New Report Warns that US Trade Negotiations are Threatening Access to Medicines Worldwide
New York/Lima May 14, 2004 - Intellectual property proposals being negotiated in a free trade agreement between the United States, Peru, and other Andean countries could severely restrict access to essential medicines for millions of people in Peru and other parts of the Andean region according to the international medical humanitarian organization Doctors Without Borders/Médecins Sans Frontières (MSF). MSF warns that the negotiations being launched next week are part of a US strategy to span the globe with bilateral and regional free trade agreements that undermine international consensus reached at the World Trade Organization (WTO) about the appropriate balance between the protection of private intellectual property and the protection of public health. These agreements will make it impossible for dozens of countries to uphold their right and obligation to ensure access to affordable medicines for their populations.
In a new report released by MSF today entitled "Access to Medicines at Risk Across the Globe: What to Watch Out for in Free Trade Agreements with the United States," the organization argues that in existing agreements, Such as those already finalized with Central American countries, Chile, Morocco, and Singapore. the US has consistently pushed through intellectual property provisions that will delay or even block generic competition - the only proven means of reducing the prices of medicines. The report issues a warning about these provisions not only to the Andean countries set to begin negotiations next week (Colombia, Ecuador, Peru, and eventually Bolivia), but also Panama, Thailand, five southern African countries, and 34 Latin American and Caribbean countries currently negotiating a Free Trade Area of the Americas (FTAA).
For Peru, the impact of such agreements on access to medicines is clear. Thanks to previous legislation that did not allow for pharmaceutical patents, a number of generic medicines exist, including antiretrovirals for people with HIV/AIDS. This market competition has forced the price of first-line AIDS medicines down to as little as $408 per person per year, compared to $4,300 per person per year for brand-name drugs.
"There are 76,000 Peruvians living with HIV/AIDS today, and hundreds and thousands more with other life-threatening diseases. Their lives depend on the availability of affordable medicines," said Cedric Martin, head of mission for MSF in Peru, where the organization provides medical care for people living with HIV/AIDS in the slums of Lima and in the city's Lurichango prison. "Every day, people with HIV/AIDS are dying in Peru, and the only hope for access to treatment is through affordable medicines. If the US gets its way, every new medicine brought to the market for AIDS and other illnesses will be unaffordable for individual patients and the health system in general."
One of the most dangerous provisions that the US is pushing in free trade agreements is a new "patent policing" role assigned to national drug regulatory authorities. Normally, it is up to patent holders to ensure their patents are enforced. The US government is also urging drug regulators to block access to generic medicines by insisting that they grant a five-year patent-like monopoly for drugs that are not patented by the original manufacturer, and by preventing the registration of generic versions of patented drugs, effectively rendering useless compulsory licensing, one of the most important safeguards WTO intellectual property rules [see technical note below for additional information].
Successful disease control programs will depend on future access to affordable generic drugs. "If generic antiretrovirals were not available, treating AIDS in Peru would cost ten times more," continued Mr. Martin. "At such a price access to medicines for the majority will be impossible."
How US trade policy aims to block access to generics: technical note on proposed intellectual property provisions commonly proposed by the US in free trade agreements and their potential impact on access to medicines in Peru
Restrictions through Patents:
- Patent Extensions: Peru could be required to provide extensions on patent-terms, beyond the 20-year monopoly period already required.
- Patents on "New Uses": The US is seeking provisions that would allow companies to apply for a new patent for each "new use" of a product. Under this provision, a drug that is currently used to treat AIDS could receive a new 20-year patent monopoly if it were found to be effective against cancer. Legislation previously enacted by the Andean region explicitly excluded new uses from their patent law, however this law would have to be repealed if the agreement between the US, Peru and other Andean countries included a provision on "new use" patents.
Restrictions through Registration:
- Linking Market Authorization to Patent Status: This provision would bar the registration of a generic drug if a patented version has already been registered. As a result, Peru's drug regulatory authority will become an enforcer of patents on medicines.
- Data Exclusivity: The US is aggressively seeking 5-10 years of exclusive protection over pharmaceutical test data needed to approve medicines for use in a country, which means that in the absence of a patent there would be a patent-like barrier to the registration and use of generic medicines. The Andean region previously adopted legislation that included data exclusivity, however this legislation was repealed when the negative impact on access to medicines was recognized. The agreement between the US, Peru, and other Andean countries would undo this pro-public health change in legislation.
Both provisions related to drug registration could have the especially harmful effect of blocking compulsory licenses. Even if Peru were to issue a compulsory license to overcome a patent barrier for a life-saving medicine, these provisions could block the registration of the drug for use in Peru, rendering the compulsory license useless.