Posted By Corri Longridge, Adrian Thorogood – Mar. 7, 2010
“Connecting the different stars in McGill’s constellation”
– Opening words of Dean of Law, Prof. Daniel Jutras
In his opening remarks, Professor Daniel Jutras, McGill’s Dean of Law, Professor anticipated a “connecting of the different stars in McGill’s constellation.” No doubt, the keynote speakers of the McGill Health Law Colloquium fit this astronomic introduction. All four were able to draw on their experiences as directors of global health initiatives and offer enlightening perspectives on global health diplomacy, linking entrepreneurial projects to specific health issues, and designing intellectual property regimes in ways that facilitate the dissemination of medicines to the world’s poor. Beyond information, they shared their inspiration and leadership. These stars came not solely to shine, but also to guide us toward solutions and collaboration.
Dr. Nick Drager, former Director of the Dept. of Ethics, Trade, Human Rights and Health Law at the World Health Organization (WHO), highlights access to clean water and adequate food, the development of sustainable sources of energy, and the consequences of climate change and population growth as the top global health issues. These complex issues construe health broadly and illuminate the need for actors from diverse disciplines to engage collaboratively.
The landscape of actors addressing global health issues is vast. Governmental actors and an increasing number of non-governmental organizations are actively negotiating to advance particular interests and shape the architecture of global health diplomacy. Clearly, the vastness of the landscape of actors has implications on rule making and raises issues of governance. Specifically, how can these actors build a global health regime capable of giving a voice to a plurality of interests while encouraging collaboration and facilitating policy coherence?
Not only is the number of actors increasing, the diversity in policy instruments available to promote global health is expanding. Actors, such as the government of Canada, need to decide where to engage, choose from the policy instruments available, and craft a comprehensive global health strategy.
Similarly, Dr. Laurette Dubé, Chair of the McGill World Platform for Health and Economic Convergence (MWP) initiative, highlights the notion that health issues are broad in scope and necessarily involve a plethora of actors. Dubé goes further and highlights that although each actor always looks at global health issues from a distinct perspective, practices where individual actors adopt policies on health issues in isolation then converge with other actors is not as effective an approach as when convergence takes place at the outset. Indeed, that is the principal objective of the MWP, an initiative that aims to bring “mainstream business into health and health into business” through creating a “think tank” to facilitate the convergence of ideas and policies in business and health. Ultimately, this “think thank” seeks to inspire dynamic change on the ground level by acting as a “spring board” for projects, such as the Business4Health Compact. The overall aim is to create sustainable business models and markets capable of driving innovation, education and social change at local, national, and global levels in ways that promote health and wealth for all.
Prof. Richard Gold, from the McGill Faculty of Law, illuminated two fundamental issues of concern in global health. First, Gold proclaimed, “the World’s medicine cabinet is empty.” Essentially, although research costs are increasing, innovation is decreasing. Second, pharmaceutical research and development (R&D) fails to address needs specific to the developing world. This failure, known as the 90/10 health gap, describes the reality that 90% of the health research expenditures worldwide are devoted to diseases afflicting only 10% of the world’s population. In response to these two problems, Gold asks: Where does Intellectual Property law (IP) fit into the puzzle of Global Health? How can IP increase innovation and shift more R&D resources onto neglected sectors?
Theoretically, IP can increase innovation in the short term by providing both an ingredient that allows actors to finance R&D projects, and leverage to negotiate to exchange information with the “big players” of a sector that hold patents. In the long term, IP can inspire innovation through encouraging actors to invest in R&D today, in the hopes of developing patentable medicines that will bring in royalties later. However, Gold emphasizes that actors must accept the limits of IP and must not exaggerate the effects IP has on increasing access to medicines. Specifically, IP only drives innovation when there is a market pull. Consequently, IP cannot foster innovation for medicines for diseases that affect a small population or when the populations affected by the disease do not have the resources to finance patenting. Moreover, because IP is only one tool working along side several other tools (e.g., subsidies, contracts, grants, tax credits, and prizes) within a greater innovation system, it is hard to distinguish and measure the effects of IP on innovation. Whether IP is the best tool to encourage innovation remains unknown.
