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
Close this folderPublic health measures
View the documentOption 1
View the documentOption 2
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

Option 2

[We affirm a Member’s ability to use, to the full, the provisions in the TRIPS Agreement which provide flexibility to address public health crises such as HIV/AIDS and other pandemics, and to that end, that a Member is able to take measures necessary to address these public health crises, in particular to secure affordable access to medicines. Further, we agree that this Declaration does not add to or diminish the rights and obligations of Members provided in the TRIPS Agreement. With a view to facilitating the use of this flexibility by providing greater certainty, we agree on the following clarifications.]33

33 During the negotiating process, the European Commission proposed the following compromise text for paragraph 4: “Nothing in the TRIPS Agreement prevents Members from pursuing and achieving public health objectives. Accordingly, the TRIPS Agreement shall be interpreted and implemented in a manner supportive of WTO Members’ ability to enhance access to affordable medicines for all in the context of public health objectives”.

The wording of the first part of paragraph 4, reflects the delicate compromise reached in Doha. It reaffirms Members’ rights to take measures “to protect public health”, in a much less elaborated way than article XX (b) of GATT and the respective provisions in the SPS and TBT agreements34.

34 The “necessity” test, central to those provisions, is not mentioned in the Doha Declaration. On the application of such test in GATT/WTO jurisprudence, see e.g., Correa (2000b).

A possible interpretation for paragraph 4 is that the TRIPS Agreement does not raise conflicts with public health. Paragraph 4 would constitute a statement of fact (“the TRIPS Agreement does not ... prevent ...”) rather than a rebalancing of the Agreement in the sense that public health overrides commercial interests. Thus, for the European Commission, “the issue is not whether or not intellectual property overrides public health or vice versa. Intellectual property and public health can and should be mutually supportive because without effective medicines, public health policies would be hampered”35. In the view of the European Commission, the statement contained in paragraph 4 “is important in order to give meaning to the obvious principle that a Member’s right (or indeed duty) to pursue public health objectives and policies is unaffected by the TRIPS Agreement”36.

35 European Commission, 2001, p. 2.

36 Ibid.

In order to give meaning to paragraph 4, however, it is possible to interpret that the intention of the Members was to indicate that in cases where there is conflict between IPRs and public health, the former should not be an obstacle to the realization of the latter37. A possible reading of this paragraph is that such a conflict may arise, and this is precisely why “the TRIPS Agreement does not and should not prevent Members from taking measures to protect public health”.

37 The Brazilian delegation pointed out at the Doha Ministerial Conference that “in the area of intellectual property, different readings of the TRIPS Agreement have given rise to tensions. To a certain extent, it is natural that conflicts of interests should reflect themselves in divergent interpretations of common rules. But the commercial exploitation of knowledge must not be valued more highly than human life. There are circumstances in which the conflict of interests will require that the State exercise its supreme political responsibility... Brazil promotes and upholds intellectual property rights...However, if circumstances so require it, Brazil, like many other countries, will not hesitate to make full use of the flexibility afforded by the TRIPS Agreement to legitimately safeguard the health of its citizens.” See also, e.g. ‘t Hoen (2001), p. 11; Raja, p. 2002, 14, and the Joint Statement of 14 November 2001, by MSF, Oxfam, TWN, CPT, Consumers International, HAI and The Third World Network Third World Economics, No. 268, 1-15 November 2001.

As mentioned, a basic issue underlying the discussions leading to the Doha Declaration was the extent to which the final proviso of article 8.1 would mean that intellectual property can override public health. One possible interpretation of this proviso is that, unlike Article XX (b) of the GATT, under the TRIPS Agreement Public Health and other reasons enumerated in Article 8.1 permit Members to adopt measures (e.g. commercialization and price controls), but not to derogate obligations relating to the availability or enforcement of IPRs. However, in the light of paragraph 4 of the Doha Declaration, it may be argued that Article 8.1 would not prevent derogation from certain obligations under the TRIPS Agreement if necessary to address public health needs.

The realization of public health becomes, with the Doha Declaration, a clearly stated purpose of the Agreement. In affirming that the TRIPS Agreement, “can and should be interpreted and implemented in a manner supportive of WTO Members’ right to protect public health and, in particular, to promote access to medicines for all”, paragraph 4 gives guidance to panels and the Appellate Body for the interpretation of the Agreement’s provisions in cases involving public health issues. In doing so, Members have developed a specific rule of interpretation that gives content to the general interpretive provisions of the Vienna Convention on the Law of the Treaties (hereinafter “the Vienna Convention”) on which GATT/WTO jurisprudence has been built up38. Therefore, in cases of ambiguity, or where more than one interpretation were possible, panels and the Appellate Body should opt for the interpretation that is effectively “supportive of WTO Members’ right to protect public health”.

38 As stated by a panel, the TRIPS Agreement has a “relatively self-contained, sui generis status within the WTO”, but it is “an integral part of the WTO system, which itself builds upon the experience of over nearly half a century under the GATT 1947”. See USA - India - Patent Protection for Agricultural and Chemical Products, WT/DS50/R, adopted on 16 January 1998, para. 7.19.

It also should be noted that paragraph 4 makes a specific reference to the issue of “access to medicines for all”, indicating that in the interpretation of the Agreement’s obligations, special attention should be given to the achievement of this goal.

Finally, paragraph 4 alludes to the implementation of the Agreement, and not only to its interpretation. Implementation takes place at the national level, but is influenced by actions taken by other governments, either in the context of bilateral dealings or in the multilateral framework. The important message of the Declaration in this regard is that the Agreement can be implemented39 in a manner supportive of WTO Members’ right to protect public health. As a result, other Members should restrain from any action that hinders the exercise of such rights by Members, especially developing countries and LDCs.

39 Since implementation is in the last instance an obligation imposed on Member States, the logical reading of the second sentence of paragraph 4 is that the Agreement should be interpreted and can be implemented in a manner supportive of WTO Members’ right to protect public health.

According to this paragraph, however, Members not only can implement the TRIPS Agreement “in a manner supportive of WTO Members’ right to protect public health”, but they should also implement it in that way. This means that all Member countries, including developed countries, are bound to contribute to the solution of the public health problems addressed by the Doha Declaration40. One possible way of doing so would be, for instance, by adopting measures to allow the export of medicines needed in a country with no or insufficient manufacturing capacity, an issue which paragraph 6 of the Declaration requires Members to address (see below).

40 See also Paragraph 17 of the general Doha Ministerial Declaration, as quoted in footnote 1 above.


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