a 
     doctor of medicine or osteopathy legally authorized to 
     practice medicine and surgery by the State in which the 
     doctor performs such activity, or any other individual 
     legally authorized by the State to perform abortions. 
     Provided, however, That any individual who is not a physician 
     or not otherwise legally authorized by the State to perform 
     abortions, but who nevertheless directly performs a partial-
     birth abortion, shall be subject to the provisions of this 
     section.

  Mr. BROWN. Mr. President, this particular amendment was allowed 15 
minutes equally divided. I do not intend to take a significant amount 
of time with it. I do want to make it clear to the Members what is 
involved.
  The current bill makes liable or potentially liable not only for the 
attending physician in this case but also, in reading the language of 
the bill, the hospital where the procedure took place. Both could be 
subject to civil and criminal actions. Also included could be the 
nurses, as well other people called in to help with other medical 
procedures that may stem from the abortion procedure. In my mind, to 
have hospital administrators, to have hospital trustees, to have 
hospitals themselves, to have nurses, to have other medical personnel 
who may be called in to assist if something goes wrong, subject to 
possible prosecution and civil liability is a great mistake. This 
amendment limits the liability, and limits the people who can have 
actions brought against them to the physician or to someone who takes 
the place of the physician such as the person who directs the abortion 
procedure.
  Specifically, we are trying to get at the person who performs the 
abortion itself. The whole purpose of this is to make sure that nurses 
and other attending personnel who are not the decisionmakers here are 
not subject to civil and criminal liability.
  Mr. President, I believe the amendment is fairly clear. I believe it 
is cleared on both sides. My hope is at the appropriate time we could 
have a rollcall vote on it.
  I ask for the yeas and nays.
  The PRESIDING OFFICER. Is there a sufficient second?
  There is a sufficient second.
  The yeas and nays were ordered.
  Mr. BROWN. I yield the floor.
  Mrs. BOXER. Mr. President, I want to say to my friend from Colorado I 
intend to support his amendment.
  I believe it is tragic that we are about to criminalize a medical 
procedure which many doctors say is necessary to save the life of a 
woman or to protect her from serious adverse health consequences. I 
think it is tragic we are going to put doctors through this Kafkaesque 
expense of winding up in prison for saving the life of a woman.
  However, what the Senator from Colorado is pointing out to us, as 
currently written, we might wind up putting other people in jail--other 
people associated with the hospital, other people who clearly should 
stay clear of this.
  Although I believe the underlying bill is leading us down a terrible 
path where we are going to haul doctors into prison for saving a 
woman's life, I certainly believe what the Senator is doing to at least 
narrow it to the doctor is something we should support.
  I will be supporting his amendment. I yield the floor.
  Mr. SMITH. We have no objection to the Brown amendment.
  The PRESIDING OFFICER. If there is no further debate on the 
amendment, the Chair would advise the Senator the yeas and nays have 
been ordered.
  Mr. BROWN. Mr. President, I ask unanimous consent to vitiate the 
request for the yeas and nays.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  The question is on agreeing to the amendment.
  The amendment (No. 3090) was agreed to.
  Mr. SMITH. I move to reconsider the vote.
  Mrs. BOXER. I move to lay it on the table.
  The motion to lay on the table was agreed to.


                           Amendment No. 3091

              (Purpose: To strike the affirmative defense)

  Mr. SMITH. Mr. President, I say to the Senator from California who is 
waiting to go on her amendment, briefly I will do the affirmative 
defense amendment and then be ready for her amendment.
  I send an amendment to the desk and ask for its immediate 
consideration.
  The PRESIDING OFFICER. The clerk will report.
  The assistant legislative clerk read as follows:

       The Senator from New Hampshire [Mr. Smith] proposes an 
     amendment numbered 3091.

  Mr. SMITH. I ask unanimous consent reading of the amendment be 
dispensed with.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  The amendment is as follows:

       On page 3, strike lines 8 through and including 16.

  Mr. SMITH. Mr. President, in view of the fact that the Senate adopted 
the life-of-the-mother exception amendment, the affirmative defense 
section of the bill is no longer necessary and I had agreed that we 
would remove that provision, providing the life-of-the-mother exception 
prevailed.
  Since it did prevail, this amendment would strike the entire 
subsection E of the bill which talks about the affirmative defense to a 
prosecution or a civil action.
  So, it is my understanding that the Senator from California agrees 
with this amendment, so unless the Senator wishes to speak, I urge its 
adoption.
  The PRESIDING OFFICER. The question is on agreeing to the amendment.
  The amendment (No. 3091) was agreed to.
  Mr. SMITH. I move to reconsider the vote. 
  
[[Page S 18224]]

  Mrs. BOXER. I move to lay it on the table.
  The motion to lay on the table was agreed to.


