March 5, 2003 Dear Mr Lamy, In view of the forthcoming WTO TRIPS Council meeting next week, we would like to bring some critical issues to your attention. The adequate protection of public health demands that WTO Members be permitted to give full effect to the letter and spirit of the Doha Declaration on TRIPS and Public Health (“Doha Declaration”) in their domestic and/or regional legislation. MSF was therefore very pleased to see the Communication of the EC to the last TRIPS Council, dated 21st November 2003 in which the EC states “…the EC reiterated its commitment to fully take the Doha Declaration into account into their trade policy, in particular in the context of technical assistance for the implementation of the TRIPS Agreement…[and calls upon] all technical assistance providers, and in particular multilateral organisations, to join them in making this commitment, and to fully integrate the Doha Declaration in their policies and practices.” However there are several bilateral and regional agreements that include provisions that threaten the implementation of the Doha Declaration including the effective use of the August 30th decision. For example the Central American Free Trade Agreement (CAFTA) recently agreed between the United States and Costa Rica, El Salvador, Guatemala, Honduras, and Nicaragua includes clear examples of “TRIPS plus” provisions. Under CAFTA, parties will be obliged to extend pharmaceutical patent terms beyond the 20 years required in WTO rules; prevent the marketing approval of generic medicines if there is a patent; 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.” Our deepest concern is with one provision (Article 15.10(3)(a)) that states that a generic producer may not obtain marketing approval of a product covered by a patent “during the term of that patent, unless by consent or acquiescence of the patent owner”. Even if a license on the patent is granted to a generic producer/importer, the patent owner appears to be able to prevent marketing approval of its equivalent medicine. This means that even with a compulsory license the relevant generic medicine cannot be marketed because the drug regulatory authorities are prohibited from granting it a marketing approval. This provision would appear to prevent the effective use of compulsory licensing including the August 30th mechanism. If this were the case and if CAFTA comes into force, then, the Doha Declaration and the August 30th Decision could be nullified for the parties to the Agreement at a single stroke. Similar provisions, all of which exceed WTO requirements, are also found in the draft FTAA agreement. CAFTA is only one of a number of Free Trade Agreements that the United States has pursued or is pursuing. MSF is concerned that further proliferation of TRIPS plus provisions in such agreements may jeopardise the progress that has been made on access to medicines. This may have enormous consequences for the health and life of millions of people. This is particularly so given the deadline of 1st January 2005 after which pharmaceutical product patent protection has to be provided by all non-Least Developing Country Members. Therefore, we request that you follow up on your commitment by raising the concerns about the threats of TRIPS plus provisions in bilateral and regional trade agreements to the full implementation of the Doha Declaration and the August 30 th decision in the TRIPS Council. We also ask you to raise these concerns with your US counterparts and to urge the US to abandon their pursuit of TRIPS plus provisions that negatively affect access to medicine in developing countries. We would be most willing to meet with you to discuss how further progress can be made in this area and to update you on developments on access to medicines in the countries where we work. Sincerely yours, Ellen ‘t Hoen Director Médecins Sans Frontières Campaign for Access to Essential Medicines cc: TRIPS Council members WHO UNAIDS