Evidence of meeting #16 for Health in the 45th Parliament, 1st session. (The original version is on Parliament’s site, as are the minutes.) The winning word was resistance.
A recording is available from Parliament.
Liberal
Bloc
Andréanne Larouche Bloc Shefford, QC
There is no interpretation. We cannot hear what Mr. Salama is saying.
Liberal
The Chair Liberal Hedy Fry
Apparently, the interpreters will no longer interpret Dr. Salama, because of the issues with the sound, so we have a problem here.
Liberal
Helena Jaczek Liberal Markham—Stouffville, ON
Perhaps I should pose my question to Ms. Buckley, if Dr. Salama can no longer be considered a witness. Is that correct?
Liberal
The Chair Liberal Hedy Fry
He is not going to be interpreted. Madame Larouche isn't going to get interpretation.
What do you think about that, Madame Larouche? Are you prepared to do without interpretation? That's asking a lot, but are you prepared?
Bloc
Andréanne Larouche Bloc Shefford, QC
Madam Chair, of course not. We are entitled to interpretation in both languages. It is my right as a member of Parliament to understand Mr. Salama's answers. It is important.
Normally, when a witness can no longer be interpreted, we can no longer ask them questions.
Liberal
The Chair Liberal Hedy Fry
Thank you.
Dr. Salama, we can no longer use you as a witness for this meeting because of the sound and the impact on the interpreters; it causes problems with their hearing. Because you cannot be interpreted and because we have a right to have testimony in both languages, we will ask you to no longer be a witness. You can leave if you wish. I am so sorry for all of this.
It's very difficult sometimes to get people virtually to get the right headsets, the right equipment. This is a problem sometimes, and I really apologize for all of this. Thank you, Dr. Salama.
Liberal
Helena Jaczek Liberal Markham—Stouffville, ON
Thank you, Madam Chair.
If Dr. Salama heard the question, perhaps he could submit a response in writing to the committee.
Liberal
The Chair Liberal Hedy Fry
Thank you. He seems to have left, but the clerk will ask him to submit a response to the committee in writing.
Liberal
Helena Jaczek Liberal Markham—Stouffville, ON
Thank you. To this point, he's certainly been a very valuable witness.
Now, I will just return to Ms. Buckley.
You were telling us about the whole process in terms of approval of new drugs into Canada's marketplace. Just to finish that conversation, would you make a recommendation that the pan-Canadian action plan on AMR include a need to look very closely at this process, with an eye to expediting it? Would you be in favour of that as a recommendation?
Senior Director, Regulatory Affairs and Clinical Research Transformation, Innovative Medicines Canada
Yes, I think I would. I would also say, though, that another thing that should be included in the AMR action plan is that full incentive, because it's sort of two separate problems. I do think there would be real value in having a look at the drug approval and reimbursement process with an eye to making it more effective so that Canadians have better access to innovative treatments.
Liberal
Helena Jaczek Liberal Markham—Stouffville, ON
I certainly concur. There are two different issues.
What the terms “push incentive” and “pull incentive” actually mean is money for research and for commercialization, presumably from the federal government, do they not? That's what is involved in a pull incentive or a push incentive.
Senior Director, Regulatory Affairs and Clinical Research Transformation, Innovative Medicines Canada
Yes, the push incentives sort of operate at the global level. There are a number of international organizations the Government of Canada supports, CARB-X being one of them, that pool money across the world to try to bring researchers together to develop new antibiotics. It could happen at the academic level. It could happen at the company level, but the idea is to drive that initial innovation.
On the pull side, as I mentioned earlier, it's essentially to correct that market failure, that failure that sort of exists with the model of something like a novel antibiotic. That's because there's that stewardship piece built into it and because you're sort of asking to have access to a treatment that you don't really want to use that often, as opposed to a normal medication where it would get approved and be accessible and anybody who needed it would have access to it. In the antibiotic space, it's different because we would want those treatments to be very limited to hospital pharmacists, to the experts, the infectious disease doctors, those who would know when it was appropriate to bring out those treatments to really deal with the cases where traditional antibiotics wouldn't be available.
Liberal
Helena Jaczek Liberal Markham—Stouffville, ON
Yes, your point about stewardship is very well taken. The market would be small. We would want it to be small.
