Health Committee on Dec. 4th, 2025

[Dr. Sameeh Salama]

What I was saying is that the United Kingdom has introduced and actually legislated a new law that came into place that would basically reimburse or pay drug developers. It's a subscription model whereby a developer that introduces a new antibiotic into the United Kingdom would be able to receive up to 10 million pounds per product per year.

The issue that we see with antibiotic resistance is that different countries see different antibiotics being introduced to that market. Due to the reduced number of antibiotics being introduced by the pharmaceutical industry, and that's really driven by the broken market within the antibiotic space, we see a serious lack of new antibiotics being introduced. To incentivize companies to get back into the space, different countries have introduced different legislation.

As mentioned, in the U.K., there's the new rule that came into place to introduce a subscription model. Sweden has piloted a guaranteed payment model, as I mentioned earlier on, and the European Union now is discussing a transferable exclusivity voucher. This would allow different companies that are introducing antibiotics into the markets to have an extension of their exclusivity beyond the patent of their antibiotics in that particular market or they can use that exclusivity voucher for other products that they introduce.

I think we can learn a lot from the European experiences. In particular, Canada has actually been working toward initiating a pilot in the antibiotic space to introduce new antibiotics. Canada lags behind the rest of the G7 and the G20 in terms of introducing antibiotics into the market. We have only three antibiotics out of 18 that are approved in the United States. We can learn from those experiences.

The one model that I think would be very helpful to follow is The Lancet's eClinicalMedicine's recommendation for a fair share of guaranteed revenue for antibiotics produced in Canada in the range of $11 million to $21 million per year.

[The Chair, Liberal, Hedy Fry]

Thank you.

You have 35 seconds.

[Andréanne Larouche, Bloc, Shefford, QC]

I want to turn to Ms. Jennifer Buckley to complete the response on international models.

Mr. Salama mentioned pilot projects in the United Kingdom, Italy and France.

Could you give us your comments on this in 30 seconds?

[Jennifer Buckley]

Just to follow up on what Dr. Salama said, the idea is to create an incentive where there isn't an incentive. The problem with the current approach, of course, is that we want there to be appropriate stewardship of these new medications. You want the medications to be available in Canada, but you want them to be available only when they're needed as opposed to free access. As a result, there will be less utilization and therefore there's less of market, which requires the pull incentives to be able to compensate for that.

As Dr. Salama said, the U.K. has a subscription model that provides that. The European Union is looking at something and France is talking about things for next year as well. Basically, the idea is to correct some of the market failures that currently exist, but also make sure that we protect and ensure that the antibiotics that do come in are available and don't themselves become resistant to treatment.

[The Chair, Liberal, Hedy Fry]

Thank you, Ms. Buckley. We've gone a bit over time on that.

I now want to go to the second round, which is a five-minute round. I will begin with the Conservatives.

Mr. Bailey, go ahead.

[Burton Bailey, Conservative, Red Deer, AB]

Thank you, Madam Chair.

Dr. Salama, Canada relies on foreign manufacturing for 90% of its antibiotics. I think you said three of 18—my information was two of 13—last-resort drugs are available versus the U.S. where all 13 are available or, with your numbers, that would be 18.

Is this vulnerability, as was exposed in the 2020 PPE shortage, why Canadians face 20% higher AMR risks?

Most importantly to me, what is the timeline for domestic production?

[Dr. Sameeh Salama]

There are different parts of your question. I'll try to address them.

In the numbers that I have—and I do have a list here—of the three out of 18 in Canada, one was approved just recently.

The issue that we have in Canada is that there are no incentives for companies to bring their products into Canada. In the models that are being entertained by other nations, we've seen legislation in the U.K., as I mentioned, as well as in Italy and in Sweden, but we don't have those.

With reliance mostly on existing drugs, we face a major problem, because any physician who wants to prescribe an antibiotic to a patient will have to go through the formulary. If the bug is resistant to the antibiotic that's on the formulary, they have to go through the special access program. That creates a logistical problem, because it's not easy to go through that process. It's time-consuming and it really puts pressure on the hospital budget, because the cost for the antibiotic has to come from the hospital budget.

Going back to your question in regard to manufacturing capacity, you're 100% correct: Over 90% of the antibiotics are manufactured in China. If you look at any issues arising between the two nations where.... We've seen with COVID that when companies become self-centred in terms of the need to satisfy the local markets, Canada will be in a very difficult situation. When we are relying on other nations to provide to us, that presents not only a health care crisis but also a national security crisis.

As my colleagues mentioned, antibiotics are at the core. They are the backbone of modern medicine. That really is something that needs to be addressed. Our manufacturing capacity is nowhere near where it needs to be. Obviously, we need to address that.

The majority of antibiotics that are being prescribed belong to a class called beta-lactams. These beta-lactam antibiotics, such as penicillin, need a specialized manufacturing facility. You cannot use the same facility to manufacture anti-cancer drugs or other drugs, because some people have sensitivities to penicillin, for example, so these drugs have to have a dedicated manufacturing facility.

We do need to address the manufacturing capacity. We need to address the R and D capacity in Canada. I mentioned incentives in my opening statement, so I'll stop here and see if there are any follow-up questions.

[Burton Bailey, Conservative, Red Deer, AB]

Thank you.

I'd like you to explain Health Canada's approval process for new medicines and give any recommendations on how this process could be improved.

[Dr. Sameeh Salama]

Perhaps Ms. Buckley would like to answer that.

