A I P P I ASSOCIATION INTERNATIONALE POUR LA PROTECTION DE LA PROPRIETE INTELLECTUELLE

Transcription

1 A I P P I ASSOCIATION INTERNATIONALE POUR LA PROTECTION DE LA PROPRIETE INTELLECTUELLE INTERNATIONAL ASSOCIATION FOR THE PROTECTION OF INTELLECTUAL PROPERTY INTERNATIONALE VEREINIGUNG FÜR DEN SCHUTZ DES GEISTIGEN EIGENTUMS Questionnaire October 2002 Q94 - GATT/ WTO Doha Health Declaration

2 Questionnaire Doha Health Declaration 1. Provided the system of a privileged compulsory license permitting not only local production but also importation is approved, should it be applicable 1.1 to pharmaceutical products needed in public health crisis such as those relating to HIV/AIDS, tuberculosis, malaria and other epidemics that represent a national emergency or other circumstances of extreme urgency (Doha Health Declaration, paragraph 5 lit. c)? 1.2 to all pharmaceutical products? 1.3 And should the term "pharmaceutical products" include within the frame of 1.1 or diagnostica? 1.5 medical instruments? 1.6 all patentable products in the pharmaceutical sector? 2. With regard to the definition of WTO member countries allowed to take advantage of importing under the privileged compulsory licensing system (eligible importing countries), 2.1 should the privilege be limited to the least developed countries? 2.2 should it be available to all least developed countries? 2.3 should it be available to countries other than least developed countries? If so, should "insufficient or no manufacturing capacity" be determined on the basis of the size of the population of the WTO member? the basis of the per capita income? the basis of the gross national product?

3 2 or on a case by case basis? 2.4 Should given categories of countries such as all developing countries be presumed to have insufficient or no manufacturing capacity? 3. With respect to the eligibility to supply pharmaceutical products (eligible exporting countries allowed to grant compulsory export licenses), should all countries or all WTO members be eligible? Or should the eligibility to grant compulsory export licenses for the supply of pharmaceutical products be restricted to certain categories of countries (e.g. developing or least developed countries)? should the eligible importing country have the right to determine the supplier and the supplying country to the exclusion of others? should the importing country have the obligation to designate the supplier and the supplying country? should the eligible exporting country have the right to grant compulsory export licenses without designating the importing country? 4. Should the privileged compulsory license system be introduced? If so, should it be introduced by interpretation of Article 30 and/or Article 31(f) of the TRIPS Agreement? or by amendment of the TRIPS Agreement? or by the - temporary - waiver of affected rights under the TRIPS Agreement in accordance with Article IX, paragraph 2, of the Marrakesh Agreement? or by exclusion of such licensing practices from dispute settlement proceedings?

4 3 5. If it was decided to introduce the privileged compulsory licensing system by way of interpretation or amendment, should the privileged compulsory licensing system be based on Article 30 or Article 31(f) of the TRIPS Agreement? * * * It would be most helpful to have your reply by November 5, Name of Group:... Name of Group Representative:...

5 WORLD TRADE ORGANIZATION WT/MIN(01)/DEC/2 20 November 2001 ( ) MINISTERIAL CONFERENCE Fourth Session Doha, 9-14 November 2001 DECLARATION ON THE TRIPS AGREEMENT AND PUBLIC HEALTH Adopted on 14 November We recognize the gravity of the public health problems afflicting many developing and least-developed countries, especially those resulting from HIV/AIDS, tuberculosis, malaria and other epidemics. 2. We stress the need for the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) to be part of the wider national and international action to address these problems. 3. We recognize that intellectual property protection is important for the development of new medicines. We also recognize the concerns about its effects on prices. 4. We agree that the TRIPS Agreement does not and should not prevent Members from taking measures to protect public health. Accordingly, while reiterating our commitment to the TRIPS Agreement, we affirm that the 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. In this connection, we reaffirm the right of WTO Members to use, to the full, the provisions in the TRIPS Agreement, which provide flexibility for this purpose. 5. Accordingly and in the light of paragraph 4 above, while maintaining our commitments in the TRIPS Agreement, we recognize that these flexibilities include: In applying the customary rules of interpretation of public international law, each provision of the TRIPS Agreement shall be read in the light of the object and purpose of the Agreement as expressed, in particular, in its objectives and principles. Each Member has the right to grant compulsory licences and the freedom to determine the grounds upon which such licences are granted. Each Member has the right to determine what constitutes a national emergency or other circumstances of extreme urgency, it being understood that public health crises, including those relating to HIV/AIDS, tuberculosis, malaria and other epidemics, can represent a national emergency or other circumstances of extreme urgency.. /.

