Neglecting the Essentials: Addressing Barriers to Accessing Off-Patent Essential Medicines for Neglected Diseases in Canada

Abstract

In Canada, less than half of the drugs that the World Health Organization classifies as Essential Medicines for the treatment of Neglected Diseases like Chagas disease, drug-resistant tuberculosis, echinococcosis, leishmaniasis, leprosy, malaria and sleeping sickness are formally available, even as collectively hundreds of patients require access to them each year. Essential Medicines, according to the WHO, are those “intended to be available within the context of functioning health systems at all times in adequate amounts, in the appropriate dosage forms, with assured quality, and at a price the individual and the community can afford”. Nevertheless, many of these Essential Medicines, like the conditions they treat, are neglected by pharmaceutical companies and governments alike in low-burden, high-income countries like Canada. The result is a reversal of the usual access to medicines narrative around novel, patented medicines unavailable in low-income countries; these are old, off-patent Essential Medicines, many of which have become widely available in low and middle-income countries yet increasingly difficult to access in many high-income countries. Their absence from countries like Canada is not due to their lack of medical utility – many of them are recognized domestically as the standard of care – but their lack of commercial value. Unfortunately, Canada’s regulatory system is premised upon keeping unsafe, ineffective or poor-quality drugs out, not bringing Essential Medicines in. As a result, these drugs must be accessed through ill-fitting mechanisms like Canada’s Special Access Programme (SAP). Other high-income countries face similar access challenges, though they may manifest in different ways; in the United States for instance, drugs that have disappeared from the Canadian market or simply never been introduced in the first place have instead had de facto monopolies unscrupulously exploited. In turn, as the COVID-19 pandemic has served to underscore, access to these Essential Medicines for Neglected Diseases is an issue that cannot be solved solely at the domestic level. Essential Medicines that threaten to disappear before the diseases they treat do also serve to highlight broader issues of domestic and international concern, from drug shortages to antimicrobial resistance. This thesis provides an in-depth exploration of the problem, and offers guidance on what Canada in particular can do about improving access to medicines, especially those for Neglected Diseases that have been largely absent from the Canadian pharmaceutical agenda.