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Implications of the Doha Declaration on the Trips Agreement and Public Health - Health Economics and Drugs Series No. 012
(2002; 56 pages) [French] [Spanish] View the PDF document
Table of Contents
View the documentForeword
View the documentAcknowledgements
View the documentAbbreviations and acronyms
View the documentExecutive summary
View the documentIntroduction
View the documentScope
View the documentThe role of TRIPS and IPRs
Open this folder and view contentsPublic health measures
Open this folder and view contentsFlexibility in TRIPS
Open this folder and view contentsMembers with insufficient or no manufacturing capacities
View the documentTransfer of technology to LDCs
View the documentExtension of transitional period for LDCs
View the documentSpecial treatment under TRIPS
View the documentLegal status of the Doha Declaration
View the documentIssues not covered in the Declaration
View the documentConclusions
View the documentAnnex 1 - Doha Declaration on the TRIPS Agreement and Public Health
View the documentAnnex 2 - Levels of development of pharmaceutical industry, by country
View the documentReferences
 

Introduction

At the Doha World Trade Organization (WTO) Ministerial Conference (9-14 November 2001), the WTO Members took the unprecedented step of adopting a special declaration1 on issues related to the Agreement on Trade-Related Aspects of Intellectual Property (TRIPS) and Public Health2. Discussion on this declaration was one of the outstanding issues at the Conference3, which launched a new round of trade negotiations on a broad range of issues4. This was the first outcome of a process that started in early 2001 when, upon the request of the African Group, the Council for TRIPS agreed to deal specifically with the relationship between the TRIPS Agreement and Public Health.

1 Paragraph 17 of the general Ministerial Declaration states: “We stress the importance we attach to implementation and interpretation of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) in a manner supportive of public health, by promoting both access to existing medicines and research and development into new medicines and, in this connection, are adopting a separate Declaration”.

2 “Doha Ministerial Declaration on the TRIPS Agreement and Public Health” (hereinafter “the Doha Declaration”), WT/MIN(01)/DEC/W/2, 14 November 2001 (see the full text in Annex 1).

3 The Director General of WTO emphasized the importance of this issue on the opening day of the Conference, indicating that agreement on public health and TRIPS was the “deal breaker” of the new round. Pascal Lamy, the EU Commissioner for Trade, stated at the Conference that “... we must also find the right mix of trade and other policies - consider the passion surrounding our debate of TRIPS and Access to Medicines, which has risen so dramatically to become a clearly defining issue for us this week, and rightly so”.

4 Including implementation, agriculture, services, industrial tariffs, subsidies, anti-dumping, regional trade agreements and environment.

The African Group’s request, supported by other developing countries, reflected growing concerns about the implications of the TRIPS Agreement (particularly the Agreement’s provisions on patents) with regard to access to drugs. The HIV crisis in sub-Saharan African countries, the attempts by the pharmaceutical industry, backed by some governments5, to block the implementation of TRIPS-compatible measures by the South African Government, and the complaint brought by the USA against Brazil in relation to compulsory licences6, were perceived as manifestations of a conflict between the recognition of intellectual property rights (IPRs) and essential public health objectives. Although one of the stated goals of the TRIPS Agreement was to reduce tensions arising from intellectual property protection7, intellectual property protection for pharmaceuticals and its effects on public health, and access to drugs in particular, remained a highly controversial issue8.

5 US Public Law 105-277 (105th Congress, 1999) established that “..None of the funds appropriated under this heading may be available for assistance for the central Government of the Republic of South Africa, until the Secretary of State reports in writing to the appropriate committees of the Congress on the steps being taken by the United States Government to work with the Government of the Republic of South Africa to negotiate the repeal, suspension, or termination of section 15 (c) of South Africa’s Medicines and Related Substances Control Amendment Act No. 90 of 1997”. After the adoption of the TRIPS Agreement, the US Government continued to list countries according to the Special 301 section of the US Trade Act, in many cases challenging provisions in national laws relevant to public health.

6 The declared intention of the Brazilian Government was to procure anti-retrovirals at prices lower than those charged by patent owners, in the framework of its government-supported program against AIDS. The USA withdrew its complaint upon an agreement with the Brazilian government in March 2001

7 See the Preamble of the Agreement, paragraph 7: “Emphasizing the importance of reducing tensions by reaching strengthened commitments to resolve disputes on trade-related intellectual property issues through multilateral procedures”.

8 See e.g., Abbott, 2002a.

The developing countries’ move to specifically address public health issues at the Council for TRIPS was grounded on the conviction that the TRIPS Agreement should not prevent Members from adopting measures necessary to ensure access to medicines and to satisfy other public health needs. Several documents, particularly by WHO9 and UNCTAD10, as well as extensive academic work11 and NGO statements12, had highlighted the flexibility allowed by the TRIPS Agreement, especially in relation to exceptions to patent rights, parallel imports and compulsory licensing. The developing countries sought a declaration, not because of the lack of clarity in the Agreement, but as a result of the obstacles that the authorities in those countries had experienced when trying to make effective use of such flexibility at the national level.

