American Journal of Law & Medicine

Intellectual property and development at WHO and WIPO.(World Health Organization, World Intellectual Property Organization)

I. INTRODUCTION

Recent activity at major intergovernmental organizations reflects a renewed emphasis on making the international intellectual property system work to foster global health in developing countries. The World Intellectual Property Organization (1) ("WIPO") recently approved a historic "Development Agenda"--a wide-ranging set of reforms that reorients WIPO towards development and reconfigures how the organization makes policy, provides technical assistance, and is administered. (2) Such an initiative may seem natural for the only inter-governmental organization (IGO) that is focused primarily on intellectual property, but such reforms are not restricted to WIPO. The World Health Organization (3) ("WHO") has launched its own development agenda of sorts--an Intergovernmental Working Group on Public Health, Innovation and Intellectual Property ("IGWG") that is tasked with preparing "a global strategy and plan of action" aimed at "securing an enhanced and sustainable basis for needs-driven, essential health research and development relevant to diseases that disproportionately affect developing countries, proposing clear objectives and priorities for research and development, and estimating funding needs in this area." (4) Several other IGOs have implemented programs designed to help developing countries build capacity to meet their intellectual property obligations in a way that fosters public health and access to medicines in those countries. (5)

In Part II of this Article, I describe these initiatives with particular emphasis on the proposals that have been approved or (in the case of the WHO working group) upon which Member states have reached consensus. In Part III, I compare the initiatives and examine how they might be expected to facilitate collaboration between the two IGOs. In Part IV, I pose some questions prompted by the diversity and ambition of the proposals that make up the initiatives. For example, given the institutional missions and commonly understood core competencies of the IGOs that have implemented these initiatives, how can they be expected interact, overlap, and/or conflict, and how might they be modified so that they build on each other? Can these initiatives be expected to improve access to medicines and needs-driven innovation in developing countries, particularly given the dire need in many developing countries for technical assistance with respect to intellectual property policy?

II. THE INITIATIVES

A. THE WIPO DEVELOPMENT AGENDA

The WIPO Development Agenda is the culmination of a three year process that began with an eight-page proposal submitted in August, 2004 by the delegations of Brazil and Argentina to the WIPO General Assembly. (6) That proposal noted "the need to integrate the 'development dimension' into policy making on intellectual property protection" (7) and called for, among other things: the establishment of a new subsidiary body within WIPO to examine technology transfer; a new treaty to promote access to the results of publicly funded research in developed countries; fair enforcement of IP rights; and more development-oriented technical cooperation and assistance. (8)

Just over three years later, the WIPO General Assembly voted to adopt forty-five recommendations made by the Provisional Committee on Proposals Related to a WIPO Development Agenda ("PCDA") and to establish a Committee on Development and Intellectual Property to implement the recommendations. (9) The PCDA's recommendations were taken from many proposals submitted by various Members over the course of four PCDA meetings. (10) The recommendations are organized into five clusters, and certain proposals are to be implemented immediately. (11)

Cluster A, "Technical Assistance And Capacity Building," contains 14 proposals calling for technical assistance that is "development-oriented, demand-driven and transparent," to quote from the first proposal. (12) Among other things, the proposals call for increased technical assistance, more transparency in technical assistance, assistance dealing with IP-related anticompetitive practices, information sharing, capacity-building, development of an intellectual property infrastructure, and provision of advice on flexibilities contained in the TRIPS Agreement. (13)

The proposals in Cluster B, "Norm-Setting, Flexibilities, Public Policy And Public Domain," comprise various institutional reforms that will govern the treaty-making process. (14) The proposals appear to reflect a deep dissatisfaction on the part of developing countries with how WIPO has been run in the past, and thus include proposals: to make the norm-setting process "inclusive and member-driven," to take into account different levels of development, to consider a balance between costs and benefits, to be in line with the principle of neutrality of the WIPO Secretariat, and to be a participatory process that takes into consideration the interests and priorities of all WIPO Member States and the viewpoints of other stakeholders--including accredited IGOs and NGOs. (15) Proposal 22 is particularly notable, as it suggests new procedures under which the WIPO Secretariat would consider specific development-focused issues as part of its norm-setting activity. (16)

