New York, 13 December 2003 — Five Central American countries are in danger of losing access to affordable medicines if United States pressure prevails in trade negotiations taking place in Washington, DC, this week, says the international medical humanitarian organization Doctors Without Borders/Médecins Sans Frontières (MSF). Although the draft text of the trade deal remains secret, it is clear from US negotiating positions and other regional agreements that proposals being discussed during this final round of US-Central America Free Trade Agreement (CAFTA) meetings include provisions for the protection of intellectual property that far exceed international norms set out by the World Trade Organization (WTO). These proposals also undermine the promises made by the US and all other WTO members two years ago when they adopted the Doha Declaration on the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement and Public Health, which unambiguously prioritized public health over the protection of intellectual property.
"HIV/AIDS kills one person in Honduras every two hours because the vast majority of people with HIV/AIDS cannot afford life-saving AIDS medicines," says Manuel Munoz, MD, who runs MSF’s AIDS treatment program in Honduras. "Right now, Honduras is not purchasing the least expensive generic medicines which could allow it to provide AIDS drugs to every Hondurans who are in urgent clinical need of antiretroviral therapy and will die without it. It would not surprise me if the government were buying more expensive medicines out of fear of US retaliation for buying generics. If CAFTA makes intellectual property protection of pharmaceuticals even more stringent, lives will be lost."
As in the Free Trade Area of the Americas (FTAA) negotiations, MSF fears that the US is pushing for provisions in CAFTA that would curtail the ability of Costa Rica, El Salvador, Guatemala, Honduras, and Nicaragua to take advantage of flexibilities existing in the WTO TRIPS Agreement and ensure generic competition—the only proven mechanism for achieving sustained and systematic price reductions—for drugs needed to treat all diseases that threaten the lives of people in Central America. One such provision, referred to as "data exclusivity," would create a new patent-like barrier to access to medicines, even when a medicine is not protected by a patent. Data exclusivity prevents drug regulatory authorities (DRAs) from authorizing the use of generic medicines for a certain period, thereby giving a de facto market monopoly to original manufacturers. The pharmaceutical industry has been pushing hard to obtain five years of data exclusivity on newly registered drugs. There is no obligation in the TRIPS Agreement to provide this protection, but the US now considers this a negotiating priority.
In 2003, the Guatemalan government modified its national intellectual property bill to provide five years of data exclusivity on drugs registered for use in the country. This means an automatic five-year delay in the availability of generic medicines in Guatemala, even though the majority of antiretrovirals medicines are not under patent there. For the 67,000 Guatemalans currently living with HIV/AIDS, five years without access to treatment can mean the difference between life and death. Guatemala is currently the only country in Central America that gives five years of data exclusivity on drugs, but MSF is deeply concerned that CAFTA threatens to extend such a provision to the rest of the region.
"If the US and other CAFTA countries trade away health they will have abandoned their responsibility to protect public health and promote access to medicines for all," said Rachel Cohen, US Director of MSF’s Campaign for Access to Essential Medicines. "People with HIV/AIDS and other illnesses will be the ones that will pay the price."
MSF currently has projects in three of the five CAFTA countries—Honduras, Guatemala, and Nicaragua—providing medical care for people living with HIV/AIDS and other sexually transmitted infections (STIs), people with Chagas' disease, and displaced and homeless populations, including street children, and indigenous people.