access to medicines and ipr advocacy in china -- review and initial swot discussion
DESCRIPTION
Access to Medicines and IPR Advocacy in China -- Review and initial SWOT discussion. Hu Yuanqiong China Access to Medicines Research Group OSF Seminar Bangkok; 2011.12.13. Context. International MSF launched campaign in 1999 Major players: WHO, Clinton Foundation, TWN, HAI, ITPC… - PowerPoint PPT PresentationTRANSCRIPT
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Hu YuanqiongChina Access to Medicines Research Group
OSF Seminar Bangkok; 2011.12.13
Access to Medicines and IPR Advocacy in China
-- Review and initial SWOT discussion
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Context International
◦ MSF launched campaign in 1999
◦ Major players: WHO, Clinton Foundation, TWN, HAI, ITPC…
◦ Local groups in developing countries: South Africa, Brazil, India, Thailand…
◦ Spotlight: ARV
National◦ 2003, Chinese
government launched national ARV treatment program, first revealed access issues
◦ Major players: INGOs, UN Agencies, local PHA groups
◦ Spotlight: ARV ( 3TC, TDF, EFV, LPV… )
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Context National law in nutshell
◦ Patent law Started product patent on medicine from 1992 WTO accession in 2001, no transition time to implement TRIPS Flexibilities in law: CL, government use, Bolar exception,
parallel import… Patentability: combination, formulation, new form, new use Opposition/Invalidation: rare between MNC and generic
◦ Drug regulatory Proxy exclusive rights: administrative protection… Data exclusivity: 6 years, not in force Linkage: non-infringement claim, start changing in practice Fast track registration: ARVs, national emergency
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Evaluation
Goal: what?Goal: what?
Subject: who is advocating?
Subject: who is advocating?
Target: advocate to whom?
Target: advocate to whom?Content: what?Content: what?Approach: how?Approach: how?
Justification: why?Justification: why?Locating advocacy
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Justification
Lamivudine:•1990 process patent, no product patent •thick layers of proxy exclusive protection • HIV formulation no marketing •GSK donation to gov •Supply unstable •2007 process patent due, GSK warning •2009 generic registered, no production •2010 generic invalidation won, 4 months margin
TDF:•2006, more than 5000 Chinese PHA opposition •2007 , TDF and pre-drug patented in China•2006 , Brazilian and Indian PHA opposition•2008 and 2009,TDF patent rejected in Brazil and India
Others……•All second line ARV patented •Intermediate and API patented?
What’s wrong and how to change?
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Goal Sustainable access
to affordable, reliable, stable supplied essential medicines
Prioritize health in public policies and laws
Scope of advocacy determined by objective and expertise:
Quality control
Supply chain
IPR policy
Pricing
Essential medicines
ARV
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Who is advocating? International in China:
◦ MSF CAME◦ Oxfam *◦ TWN◦ WHO◦ Clinton Foundation◦ UNAIDS◦ UNDP◦ UN Theme group – Sub-
working group ◦ DFID *
National: ◦ ITPC-China◦ AIDS Care China◦ Ark of Love◦ Mangrove◦ Aizhixing◦ Yirenping◦ China Global Fund Watch
Initiative◦ Shanghai Beautiful Life◦ China Access to Medicines
Research Group◦ Grass roots PHA groups…
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Key messaging
Maximizing patent flexibility in law◦ Expanding CL grounds ◦ Balancing protection on patent holder and
licensee Utilizing patent flexibility for public health
◦ ARV as potential breakthrough ◦ Feasibility of CL and non-commercial use◦ Patentability discussion – which is suitable?
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Target and Approaches
Target: Government – MOH, MofCom, SIPO, SFDA
Approaches: ◦ Law review, comments ◦ Civil motion to NPC ◦ Ally with academic & gov think tank
Examples: ◦ CL motion ◦ Patent law, CL rules revision
comments ◦ MOH submission
Target: MNC Approaches:
◦ Price Negotiation ◦ Patent opposition ◦ Boycott campaign
Examples: ◦ EFV negotiation with Merk
(ACA)◦ TDF opposition ◦ 2007 Abbott boycott
Crosscutting approaches: ◦ Seminar, workshop (international, national)
◦ Research (joint), translation, information sharing, publication◦ Network building and maintaining
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Evaluation Raising issue?
◦ Gov increased use of language (CL, public interest…)◦ Gov – NGO intercourse in law making started shifting ◦ Informal intellectual network set, incl. media ally◦ Law and policy progress in paper
Setting agenda? ◦ Drug based, issue based◦ Face-to-face lobby based ◦ Opportunistic, individual
Actual change? ◦ No actual breakthrough in using flexibility
Sensitive to external change? ◦ Little done on new phenomena of FTA, ACTA, IMPACT…◦ Little done on innovation discussion
All stakeholders engagement?◦ not enough strategic engagement with generic companies
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Tentative SWOT Strength: -Existing intellectual network -Experiences with ARV advocacy -Potential technical allies with patent practitioners -Right political will in SIPO and SFDA -Developing civil society culture -Regional and international NGO network
Weakness:-Local knowledge building and research -Transparent and collaborative NGO culture in making -Civil society and capacity in developing -MOH not on board -Local linking to regional & international -Restricted to ARV -Public engagement low
Opportunities:
-Health reform -Global Fund phase out ?-Continued IP network engagement -Evolving civil society -Power of new media -Increasing local industry awareness -Positive research ally and advocate
Threats:-Corruption and non-transparent policy making -Access to information and data -Freedom of speech and assembly -Overwhelmed pro-WTO/IP phenomena -NGO policy in general -Global financial crisis
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Thanks!