                           amendment no. 3092

            (Purpose: To provide for a substitute amendment)

  Mrs. FEINSTEIN. Mr. President, I send an amendment to the desk for 
Senator Simpson and myself and ask for its immediate consideration.
  The PRESIDING OFFICER. The clerk will report.
  The assistant legislative clerk read as follows:

       The Senator from California [Mrs. Feinstein], for herself, 
     Mr. Simpson, Mrs. Boxer, Mr. Simon, and Ms. Moseley-Braun, 
     proposes an amendment numbered 3092.
       Strike out all after the enacting clause and insert in lieu 
     thereof the following:

     SECTION 1. SENSE OF THE SENATE.

       (a) Findings.--The Senate finds that--
       (1) the United States has the most advanced medical 
     training programs in the world;
       (2) medical decisions should be made by trained medical 
     personnel in consultation with their patients based on the 
     best medical science available;
       (3) it is the role of professional medical societies to 
     develop medical practice guidelines and it is the role of 
     medical education centers to provide instruction on medical 
     procedures;
       (4) the Federal Government should not supersede the medical 
     judgment of trained medical professionals or limit the 
     judgment of medical professionals in determining medically 
     appropriate procedures;
       (5) the Federal criminal code is an inappropriate and 
     dangerous means by which to regulate specific and highly 
     technical medical procedures; and
       (6) the laws of 41 States currently restrict post-viability 
     abortions.
       (b) Sense of Senate.--It is the sense of the Senate that 
     Congress should not criminalize a specific medical procedure.

     SEC. 2. RULE OF CONSTRUCTION.

       Nothing in Federal law shall be construed to prohibit the 
     States, local governments, local health departments, medical 
     societies, or hospital ethical boards from regulating, 
     restricting, or prohibiting post-viability abortions to the 
     extent permitted by the Constitution of the United States.

  The PRESIDING OFFICER. The Senator from California is recognized for 
20 minutes. The Senator from New Hampshire is recognized for 15 
minutes.
  Mrs. FEINSTEIN. Mr. President, I want to make clear that this 
amendment is presented as a substitute.
  I am pleased it was read because it makes clear the following: First, 
that it is the sense of the Senate that Congress should not criminalize 
a medical procedure.
  Second, that nothing in Federal law should be construed to prohibit 
the States, local governments, local health departments, medical 
societies, or hospital ethical boards from regulating, restricting, or 
prohibiting postviability abortions to the extent permitted by the U.S. 
Constitution.
  The U.S. Congress is not the appropriate place to be making decisions 
about medical procedures, whatever they are. The bill before us would 
criminalize one procedure, a procedure that does not appear in medical 
literature, a procedure that is worded vaguely.
  All I ask is that the Members of this body read the actual 
legislation. Many Members who have spoken in favor of the legislation 
point to the use of scissors, the cutting of tissue, the draining of 
fluid from the brain. Nowhere does the legislation itself specifically 
refer to that kind of procedure. In its very vagueness, it affects more 
than one procedure and it can affect more than postviability abortions.
  So, my point is twofold. One, that this body is not the appropriate 
place to be making medical decisions and that, two, under current 
Federal law, States can choose to regulate, restrict, or prohibit 
postviability abortions as 41 do now.
  When physicians make a decision to use a particular treatment, they 
very thoroughly evaluate a number of factors: evidence from scientific 
literature, the risks and benefits for the patient--for example, 
possible side effects--future health, quality of life, the efficacy of 
the treatment--what the outcome will be--the safety of the treatment, 
the patient's preferences. These are often complicated decisions, 
representing a systematic strategy developing from multiple decisional 
building blocks. Medical decisionmaking is not simple and these are not 
decisions we should or can make.
  We should also understand that medical decisionmaking is 
individualized. Every case is different. Every human body is different. 
Every patient brings a unique medical history into the doctor's office. 
Physicians have to evaluate every situation as it presents itself and 
often at the last minute.
  The risks of a particular procedure depend, often, on the patient. 
For example, a hip replacement that restores function in one patient 
can be life-threatening to another, for example, to one who has heart 
disease. Medical science and treatments are constantly evolving. 
Medicine is becoming increasingly specialized. Technology is advancing. 
Today's standard of practice can be out of date in 5 years. The human 
body will always have some degree of mystery, as science stretches to 
understand how the body works and does not work. Congress cannot keep 
up with these changes. That is not our job.
  Mr. President, physicians go to college for 4 years, to medical 
school for 4 years, to residency training for 3 to 6 years. In some 
States, to keep their licenses current, they are required to undergo 
continuing education annually. They get extensive training. Medical 
decisionmaking, I believe, is a job for trained physicians.


