[Ip-health] US Senate Res: Respect Doha Declaration and more

[robert weissman]

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... (Introduced in
Senate)

SRES 241 IS

110th CONGRESS

1st Session

S. RES. 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.

IN THE SENATE OF THE UNITED STATES

June 20, 2007

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

RESOLUTION

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.

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 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.