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Towards a global system for access and benefit sharing of pathogen materials. IASC Governing pooled knowledge resources September, 2012 Rosa Castro . Sharing pathogen materials. The Influenza case (H5N1) Indonesia, 2007. Avian Influenza H5N1.
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Towards a global system foraccess and benefit sharingofpathogenmaterials IASC Governing pooled knowledge resources September, 2012 Rosa Castro
Sharing pathogen materials The Influenza case (H5N1) Indonesia, 2007
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
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
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
Patents vs. accessa multi-level debate Trade-off between
A “new” global challenge • Influenza preparedness • Access to samples
Patents and access to upstream technologies The “domestic” debate
Biotechnology patents • Patents on upstream technologies • Patents on end-products • Do patents hinder or foster innovation?
Empirical evidence • Ignoring and infringing patents • Problems with publication delays • Problems with sharing biological materials (Material Transfer Agreements MTA’s)
Policy challenges Sharing viruses and pathogens
Property rights & Biological Materials • Influenza samples • MTA’s • Patents? • Property: caught between the commons or anti-commons?
Open access and A2K • Favouring follow-on research • Effects on incentives for R&D activity • Is it enough? Biological materials • Bio-security concerns…
Global rules and Institutions Obstacles or facilitators?
TRIPS • Patent protection • Minimum harmonization • Flexibilities for implementation
Convention on Biological Diversity CBD • Sovereignty over natural resources, biological material, genetic resources • Prior and informed consent PIC • Access and Benefit Sharing ABS
WHO • International Health Regulations 2005 • Pandemic Influenza Preparedness Framework 2011
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)
Global Health Cooperation • Surveillance & Response for global threats • Sharing knowledge between scientific community • Incentives for cooperation
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
Concluding remarks • A system for biological materials? • Balancing incentives to innovate with access • Coherence of the system • Multiplication and fragmentation of GHG institutions
" 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.