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

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… ）

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

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

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?

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

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…

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?

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

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

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

Thanks!