6 WT/MIN(01)/DEC/2 Page 2 The effect of the provisions in the TRIPS Agreement that are relevant to the exhaustion of intellectual property rights is to leave each Member free to establish its own regime for such exhaustion without challenge, subject to the MFN and national treatment provisions of Articles 3 and We recognize that WTO Members with insufficient or no manufacturing capacities in the pharmaceutical sector could face difficulties in making effective use of compulsory licensing under the TRIPS Agreement. We instruct the Council for TRIPS to find an expeditious solution to this problem and to report to the General Council before the end of We reaffirm the commitment of developed-country Members to provide incentives to their enterprises and institutions to promote and encourage technology transfer to leastdeveloped country Members pursuant to Article We also agree that the least-developed country Members will not be obliged, with respect to pharmaceutical products, to implement or apply Sections 5 and 7 of Part II of the TRIPS Agreement or to enforce rights provided for under these Sections until 1 January 2016, without prejudice to the right of least-developed country Members to seek other extensions of the transition periods as provided for in Article 66.1 of the TRIPS Agreement. We instruct the Council for TRIPS to take the necessary action to give effect to this pursuant to Article 66.1 of the TRIPS Agreement.

7 AGREEMENT ON TRADE-RELATED ASPECTS OF INTELLECTUAL PROPERTY RIGHTS Members, Desiring to reduce distortions and impediments to international trade, and taking into account the need to promote effective and adequate protection of intellectual property rights, and to ensure that measures and procedures to enforce intellectual property rights do not themselves become barriers to legitimate trade; Recognizing, to this end, the need for new rules and disciplines concerning: (a) (b) (c) (d) (e) the applicability of the basic principles of GATT 1994 and of relevant international intellectual property agreements or conventions; the provision of adequate standards and principles concerning the availability, scope and use of trade-related intellectual property rights; the provision of effective and appropriate means for the enforcement of traderelated intellectual property rights, taking into account differences in national legal systems; the provision of effective and expeditious procedures for the multilateral prevention and settlement of disputes between governments; and transitional arrangements aiming at the fullest participation in the results of the negotiations; Recognizing the need for a multilateral framework of principles, rules and disciplines dealing with international trade in counterfeit goods; Recognizing that intellectual property rights are private rights; Recognizing the underlying public policy objectives of national systems for the protection of intellectual property, including developmental and technological objectives; Recognizing also 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; Emphasizing the importance of reducing tensions by reaching strengthened commitments to resolve disputes on trade-related intellectual property issues through multilateral procedures; Desiring to establish a mutually supportive relationship between the WTO and the World Intellectual Property Organization (referred to in this Agreement as "WIPO") as well as other relevant international organizations;

8 Hereby agree as follows: PART I GENERAL PROVISIONS AND BASIC PRINCIPLES Article 1 Nature and Scope of Obligations Article 7 Objectives The protection and enforcement of intellectual property rights should contribute to the promotion of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligations. Article 8 Principles 1. Members may, in formulating or amending their laws and regulations, adopt measures necessary to protect public health and nutrition, and to promote the public interest in sectors of vital importance to their socio-economic and technological development, provided that such measures are consistent with the provisions of this Agreement. 2. Appropriate measures, provided that they are consistent with the provisions of this Agreement, may be needed to prevent the abuse of intellectual property rights by right holders or the resort to practices which unreasonably restrain trade or adversely affect the international transfer of technology. PART II STANDARDS CONCERNING THE AVAILABILITY, SCOPE AND USE OF INTELLECTUAL PROPERTY RIGHTS ( ) SECTION 5: PATENTS

9 Article 27 Patentable Subject Matter 1. Subject to the provisions of paragraphs 2 and 3, patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application. 1 Subject to paragraph 4 of Article 65, paragraph 8 of Article 70 and paragraph 3 of this Article, patents shall be available and patent rights enjoyable without discrimination as to the place of invention, the field of technology and whether products are imported or locally produced. 2. Members may exclude from patentability inventions, the prevention within their territory of the commercial exploitation of which is necessary to protect ordre public or morality, including to protect human, animal or plant life or health or to avoid serious prejudice to the environment, provided that such exclusion is not made merely because the exploitation is prohibited by their law. 3. Members may also exclude from patentability: (a) (b) diagnostic, therapeutic and surgical methods for the treatment of humans or animals; plants and animals other than micro-organisms, and essentially biological processes for the production of plants or animals other than non-biological and microbiological processes. However, Members shall provide for the protection of plant varieties either by patents or by an effective sui generis system or by any combination thereof. The provisions of this subparagraph shall be reviewed four years after the date of entry into force of the WTO Agreement. Article 28 Rights Conferred 1. A patent shall confer on its owner the following exclusive rights: (a) (b) where the subject matter of a patent is a product, to prevent third parties not having the owner s consent from the acts of: making, using, offering for sale, selling, or importing 2 for these purposes that product; where the subject matter of a patent is a process, to prevent third parties not having the owner s consent from the act of using the process, and from the 1 For the purposes of this Article, the terms "inventive step" and "capable of industrial application" may be deemed by a Member to be synonymous with the terms "non-obvious" and "useful" respectively. 2 This right, like all other rights conferred under this Agreement in respect of the use, sale, importation or other distribution of goods, is subject to the provisions of Article 6.

