TRIPS Agreement: waiver from notification requirements for issuing compulsory licenses for exports of pharmaceutical products to LDCs

Article 31(f) of the TRIPS Agreement states products made under compulsory licensing must be “predominantly for the supply of the domestic market”. Paragraph 6 of the Doha Ministerial Declaration on the TRIPS Agreement and Public Health 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“. General Council Decision of 30 August 2003 adopted a waiver to article 31(f) which allows producers to export drugs produced under compulsory licensing to countries without manufacturing capacity.  The Decision however requires that the importing country demonstrate lack of manufacturing, except in the case of the least developed countries. As stated in the Annex on the Assessment of Manufacturing Capacities in the Pharmaceutical Sector “Least-developed country Members are deemed to have insufficient or no manufacturing capacities in the pharmaceutical sector.” Subsequently, on 6 December 2005, a Protocol to amend the TRIPS Agreement to give this provision a permanent legal status was submitted for signature by Members. It was formally built into the TRIPS Agreement after acceptance of the Protocol amending the TRIPS Agreement by two thirds of the WTO’s members. The amendment took effect on 23 January 2017 and replaced the 2003 waiver for members who have accepted the amendment.

Latest status: INTELLECTUAL PROPERTY – TRIPS & PUBLIC HEALTH; Members accepting amendment of the TRIPS Agreement


Resources:

  1. IP/C/W/631/Add.7: Council for Trade-Related Aspects of Intellectual Property Rights – REPORT ON THE IMPLEMENTATION OF ARTICLE 66.2 OF THE TRIPS AGREEMENT
  2. Special and Differential Treatment Provisions in WTO Agreements and Decisions – Note by the Secretariat
  3. Implementation of paragraph 6 of the Doha Declaration on the TRIPS Agreement and public health
  4. Paragraph 18 of the Doha Ministerial Declaration
  5. Doha Ministerial Declaration on the TRIPS Agreement and Public Health
  6. WTO document WT/L/641, 8 December 2005, “Amendment of the TRIPS Agreement – Decision of 6 December 2005African Regional Intellectual Property Organization (ARIPO)
  7. African Intellectual Property Organization (OAPI)
  8. WT/L/1024-AMENDMENT OF THE TRIPS AGREEMENT – SIXTH EXTENSION OF THE PERIOD FOR THE ACCEPTANCE BY MEMBERS OF THE PROTOCOL AMENDING THE TRIPS AGREEMENT (Decision of 30 November 2017)