1. Traditional Medicine and HIF: Perspectives from India New Delhi May 12 th and 13 th 2011 Sachin Chaturvedi 1

2. Innova P-2 Project -We seek to develop a plan for amending the current Intellectual Property Rights (IPR) regime for rewarding pharmaceutical innovations -The problems of the current IPR regime have become obvious in light of the various health emergencies we have faced in last several occasions -This is a challenge that lies at the heart of biomedical ethics striving for sustainable world development. 2

3. Innova P-2 Project -Our effort to take up the challenge focuses on a potential two-tiered patent system, code-named “Patent-2” scheme -Patent-2 would be complementary to the existing monopoly patents, leaving innovators free to choose a patent of either kind. -Patent-2 holders would not have veto powers over the reproduction of their inventions (as is currently the case). - Thus allowing medicines to become available at competitive market prices without delay 3

4. Innova P-2 Project Patent-2 holders would instead be rewarded out of public funds in proportion to the impact of their invention on the global burden of disease (GBD) 4

5. Objectives of the Project 1 Advance knowledge and ethical insight into reform plans for the current IPR system 2 Finalise an existing plan to amend the current IPR system in the area of pharmaceutical innovation. 4 Promote urgent policy developments on IPR by forging a consensus for the new system and providing a policy action plan. 5

6. Objectives of the Project 3Provide a reality check and obtain support for the new system from the world’s two most powerful developing/emerging country actors (India and China). 6

7. Reality Check: Deliverables D3.1 Protective mechanism (against gaming, corruption), internal report delivering suggestions for reducing the chances of corruption. Month 15. D3.2 Report on possible alignment of Innova-P2 goals with related Indian and Chinese WTO-work. Month 22. D3.3 Reform Plan – Report on common policy ground between India and China on TRIPS reform plan. Month 30. 7

8. CASTED – RIS Consultations Common perspectives on several of these issues. Informal consultations in Delhi (2007 ) and Oslo (2008). Detailed Consultations in Beijing in May (2009) and August (2009). 8

9. CASTED – RIS Consultations: May 2009 China –India are important stakeholders in the realm of TM and that China, with traditional Chinese medicine (TCM) India with traditional Indian medicine (TIM) have major public issues for promoting utilisation of traditional medicine Formation of a China-India Traditional Medicine Health Impact Initiative(CITHII) Global regimes related to drug standards and IP standards, which may be linked with ongoing debates at WTO and WHO The question is how to move forward!! 9

10. Idea of HIF Any firm receiving marketing approval for a new medicine would be offered a choice between (a) exercising its usual patent rights through high prices or (b) registering its product with the HIF. Registration would require the firm to sell its product worldwide at an administered price near the average cost of production and distribution. The HIF seeks to reward any new medicine, if priced at cost, on the basis of its global health impact. 10

11. Idea of HIF In exchange, the firm would receive from the HIF a stream of payments based on the assessed global health impact of its drug. The HIF is, in other words, an optional pay-for- performance scheme for new pharmaceuticals. How to fit in TM? 11

12. How to Move towards TM Fund!! Can we use HIF Indicators First Mile Problem: Focus on TM as an essential medicine alternative Performance Indicators like Patient usage data; clinical trials data China-India Traditional Medicine Health Impact Initiative (CITHII) 12

13. WoodFireEarthMetalWater Peculiarities of TCM 13

14. Peculiarities of TIM Pitta KaphaVata Akasha Vayu (Sky/Air) Prithvi Aapa (Earth) Teja (Fire) 14

15. Patent Status (Patwardhan et. al. 2005) DatabaseAyurvedicTIMChinese Medicine TCM PubMed104536110,2786,847 Science Direct 8777990612 USPTO (applied) 26-259- USPTO (granted) 3-195- 15

16. TM: Key issues National Policy and Regulation Safety, Efficacy and Quality Access: Main Streaming 16

17. National Policy and Regulation Joint Approach on Standards and Clinical Trials Developing joint approach to standards and clinical trials will benefit both countries. Both countries can work with ISO in them and this will be very relevant for developing global standards for various traditional medicinal systems. Besides this such a joint approach will pave way for more co-operation and capacity building in TM sector in both countries. 17Chaturvedi, RIS

18. National Policy and Regulation Joint Approach on Standards and Clinical Trials Needs and requirements of TM system are more of standardization and development of objective tests. Keeping the basic premise of distributing rewards on the basis of the impact of a drug on human health, the system may have to amplify its scope to include development of objective technical standards (pharmacopoeia) in the traditional medicine system. as safe and effective for use under the conditions prescribed, recommended or suggested. Labelling may be one way to address this. 18Chaturvedi, RIS

19. Joint Approach on IP While in the case of modern medicine perhaps IP plays a very crucial role in promoting innovation, it may not be the case in the field of traditional medicine. The two countries need to work jointly in the regulatory and IP related areas that are essential to augment the use of traditional medicines in these two countries. National Policy and Regulation 19

20. Main Message from the Report National Policy Regulation Safety, Efficacy and Quality Access Main Streaming Need for International Initiatives 20