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May 24, 2002

Original: English



Name (s) Asia I. Russell
Organization (s) Health GAP Coalition (Global Access Project)
ACT UP Philadelphia (AIDS Coalition to Unleash Power)
Country US

May 2002

TO: Chair of the Committee of Government Representatives on the Participation
of Civil Society
c/o Secretaría del Área de Libre Comercio de Las Américas (ALCA)
Apartado Postal 89-10044
Zona 9, Cuidad de Panamá
Republica de Panamá

To Whom it May Concern:

The Health GAP (Global Access Project) Coalition and ACT UP Philadelphia submit these comments in response to the Open Invitation to Civil Society in FTAA Participating Countries (1 November 2001).

Health GAP and ACT UP Philadelphia1 are U.S. AIDS activist organizations fighting for access to affordable HIV treatment in developing countries where 95% of the world’s 40 million people with HIV live.2

Health GAP and ACT UP are particularly concerned with the impact of intellectual property protection on public health and access to essential medicines; the health impact of regional, international, and bilateral trade agreements; and the impact of trade policies pursued by the United States on securing trade agreements that promote public health.

Our comments are confined to the potential impact draft negotiating texts of the Free Trade Area of the Americas (FTAA) would have, if implemented, on public health and access to medicines in developing countries. Specific attention is given to the draft intellectual property chapter.

Access to affordable medicines and public health: imperatives that must direct FTAA negotiations

Access to affordable medicines is a public health and a moral imperative that must guide the negotiation of trade agreements, especially agreements negotiated with developing countries.

The interests of developed countries, especially the United States, as well as the proprietary pharmaceutical industry, in creating stringent patent monopolies on life extending medicines in developing countries has too often resulted in trade agreements that prioritize intellectual property rights, no matter the public health costs.

The draft negotiating texts indicate that without dramatic revisions, the FTAA could implement sweeping provisions regarding intellectual property protection that will undermine public health and will jeopardize progress on the issue of intellectual property rights and access to medicines made at the World Trade Organization (WTO) Ministerial Meeting in Doha (November 2001).

At that meeting, the WTO’s Africa Group successfully led negotiations of a Ministerial Declaration affirming that WTO rules should not jeopardize countries’ abilities to protect the public health. Unfortunately the clear, pro-public health interpretation of WTO rules secured at Doha will be superseded in FTAA countries by an agreement that exceeds WTO requirements.

By running roughshod over the legitimate and urgent public health interests of poor people with HIV and other diseases of poverty, an FTAA negotiated under the terms of the current draft text would have the direct impact of restricting access to affordable medicines in Latin America and the Caribbean.

Because countries in South America such as Brazil have the capacity to produce generic medicines for export, an FTAA negotiated without prioritizing access to medicines would also impinge on the ability of developing and least developed countries outside of the FTAA to respond to HIV/AIDS and other unaddressed public health needs.

Specifically, countries in hard-hit regions such as sub-Saharan Africa are poised to benefit from importing affordable life-extending medicines produced in South America. The FTAA will threaten these efforts-unless negotiated with a prioritization of protecting public health.

Unfortunately the United States is seeking an FTAA that increases countries’ obligations to uphold intellectual property rights-above and beyond the significant requirements set out by the WTO.3

The FTAA must not expand countries’ obligations under TRIPS

The countries negotiating the FTAA are already members of the WTO; as such they are already bound to uphold the stringent intellectual property protection rules mandated by the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). Intellectual property holders-including the proprietary pharmaceutical industry-as well as developing and developed countries agree that TRIPS is a strong agreement that favors the interests of intellectual property holders.4

In addition to other forms of intellectual property protection, TRIPS requires all WTO Members to implement and enforce 20-year patent protection on inventions including essential HIV medicines. This obligation, however, includes provisions designed to remedy unintended consequences of patent monopolies. An important public health provision is compulsory licensing-licensing the manufacture of an invention such as a medicine without the permission of the patent holder. Compulsory licensing dissolves patent monopolies and as a result reduces prices. TRIPS rules already permit a country-for example, the Dominican Republic-to issue a compulsory license to a generic drug company for the production of a medicine on patent in the Dominican Republic. TRIPS sets out several specific requirements and obligations that must be respected when a WTO Member issues a compulsory license, including provisions for compensation of the patent holder.5

Limits to Compulsory Licensing

The WTO Ministerial Declaration on TRIPS and Public Health states “Each member has the right to grant compulsory licenses and the freedom to determine the grounds upon which such licenses are granted.” 6 Bracketed provisions of the draft FTAA negotiating text would circumscribe this right in a manner that will have dire impact on public health and medicines access-in FTAA countries and beyond.

