Testimony of MSF at the Public Hearing Concerning Market Access in the Free Trade Area of the Americas Negotiations of the Office of the United States Trade Representative

I am pleased to provide this brief testimony-which focuses entirely on the potential negative consequences of the Free Trade Area of the Americas (FTAA) on access to essential medicines in developing countries in the Americas-on behalf of Doctors Without Borders/Médecins Sans Frontierès (MSF), an international medical humanitarian organization with field operations in nearly 90 countries. Too often in the countries where MSF works, we have been forced to watch our patients die because they cannot afford the drugs that could improve, extend, or save their lives, and for us this is simply unacceptable-it is a violation of our medical ethics. In the Americas, this has been particularly true for our teams providing AIDS care and treatment in places like Guatemala, Honduras, Nicaragua, El Salvador, and Peru, who have witnessed countless unnecessary deaths due to the lack of access to antiretroviral (ARV) therapy and other essential AIDS medicines.

There are currently 1.8 million people living with HIV/AIDS in Latin America and Caribbean, and 110,000 AIDS deaths were recorded in the region in 2001. The Caribbean is the second-most affected region in the world, after sub-Saharan Africa. Hundreds of thousands of people with HIV/AIDS in developing countries in the Americas do not have access to antiretroviral therapy simply because they cannot afford it.

Just two years ago, the average cost of a triple combination of antiretrovirals was between $10,000-$15,000 per patient per year, and today it is available for under $300 per patient per year. These price reductions were the direct result of international public pressure and generic competition, particularly from Indian and Brazilian manufacturers. Generic competition was possible because of the lack of patent protection in those countries. In the coming years, such competition will not be possible due to the filing of patents on pharmaceuticals in key developing countries with manufacturing capacity, unless flexible conditions for granting compulsory licenses are available and compulsory licenses are routinely issued to address public health concerns. Compulsory licensing of pharmaceuticals is one of the most important policy tools for ensuring generic competition, which will be key to improving access to HIV/AIDS medicines in Latin America and the Caribbean.

When 142 countries adopted the Doha Declaration on the TRIPS Agreement and Public Health in November 2001, public health needs were firmly placed above commercial interests and much needed clarifications about key flexibilities in the TRIPS Agreement related to public health were offered. The very fact that public health, and in particular access to medicines, has been singled out as an issue needing special attention in TRIPS implementation acknowledges that health care and health care technologies must be treated differently from other commodities and gives countries leeway for taking measures to counter the negative effects of excessive intellectual property protection on health.

The FTAA threatens to undermine the achievements in Doha. In particular, USTR's negotiating position in FTAA gives rise to serious questions about the U.S government's true motives in agreeing to the Doha Declaration. The Doha Declaration must remain a ceiling for FTAA negotiations on intellectual property rights as they relate to public health technologies, and the U.S. government must not renege on the commitments it made in Doha.

It is clear in information about the U.S.'s FTAA negotiating objectives that the U.S. is pushing to impose standards on pharmaceuticals that far exceed requirements set forth in the TRIPS Agreement, and that, in some cases, these standards directly contradict the spirit and letter of the Doha Declaration, which clearly recognized concerns about the effects of patents on prices and stated unambiguously that TRIPS 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."

I would like to site four examples of this:

1. Dramatic limitations on the circumstances under which compulsory licenses on pharmaceuticals may be issued. Although the Doha Declaration has reaffirmed the right of WTO Member countries to issue a compulsory license for whatever reason (not only in cases of emergency), the U.S. proposal explicitly provides that compulsory licenses shall be granted only in four limited circumstances (public non-commercial purposes, situations of a declared national emergency, other situations of extreme urgency, or declared anti-competitive practices) and solely for purposes of government use. Should such a provision be adopted, it would cancel the possibility of granting compulsory licenses to remedy patent abuses, such as excessive pricing, and to foster competition in the private sector to increase access to patented essential medicines.

2. Extensions of patent terms on pharmaceuticals beyond the 20-year minimum in TRIPS. The U.S. proposes to extend the term of a patent in exchange for "early registration of generics" and to compensate for unreasonable administrative or regulatory delays that occurred while granting the patent. This is not required by the TRIPS Agreement and a WTO panel expressly stated that such patent extensions do not constitute a "legitimate interest" of patent owners.

3. Abusive powers to regulatory authorities to enforce patents. The U.S. proposes that drug regulatory authorities notify the patent owner of the identity of any company that is seeking approval to market a generic version of the patented invention while the patent is in effect. This effectively means that drug regulatory authorities will function as patent enforcement agencies and is likely to result in unjustified patent extensions. Such a proposal can only serve to protect invalid patent claims, as valid claims receive adequate protection through normal judicial processes.

4. Exclusive rights over pharmaceutical data. Although the TRIPS Agreement only requires WTO Members to protect "undisclosed test or data" against "unfair commercial use" and "disclosure" in the framework of unfair competition law, the U.S. is proposing to grant exclusive rights on pharmaceutical data for at least five years. Such a proposal will result in delaying and limiting generic competition in cases where a patent does not exist or a compulsory license has been granted.

The U.S. negotiating objectives for FTAA aim to strengthen patent rights beyond what is required in TRIPS, and reduce the extent of the safeguards to the detriment of public health-they are clearly "TRIPS-plus." If the U.S. achieves its negotiating objectives, FTAA will negate the achievements of the Doha Declaration and could have devastating consequences in terms of access to medicines for millions of people in low- and middle-income
countries in the Americas with HIV/AIDS and other neglected diseases. For them, this is a matter of life and death, and we therefore urge the U.S. government in the strongest possible terms to abandon TRIPS-plus
negotiating objectives and negotiate FTAA in keeping with the spirit and letter of the Doha Declaration.

Thank you for your attention.

Rachel M. Cohen