Thank you for the opportunity to appear before the committee.
I work as an emergency physician in downtown Toronto. Between 2001 and 2016, I taught health policy at York University. Over the past 40 years, I've been involved in researching and writing about pharmaceutical policy issues.
I want to address the question about proposed reforms to the Canadian regulatory system, although I will also touch on some points that Mr. Labrie made.
When the pandemic started, Health Canada brought in an interim order to allow for a more rapid introduction of products to treat and prevent COVID-19. More recently, it's produced a discussion document about what it terms “agile regulations”, which are supposed to decrease regulatory burden and get new drugs onto the market in Canada faster.
The first point to make is contrary to Mr. Labrie's. Independent research has shown that only about 10% of new drugs that are introduced into Canada—or, in fact, in other markets—offer any substantial therapeutic gain over what already exists. This applies to drugs that are approved in general. It applies to drugs that are approved through Health Canada's priority review process. It applies to drugs that are approved with limited data through the notice of compliance with conditions process.
Even if you look at what are called first-in-class drugs—drugs that are unlike anything else on the market—the proportion of those that are innovative is only about one in six. When you look at drugs for orphan diseases, about one in five of these are substantial therapeutic improvements. This is not based on my assessment. This is based on independent assessments by organizations that have nothing to do with the pharmaceutical industry.
When we think about changing the regulatory system, we also need to think about the safety of drugs that are on the market. The push for agile regulation makes mention of safety, but it seems to put safety second to reducing regulatory burden, which is a mistake. It ignores what we know about the safety of drugs that come on the market based on how long they are reviewed by organizations like Health Canada.
If a drug goes through a standard review process, eventually about one in five of those drugs will acquire a serious safety warning. If it goes through a priority review process, which is shorter—instead of the standard 300 days, it's 180 days—one-third of those drugs will acquire a serious safety warning, up from one in five. If you look at drugs that go through a notice of compliance with conditions process, about one in four of those drugs will acquire a serious safety warning.
There are consequences to changing the regulatory system in terms of safety. Currently, in any five-year period, if you look at the drugs that are withdrawn from the Canadian market, about one out of every 20 will eventually be pulled from the market for safety reasons. If we go ahead with changes in the regulatory system, that percentage may increase.
In conclusion, it's reasonable to change how we get drugs on the market in response to a pandemic. As a doctor in the emergency department, I recognize that. If you're talking about making long-term permanent changes, then you have to look at whether that results in better, more effective drugs reaching the market and in the increased or decreased safety of the products that come onto the market.
Until Health Canada can come up with good data to show that we'll get more therapeutically efficient drugs and more safety, we should not be going ahead.
Thank you.