10 acts of: using, offering for sale, selling, or importing for these purposes at least the product obtained directly by that process. 2. Patent owners shall also have the right to assign, or transfer by succession, the patent and to conclude licensing contracts. Article 29 Conditions on Patent Applicants 1. Members shall require that an applicant for a patent shall disclose the invention in a manner sufficiently clear and complete for the invention to be carried out by a person skilled in the art and may require the applicant to indicate the best mode for carrying out the invention known to the inventor at the filing date or, where priority is claimed, at the priority date of the application. 2. Members may require an applicant for a patent to provide information concerning the applicant s corresponding foreign applications and grants. Article 30 Exceptions to Rights Conferred Members may provide limited exceptions to the exclusive rights conferred by a patent, provided that such exceptions do not unreasonably conflict with a normal exploitation of the patent and do not unreasonably prejudice the legitimate interests of the patent owner, taking account of the legitimate interests of third parties. Article 31 Other Use Without Authorization of the Right Holder Where the law of a Member allows for other use 3 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, the following provisions shall be respected: (a) (b) authorization of such use shall be considered on its individual merits; such use may only be permitted if, prior to such use, the proposed user has made efforts to obtain authorization from the right holder on reasonable commercial terms and conditions and that such efforts have not been successful within a reasonable period of time. This requirement may be waived by a Member in the case of a national emergency or other circumstances of extreme urgency or in cases of public non-commercial use. 3 "Other use" refers to use other than that allowed under Article 30.

11 In situations of national emergency or other circumstances of extreme urgency, the right holder shall, nevertheless, be notified as soon as reasonably practicable. In the case of public non-commercial use, where the government or contractor, without making a patent search, knows or has demonstrable grounds to know that a valid patent is or will be used by or for the government, the right holder shall be informed promptly; (c) (d) (e) (f) (g) (h) (i) (j) (k) (l) the scope and duration of such use shall be limited to the purpose for which it was authorized, and in the case of semi-conductor technology shall only be for public non-commercial use or to remedy a practice determined after judicial or administrative process to be anti-competitive; such use shall be non-exclusive; such use shall be non-assignable, except with that part of the enterprise or goodwill which enjoys such use; any such use shall be authorized predominantly for the supply of the domestic market of the Member authorizing such use; authorization for such use shall be liable, subject to adequate protection of the legitimate interests of the persons so authorized, to be terminated if and when the circumstances which led to it cease to exist and are unlikely to recur. The competent authority shall have the authority to review, upon motivated request, the continued existence of these circumstances; the right holder shall be paid adequate remuneration in the circumstances of each case, taking into account the economic value of the authorization; the legal validity of any decision relating to the authorization of such use shall be subject to judicial review or other independent review by a distinct higher authority in that Member; any decision relating to the remuneration provided in respect of such use shall be subject to judicial review or other independent review by a distinct higher authority in that Member; Members are not obliged to apply the conditions set forth in subparagraphs (b) and (f) where such use is permitted to remedy a practice determined after judicial or administrative process to be anti-competitive. The need to correct anti-competitive practices may be taken into account in determining the amount of remuneration in such cases. Competent authorities shall have the authority to refuse termination of authorization if and when the conditions which led to such authorization are likely to recur; where such use is authorized to permit the exploitation of a patent ("the second patent") which cannot be exploited without infringing another patent ("the first patent"), the following additional conditions shall apply:

12 (i) (ii) (iii) the invention claimed in the second patent shall involve an important technical advance of considerable economic significance in relation to the invention claimed in the first patent; the owner of the first patent shall be entitled to a cross-licence on reasonable terms to use the invention claimed in the second patent; and the use authorized in respect of the first patent shall be nonassignable except with the assignment of the second patent. Article 32 Revocation/Forfeiture An opportunity for judicial review of any decision to revoke or forfeit a patent shall be available. Article 33 Term of Protection The term of protection available shall not end before the expiration of a period of twenty years counted from the filing date. 4 Article 34 Process Patents: Burden of Proof 1. For the purposes of civil proceedings in respect of the infringement of the rights of the owner referred to in paragraph 1(b) of Article 28, if the subject matter of a patent is a process for obtaining a product, the judicial authorities shall have the authority to order the defendant to prove that the process to obtain an identical product is different from the patented process. Therefore, Members shall provide, in at least one of the following circumstances, that any identical product when produced without the consent of the patent owner shall, in the absence of proof to the contrary, be deemed to have been obtained by the patented process: (a) (b) if the product obtained by the patented process is new; if there is a substantial likelihood that the identical product was made by the process and the owner of the patent has been unable through reasonable efforts to determine the process actually used. 4 It is understood that those Members which do not have a system of original grant may provide that the term of protection shall be computed from the filing date in the system of original grant.

