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Pacific region health groups urge TPP ministers to end harmful impact of FTAs on access to medicines

February 15, 2011

Hon. Craig Emerson, Trade Minister
Department of Foreign Affairs and Trade of Australia

H.R.H. Prince Mohamed Bolkiah, Minister
Ministry of Foreign Affairs and Trade of Brunei Darussalam

Hon. Alfredo Moreno Charme, Minister
Ministry of Foreign Affairs of Chile

YAB Datuk Seri Mustapa Mohamed, Minister
Ministry of International Trade and Industry, Malaysia

Hon. Tim Groser, Trade Minister
Ministry of Foreign Affairs and Trade of New Zealand

Hon. Eduardo Ferreyros Kuppers, Minister
Ministry of Foreign Trade and Tourism of Peru

Hon. Lim Hng Kiang, Minister
Ministry of Trade and Industry of Singapore

Amb. Ronald Kirk, Trade Representative
Office of the United States Trade Representative

Hon. Vu Huy Hoang, Minister
Ministry of Industry and Trade, Vietnam

Re: Safeguarding Access to Medicines in the Trans-Pacific Partnership Agreement

Dear Trade Ministers,

We, the undersigned civil society organizations, write to you regarding intellectual property
provisions in the proposed Trans-Pacific Partnership Agreement (TPPA). We are concerned that
intellectual property measures that may be included in an eventual agreement could undermine
patients’ access to vital medicines, and contravene promises of a new trade model and “21st
century” agreement.

Nearly two billion people still lack regular access to medicines in developing countries. Although several important factors contribute to this, one critical problem is the high price of
monopolized medicines. Intellectual property provisions that go beyond the standard required by
the World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property
(WTO’s TRIPS) – so-called “TRIPS-plus” measures – restrict generic competition, leading to
medicine prices that are unaffordable for most people, and healthcare costs that can restrict
health programs’ abilities to provide treatment or other services, in both developing and
wealthier countries.

The parties should seek to end the harmful impact of trade agreements on access to medicines.
In the past, the United States (among other countries) has negotiated trade agreements imposing
TRIPS-plus measures on trading partners, and limiting flexibilities that could otherwise help
promote cost-lowering competition.

Therefore, the best result for many parties to the Trans-Pacific Partnership Agreement may be no
intellectual property or pharmaceuticals provisions at all.

Nevertheless, we urge countries that are considering intellectual property chapters in the TPPA
to table alternatives to the TRIPS-plus model, including forward-looking proposals that would:

- Establish TRIPS as the maximum standard of substantive protection required by the TPPA
and preexisting trade agreements in the region, and
- Assist the effective implementation of TRIPS flexibilities.

We are available to discuss these proposals and some suggested components in detail.

The U.S.-Peru Trade Promotion Agreement, the most recent U.S. trade agreement to be ratified
and implemented, benefited from an historic agreement between the U.S. Congress and the
previous administration. This May 10th, 2007 agreement achieved an unprecedented reversal in
the decade-long trend of increasingly severe intellectual property provisions. Intellectual
property provisions in the U.S.-Peru agreement make patent term extensions and patent linkage
voluntary instead of mandatory, and place limits on the term and scope of data exclusivity.

The May 10th agreement fell short of adequately addressing access to medicines concerns. Its
provisions, including data exclusivity, still imposed new costs on public health. Nevertheless, it
represented an important progression in U.S. policy. The other TPPA parties should insist that
any intellectual property text tabled by the United States build on this progress, beginning by
eliminating data exclusivity requirements. Data exclusivity requirements compromise access to
medicines and are inconsistent with ethical standards regarding the duplication of tests on
humans or vertebrate animals.

Under no circumstances should the TPPA undermine the May 10th agreement by insisting on
stricter intellectual property measures than those included in the US-Peru FTA. Under no
circumstances should the TPPA require accession or adherence to the terms of the controversial
proposed Anti-Counterfeiting Trade Agreement (ACTA). And under no circumstances should
the TPPA impose procedural or substantive restrictions on the ability of government agencies,
including those at the state level, to regulate drug prices through reimbursement policies.

