IASCGoverning pooled knowledge resources

September, 2012

Rosa Castro

Towards a global system for access and benefit sharing of pathogen

materials

Sharing pathogen materials

The Influenza case (H5N1) Indonesia, 2007

Avian Influenza H5N1Estimated pandemic risk of 65

million deathsMajority of cases in IndonesiaVirus samples needed to develop

vaccines, diagnostic kits and for surveillance purposes

Indonesia’s refusal to shareNo mandatory international obligationsSamples 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

technologiesThe “domestic” debate

Biotechnology patentsPatents on upstream technologies

Patents on end-products

Do patents hinder or foster innovation?

Empirical evidence

Ignoring and infringing patentsProblems with publication

delaysProblems 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 A2KFavouring follow-on researchEffects on incentives for R&D

activity Is it enough? Biological materialsBio-security concerns…

Global rules and Institutions

Obstacles or facilitators?

TRIPSPatent protection Minimum harmonizationFlexibilities for implementation

Convention on Biological Diversity CBD

Sovereignty over natural resources, biological material, genetic resources

Prior and informed consent PICAccess and Benefit Sharing ABS

WHOInternational Health Regulations

2005Pandemic Influenza Preparedness

Framework 2011

PIP FrameworkNot-binding textCommitments to shareCommitments to enhance access2 Standard Material Transfer Agreements

Between country of origin and WHO (non-commercial)

Between WHO and external users (commercial)

OptionsInformation Materials

Open access No patents Free availabilityCommons Patents/licensing

possibleMicrobial/Virus Commons

Property rule Patent protection MTA’s

Liability rule Compulsory licensing

Compulsory access

Global alternativesSystem Who has

access to materials?

Access to end products?

Institution

Public domain All, but industrialized countries are advantaged

Market-based Default regime Before CBDBefore WHO 2011

Joint ownership/Limited public domain/Commons pool(default rule)

All, but industrialized countries are advantaged

•Subject to MTA•Different for membersand non-members

ITPGRMicrobial commons

Sovereignty Access and sharing

All at ABS conditions

Equitable access for developing countries

CBDPIP Framework

Comparing policy options

Policy option Benefits Costs Institutions involved

Working within IP system

No policy change needed

ABS not guaranteed

WTOContracts (MTA’s)

Reforming current IP system

ABS could be included

Policy change needed

WTO-CBDWHO

Global health challenges

Global Health CooperationSurveillance & Response for global

threatsSharing knowledge between scientific

communityIncentives for cooperation

Global Health Multi-stakeholders; institutions, NGO’s,

Industry, scientific communityMultiple issues: trade, health, human

rightsProliferation of institutions and initiatives

in need of a coherent framework

Concluding remarksA system for biological materials?

Balancing incentives to innovate with accessCoherence 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.