[Jennifer Buckley]

Currently, the Health Canada approval process is actually not the major problem with the regulatory and reimbursement process. There are current challenges in terms of backlog, but for the most part, the way that Health Canada approves drugs is consistent with international approaches. They're considered a world-class regulator and they do a fairly good job of doing that. The challenges come after Health Canada approval.

It take two and half years after that approval for drugs to be listed on the public formulary. There are quite a few steps in the process that happen after that approval, and they are the reasons that we see challenges for Canadians in getting access to antibiotics, as well as to a host of other drugs.

Health Canada can always get better, and we all can get better, but I would say that it's actually post Health Canada approval that the real challenges are faced in terms of access to medications in this country.

[The Chair, Liberal, Hedy Fry]

Thank you.

I now go to Ms. Sidhu for the Liberals.

You have five minutes, please.

[Sonia Sidhu, Liberal, Brampton South, ON]

Thank you, Madam Chair.

Thank you to all the witnesses.

Dr. Fafard, we know that the AMR strategy places strong emphasis on early detection and rapid diagnosis. How can we expand laboratory capacity to help identify emerging resistant infections more quickly, with actionable results?

[Judith Fafard]

Thank you for your question.

Many resistance tests rely on culturing the microorganism and growing it in a medium that contains the antibiotic. This is known as phenotypic resistance. Genotypic detection needs to be improved through polymerase chain reaction, or PCR, tests to detect resistance quickly. This could improve how quickly scientists are able to detect resistance.

We also have problems related to last-line beta-lactams, which Mr. Salama mentioned. These antibiotics are available through Health Canada's special access program. Some are approved by Health Canada.

We do not yet have commercial tests approved by Health Canada to verify resistance to most of these antibiotics. We have to rely on reference laboratories, such as the National Microbiology Laboratory or provincial public health laboratories, to perform the tests, which increases the time it takes to obtain this information.

[Sonia Sidhu, Liberal, Brampton South, ON]

To follow up, regarding collaboration across jurisdictions and sharing data between laboratories, from your perspective, what improvement would help strengthen coordination between provincial labs and federal surveillance programs?

[Judith Fafard]

Advocating for the harmonization of diagnostic methods and protocols could help facilitate the flow of information. Agreements must also be reached between different levels of government if we want to see genuine data sharing.

[Sonia Sidhu, Liberal, Brampton South, ON]

Thank you.

Dr. Salama, you talked about the Italy model and the Sweden model, but, in Canada, how can industry, government and academic researchers work more closely to address AMR collectively?

[Dr. Sameeh Salama]

I mentioned earlier the pan-Canadian action plan that was launched in 2023, which addressed the four pillars. The four pillars that are outlined in the action plan are surveillance, stewardship, prevention control, and research and development, but the plan also included leadership. That plan was really supposed to be a funded plan that would drive that kind of partnership between the various levels of government and also between academia and industry. It has now been two years since the launch of the plan, and we are still really not seeing a great deal of push, just because that plan has not really been well funded. That's why I'm proposing that we take a look at the pan-Canadian plan 2.0.

The idea here really is to try to stretch that research and innovation across all four pillars. That would allow for more interaction. I would like to emphasize that there needs to be a strong partnership with industry in terms of how these plans are put together so that they are really implementable. We do see great work, great research, happening in Canada here at the academic level, for example, but we don't really see a translation of that into products and services. That's because a lot of the research that happens at the university level is not able to make it. That's why we're calling for push incentives to stimulate the translation of those innovations from the academic level into actual products and services, and similarly for pull incentives.

[Sonia Sidhu, Liberal, Brampton South, ON]

To follow up quickly, if you can, explain what role surveillance plays in the national and global responses to AMR.

[Dr. Sameeh Salama]

I'm not involved in surveillance, so I will not be able to answer that.

[The Chair, Liberal, Hedy Fry]

Is there anyone who wishes to answer that?

[Sonia Sidhu, Liberal, Brampton South, ON]

Ms. Buckley.

[Jennifer Buckley]

I also wouldn't be able to answer a question on surveillance. I apologize.

[The Chair, Liberal, Hedy Fry]

We're going over time now, Dr. Sidhu. Maybe we can explore that with Dr. Fafard or with somebody else later.

Thank you.

Now we'll go to Madame Larouche for six minutes, please.

[Andréanne Larouche, Bloc, Shefford, QC]

Thank you very much, Madam Chair.

For this second round of questions, I will first address you, Ms. Fafard.

In your presentation, you spoke about the need to encourage research and surveillance programs, as well as the economic impact of antimicrobial resistance.

At our last meeting, I did not have enough time for the witness to elaborate. At the end of the meeting, the witness mentioned a lack of means and resources, implying that investments in the health care system were crucial and could have an impact.

Research is also a part of all this, but do you agree that increasing transfers to the provinces for health care and investing directly in the health care system are two important aspects?

How would providing more financial resources to the health care system in Quebec and other provinces help the situation?

[Judith Fafard]

I imagine there are similar problems in other Canadian provinces and territories, but Quebec's health care system is currently under financial pressure. Resources are therefore being allocated to address immediate problems and emergencies.

Although antimicrobial resistance is becoming an increasingly important issue, it may still seem to decision-makers that it is a distant priority in the grand scheme of priorities and emergencies. Allocating resources to research on antimicrobial resistance, monitoring programs, detection tests and the acquisition of new drugs or formulations in pharmacies may be postponed in order to devote scarce resources to more pressing curative problems.