New Zealand’s recent TPPA proposal states the parties “should be cautious about moving
beyond TRIPS standards under [the] TPP,” noting that “there is a tendency towards
overprotection of IP in all our societies, particularly in the areas of copyright and patents.”
New Zealand proposes an alternative “TRIPS-aligned” structure, focusing on operational
coherence and enforcement, and capacity-building in developing countries. We applaud New
Zealand for introducing this alternate vision.

New Zealand’s proposal is a better starting point for any regional IP negotiation than the U.S.-
sponsored TRIPS-plus status quo. There are still dangers in each of New Zealand’s proposed
focus areas, including considerably increasing the bias of IP enforcement policy toward rights
holders. [1] This reveals the risks inherent in negotiating any intellectual property or
pharmaceuticals provisions in the TPPA. But New Zealand’s paper also reflects growing
awareness of the dangers of TRIPS-plus measures and rigid exclusive rights in many countries.

A 21st century agreement must not accept harmful 20th century terms. Instead, the TPPA should
look forward to new, open and flexible policy models. The TPPA should facilitate, rather than
impede, the parties honoring their commitments to access and innovation. The TPPA should
preserve countries’ options to “explore and, where appropriate, promote a range of incentive
schemes for research and development including addressing, where appropriate, the de-linkage
of the costs of research and development and the price of health products,” in accordance with
World Health Assembly Resolution 61.21.

Finally, the TPPA must respect the WTO’s 2001 Doha Declaration on the TRIPS Agreement and
Public Health – not only in principle, but in practice – including specifically Doha’s guarantee
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.”

Broad public consultation, input and review of proposed agreement terms will be essential to
safeguarding the sensitive public health interests at stake. We urge the TPPA parties to agree in
Chile to release the draft texts and associated country papers after each negotiating round.
We look forward to discussing these issues further. Please direct inquiries to Peter Maybarduk at
Public Citizen, 1600 20th Street NW, Washington, D.C. 20009, USA, pmaybarduk@citizen.org,
tel. +1 (202) 588-1000.

Sincerely,

- Australian Fair Trade and Investment Network (AFTINET)
- Asia Pacific Network of PLHIV (APN+)
- Continental Social Alliance (ASC) Chile
- Forum on Democracy on Trade
- Foundation for Integrative AIDS Research (FIAR)
- Global Network of People Living with HIV (GNP+)
- Health Action International (HAI) Global
- Health Action International Peru
- Health GAP (Global Access Project)
Initiative for Access, Medicines and Knowledge (I-MAK)
- International Treatment Preparedness Coalition (ITPC)
- Latin America-Caribbean-Global Alliance for Access to Medicines (Alianza LAC-Global)
- Network: A National Catholic Social Justice Lobby
- People’s Health Movement OZ (PHM OZ Australia)
- People’s Health Movement Vietnam
- Peruvian Network for Globalization with Equity (RedGE)
- Positive Malaysian Treatment Access & Advocacy Group (MTAAG+)
- Public Citizen
- Public Health Association of Australia (PHAA)
Universities Allied for Essential Medicines (UAEM)

With global partner signatories:
- Africa Europe Faith and Justice Network (AEFJN)
- AYPADCAM Cameroon
- Brazilian Interdisciplinary AIDS Association (ABIA)
- Canadian HIV/AIDS Legal Network
- Centre for Health Policy and Innovation
- Delhi Network of Positive People (DNP+) India
- Economic Governance for Health (Scotland)
- FTA Watch Thailand
- Foundation IFARMA Colombia
- Foundation Mission Health Colombia
- Health Action International Bolivia
- Health Action International Colombia
- Health Action International Ecuador
- Health Action International Europe
- IPLeft (Korea)
- Salud y Fármacos
- Thai AIDS Treatment Action Group
- Working Group on Intellectual Property of the Brazilian Network for the Integration of Peoples
(GTPI)

Notas:

[1For further analysis of New Zealand’s proposal, the TPPA and access to medicines, see the memos by Third World
Network, the Network for Globalization with Equity (RedGE), American University’s Program on Information
Justice and Intellectual Property (PIJIP), and Public Citizen, each available at:
http://citizen.org/access.


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