Local Pharmaceutical Production in Africa International Conference Cape Town, 4-6 April 2011 IPRs and Public Health: Lessons Learned Current Challenges The Way Forward Roger Kampf WTO Secretariat 1 Acknowledging that IPRs interact with public health at all levels Intellectual Property Rights Individual deals, projects, partnerships Policies & strategies for IP management at institutional level National policy settings for public-funded / public-interest research National legal framework & innovation policy International legal framework & cooperation 1
Where Do We Come From: the Interface between IPRs and Public Health Since last decade: Increased attention paid to impact of IPRs on innovation of and access to medicines Moved to centre of cross-cutting debate between separate policies TRIPS-related issues: IPR as an important factor for development of new medicines, but: concerns expressed about effect on prices Importance of flexibilities recognized, but: need to preserve balance of rights and obligations TRIPS as part of wider national and international action to address health problems Addressed at various levels: International organizations (WHO, WTO, WIPO, etc.) recognition of importance of cooperation Free Trade Agreements Domestically The Starting Point: Key TRIPS Provisions Objectives and principles balanced approach, adapted to domestic policy objectives Patents a range of flexibilities: Definition of patentable subject-matter Optional exclusions Disclosure requirements Permissible exceptions, including for experimental use and regulatory review purposes Compulsory licensing Exhaustion - national vs. international, freedom to choose Test data protection is mandatory, but how to protect is not prescribed Enforcement links to public health Transition periods for LDCs 2013 in general, 2016 in pharmaceutical sector 4 2
The Turning Point: Doha Declaration General statements: TRIPS Agreement does not and should not prevent Members from taking measures to protect public health. TRIPS can and should be interpreted and implemented in a manner supportive of Members right to protect public health and, in particular, to promote access to medicines for all Clarification of: compulsory licences: right to grant, freedom to determine grounds emergency situations: right to determine what constitutes a national emergency of other circumstance of extreme urgency exhaustion: freedom to establish own regime What the Doha Declaration Achieved Shaped framework for multilateral cooperation on IP and public health Supports governments to make use of TRIPS flexibilities Contributed to lower prices for certain medicines (first-line ARVs) Reinforced understanding that TRIPS supports a balanced and flexible IP framework responsive to broader policy agenda Led to adoption of Paragraph 6 System Extended LDC transition period 3
Paragraph 6: Identifying the Issue Members can issue compulsory licences for importation / domestic production Availability of supply from generic producers in third countries? Art. 31(f) requires production under compulsory licenses "predominantly for the supply of the domestic market of the Member Concern: countries with important generic industry obliged to provide full patent protection for pharma products since 2005 Need to address legal problem resulting from Art.31(f) conditions in exporting Member Paragraph 6: Proposing a Solution Removes a specific legal obstacle Consists of three derogations from: Art.31(f) for exporting Members, subject to conditions on transparency and safeguards Art.31(h) for importing Members provided paid in exporting Member on same products Art.31(f) for any LDC or developing country party to RTA where at least half are LDCs and share health problem in question Adopted in the light of General Council Chairman s statements Setting out several key shared understandings of Members on interpretation and implementation of the system 4
Remember: Paragraph 6 Is an additional flexibility made available to Members Addresses a health problem in the importing country and a legal problem in the exporting country Is applicable to narrowly defined situations Para.6 was never designed to and will never address all problems in the field of public health Facilitates imports of medicines produced under compulsory licence elsewhere Para.6 is primarily not about local production Has been used once so far Growing importance as full patent protection for pharmaceutical products is put in place in major exporting countries? Is it producing the expected results? Debate in TRIPS Council: narrow and broader aspects 9 Looking at the Broader Picture (1) Access to information about IPR status: Why: to determine freedom to operate in research and development and to design access and business strategies (e.g. R&D, tech transfer, production, procurement, etc.) What: information about specific technologies and products, specific markets, right holders, legal status of IPRs Who: important for key stakeholders, including policy makers, research institutions, business, procurement agencies, etc. Challenges: Easy access to reliable sources, providing regularly updated information Limited resources and lack of expertise Interdepartmental cooperation Language barriers 10 5
Looking at the Broader Picture (2) Other key factors which have been identified next to IPRs: Funding Partnerships Pricing (including transparency mechanisms) procurement practices Competition policies Taxes, tariffs and mark-ups Quality, safety and efficacy Available data: which, who and where 11 Local Production: Key IPR Aspects Compare national law & international obligations Consider TRIPS flexibilities Transition periods Licensing & Para.6 Syst. Determine IP policy & strategy on innovation & production Local Produc tion Analyse patent status Access to reliable data Cooperation Capacity 12 6
The WTO s Contribution Making available a forum for debate upon request by Members Examples: annual review of Paragraph 6 System; review of incentives to transfer technology (Art.66.2); enforcement trends Awareness raising Example: tailor-made regional and national workshops Provision of factual / technical information Individual requests Symposia Solving disputes Example: WT/DS114/R Note: WTO Secretariat has no mandate to interpret TRIPS provisions or to assess use of TRIPS flexibilities Lessons Learned & Way Forward (1) Need to ensure optimal outcomes within given policy space Shaped in part by IPR regime and IP management strategies IPRs cannot be considered in isolation They are to be treated as part of a much bigger puzzle Need to bear overall objective in mind = bringing medicines to patients Use of TRIPS flexibilities should not become an end in itself TRIPS implementation and use is not a mere transcript of provisions into national law Each country needs to reflect on contribution to domestic policy objectives (in particular social, economic and developmental) and, on that basis, decide on most appropriate approach Selected country experiences 14 7
Lessons Learned & Way Forward (2) More factual and technical information required in order to determine innovation and access policies and strategies Facilitate access to existing data Gather new data Coherence, cooperation and dialogue required at all levels to effectively respond to public health challenges and to practical needs: Multilateral: Doha Declaration as a benchmark and landmark reference point also for WHO (e.g. GSPOA) and WIPO (e.g. Development Agenda) Towards and effective and complementary partnership - trilateral process, symposia and beyond Regional: Make better use of scarce resources Domestic: Respond to multiple challenges (legislative changes, competent trade/ip/health authorities, participation in international bodies) Involve all relevant government departments and private sector 15 Some References WTO Webpage dedicated to public health: http://www.wto.org/english/tratop_e/trips_e/pharmpatent_e. htm Basic introduction to TRIPS and pharmaceuticals, including patents and compulsory licensing Information regarding Paragraph 6 System, including notifications received, how to accept the Protocol, status of acceptances and national implementing legislation WTO Webpage dedicated to LDC needs assessment: http://www.wto.org/english/tratop_e/trips_e/ldc_e.htm Doha Declaration on TRIPS and Public Health (WT/MIN(01)/DEC/2) Implementation of paragraph 6 of the Doha Declaration on TRIPS and Public Health (WT/L/540 and Corr.1) Protocol Amending the TRIPS Agreement (WT/L/641) Extension of transition period for LDCs with respect to pharmaceutical products (IP/C/25) General extension of transition period for LDCs (IP/C/40) 16 8