Cluster C, "Technology Transfer, Information and Communication Technologies (ICT) And Access To Knowledge," comprises nine proposals focusing on IP-related technology transfer to developing countries and the IP-related aspects of ICT for developing countries. (17) This Cluster seems intended to address a perception that WIPO's technical assistance has in the past been biased towards stronger intellectual property protections and enforcement to the detriment of developing countries. (18)

Cluster D, "Assessment, Evaluation and Impact Studies" proposes a "yearly review and evaluation mechanism for the assessment of all its development-oriented activities" and also recommends conducting new studies and other assessment activities aimed at evaluating the impact of IP on development. (19)

Cluster E, "Institutional Matters Including Mandate and Governance," (20) presents a far-reaching set of proposals designed to broaden WIPO's mandate so that it is more development-oriented. These proposals include WIPO studies on brain drain, intensified cooperation on IP-related issues with other United Nations agencies, and enhanced measures to ensure participation of civil society groups. (21)

Cluster F, "Other Issues," citing Article 7 of TRIPS, proposes that WIPO "approach intellectual property enforcement in the context of broader societal interests and especially development-oriented concerns." (22)

The WIPO Development Agenda has been described as "an unparalleled opportunity, especially for developing countries and public interest organizations, to place at the centre of the IP debate the question of the interrelation between IP and various facets of development." (23) Indeed, it certainly reads as an ambitious reform that would move WIPO away from its traditional, singular emphasis on the promotion and expansion of intellectual property rights towards an organization that is development-oriented from the top down.

While the Development Agenda is clearly focused on the needs of developing countries, the forty-five proposals make no mention of public health, even though the issue of access to medicine for developing countries has been a major driver of the process. For example, the issue of public health is prominently featured in the August 2004 proposal by Brazil and Argentina. (24) Furthermore, proposals discussing public health were introduced throughout the process. (25)

B. THE WHO's INTERGOVERNMENTAL WORKING GROUP ON PUBLIC HEALTH AND INTELLECTUAL PROPERTY

The World Health Organization's most recent effort to explore the link between intellectual property rights and public health officially began in 2003 with a short report by the Secretariat to the fifty-sixth World Health Assembly, stressing the importance of innovation and the fact that "a significant proportion of the world's population, especially in developing countries, has yet to derive much benefit from innovations that are commonplace elsewhere." (26) The report points out language in TRIPS regarding public health, nutrition and technology transfer, and offers several ways in which expansive intellectual property rights can jeopardize public health in developing countries--such as through prohibitively high prices, adverse affects on innovation, and inadequate capacity to manage intellectual property systems. (27)

The report suggested that "rigorous analysis of the scientific, legal, economic, ethical, and human rights aspects of intellectual property as it relates to public health, and careful monitoring of this relationship in different national contexts could prove invaluable for national and international policies and practices that ensure both innovation to respond to unmet needs and access to existing technologies for health." (28) The World Health Assembly responded by establishing a Commission on Intellectual Property Rights, Innovation and Public Health ("CIPIH") that would:

 
   collect data and proposals from different actors involved and 
   produce an analysis of intellectual property rights, innovation 
   and public health, including the question of appropriate funding 
   and incentive mechanisms for the creation of new medicines and 
   other products against diseases that disproportionately affect 
   developing countries. (29) 

CIPIH, which comprised a diverse group representing academia, industry, and public health advocates, among other groups, (30) spent the next two years conducting extensive research, holding meetings with stakeholders, hosting workshops, and commissioning studies. In April 2006, it submitted a comprehensive report addressed to the Director-General of WHO. (31) The report attempts to examine public health and development not just as they relate to intellectual property rights, but in the context of "the bigger picture," (32) taking in such factors as regulation and political commitment. (33) The report comprehensively examines the development and delivery of medicines in three parts: early stage research, "the long road from discovery to development," and delivery. The report then examines how innovation can be fostered in developing countries and concludes with a chapter setting forth recommendations. CIPIH concludes, among other things, that the necessary incentives are limited or non-existent with respect to the development of drugs that address health problems predominantly found in developing countries, getting drugs to patients is a major challenge in this area, and that, while much has been done to provide additional support, significant controversy remains as to the efficacy of various intellectual property tools such as recent TRIPS amendments. …

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