Public Health, Innovation and Intellectual Property Global strategy and Plan of Action

1. Public Health, Innovation and Intellectual PropertyGlobal strategy and Plan of Action Dr Gaudenz Silberschmidt, Vice-Director, Swiss Federal Office of Public Health Visiting Fellow, Global Health Policy Center Center for Strategic and International Studies IGWG process Gaudenz Silberschmidt, Switzerland

2. Historical background • 1997-2001 South Africa court case on HIV drugs • 2001 Doha declaration • 2003: World Health Assembly Resolution WHA 56.27 Intellectual property rights, innovation and public health: 2. REQUESTS the Director-General: (2) by the time of the 113th session of the Executive Board (January 2004), to establish the terms of reference for an appropriate time-limited body to collect data and proposals from the different actors involved and produce an analysis of intellectual property rights, innovation, and public health, including the question of appropriate funding and incentive mechanisms for the creation of new medicines and other products against diseases that disproportionately affect developing countries, and to submit a progress report to the Fifty-seventh World Health Assembly and a final report with concrete proposals to the Executive Board at its 115th session (January 2005); IGWG process Gaudenz Silberschmidt, Switzerland

3. Commission on Intellectual Property Rights, Innovation and Public Health CIPIH • Established in February 2004 • Chair Ruth Dreifuss, former Swiss President • 10 Commissioners appointed by WHO DG in their individual capacity and not as representatives of an institution or government. • WHO Executive board in Jan 2005 prolonged the mandate • Submitted in 3 April 2006 a 218 page report entitled:„Public health, innovation and intellectual property rights” • 60 recommendations for action IGWG process Gaudenz Silberschmidt, Switzerland

4. Resolution WHA59.24 Resolution WHA59.24 Public health, innovation, essential health research and intellectual property rights: towards a global strategy and plan of action • based on 2 draft from secretariat and from Brazil/ Kenya • welcomed the report of the CIPIH and established IGWG on PH, I, IP with the following mandate: • Draw up a draft global strategy (GS) and plan of action (PA) to provide a medium-term framework based on the CIPIH’s recommendations. Such GS and PA would aim at, inter alia, securing an enhanced and sustainable basis for needs-driven, essential health research and development relevant to diseases that disproportionately affect developing countries. • Submit the drafts of the GS and PA to the 61st World Health Assembly through the Executive Board IGWG process Gaudenz Silberschmidt, Switzerland

5. IGWG process (1/2) • Domestic and regional preparations • 1st session of IGWG (Geneva, 4-8 December 2006) → General discussion on the different elements of a PA and a GS (document of the secretariat not submitted to a negotiation process) • WHO EB Jan 2007: Joint proposal Kenya / Switzerland for resolution on early implementation of “low hanging fruits” • 60th WHA (May 2007): Resolution WHA60.30 encouraged the DG to guide the process (Brazilian proposal on incentive mechanisms that address the linkage between the cost of research and development and the price of health-care products) • August 2007: Draft GS and PA prepared by WHO Secretariat as a basis for negotiation at the 2nd session – regional consultations IGWG process Gaudenz Silberschmidt, Switzerland

6. IGWG process (2/2) • 2nd session of IGWG (Geneva, 5-10 November 2007): considered the draft GS and PA in 2 drafting groups (on strategy) and a subgroup (on plan of action). The session was suspended on 10 November 2007 • Additional meeting of the IGWG subgroup on the plan of action: 17-19 March 2008 • Informal meeting of the head negotiators, co-hosted by Brazil, Kenya, Norway, Switzerland and Thailand (19-20 March 2008), • 2nd resumed session of IGWG from 28 April to 3 May 2008 • Adoption of GS & PA at 61th WHA 19-24 May 2008:WHA 61.24 Global strategy and plan of action on public health, innovation and intellectual property IGWG process Gaudenz Silberschmidt, Switzerland

7. Global Strategy • Narrative section on the context, aim and focus of the strategy • 8 elements (with a list of specific actions to be taken): 1. Prioritizing research and development needs 2. Promoting research and development 3. Building and improving innovative capacity 4. Transfer of technology 5. Application and management of IP to contribute to innovation and promote public health 6. Improving delivery and access 7. Promoting sustainable financing mechanisms 8. Establishing monitoring and reporting systems IGWG process Gaudenz Silberschmidt, Switzerland

8. Plan of Action Matrix indicating: • Elements and sub-elements (concluded) • Specific actions (concluded) • Potential stakeholders (governments, WHO, other IO, pharmaceutical industry, research institutions, NGOs etc.) (nearly concluded) • Time frame (to be finalized by WHO until end of 2008) • Progress indicators (to be finalized by WHO until end of 2008) IGWG process Gaudenz Silberschmidt, Switzerland

9. Some key issues (1/3) • Complexity of innovation cycle (broad approach) • Strategy vs. Action • Legal status as “soft law” • Not mainly about IP, but also about IP • Role of WHO • Capacity building • Transfer of technology (research, development and production) • “diseases that disproportionately affect developing countries” OR “Type II and Type III diseases” and the needs of developing countries in relation to Type 1 diseases” IGWG process Gaudenz Silberschmidt, Switzerland

10. Some key issues (2/3) • Promote research • New complementary / alternative incentive schemes for R&D • Delivery & Access • Sustainable financing mechanisms • Traditional medicines • Link to human rights • Health system issues such as health care personnel • Implementation and Monitoring IGWG process Gaudenz Silberschmidt, Switzerland

11. Some key issues (3/3) • Different government sectors (health, foreign affairs, trade, IP, development, research, finance, etc.) • Role of experts • Role of NGOs • Role of industry • Aspects of the negotiation: • Importance of contacts outside the negotiation room • The last night • The negotiations on the resolution • Implementation IGWG process Gaudenz Silberschmidt, Switzerland

12. Upcoming challenges / Conclusions • Complete the action plan • WHO & IP • Implementation, implementation, implementation • Switzerland is working on a cross-government implementation plan for the WHO GS&PA on PHI • Policy coherence in national global health policies (e.g. Swiss Health Foreign Policy) • How to deal with differential prizing in emerging economies with legitimate markets and legitimate demands for access for the poor? • Links to challenges in pharmaceutical policies of industrialized countries (e.g. lack of research in antibiotic resistance) IGWG process Gaudenz Silberschmidt, Switzerland

13. www.atmindex.org IGWG process Gaudenz Silberschmidt, Switzerland