Press release |

Provisions in CAFTA Restrict Access to Medicines

New York, 3 February 2004 — As 34 Latin American and Caribbean countries gather in Puebla, Mexico, to resume negotiations of the Free Trade Area of the Americas (FTAA), the international humanitarian medical organization Doctors Without Borders/Médecins Sans Frontières (MSF) continues to call on countries to make public health a priority and insist that intellectual property provisions be excluded from the FTAA agreement. The new round of FTAA negotiations comes days after the final text of the US-Central American Free Trade Agreement (CAFTA) was made public, confirming fears that higher levels of intellectual property protection will restrict access to medicines in the region.

Under CAFTA, Costa Rica, El Salvador, Guatemala, Honduras, and Nicaragua will be obliged to extend pharmaceutical patent terms beyond the 20 years required in World Trade Organization (WTO) rules; prevent the marketing approval of generic medicines if a patented version of the product is registered; and grant additional exclusive marketing rights by prohibiting drug regulatory agencies to use original pharmaceutical test data for the registration of generic medicines, a restriction referred to as "data exclusivity." These same provisions, all of which exceed WTO standards, are in the draft FTAA agreement, and will severely restrict or block generic competition, the only proven mechanism for reducing the prices of medicines.

Provisions related to marketing authorization are particularly worrisome.  For instance, if an existing AIDS drug is not registered in one of the five CAFTA countries because the manufacturer has no interest in the market, under CAFTA, registration of generics would be prevented for five years, even if the drug is not patented, and until the end of the patent term if it is.  Unlike with patents, which authorities can redress through compulsory licensing, there is no recourse to provisions restricting marketing authorization.  

"People with HIV/AIDS in Central America do not have five years or more to wait for affordable AIDS drugs to become available," said Antonio Girona, Head of Mission for MSF’s AIDS treatment program in Honduras. "Thousands are dying now, and many will die within one or two years of first developing symptoms of AIDS."

The outcome of CAFTA negotiations shows that, when negotiating with the US bilaterally or in small groups, countries are likely to agree to stringent intellectual property provisions that exceed international standards.  MSF urges other countries in the Americas not to agree to such overly restrictive measures in the FTAA or in other bilateral or plurilateral agreements.

"CAFTA negotiators have given in to US pressure and failed their people by agreeing to measures that place profits above people’s lives," said Rachel Cohen, US Director of MSF’s Campaign for Access to Essential Medicines.  "FTAA negotiators must not follow suit. The only way for countries in the FTAA region to uphold their obligation to protect public health is to refuse to negotiate intellectual property provisions altogether."