Innovative new medicines can have a profound impact on the health and wellbeing of those stricken with illness. Unfortunately, Canadians are often denied these benefits for months, if not years, while they wait for their government to approve drugs already deemed safe and effective by regulators in the European Union and United States. Smarter regulation could save resources, reduce patient suffering, and improve the lives of Canadians.
Canada’s current approach, which duplicates approval processes undertaken in the U.S. and Europe, imposes considerable delays on Canadians struggling with illness. Between 2005 and 2011/12, all but two of the new drugs approved by Health Canada were also approved in the United States and Europe. Americans received access to these medicines a median of 350 days earlier while Europeans got access a median of 263 days earlier.
A closer look suggests the delays did much more than cause needless discomfort. For example, some cancer drugs that can extend life for very ill patients were delayed by more than a year compared with access in the U.S. or Europe. A new therapy for potentially life-threatening blood-related diseases was approved in the U.S. and Europe almost two years earlier than in Canada.
There are two main reasons for this delay in getting new medicines to Canadians. First, because companies must submit medicines for duplicative approval by Health Canada, differences in dates on which applications are submitted to regulators deny access to drugs in the interim. This is compounded by the fact that Health Canada takes longer than U.S. and European regulators to provide approval. On average, 93 per cent of the Canada-U.S. drug lag and 75 per cent of the Canada-Europe drug lag between 2005 and 2011/12 was the result of a difference in submission dates, with the remaining difference resulting from slower regulatory approvals after submission. There are many possible reasons for this, ranging from Canada’s small market size to weaker protections for pharmaceutical innovator intellectual property to restrictive public reimbursement policies.
Canadian regulations clearly restrict access to new medical innovations by placing a general ban on their use until Health Canada completes duplicate reviews already undertaken (earlier and faster) by regulators in Europe and the U.S. Regulators in these jurisdictions bear responsibility for the health and safety of populations (more than 500 and 300 million respectively) that dwarf Canada’s population of less than 35 million.
These realities point to a straightforward solution: rather than require Health Canada to approve all new drugs, Canada could consider either a U.S. or European approval sufficient for market access. Such an approach would improve access to medicines by eliminating the lag caused by differences in submission and by slower approvals, while maintaining a strict regime for drug approvals by well-resourced and respected agencies. Between 2005 and 2011/12, acceptance of U.S. or European approvals would have provided Canadian patients access to at least 152 new medicines a median of 494 days earlier (not to mention access to many drugs not available, either because of delay, denial, or non-submission, in Canada).
Importantly, relieving Health Canada of its regulatory monopoly would not prevent the agency from overseeing safety warnings and drug withdrawals. It would not result in the elimination of Canadian approvals either: these could still be done on a non-mandatory basis, with drugs approved in the U.S. or Europe subject to a labeling requirement. That would leave the decision over whether European and U.S. approvals provide sufficient protection from the risks associated with a new drug to Canadian patients, who would have the freedom to wait for Health Canada approval voluntarily.
While this change has the potential to free up resources, they need not all be saved (though there is merit in doing so). In part, resources might be directed to further support surveillance of drugs that have already been approved, and fund better communications about prescription drugs and their side effects to both patients and physicians. Such a shift would leave more control of the risk/benefit trade-off of different treatments in the hands of those directly exposed to it, rather than to risk-averse regulators who have strong incentives to minimize risk at the expense of lost benefit. This is particularly important when more and more complex products are being approved.
Replacing Health Canada’s regulatory monopoly for new drugs with acceptance of European and U.S. approvals for market access in Canada would provide faster access to the important health benefits these medicines create, and could be paired with a higher level of information about the potential risk/benefit tradeoffs associated with each. The result would be better, and likely safer and more informed, access to new medical advances for Canadians.