Pathogens Materials: coherence as an operational challenge for WHO, the CBD ABS regime and TRIPS

1. Pathogens Materials: coherence as an operational challenge for WHO, the CBD ABS regime and TRIPS Prof. Frederick M. Abbott WTO PUBLIC FORUM 2010  THE (ELUSIVE?) QUEST FOR COHERENCE IN GLOBAL NEGOTIATIONS AND NORMS: THE CASE OF THE TRIPS AGREEMENT AND THE CONVENTION ON BIOLOGICAL DIVERSITY (CBD) Organized by International Centre for Trade and Sustainable Development (ICTSD) September 17, 2010

2. The challenge to global governance • Sharing of biological materials with human pathogenic potential is necessary from a public health standpoint for the development of vaccines and therapeutic treatments • In some circumstances, e.g., threat of pandemic, prompt sharing critical to avoidance of widespread human suffering and destabilization of global economy and political environment • Probability of H5N1 pandemic may be low, but risk to human well-being practically incalculable • In other circumstances, e.g., emergence of pathogenic bacteria with limited transmission profile, promptness of sharing a less critical factor, but access to natural biological materials nonetheless essential to R&D

3. Multilateral institutional response inadequate • Multiyear negotiations within IGM-PIP framework at WHO remain stalled, and negotiating texts reflect relatively weak compromise positions on fundamental questions such as sharing obligations • Proposals regarding financing to address developing country equity and self-sufficiency concerns are not robust • Problems of addressing “the common good” through stakeholder-based negotiations difficult to overcome

4. Coherence problem emerges at late stage • Biological materials with pathogenic potential appear within technical scope of CBD subject matter (i.e., “biological resources”) • Definitional scope of “genetic materials”/genetic resources that are subject to access and benefit sharing obligations may exclude viruses due to lack of “functional” heredity • Prior CBD efforts to clarify exclusion of “human genetic resources” probably irrelevant • Problem manifests in ABS Working Group and Protocol negotiations

5. Draft ABS Protocol presents multiple problems of coherence for WHO PIP Working Group • Protocol a separate agreement from CBD • Protocol may exclude “human genetic resources” and/or “human pathogens” from its scope • Protocol may include provision addressing relationship with WHO treatment of “pathogens” or “genetic materials”, that may provide for a sharing obligation consistent with future WHO rules • But …

6. Multiple problems of coherence • If “human pathogens” and/or “human genetic resources” are excluded from the scope of the Protocol, they would likewise be excluded from the link to WHO rules, and nevertheless would remain subject to the CBD (even if in some cases, i.e. viruses, excluded from the ABS obligations) • How will biological materials with human pathogenic potential be treated by the ABS Protocol and CBD if there is no WHO agreement? Will they be subject to the International Health Regulation? • Assuming that two sets of agreements come into effect: will ABS Protocol serve as “gap filler” for WHO regime?

7. Patent issue coherence • WHO treatment of patenting virus genetic resources and derivatives remains unresolved • Some possibility for exclusion of patenting unmodified genetic resources, but treatment of derivatives remains contentious • Current ABS Protocol largely relies on national approaches to terms of ABS agreements, but extends obligations for certification of compliance by relevant patent offices • Some proposals for application of penalties • Assume arguendo completion of WHO PIP agreement and ABS Protocol: WHO solution would apply to pandemic influenza viruses but not to other materials potentially covered by CBD/ABS

8. Scope of parties and WTO • United States is not party to CBD and apparently may not be party to ABS Protocol • Country with the largest investments in biotechnology sector excluded from arrangements • United States prospectively is party to WHO solution • Parties to CBD apparently need not accept Protocol • None of the above addresses relationship to Doha negotiations regarding relationship between TRIPS Agreement and CBD

9. Conclusion and suggestion • Countries are negotiating toward potential multilateral legal swamp • The problem of access to pathogen materials is not likely helped by a legal regime of “constructive ambiguity” • WHO is more logical venue for negotiations on sharing of pathogen materials than CBD, but developing country voice at WHO not so well empowered, leaving CBD/ABS as attractive alternative • Countries should commit the subject of pathogen materials to a single forum and approach with a firm resolve to bridge differences in the interests of global public health, including appropriate interim measures