13 2. Any Member shall be free to provide that the burden of proof indicated in paragraph 1 shall be on the alleged infringer only if the condition referred to in subparagraph (a) is fulfilled or only if the condition referred to in subparagraph (b) is fulfilled. 3. In the adduction of proof to the contrary, the legitimate interests of defendants in protecting their manufacturing and business secrets shall be taken into account. ( ) SECTION 7: PROTECTION OF UNDISCLOSED INFORMATION

14 ANNEX 1 MARRAKESH AGREEMENT ESTABLISHING THE WORLD TRADE ORGANIZATION [ ] Article IV Structure of the WTO 1. There shall be a Ministerial Conference composed of representatives of all the Members, which shall meet at least once every two years. The Ministerial Conference shall carry out the functions of the WTO and take actions necessary to this effect. The Ministerial Conference shall have the authority to take decisions on all matters under any of the Multilateral Trade Agreements, if so requested by a Member, in accordance with the specific requirements for decision-making in this Agreement and in the relevant Multilateral Trade Agreement. 2. There shall be a General Council composed of representatives of all the Members, which shall meet as appropriate. In the intervals between meetings of the Ministerial Conference, its functions shall be conducted by the General Council. The General Council shall also carry out the functions assigned to it by this Agreement. The General Council shall establish its rules of procedure and approve the rules of procedure for the Committees provided for in paragraph The General Council shall convene as appropriate to discharge the responsibilities of the Dispute Settlement Body provided for in the Dispute Settlement Understanding. The Dispute Settlement Body may have its own chairman and shall establish such rules of procedure as it deems necessary for the fulfilment of those responsibilities. 4. The General Council shall convene as appropriate to discharge the responsibilities of the Trade Policy Review Body provided for in the TPRM. The Trade Policy Review Body may have its own chairman and shall establish such rules of procedure as it deems necessary for the fulfilment of those responsibilities. 5. There shall be a Council for Trade in Goods, a Council for Trade in Services and a Council for Trade-Related Aspects of Intellectual Property Rights (hereinafter referred to as the "Council for TRIPS"), which shall operate under the general guidance of the General Council. The Council for Trade in Goods shall oversee the functioning of the Multilateral Trade Agreements in Annex 1A. The Council for Trade in Services shall oversee the functioning of the General Agreement on Trade in Services (hereinafter referred to as "GATS"). The Council for TRIPS shall oversee the functioning of the Agreement on Trade- Related Aspects of Intellectual Property Rights (hereinafter referred to as the "Agreement on TRIPS"). These Councils shall carry out the functions assigned to them by their respective agreements and by the General Council. They shall establish their respective rules of procedure subject to the approval of the General Council. Member-ship in these Councils shall be open to representatives of all Members. These Councils shall meet as necessary to carry out their functions.

15 6. The Council for Trade in Goods, the Council for Trade in Services and the Council for TRIPS shall establish subsidiary bodies as required. These subsidiary bodies shall establish their respective rules of procedure subject to the approval of their respective Councils. 7. The Ministerial Conference shall establish a Committee on Trade and Development, a Commit-tee on Balance-of-Payments Restrictions and a Committee on Budget, Finance and Administration, which shall carry out the functions assigned to them by this Agreement and by the Multilateral Trade Agreements, and any additional functions assigned to them by the General Council, and may establish such additional Committees with such functions as it may deem appropriate. As part of its functions, the Committee on Trade and Development shall periodically review the special provisions in the Multilateral Trade Agreements in favour of the least-developed country Members and report to the General Council for appropriate action. Membership in these Committees shall be open to representatives of all Members. 8. The bodies provided for under the Plurilateral Trade Agreements shall carry out the functions as-signed to them under those Agreements and shall operate within the institutional framework of the WTO. These bodies shall keep the General Council informed of their activities on a regular basis. Article IX Decision-Making 1. The WTO shall continue the practice of decision-making by consensus followed under GATT Except as otherwise provided, where a decision cannot be arrived at by consensus, the matter at issue shall be decided by voting. At meetings of the Ministerial Conference and the General Council, each Member of the WTO shall have one vote. Where the European Communities exercise their right to vote, they shall have a number of votes equal to the number of their member States 2 which are Members of the WTO. Decisions of the Ministerial Conference and the General Council shall be taken by a majority of the votes cast, unless otherwise provided in this Agreement or in the relevant Multilateral Trade Agreement The Ministerial Conference and the General Council shall have the exclusive authority to adopt interpretations of this Agreement and of the Multilateral Trade Agreements. In the case of an interpretation of a Multilateral Trade Agreement in Annex 1, they shall exercise their authority on the basis of a recommendation by the Council overseeing the functioning of that Agreement. The decision to adopt an interpretation shall be taken by a three-fourths majority of the Members. This paragraph shall not be used in a manner that would undermine the amendment provisions in Article X. 3. In exceptional circumstances, the Ministerial Conference may decide to waive an obligation imposed on a Member by this Agreement or any of the Multilateral Trade 1 The body concerned shall be deemed to have decided by consensus on a matter submitted for its consideration, if no Member, present at the meeting when the decision is taken, formally objects to the proposed decision. 2 The number of votes of the European Communities and their member States shall in no case exceed the number of the member States of the European Communities. 3 Decisions by the General Council when convened as the Dispute Settlement Body shall be taken only in accordance with the provisions of paragraph 4 of Article 2 of the Dispute Settlement Understanding.

