Compulsory licensing of generic drugs remains mired in quagmires.

The goal was straightforward and highly-laudable: find ways of providing access to cheaper, generic versions of patented drugs in developing countries to combat public health crises resulting from HIV/AIDS, tuberculosis, malaria or other epidemics. Yet, nearly a decade after global agencies began to pave the way for developing countries to buy or manufacture patented medicines at low prices to treat or prevent diseases, so-called compulsory licensing of generic drugs that are therapeutic equivalents of their patented counterparts (or what is often referred to as the “Doha declaration”) appears relentlessly mired in legal bogs. Developed and developing countries squabble endlessly over aspects of the issue in world trade circles and courts. A World Trade Organization provision that aimed to allow developed countries like Canada to aid the cause by producing generics for export to countries with insufficient capacity to produce their own has yielded exactly one instance in which a drug was actually delivered to such a country. In the developed world, governments and the brand-name pharmaceutical industry appear to find clever ways to undermine attempts to get cheaper generic drugs to needy nations, seemingly in the interest of protecting the health of their own pharmaceutical industry or, more specifically, the health of company bottom lines. Meanwhile, India serves as the world’s supplier of generic drugs, essentially using a phase-in period in its compliance with international property rights law to mass produce cheap generic drugs for the developing world. China and Brazil threaten to step in to fill the void once India completes its transition to compliance. In short, the world of patent protection for pharmaceuticals, and compulsory licensing exemptions therein, remains a tangled, complex weave of policies, regulations and developments that, if nothing else, ensures that lawyers around the world are not lacking for business. As to what impact compulsory licensing has had in nations facing public health emergencies, Ellen ‘t Hoen, senior advisor on intellectual property for UNITAID, says that “while most countries’ national legislation contain provisions for use of compulsory licensing, it does not mean countries use it in practice.” In Canada, the debate over compulsory licensing has primarily revolved around what is called “Canada’s Access to Medicines Regime” (CAMR), a framework built upon “An Act to amend the Patent Act and the Food and Drugs Act — The Jean Chrétien Pledge to Africa,” and subsequent regulations designed as part of the Canadian response to the World Trade Organization’s decision to allow member countries to produce lowcost generics for export in special circumstances. It has been successfully used exactly once, and then only after considerable effort. In 2008, the generic manufacturer Apotex became the first and only drug maker in the developed world to use the exemption when it shipped seven million tablets of Apo-