[Congressional Record (Bound Edition), Volume 149 (2003), Part 5]
[Senate]
[Pages 7116-7117]
[From the U.S. Government Publishing Office, www.gpo.gov]




BIOLOGICAL, CHEMICAL, AND RADIOLOGICAL WEAPONS COUNTERMEASURES RESEARCH 
                                  ACT

  Mr. HATCH. Mr. President, I rise to speak about my cosponsorship, 
with Senator Lieberman, of the bipartisan Biological, Chemical, and 
Radiological Weapons Countermeasures Research Act of 2003. Senator 
Lieberman and I also offered similar legislation, S. 3148, in the 107th 
Congress.
  I think that when our colleagues, the administration, academic 
biomedical researchers, patient advocacy organizations, and the general 
public study the ambitious set of incentives contained in the 
Lieberman-Hatch bill, they will conclude that this measure can 
materially improve our national security. If adopted, this legislation 
will allow the families of Utah and in our sister states across America 
to live with a greater measure of safety.
  Although this is a complex piece of legislation, its goal is simple. 
The Lieberman-Hatch bill will establish a unique public-private sector 
relationship that will result in stimulating the private sector to 
increase its scope and pace of research and development activities for 
a wide range of medical products intended to deter and respond to acts 
of biological, chemical, or radiological terrorism.
  Senator Lieberman and I believe that the best way to discourage and 
prevent acts of bioterrorism is to be able to demonstrate our capacity 
to develop, produce, and distribute biological, chemical, and 
radiological weapons countermeasures.
  In short, if our medicine chest is full and we show the world that we 
have the ability to rapidly discover new countermeasures, we will 
decrease the likelihood of ever having to deploy these countermeasures 
in the first place. For example, in the last 18 months we have made 
great strides in ramping up production of, and our capacity to 
distribute, smallpox vaccine. In fact, few, in any, countries could 
respond more effectively than the United States to the introduction of 
smallpox. Our enemies in Baghdad and those hiding in mountains of 
Afghanistan might do more harm to themselves and their neighbors if a 
worldwide smallpox outbreak occurs.
  Unfortunately, there are dozens, and perhaps many more, biological 
and chemical threats for which we have no adequate response. As well, 
this latest outbreak of antibiotic- and antiviral-resistant pneumonia 
points out the need to develop responses to new public health threats 
whether they are spread intentionally or naturally. This bill tries to 
create a new paradigm for the development of vital bioterrorism 
countermeasures that could also serve as a model for stimulating 
private sector drug discovery activities in other important areas such 
as cancer, heart disease, and infectious and rare diseases.
  Senator Lieberman and I praise the work that has already been done to 
help our nation meet this new type of

[[Page 7117]]

threat. Senators Byrd, Stevens, Specter, and Harkin made available a 
substantial amount of new resources immediately in the aftermath of the 
September 11th and the October, 2001 anthrax attacks.
  Last year, Senators Gregg, Kennedy, and Frist led the effort to pass 
important bioterrorism legislation to improve the public health 
infrastructure so that our country can better respond to public health 
emergencies.
  The Bush administration is currently working closely with Congress on 
the Project BioShield program. We salute these efforts. We are pleased 
that the Administration is now embracing the concept of a guaranteed 
market that was part of last year's Lieberman-Hatch bill, S. 3148. We 
urge the Administration and Congress to adopt other critical features 
of Lieberman-Hatch.
  The Lieberman-Hatch bill is a bold attempt to move the ball closer to 
the goal line. Our bill attempts to complement all the previous efforts 
to build up the capacity for public sector responses with a set of 
incentives designed to unleash the creative genius and substantial 
resources of the private sector actors within our Nation's biomedical 
research enterprise.
  Let me quickly summarize the major features of the bill.
  The Department of Homeland Security sets the countermeasures research 
agenda so that firms know beforehand the research targets. Interested 
companies register with DHS and become obligated to report their 
activities and subject their plants to inspection.
  The legislation allows a participating company seeking to fund 
eligible research to elect from among four types of tax incentives. 
First, we provide for the establishment of R&D limited partnerships. 
Second, we create the authority for qualified firms to issue a new 
class of stock that would be subject to no capital gains tax. Third, we 
create a new tax credit to help fund the research. Fourth, we allow for 
a special tax credit for research conducted at non-profit and academic 
research institutions.
  Anyone familiar with the current dismal financial state of affairs 
within the biotechnology industry will understand the attraction of 
these tax provisions. Many struggling firms might find it prudent to 
explore the benefits of adjusting their research portfolios to include 
countermeasure research and development.
  The legislation authorizes funding for a program whereby companies 
successfully developing countermeasures that secure FDA approval can be 
guaranteed a market at a pre-negotiated price and pre-negotiated 
quantities.
  Our legislation also contains some fundamental revisions in 
pharmaceutical intellectual property laws. As author of the Drug Price 
Competition and Patent Term Restoration Act of 1984, I hold these 
provisions near and dear.
  Essentially, the bill adopts a policy of day-for-day patent term 
restoration for each day lost during FDA review. Under the current 
provisions of the 1984 Hatch-Waxman law, no patent may be restored by 
more than five years and then only if the effective patent term does 
not exceed 14 years regardless of whether the FDA review takes longer 
than five years.
  The legislation also grants a ten year period of marketing 
exclusivity for any approved countermeasure, regardless of a product's 
patent status. This means that FDA could not approve a competitor 
product until that period expires. This provision operates in parallel 
with patent protections and serves as a floor time period during which 
generic versions of the pioneer countermeasure product could enter the 
market. Current U.S. law only provides for a five year marketing 
exclusivity period while most European Union countries and Japan 
already provide a ten year marketing exclusivity period.
  The Lieberman-Hatch bill also allows certain types of biotechnology 
companies, specifically those with less than $750 million in paid-in 
capital, to extend any patent by two years if the firms successfully 
develop a countermeasure.
  I can tell you that these substantial changes in the area of 
intellectual property will get a positive reaction in corporate 
boardrooms; resources will flow in the direction of products eligible 
for these new intellectual property protections and products will be 
developed to help our country respond to bioterrorist threats.
  In addition to the guaranteed market provisions, targeted tax breaks, 
and intellectual property incentives, the Lieberman-Hatch legislation 
also contains liability provisions; accelerated FDA approval 
procedures, and a limited antitrust exemption.
  In summary, the Lieberman-Hatch bill contains an array of incentives 
designed to spur a robust response from the private pharmaceutical 
sector. If we are going to increase our ability to defend the American 
homeland, we need to be certain that both the public and private 
sectors' are fully engaged. That is exactly what our bill will help 
accomplish by unleashing the energy and resources of those private 
sector firms engaged in biomedical research and development.
  I urge all of my colleagues and others with an interest in homeland 
security to study the bipartisan Lieberman-Hatch Biological, Chemical, 
and Radiological Weapons Countermeasures Research Act of 2003. I 
believe that when our legislation is examined, it will attract broad 
and strong bipartisan support.
  Let me close by commending my friend from Connecticut, Senator Joe 
Lieberman, for his vision, energy, and leadership in this critically 
important area. I would also like to commend the efforts of our 
bipartisan group of partners in the House, Congressmen Tom Davis, Cal 
Dooley, Curt Weldon, and Norm Dicks.

                          ____________________