16 Agreements, provided that any such decision shall be taken by three fourths 4 unless otherwise provided for in this paragraph. of the Members (a) A request for a waiver concerning this Agreement shall be submitted to the Ministerial Conference for consideration pursuant to the practice of decision-making by consensus. The Ministerial Conference shall establish a time-period, which shall not exceed 90 days, to consider the request. If consensus is not reached during the time-period, any decision to grant a waiver shall be taken by three fourths 4 of the Members. (b) A request for a waiver concerning the Multilateral Trade Agreements in Annexes 1A or 1B or 1C and their annexes shall be submitted initially to the Council for Trade in Goods, the Council for Trade in Services or the Council for TRIPS, respectively, for consideration during a time-period which shall not exceed 90 days. At the end of the time-period, the relevant Council shall submit a report to the Ministerial Conference. 4. A decision by the Ministerial Conference granting a waiver shall state the exceptional circumstances justifying the decision, the terms and conditions governing the application of the waiver, and the date on which the waiver shall terminate. Any waiver granted for a period of more than one year shall be reviewed by the Ministerial Conference not later than one year after it is granted, and thereafter annually until the waiver terminates. In each review, the Ministerial Conference shall examine whether the exceptional circumstances justifying the waiver still exist and whether the terms and conditions attached to the waiver have been met. The Ministerial Conference, on the basis of the annual review, may extend, modify or terminate the waiver. 5. Decisions under a Plurilateral Trade Agreement, including any decisions on interpretations and waivers, shall be governed by the provisions of that Agreement. Article X Amendments 1. Any Member of the WTO may initiate a proposal to amend the provisions of this Agreement or the Multilateral Trade Agreements in Annex 1 by submitting such proposal to the Ministerial Conference. The Councils listed in paragraph 5 of Article IV may also submit to the Ministerial Conference proposals to amend the provisions of the corresponding Multilateral Trade Agreements in Annex 1 the functioning of which they oversee. Unless the Ministerial Conference decides on a longer period, for a period of 90 days after the proposal has been tabled formally at the Ministerial Conference any decision by the Ministerial Conference to submit the proposed amendment to the Members for acceptance shall be taken by consensus. Unless the provisions of paragraphs 2, 5 or 6 apply, that decision shall specify whether the provisions of paragraphs 3 or 4 shall apply. If consensus is reached, the Ministerial Conference shall forthwith submit the proposed amendment to the Members for acceptance. If consensus is not reached at a meeting of the Ministerial Conference within the established period, the Ministerial Conference shall decide by a two-thirds majority of the Members whether to submit the proposed amendment to the Members for acceptance. 4 A decision to grant a waiver in respect of any obligation subject to a transition period or a period for staged implementation that the requesting Member has not performed by the end of the relevant period shall be taken only by consensus.

17 Except as provided in paragraphs 2, 5 and 6, the provisions of paragraph 3 shall apply to the proposed amendment, unless the Ministerial Conference decides by a three-fourths majority of the Members that the provisions of paragraph 4 shall apply. 2. Amendments to the provisions of this Article and to the provisions of the following Articles shall take effect only upon acceptance by all Members: Article IX of this Agreement; Articles I and II of GATT 1994; Article II:1 of GATS; Article 4 of the Agreement on TRIPS. 3. Amendments to provisions of this Agreement, or of the Multilateral Trade Agreements in Annexes 1A and 1C, other than those listed in paragraphs 2 and 6, of a nature that would alter the rights and obligations of the Members, shall take effect for the Members that have accepted them upon acceptance by two thirds of the Members and thereafter for each other Member upon acceptance by it. The Ministerial Conference may decide by a three-fourths majority of the Members that any amendment made effective under this paragraph is of such a nature that any Member which has not accepted it within a period specified by the Ministerial Conference in each case shall be free to withdraw from the WTO or to remain a Member with the consent of the Ministerial Conference. 4. Amendments to provisions of this Agreement or of the Multilateral Trade Agreements in Annexes 1A and 1C, other than those listed in paragraphs 2 and 6, of a nature that would not alter the rights and obligations of the Members, shall take effect for all Members upon acceptance by two thirds of the Members. 5. Except as provided in paragraph 2 above, amendments to Parts I, II and III of GATS and the respective annexes shall take effect for the Members that have accepted them upon acceptance by two thirds of the Members and thereafter for each Member upon acceptance by it. The Ministerial Conference may decide by a three-fourths majority of the Members that any amendment made effective under the preceding provision is of such a nature that any Member which has not accepted it within a period specified by the Ministerial Conference in each case shall be free to withdraw from the WTO or to remain a Member with the consent of the Ministerial Conference. Amendments to Parts IV, V and VI of GATS and the respective annexes shall take effect for all Members upon acceptance by two thirds of the Members. 6. Notwithstanding the other provisions of this Article, amendments to the Agreement on TRIPS meeting the requirements of paragraph 2 of Article 71 thereof may be adopted by the Ministerial Conference without further formal acceptance process. 7. Any Member accepting an amendment to this Agreement or to a Multilateral Trade Agreement in Annex 1 shall deposit an instrument of acceptance with the Director- General of the WTO within the period of acceptance specified by the Ministerial Conference. 8. Any Member of the WTO may initiate a proposal to amend the provisions of the Multilateral Trade Agreements in Annexes 2 and 3 by submitting such proposal to the Ministerial Conference. The decision to approve amendments to the Multilateral Trade Agreement in Annex 2 shall be made by consensus and these amendments shall take effect for all Members upon approval by the Ministerial Conference. Decisions to approve amendments to the Multilateral Trade Agreement in Annex 3 shall take effect for all Members upon approval by the Ministerial Conference.

