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World Health Organization 2011

This report identifies and analyses trends in the local production of medicines in developing countries and related technology transfer. The objective is to assist the World Health Organization (WHO) in its support for Member States in implementing the global strategy and plan of action on public health innovation and intellectual property with particular reference to the promotion of capacity-building for local production in developing countries. The methodology of research included interviews with a range of stakeholders, including industry actors, operators of product development partnerships (PDPs), government officials and members of public health advocacy groups; review of literature and Internet resources; and participation in meetings with stakeholder groups in Africa, Asia and Latin America.

This report makes a number of recommendations. These are focused mainly on the role that WHO, working in partnership with others, can take with respect to transfer of technology and local production of medicines in developing countries.

 

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Global Health Programme Working Paper No. 7/2011, November 15, 2011

In the decade since the Doha Declaration was adopted, significant progress has been made in addressing problems associated with innovation and access to medicines, including through expanded financial support for procurement and distribution of treatments and vaccines and the establishment of new research and development (R&D) mechanisms. There has been enhanced cooperation among WHO, WIPO and the WTO. Nevertheless, significant gaps remain in placing the development and supply of medicines to the world’s population on a sustainable footing; gaps that are exacerbated by the present trend toward restrained government spending. This paper reflects on the political and legal constellation making progress on global public health matters difficult, and on economic and scientific trends in the medicines sector that may affect policy over the next decade. A sustainable medicines supply system should proceed from “first principles”, encompassing financing mechanisms to assure that essential medicines are provided for all, while affording opportunity to countries at all levels of development to offer access to advanced treatments on a fair compensation basis. Improved mechanisms to incentive R&D are necessary and feasible. First principles should encompass rational prescribing based on the best interests of the patient, and should attend to regulation and enforcement adequate to assure quality, safety and efficacy. Development of a sustainable system could require some modification to the WTO TRIPS Agreement, but this should not be a determinative factor in considering an improved international framework. A new mechanism for global coordination of medicines strategy may be helpful.

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ICTSD Programme on IPRs and Sustainable Development, No. 30, October 2010

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.

North American Free Trade Agreement (1992)

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North American Free Trade Agreement, Dispute Settlement  

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North American Free Trade Agreement, Case Law

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Intellectual property, International Protection

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in THE GLOBAL FLOW OF INFORMATION: LEGAL, SOCIAL, AND CULTURAL PERSPECTIVE 175-189 (eds. R. Subramanian & E. Katz), New York Univ. Press, 2011

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New information technologies enable individuals in disparate locations to conduct cutting-edge research, to move that research into the development and testing of new medicines, to manufacture high-quality products, and to move those products to patients around the world. Conceptually, the world pharmaceuticals supply market may become increasingly competitive at all stages: basic research, product development, manufacturing and distribution. The diffusion of technological competence to major developing country actors in the pharmaceutical sector, such as India and China, as well as to more specialized actors such as Bangladesh (manufacturing) and Singapore (research), could result in a significant expansion of the pool of products available to treat disease, as well as more affordable prices to consumers.

This chapter argues that the emergence of wider competition in the quest for new products, the development of those products, and the improvement of production technologies and distribution to patients/end users are strongly in the welfare interest of the global public. It further argues that emerging market countries are not yet at the stage in which the application of competition law will adequately promote and protect domestic pharmaceutical companies. It recommends that emerging market countries adopt industrial policies designed to promote and protect their infant pharmaceutical supply sectors. It recognizes that the United States, among other OECD countries, significantly subsidizes and otherwise protects its pharmaceutical industry and that emerging market countries cannot realistically compete with the advantages presently held by OECD industries without adopting and implementing their own industrial policy measures.

Health Research for Action Final Report- Main Report, Vol. 1, 2009  

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Country Studies, Vol. 2, 2009 download here

The objectives of this study were: (a) to explore the possibilities of developing a harmonized, pro-public health regional (Caribbean) IP regulation and drug policy (to include generic drugs) framework; (b) to make recommendations on the promulgation/up-dating of IP legislation and regulation that will maximize TRIPS flexibilities while being TRIPS compliant; (c) to identify the requirements and process for establishing a regional negotiating platform for drugs; (d) to identify mechanisms for building/strengthening coalitions and negotiating positions at the WTO, and in bilateral and regional fora for ensuring access to drugs; and (e) to make recommendations on the adequacy of the systems in Member States for regulation of the pharmaceutical market to ensure the timely supply of safe, effective and quality medicines.