Challenges for intellectual property management of HIV vaccine-related research and development.(The Canadian Context, part 2)

On 20 February 2007, Prime Minister Stephen Harper announced a commitment by the Government of Canada and the Bill & Melinda Gates Foundation to fund and support the Canadian HIV Vaccine Initiative (CHVI), (1) an effort to accelerate the development of an HIV/AIDS vaccine and address critical research gaps identified by the Global HIV/AIDS Vaccine Enterprise (GHAVE). (2) The goal of the CHVI is to coordinate research within Canada as well as Canadian contributions to the international efforts to develop safe, effective, affordable, and globally accessible vaccines. (3)

Canada's commitment to HIV vaccine research is longstanding. In 2002, Canada promised at the XIV International AIDS Conference, held in Barcelona, to develop a Canadian HIV/AIDS vaccine plan focusing "on vaccine production and equitable distribution ... this plan will support the global vaccine effort and will contribute to a better understanding of the complex legal, ethical and human rights issues involved in addressing access to vaccines and treatments for people living with HIV/AIDS, nationally and globally." (4) The Canadian HIV Vaccines Plan: Towards a World Without AIDS was published in 2006, (5) and calls for Canada to contribute towards

 
   global efforts to develop and deliver HIV vaccines, including 
   strong community-based organizations; a strong research capacity; 
   immune-monitoring capability; long-term relationships with research 
   partners in the developing world; infrastructure in Canada and 
   internationally; recognition of our strengths in social science, 
   legal issues and human rights; new possibilities for production 
   plants; emerging private-public sector partnerships; international 
   recognition for diplomacy; and a strong health care ... system. (6) 

To accomplish these goals, it is necessary to ascertain and respond to the key non-science challenges to HIV vaccine research in Canada, focusing on any potential intellectual property (IP) bottlenecks. This paper builds upon the key issues identified in Part One of this series of two papers on "Challenges for Intellectual Property Management of HIV Vaccine-Related Research and Development" [hereinafter, Part One]. Following that review of the global literature and consultations with international experts, (7) we consulted with representatives from the CHVI and developed sector-specific interview guides for academic researchers, government, and industry representatives in Canada. We conducted individual or group interviews with 21 key informants in Canada, including CHVI representatives, experts in intellectual property law, management and ethics, as well as academic and private sector HW vaccine researchers. (8) Here, we present the conclusions from those interviews, a discussion of key concerns, and potential solutions.

The consultations focused on the main non-science barriers to HIV vaccines (R&D) in Canada. The main challenges identified from a research perspective surprisingly did not include issues related to IP, but were, instead, inadequate funding for research, clinical trials and gap funding for taking innovative research to the proof of principle stage. There are also problems associated with the creation of effective research networks and collaborative models. Further downstream, there will be major challenges associated with manufacturing and distributing vaccines, particularly in developing countries, and the associated risks of liability for adverse events, such as allergic reactions to the vaccine. This latter issue has already come to the fore in HIV vaccine clinical trials known as the Step Study. The vaccine, manufactured by Merck and Co., was found to increase the susceptibility of participants to HW infection if they had high levels of antibodies to adenovirus 5. Adenovirus 5 was a component of the vaccine and is one of the causes of the common cold. Indeed, an independent Data and Safety Monitoring Board went so far as to recommend unblinding the results and notifying participants whether they received the Merck vaccine or the placebo.

However, we were specifically interested in potential challenges for Canadian researchers and HIV vaccine development posed by (IPRs) in the HIV vaccine space. As outlined in Part One of this series, those challenges include the potential for a patent thicket whereby a plethora of patents on essential vaccine components and processes held by a variety of entities will make it virtually impossible to negotiate all of the licenses necessary to manufacture and deliver an HIV vaccine. We therefore asked a series of questions related to IP management (Appendix One). When probed, interviewees suggested that Material Transfer Agreements (MTAs), the licenses for use whereby tools and materials necessary for research are transferred between researchers or institutions, were a greater hindrance to vaccine research in Canada than were patents per se. This is in accordance with surveys of researchers in a range of life sciences disciplines conducted in the United States, where most researchers operate under the assumption that their research activities will not trigger a patent infringement suit--not because there is, in fact, a statutory or common law research exemption, but because the adverse publicity and cost of such a suit make it unlikely that a patent holder would assert its rights against a public sector researcher. Instead, access to materials required for research may be denied for practical reasons (e.g., the cost, labour and time involved in shipping samples), because of old fashioned competition between researchers, and because university technology transfer offices have inserted overly complex terms into MTAs, based on unrealistic expectations of returns to the institution or potential liabilities.

In relation to experienced or potential IP roadblocks as HIV vaccine R&D advances in Canada, we then asked interviewees from each sector--academia, government, industry--about their respective roles in avoiding and/ or overcoming patent-related roadblocks, potential models for enhancing collaboration between public sector researchers and industry, and how best to align Canadian policies with those being developed internationally to enhance HIV vaccine R&D and ensure global access to its products and processes. What follows is a summary of the key issues and potential solutions raised during our consultations.