"Almost 2 million people in the Caribbean and Central and South America are HIV-positive," said Rob Weissman of Health GAP. "George Bush and US Trade Representative Robert Zoellick would consign tens of thousands of them, or maybe many more, to death Ð simply to serve the short-term profit interests of the brand-name drug companies."

"Generic competition has driven down the price of AIDS drugs by more than 98 percent, from $10,000 to $140 per person, per year," according to Asia Russell of Health GAP. "But those price savings are only available to countries that can use generics. Future reductions in the price of other AIDS drugs, and other medications, will only come with generic competition. Yet the United States is backing a multitude of proposals that would delay such competition."

Proposed FTAA intellectual property provisions would in a variety of ways interfere with countries' rights under World Trade Organization rules to undertake compulsory licensing Ð by which the government authorizes itself or a third party to make use of an on-patent product, with payment of reasonable compensation to the patent holder. Other provisions would require generic companies to wastefully redo costly tests to obtain marketing approval Ð beyond the capacity of almost all of the relatively small generic companies Ð or to delay using the results of tests already completed by brand-name companies for a period of five years.

"Every country in the FTAA negotiations is already obligated to respect the intellectual property protections mandated by the World Trade Organization," continued Weissman. "Those protections are more than sufficient for brand-name drug companies. They don't need more, and they shouldn't be given more in the FTAA. In addition, these barriers also undermine the WTO's Doha Declaration on TRIPs and Public Health, an agreement signed by the United States. The Doha Declaration unequivocally stated that public health takes precedence over drug company patents and profits. With millions of lives at stake, Ambassador Zoellick has used every opportunity to violate the spirit and the letter of the Doha declaration for the benefit of US drug companies."

"There is a simple solution to these problems," said Russell. "There should be no intellectual property provision in the FTAA, nor any investment protections. Brazil has proposed such provisions. It is time for the United States to put the interests of patients over profits, and agree to exclude intellectual property and investment from the FTAA."

Numerous provisions in the draft FTAA text would delay the introduction of generic competition, the most important means to drive down the price of pharmaceuticals.

Key problem provisions in the current text would:

1. Limit compulsory licensing to the public sector and for emergencies or to remedy anti-competitive practices. The exclusion of private sector entities from receiving compulsory licensing is a major, and dangerous, exclusion. In many developing countries, the public sector is too impoverished to provide full access to healthcare. Private sector involvement is typically a vital supplement -- not a substitute -- for the public sector. Where compulsory licensing is important to facilitate access to medicines, a limit to the public sector will likely mean that many people are denied access to medicines.

2. Prohibit the export of compulsorily licensed goods. Exports are important for efficient and effective compulsory licensing both in the exporting and importing countries, so that sufficient economies of scale are obtained. This prohibition would interfere with such efficiencies, and in many cases prevent compulsory licensing from being viable. It would bar the exports contemplated by the Doha Declaration Paragraph 6 "solution."

3. Bar the use of compulsory licensing until four years after a patent was granted. Delays in issuing a compulsory license delay the benefits of competition and lower prices to consumers.

4. Link approval to market pharmaceuticals to patent status, effectively making drug regulatory agencies into patent enforcement agencies. If generic companies cannot gain regulatory approval to put a drug on the market, they will have less economic incentive to challenge the validity of claimed patents. They will have to wait until a patent challenge -- which may take many years -- is resolved by the courts before putting their product on the market. In many cases, the costs of legal representation plus delay will simply be too high, and they will wait for all patents claimed on a product to expire before entering the market. This may delay the entrance of generics by years.

5. Require all countries to grant five years of exclusivity protections to marketing approval data, imposing an important bar to timely compulsory licensing. If generics firms are not able to rely on the safety and efficacy date submitted by brand-name companies, in many cases they simply will not enter the market until they are permitted to rely on the data. The impact of this provision is likely to be to bar compulsory licensing for the term of the data protection.

6. Extend the patent term, to offset regulatory delays and to match extended terms in other countries.

There are other potential problems for ensuring broad access to medicines and use of compulsory licensing in the investment chapter of the FTAA, which would cover intellectual property. Performance requirement and expropriation provisions both could either block compulsory licensing altogether, or dramatically chill use of compulsory licensing. Even if compulsory licensing were exempted from the investment chapter, countries would know that if they did compulsory licensing wrong, they would be subject to the severe penalties and enforcement mechanisms available under the investment chapter.

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