Traditional Medicine and HIF:Perspectives from India

New Delhi

May 12th and 13th 2011

Sachin Chaturvedi1

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.

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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

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)

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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.

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Objectives of the Project

3 Provide a

reality check

and

obtain support

for the new system from the world’s two most powerful

developing/emerging country actors (India and China).

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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.

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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).

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CASTED – RIS Consultations: May 2009China –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

Idea of HIF

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Idea of HIF

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How to Move towards TM Fund!!

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Peculiarities of TCM

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Peculiarities of TIM

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Patent Status (Patwardhan et. al. 2005)

Database Ayurvedic TIM Chinese Medicine

TCM

PubMed 1045 361 10,278 6,847

Science Direct

87 77 990 612

USPTO (applied)

26 - 259 -

USPTO (granted)

3 - 195 -

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TM: Key issues

• National Policy and Regulation • Safety, Efficacy and Quality• Access: Main Streaming

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National Policy and RegulationJoint 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

National Policy and RegulationJoint 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

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

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Main Message from the Report

• National Policy • Regulation • Safety, Efficacy and Quality• Access• Main Streaming• Need for International Initiatives

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