[Congressional Record (Bound Edition), Volume 153 (2007), Part 12]
[Senate]
[Pages 16659-16660]
[From the U.S. Government Publishing Office, www.gpo.gov]




  SENATE RESOLUTION 241--EXPRESSING THE SENSE OF THE SENATE THAT THE 
 UNITED STATES SHOULD REAFFIRM THE COMMITMENTS OF THE UNITED STATES TO 
THE 2001 DOHA DECLARATION ON THE TRIPS AGREEMENT AND PUBLIC HEALTH AND 
 TO PURSUING TRADE POLICIES THAT PROMOTE ACCESS TO AFFORDABLE MEDICINES

  Mr. BROWN submitted the following resolution; which was referred to 
the Committee on Finance:

       Whereas the World Trade Organization (WTO) administers and 
     enforces the Agreement on Trade-Related Aspects of 
     Intellectual Property Rights (in this preamble referred to as 
     ``the TRIPS Agreement'') to safeguard access to essential 
     drugs;
       Whereas, in 1999, the World Health Assembly, by consensus 
     including the United States, adopted Resolution 52.19 on the 
     World Health Organization's Revised Drug Strategy, which 
     expressed concern ``about the situation in which one third of 
     the world's population has no guaranteed access to essential 
     drugs, [and] in which new world trade agreements may have a 
     negative impact on local manufacturing capacity and the 
     access to and prices of pharmaceuticals in developing 
     countries,'' and urged member states to ``ensure that public 
     health rather than commercial interests have primacy in 
     pharmaceutical and health policies and to review their 
     options under'' the TRIPS Agreement;
       Whereas, in 2001, the member states of the WTO, by 
     consensus including the United States, adopted the Doha 
     Declaration on the TRIPS Agreement and Public Health, in 
     which member states agreed that ``intellectual property 
     protection is important for the development of new 
     medicines'', but also expressed ``concerns about its effects 
     on prices'';
       Whereas the Doha Declaration further states that the TRIPS 
     Agreement ``can and should be interpreted and implemented in 
     a manner supportive of WTO Members' right to protect public 
     health and, in particular, to promote access to medicines for 
     all'';
       Whereas Article 31 of the TRIPS Agreement allows each 
     member state the flexibility to issue compulsory licences 
     which permit the use of the subject matter of a patent, and 
     gives member states broad latitude for such use;
       Whereas the World Health Organization's 2006 Report of the 
     Commission on Intellectual Property Rights, Innovation and 
     Public Health emphasized the need for innovation in medical 
     technologies and access to such innovation, and the report 
     also--
       (1) states that the Doha Declaration clarifies the right of 
     governments to use compulsory licensing as a means of 
     resolving tensions that may arise between public health and 
     the protection of intellectual property rights, and to 
     determine the grounds for using compulsory licensing;
       (2) recommends that developing countries provide for the 
     use of compulsory licensing provisions in legislation as one 
     means to facilitate access to affordable medicines through 
     import or local production;
       (3) recommends that bilateral trade agreements not seek to 
     impose obligations to protect intellectual property rights 
     that are greater than those required under the TRIPS 
     Agreement, because such obligations could potentially reduce 
     access to medicines in developing countries; and
       (4) recommends that developing countries should not impose 
     restrictions for the use of, or reliance on, data from 
     pharmaceutical development tests in ways that would exclude 
     fair competition or impede the use of flexibilities built 
     into the TRIPS Agreement, unless such a restriction is 
     required for public health reasons;
       Whereas the Governments of Thailand and Brazil have issued 
     compulsory licenses to gain access to less expensive versions 
     of second-generation anti-retroviral drugs in order to treat 
     a much larger number of HIV/AIDS patients;
       Whereas the Government of the United States has recognized 
     the right of the Government of Thailand to issue compulsory 
     licenses in accordance with the laws of Thailand and the 
     obligations of the Government of Thailand as a member of the 
     WTO;
       Whereas the 2007 ``Special 301'' Report, the annual review 
     of intellectual property rights protection and enforcement 
     conducted by the Office of the United States Trade 
     Representative, elevated Thailand to the Priority Watch List, 
     pursuant to section 182 of the Trade Act of 1974 (19 U.S.C. 
     2242), for reasons including ``indications of a weakening of 
     respect for patents, as the Thai Government announced 
     decisions to issue compulsory licenses for several patented 
     pharmaceutical products'';
       Whereas the 2007 ``Special 301'' Report singled out Brazil 
     for having ``at times indicated consideration of the use of 
     compulsory licensing on patented pharmaceutical products'';
       Whereas the 2007 ``Special 301'' Report cited 21 developing 
     countries for ``inadequate'' intellectual property rights 
     protections on pharmaceutical test data;
       Whereas the United States Trade Representative has 
     negotiated or is seeking to complete several bilateral or 
     regional trade agreements with developing countries that 
     contain further obligations to protect intellectual property 
     rights, including--
       (1) limitations on the grounds for issuing compulsory 
     licenses;
       (2) requirements that countries adopt periods of data 
     exclusivity on the scientific evidence used to determine that 
     drugs are safe and effective, which either delays the timely

[[Page 16660]]

     entry of generic drugs into the market or forces competitors 
     producing generic drugs to invest in costly, time-consuming, 
     and redundant clinical trials, including trials that violate 
     ethical rules concerning the repetition of experiments on 
     humans;
       (3) extensions of patent terms beyond 20 years;
       (4) linkage between drug registration and assertions of 
     patent protection, so that agencies responsible for the 
     regulation of drugs are prohibited from granting marketing 
     approval to a generic version of a medicine if the product is 
     covered by a patent; and
       (5) obligations to extend patent protection to minor 
     improvements in, or new uses of, older products; and
       Whereas the United States is a user of flexibilities 
     provided in the TRIPS Agreement, including the use of 
     involuntary authorizations to use the subject matter of 
     patents in a number of important sectors, including medical 
     devices, software, and automobile manufacturing: Now, 
     therefore, be it
       Resolved, That it is the sense of the Senate that the 
     United States should--
       (1) honor the commitments the United States made in the 
     2001 World Trade Organization Doha Declaration on the TRIPS 
     Agreement and Public Health, which allows member states of 
     the World Trade Organization to use ``to the full'' the 
     flexibilities in the Agreement on Trade-Related Aspect of 
     Intellectual Property Rights (in this resolution referred to 
     as ``the TRIPS Agreement'') ``to protect public health and, 
     in particular, to promote access to medicines for all,'' 
     including the issuance of compulsory licenses on grounds 
     determined by member states;
       (2) not place countries on the ``Special 301'' Priority 
     Watch List under section 182 of the Trade Act of 1974 (19 
     U.S.C. 2242) for exercising the flexibilities on public 
     health provided for in the TRIPS Agreement, such as issuing 
     compulsory licenses to obtain access to generic medicines in 
     accordance with the Doha Declaration;
       (3) not ask trading partners who are developing nations to 
     adopt measures to protect intellectual property rights that 
     relate to public health in excess of protections required in 
     the TRIPS Agreement; and
       (4) support new global norms for promoting medical research 
     and development that seek to provide a sustainable basis for 
     a needs-driven essential health agenda.

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