Ten Years of the Doha Declaration: The State of Implementation Geneva 14 November

Declaration on the TRIPS Agreement and Public Health, WT/MIN(01)/DEC/2 ‘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.’ 2

WIPO Conventions TRIPS flexibility: not to comply with WIPO Conventions beyond those required by TRIPS Some WTO accessions (including by LDCs) require the joining of additional WIPO Conventions including unspecified/all WIPO Conventions in Vanuatu’s accession, pm-4-6-meg?da=y. Some developed country FTAs eg EFTA (eg with Egypt), EU (eg leaked proposal to ASEAN), USFTAs require the joining of/complying with TRIPS+ Conventions including the PCT 3

Patentability standards TRIPS flexibility: defining patentability standards within Art 27 TRIPS Eg India’s s3(d) not inventions: ‘the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant;’ f%20Patent%20Office%20Practice%20and%20Procedure%20- %20html/Act/Section%203.htm US proposed text in TPPA: ‘the Parties confirm that: patents shall be available for any new forms, uses, or methods of using a known product; and a new form, use, or method of using a known product may satisfy the criteria for patentability, even if such invention does not result in the enhancement of the known efficacy of that product.’ 4

Patents on new uses TRIPS flexibility: not to have patents on new uses Some developed country FTAs eg EFTA (eg Korea), USFTAs (eg Morocco, US proposal in TPPA) require patents on new uses UN Special Rapporteur on the Right to Health: ‘Developing countries and LDCs should establish high patentability standards and provide for exclusions from patentability, such as new forms and new or second uses, and combinations, in order to address evergreening and facilitate generic entry of medicines.’ 12_en.pdf 5

Patents on diagnostic, surgical and therapeutic methods TRIPS flexibility: Art 27.3(a): can exclude from patentability: diagnostic, therapeutic and surgical methods for the treatment of humans or animals Some developed country FTAs eg USFTAs (eg US proposal in TPPA) require patents to be available for diagnostic, therapeutic, and surgical methods for the treatment of humans or animals. 6

Pre-grant patent opposition TRIPS flexibility: pre-grant patent opposition is allowed Some developed country FTAs eg USFTAs (eg Bahrain, Morocco, US proposal in TPPA) prohibit pre-grant patent opposition UN Special Rapporteur on the Right to Health: ‘Developing countries and LDCs should establish liberal pre-grant, post- grant opposition and revocation procedures, which can be taken advantage of by all concerned stakeholders, including patients’ groups.’ 7

Patent term extensions TRIPS flexibility: Art 33: 20 year patent terms are sufficient Some developed country FTAs eg EFTA (eg Chile, Korea), EU (eg proposal to ASEAN, India), US (eg CAFTA, US proposal in TPP) require patent term extensions beyond 20 years UN Special Rapporteur on the Right to Health: ‘Developing countries and LDCs should not introduce TRIPS-plus standards in their national laws. Developed countries should not encourage developing countries and LDCs to enter into TRIPS- plus FTAs’ 8

Compulsory licences TRIPS flexibility: compulsory licence grounds are not limited Reaffirmed in Doha Declaration on TRIPS and Public Health 5(b): ‘Each Member has the right to grant compulsory licences and the freedom to determine the grounds upon which such licences are granted’ Some FTAs such as US-Singapore restrict the situations in which compulsory licences can be used UN Special Rapporteur on the Right to Health: ‘Developing countries and LDCs need to incorporate in their national patent laws all possible grounds upon which compulsory licences, including government use, may be issued.’ 9

Parallel importation TRIPS flexibility: Art 6: parallel importation is permitted Reaffirmed in Doha Declaration on TRIPS and Public Health 5(d): ‘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 4.’ Some FTAs such as US-Morocco prevent parallel importation UN Special Rapporteur on the Right to Health ‘Developing countries and LDCs should adopt the principle of international exhaustion and provide for parallel importation with simplified procedures in their national laws.’ 10