18 9. The Ministerial Conference, upon the request of the Members parties to a trade agreement, may decide exclusively by consensus to add that agreement to Annex 4. The Ministerial Conference, upon the request of the Members parties to a Plurilateral Trade Agreement, may decide to delete that Agreement from Annex Amendments to a Plurilateral Trade Agreement shall be governed by the provisions of that Agreement.

19 ANNEX 2 Text of document WT/L/93, dated 24 November 1995 DECISION-MAKING PROCEDURES UNDER ARTICLES IX AND XII OF THE WTO AGREEMENT Statement by the Chairman As agreed by the General Council on 15 November 1995 On occasions when the General Council deals with matters related to requests for waivers or accessions to the WTO under Articles IX or XII of the WTO Agreement respectively, the General Council will seek a decision in accordance with Article IX:1. Except as otherwise provided, where a decision cannot be arrived at by consensus, the matter at issue shall be decided by voting under the relevant provisions of Articles IX or XII. The above procedure does not preclude a Member from requesting a vote at the time the decision is taken. Consequently, if any Member has a particular problem with a proposed decision regarding a request for a waiver or an accession to the WTO, it should ensure its presence at the meeting in which this matter will be considered. The absence of a Member will be assumed to imply that it has no comments on or objections to the proposed decision on the matter.

20 WORLD TRADE ORGANIZATION IP/C/W/ July 2002 ( ) Council for Trade-Related Aspects of Intellectual Property Rights PROPOSALS ON PARAGRAPH 6 OF THE DOHA DECLARATION ON THE TRIPS AGREEMENT AND PUBLIC HEALTH: THEMATIC COMPILATION Note by the Secretariat This document has been prepared under the Secretariat's own responsibility and without prejudice to the positions of Members and to their rights and obligations under the WTO I. MEASURES TO FACILITATE EXPORTS TO MEMBERS WITH INSUFFICIENT MANUFACTURING CAPACITIES... 4 A. SCOPE AND COVERAGE Product coverage Beneficiary importing Members... 5 (a) General eligibility... 5 (b) Importing countries where the product is not patented... 6 (c) Assessment of insufficient manufacturing capacity Eligible supplying Members... 8 B. CONDITIONS General considerations Safeguards against diversion Transparency Involvement of right holder Applicability of Article 30/31 conditions (a) In exporting countries (b) In importing countries (c) Remuneration to right holder C. LEGAL MECHANISMS II. MEASURES TO FACILITATE PRODUCTION UNDER COMPULSORY LICENCES IN COUNTRIES WITH PRESENTLY INSUFFICIENT MANUFACTURING CAPACITY Transfer of technology Meaning of "domestic market" III. OTHER PROPOSALS Transition periods Exclusive marketing rights Integral to Declaration Moratorium Non-violation Public competitive tenders... 21

21 1. At the TRIPS Council meeting of June 2002, the Secretariat was requested to prepare by mid-july a thematic compilation of the five written proposals that had been received on the implementation of paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health. The paper would identify the various elements or components of the proposals and then set out, in synoptic form, how each addresses these elements. The note would also take into account any additional points made in the oral discussion in the Council. In addition, the note would provide factual information regarding each of the different legal techniques that had been proposed, including the procedural requirements relating to each one and information on GATT/WTO experience with the use of these techniques. 2. This note aims to respond to this request. It contains a listing of the elements that have been put forward for inclusion in a TRIPS Council recommendation to the General Council, covering both points of substance and of legal mechanism. The second part of the paper that was requested, namely that relating to information on the procedural requirements of each proposed legal mechanism and experience with the use of that mechanism will be issued shortly as an addendum to this note. 3. The five written proposals submitted to the June 2002 meeting of the Council for TRIPS are as follows: Document Reference Submitted by How referred to IP/C/W/351 Kenya on behalf of the African group African group IP/C/W/352 European Communities and their member States European Communities and their member States IP/C/W/354 United Arab Emirates United Arab Emirates IP/C/W/355 Brazil on behalf of the delegations of Bolivia, Brazil, Cuba, China, Dominican Republic, Ecuador, India, Indonesia, Pakistan, Peru, Sri Lanka, Thailand and Venezuela (at the TRIPS Council meeting, the Philippines also associated itself with the proposal). Group of developing countries IP/C/W/358 United States United States 4. It is important to note that this document is a checklist of elements proposed for a TRIPS Council recommendation and does not purport to reflect fully the views contained in the proposals and statements of Members. Explanations given of the reasons for a suggested element have not been included, except where they help to clarify the substance of the proposed element. Moreover, the paper does not record expressions of support by other Members for the elements that are listed in it. For a full description of the positions of individual delegations, the proposals submitted and the minutes of the Council meeting recording the statements made should be consulted. 5. The order of the listing of the proposals follows the numbering of the documents in which they are contained (i.e. the order in which they were received). Additional points or clarifications made by Members associated with a group submission have been placed below the heading relating to that submission, but this should not be taken to mean that the others in the group necessarily endorse the point. 6. Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health calls for an expeditious solution to the problem of WTO Members with insufficient or no manufacturing capacities in the pharmaceutical sector in making effective use of compulsory licensing under the

