December 27, 2002

Dear Minister

Through the Doha Declaration on the TRIPS Agreement and Public Health, the United States joined others in acknowledging the serious public health crisis -- especially those resulting from HIV/AIDS -- afflicting Africa and other developing and least-developed countries.

As you know, Paragraph 6 of this declaration recognized that WTO members with insufficient or no manufacturing capacities in the pharmaceutical sector could face difficulties in making effective use of compulsory licensing under the TRIPS Agreement in order to address these health crisis; it also instructed members to find an expeditious solution to this problem before the end of the year. Throughout the ensuing negotiations to develop such a solution, the United States has remained committed to the Doha Declaration and has worked intensively to find a solution that will provide life-saving drugs to those truly in need. You have my assurance that we will continue to work with you towards that end.

As the negotiations drew to a close, however, it became clear to us that some WTO members and advocacy organizations sought to expand the scope of disease beyond that intended at Doha to allow countries to override drug patents to treat a wide range of public health concerns, including obesity, asthma, cancer, diabetes, among others -- even including the use of Viagra. We were seriously concerned that this approach could substantially undermine the WTO rules on patents that provide incentives for the development of new pharmaceutical products.

We will continue to work with other WTO members to try to find a solution within the WTO. However, in the meantime, because we take seriously our pledge at Doha and our responsibility to ensure that those countries most in need have access to medicines to treat infectious epidemics, we have made an additional commitment, effective immediately; the United States will not challenge any WTO member that exports such medicine, produced under compulsory license, to a country in need. Your government may wish to join in this pledge until such time as a multilateral solution can be adopted.

We will notify the WTO in early January of the specific terms and conditions of our moratorium which I have attached for your reference.

The key elements of this moratorium include a commitment not to pursue dispute settlement against a member that notifies the TRIPS Council of its intention to issue a compulsory license to permit the production and export of a patented pharmaceutical product or HIV/AIDS test kit to eligible importing economies. Eligible importing economies will be those economies other than those classified by the World Bank as =93High Income Economies,=94 that: (1) are facing a grave public health crisis associated with HIV/AIDS, malaria or tuberculosis or other infectious epidemics of comparable scale and gravity, including those that may arise in the future; (2) have no or insufficient production capacities in the pharmaceutical sector; and (3) have so notified the TRIPS Council. The moratorium will also include measures to guard against product diversion, including to ensure that the product can be easily identified and a requirement that all countries, to the extent of their ability, act to ensure that the drugs are not diverted from countries in need to wealthier markets.

Once again, thank you for your consideration of what I know is a difficult issue with important implications. We are prepared to continue to work on an effort to construct a multilateral solution in the new year. We hope, in the interim, that this moratorium will assist those poor countries that Paragraph 6 of the Doha Declaration was supposed to reassure. If you choose to join us in providing this assurance, it will assist our common cause.

Sincerely

Robert B. Zoellick
Ambassador
United states Trade Representative