       an example of decisionmaking: medical practice guidelines

  For almost 60 years, the medical profession in this country has been 
developing medical practice guidelines. According to the Institute of 
Medicine, clinical practice guidelines are ``systematically developed 
statement to assist practitioner and patient decisions about 
appropriate health care for a specific clinical circumstances.'' They 
are guidelines--guidance--not enforceable rules. There are over 24,000 
developed by over 75 organizations.
  Medical practice guidelines are designed to improve patient outcomes. 
They help medical practitioners and patients make decisions about 
prevention, diagnosis and treatment of specific clinical conditions. 
For example, guidelines have been developed for the treatment of benign 
prostatic hyperplasia, pressure ulcers, and stroke rehabilitation.
  Developing practice guidelines is a complicated process. To develop a 
guideline, panels of experts are convened. They review all available 
literature, all available evidence of patient outcomes, a review that 
can take up to 9 months. They are subjected to peer review for 
scientific validity and pilot testing. Development of one guideline can 
take from 1\1/2\ to 3\1/2\ years.
  The point here is that there is an orderly, scientific, deliberative, 
professional, and balanced approach for making medical decisions. It is 
complicated. It is based on the patient's best interest.
  Medical decisionmaking is not and should not be a legislative or 
political process.


                             unprecedented

  Congress has legislated medical benefits, reimbursement policies, 
quality standards, training requirements. But Congress has never banned 
or criminalized a specific medical procedure. This is the first time 
Congress has tried to outlaw a medical procedure.
  My amendment is quite simple. It says, in essence, that Congress 
should not be making medical decisions and that States can regulate 
post-viability abortions.
  I can go on, but in the interest of time, and giving my cosponsors 
the opportunity to speak, I want to just say one other thing. I have 
followed this debate very carefully. I want particularly to commend my 
friend and colleague, the junior Senator from California. I think she 
has been quite eloquent in defining what this procedure is, and what 
this procedure is not, the enormous vagueness of the bill and the human 
tragedies involved.
  Post-viability abortions can be banned by every State and 41 have 
chosen to do so. This legislation is not necessary. This legislation 
puts the Congress in the position of deciding medical procedures, and I 
do not believe we can or should do this. This substitute amendment 
clearly states what I believe is right.
  Mr. President, I yield 10 minutes to the Senator from Wyoming.
  The PRESIDING OFFICER. The Senator from Wyoming is recognized for 10 
minutes.
  Mr. SIMPSON. Mr. President, I rise in support of the Feinstein 
substitute 

[[Page S 18225]]
which is a reiteration of current law. Under the substitute, nothing in 
Federal law shall be construed to prohibit the States, local 
governments, local health departments, and medical societies from 
regulating, restricting, or prohibiting post-viability abortions to the 
extent permitted by the Constitution. Let me say it again, this is 
current law and this substitute explicitly states what the law of the 
land is. Under Roe versus Wade, States may proscribe post-viable 
abortions except when it is necessary to preserve the life or health of 
the mother--41 States currently regulate post-viable abortions. We do 
not need H.R. 1833 because we already have current laws which address 
the central issue of the pending legislation.
  I have been pro-choice throughout my entire public life, never 
wavered, never waited to take a poll, ever since that first wrenching 
debate in the Wyoming State Legislature because our law was the same as 
Missouri's, which was struck down by Roe versus Wade. And so we had to 
change it, and we did, and I shall never forget the debate. Abortion is 
such a deeply personal and, to some, a spiritual issue. It is not one 
that belongs in the public domain. That is my view. It is not one that 
should be in a legislative body, to me, as a man--not a legislator, but 
a man, I cannot presume to limit the options of any woman who is 
anguishing over a crisis pregnancy. That is what I have always 
believed, and what I have always tried to state so clearly. And as a 
man, I do not think a man should even vote on this issue. That is how I 
feel about this.