One bracketed provision in the intellectual property chapter7  would limit compulsory licensing only to three cases: government non-commercial use, to redress anticompetitive activities, and in cases of national emergency. Instead of TRIPS, which explicitly permits countries to make their own determinations regarding the circumstances that would trigger an interruption in patent monopolies, the FTAA is being negotiated to restrict the right of countries to use compulsory licensing except in extremely limited cases.

TRIPS should constitute a ceiling, not a floor for trade agreements’ provisions regarding intellectual property rights. Countries should be encouraged and supported in employing compulsory licensing whenever it will promote access to life extending medicine, rather than being subjected to burdensome restrictions and criteria.

An especially troubling bracketed provision would prohibit compulsory licensing for export (8.64 (6) (b)). The countries with the most acute need for affordable medicines are typically countries with the least capacity for production at economies of scale. Clarifying TRIPS to permit exporting drugs manufactured under compulsory license to countries with little to no capacity for local production is a problem the WTO is currently debating, and must resolve by the end of 2002. An effort by FTAA negotiations to sabotage pro-public health interpretations of TRIPS to permit the most rational, pro-public health solution to countries obtaining exported, low cost medicines is unacceptable.

Extension of the Patent Term

Bracketed FTAA text would also set out an extension of a country’s patent term (8.65 (8)). There is no acceptable justification for extending already lengthy monopolies on medicines and other essential health products. Instead this extension would increase benefits to intellectual property holders with no foreseeable benefit to developing countries. Twenty years is quite sufficient; the U.S. support for this extension-in the FTAA as well as currently negotiated bilateral trade agreements-is unjustifiable.

Linking Marketing Approval to Patent Status

Draft bracketed text would link a drug’s marketing approval to its patent status (8.65 (3)). This TRIPS-plus provision has in the United States resulted consistently in price gouging of consumers; drug companies routinely exploit this link to obstruct the rapid entry of quality generics to the market once a patent expires.

Exporting the United States’ link between drug marketing approval and patent status is bad for public health; the enforcement provisions of TRIPS are sufficient to protect a patent holder from infringement; linking marketing approval with the patent status of a drug only invites illegitimate patent claims.

Data Exclusivity Requirements

Another TRIPS-plus provision in draft FTAA text would require five years of protection for data submitted by a company used to show a drug’s safety and efficacy (8.65 (1)). TRIPS does not set out an explicit time limit for countries to protect pharmaceutical test data.

The draft FTAA’s requirement of five years of data exclusivity would potentially prevent the introduction of generic medicines under compulsory licensing, as companies producing medicines under compulsory license would require access to test data in order to market the drug.

Countries should be afforded the ability to protect pharmaceutical test data as they see fit, interpreting the TRIPS requirement of “reasonable” protection, rather than expand on their TRIPS obligations by establishing a five-year requirement.

Public health must come first in the FTAA

The FTAA has been negotiated heretofore without regard to its potential impact on public health and access to medicines. Provisions of the draft text stand to undermine progress achieved at the WTO while potentially eliminating poor country access to generic medicines produced in FTAA countries for export to non-FTAA countries. While the U.S. intends to use the FTAA to expand countries’ obligations to protect intellectual property rights we feel there is no justifiable reason the intellectual property provisions of the FTAA should strengthen countries’ obligations under TRIPS.

The imperative of access to medicines and the promotion of public health must figure foremost in negotiations of the FTAA; civil society will not accept intellectual property rights provisions that jeopardize the lives of people with HIV or other life threatening conditions through limiting access to essential medicines and undermining public health.


Asia Russell
for Health GAP and ACT UP Philadelphia


cc: Ambassador Robert Zoellick, United States Trade Representative
Ambassador Peter Allgeier, Deputy United States Trade Representative
Joseph Papovich, Assistant USTR for Services, Investment, and Intellectual Property

1 Health GAP (Global Access Project) was founded in 1999; founding member organizations include ACT UP Philadelphia, ACT UP New York, Mobilization Against AIDS International, and the International Gay and Lesbian Human Rights Commission. ACT UP (the AIDS Coalition to Unleash Power) is a 15-year-old AIDS activist organization.

2 UNAIDS, “AIDS Epidemic Update.” December 2001.

3 See, eg USTR, “FTAA Negotiating Group on Intellectual Property, Public summary of U.S. Position.” n.d. and “U.S. Push for Patent Rules Meets Resistance from Chile in FTA Talks.” Inside US Trade 22 March 2002.

4 See, eg “Bilateral and Multilateral FTA Negotiations: Opportunities for Improved IP Protection and Market Access.” PhRMA, Appendix 1 to Special 301 Submission, 2001

5 Other conditions include but are not limited to: an effort to obtain authorization from the rights holder (TRIPS Article 31.b); that the compulsory license be non-exclusive, non-assignable, and predominantly for use in the domestic market (TRIPS Articles 31.d, e, and f)

6 World Trade Organization, “Declaration on the TRIPS agreement and public health.” 14 November 2001.

7 page 8.64 (6)


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