An International Legal Framework for the Sharing of Pathogens: Issues and Challenges

Access to biological material with human pathogenic potential (pathogen materials) is important because research directed toward the development of new drugs and vaccines is dependent on scientific analysis of the underlying causes of disease. Member States of the World Health Organization (WHO) began to address problems associated with the sharing of pathogen materials when controversy arose in 2007 following Indonesia’s decision to withhold samples of biological material containing the H5N1 virus (avian flu) from WHO researchers.As a general proposition, states have sovereign rights of ownership and control over access to biological resources located within their territories and thus may determine the conditions of access to those resources. This includes ownership and control over access to pathogen materials. Sovereign control over pathogen materials and access to them is complicated by the fact that they have a tendency to spread geographically, and at some stage, to cross national borders in the absence of intentional human intervention. These sovereign rights, however, do not imply that the host state is not constrained by international legal obligations, such as the obligation to protect human rights related to life and health and the obligation to protect against harm to neighboring states. As a general proposition, states have sovereign rights of ownership and control over access to biological resources located within their territories and thus may determine the conditions of access to those resources. This includes ownership and control over access to pathogen materials. Sovereign control over pathogen materials and access to them is complicated by the fact that they have a tendency to spread geographically, and at some stage, to cross national borders in the absence of intentional human intervention. The ownership and control of pathogen materials are regulated at the international level by a set of norms involving: public international law, the Convention on Biological Diversity (CBD), the WHO Constitution and the International Health Regulations (IHR), the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and international human rights norms. Supplemental norms are under negotiation at the WHO (in the Intergovernmental Meeting on Pandemic Influenza Preparedness) under the CBD (in the Ad Hoc Open-Ended Working Group on Access and Benefit Sharing) and at the WTO (as part of the Doha Round). The reasons pathogen materials may, or may not, be subject to the regime established by the CBD are technically complex from a legal standpoint. Pathogen materials, as a general matter, probably are covered by the CBD, though this is not intended to suggest that the CBD is better equipped than the WHO to address the sharing of pathogen materials in the public health context, but rather addresses the existing or “default” legal situation. There is room for debate concerning whether the CBD, or at least its provisions on ABS, covers viruses, because of specific definitional language in the CBD. New rules related to pathogen materials sharing should most appropriately be negotiated at the WHO, because of the specific relationship to public health, which is most closely associated with the WHO charter. Protecting global health will require that countries share at least some categories of pathogen materials. An important element of the WHO negotiations is to define the availability of IPRs protection for the results of research and development. A negotiated framework must necessarily address the question of the extent to which recipients of such materials may apply for and obtain patents and/or the terms and conditions that will be applicable with respect to any patents obtained. Underlying the WHO negotiations is the question of affordable access to vaccines and treatments for developing countries, which is a presumed condition of a pathogen materials sharing obligation, at least among some WHO Member States. There is a real risk that the result will be a two-tiered system of access to pathogen materials: one addressing certain influenza viruses under the auspices of the WHO and another addressing pathogen materials more generally under the auspices of the ABS Protocol and/or the CBD. As a practical matter, subjecting states, economic operators and individuals to separate agreements covering the same subject matter may create confusion, particularly if the relationship between the agreements is not clearly specified and the rights and obligations are not in harmony. When public health interests are at stake, it is important to avoid a result that generates legal uncertainty and insecurity.Recognizing that negotiators at the WHO and the CBD are engaged in substantially independent and complex exercises each in their own right, greater attention should be focused on how the results of these exercises will relate to each other. Moreover, negotiators at the WHO should be cognizant of the fact that the current IGM-PIP negotiations are not taking place in a legal vacuum. This not only suggests that increased effort should be made to bring the current negotiations that address influenza viruses to a satisfactory conclusion, but also that these negotiations should be followed by a broadened effort to more generally address pathogen materials.