[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[H. Res. 525 Introduced in House (IH)]







110th CONGRESS
  1st Session
H. RES. 525

 Expressing the sense of the House of Representatives 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.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             June 28, 2007

Mr. Allen submitted the following resolution; which was referred to the 
                      Committee on Ways and Means

_______________________________________________________________________

                               RESOLUTION


 
 Expressing the sense of the House of Representatives 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.

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 licenses 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 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 House of Representatives 
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 which are developing countries 
        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.
                                 <all>