WTO DECISION ON THE IMPLEMENTATION OF PARAGRAPH 6 OF THE DOHA DECLARATION ON THE TRIPS AGREEMENT AND PUBLIC HEALTH
Although existing provisions of the TRIPS Agreement permit the grant of compulsory licences to enable generic production of medicines, countries without domestic manufacturing capacity cannot avail themselves of this flexibility. The option of importing generic medicines is hampered by the restriction in the TRIPS Agreement that requires production under compulsory licence to be predominantly for the supply of the domestic market. This has raised concern that exporting countries may have difficulties exporting sufficient quantities to meet the needs of those countries with insufficient or no manufacturing capacity. Paragraph 6 of the Doha Declaration recognized this problem in 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" and thus instructed the TRIPS Council to find an expeditious solution to this problem and to report to the General Council before the end of 2002.
On 30 August, 2003, following nearly two years of negotiations, the General Council of the WTO finally adopted the Decision on Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health (the August Decision). The WTO solution is essentially a waiver of the export restriction, thereby allowing the total amount of production under a compulsory licence to be exported.
The full impact of the August Decision will depend on the extent to which national laws allow for it, and will require specific changes to national laws.
- Statement by the representative of the World Health Organization at the WTO TRIPS Council, 17 September 2002, Geneva.