Essential Action Preliminary Assessment of FTAA Intellectual Property Proposals’ Effect on Access to Medicines

The just-released draft of the FTAA chapter on intellectual property rights is primarily in brackets, meaning that terms have not been agreed on. This makes it impossible to say precisely what is “in” the FTAA, because a single provision may be followed by an alternative that directly contravenes it.
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For Immediate Release,
Contact: Robert Weissman,
202-387-8030

The just-released draft of the FTAA chapter on intellectual property rights is primarily in brackets, meaning that terms have not been agreed on. This makes it impossible to say precisely what is “in” the FTAA, because a single provision may be followed by an alternative that directly contravenes it. [The text is at < http://www.ftaa-alca.org/alca_e.asp>.]

What can be said is this: There are numerous proposed provisions in the FTAA that would go far beyond WTO rules and would dramatically limit countries’ ability to promote access to medicines. Lives are at stake in the negotiations that determine whether these provisions are incorporated into the final agreement, and in the national deliberations over whether a final agreement is adopted. To take one example, under these harmful provisions, Brazil, which runs what may be the developing world’s most effective HIV/AIDS treatment program, may find itself facing difficulties in making new drugs available.

The text does not indicate which country or countries proposed or support specific provisions. But it is a safe bet that the United States is backing many of the worst proposals, which also appear in the U.S. summary FTAA proposals. These proposals were released several months ago, and are on the USTR web page www.ustr.org.

Among the worst proposals are the following:

-A limitation on compulsory licensing to the public sector (see page 8.64 (6)). Under this proposal, compulsory licenses could only be issued to a government, or private parties selling exclusively to the government. This would prevent, for example, Costa Rica from issuing a compulsory license on HIV/AIDS drugs to an Indian generic manufacturer, for sale in the private sector.

-An extension of patent terms to compensate for delays in granting the patent (see page 8.65 (8)). This provision would extend monopoly protections for drug manufacturers and permit further gouging of consumers. WTO rules already obligate countries to grant 20-year patents, a period reached taking into account potential delays in the granting of patents. Adding additional time to the patent term is simply a gift to brand-name drug companies and other patent holders, at the expense of consumers.

-New protections for marketing approval (“registration”) data (see page 8.65 (1)). The FTAA proposal would require five years protection for the data submitted to show drugs are safe and efficacious. (WTO rules are vague on registration data, requiring protection of the data against unfair commercial use but imposing no clear mandates.) To gain marketing approval, generic companies typically show that their product is bioequivalent to a patented product (that is, that the generic is chemically similar and works the same in the human body) and then rely on the patented productÕs safety data to earn approval. In many instances, if a generic company cannot use the already-generated registration data, it will not introduce a generic version of the patented product; and if it regenerates the data, consumers suffer from delay of introduction of the generic version. Registration data protections are important for new drugs that are not patent-protected or in cases of compulsory licensing. If a compulsory license is granted for a drug for which registration data exclusivities remain in force, the data exclusivity can block the generic from gaining marketing approval.

We will have a fuller analysis of the effect of the intellectual property provisions of the draft FTAA on access to medicines — as well as an assessment of how the investment proposals might impact access to medicines — as soon as possible.