Canada should permanently expand drug approval process in post-COVID world

The rapid approval of COVID-19 vaccines in Canada is unprecedented. The urgent need for vaccines, coupled with a federal government interim order to expedite access, meant the vaccines were approved by Health Canada in a timeframe similar to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

With renewed focus on the importance of timely approval of therapies, it’s worth considering whether there are lessons in efficiency and international cooperation to carry into the post-pandemic world.

Canada usually lags months, sometimes years, behind the FDA and the EMA in approving new innovative drugs. For example, a recent study published by the Fraser Institute found almost 95 per cent of 224 new drugs approved by Health Canada (between 2012/13 and 2018/19) were authorized a median of nine and a half months earlier by the FDA and more than five months (median) earlier by the EMA.

Why?

Not because Canada’s review process for new drugs takes longer, and not because of safety concerns. Rather, it’s because applications for marketing authorization are commonly submitted to Health Canada after the FDA and the EMA. Simply put, Canada is a secondary market after the United States and the European Union—hardly a surprise when they have populations nine to 10 times Canada’s. Further, Canada’s restrictive price controls and weaker intellectual property protections are unlikely to incentivize early submission.

Health Canada’s standards of scientific rigour and timeliness in approving new drugs remain consistent with those of the FDA and the EMA, both respected regulatory agencies. Therefore, as proposed in the Fraser Institute study, Canada should replace or augment its authorization process with agreements to recognize drug approvals by these agencies.

This move would potentially reduce the costs of entry to the Canadian market and shorten the delay Canadians currently experience before new drugs can be marketed. Additionally, Health Canada could use staff currently employed in regulatory approval to improve “post-marketing” monitoring of drug safety issues. This is crucial because Canada’s adverse reaction monitoring system is a passive model developed more than 50 years ago that relies on health professionals not only recognizing an adverse reaction but taking the time to report it to Health Canada. A more proactive system would benefit both patients and health professionals.

Although acceptance of drugs approved in the U.S. or Europe may have seemed unthinkable in the past, the importance of international cooperation was widely recognized in the global response to the pandemic. Indeed, the interim order for COVID-19 therapies includes the ability to use decisions of trusted foreign regulatory authorities in certain circumstances.

Health Canada’s move towards more “agile licensing” could be expanded to include acceptance of life-changing drugs based on decisions made by other authorities in some situations. However, these situations may be rare because blanket acceptance of drugs approved elsewhere would mean surrendering Canada’s right to decide what drugs can be marketed.

And yet, acceptance of new drugs approved by the FDA or the EMA could lead to earlier marketing availability in Canada, but probably not to earlier patient accessibility. For one thing, manufacturers may not be ready to launch new drugs in Canada at the same time as in the U.S. and Europe due, for example, to limited supply.

More crucially, drug developers face numerous barriers in getting their products to Canadians including inhospitable government-controlled health technology assessment and price negotiation organizations, and public drug plans reluctant to cover more drugs. These obstacles would continue to delay patient access.

Unfortunately, it seems Ottawa’s recognition of the importance of timely access to innovative life-changing therapies may have been only temporary. Instead of easing access to innovative medicines, the Trudeau government is adding a further impediment in January 2022 with changes to the Patented Medicine Prices Review Board that will lead to significant price reductions, resulting in increased delays in access or no access at all.

As we enter the post-pandemic world, the federal government must recognize and remember the health and economic benefits of timely access to new medicines in the long run—not just during a pandemic.