  I do not advocate or promote abortion. It is obviously one of the 
most difficult choices or options that any woman should ever, ever 
make. I really do not know many folks who advocate or promote abortion, 
nor does anybody else in this land. That is not what people do--promote 
abortion. It is an alternative. It is an option. It is obviously one of 
the most difficult choices or options that any man or women--sometimes 
men must make--buy principally the woman. I have always supported 
alternatives to abortion--and think it is so very important to assure a 
pregnant woman that there are many alternatives to abortion and that 
there are many fine support systems available for those who may choose 
any of the alternatives. And yes, yes, abstinence is still the best, 
and Who would disagree with that? But that is not what we are talking 
about.
  And I respect and am acutely conscious of the fact that many persons 
who grapple with the issue of abortion do so from very different moral 
or religious or philosophical differences, and I do not spend any part 
of my life trying to inflict--and that is the word I want to use--
inflict my personal views on others. I see that happening here. Not 
with the Senator from New Hampshire, a lovely friend, but from others, 
especially in the hallways, who do it with steely-eyed zealotry that I 
tire of.
  My respect for this very real facet of the human condition has led me 
to the conclusion that abortion presents a deeply personal decision for 
any woman--decisions which should not and realistically could not be 
prescribed or directed through the legislative process in any way.
  We in the Senate should never be criminalizing a specific medical 
procedure. That is what the substitute states.
  So here we are overstepping court cases. There is a strong absence of 
Government interest in this legislation. It is not here. It purports to 
prohibit abortions using a particular procedure, and then says 
abortions will be performed only in a particular manner. There is no 
reasonable Government interest served by forcing a patient to undergo 
one type of abortion instead of another, especially if the prohibited 
procedure is safer for the health of the woman.
  We in this Congress should not be legislating in this area. This is 
overreaching in every sense. Under this bill, it would remain legal. 
Get this--somebody has to really explain this to me. It would remain 
legal for a woman to obtain this procedure only if she did not cross 
State lines. This seems to me too clever by half. I thought this was 
the most horrendous, searing, murderous, vicious procedure that we have 
seen in modern times, and yet you are going to be able to do it in your 
own backyard, in your own State. That is absurd.
  Now we have a new Federal court case, the Lopez decision. That is how 
they got clever by half on this one.
  This bill also uses a term I have never before seen in the statute, 
and I have been doing this for 30 years. Anyone who knowingly performs 
a partial-birth abortion ``and thereby kills a human fetus.'' That is 
what it says. ``Abortion is thereby killing.'' On line 15 of the bill, 
the language reads, ``partially vaginally delivers a living fetus 
before killing the fetus.'' I have never seen that in my life in a 
statute. Where did it come from? It is a manifestation of a 
manipulative group trying to desperately knock off Roe v. Wade. That is 
what it is. It is exceptionally unclear about the precise nature of the 
procedure. Six doctors testified they never heard of the procedure 
before.
  I sat and listened to that. I have seen all of the pictures before. 
We are going to have all of them--one-eyed children, brains on the 
outside, compressed skulls. I have seen it all. I have seen the whole 
works, always with the eternal difficulty of imposing restrictions on a 
decision which must be made from one's only very unique position, and 
principally by a woman, from one's own culture, one's own history, and 
one's own deep personal and spiritual viewpoint.
  All through the years I have had the accolades sometimes of being 
called a baby killer. I really do not appreciate that. I handle it very 
well now. I just say, I do not have to take that guff from you. So I 
have been there.
  In my fine State of Wyoming--and I am going to conclude my remarks 
within my limit--listen to what we have to do in this. It should not be 
partisan. And in our State, the Wyoming Republican Party passed a 
platform plank in 1994 at its State convention that said this: ``The 
Wyoming Republican Party welcomes individuals on each side of the 
abortion issue, encourages their open discussion, solicits their active 
participation in the party, and respects their positions and beliefs.''
  Then, do you know what we did? We did a resolution because we had a 
November resolution on the ballot which was soundly rejected. Here is 
what it said: ``The Republican Party believes that Republicans are 
people of principle on each side of the abortion issue who firmly and 
intractably hold their beliefs; by establishing a party position, we 
recognize that a resolution will never change these beliefs, but it 
will serve to divide the party on other issues, and we urge all 
Republicans to firmly debate these beliefs.''
  That passed unanimously by voice vote. We ought to do more of that in 
America. And men, in my mind, should never be in this intensely 
intimate personal struggle for a woman.
  I urge my colleagues to vote in favor of the substitute.
  Mr. JEFFORDS. Mr. President, I rise today in support of the amendment 
expressing the sense of the Senate that the Congress should not 
criminalize a specific medical procedure, and that the States should 
not be prohibited from regulating or restricting postviability 
abortions to the extent that the Constitution permits them to do so. I 
also want to state again my firm belief in the wisdom of the Supreme 
Court decision Roe versus Wade, which held that under the 
constitutional right to privacy, a woman has a right of self-
determination with regard to her pregnancy and reproductive health.
  In November I spoke in support of referring this bill to the 
Judiciary Committee for a hearing, and I'd like to thank my colleagues 
for joining me to support the passage of that motion. I think we 
learned a great deal from the hearing. One of the things that struck me 
was that the term ``partial birth'' is not a term that is clearly 
defined in the medical profession. This bill purports to be a very 
narrow measure that outlaws only one alternative to a woman who learns 
late in her pregnancy that it is not possible for her to carry her 
child to term. But we've learned that there is not a medical procedure 
known as a partial birth abortion. I suppose you can argue that those 
of us on this side of the issue shouldn't have a problem criminalizing 
a procedure that doesn't really exist. My response to that argument is 
predictable: why bother to criminalize a procedure that doesn't really 
exist? 

[[Page S 18226]]
Moreover, rules of statutory interpretation will demand that the courts 
find some meaning in this law, because Congress is assumed to do 
nothing in vain. Somehow, the courts will have to put some definition 
on the term ``partial birth abortion,'' even though a clear 
understanding of what we're outlawing has eluded many of us.
  I'd like to quote briefly Dr. J. Courtland Robinson, who spoke at the 
hearing a couple of weeks ago and highlighted this point:

       I have to wonder what you are really trying to ban with 
     this legislation. It sounds as if you are trying to leave any 
     later abortions open to question.

