Halfway through April, Alberta Premier Jason Kenney attempted to extend his pipeline-based governance model to the pharmaceutical pipeline, tweeting "I have directed our officials to consider use of COVID19 tests, vaccines, or medications that have been approved by the high standards of at least one credible peer country's drug agency, e.g. [EU Medicines Agency, US FDA]. We won't wait for Health CDA to play catch up." He would reiterate these sentiments on CBC's Power and Politics.
Yet while any wider aspirations to Alberta usurping Health Canada's regulatory role have rightly been shot down as, among other things, constitutionally dubious, most responses to his comments have overlooked the fact that there actually is a perfectly legal way for Alberta to import drugs approved in certain foreign jurisdictions, but not by Health Canada. It just may not be a mechanism that fits Kenney's approach to governing.
The Access to Drugs in Exceptional Circumstances pathway was created in 2017. It allows an individual jurisdiction (like a province or territory, but also some federal bodies) to temporarily import a drug or vaccine not approved by Health Canada, but approved in the United States, European Union or Switzerland, in response to an "urgent public health need." So far, so good for Kenney's tweet manifesting in reality (though it doesn't extend to products approved in Australia as he mused on Power and Politics). There are still a range of barriers, however, to Alberta importing a new COVID-19 drug or vaccine.
The first, and most obvious, is that there is no COVID-19 drug or vaccine currently approved in any of those jurisdictions. Furthermore, one requirement is that the drug being imported has to be approved in the foreign jurisdiction for the indication it's being imported for. In other words, it can't be approved for some other condition, but imported for COVID-19. Fingers crossed, however, that there might soon be something to import.
Then would come what might be the biggest psychological barrier for Kenney. The exceptional circumstances pathway was created in response to the opioid crisis. Indeed, the reason Switzerland is on the list is because that's the jurisdiction that has approved diacetylmorphine (better known as heroin). Kenney has strongly expressed his aversion to the idea of the Alberta government supplying such drugs. However, the other example explicitly mentioned when this new mechanism appeared in the Canada Gazette was "flu pandemic," so perhaps Kenney can still use it without feeling like he might be inadvertently supporting harm reduction.
The last hurdle is that at the end of the day, it's not actually Kenney who gets to make the call. It's the province's chief medical officer of health (currently the eminently sensible Dr. Deena Hinshaw), meaning a decision to fast-track access to a medicine before it is approved by Health Canada is, quite rightly, a public health decision, not a political one. And, as one final note, the federal minister of health ultimately still has discretion over whether to add the requested drug or vaccine to the list of products for import; thus, while it's possible to sidestep Health Canada drug approval, Alberta couldn't sideline the federal government entirely.
Use of the exceptional access mechanism has not been all that exceptional since its creation. Multiple jurisdictions have requested products in response to the opioid crisis, including diacetylmorphine and forms of suboxone. A flu vaccine has been listed for use across Canada. Interestingly, the drug the most jurisdictions have requested individually since 2017 -- the Public Health Agency of Canada has currently made a blanket Canadian request -- is for an urgent public health need not originally contemplated when creating the mechanism. A tuberculosis drug called rifapentine, which has been available in the United States since the late 1990s but shows no signs of imminent approval here, has been used by jurisdictions all across the country to treat latent (infected but not yet sick) TB. There's a certain irony to the most widespread use of exceptional access being for a public health crisis that no longer attracts much high-level political attention, but never actually went away. Rifapentine also seems to be the only drug Alberta has ever individually requested under the exceptional access pathway. It did so before Jason Kenney became premier.
Adam R. Houston is a PhD candidate in the faculty of law at the University of Ottawa working on access to medicines issues at the intersection of law and health. Twitter: @HealthLawAdamH
Image: Stock Catalog/Flickr
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