[Congressional Record Volume 151, Number 17 (Wednesday, February 16, 2005)]
[Senate]
[Pages S1498-S1499]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




   THE DOHA DECLARATION AND THE TRADE PROMOTION AUTHORITY ACT OF 2002

  Mr. KENNEDY. Mr. President, the Trade Promotion Authority Act of 2002 
gives the President and the U.S. Trade Representative the power to 
negotiate bilateral and multilateral trade agreements that must be 
given expedited consideration by Congress. The Doha Declaration was 
adopted by the World Trade Organization at the Fourth Ministerial 
Conference at Doha, Qatar, on November 14, 2001, and addresses the need 
for access to medicines for all and how to reconcile that need with 
intellectual property protections.
  When the Trade Act came to the floor of the Senate, Senator Feinstein 
and I offered an amendment to the section on the negotiating objectives 
of the United States in trade negotiations. Our amendment made it a 
principal objective of the United States to respect the Doha 
Declaration in all trade negotiations. Regrettably, in several trade 
agreements since then, administration has refused to fulfill this 
obligation.
  The basic issue was the interpretation of the so-called TRIPS 
agreement on intellectual property protections such as patents and 
copyright. The Doha Declaration specifically states that the TRIPS 
agreement ``does not and should not prevent members from taking 
measures to protect public health.'' It recognized the need to 
interpret and implement TRIPS in a way that supports a nation's ``right 
to protect public health and, in particular, to promote access to 
medicines for all.''
  The Doha Declaration went on to specify that ``[e]ach member country 
has the right to grant compulsory licenses and the freedom to determine 
the grounds upon which such licenses are granted.'' It stated that each 
member nation is ``free to establish its own regime'' on whether a sale 
of a patented product by the patent owner or licensee exhausts the 
patent, so that it cannot be asserted against subsequent purchasers or 
users of the product.
  The Doha Declaration recognized a basic principle--poor people in the 
developing nations often cannot afford many patented drugs, even though 
the drugs are their only hope for surviving AIDS and other serious and 
life-threatening diseases.
  The Doha Declaration is clearly intended to prevent patents from 
blocking access to life-saving drugs. Developing nations obviously do 
not have the capacity to manufacture drugs themselves, and they must be 
free to purchase these drugs from another country.
  Our amendment to the Trade Promotion Authority Act reinforces the 
Doha Declaration. The Bush administration should be using it to 
negotiate trade agreements that allow urgently needed access to 
medicines. Instead, the administration has used trade agreements to 
promote the interests of the pharmaceutical industry at the expense of 
access to drugs in developing nations.
  Again and again, the administration has defied the Doha Declaration 
and imposed unjustified restrictions on the availability of patented 
drugs. They've done it on trade agreements with Australia, with Jordan, 
with Morocco, with Singapore, and other nations. In these agreements, 
the Bush administration has undermined the very core of the Doha 
Declaration. They're trying to do it now in the Central American Free 
Trade Agreement.
  They block the approval and use of generic version of drugs. They 
prevent new treatments for HIV/AIDS from getting to the people of the 
developing world.
  It's an outrageous policy. The administration has made it U.S. policy 
to block affordable, life-saving drugs for AIDS for the people of 
Central America, because they feel it's more important to protect the 
profits of brand name drug companies..
  The administration is defying the statutory requirement of the Doha 
Declaration, that our objective in these agreements must be to 
guarantee access to essential drugs for the sick and the poor in the 
developing nations of the world.
  They use countless legal tactics to cause delays in the approval of 
generic drugs in developing countries, even

[[Page S1499]]

when patents are invalid or are not infringed at all by the generic 
drug. In essence, the administration has set up a bottleneck to prevent 
approval of generic drugs in many countries of the developing world. 
That's completely at odds with the Doha Declaration.
  U.S. law allows a generic drug company to use a patented drug to 
develop a generic version of the drug before the patent has expired. It 
takes time to develop a drug, test it, and have it reviewed by the FDA.
  The theory of the law is that a generic drug company should be able 
to complete this approval process before the patent expires, so that 
developing countries can get generic versions of drugs as quickly as 
possible.

