1. Global Patent Debate K.Ravi Srinivas May 12-13, 2011

2. TRIPS AND ACCESS TO MEDICINES  Issues like CL, Flexibility in TRIPS dominated the debate  Issue was how to implement TRIPS  TRIPS Flexibility  Configuring TRIPS with development Policy  AIDS CRISIS- SOUTH AFRICA DOHA DECLARATION

3. Innovation Issues  Is Patent Regime the best incentive system  Non-Patent, Public Funded Interventions- Big Science as example  Incentivizng Innovation without relying on patents  Mix of various carrots and sticks for innovation

4. Innovation and Access  The 10/90 Gap and the dual issue of innovation but no access and access but expensive  Type I,II,III diseases and changing epidemiology disease- cardiovascular emerging as major killer, diabetes, cancer  Innovation + Access but can patent system ensure both

5. THE CIPIH Report& After  Highlighted the problems with current innovation regime under TRIPS but did not suggest radical solutions  Sensitized global community  IGWG Process – lots of studies, and discussions but money?  Identifying new mechanisms  Global issues and global solutions

6. PUSH&PULL Mechanisms  Developed to address deficiencies in current models  Studies on pros and cons of each mechanism  Most of them have not been tried or tried on limited scale (AMC, Orphan Drug)  Will they alone solve the critical issue of 10/90 Gap or will they be piece meal solutions  The unanswered question- choosing the best 20 from these to test further

7. Push &Pull Mechanisms  Implementing them in developing countries, LDCs  Identifying which works well for what  Limitations of using models like Orphan Drug Act when most countries don’t have Pharma R&D  AMCs, Prizes and Fund Proposals – who will fund and how

8. Push &Pull Mechanisms  Complementary mechanisms –are they feasible  Combining Licensing with push&pull  Using patent pools, liability regimes  But two big IFS  How do we know a priori that this will work  Are they sufficient to incentivize when the market is small and outcome is uncertain  Push&Pull necessary but not sufficient

9. The Other Options  Open Source- Open Innovation  Global R&D Networks that are funded and share the IP  Differential Pricing- Incentives to be given  Cost of clinical trials- share, subsidize or give tax credits  Drugs as Global Public Good

10. South-South  South-South can work but the barriers are many  South-South Industry dynamics and global market mechanisms- dilemmas for developing countries  Increasing North-South and less South-South  Can South goad the private sector in South

11. Are we groping in the dark  It seems to be so- lots of talk, some successful examples but lack of progress  Increasing cost of R&D and less return in terms of NCEs  Type I- more people in developing countries, less access- public health implications  So what can be done

12. Where do we go from here  The path ahead is not clear  because Doha Round is failing  WHO WGA may suggest solutions but money?  The unworkable Para 6 solution  Increasing costs, less no. of block busters  The limitations of relying on patents and markets and demand driven solutions  The yawning gap between access and affordability

13. Need for Finding Durable Solutions  Rethink innovation mechanisms  Drugs as public good- more public funding and more PP mode R&D  Identify right incentives, push and pull mechanisms  Better use of alternative licensing, public procurement  Global Action Plan is needed with better co- ordination and targets in funding  Combine patent pools, Open Source and encourage sharing by rewarding sharing

14. Can we do it  Yes, we can provided countries come together to fund R&D on a global basis  More South-South where relevant  Think beyond patents and TRIPS  Take this as a major challenge in view of demographic and epidemiologic transitions

15. Thanks  Comments to  ravisrinivas@ris.org.in ravisrinivas@ris.org.in