For its part, Health Canada contends that public safety and accessibility to valuable drugs can be mutually inclusive, according to Meena Ballantyne, Assistant Deputy Minister of the Health Products and food Branch, who wrote in the Hill Times:
“This work is focused on improving safety surveillance once a drug is on the market. But it will not compromise or weaken—in any way—the rigorous, world-class safety standards Health Canada currently applies before a drug can be authorized for sale to Canadians. Companies will always be required to demonstrate that a therapeutic product’s benefits outweigh its risks before it is authorized. In considering improvements to current legislation and regulation, we recognize that clinical trials are effective, but there are rare cases where problems emerge only after a drug’s been taken by a greater number of patients following approval. As a result, ideas are being proposed in these workshops to stimulate discussion with stakeholders on more effective ways to monitor the safety of drugs not only during clinical trials but also after they’re authorized for sale. Helping Canadians maintain and improve their health is Health Canada’s mandate. These discussions and the legislative and regulatory proposals that may arise from them would enhance our capacity to fulfill that important role.”
At the moment, there’s no indication that Health Canada will lean too far towards speed or safety, but the stakes are high nevertheless and the margins of error are great. The pressure from industry to remove barriers to market access for drugs is considerable. Likewise, many patient groups eagerly await new drugs for any number of ailments, illnesses, and conditions.
If the purpose of drugs is to improve quality of life and treat diseases, however, then safety advocates rightly prioritize rigorous regulations that primarily intend to protect the public. So while Health Canada seeks a middle ground between accessibility and safety, its most prudent err on the side of caution and public safety.
For more on the political, safety, and cost isues involved on the issue, see the following news articles