  Dr. Robinson continues:

       I know that a number of physicians who have performed 
     abortions for years, who are experts in the field, look at 
     this legislation and do not understand what you mean or what 
     you are trying to accomplish. It seems as if this vagueness 
     is intentional, and I, as a physician, cannot countenance a 
     vague law that may or may not cut off an appropriate surgical 
     option for my patients. Sometimes, as any doctor will tell 
     you, you begin a surgical procedure expecting it to go one 
     way, only to discover that the unique demands of the case 
     require that you do something different.

  Dr. Robinson highlights a point I've made many times before. We can't 
adequately define the procedure we mean to outlaw because we're not 
doctors. I share Dr. Robinson's fear that because this law is so vague 
and because we are denying doctors the ability to use their best 
medical judgment, physicians will be deterred from performing any late 
term abortion procedure. Late term abortions will be unavailable and 
women will die.
  This is an unprecedented intrusion into the practice of medicine. In 
my view decency and common sense would require us to recognize that it 
is not the job of the Congress to come between physicians and their 
patients.
  I also want to speak briefly in support of section two of Senator 
Feinstein's amendment. I think her amendment is entirely consistent 
with the thinking in much of the legislation we have debated recently. 
On a number of matters we are choosing to leave regulation to the 
States; indeed, we are deregulating at the Federal level so that we may 
leave the States the flexibility to enact their own laws on welfare, 
Medicaid, and so forth. I must admit that it seems strange to me that 
in this area alone we are undertaking Federal regulation where there 
has been none. In doing so we are taking away from the States the right 
to legislate on this issue as they see necessary. In fact, we know that 
41 of the States already have laws regulating access to post-viability 
abortions.
  I have expressed before my support for the enduring wisdom of Roe 
versus Wade decision. I think Senator Feinstein's amendment is 
consistent with that decision. In Roe, the Court found that under the 
constitutional right to privacy, a woman has the right to make her own 
decisions where her pregnancy and reproductive health are concerned--
especially, the Court said, ``when her right to life is threatened.'' 
The bill we are now considering is a direct challenge to that historic 
decision's protection of a woman's life and health. Concern about a 
woman's life has been abandoned in the partial birth abortion 
legislation we've been discussing, but Roe versus Wade requires that 
even where a state chooses to outlaw post-viability abortions, it may 
not under any circumstances outlaw abortions necessary to preserve the 
life or health of the mother.
  I will say again that I believe doctors must be able to put the 
welfare of their patients first. Doctors should be able to use whatever 
procedure will, in their professional judgment, be safest for the 
mothers, their patients. Toward this goal, I wholeheartedly support the 
sense-of-the-Senate amendment that Congress should not criminalize a 
specific medical procedure, and the rule of Construction permitting the 
States to regulate post-viability abortions to the extent permitted by 
the Constitution.
  The PRESIDING OFFICER. Who yields time?
  Mrs. FEINSTEIN. Mr. President, how much time remains?
  The PRESIDING OFFICER. Six minutes and thirty seconds.
  Mrs. FEINSTEIN. Mr. President, I ask unanimous consent that the 
following be added as cosponsors: Senator Boxer, Senator Simon, Senator 
Moseley-Braun, and Senator Bryan.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mrs. FEINSTEIN. I yield the remainder of my time to the junior 
Senator from Illinois.
  The PRESIDING OFFICER. The Senator from Illinois.
  Ms. MOSELEY-BRAUN. Thank you, Mr. President. I will be brief.
  I want to thank the Senator from California for the amendment, and I 
am delighted to be a cosponsor of it.
  Mr. President, this bill represents the first time, to my knowledge, 
that the Congress has attempted to tell a doctor that he or she cannot 
perform a specific medical procedure.
  Let us be clear about what Congress is proposing to do with this 
legislation. We are proposing to criminalize a medical procedure 
against the recommendation of this Nation's OB-GYN's and against the 
recommendation of this Nation's 2.2 million registered nurses.
  This bill arbitrarily prohibits one type of procedure even when the 
procedure best protects the life and health and fertility of a woman, a 
citizen of this country. If a woman has a late-term abortion, her 
decision relies on the best medical advice of the doctor, advice based 
on years of medical training and service.
  None of us, or few of us in this body, have spent years studying and 
practicing medicine. How many of the Members of this body are 
physicians? We have only one doctor serving in the Senate, and he is 
not an OB-GYN. Are we qualified to make a medical judgment--a medical 
recommendation--that could leave a woman sterile, or severely ill, or, 
worse yet, dead? I think not.
  I know, frankly, that if I were ill, or the Presiding Officer were 
ill, his family would take him to a doctor, not to another Senator, 
unless, of course, that Senator was a doctor, and there is only one of 
those.

