INTELLECTUAL PROPERTY:TECHNICAL COOPERATION — KEY DOCUMENTS

III. TRIPS and Public Health

Many aspects of the WTO's work impact on public health. These include the IP rules and flexibilities within the international legal system that affect innovation and access to medical technologies. Since the adoption of the Doha Declaration on the TRIPS Agreement and Public Health in 2001, the issue has moved to the centre of a cross-cutting debate between different policies and distinct areas of technical expertise. WTO Members have sought to ensure that TRIPS rights and obligations are applied in a balanced manner, so that optimal results can be achieved for public health. This concern is addressed by a number of instruments adopted after the entry into force of the TRIPS Agreement, which clarified and confirmed existing flexibilities and also added new flexibilities. Relevant texts are briefly introduced below.

WTO Members first explicitly recognized the need for a balanced approach in the Doha Declaration on the TRIPS Agreement and Public Health (WT/MIN(01)/DEC/2). The Declaration stressed the need for the TRIPS Agreement to be part of the wider national and international action to address public health problems afflicting many developing and least developed countries, especially those resulting from HIV/AIDS, tuberculosis, malaria and other epidemics. By clarifying TRIPS flexibilities of direct relevance to public health and supporting governments in making use of such flexibilities, the Declaration reinforced the understanding that TRIPS supports a balanced and flexible IP framework which is responsive to the broader policy agenda. It also shaped the framework for multilateral cooperation on IPRs and public health, and led to the adoption of certain additional flexibilities.

Those flexibilities include a new mechanism that aims to facilitate access to medicines for WTO Members with insufficient or no manufacturing capacities in the pharmaceutical sector. Under the mechanism, special compulsory licences can be granted to generic suppliers, in order to manufacture medicines exclusively for export to countries in need.

Another flexibility concerns the extension of the transition period for least-developed country Members to 1 January 2033 (IP/C/73). LDCs are thus exempted from any obligation to protect or enforce rights relating to patents or undisclosed information with respect to pharmaceutical products. A General Council decision also waives the obligations to grant exclusive marketing rights and to provide for the possibility of filing mailbox applications, for LDC Members until 1 January 2033, (WT/L/971).  The relevant texts are listed below.

As part of their ongoing efforts to support Members in building capacity to deal with issues at the crossroad between public health, trade and IPRs, the WHO, WIPO and WTO have reinforced their cooperation. In this context, a trilateral study on "Access to Medical Technologies and Innovation" was launched in 2013 and a series of technical symposia has been organized since 2010. 

Key documents/resources:

  • Doha Ministerial Declaration on the TRIPS Agreement and Public Health — Adopted on 14 November 2001 (WT/MIN(01)/DEC/2)
  • Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health — General Council Decision of 30 August 2003 (WT/L/540 and WT/L/540/Corr.1). The mechanism established under this Decision makes an additional flexibility available to Members to grant special compulsory licences to export medicines
  • Statement read out by the Chairman of the General Council and Annex (excerpt from the General Council minutes (WT/GC/M/82))
  • Amendment of the TRIPS Agreement — General Council Decision of 6 December 2005 (WT/L/641) which submitted the Special Compulsory Licensing Mechanism to members for acceptance as a permanent amendment to the TRIPS Agreement
  • Statements read out by the Chairman of the General Council and attachment (excerpt from the General Council Minutes (WT/GC/M/100))
  • Amendment of the TRIPS Agreement — Eighth Extension of the Period for the Acceptance by Members of the Protocol Amending the TRIPS Agreement — General Council Decision of 22 November 2021 (WT/L/1122)
  • Annual Review of the Special Compulsory Licensing System — Report to the General Council (IP/C/84)
  • Notification under Paragraph 2(a) of the Decision of 30 August 2003 on the Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health from Rwanda (IP/N/9/RWA/1)
  • Notification under Paragraph 2(c) of the Decision of 30 August 2003 on the Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health from Canada (IP/N/10/CAN/1)