Ubaka Ogbogu is an associate professor in the Faculties of Law and Pharmacy and Pharmaceutical Sciences at the University of Alberta, and a Pierre Elliott Trudeau Foundation Fellow. Lorian Hardcastle is an assistant professor in the Faculty of Law and Cumming School of Medicine at the University of Calgary.
On Apr. 12, in response to a perceived delay in Health Canada’s approval of a Canadian-made testing kit for COVID-19, Alberta Premier Jason Kenney tweeted that he had directed Alberta officials to “consider use” of “tests, vaccines, or medications that have been approved by the high standards of at least one credible peer country’s drug agency.”
Mr. Kenney’s pronouncement prompted some plaudits, including from federal Conservative Leader Andrew Scheer, but it also caused outrage, forcing Ottawa to defend its response. But mostly, it raised a host of constitutional, logistical and political problems that must be addressed.
In most countries, the regulation of health products, including drugs and medical devices, is a national concern. There are good reasons for this, including avoiding a patchwork of decentralized approaches that can hamper efficient regulation and, ultimately, the safety and quality of a nation’s supplies. In Canada, the federal government has been regulating health products through the Food and Drugs Act for 100 years. Drug and device approvals are an exceedingly complex process that requires significant expertise and detailed regulatory procedures.
Canada’s constitution grants the federal government power over “criminal law,” which includes regulating public health threats arising from the safety of food, drugs, and other products. Although the provinces have some health-related powers, such as the regulation of hospitals, these powers are not as clearly relevant to drug approvals. Even if the federal government and the provinces could both regulate in this space, any conflict would be resolved in favour of the federal government. Putting aside constitutional technicalities, provincial incursion into health-product regulation would disrupt Canada’s complex health care system, which hinges on co-operation between the two levels of government.
History has taught us that relaxed or inefficient regulation can produce disastrous consequences, as with thalidomide in the 1960s, and it is unclear how Alberta would marshal the resources to accomplish this complex task on its own. Furthermore, drugs are imported into Canada pursuant to federal authorization, so it is unclear whether Alberta could even import drugs or devices that it had approved, unless those products were already manufactured or could be manufactured in Canada.
While Mr. Kenney’s position may seem like mere bluster, it is part of a dangerous trend that emphasizes approval speed over safety and efficacy. This trend has led to a huge exploitative market for unapproved and unproven therapies, many of which rely on falsehoods and half-truths that work to lure the public into thinking that quicker is always better, scientific evidence be damned. But studies show that around 90 per cent of drug trials fail. If the regulatory system did not exist or was not rigorous, all these failures might make it to the market – and as things stand now, some still do.
Speed (albeit balanced with good science) is not entirely absent from our current system of regulation. Health Canada has expedited approval processes for products that have shown enough scientific promise to be used in limited and compassionate circumstances. But speed must be balanced with safety and efficacy. Evidence shows that expedited drug approvals are linked to more adverse events.
If Mr. Kenney was genuinely concerned with the approval times for particular unapproved drugs or medical devices, he ought to have offered to work with federal regulators instead of sending inflammatory tweets that undermine the public’s trust in Health Canada, which is essential during a pandemic. It is also inappropriate to politicize what should be a science-focused approval process. As it turned out, this was an issue that Health Canada was already working on, given that a test kit was approved that day.
By responding to a concern of a single product by suggesting that Alberta will usurp the regulation of medical devices, drugs and vaccines without the necessary expertise, Mr. Kenney is reacting in a knee-jerk fashion – one that is also constitutionally dubious.
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