IASC Governing pooled knowledge resources September, 2012 Rosa Castro Towards a global system for access and benefit sharing of pathogen materials.

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Presentation transcript:

IASC Governing pooled knowledge resources September, 2012 Rosa Castro Towards a global system for access and benefit sharing of pathogen materials

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. access a multi-level debate Trade-off between patentsaccess Incentives to innovate Access to innovation

A “new” global challenge Influenza preparedness Access to samples

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)

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…

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)

Options InformationMaterials Open accessNo patentsFree availability CommonsPatents/licensing possible Microbial/Virus Commons Property rulePatent protectionMTA’s Liability ruleCompulsory licensingCompulsory access

Global alternatives SystemWho has access to materials? Access to end products? Institution Public domainAll, but industrialized countries are advantaged Market-basedDefault regime Before CBD Before WHO 2011 Joint ownership/ Limited public domain/ Commons pool (default rule) All, but industrialized countries are advantaged Subject to MTA Different for members and non-members ITPGR Microbial commons Sovereignty Access and sharing All at ABS conditionsEquitable access for developing countries CBD PIP Framework

Comparing policy options Policy optionBenefitsCostsInstitutions involved Working within IP system No policy change needed ABS not guaranteed WTO Contracts (MTA’s) Reforming current IP system ABS could be included Policy change needed WTO-CBD WHO

Global health challenges

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.