  The fact of the matter is that this is a medical decision, and the 
decision here that a woman makes regarding her pregnancy should be made 
with her family in consultation with her doctor and, of course, her 
faith.
  Yesterday, I talked about this as an issue of fundamental liberty for 
female citizens. Let me submit to you that it is not only a matter of a 
woman's liberty and right to control her own body that is at stake with 
this legislation; it is also a doctor's right to treat--to treat his 
patient, and to treat his patient under very difficult circumstances 
indeed.
  It seems to me that as we dabble around we are in the process of 
limiting the liberties of the unborn that have been spoken of will be 
born to. I think, Mr. President, that is a grievous error for which we 
will all have great regret.
  I thank the Senator from California. The good news about this 
amendment is that it can improve what is a bad bill. The bad news about 
it, or maybe the good news about it, is hopefully medical science will 
overcome this situation. But, quite frankly, for the present we should 
not be dabbling where we have no knowledge, where we have no expertise, 
and in a way that will injure and jeopardize the health, safety, and 
indeed even the lives of millions of American women.
  Thank you. I yield the floor.
  Mr. President, I do not know if this letter has been made a part of 
the Record. I ask unanimous consent that it be printed in the Record. 
It is a letter dated November 6 from the American College of 
Obstetricians and Gynecologists in opposition to this legislation.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

                                           The American College of


                              Obstetricians and Gynecologists,

                                 Washington, DC, November 6, 1995.
     Hon. Robert Dole,
     Majority Leader, The Capitol,
     Washington, DC.
       Dear Majority Leader Dole: The American College of 
     Obstetricians and Gynecologists (ACOG), an organization 
     representing more than 35,000 physicians dedicated to 
     improving women's health care, does not support H.R. 1833, 
     the Partial-Birth Abortion Ban Act of 1995. The College finds 
     very disturbing that Congress would take any action that 
     would supersede the medical judgment of trained physicians 
     and criminalize medical procedures that may be necessary to 
     save the life of a woman. Moreover, in defining what medical 
     procedures doctors may or may not perform, H.R. 1833 employs 
     terminology that is not even recognized in the 

[[Page S 18227]]
     medical community--demonstrating why Congressional opinion should never 
     be substituted for professional medical judgment.
       Thank you for considering our views on this important 
     matter.
           Sincerely,
                                                Ralph W. Hale, MD,
                                               Executive Director.

  Mr. SMITH. Mr. President, so we all understand, the Feinstein 
substitute amendment is the killer amendment. It simply guts the bill. 
The earlier amendment was the Boxer amendment, which was defeated.
  This amendment, no less than the Boxer amendment before it a short 
while ago, is the partial-birth abortion-on-demand amendment. And this 
amendment would totally eliminate the Partial-Birth Abortion Ban Act.
  So if you support the bill, and you voted no on the Boxer amendment, 
you should vote no on the Feinstein amendment because it would replace 
the bill with current law. Current law is partial-birth abortion on 
demand--I might add, through all 9 months of pregnancy for whatever 
reason.
  In other words, Mr. President, if you want to go back on what you 
voted for, what you support, the partial-birth abortion ban, then you 
would have to vote for Feinstein.
  In essence and in conclusion, this is a gutting amendment. It goes 
back to current law. It just eliminates the entire bill.
  For that reason, obviously, we oppose it, and I encourage all of 
those who voted no on Boxer who want the partial-birth abortion ban as 
described in our legislation to vote no on the Feinstein amendment.
  At this point, unless my colleagues would like some of my time--I 
would be happy to yield it--I have no further desire for time.
  Mrs. FEINSTEIN. I thank the Senator. I yield the time.
  Mr. SMITH. I yield back the remainder of my time.
  The PRESIDING OFFICER. The Senator yields back the remainder of his 
time.
  The question is on agreeing to the amendment.
  Mrs. FEINSTEIN. Mr. President, I ask for the yeas and nays.
  The PRESIDING OFFICER. Is there a sufficient second?
  There is a sufficient second.
  The yeas and nays were ordered.
  Mr. SMITH. Mr. President, I would just ask unanimous consent that 
Senator Brown and I be allowed to do a brief colloquy on a matter that 
I neglected to mention and then we will vote.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mr. BROWN addressed the Chair.
  The PRESIDING OFFICER. The Senator from Colorado.
  Mr. BROWN. Mr. President, this bill would expose physicians to 
criminal and civil liability for performing a partial-birth abortion, 
and I believe it is critical that we be very clear as to what is 
covered by the bill. The bill defines a ``partial-birth abortion'' as 
``an abortion in which the person performing the abortion partially 
vaginally delivers a living fetus before killing the fetus and 
completing the delivery.''
  It is my understanding that ``partially vaginally delivers'' means 
the person performing the abortion actively removes a portion of the 
fetus from the uterus, through the cervyx and into the birth canal. And 
I would ask the manager if this is his understanding as well?
  Mr. SMITH. The Senator from Colorado is correct. ``Partially 
vaginally delivers'' means the physician delivers part of the baby 
through the cervyx and into the birth canal.
  Mr. BROWN. At the Judiciary Committee hearing, Dr. Robinson, of the 
Johns Hopkins University, mentioned that it is possible for a portion 
of the fetus, such as a hand or foot, to slip accidentally through the 
cervyx and into the birth canal without active removal by the 
physician. I assume the manager does not intend to include those cases 
in the definition of partial-birth abortion. Am I correct?
  Mr. SMITH. The Senator from Colorado is correct. This bill would only 
cover those circumstances where someone intentionally delivers part of 
a living baby through the cervyx and into the birth canal.
  Mr. BROWN. The definition also states that it only applies to 
``partial vaginal delivery of a living fetus.'' In other words, if the 
fetus had died before being partially removed from the uterus, this 
measure would not prohibit a physician from safely removing the dead 
fetus from the mother. Is that correct?
  Mr. SMITH. The Senator is correct. That is correct.
  Mr. BROWN. Finally, Mr. President, it is my understanding this bill 
applies only to those who knowingly perform a partial-birth abortion. 
In other words, a physician must intentionally partially deliver a 
living fetus and then deliberately kill the fetus to be subject to 
criminal or civil liability. For example, under this bill, if a doctor 
fully intends to deliver a living baby but due to an accident during 
delivery the fetus dies, the doctor would not be subject to criminal or 
civil liability. Is that correct?
  Mr. SMITH. The Senator is correct.
  Mr. BROWN. I thank the Senator for his time and particularly for what 
I think will be a helpful colloquy in being very specific as to what 
the words and terms used in the bill mean.
  Mr. President, I yield the floor.
  The PRESIDING OFFICER. The question is on agreeing to amendment No. 
3092 offered by the Senator from California. The yeas and nays have 
been ordered. The clerk will call the roll.
  The assistant legislative clerk called the roll.
  Mr. LOTT. I announce that the Senator from Alabama [Mr. Shelby] is 
necessarily absent.
  Mr. FORD. I announce that the Senator from New York [Mr. Moynihan] is 
necessarily absent.
  The PRESIDING OFFICER (Mrs. Hutchison). Are there any other Senators 
in the Chamber who desire to vote?
  The result was announced--yeas 44, nays 53, as follows:

                      [Rollcall Vote No. 595 Leg.]

                                YEAS--44

     Akaka
     Baucus
     Bingaman
     Boxer
     Bradley
     Bryan
     Bumpers
     Byrd
     Campbell
     Chafee
     Cohen
     Daschle
     Dodd
     Feingold
     Feinstein
     Glenn
     Graham
     Harkin
     Hollings
     Inouye
     Jeffords
     Kassebaum
     Kennedy
     Kerrey
     Kerry
     Kohl
     Lautenberg
     Leahy
     Levin
     Lieberman
     Mikulski
     Moseley-Braun
     Murray
     Nunn
     Pell
     Pryor
     Robb
     Rockefeller
     Sarbanes
     Simon
     Simpson
     Snowe
     Specter
     Wellstone

                                NAYS--53

     Abraham
     Ashcroft
     Bennett
     Biden
     Bond
     Breaux
     Brown
     Burns
     Coats
     Cochran
     Conrad
     Coverdell
     Craig
     D'Amato
     DeWine
     Dole
     Domenici
     Dorgan
     Exon
     Faircloth
     Ford
     Frist
     Gorton
     Gramm
     Grams
     Grassley
     Gregg
     Hatch
     Hatfield
     Heflin
     Helms
     Hutchison
     Inhofe
     Johnston
     Kempthorne
     Kyl
     Lott
     Lugar
     Mack
     McCain
     McConnell
     Murkowski
     Nickles
     Pressler
     Reid
     Roth
     Santorum
     Smith
     Stevens
     Thomas
     Thompson
     Thurmond
     Warner

                             NOT VOTING--2

     Moynihan
     Shelby
       
  So the amendment (No. 3092) was rejected.
  Mr. SMITH. Madam President, I move to reconsider the vote.
  Mr. GRAMM. I move to table the motion.
  The motion to lay on the table was agreed to.
  The PRESIDING OFFICER. The question is on the engrossment of the 
amendments and third reading of the bill.
  The amendments were ordered to be engrossed, and the bill to be read 
a third time.
  The bill was read a third time.
  Mr. DOLE. I ask for the yeas and nays.
  The PRESIDING OFFICER. Is there a sufficient second?
  There is a sufficient second.
  The yeas and nays were ordered.
  The PRESIDING OFFICER. We now have 4 minutes of debate equally 
divided.
  Mrs. BOXER. Madam President, I ask my colleagues if they could give 
me their attention for 2 minutes of what has been a very difficult 
debate. Just for 2 minutes.
  I ask you to vote ``no'' on the final passage of this radical bill. 
It outlaws an emergency medical procedure which doctors have testified 
is used to save the life of a woman or to avert serious adverse health 
consequences.
  A woman like this, Coreen Costello, who asks us to put aside our 
party affiliation and remember her. Despite 

[[Page S 18228]]
the other side saying she did not have the procedure outlawed in this 
bill, she did. She wrote us and told us that today and she testified 
that she did.
  My colleagues, I am down to the last 60 seconds. This is what Coreen 
Costello said. Please listen:

       When families like ours are given this kind of tragic news 
     the last people we want to seek advice from are politicians. 
     We talk to our doctors, lots of doctors. We talk to our 
     families and other loved ones, and we ponder long and hard 
     into the night with our God.

