The following text is submitted as a non-paper by the above-indicated delegations and is without prejudice to individual country positions and their right to submit additional proposals.

MINISTERIAL DECLARATION ON THE TRIPS AGREEMENT AND PUBLIC HEALTH

Ministers,

Affirming that the protection and promotion of public health and nutrition is a fundamental obligation and prerogative of the State and that Members retain their sovereign power in this regard;

Realizing that the inability of large segments of the population to obtain medicines and treatment at prices they can afford threatens the vital interest of States in protecting and promoting public welfare, preserving law and order, and maintaining social cohesion;

Discharging the obligation to protect and promote the fundamental human rights to life and the enjoyment of the highest attainable standard of physical and mental health, including the prevention, treatment and control of epidemic, endemic, occupational and other diseases and the creation of conditions which would assure to all medical service and medical attention in the event of sickness, as affirmed in the International Covenant on Economic, Social and Cultural Rights;

Cognizant of the concerns expressed by non-governmental organizations, public health advocates and the worldwide public regarding potential implications of the Agreement on Trade-Related Aspects of Intellectual Property Rights (the “TRIPS Agreement”) on the availability and affordability of needed medicines and other health care products;

Concerned about the lack of adequate research and development on medicines for the prevention and treatment of diseases predominantly affecting people in developing and least-developed countries;

Emphasizing that the protection of intellectual property rights, in particular patent protection, should encourage the development of new medicines and the international transfer of and access to technology to promote the development and maintenance of sustainable domestic manufacturing capacities for medicines and other health care products;

Recognizing that in implementing domestic health policies, especially as regards the availability and affordability of medicines and other health care products, both the research-based and the generics pharmaceutical industries have important and complementary roles to perform, particularly in developing and least-developed countries;

Stressing the importance of the participation of public health officials in discussions and decision-making on intellectual property rules that may have an effect on the availability of and access to health care products;

Recalling the Preamble of the TRIPS Agreement, which, among others, prescribes that measures and procedures to enforce intellectual property rights should not themselves become barriers to legitimate trade and recognizes the special needs of the least-developed country Members in respect of maximum flexibility in the domestic implementation of laws and regulations in order to enable them to create a sound and viable technological base;

Recalling further Article XI.2 of the Marrakesh Agreement Establishing the World Trade Organization and the Decision on Measures in Favour of Least-Developed Countries adopted on 15 December 1993;

Reaffirming the General Council decision of 7-8 February 2000 (WT/GC/M/53) that the mandated review of the TRIPS Agreement, among others, should address the impact of the agreement on the trade and development prospects of developing countries;

Acknowledging the vulnerability of developing and least-developed country Members to the imposition or the threat of imposition of sanctions and to the prospect of being deprived of incentives or other benefits, including those imposed or offered, as the case may be, beyond the framework of the WTO;

Recognizing that challenges within the WTO dispute settlement system may in themselves inhibit or curtail the ability of Members to formulate and implement measures to protect and promote public health;

Noting the on-going examination by the Council for TRIPS on the scope and modalities for the possible application of subparagraphs 1 (b) and 1 (c) of Article XXIII of GATT 1994 to the settlement of disputes under the TRIPS Agreement;

Recognizing that public health crises of unprecedented consequences, of which HIV/AIDS is a most dramatic example, afflict developing countries;

Anticipating that drawing attention to and reaffirming the context of the TRIPS Agreement and certain provisions thereof as an initial concrete step will further encourage Members, particularly developing and least-developed country Members, towards considering every possible policy option for the protection and promotion of public health;

Emphasizing the fundamental importance of the objectives and principles of the TRIPS Agreement;

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.

3. Each Member has the right to allow other use[1] 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 where 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 (c) of Article XXIII of GATT 1994 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.

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 66.1 and 65.4 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.