In terms of those pull incentives, though, Dr. Salama referenced the U.K. Have they been used anywhere in the form of a loan in some way to the pharmaceutical companies? After all, pharmaceutical companies do make a great deal of money on other medications. In developing a new antimicrobial drug, they're obviously going to face, as we've said, a very small market, but in the grand scheme of things, they are very profitable companies, so would it not be reasonable, as is done in federal economic development grants, to do it in the form of a loan?
Senior Director, Regulatory Affairs and Clinical Research Transformation, Innovative Medicines Canada
I can only speak to the U.K. model. As Dr. Salama said, it is a subscription model. It's essentially a process to guarantee a price based on access.
The EU one is slightly different. Again, that hasn't been adopted yet. They're exploring it, and that's sort of a transfer of exclusivity. It's not necessarily a direct financial contribution, but a recognition of the ability to have longer market access for another treatment in exchange for that.
I'm certainly happy to follow up with more details on that and to do some exploration about whether or not there would be some value in that. At this point, what the global pull incentive process would look like hasn't been discussed. There has been quite a bit of research done on what it would need to look like at the global level to really drive innovation in this space. They've strongly suggested the pull incentive and have identified what the fair share would be by country, based on population size and so on, but I can certainly follow up with more information for you after the meeting.
Liberal
The Chair Liberal Hedy Fry
Thank you. If you have it in writing, you could send it to the clerk so that it can be distributed to the committee.
If I may be so bold, because I've been here for so long, there used to be something called Technology Partnerships Canada in the 1990s and the early 2000s. It was run by the federal government. It was cancelled by a new administration in 2006 and it has never been brought back, but I do know that the person who was the deputy minister at the time who ran it at Industry Canada is now a senator, Senator Peter Harder. I don't know if the committee would like to hear from him, but he might be able to tell us how it worked and whether there is a made-in-Canada model we can go back to or whether we can just look at other models and find another one.
I now go to another round.
Mr. Mazier, for the Conservatives, you have five minutes, please.
Conservative
Liberal
The Chair Liberal Hedy Fry
No, we're going to go to her after you. We have time. It's only 12:20, Mr. Mazier.
Conservative
Dan Mazier Conservative Riding Mountain, MB
Okay, thank you.
Thank you, Chair, and thank you to the witnesses.
In a 2023 report on antimicrobial resistance, the Auditor General found concerns in Health Canada's oversight of drug regulation, including delays, poor tracking systems and a lack of performance measurement.
Ms. Buckley, according to the Auditor General, the government had not implemented key recommendations from previous audits. What are the risks when continued problems go unaddressed by this government?
Senior Director, Regulatory Affairs and Clinical Research Transformation, Innovative Medicines Canada
I haven't seen the report, so I can't speak in great detail to it.
I do know, as I work fairly closely with Health Canada, that there have been efforts made recently to address some of the challenges that have arisen with concerns regarding backlogs, etc., and to look at regulatory modernization to build on lessons learned over the last number of years, but without seeing the report itself, I can't speak to it.
Conservative
Dan Mazier Conservative Riding Mountain, MB
What are the risks? If items are not addressed, which they haven't been, what is at risk here?
Senior Director, Regulatory Affairs and Clinical Research Transformation, Innovative Medicines Canada
Again, it's hard to speak without knowing exactly what the risks are, but there's always a risk when challenges that have been identified are not addressed.
However, as I said earlier, I think I probably would need to see the report itself to really be able to answer a question about the specific risks related to those issues.
Conservative
Dan Mazier Conservative Riding Mountain, MB
Ms. Buckley, in budget 2024, the government granted the Minister of Health the authority to “rely on information or decisions of select foreign regulatory authorities in specific instances to satisfy requirements in the Food and Drugs Act and/or its regulations.”
This was supposed to reduce regulatory duplication by recognizing the work of foreign regulatory authorities. According to the government, they have not exercised this new authority.
Can you comment on this and explain what it means?
Senior Director, Regulatory Affairs and Clinical Research Transformation, Innovative Medicines Canada
I can, actually.
The reliance order would allow Health Canada to work with trusted foreign regulators, such as the European Medicines Agency, the Medications and Health Products Regulatory Agency in the U.K. and the FDA in the U.S., for example, to essentially rely on their decisions related to treatment, based on their assessment. That is in the works.
From what we've been told, regulations will be put into the Canada Gazette later this month to actually put in place the ability to do that. The expectation is that this will be done and that it will be available to Health Canada by, I believe, the summer of 2026, so to your point that they have not yet implemented it, they are taking steps to have it available, which is a great development.