  Coreen asks us to vote against this bill.

       It will deny women a life saving and health saving option 
     in a tragic emergency situation. You would not do it to your 
     own wife. You would not do it to your own daughter. I ask 
     you, please, do not do it to America's wives and to America's 
     daughters.

  There is no true life exception. It was a partial exception. It was 
different than the normal Hyde language. So this is indeed a radical 
proposal. Please vote ``no'' on final passage. President Clinton will 
veto this bill.
  The PRESIDING OFFICER. The Senator from New Hampshire is recognized 
for 2 minutes.
  Mr. SMITH. Madam President, the House of Representatives recently 
voted overwhelming by a two-thirds majority to ban partial-birth 
abortion. The vote on the ban was 288-139.
  This is not a radical extreme bill. It was supported by liberal 
Democrats such as Patrick Kennedy; liberal Republicans, moderate 
Republicans, such as Susan Molinari; pro-choice, pro-life. It is not a 
radical bill. Rich Gephardt supported it and others.
  We have added a life-of-the-mother exception which was requested by 
some of my colleagues on both sides of the aisle. We did that. I hope 
we can get a similar, bipartisan overwhelming majority here in the 
Senate like we had in the House to stop what I believe is a very cruel 
practice.
  Let me conclude on this point, because Senator Boxer and I have been 
debating this on and off for several days now. The photograph that is 
being displayed here is of a woman who went through a terrible ordeal. 
We all know that. We have great sympathy for what she went through. But 
she did not have the partial-birth abortion. She did not have a 
partial-birth abortion. This would not have stopped the procedure that 
Coreen Costello had.
  I urge my colleagues to vote for final passage. I yield the floor.
  The PRESIDING OFFICER. All time has expired.
  The bill having been read the third time, the question is, Shall the 
bill pass?
  The yeas and nays have been ordered.
  The clerk will call the roll.
  The legislative clerk called the roll.
  Mr. FORD. I announce that the Senator from New York [Mr. Moynihan] is 
necessarily absent.
  The PRESIDING OFFICER. Are there any other Senators in the Chamber 
desiring to vote?
  The result was announced--yeas 54, nays 44, as follows:

                      [Rollcall Vote No. 596 Leg.]

                                YEAS--54

     Abraham
     Ashcroft
     Bennett
     Biden
     Bond
     Breaux
     Brown
     Burns
     Coats
     Cochran
     Conrad
     Coverdell
     Craig
     D'Amato
     DeWine
     Dole
     Domenici
     Dorgan
     Exon
     Faircloth
     Ford
     Frist
     Gorton
     Gramm
     Grams
     Grassley
     Gregg
     Hatch
     Hatfield
     Heflin
     Helms
     Hutchison
     Inhofe
     Johnston
     Kempthorne
     Kyl
     Lott
     Lugar
     Mack
     McCain
     McConnell
     Murkowski
     Nickles
     Pressler
     Reid
     Roth
     Santorum
     Shelby
     Smith
     Stevens
     Thomas
     Thompson
     Thurmond
     Warner

                                NAYS--44

     Akaka
     Baucus
     Bingaman
     Boxer
     Bradley
     Bryan
     Bumpers
     Byrd
     Campbell
     Chafee
     Cohen
     Daschle
     Dodd
     Feingold
     Feinstein
     Glenn
     Graham
     Harkin
     Hollings
     Inouye
     Jeffords
     Kassebaum
     Kennedy
     Kerrey
     Kerry
     Kohl
     Lautenberg
     Leahy
     Levin
     Lieberman
     Mikulski
     Moseley-Braun
     Murray
     Nunn
     Pell
     Pryor
     Robb
     Rockefeller
     Sarbanes
     Simon
     Simpson
     Snowe
     Specter
     Wellstone

                             NOT VOTING--1

       
     Moynihan
       
  So the bill (H.R. 1833), as amended, was passed.
  Mr. SMITH. Madam President, I move to reconsider the vote by which 
the bill was passed.
  Mr. FORD. I move to lay that motion on the table.
  The motion to lay on the table was agreed to.
  Mr. BINGAMAN addressed the Chair.
  The PRESIDING OFFICER. The Senator from New Mexico.

                          ____________________