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Global System for Pathogen Material Access and Benefit Sharing: A Critical Analysis

Exploring the complexities of sharing pathogen materials, particularly in the case of Influenza (H5N1) in Indonesia in 2007, examining issues related to patents, property rights, and international obligations. The text analyzes the implications for innovation, access to vaccines, and the role of global institutions in promoting cooperation for global health challenges.

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Global System for Pathogen Material Access and Benefit Sharing: A Critical Analysis

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  1. Towards a global system foraccess and benefit sharingofpathogenmaterials IASC Governing pooled knowledge resources September, 2012 Rosa Castro

  2. Sharing pathogen materials The Influenza case (H5N1) Indonesia, 2007

  3. Avian Influenza H5N1 • Estimated pandemic risk of 65 million deaths • Majority of cases in Indonesia • Virus samples needed to develop vaccines, diagnostic kits and for surveillance purposes

  4. Indonesia’s refusal to share • No mandatory international obligations • Samples would be used by pharmaceutical companies with commercial purposes • Vaccines and medicines would be patented • No guarantee that Indonesia would have access to end-products

  5. Two important proprietary issues • Property over samples • Individual rights of donors • Sovereignty of states over their natural resources • Property over technologies (patents and other IP rights) • Patents and A2K

  6. Patents vs. accessa multi-level debate Trade-off between

  7. A “new” global challenge • Influenza preparedness • Access to samples

  8. Patents and access to upstream technologies The “domestic” debate

  9. Biotechnology patents • Patents on upstream technologies • Patents on end-products • Do patents hinder or foster innovation?

  10. Empirical evidence • Ignoring and infringing patents • Problems with publication delays • Problems with sharing biological materials (Material Transfer Agreements MTA’s)

  11. Policy challenges Sharing viruses and pathogens

  12. Property rights & Biological Materials • Influenza samples • MTA’s • Patents? • Property: caught between the commons or anti-commons?

  13. Open access and A2K • Favouring follow-on research • Effects on incentives for R&D activity • Is it enough? Biological materials • Bio-security concerns…

  14. Global rules and Institutions Obstacles or facilitators?

  15. TRIPS • Patent protection • Minimum harmonization • Flexibilities for implementation

  16. Convention on Biological Diversity CBD • Sovereignty over natural resources, biological material, genetic resources • Prior and informed consent PIC • Access and Benefit Sharing ABS

  17. WHO • International Health Regulations 2005 • Pandemic Influenza Preparedness Framework 2011

  18. PIP Framework • Not-binding text • Commitments to share • Commitments to enhance access • 2 Standard Material Transfer Agreements • Between country of origin and WHO (non-commercial) • Between WHO and external users (commercial)

  19. Options

  20. Global alternatives

  21. Comparing policy options

  22. Global health challenges

  23. Global Health Cooperation • Surveillance & Response for global threats • Sharing knowledge between scientific community • Incentives for cooperation

  24. Global Health • Multi-stakeholders; institutions, NGO’s, Industry, scientific community • Multiple issues: trade, health, human rights • Proliferation of institutions and initiatives in need of a coherent framework

  25. Concluding remarks • A system for biological materials? • Balancing incentives to innovate with access • Coherence of the system • Multiplication and fragmentation of GHG institutions

  26. " Shortly after a large-scale clinical trial in 1955, the first inactivated polio vaccine was being injected into tens of millions of people around the world … Asked why he had not obtained a patent on the phenomenally successful vaccine, Jonas Salk reportedly replied, 'that would be like patenting the sun.' ” Alan, Dove, J. Clin Investig 2002; 110:425-7.

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