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Proposals for decisions on TRIPS and Public Health at Doha

by Chakravarthi Raghavan

Geneva, 25 July 2001 - The Doha Ministerial Declaration should reaffirm the right of WTO members to determine the grounds on which compulsory licenses may be issued, including for protection of public health and nutrition, and ensure that all provisions of the TRIPS agreement are clarified and interpreted in accord with articles 7 and 8 of the TRIPS agreement, the Group of African and other Developing Countries proposed Tuesday at the World Trade Organization.

In a statement at the informal meeting of the TRIPS Council on TRIPS and Public Health, setting out the ‘vital elements’ for specific actions to be included in the Doha Ministerial Declaration, , Mr. Tadeous Chifamba of Zimbabwe, speaking on behalf of the Group of African and other developing Countries (a total of 41), called for reaffirmation that “nothing in the TRIPS agreement prevents WTO members from resorting to parallel imports and an agreement on moratorium on all dispute actions aimed at preventing or limiting capacity of members to promote access to medicines and protect public health.”

Chifamba’s statement was supported by Malaysia, Indonesia, Peru, Venezuela, Ecuador, Philippines, Egypt, India, Brazil, and Bolivia on behalf of the Andean Group.

The other vital elements included in statement call for:

        An undertaking (by all WTO members) to recognise and give effect to a compulsory license issued by another member to a manufacturer in their territory for the production of drugs or medicine intended for the market of the member issuing the license, and

        Extension of transition periods for developing and least developed countries

The statement noted “the wide support for TRIPS and public health issues” to be addressed at the Doha ministerial conference and said it would be appropriate for members to consider the course of action to be taken, and for the work in the TRIPS Council on this issue to be coordinated with the preparatory process for Doha. The African and other developing countries recommended that the chairman of the TRIPS Council initiate necessary steps to identify the elements for inclusion into the ministerial declaration and to include “the vital elements” identified in the group statement. Earlier, the statement referred to the interpretations of the TRIPS agreement being provided by the WTO secretariat and which had been commended by the US at the 20 June meeting of the TRIPS Council, and said the African and other developing countries considered it “inappropriate” for the secretariat to provide such interpretations.

“We would strongly suggest that the Secretariat strives to maintain its objectivity in such matters,” it added.

According to some of the members of the group, while their objection related to “some documents” prepared by the secretariat (and presumably those posted on the WTO’s website accessible to the public), the members had also been concerned over interpretations being provided by the secretariat to some member countries and to secretariats of international organisations to ‘persuade’ them to take a similar restrictive view.

The statement noted that the Special Discussion in the TRIPS Council on June 20 demonstrated the high level of interest and commitment of the WTO Membership to address the concerns raised by developing countries on the issue of the TRIPS Agreement and Public Health. “Indeed, we are very encouraged by the degree of agreement, as indicated in the Members’ statements, on the need to ensure that the implementation of the TRIPS Agreement does not prevent Members from adopting measures to protect public health and ensure access to affordable medicines” and the general support for concrete measures to be taken at the Doha Ministerial Conference to this effect.

The statement also referred to paper cosponsored by more than a third of the WTO Membership and presented to the TRIPS Council on 20 June, setting out their common understanding of the provisions of TRIPS Agreement related to public health issues, and said a large number of Members had also added their support to several elements contained in the joint developing country paper.

“However, we take note of some questions raised by a number of delegations, and we look forward to reaching agreement on those points, so that we may proceed swiftly towards achieving a tangible result for our discussions, in time for Doha.”

In the interest of maintaining the momentum of the important discussions, they would address those substantive issues and questions raised by some delegations during the formal session on June 20, with a view to achieving a convergence of views; offer procedural suggestions with regard to on-going preparations for the Ministerial Conference in Qatar, regarding the issue of the TRIPS Agreement and Public Health; and provide recommendations for some of the elements to be included in the Ministerial Declaration on this issue.

While taking note of and thanking the Secretariat for its document, the ‘Checklist of Articles of the TRIPS Agreement and matters raised in relation to them at the Council’s special discussion on intellectual property and access to medicines’, the statement said, that although the Checklist does not adequately reflect the high degree of convergence amongst the WTO Membership on key issues raised during the Special Discussion, “we nonetheless understand the need for the Secretariat to maintain its position of neutrality on matters related to the interpretation of the WTO Agreements.”

“In this connection,” the statement added, “we refer to the US statement on June 20, which invited other Members to refer to some documents prepared by the Secretariat for ‘explanations’ on the provisions of the TRIPS Agreement.

“We do not consider it appropriate for the WTO Secretariat to provide interpretations of the provisions of the TRIPS Agreement, and would strongly suggest that the Secretariat strives to maintain its objectivity in such matters.”

The group statement went on to provide some preliminary comments, on the interventions of a number of delegations, including the USA, the EC and Switzerland.

On the US statement, urging the adoption of a ‘comprehensive approach’ to deal with serious health problems, Chifamba on behalf of the African Group and other developing countries said that, certainly, in other international fora and at the national level, “our respective governments are engaged in the serious work of identifying and implementing various solutions to address public health issues.”

