Developing country proposals for Ministerial Declaration on TRIPS

by Chakravarthi Raghavan

Geneva, 19 Sep 2001 - - A group of 46 developing countries (from Africa, Asia, Latin America and Caribbean) put forward Wednesday at a meeting of the WTO-TRIPS Council, as a ‘non-paper’, a draft for a Ministerial Declaration for interpreting and clarifying the TRIPS Agreement and the rights under it of Members to take actions for protection of public health, use of compulsory licences, due restraint on raising disputes.

The ‘non-paper’ - an euphemism for proposals put forward informally and on whose specific language the sponsors were open to negotiations - was introduced by Zimbabwe’s Minister Counsellor, Mr. Tadeous Chifamba, on behalf of the 30-member Africa Group, Bangladesh, Barbados, Bolivia, Brazil, Cuba, the Dominican Republic, Ecuador, Haiti, Honduras, India, Indonesia, Jamaica, Pakistan, Paraguay, the Philippines, Peru, Sri Lanka, Thailand and Venezuela.

Trade diplomats said, as the Council broke up for lunch, that the EC had expressed support for a Ministerial Declaration (though not specifically addressing all the points in the non-paper).

The United States merely repeated its statement at the last TRIPS Council meeting, while Switzerland again took a hard-line of opposition. The two said they would be putting forward their own joint paper by the afternoon meeting.

The 46 developing countries have been spearheading the fight inside the WTO on TRIPS and Public Health and access to medicines.

The draft declaration, with some 17 pre-ambular paragraphs, would have the Ministers declare that nothing in TRIPS shall prevent members from taking measures to protect public health, the right of members to allow compulsory licensing and for such licences by one Member being recognized by another, authorizing such licences without having to go through time-consuming procedures and conditions in some specified circumstances, for establishing and maintaining (relatively easier) marketing approval procedures for generic products, authorizing production and export of medicines without the consent of rights holders to address public health needs in importing WTO members.

The declaration would also call on WTO members not to impose or threaten sanctions or grant of incentives or benefits so as to curtail ability of developing and least developed country Members to avail of possible policy options, utmost restraint in pursuing dispute processes, extension of transition periods for the least developed countries (in terms of Art. 65.4 and 66.1 of TRIPS).

Following is the text of the operative paras of the non-paper: ....

“The Ministers Declare that

1.   Nothing in the TRIPS Agreement shall prevent Members from taking measures to protect public health. 2. Each Member retains the right to establish its own policy and rules regarding the exhaustion of intellectual property rights (which enables parallel imports).

3.   Each Member has the right to allow other use (other than that allowed under Art. 30 of TRIPS, namely for members to statutorily provide limited exceptions to the exclusive rights of the patent holder), of the subject matter of a patent without the authorization of the right holder, including use by the government or third parties authorized by the government, and to determine the grounds upon which such use is allowed..

4.   In the case of a national emergency or other circumstances of extreme urgency or in cases of public non-commercial use, Members may grant compulsory licenses without prior efforts on the part of the user to obtain authorization from the right holder.

5.   A compulsory license issued by a Member may be given effect by another Member. Such other Member may authorize a supplier within its territory to make and export the product covered by the license predominantly for the supply of the domestic market of the Member granting the license. Production and export under these conditions do not infringe the rights of the patent holder.

6.   Members are not obliged to apply the conditions set forth in subparagraphs (b) and (f) of Article 31 of the TRIPS Agreement (the article setting non-exhaustively some conditions, but not limiting rights of members to issue such licences on other grounds) where the use of the subject matter of a patent is permitted to remedy a practice determined after judicial or administrative process to be anti-competitive.

7.   Nothing in the TRIPS Agreement shall prevent Members from establishing or maintaining marketing approval procedures for generic medicines and other health-care products, or applying summary or abbreviated marketing approval procedures based on marketing approvals granted earlier for equivalent products.

8.   Nothing in the TRIPS Agreement shall prevent Members from disclosing or using information held by its authorities or the patent holder where it is so required for reasons of public interest, including where such disclosure or use is necessary to implement effectively any compulsory licenses or other measures adopted by public authorities in the public interest.

9.   Under Article 30 of the TRIPS Agreement, Members may, among others, authorize the production and export of medicines by persons other than holders of patents on those medicines to address public health needs in importing Members.

10. Each Member shall, within or beyond the framework of the WTO, refrain from imposing or threatening to impose sanctions and refrain from employing the grant of incentives or other benefits in a manner which could curtail the ability of developing and least-developed country Members to avail themselves of every possible policy option to protect and promote public health.

11. Members shall exercise utmost restraint in initiating and pursuing dispute settlement proceedings relating to measures adopted or implemented, particularly by developing and least-developed country Members, to protect and promote public health.

12. In its examination of the scope and modalities for the possible application of subparagraphs 1 (b) and 1 ) of Article XXIII of GATT 1994 (the socalled ‘non-violation’ disputes, or application of measures whether or not in conflict with TRIPS provisions or a catch-all ‘any other situation) to the settlement of disputes under the TRIPS Agreement, and without prejudice to recommendations that the Council for TRIPS may adopt and submit to the Ministerial Conference on other relevant aspects, in no event shall such subparagraphs be rendered applicable to measures adopted and implemented by Members, particularly developing and least-developed country Members, to protect and promote public health.

[The issue of invoking dispute procedures for non-violation disputes as such under TRIPS, covering the entire range of TRIPS provisions, is already mandated to be reviewed and recommendations made to the Ministerial Conference]

13. In view of the special needs and requirements of developing and least-developed country Members, their economic, financial and administrative constraints, and their need for flexibility to create a viable technological base, the transition periods provided for their benefit under Articles 65.4 (transition period for providing product patents, where only process patents are provided) and 66.1 of the TRIPS Agreement shall be extended for another period of five (5) years from the expiration of the transition period provided thereunder, particularly in respect of the obligation to render available patent protection on products or processes relating to public health, without prejudice to further extensions.

14. The TRIPS Council shall monitor and evaluate on an ongoing basis, in collaboration with relevant international organizations, the effects of the TRIPS Agreement on health, with particular emphasis on access to medicines and research and development on medicines for the prevention and treatment of diseases predominantly affecting people in developing and least-developed countries. – SUNS4970

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

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