Challenges for intellectual property management of HIV vaccine-related research and development.(The Global Context, part 1)

The HIV/AIDS (1) pandemic is one of the defining issues of the 21st century. (2) AIDS is the leading cause of death in Africa and the fourth-leading cause of death globally. (3) UNAIDS estimated that 33.2 million people were living with HIV in 2007. (4) More than twenty million people have already died from AIDS and sixty-five million will face death over the next twenty years. (5) The majority of these live in the developing world among the world's poor, powerless and marginalized.

Despite the increased focus on the global AIDS pandemic since the XIII International AIDS Conference in Durban, South Africa in July 2000, and despite some very significant developments since that time, the vast majority of people living with HIV/AIDS still lack access to affordable and effective treatment programs and medications. (6) The best long-term hope for controlling HIV/AIDS, therefore, is the development and widespread distribution of a safe, effective and affordable vaccine.

Research into vaccines is in accord with the Declaration of Commitment on HIV/AIDS, signed in June 2001 by 189 member states of the United Nations. The declaration recognized the need for a strong global response to the AIDS epidemic and, as part of that response, the need for HIV vaccine research, development and access. The Declaration committed member states to:

[e]ncourage increased investment in HIV/AIDS-related research, nationally, regionally and internationally, in particular for the development of sustainable and affordable prevention technologies, such as vaccines and microbicides, and encourage the proactive preparation of financial and logistic plans to facilitate rapid access to vaccines when they become available. (7)

Unfortunately, despite more than twenty years of research, no effective HIV vaccine aimed at either prevention or treatment of infected individuals has been forthcoming for either the developed or developing world. On the promising front, in the last ten years, three developments have helped accelerate HIV vaccine Research and Development (R&D). The first is the creation of public-private partnerships (PPPs) that capitalize on the strengths of the public and private sectors such as the International AIDS Vaccine Initiative (IAVI) and the Global Aids Vaccine Alliance launched in 2000 (GAVI); the second is the global connection of researchers, government agencies and international organizations under the Global HIV/AIDS Vaccine Enterprise (GHAVE) with an aim to coordinating research, knowledge sharing and capacity building; and the third is the infusion of funding spearheaded by philanthropic partners including the Bill & Melinda Gates Foundation (the Gates Foundation) and the creation of PPPs such as the United States' Collaboration for AIDS Vaccine Discovery (CAVD).

Considerable research is being conducted and better coordinated at the global level now, with the hope that one or more vaccine candidates will emerge in the next decade. Of great concern to those in the research and funding enterprise is ensuring global access to vaccines and related products once they are developed. That access is particularly important in the developing world where AIDS continues to kill and infect millions of men, women and children. Balancing the need to provide incentives for R&D of HIV vaccines with the need for affordable global access to those vaccines is one of the most pressing challenges in international public health. A critical factor in this balancing act is the management of intellectual property rights (IPRs).

Here we discuss potential roadblocks to the coordinated international efforts for HIV vaccine development and, in particular, potential roadblocks caused by IPRs in the process of vaccine development and potential roadblocks caused by IPRs to global access to vaccines, once developed. In our second, companion paper, we discuss the same issues from a Canadian perspective. (8) This paper is divided into four sections. Part one lays out the background issues for managing and coordinating international vaccine research. It covers some differences between vaccine and pharmaceutical R&D, outlines HIV vaccine R&D to date and lays out the intellectual property (IP) issues most relevant to HIV vaccine R&D. Part two outlines IP management techniques that can be used to avoid blockage to research tools or IP blocks to on-going research projects. Part three outlines IP management strategies that can be used to ensure global access to the outcomes of funded research projects. We conclude with a summary of strategies available to governments (through funding agencies or otherwise) to encourage HIV vaccine research and to ensure global access to the products and processes produced by that research.