Download Technology Absorption and Capacity Development

Traditional Medicine and HIF:
Perspectives from India
New Delhi
May 12th and 13th 2011
Sachin Chaturvedi
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Innova P-2 Project
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We seek to develop a plan for amending the current
Intellectual Property Rights (IPR) regime for
rewarding pharmaceutical innovations
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The problems of the current IPR regime have become
obvious in light of the various health emergencies we
have faced in last several occasions
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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
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Our effort to take up the challenge focuses on a
potential two-tiered patent system, code-named
“Patent-2” scheme
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Patent-2 would be complementary to the existing
monopoly patents, leaving innovators free to choose a
patent of either kind.
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Patent-2 holders would not have veto powers over the
reproduction of their inventions (as is currently the
case).
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Thus allowing medicines to become available at
competitive market prices without delay
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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
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
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 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!!
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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
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-forperformance scheme for new pharmaceuticals.
• How to fit in TM?
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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)
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Peculiarities of TCM
Wood
Water
Metal
Fire
Earth
13
Peculiarities of TIM
• Vata
• Kapha
Akasha
Vayu
Prithvi
Aapa
(Sky/Air)
(Earth)
Teja (Fire)
• Pitta
14
Patent Status (Patwardhan et. al. 2005)
Database Ayurvedic TIM
Chinese TCM
Medicine
PubMed
1045
361
10,278
6,847
Science
Direct
USPTO
(applied)
87
77
990
612
26
-
259
-
-
195
-
USPTO
3
(granted)
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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 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.
Chaturvedi, RIS
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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.
Chaturvedi, RIS
18
National Policy and Regulation
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.
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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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