Pandemic Influenza Preparedness. Vaccine Sharing. Robert Gatter Center for Health Law Studies

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1 Pandemic Influenza Preparedness and the Global Stalemate over Vaccine Sharing Robert Gatter Center for Health Law Studies Saint Louis University

2 GISN and Indonesia sprotests WHO member states share flu virus samples via Global Influenza Surveillance Network. Indonesia shares H5N1 samples in 2005, which are provided via GISN to private manufacturer that uses samples to develop and patent vaccine, which Indonesia cannot afford to purchase. In 2007 Indonesia refuses to share virus samples, claiming they are sovereign property. This triggers WHO process to create flu virus and vaccine sharing framework. Sources: Vezzani, Preliminary Remarks on Envisaged WHO Pandemic Influenza Preparedness Sources: Vezzani, Preliminary Remarks on Envisaged WHO Pandemic Influenza Preparedness Framework, J. World Intell. Prop. (2010); Sedyaningsih et al, Towards Mutual Trust, Transparency and Equity in Virus Sharing Mechanism: The Avian Influenza Case of Indonesia, 37 Ann Acad Med Singapore 482 (2008).

3 Intergovernmental Negotiations Consensus on -- importance of virus sharing; standard material transfer agreement; benefit sharing includes stockpiling antivirals, royalty free transfer of virus strains, aid in building vaccine manufacturing capacity, vaccine sharing, tiered pricing. Disagreement whether vaccine sharing a mandatory quid pro quo for virus sharing; IP rights for vaccine manufacturers. May 2010 WHO Health Assembly instructs Director General to facilitate resolution of differences. Sources: WHO, Pandemic Influenza Preparedness: Sharing of Influenza Viruses and Access to Vaccines and Other Benefits, Doc A63/4 (April ); Fidler, Netotiating Equitable Access to Influenza Vaccines, 7(5) PLoS Medicine e (2010); (May 21, 2010).

4 2009 H1N1 Confirms Inequities Developed nations purchase almost entire supply of pandemic vaccine through advance orders with drug manufacturers. Vaccine donations to other nations (including to Mexico) are too little and too late. - Pledged donations sufficient to serve only 2% of populations of f95 poorest countries. - No donated vaccine arrives until Feb/March 2010 after infections had peaked in Northern Hemisphere. Yet developing nations did not withhold H1N1 virus samples. Sources: Chan Chee Khoon, Equitable Access to Pandemic Flu Vaccines, Third World Network (March 31, 2010); Robert Roos, WHO: Pandemic Showed Limits of Vaccine Production Capacity, CIDRAP News (May 21, 2010); Fidler.

5 H1N1 Confirms Inadequacy of Production Capacity WHO s goal for vaccine production is supply sufficient to serve 2 billion people within 6 months of outbreak. For 2009 H1N1, global vaccine supply reached 1.35 billion doses after 12 months. Sources: WHO, Global Pandemic Influenza Action Plan to Increase Vaccine Supply, WHO/IVBB/06.13, page 7 (Sept 2006); Partridge & Kieny, Global Production of Seasonal and Pandemic (H1N1) Influenza Vaccines in and Comparison with Previous Estimates and Global Action Plan Targets, 28 Vaccine 4709 (2010).

6 Inequities in Production Location Vaccine production capacity almost entirely in developed nations; 80% of H1N1 vaccine produced by manufacturers in seven most industrialized countries. New production facilities coming online in 9 new countries (e.g., Brazil, Mexico, Indonesia) Australian vaccine manufacturer pressured to fill Australia s orders in full before filling orders of any other country; Canada places vaccine orders with Canadian manufacturer only. Sources: Partridge and Kieny; Fidler.

8 Other Related Developments U.S. calls for re-engineering engineering pandemic influenza vaccine production to speed availability and calls for improvements in international surveillance of human influenza and virus sharing. UN Hanoi Declaration calls for greater surveillance of animal health especially in developing countries among small-scale poultry farms so as to protect against risks of pandemic influenza. Sources: PCAST, Report to the President on Reengineering the Influenza Vaccine Production Enterprise to Meet the Challenges of Pandemic Influenza (August 2010); UN and World Bank, Animal and Pandemic Influenza: A Framework for Sustaining Momentum, Chapter 3 (July 2010).

9 Conclusions Surveillance and virus sharing never more important H1N1 shows inadequacy of voluntary vaccine sharing International efforts must combine human and animal surveillance especially in developing nations where small-scale farming is common. Ongoing expansion of global pandemic vaccine production capacity and demand for flu vaccine only a long-term solution. To assure international cooperation in virus sharing some form To assure international cooperation in virus sharing, some form of mandatory sharing of pandemic vaccine in a timely manner is needed.

Brief history of the development of the Framework on Sharing influenza viruses and access to vaccines and other benefits

Brief history of the development of the Framework on Sharing influenza viruses and access to vaccines and other benefits The Intergovernmental (IGM) Process Since the late 1940's, WHO has coordinated a