TRIPS and public health

The WTO Doha Declaration on the TRIPS Agreement and Public Health, agreed by WTO members in 2001, helped to frame the health policy context of the intellectual property system. It stressed the need for the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) to be part of the wider national and international action to address public health problems afflicting developing countries and least-developed countries. The Declaration identified specific options open for governments to address public health needs, also termed ‘flexibilities’, and the importance of such flexibilities was highlighted more recently by their inclusion in the Sustainable Development Goals.

> Back to TRIPS issues

WHO-WIPO-WTO

Notifications

> TRIPS and public health: notifications

> Guide to Notifications

> Consult the guide to downloading files

News

Compulsory licences for export of medicines

The flexibilities identified in the Doha Declaration include “the right to grant compulsory licences”. A compulsory license is issued by a government authority or a court to make certain use of a patented invention without the consent of the patent holder. This mechanism is generally present in most patent laws, is recognized as a permissible option or flexibility under the TRIPS Agreement, and has been used by a number of WTO members in the pharmaceutical field. However, TRIPS rules originally restricted compulsory licences to serve mainly the domestic market, unless they were issued to deal with anti-competitive behaviour.

The Doha Declaration recognized that this restriction on compulsory licensing could hamper its effective use by countries with insufficient or no manufacturing capacities in the pharmaceutical sector. The amendment of the TRIPS Agreement aims at removing this difficulty by creating an additional form of compulsory licence that had not existed before: a compulsory licence especially tailored for the export of medicines to countries in need – in effect, a 'trade related' compulsory licence. This mechanism was sometimes termed the 'paragraph 6 system', from its origins in the Doha Declaration.

The new Article 31bis of the TRIPS Agreement gives full legal effect to this system and allows low cost generic medicines to be produced and exported under a compulsory licence exclusively for the purpose of serving the needs of countries that cannot manufacture those products themselves. For the minority of WTO members yet to accept the amendment, an interim waiver will continue to apply.

Amendment to the TRIPS Agreement

News item on entry into force of the amendment.

Video statements: some of the key players share their thoughts on the entry into force of the amendment.

Factsheet on the TRIPS amendment

Text of the 2005 decision amending the TRIPS Agreement

Amendment of the TRIPS Agreement: How many members have accepted the amendment?

How to accept the protocol amending the TRIPS Agreement: Background information for members on procedures

Implementing compulsory licences for export of medicines

Special compulsory licences for export of medicines: key features of WTO Members' implementing legislation: Staff Working Paper

National implementation legislation: countries implementing the system in their laws

Use of the mechanism

Guide to Notifications

Background information

Extract on special compulsory licences from the WHO-WIPO-WTO Study, “Promoting Access to Medical Technologies and Innovation: Intersections between public health, intellectual property and trade”

Frequently asked questions: compulsory licensing of pharmaceuticals and TRIPS

TRIPS Council annual reports on the paragraph 6 system

Official texts

2021: Decision to extend deadline for accepting TRIPS Agreement amendment
2015: Decision on Least Developed Country Members – Obligations under Article 70.8 and Article 70.9 of the TRIPS Agreement with Respect to Pharmaceutical Products adopted by the General Council on 30 November 2015 following a recommendation by the Council for TRIPS. This Decision complements the aforementioned decision to extend the transition period for least developed country Members by waiving certain obligations that would have otherwise been applicable during the transition period. This includes an extension of the waiver to give exclusive marketing rights to pharmaceutical products that was initially put in place in 2002, and also adds a new waiver of the obligation to provide for the possibility of filing mailbox applications. Both waivers apply until 1 January 2033. The Decision was taken with a view to ensuring attainment of the objectives of paragraph 7 of the Doha Declaration on the TRIPS Agreement and Public Health.
2015: Decision on the Extension of the Transition Period under Article 66.1 of the TRIPS Agreement for Least-Developed Country Members for Certain Obligations with Respect to Pharmaceutical Products adopted by the TRIPS Council on 6 November 2015. This Decision extends the earlier decision that was taken by the TRIPS Council in 2002 in order to implement paragraph 7 of the Doha Declaration on the TRIPS Agreement and Public Health. Least-developed countries will not have to protect pharmaceutical patents and test data until 1 January 2033.
2005: Hong Kong Ministerial Declaration Paragraph 40 on TRIPS and Public Health
2005: Decision on the Amendment of the TRIPS Agreement, adopted by the General Council, 6 December 2005. The decision adopts a Protocol of Amendment that is open for members to accept. The amendment itself will come into force after two thirds of members have accepted it, and will replace the August 2003 decision, as instructed in Paragraph 11 of that text. The decision was adopted in the light of a statement read out by the chairperson, who also read out a statement on “non-violation” complaints.
> How many members have accepted the amendment?
2003: Decision on the Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, adopted by the General Council on 30 August 2003. This “waiver” removes limitations on exports under compulsory licence to countries that cannot manufacture the pharmaceuticals themselves. This Decision was adopted by the General Council in the light of a statement read out by the Chairman.
2002: Decision on Least-Developed Country Members — Obligations Under Article 70.9 of the TRIPS Agreement with Respect to Pharmaceutical Products, adopted by the General Council on 8 July 2002. This Decision was also taken with a view to ensuring attainment of the objectives of paragraph 7 of the Doha Declaration on the TRIPS Agreement and Public Health. It says least-developed countries will not have to give exclusive marketing rights to pharmaceuticals that are subject of a patent application until 1 January 2016.
2002: Decision on the Extension of the Transition Period under Article 66.1 of the TRIPS Agreement for Least-Developed Country Members for Certain Obligations with Respect to Pharmaceutical Products, adopted by the TRIPS Council on 27 June 2002. This Decision implements the second and third sentences of paragraph 7 of the Doha Declaration on the TRIPS Agreement and Public Health. Least-developed countries will not have to protect pharmaceutical patents and test data until 1 January 2016.
2001: Declaration on the TRIPS Agreement and Public Health, adopted on 14 November 2001 by the Fourth WTO Ministerial Conference, Doha, Qatar.
2001: Paragraph 17 of the main Doha Declaration, adopted on 14 November 2001 by the Fourth WTO Ministerial Conference, Doha, Qatar.