[Congressional Record Volume 147, Number 49 (Thursday, April 5, 2001)]
[Senate]
[Pages S3552-S3554]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. SPECTER (for himself, Mr. Harkin, Mr. Thurmond, Mr. 
        Chafee, Mr. Smith of Oregon, Mr. Hollings, Mr. Reid, Mrs. 
        Murray, Mrs. Clinton, Mr. Corzine, Mrs. Feinstein, Mr. Kerry, 
        and Mr. Inouye):
  S. 723. A bill to amend the Public Health Service Act to provide for 
human embryonic stem cell generation and research; to the Committee on 
Health, Education, Labor, and Pensions.
  Mr. SPECTER. Mr. President, I have sought recognition today to 
introduce the ``Stem Cell Research Act of 2001.'' As chairman of the 
Senate appropriations subcommittee that funds medical research, my 
distinguished colleague, Senator Tom Harkin and I convened a series of 
seven hearings to learn more about an exciting medical discovery and 
the promise it holds. The source of this new hope is what scientists 
call ``stem cells.'' These are living cells which, in their earliest 
stages, have the ability to transform into any type of cell in the 
human body. If the scientists are correct, a stem cell implanted in a 
heart, for example, would become a healthy heart cell; if the same stem 
cell were implanted in a liver, it would grow into a healthy liver 
cell. It is this remarkable adaptability that leads scientists to 
believe that one day, stem cells could be transplanted to any part of 
the body to replace tissue that has been damaged by disease, injury or 
aging.
  A team of researchers also found that human embryonic stem cells that 
were injected into the spinal cords of monkeys stricken with Lou 
Gehrig's disease showed promising signs of movement. These early 
research findings indicate that stem cells hold hope for countless 
patients with cancer, Parkinson's, heart disease, Alzheimer's and 
spinal cord injury, just to name a few. These cells could become a 
veritable fountain of youth.
  What had been delaying the advancement of this new line of research 
is a provision in the Labor-HHS appropriations bill that prohibits 
research on

[[Page S3553]]

human embryos. In early 1999, the Department of Health and Human 
Services ruled that Federal researchers could conduct research on stem 
cell lines derived from private sources. I applaud the HHS ruling and 
encourage the NIH to review, on an expedited basis, the compliance 
applications they recently received. However, we have a duty to 
accelerate medical research by allowing researchers to utilize Federal 
funds to derive their own stem cells.
  Human embryonic stem cell research holds such potential for millions 
of Americans who are sick and in pain that we believe it is wrong for 
us to prevent or delay our world-class scientists from building on the 
progress that has been made.
  Our legislation creates one narrow and specific source for Federal 
researchers to obtain embryos for use in stem cell research: embryos 
which would otherwise be discarded from in-vitro fertilization clinics, 
with the expressed consent of the donating families. In addition, a 
provision is included which requires that all Federally-funded research 
must adhere to strict procedural and ethical guidelines to ensure that 
such research is conducted in an ethical, sound manner. It is important 
to note that as it stands today, embryonic stem cell research in the 
private sector is not subject to Federal monitoring or ethical 
requirements.
  I am pleased that my colleagues, Senators Thurmond, Chafee, G. Smith, 
Hollings, Reid, Murray, Clinton, Corzine, Feinstein, Kerry, and Inouye 
have joined me and Senator Harkin as original cosponsors of this vital 
legislative effort. I urge all of my colleagues to join us in 
supporting this important legislation that will give many Americans the 
promise to treat diseases that today are incurable.
  I ask unanimous consent that the text of the bill be printed in the 
Record.
  There being no objection, the bill was ordered to be printed in the 
Record, as follows:

                                 S. 723

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Stem Cell Research Act of 
     2001''.

     SEC. 2. HUMAN EMBRYONIC STEM CELL GENERATION AND RESEARCH.

       Part H of the Title IV of the Public Health Service Act (42 
     U.S.C. 289 et seq.) is amended by inserting after section 
     498B the following:

     ``SEC. 498C. HUMAN EMBRYONIC STEM CELL GENERATION AND 
                   RESEARCH.

       ``(a) In General.--Notwithstanding any other provision of 
     law, the Secretary may only conduct, support, or fund 
     research on human embryos for the purpose of generating 
     embryonic stem cells and utilizing stem cells that have been 
     derived from embryos in accordance with this section.
       ``(b) Sources of Embryonic Stem Cells.--For purposes of 
     carrying out research under subsection (a), the human 
     embryonic stem cells involved shall be derived only from 
     embryos that have been donated from in-vitro fertilization 
     clinics after compliance with the following:
       ``(1) Prior to the consideration of embryo donation and 
     through consultation with the progenitors, it is determined 
     that the embryos will never be implanted in a woman and would 
     otherwise be discarded.
       ``(2) The embryos are donated with the written informed 
     consent of the progenitors.
       ``(c) Restrictions.--
       ``(1) In general.--The following restriction shall apply 
     with respect to human embryonic stem cell research conducted 
     or supported under subsection (a):
       ``(A) The research involved shall not result in the 
     creation of human embryos.
       ``(B) The research involved shall not result in the 
     reproductive cloning of a human being.
       ``(2) Prohibition.--
       ``(A) In general.--It shall be unlawful for any person 
     receiving Federal funds to knowingly acquire, receive, or 
     otherwise transfer any human embryos for valuable 
     consideration if the acquisition, receipt, or transfer 
     affects interstate commerce.
       ``(B) Definition.--In subparagraph (A), the term `valuable 
     consideration' does not include reasonable payments 
     associated with transportation, transplantation, processing, 
     preservation, quality control, or storage.
       ``(d) Guidelines.--The Secretary, in conjunction with the 
     Director of the National Institutes of Health, shall issue 
     guidelines that expand on the rules governing human embryonic 
     stem cell research (as in effect on the date of enactment of 
     this section) to include rules that govern the derivation of 
     stem cells from donated embryos under this section.
       ``(e) Reporting Requirements.--The Secretary shall annually 
     prepare and submit to the appropriate committees of Congress 
     a report describing the activities carried out under this 
     section during the preceding fiscal year, and including a 
     description of whether and to what extent research under 
     subsection (a) has been conducted in accordance with this 
     section.''.