9 See, e.g., Velasquez and Boulet (1999).

10 UNCTAD (1996).

11 See an annotated bibliography in WHO (2001).

12 See, e.g., Oxfam (2002), Médecins Sans Frontières (2001); VSO (2001).

The relationship between public health and the TRIPS Agreement had been examined in 1996 by the World Health Assembly, which addressed the subject in a resolution on the Revised Drug Strategy13. Subsequent resolutions adopted by the World Health Assembly in 200114, addressed the need to evaluate the impact of the TRIPS Agreement on access to drugs, local manufacturing capacity and the development of new drugs15.

13 WHO was mandated “to report on the impact of the work of the WTO with respect to national drug policies and essential drugs and make recommendations for collaboration between WTO and WHO, as appropriate” (Resolution WHA49.14, 25 May 1996).

14 Resolutions WHA54.10 and WHA54.11.

15 The UN Sub-Commission for the Promotion and Protection of Human Rights also pointed out the “apparent conflicts between the intellectual property rights regime embodied in the TRIPS Agreement, on the one hand, and international human rights law, on the other”, including human rights to food, health and self-determination (Commission on Human Rights, Sub-Commission on the Promotion and Protection of Human Rights, Fifty-second session, Agenda item 4, The Realization of Economic, Social and Cultural Rights, Intellectual Property Rights and Human Rights).

The Council for TRIPS systematically considered the relationship between public health and TRIPS for the first time in a special session in June 2001. A number of developing countries16 and the European Commission and its Member States17 each submitted documents to the Council. In August and September 2001, the TRIPS Council held additional sessions for discussions on this issue. At the June meeting, the African Group and other developing countries18 presented a draft text for a ministerial declaration on the TRIPS Agreement and Public Health. This proposal was a comprehensive text addressing political principles to ensure that the TRIPS Agreement does not undermine the legitimate right of WTO Members to formulate their own public health policies, as well as practical clarifications for provisions related to compulsory licensing, parallel importation, production for export to a country with insufficient production capacity, and data protection (Article 39.3 of the TRIPS Agreement). The text also included a proposal for evaluation of the effects of the TRIPS Agreement, with particular emphasis on access to medicines and research and development for the prevention and treatment of diseases predominantly affecting people in developing and least developed countries (LDCs). The USA, Japan, Switzerland, Australia and Canada circulated a non-paper with alternative text stressing the importance of intellectual property protection for research and development, arguing that intellectual property contributes to public health objectives globally. An EC non-paper was also circulated that proposed possible solutions to the problem of production for exports to fulfil a compulsory licence in a country with no or insufficient production capacity. Negotiations on these texts took place at the General Council.

16 See the submission by the African Group, Barbados, Bolivia, Brazil, Cuba, Dominican Republic, Ecuador, Honduras, India, Indonesia, Jamaica, Pakistan, Paraguay, Philippines, Peru, Sri Lanka, Thailand and Venezuela (IP/C/W/296).

17 See IP/C/W/280, 12 June 2001.

18 Bangladesh, Barbados, Bolivia, Brazil, Cuba, Dominican Republic, Ecuador, Haiti, Honduras, India, Indonesia, Jamaica, Pakistan, Paraguay, Philippines, Peru, Sri Lanka, Thailand, and Venezuela.

The eventual adoption of a declaration on Public Health and TRIPS was the outcome of a carefully elaborated strategy by developing countries19. Despite the initial resistance by some developed countries20, the Doha Declaration was adopted by consensus, on the basis of last minute compromises and a delicate balance in wording21.

19 “Doha is a concrete success to which developing countries and NGOs can point. Whether Doha represents a significant shift in the power of developing countries to influence the standard-setting process in intellectual property within WTO remains a matter of conjecture” (Drahos, 2002, p. 26).

20 For some observers, the “anthrax crisis” shifted the balance to the public interest side in the Doha debate on public health and TRIPS (see, e.g., South Centre, 2001, p. 11). “The US was suddenly faced with a situation where there was a perceived need for immediate and widespread access to a product still on-patent, where the exclusive owner of that patent, Bayer in this case, appeared unable or unwilling to offer enough supplies to meet immediate demand. The US Government’s first instinct was to consider the compulsory licence option and seek out alternative manufacturers.” (Kettler, 2002, p. 9) The Canadian government also took actions to ensure supply of the anti-anthrax drug despite the patent held by Bayer (see, e.g., Harmon, 2001).

21 Developing countries, in particular, abandoned for study their original position asking for the declaration to state that “Nothing in the TRIPS Agreement shall prevent Members from taking measures to protect public health” (IP/C/W/312, WT/GC/W/450, 4 October 2001), which had been one of the main points of contention during the preparatory work.

 

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