Access to Medicines and IPR Advocacy in China -- Review and initial SWOT discussion

1. 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

2. 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…）

3. 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

4. Locating advocacy Justification: why? Evaluation

5. Justification • 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 • 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 • Others…… • All second line ARV patented • Intermediate and API patented? What’s wrong and how to change?

6. 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: ARV

7. Who is advocating? International in China: MSF CAME Oxfam * TWN WHO Clinton Foundation UNAIDS UNDP UNTheme 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…

8. 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?

9. 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

10. 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

11. Tentative SWOT

12. Thanks!