Right idea, wrong result--Canada's access to medicines regime.

I. INTRODUCTION In 2007, an estimated 33.2 million people were living with HIV, 2.5 million had become infected, and 2.1 million died from the virus.1 The majority of infected individuals reside in Africa, where in some countries as many as 33.4% of adults have HIV.2 In developed countries, effective drug therapies have reduced AIDS-related deaths by over seventy percent each year.3 These drugs have been so effective that over the last two years the global number of individuals dying from AIDS-related illness has actually declined.4 These therapies, however, are currently sold for $10,000 USD a year,5 a purchase price that is not feasible for low income countries where the annual health expenditure may be only $29 per person.6 A lack of essential medicine is not only a problem for those suffering from AIDS. Low and middle-income countries are disproportionately burdened by many additional chronic and infectious illnesses.7 The World Health Organization ("WHO") estimates that one third of the world's population cannot regularly access essential medicines.8 The WHO cites the high cost of drugs as one of the major hurdles countries face in obtaining access to medication.9 However, the high cost of these brand-name medications does not reflect their minimal production costs.10 Drug manufacturers can produce generic versions of these drugs for as little as l/30th of the cost of their brand-name counterparts.11 Pharmaceutical products, including HIV/ AIDS medications, enjoy strong intellectual property protection under the World Trade Organization's Agreement on the Trade Related Aspects of Intellectual Property ("TRIPS").12 After TRIPS was implemented, drug prices increased which created problems for the governments of developing countries that wanted lower prices for medication but were under pressure to comply with TRIPS.13 While TRIPS does not explicitly provide for compulsory licensing of pharmaceuticals, Article 31 of the Agreement allows for the use of patents without authorization by the patent owner if, among other things: (l) the user has attempted to obtain the owner's permission;14 (2) the license is predominantly for the supply of a domestic market; and (3) the patent holder is adequately compensated.15 Article 31, when read with Article 27, led to some confusion about patent protection under the Agreement.16 Article 27 excludes from patentability inventions that are "necessary to protect ordre public or morality, including to protect human, animal or plant life or health or to avoid serious prejudice to the environment" and allows countries to exclude from patentability diagnostic, therapeutic and surgical treatments for humans and animals.17 This seems to imply that patented medications necessary for human wellbeing would not receive intellectual property protection under TRIPS. In response to concerns about access to medication in developing countries and confusion regarding the meaning of Articles 31 and 27, the World Trade Organization ("WTO") adopted the Doha Declaration in 2001 ("the Declaration").18 The Declaration specifies that national governments can issue compulsory licenses when public health concerns outweigh the importance of intellectual property protection.19 It allows the developing country to determine what constitutes a national public health emergency and clarifies that public health crises, including HIV/AIDS, can be classified as national emergencies.20 The Declaration, however, fails to modify Article 31, Paragraph 6, which prohibits the export of medication made under a compulsory license - although the WTO did acknowledge that this provision prevents countries with no manufacturing capacity from issuing a compulsory license.21 To remedy this, the WTO clarified the meaning of Article 31(f) and 31(h) when it issued the Implementation of Paragraph 6 of the Doha Declaration on the Trips agreement and Public Health ("the Paragraph 6 Decision").22 The Paragraph 6 Decision allows a country with manufacturing capacities to issue a compulsory license to produce generic drugs for export to countries that lack the capacity to manufacture their own generic drugs. …