Data protection TRIPS flexibility: Art 39.3: ‘Members, when requiring, as a condition of approving the marketing of pharmaceutical or of agricultural chemical products which utilize new chemical entities, the submission of undisclosed test or other data, the origination of which involves a considerable effort, shall protect such data against unfair commercial use.’ Some WTO accessions (eg Cambodia, Vanuatu in transition period), USFTAs (eg CAFTA), EFTA FTAs (eg Lebanon, Tunisia) and EU FTAs (eg proposals to ASEAN and India) require data exclusivity UN Special Rapporteur on the Right to Health: ‘Developing countries and LDCs should not introduce TRIPS-plus standards in their national laws. Developed countries should not encourage developing countries and LDCs to enter into TRIPS- plus FTAs’ 11

Linkage TRIPS flexibility: no requirement to provide linkage Some WTO accessions (eg Cambodia, Vanuatu during transition period) and FTAs eg US-CAFTA require linkage UN Special Rapporteur on the Right to Health: ‘Developing countries and LDCs should not introduce TRIPS-plus standards in their national laws. Developed countries should not encourage developing countries and LDCs to enter into TRIPS- plus FTAs’ 12

Enforcement eg border measures TRIPS flexibility: Art 51 only requires WTO Members to allow for suspension into free circulation when suspect importation of counterfeit trademark or pirated copyright goods Some FTAs eg EU proposals to ASEAN and India require suspension when suspect import, export, free warehouse of infringing patents (and other IP), EU-CARIFORUM EPA agree to collaborate to expand this to patents 13

Transition periods TRIPS flexibility: Art 66.1 LDC transition period: ‘The Council for TRIPS shall, upon duly motivated request by a least-developed country Member, accord extensions of this period.’ Doha Declaration on TRIPS and Public Health 7: ‘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.’ Vanuatu’s WTO accession: ‘Vanuatu confirmed that it would apply the Agreement on Trade-Related Intellectual Property Rights by no later than 1 December 2012‘ UN Special Rapporteur on the Right to Health ‘LDCs should make full use of the transition period’ 14

UNAIDS, UNDP, WHO: 2011 ‘UNAIDS, UNDP and WHO urge countries, where appropriate, to use the intellectual property and trade flexibilities set out in the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), and the Doha Declaration on the TRIPS agreement and public health, in order to reduce the price of HIV medicines and expand access to people most in need.’ ‘proposed bilateral and regional free trade agreements could limit the ability of developing countries to use the TRIPS flexibilities. Governments in both developed and developing countries should ensure that any free trade agreements comply with the Principles of the Doha Declaration.’ ressrelease/2011/ _PR_TRIPS_en.pdf

16 WHO’s Commission on Intellectual Property Rights, Innovation and Public Health: some relevant recommendations In bilateral trade negotiations, it is important that the provisions in the texts respect the principles of the Doha Declaration. Bilateral trade agreements should not seek to incorporate TRIPS-plus protection in ways that may reduce access to medicines in developing countries. Re data exclusivity: A public health justification should be required for data protection rules going beyond what is required by the TRIPS agreement. The Doha Declaration clarifies the right of governments to use compulsory licensing as a means of resolving tensions that may arise between public health and intellectual property, and to determine the grounds for using it. Developing countries should provide in their legislation for the use of compulsory licensing provisions, consistent with the TRIPS agreement, as one means to facilitate access to cheaper medicines through import or local production. ‘Public health Innovation and Intellectual Property Rights, April 2006

Recommendations from the UN Special Rapporteur on the Right to Health (Grover) ‘States need to take steps to facilitate the use of TRIPS flexibilities.’ ‘TRIPS and FTAs have had an adverse impact on prices and availability of medicines, making it difficult for countries to comply with their obligations to respect, protect, and fulfil the right to health.’

18 World Health Assembly resolutions Urged Member States to take into account in bilateral trade agreements the flexibilities contained in the Agreement on Trade-related Aspects of Intellectual Property Rights and recognized by the Declaration on the TRIPS Agreement and Public Health adopted by the WTO Ministerial Conference (Doha, 2001); WHA Resolution Urged Member States to consider, whenever necessary, adapting ‘national legislation in order to use to the full the flexibilities contained in the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS)’ WHA Resolution 56.27

Thank you 19