“It is not within the mandate of the TRIPS Council to talk of the infrastructure in different countries, in terms of hospitals, doctors and nurses. Nor will it be useful for this forum to discuss the global funds and other initiatives for the purchase and distribution of medicines. These issues belong to, and are being addressed, in the appropriate fora and institutions.”

The work in the TRIPS Council was “limited to addressing the impact of the TRIPS Agreement on public health and access to affordable medicines.”

“We must be clear about the mandate and objective of our exercise in this forum; that is, to examine the relationship between the various provisions of the TRIPS Agreement and issues of public health and access to medicines, and most importantly, to ensure that the implementation of the TRIPS Agreement does not become an obstacle to the promotion of access to affordable medicines and the protection of public health. Members have the right under the TRIPS Agreement to determine the grounds on which compulsory licenses can be issued.”

The US had said (on June 20) that Article 31 of the TRIPS Agreement did not ‘itemize the purposes for which compulsory licenses may be granted’, rather it established the conditions to be met with respect to compulsory licenses. The EC and Switzerland had also said that, ‘compulsory licenses can be issued for any reason, including of course public health.’

“Under the TRIPS Agreement,” Chifamba said in the joint statement on Wednesday, “Members are free to determine the grounds upon which to issue compulsory licenses. In addition, Members are also free to determine and implement in national law the meaning of terms in the TRIPS Agreement.”

On the relationship between Article 31 and Article 27.1, the statement reiterated that both sets of provisions addressed “different matters and circumstances.” As stated in the paper co-sponsored by developing countries (on June 20), Articles 27.1 and 28 “do not limit the right of Members to issue compulsory licenses.”

“We do not believe that these provisions prohibit the grant of compulsory licenses in cases where the patent fails to be worked or is insufficiently worked. As with all other provisions of the TRIPS Agreement, Articles 31 and 27.1 should certainly be read in light of the objectives and principles of the TRIPS Agreement.”

Under Article 31 (b), the requirement to obtain authorization from the patent holder can be waived in cases of national emergency, extreme urgency and for public non-commercial use. The US reading of this provision seemed to suggest that the application of the waiver depends on the time element.

“ It is clear that Article 31 (b) is not be limited to a question of time, but rather is dependent on situations of critical and extreme importance in which government deem it necessary to issue compulsory licenses. In this respect, governments have the prerogative to determine when a situation constitutes one of national emergency or extreme urgency.”

“The Africa Group has already stated its understanding that legitimate grounds for the issuance of a compulsory license may include the following: (1) where there is non-working or insufficient working of a patent; (2) for the importation of a product under patent protection; (3) for the export of a product produced under compulsory license; and (4) for a foreign manufacturer to produce goods intended for the market of the Member issuing the license. We also said that with respect to item (4), Members should undertake to recognise and give due effect to such compulsory licenses. We note that the EC has referred to such an interpretation and we look forward to discussing this issue to secure consensus on this point.”

As regards “parallel imports”, “we believe that a restrictive view of Article 6 will, only work towards limiting access to affordable medicines. Article 6 confers upon Members the right to adopt the principle of international exhaustion of rights in their national legislation. Article 6 is a crucial element in the balance of rights and obligations in the TRIPS Agreement, and should be regarded as an essential tool in a country’s arsenal of national health policies. This fact is evidenced in the practice of certain developed countries.

“We further wish to clarify that parallel importation is allowed under the TRIPS Agreement in several circumstances including, (1) where the patented product has been marketed in another country, by the patent holder or with his consent, or (2) where the product is sold in another country under a compulsory license, or (3) where the product is marketed in another country through other legitimate means without the authorization of the patent holder (such as where the product is not patent protected in the exporting country).”

The Africa Group and other developing countries also wished to reiterate their position that “on-going discussions and initiatives in other fora should not prejudice the rights of governments to adopt policy options available under the TRIPS Agreement.”

Therefore, the discussions on the global tiered pricing scheme should not affect the right of Members to adopt parallel import measures.

In view of the wide support for the TRIPS and public health issue to be addressed at the Doha Ministerial Conference, it would be appropriate for Members to consider the course of action to be pursued. “In our opinion, we think that our work in the TRIPS Council should be coordinated with that of the preparatory process for the Doha Ministerial Conference.”

For this purpose, the Chairman of the TRIPS Council should initiate the necessary processes to identify the elements for inclusion into the Doha Ministerial Declaration. The vital elements would include the following:

        Recognition of the paramount importance of the objectives and principles of the TRIPS Agreement set out in Articles 7 and 8, in the interpretation of provisions in the Agreement. All provisions of the TRIPS Agreement must be clarified and interpreted in the context of and against the background of Articles 7 and 8 of the TRIPS Agreement.

        Reaffirmation of Members’ right to determine the grounds on which compulsory licenses may be issued, including that of protection of public health and nutrition.

        Undertaking to recognise and give due effect to a compulsory license issued by another Member to a manufacturer in their territory for the production of drugs or medicine intended for the market of the Member issuing the license.

        Reaffirmation of the fact that nothing in the TRIPS Agreement prevents WTO Members from resort to parallel imports.

        Agreement to observe a moratorium on all dispute actions that are aimed at preventing or limiting Members’ capacity to promote access to medicines and protect public health. – SUNS4944

The above article first appeared in the South-North Development Monitor (SUNS) of which Chakravarthi Raghavan is the Chief Editor.

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