  That process is permitted by TRIPS, which means it is permitted by 
the trade agreements the administration has negotiated. It is not 
required by those agreements, however, and the administration has not 
tried to include it. In fact, they give brand name drug companies the 
opportunity to block that process in each of these developing 
countries. It's another example of the administration cynically 
protecting the interests of the brand name drug companies in violation 
of the law.
  The administration claims that its tactics are consistent with 
another objective of the Trade Act, which is to seek standards for 
intellectual property protection and enforcement in other countries. 
That's true, but it's in the same provision in the act as the Doha 
Declaration.
  The administration has a good track record in protecting the brand 
name drug industry, but it has never gotten even one provision that 
respects the Doha Declaration. Selectively interpreting laws to apply 
one provision and ignore another is unacceptable.
  It's no secret that the brand name drug companies want better patents 
and longer exclusivities in the United States. But it's wrong for the 
administration to side with them in trade agreements that defy the Doha 
Declaration.
  The administration has systematically blocked Congress from changing 
intellectual property protections except in ways that benefit brand 
name drug companies. It gets even worse. When brand name drug companies 
successfully lobby for protections under the laws of our trading 
partners that are greater than those under U.S. law, the industry then 
argues that the United States should ``harmonize'' its intellectual 
property protections with those of our trading partners. That's a slap 
in the face to Congress and the American people. They should not be 
forced by the Bush administration to endure even higher drug prices 
than they do today.
  The question is: What should be done to put real teeth in Doha 
Declaration in trade negotiations?
  First, the administration should follow U.S. law and respect the 
declaration in future negotiations, such as those about to begin with 
the nations of the Andes. It should immediately stop seeking 
intellectual property protections that prevent access to medicines for 
all and should start to seek those that promote greater access to 
medicines for all.
  Second, the negotiators for countries of the developed and developing 
world should stop every time the U.S. Trade Representative asks for an 
intellectual property provision, especially one directed specifically 
at drug patents or drug data exclusivity, and ask how that provision 
affects access to needed drugs.
  The U.S. Trade Representative should not be surprised if negotiators 
from developing nations refuse to accept restrictive provisions that 
violate the Doha Declaration. They should challenge our Trade 
Representative to obey the rule of law.
  And here in Congress, we have to do a better job of insisting that 
our trade agreements comply with the letter and the spirit of the Doha 
Declaration. It's the law of the land, and it's a matter of life and 
death for hundreds of millions of people in other lands. The tactics we 
are so shamefully using against them can only breed greater resentment 
and greater hatred of the United States. And we can't afford to let 
that happen at this critical time in our role in the world.
  I ask unanimous consent that a brief description of provisions in 
trade agreements that violate the Doha Declaration be printed in the 
Record as a technical appendix.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

  Technical Appendix to Statement of Senator Edward M. Kennedy on the 
     Doha Declaration and the Trade Promotion Authority Act of 2002


                Compulsory Licensing and Parallel Trade

       The Administration has successfully imposed restrictions on 
     the right to compulsory license medicines in the trade 
     agreements with Australia, Jordan, and Singapore. The 
     Administration has obtained provisions that can block 
     parallel imports in trade agreements with both developed and 
     developing nations, such as Australia, Morocco, and 
     Singapore. For the Doha Declaration to work, both developed 
     and developing countries must be able to issue compulsory 
     licenses and then engage in parallel importation of the drug 
     from the developed country that can manufacture the drug to 
     the developing country whose people need the drug, yet these 
     agreements undermine both compulsory licensing and parallel 
     importation.


                           Data Exclusivities

       The Administration has also pursued data exclusivities to 
     protect brand name drugs in trade agreements with Australia, 
     Bahrain, Chile, Jordan, Morocco, and Singapore, and now seeks 
     them in the Central American Free Trade Agreement. To receive 
     authorization to market a drug, many countries, like the 
     United States, require the drug manufacturer to present data 
     to show that the drug is safe and effective for its intended 
     use. The clinical trials to produce these data can be quite 
     expensive, and protecting these data for a period of years--
     meaning that the data may not be used to approve another, 
     similar product--can create an incentive for and protect the 
     investment in producing them.
       In the developing world, however, data exclusivities 
     prohibit a country from approving even a compulsory licensed 
     version of a patented drug. The trade agreements that require 
     exclusivities provide no mechanism to allow for distribution 
     of compulsory licensed products notwithstanding the 
     exclusivities. The exclusivities therefore will block 
     compulsory licensed versions of the new treatments for HIV/
     AIDS and other serious diseases from getting to the people of 
     the developing world, at least until the data exclusivities 
     have expired.


               Linkage between Patents and Drug Approval

       Most recently, the Administration has also negotiated for 
     provisions in trade agreements with the countries of Central 
     America that link approval of generic drug products to the 
     status of patents on the pioneer drug product. In other 
     words, approval of generic drugs is blocked if there are 
     patents and the government approval agency has not 
     ascertained whether the generic product infringes a brand 
     name drug patent.
       In the United States, approval of a generic drug is blocked 
     because of a patent only if the brand name company sues to 
     defend the patent. The obligation is not on the Food and Drug 
     Administration, which has repeatedly stated that it has no 
     capacity to assess or evaluate patents. The Administration's 
     trade agreements place the responsibility to defend brand 
     name drug patents on the FDA's of the developing nations, 
     which we can only assume are more overburdened than our own 
     FDA and similarly lack the expertise to assess and evaluate 
     patents. The inevitable result will be delays in the approval 
     of generic drugs in developing countries caused by patents 
     that are invalid or that are not infringed by the generic 
     drug.


                          The Bolar Amendment

       In the United States, the Bolar Amendment allows a generic 
     drug company to use a patented invention to develop a generic 
     version of a drug before the patent has expired because it 
     takes time to develop and test a drug and have it reviewed by 
     the FDA and a generic drug company should be able to complete 
     this process before the patent has expired.
       Without a Bolar provision, a drug patent is arbitrarily 
     extended because of the time needed for drug formulation and 
     approval. The Bolar Amendment in a developing country will 
     improve timely access to medicines for the sick and poor. The 
     Administration has not sought to mandate the Bolar provision 
     in trade agreements, however.

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