Evidence of meeting #21 for Health in the 39th Parliament, 2nd Session. (The original version is on Parliament’s site, as are the minutes.) The winning word was drugs.
A recording is available from Parliament.
Executive Director, Li Ka Shing Knowledge Institute, St. Michael's Hospital
I guess my short answer would be that I would have preferred wording, not being a lawyer, saying that the post-marketing surveillance would “augment” the information from the initial randomized trials, rather than, as I think you said, “replace”, or whatever.
Executive Director, Li Ka Shing Knowledge Institute, St. Michael's Hospital
“Shift the focus”, yes.
Assistant Professor, Centre for Health Services and Policy Research, University of British Columbia
I would just reiterate that progressive licensing makes sense if it is to add to the existing rigour that is in pre-market. And you are right: I think Canada does have mechanisms in place to expedite access to medicines for people in dire circumstances.
NDP
Lawyer, As an Individual
Yes. In my view, progressive licensing means reducing the bar.
NDP
Judy Wasylycia-Leis NDP Winnipeg North, MB
Okay.
There are two other things we've heard from others about what makes a good post-market surveillance system. One is that we must make sure that Health Canada is completely transparent about the drug approval process. That means trying to find a way to convince Health Canada to put everything on a website about drug approvals and non-approvals.
What do you think of that? I think you've hinted at it already.
The second is establishing an independent board to evaluate prescription drug safety.
Thirdly, there's an issue we haven't touched on much yet: doing everything we can to speak against and stop direct-to-consumer advertising of drugs.
On those three issues, what do you think?
Executive Director, Li Ka Shing Knowledge Institute, St. Michael's Hospital
Those strike me as reasonable. Also, I would not forget the provinces and physicians as important targets of post-marketing surveillance. In other words, Health Canada has a very blunt instrument, which is taking the drug off the market or not. As a physician, I would benefit a great deal from this kind of post-marketing surveillance because it would help me decide which kinds of patients...and it'll help me to better understand the risks and benefits in the real world.
NDP
Judy Wasylycia-Leis NDP Winnipeg North, MB
What you're saying is that the provinces should be integrated into a coordinated national approach across the country.
Executive Director, Li Ka Shing Knowledge Institute, St. Michael's Hospital
I'm saying that the information from the post-marketing surveillance will be as useful, if not more useful, to the provinces, the practising doctors, and the patients who have much more subtle things to do in their life than saying the drug can or cannot be licensed.
Assistant Professor, Centre for Health Services and Policy Research, University of British Columbia
Perhaps what one needs to do is take the pressure off Health Canada by actually introducing legislation that requires a new degree of transparency with respect to clinical trials that are used to approve or not approve medicines. Right now the onus and the blame seem to lie with the bureaucrats and executives who run the system. Maybe the solution is to take that pressure off them and actually pass some sort of transparency legislation around drug safety.
Lawyer, As an Individual
I agree with that last comment.
Also, an independent board for approvals could be a good idea. There's nothing wrong with a department doing it as long as the department acts independently and in the best interests, perhaps as legislatively required.
Your last question was on direct consumer advertising. I think that's terrible. It's supposed to be prohibited in Canada, but it's not really enforced, and the industry is trying to get around it.
Health Canada is at least trying to protect the standards we have now, but I believe most drug companies are trying to go directly to the consumer to avoid all the necessary approvals and so on.
NDP
Judy Wasylycia-Leis NDP Winnipeg North, MB
There is a section in Bill C-51 on clinical trials, which I would like you to look at. It's on pages 19 and 20. It would be helpful to have your written comments on that, along with the other request we made to you today.
Conservative
The Chair Conservative Joy Smith
I think, Judy, due to the time element, we're going to have to ask for those comments in writing. If you submit them to the clerk, we'll ensure that those comments will be distributed.
Could we now have Mr. Temelkovski?
Liberal
Lui Temelkovski Liberal Oak Ridges—Markham, ON
Thank you very much, Madam Chair.
Thank you to the presenters.
Mr. Orr, you mentioned that you worked on legislation in several jurisdictions. Are there any models from these jurisdictions that we might learn from?
Lawyer, As an Individual
No, I have not drafted medical device...this is only in the federal sphere in Canada, and I have not done anything in that sphere. Health Canada has not asked me to draft any of its legislation in this area.
There are other jurisdictions. We'd have to look outside of Canada to the United States or Europe. Unfortunately, the United States is not a particularly good model, because that's where many industries are located. I think Canada was a leader in this area but is no longer. Decades have gone by.
Unfortunately, I believe that globally the protection of the public has been reduced. International harmonization means a race to the bottom and lowering the standards. Canada has done that to make it easier to allow drugs on the market.
Liberal
Lui Temelkovski Liberal Oak Ridges—Markham, ON
Thank you.
We've heard from other physicians that they are reluctant to fill out reports on adverse reactions. The reason is that they do not receive any material back. It seems to be a one-way street. Do you share that view? Also, what carrots can we use to have physicians and other stakeholders be active in reporting adverse reactions?
Executive Director, Li Ka Shing Knowledge Institute, St. Michael's Hospital
I personally don't share it. If I were reporting an adverse reaction, I hope I would be doing it out of altruism. The fact that I wouldn't immediately get a response back wouldn't bother me.
I think there are two issues.
To use the example of Vioxx, which everybody now accepts increases the risk of heart attacks, I've had a lot of patients on Vioxx. I'm sure some of my patients on Vioxx had a heart attack, but I never put the two together until the studies were done. A lot of elderly people have heart attacks. When that happens, you don't think about it. I think that's a great example.
If someone had a really weird reaction shortly after starting a drug, most doctors would say maybe the two were connected. But for someone having a heart attack six months after starting Vioxx, it wouldn't have occurred to me. I think it highlights the problems of sort of spontaneous adverse reporting and why you need to look at some of these databases.
Those would be my two comments.
Assistant Professor, Centre for Health Services and Policy Research, University of British Columbia
I'd echo that. One of the main issues here is that ADR reporting is one signal. It's a challenge sometimes to detect those rare occurrences and connect the dots. It's the reason why post-market surveillance and post-market drug safety and effectiveness have to be monitored and evaluated by using a variety of tools, not the least of which is ADR reporting, but also administrative data analyses, and running brand-new trials and other mechanisms.
Liberal
Lui Temelkovski Liberal Oak Ridges—Markham, ON
What role do you see for pharmaco-surveillance centres of excellence in Canada?
Executive Director, Li Ka Shing Knowledge Institute, St. Michael's Hospital
I see those centres being linked to the variety of stakeholders we've talked about--the federal government, the provinces, physicians, and patients--identifying areas of research priority. They would do that highly policy-relevant research and feed that information directly back to Health Canada, the provinces, and the policy-makers so they can use that in their policy-making. That's what I see.
Assistant Professor, Centre for Health Services and Policy Research, University of British Columbia
I see there also being an advantage in having regional centres of excellence. I think we've thrown the idea out there of having three to five centres in the country. Getting closer to the practitioners--those people who are prescribing and dispensing medicines--is important because it builds relationships so the information can be more readily translated into new practices, let alone regulatory policies.
So there's some value in having a network of centres rather than just a single, more isolated centre in the country.