It shouldn’t take a crisis to spur sensible reforms that improve access to essential medicines.
Health Canada has announced new regulations that respond to the opioid crisis by making it easier to access treatments not yet authorized for sale in Canada but which are available in the United States, the European Union or Switzerland, including prescription heroin. These changes should be applauded as a valuable public health measure. They permit the temporary large-scale importation and use of such treatments “for an urgent public health need.” While primarily a reaction to the opioid crisis, the changes would also apply in a similar scenario like a flu pandemic.
Although these reforms are a positive step, it is unfortunate that it took a widespread emergency, with so much tragic loss of life, to spur fairly simple regulatory changes to address an obvious problem of lack of access to vital medications. The government should now move to adopt similar reforms addressing other long-standing concerns about limited access to medicines; these concerns have been largely ignored while the conditions they treat simmer below crisis level.
The same week these regulations were published, the World Health Organization trumpeted successes in increasing access to treatment for neglected tropical diseases (NTDs). And yet Canada is untouched by these improvements to access. At first glance, the fact that tropical diseases are neglected here may not seem surprising to anyone who has experienced a Canadian winter. Yet with one in five Canucks born abroad and many more travelling to warmer climes for business and pleasure, there are always Canadians in urgent need of access to effective treatment
Given the large burden of these diseases worldwide, drugs to treat them are of such importance to global health that they are considered “Essential Medicines” by the World Health Organization, appearing on the WHO Model Lists of Essential Medicines. Yet many of them are not sold in Canada at all, despite being widely and affordably available in much of the world for decades. Such medicines include both of the drugs recognized with the Nobel Prize for Medicine in 2015: artemisinin, the basis of the global standard for malaria treatment, and ivermectin, a crucial antiparasitic drug used by hundreds of millions of people every year.
Actually, “not sold in Canada” isn’t quite true: as any veterinarian treating a parasite-ridden dog will tell you, ivermectin is readily available in Canada, but only for nonhuman patients. For humans, it and numerous other Essential Medicines are available only through Health Canada’s Special Access Programme (SAP), a bureaucratic mechanism designed for emergency access for patients on an individual basis to new medicines not yet approved for sale in Canada. In the absence of any other mechanism, the SAP has also been pressed into service as the only method of obtaining a range of proven essential medicines.
To be clear, the underlying reasons that Canadians cannot otherwise access these essential medicines have nothing to do with the utility of the drugs themselves. The Regulatory Impact Analysis Statement accompanying the regulations explains that some treatments for opioid use are not marketed here for reasons that “may include a business decision by the manufacturer to not apply for an authorization [to sell the drugs] in Canada because it is a smaller market, or a business decision to seek authorization in Canada at a later date.” The fact that many essential medicines are decades old, with their patents long expired, means profit-seeking drug companies have even less incentive to go through the process and expense of seeking authorization than they do for new products. As a result, drugs of proven utility have been left in regulatory limbo for decades even as the Canadian government sponsors programs to expand their use in other countries.
Other essential medicines, like cycloserine (for drug-resistant tuberculosis) and pyrimethamine (for both malaria and toxoplasmosis), were actually sold in Canada until the companies selling them simply decided to stop. In other words, some essential medicines are unavailable not because they are not essential, or because patents impede access, but because nobody wants to sell them. Thus, important drugs that have been well understood for decades suddenly become “new” again, square pegs to be pounded through the round hole of the Special Access Programme at the expense of timely, reliable access.
Under the SAP, the process of applying for access begins only after a specific patient is already seriously ill and in need of a drug that is not available in Canada. Having to go through this process, which requires substantial documentation for each course of treatment for each patient, can create delays in access. Sometimes the application is not approved at all. The new regulations preapprove bulk importation of certain products, shifting the remaining administrative requirements until after the drug has arrived in Canada. Just as the government is now explicitly acknowledging that the SAP “was never intended for use in a population health treatment context to address a public health emergency such as the current opioid crisis in Canada,” the time has come to recognize that it was also never intended as a path to accessing proven essential medicines of long-established importance.
Having no recourse other than applying to the SAP affects the ability of physicians to meet well-established standards of care, not only for NTDs but also for diseases that have been the cause of past Canadian health crises. Tuberculosis was Canada’s leading cause of death at the time of Confederation; as the country celebrates its 150th birthday, TB’s profile may have declined but the disease itself persists. For Indigenous communities where it remains a serious threat, the new regulations are already proving valuable: The initial list of drugs that can be imported includes rifapentine, an essential medicine for treating latent TB infection, for use in populations under the jurisdiction of the First Nations and Inuit Health Branch.
Meanwhile, elsewhere in the country, migration and travel have drawn Canada into the global epidemic of multidrug-resistant TB. Nonetheless, more than half of the essential medicines used to treat drug-resistant TB, including both older drugs and new medicines like bedaquiline and delamanid, are not sold in Canada, and there is little indication they will be coming to market here. Where the urgent need for treatment is at the individual rather than population level, the SAP remains the only option. Whether new or old, medicines are effective only if they can actually be used.
Connecting Canadians with proven essential medicines for serious diseases in a timely manner should be a priority well before a problem becomes an “urgent health need” at the population level. Instead, we are at the mercy of ill-fitting bureaucratic mechanisms and businesses that see us as a “smaller market.” Health Canada has decided, quite sensibly, that the severity of the opioid crisis justifies the importation of drugs that are not only unapproved for sale in Canada but also, in some cases, subject to further restrictions under the Controlled Drugs and Substances Act. Importing prescription heroin (diacetylmorphine) is likely to remain politically controversial despite its utility; by contrast, the most controversial issue about Nobel-Prize-winning essential medicines is simply why they are not already available.
Improving Canadians’ access to an identified list of proven essential medicines using a mechanism similar to these regulations should be uncontroversial and an easy win for public health, even in the absence of a catastrophic catalyst. Many of these medicines are available not only in the US, the EU and Switzerland but in a large number of countries other than Canada; high-quality, reliable sources should not be difficult to find. The new regulations show that solutions are possible; if action only follows a full-blown crisis, it will always come too late.
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