Similarly, although IP is theoretically a tool that actors can use to reduce the 90/10 health gap, the challenge is to design a global health regime that ensures actors use IP in ways that are equitable and promote health and wealth for all. Gold suggests five potential ways to help reduce the 90/10 health gap:
1) Increase the purchasing power of individual actors and strengthen weak markets by creating funds that save costs through the purchase of medicines in bulk or by using funds to subsidize drug purchases. However, this solution simply encourages actors to work within the existing global health framework and fails to redesign current regimes in a way that is more equitable.
2) Lower the costs of medicines through compulsory licensing. Unfortunately, although international trade allows compulsory licensing, governments must be willing to craft compulsory licensing regimes that are not procedurally onerous for the generic companies and developing countries wishing to benefit from such regimes.
3) Reduce transaction costs. For example, mechanisms could be created to reduce the cost of exchanging “know how” between generic companies and the companies that hold patents to produce “fixed-dose combination” medicines. However, this solution requires trust among the different actors, which is not always present.
4) Develop alternative incentives. For example, creating prize funds to allocate financial rewards based on the magnitude of decrease in disease. Unfortunately, this solution depends on two things that don’t exist. First, good data and a method to calculate the impact of an individual actor on the fluctuation in rates of disease observed in the data. Second, it is critical to establish a causal link, to know whether a particular intervention is responsible for a particular positive effect.
5) Lowering the cost of innovation through sharing information and patents. For example, creating Public Private Partnerships such as the Drugs for Neglected Diseases initiative, DNDi.
Clearly, as each approach has limitations, finding comprehensive solutions to global health issues will likely require combining several approaches and involve diverse actors. Ultimately, the actors need to work towards the establishment of a shared vision of global health and build regimes able to drive incentives that fit needs of global health.
Mr. Richard Elliott, Executive director of Canadian HIV/AIDS Legal Network also spoke to ways that IP laws could play a greater role in helping to build a more equitable global health regime. Specifically, through facilitating access to affordable generic medications in developing countries that have insufficient manufacturing capabilities. Under the WTO’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), member countries, including Canada, are required to develop minimum standards of intellectual property protection within specific timeframes. Such standards effectively create temporary monopolies on the making and selling of medicines that increases the price of medicines and reduces access to medicines in developing countries. In an attempt to minimize the foreseeable negative impact of TRIPS on developing countries, the treaty provides for “flexibilities” in patent rules, including compulsory licensing. Compulsory licensing is a legal tool that allows generic manufacturers to produce and sell generic versions of a particular medicine without the consent of the company who holds the patent on the original product. This tool can effectively limit the ability of patents to create monopolies, create competition and ultimately drive down the prices of medicines. For example, compulsory licensing has helped reduce the price of AIDS medicines for developing countries by 95 percent.
In 2004, the Canadian Parliament unanimously passed Canada’s Access to Medicines Regime (CAMR) a federal law to improve public health in developing countries by facilitating access to medicines for epidemic diseases, including HIV/AIDS, tuberculosis, and malaria. Unfortunately, since the law was passed, it has only been used once – for one shipment of AIDS drugs to Rwanda, and it is unlikely to be used again because the procedure is onerous. Developing countries and generic companies who apply for compulsory licenses need to do so on a country-by-country and order-by-order basis. Moreover, each compulsory license is severely restricted: it is good for only a limited period and for a limited quantity of drug.
Essentially, Canada needs to reform CAMR. One idea for reform, the “one-license solution”, involves streamlining the process by issuing compulsory license for a particular medicine without limiting the quantity or the number of countries covered by the law. Bill S-232 and Bill C-393, legislation currently before Parliament, embody the efforts of NGOs and parliamentarians to improve Global health and propose to streamline CAMR. These bills invite the Canadian government to improve CAMR, bring to fruition the intentions of including “flexibilities” in the TRIPS agreement, and ultimately “promote access to medicines for all” and protect Global public health.
The colloquium, made possible by students from both the medicine and law faculties, established the university’s role in global health as a forum for ideas, a loom capable of weaving unified purpose from disparate perspectives.