22 IP/C/W/363 Page 3 TRIPS Agreement. Some elements of the proposals appear to do this primarily by seeking to facilitate exports to Members with insufficient manufacturing capacities. These elements are listed in Section I of the paper, which deals in turn with issues of scope and coverage, conditions and legal mechanisms. Some other proposed elements appear to be directed primarily at overcoming problems of manufacturing capacity and market size so as to facilitate production under compulsory licences in countries with presently insufficient manufacturing capacity; these are listed in Section II. Of course, some of the proposals listed in Section I can also be of relevance to enhancing local capacity/market size and vice versa. In addition, a number of other proposals have been made which may be equally relevant to both of these concerns or are otherwise not easy to place; they are listed in Section III, entitled "Other Proposals"

23 I. MEASURES TO FACILITATE EXPORTS TO MEMBERS WITH INSUFFICIENT MANUFACTURING CAPACITIES A. SCOPE AND COVERAGE 1. Product coverage African group "Pharmaceutical products", which should be understood to include, medicines, related technical processes, and related technical equipment (IP/C/W/351). European Communities and their member States The product scope should be defined as pharmaceutical products needed to deal with public health problems afflicting many developing and least-developed countries, especially those resulting from HIV/AIDS, tuberculosis, malaria and other epidemics. It would cover patented pharmaceutical products and pharmaceutical products manufactured through a patented process (IP/C/W/352). United Arab Emirates Medicines and other public health-related products (statement). Group of developing countries The proposed solution envisages the export of patented public health-related products (IP/C/W/355). - In no way should the solution be limited to products meant to address diseases specifically mentioned in the Declaration (Argentina, Brazil). - Not just medicines but also active pharmaceutical substances and diagnostic kits; at the very least there should be constructive ambiguity on this issue. (Brazil). - Products required in those cases which national governments consider to be national emergencies should be included (Colombia). United States The solution should be confined to patented pharmaceuticals needed to address a public health problem, especially those resulting from HIV/AIDS, malaria and tuberculosis and other epidemics, afflicting a developing or least-developed country Member (IP/C/W/358). Others - Any type of patented medicine should qualify for measures taken under paragraph 6 (Norway). - The scope of the diseases should be limited to the ones in the Declaration (Japan).

24 IP/C/W/363 Page 5 2. Beneficiary importing Members (a) General eligibility African group Exports of necessary pharmaceutical products should be to any country, particularly developing and least developed Members, that needs support to address public health concerns (IP/C/W/351). Do not believe that the Doha Declaration excludes any Member but would respect choice of developed countries not to be included (Kenya). European Communities and their member States Members that would qualify for importing these products would be developing country Members, focusing especially on least developed country Members and low income Members, with no or insufficient domestic manufacturing capacity, or, in case that product is patented in that Member, no or insufficient manufacturing capacity other than that of the patent holder of the product in that Member (IP/C/W/352). United Arab Emirates Should take care of all developing countries with insufficient capacities to make effective use of compulsory licensing. Should be made available to all Members without further distinction or categorization of developing countries (IP/C/W/354). Group of developing countries Need not and should not be limited to a specific category of countries. In any event, developing countries, in particular least-developed countries, should certainly be among the main beneficiaries (IP/C/W/355). United States Those developing and least developed countries that are afflicted by public health problems, especially those resulting from HIV/AIDS, malaria and tuberculosis and other epidemics, and that have insufficient or no manufacturing capacities in the pharmaceutical sector (IP/C/W/358). Others - The high-income countries under the World Bank classification should not make use of a paragraph 6 solution (Switzerland).

25 (b) Importing countries where the product is not patented African group Members may take measures such as compulsory licences, parallel imports, other importation, and exportation where there are patents in force on the pharmaceutical products concerned as well as where there are no such patents, or where the TRIPS Agreement or the provisions on pharmaceutical patents are not yet in force (IP/C/W/351). European Communities and their member States Recognize that there could be cases where the product in question is not patented in the country of consumption and no special conditions are required to be applied in such a case (IP/C/W/352). The intention to request another Member to issue a licence should be notified to the WTO (statement). Group of developing countries The expeditious solutions envisaged by the TRIPS Council should also apply to countries where no patents exist (IP/C/W/355). United States If the needed pharmaceutical is not patented in the territory of the importing country, the proposed mechanism would apply where a request has been made by the importing Member to a developing or least-developed Member to manufacture and export the needed pharmaceutical to its territory (IP/C/W/358).