  Mr. HARKIN. Mr. President, I am pleased to join my distinguished 
colleague, Senator Specter, on the introduction of the ``Stem Cell 
Research Act of 2001.'' I want to commend Senator Specter for having 
the leadership and foresight to introduce legislation which will 
broaden the ability of federally-funded scientists to pursue stem cell 
research, under certain, limited conditions.
  From enabling the development of cell and tissue transplantation, to 
improving and accelerating pharmaceutical research and development, to 
increasing our understanding of human development and cancer biology, 
the potential benefits of stem cell research are truly awe-inspiring.
  Stem cells hold hope for countless patients through potentially 
lifesaving therapies for Parkinson's, Alzheimers, stroke, heart disease 
and diabetes. Also exciting is the possibility that researchers may be 
able to alter stem cells genetically so they would avoid attack by the 
patient's immune system.
  Currently, for example, researchers are conducting groundbreaking 
research on the devastating condition commonly known as ``Lou Gehrig's 
disease.'' They are injecting stem cells into the spinal cords of 
moneys in an attempt to treat the disease. And they are reporting very 
promising early results.
  But the potential benefits of this study and others could be delayed 
or even denied to patients without a healthy partnership between the 
private sector and the federal government.
  While market interest in stem cell technology is strong, and private 
companies will continue to fund this research, the government has an 
important role to play in supporting the basic and applied science that 
underpins these technologies. The problem is that early, basic science 
is always going to be underfunded by the private sector because this 
type of research does not get products onto the market quickly enough. 
The only way to ensure that this research is conducted is to allow the 
NIH to support it.
  The Department of Health and Human Services ruled last year that 
under the current ban on human embryo research, federally-funded 
scientists can conduct stem cell research if they use cell lines 
derived from private sources. Unfortunately, the current administration 
has placed this ruling under review. We are anxiously awaiting the 
outcome of this review.
  In the meantime, I am pleased to join my colleagues in stating my 
strong support for stem cell research. There is broad agreement, across 
party lines, that this research is important, it could save lives, and 
it should not be halted.
  In its report, ``Ethical Issues in Human Stem Cell Research,'' the 
National Bioethics Advisory Commission (NBAC) concludes that stem cell 
research should be allowed to go forward with federal support, as long 
as researchers were limited to only two sources of stem cells: fetal 
tissue and embryos resulting from infertility treatments. And they 
recommend that federal support to be contingent on an open system of 
oversight and review.
  NBAC also arrived at the important conclusion that it is ethically 
acceptable for the federal government to finance research that both 
derives cell lines from embryos and that uses those cell lines. Their 
report states, ``Relying on cell lines that might be derived 
exclusively by a subset of privately funded researchers who are 
interested in this area could severely limit scientific and clinical 
progress.''
  The Commission goes on to say that ``scientists who conduct basic 
research and are interested in fundamental cellular processes are 
likely to make elemental discoveries about the nature of ES [embryonic 
stem] cells as they derive them in the laboratory.''
  NBAC's report presents reasonable guidelines for federal policy. Our 
bill bans human embryo research, but allows federally-funded scientists 
to derive human pluripotent stem cells from human embryos if those 
embryos are obtained from IVF clinics, if the donor has provided 
informed consent and the embryo was no longer needed for fertility 
treatments. The American Society of Cell Biology estimates that

[[Page S3554]]

100,000 human embryos are currently frozen in IVF clinics, in excess of 
their clinical need.
  In addition, our language requires HHS and NIH to develop procedural 
guidelines to make sure that stem cell research is conducted in an 
ethical, sound manner. As it stands today, stem cell research in the 
private sector is not subject to federal monitoring or ethical 
requirements.
  Mr. President, stem cell research holds such hope, such potential for 
millions of Americans who are sick and in pain, it is morally wrong for 
us to prevent or delay our world-class scientists from building on the 
progress that has been made.
  As long as this research is conducted in an ethically validated 
manner, it should be allowed to go forward, and it should receive 
federal support. That is why Senator Specter and I have joined together 
on legislation that will allow our nation's top scientists to pursue 
critical cures and therapies for the diseases and chronic conditions 
which strike too many Americans. I urge my Senate colleagues to join us 
in supporting this bill.

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