American Journal of Law & Medicine

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 1/30th 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: (1) 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 well-being 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. (23) There are several limits on the use of this provision, however, including a requirement that the exporting country compensate the patent holder. (24) In addition, licenses authorize a limited amount of pharmaceutical product, and those products must be specially labeled to distinguish them from other versions of the drug. (25)

Canada was one of the first countries to amend its patent laws to conform with the Paragraph 6 Decision when, in 2005, they adopted the Jean Chretien Pledge to Africa, (26) now known as Canada's Access to Medicines Regime ("CAMR"). (27) In 2007, Canada became the first country to authorize the manufacture of generic medications under the Paragraph 6 Decision when it authorized Apotex Inc. to manufacture 260,000 packs of TriAvir, an HIV/AIDS medication, for export to Rwanda. (28) Some individuals in the brand-name pharmaceutical industry support this initiative, while others argue the law focuses too much on cost as a barrier to access when the real problems concern "resources, health care capacities, infrastructure and access to sustainable financing." (29) Despite these objections, however, the WHO maintains that cost is one of the major obstacles to providing access to essential medications in developing countries. (30) Developing countries spend as much as seventy percent of their health care budgets on medication, while developed countries usually spend less than fifteen percent of theirs on medication. (31) Thus, while high pharmaceutical prices may not be the only factor impeding developing countries' access to essential medicines, it is clearly a key factor that must be addressed in order to solve the problem.

Part II of this note will examine in greater detail the history of TRIPS leading up to the Paragraph 6 Decision. Part III will review the provisions of CAMR. Part IV will analyze the law, its strengths, weaknesses, and changes that would make CAMR a more effective mechanism for increasing access to essential medication. This note will conclude that although Canada's enactment of CAMR is a step in the right direction, if it wants to provide a viable solution to problems with access to essential medicines, CAMR must be amended to make the process for obtaining a compulsory license more efficient.

II. TRIPS LEADING UP TO THE PARAGRAPH 6 DECISION

TRIPS is an international agreement on intellectual property protection for patents, copyrights, trademarks, industrial design, and trade secrets. (32) The Agreement allows the granting of patent protection to inventions in all fields of technology, including the pharmaceutical industry, provided that the patented product is new, involves an inventive step, adds something new to the prior art or existing products, and is capable of an industrial application. (33) Patent holders are given protection for no less than twenty years and are able to prevent others from "making, using, offering for sale, selling, or importing their product." (34) If the patented subject matter is a process, patent holders are able to prevent others from "using, offering for sale, selling, or importing for these purposes at least the product obtained directly by that process." (35)

Article 31 of TRIPS allows governments or other third parties to use the subject matter of a patent without authorization under a compulsory license as long as certain conditions are met. (36) The user must make an effort to obtain the permission of the patent holder, except in situations of extreme urgency or national emergency. (37) Even in the event of national emergency, the patent owner must be given notice of the use as soon as reasonably practicable. (38) The scope and duration of the unauthorized use is only for as long as the emergency exists, and the use is limited to the purpose for which the license was obtained. (39) The compulsory license is non-exclusive, non-assignable and primarily for the supply of domestic markets. (40) When the circumstances creating the need cease to exist and are unlikely to reoccur, the authorization for the use terminates. (41) While using a patented technology under this provision, governments and third parties must pay the patent holder adequate remuneration. (42)

Article 31 provisions for compulsory licensing were very problematic and many developing countries were concerned that strict enforcement would be harmful to public health and deny access to medications needed to deal with public health crises. …

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