26 IP/C/W/363 Page 7 (c) Assessment of insufficient manufacturing capacity African group Limitations of small domestic markets should also be addressed (Kenya). European Communities and their member States It is up to each Member to determine whether it has sufficient manufacturing capacity but the TRIPS Council should ensure that this is done on the basis of objective criteria, perhaps looking at an indicative list of such criteria (statement). In assessing whether a country has insufficient manufacturing capacity, capacity held by the patent holder of the product in that Member should be excluded (IP/C/W/352). Group of developing countries Each Member shall have the right to determine whether it is in a situation of insufficient or no manufacturing capacity in the pharmaceutical sector (IP/C/W/355). - Assessment should be made product-by-product (Brazil). - Production capabilities in active substances and not just final pharmaceutical products should be taken into account (Brazil, Sri Lanka). - Assessment should not be limited to any one point in time as ability to manufacture is a dynamic concept (India). - Manufacturing capacity should not be viewed solely in terms of technological capability but should take into account economic feasibility and economies of scale (Malaysia). United States Members should establish a procedure to clarify which developing country members can be considered to have insufficient or no manufacturing capacity in the pharmaceutical sector or at least the factors to be taken into consideration. All least developed Members would be considered to have insufficient capacity in the pharmaceutical sector (IP/C/W/358). Others - The meaning of manufacturing capacities in the pharmaceutical sector should be limited to the scope of the diseases mentioned in the Declaration. A fact-finding survey should be conducted with regard to which countries faced difficulties on which diseases and with what level of seriousness, taking into account the patent status for the products in that country (Japan). - One has to make a concrete assessment of a given member's capacity to produce a specific drug as even if a Member has general production capacity it is not clear it would be able to adjust its production lines to produce the specific drug in sufficient time or expense (Norway). - Least-developed countries according to ECOSOC's annual list should qualify automatically as recipient countries without any further examination as to eligibility. For the rest, a case-bycase examination to decide whether a Member has sufficient manufacturing capacity is appropriate (Switzerland).

27 3. Eligible supplying Members African group No basis whatsoever in the Doha Declaration to limit the sources of supplies of pharmaceutical products to developing and least-developed countries (Kenya). Restricting supplying members to developing countries would narrow the options available to the people most in need of the medicines as not many developing countries have the capacity to export (Zimbabwe). European Communities and their member States No fixed views (statement). Group of developing countries No basis in the Doha Declaration to exclude developed countries from being sources of supply under a paragraph 6 solution and indeed, this may place significant restrictions on offers (Brazil). United States The mechanism shall operate to permit a developing county Member having sufficient manufacturing capacity in the pharmaceutical sector to export needed pharmaceuticals (IP/C/W/358). A solution could only provide or facilitate technology transfer to developing country Members if developed country Members were not included as exporters (statement). Others - Developing countries should be the suppliers, at least in cases where the money from the Global Fund is used to fight epidemics (Czech Republic). - If production capacity is simply not available in a developing country, a requesting country would have to have its medicines supplied by an industrialised country. A recipient country should be able to seek authorisation for more than one patented product with the same therapeutic effect and in more than one producing country at the same time if several countries are producing the medicines in question (Norway).

28 IP/C/W/363 Page 9 B. CONDITIONS 1. General considerations African group Any safeguards agreed to must not be costly, complicated, burdensome, inconsistent with available resources and development needs, and negate or undermine the envisaged solution and must be in accordance with the TRIPS Agreement (Kenya). European Communities and their member States There is the need to ensure that the necessary measures are taken to avoid abuses and trade diversion. Such measures should be reasonable in view of the complexity of the problems and the situations that may arise from the practical application of the proposed exception (IP/C/W/352). Group of developing countries It would be unacceptable to consider safeguards or conditions that would in any way limit either the flexibilities of Members under the TRIPS Agreement or the clarifications established in the Doha Ministerial Declaration on the TRIPS Agreement and Public Health. However, in line with the spirit of the "limited" exceptions in Article 30, Members may consider the possibility of establishing appropriate safeguards that would ensure legal predictability in this particular use of the provision, if such safeguards do not have the effect of undermining its practical use, or to prejudice the existing right of countries to use Article 30 of TRIPS in other circumstances (IP/C/W/355). United States The balance in the TRIPS Agreement and the Doha Declaration which recognize the importance of patents in providing incentives for new vaccines and medicines should be respected (Statement). Others - When drawing up conditions and safeguards the Council should not set stricter conditions for Members not possessing sufficient manufacturing capacity in the pharmaceutical sector than those set in Article 31 for those that have such an industrial base (Hungary).