WORLD TRADE
ORGANIZATIONIP/C/W/312
WT/GC/W/450
4 October 2001
(01-4803)
Council for Trade-Related Aspects of
Intellectual Property Rights
General CouncilOriginal: English
PROPOSAL BY THE AFRICAN GROUP, BANGLADESH, BARBADOS, BOLIVIA,
BRAZIL, CUBA, DOMINICAN REPUBLIC, ECUADOR, HAITI, HONDURAS,
INDIA, INDONESIA, JAMAICA, PAKISTAN, PARAGUAY, PHILIPPINES,
PERU, SRI LANKA, THAILAND AND VENEZUELA
During the special discussion of the TRIPS Council on 19 September 2001, the following
proposal was communicated to the Secretariat fo r circulation among Members of the Council by
Zimbabwe on behalf of the above-mentioned delegations.  When submitting the text, the delegations
in question indicated that this was without prejudice to individual country positions and their right tosubmit additional proposals.
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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 Memb ers 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 v ital 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 ofsickness, 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 andaffordability of needed medicines and other healthcare 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;IP/C/W/312
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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 main tenance of sustainable domestic manufacturing
capacities for medicines and other healthcare products;
recognizing that in implementing domestic health policies, especially as regards the
availability and affordability of medicines and other healthcare 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 healthcare 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 barriersto 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 Fa vour 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 agreementon 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 formul ate and implement measures to protect and promote
public health;
noting the ongoing 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:IP/C/W/312
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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 use1 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 licences without prior efforts on
the part of the user to obtain authorization from the right holder.
5. A compulsory licence 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 licence predominantly for the supply of the domestic market of the Member
granting the licence.  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 preven t Members from establishing or maintaining
marketing approval procedures for generic medicines and other healthcare 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 effectivelyany compulsory licences 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 thosemedicines 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 countryMembers 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 andleast-developed country Members, to protect and promote public health.
                                                     
1 "Other use" refers to use other than that allowed under Article 30 of the TRIPS Agreement.IP/C/W/312
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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 noevent 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 period provided for their benefitunder Articles 65.4 and 66.1 of the TRIPS Agreement shall be extended for another period of
five (5) years from the expiration of the transition periods 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.
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