It would be important to increase health transfers to Quebec and the other provinces in order to provide them with more financial resources.
Would you agree?
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.
Bloc
Andréanne Larouche Bloc Shefford, QC
It would be important to increase health transfers to Quebec and the other provinces in order to provide them with more financial resources.
Would you agree?
Medical Doctor, As an Individual
I cannot comment on the origin of the resources, but having more resources in health systems would be beneficial.
Bloc
Andréanne Larouche Bloc Shefford, QC
In addition to health care transfers, the federal government is responsible for supplying personal protective equipment, or PPE, funding research and procuring vaccines.
What would be one priority to keep in mind?
Medical Doctor, As an Individual
As I mentioned in my presentation, I believe that improving our monitoring systems in order to better target interventions would be important.
Bloc
Andréanne Larouche Bloc Shefford, QC
Mr. Salama, in your presentation, you also mentioned the importance of protecting the health care system.
In addition to the answers to the questions I just asked Ms. Fafard regarding the resource and financial needs of the health care system, how could increased federal government transfers and investments in the health care system be useful in the fight against antimicrobial resistance?
Chair, Canadian Antimicrobial Innovation Coalition, Chief Scientific Officer, Fedora Pharmaceuticals Inc.
As I mentioned before, the one thing being faced by hospital budgets is the fact that whenever we need to prescribe an antibiotic that is not on the formulary, the hospital has to make a decision to order that antibiotic. If a hospital administrator is faced with a decision to either order an MRI or put money toward antibiotics on a special access program, guess what will go through?
If we are not able to fix the system at the root of the problem and address it by providing incentives to bring more antibiotics in the country to make sure they are on the formulary, this pressure will continue on the hospital budget. I see that from a local issue at the hospital level, but you can multiply that across hospitals right across the country.
Bloc
Andréanne Larouche Bloc Shefford, QC
Thank you.
Ms. Buckley, you began your opening remarks by talking about the story of a patient with a serious illness. I would like to give you the opportunity to take more time to explain how this case illustrates the issue of antimicrobial resistance. The ideal medicine for him was not available.
Did I understand that correctly?
Please explain this patient's situation to us in detail.
Senior Director, Regulatory Affairs and Clinical Research Transformation, Innovative Medicines Canada
The challenge, currently, is that there will be patients who will have a resistant infection. Physicians who are treating the patient will try what they have available on the formulary, so that's first-line or second-line antibiotics. When they get to a point that those that are currently available are not working, they have to try third-line and sometimes fourth-line antibiotics.
Generally speaking, we don't have access to those in Canada, so those medications must be sourced through a special access program where they're imported from another country where they are available. With some of these infections, that delay in treatment can actually be fatal or it can cause much more serious consequences for the patients because of that delay.
Liberal
Conservative
Matt Strauss Conservative Kitchener South—Hespeler, ON
Ms. Buckley, multiple witnesses today, and actually in a meeting earlier, mentioned this issue that only three out of 18 new antibiotics over the last 10 years have made their way to Canada. In another answer, you were describing that, by your lights, the problem isn't Health Canada and the regulatory process necessarily, but post Health Canada.
To zero in on these 15 missing antibiotics, are they post Health Canada or are they pre-Health Canada? Why specifically did they not make it here?
Senior Director, Regulatory Affairs and Clinical Research Transformation, Innovative Medicines Canada
I don't know that I can speak in specific detail about those antibiotics, but I can tell you that generally what happens is companies will decide not to even attempt to get a regulatory approval in Canada, given the challenges post approval. Because it takes up to two years for those things to be listed, they may not even try to get a regulatory approval at all. That's what causes the challenge with access. They're not even launched here. We don't try to approve them here.
Conservative
Matt Strauss Conservative Kitchener South—Hespeler, ON
Can you educate me on what this post-approval process is? Is it under the federal government's auspices or not, if it's post Health Canada?
Senior Director, Regulatory Affairs and Clinical Research Transformation, Innovative Medicines Canada
It's a combination of federal and provincial responsibilities. Generally, what happens is that there is a Health Canada approval, which looks at the quality, safety and efficacy of a treatment to make sure it's safe for patients and it's effective.
Then it will go through a health technology assessment done by the Canadian drug agency, which is a federal agency but not part of the government. It's a stand-alone agency. They will look at the treatment to determine whether or not it's cost-effective for the health system. Is the cost congruent with investments based on whether it's going to have a big enough impact on patient care?
Then it moves to the provincial level. The CDA will determine whether or not it's cost-effective and then it goes to the provinces through something that's called the pan-Canadian Pharmaceutical Alliance. In that step, there will be a negotiation between the provinces and the companies to determine what the price may be and whether it will get listed. Once that's decided, it will be listed on the provincial formularies.
That can take two and a half years. If you look at the list time to market for, say, a private sector...or something listed on a private plan, it takes much less time. The challenge with the process is, of course, that there are multiple steps, as I've just explained by going through them, but there can also be delays even between when those steps happen. Something may be completed and it may take up to six months for the next step to even pick up the file and work on that.
All those steps and all that process means it takes a really long time for the drugs to get to Canadians.
Conservative
Matt Strauss Conservative Kitchener South—Hespeler, ON
It seems to me that Health Canada decides if this is safe and effective, based on your answer. Then the CDA decides if it's cost-effective and then provincial governments, with some interface with hospitals, decide whether they're actually going to pay for it.
It seems like those second and third steps—is it cost-effective and should we pay for it—are the same step. It almost seems to me like that second step with CDA could be removed or abolished. What would you think of that?
Senior Director, Regulatory Affairs and Clinical Research Transformation, Innovative Medicines Canada
I'm not sure I can answer that question, but I certainly can follow up with some additional information on that once I speak with some of my colleagues, if that would be appropriate.
Conservative
Matt Strauss Conservative Kitchener South—Hespeler, ON
Yes, it would be interesting.
How does it manage to take two and a half years to do this, post Health Canada? If I think of how I would analyze whether a drug is cost-effective, I don't see how I spend two and a half years doing that. Do you have any info on that?
Senior Director, Regulatory Affairs and Clinical Research Transformation, Innovative Medicines Canada
As I said, the steps themselves take some time. There's obviously some work that needs to be done, but one of the challenges is that there are delays in when things are picked up.
For Health Canada and CDA, the gap between those two steps in the process seems to be getting shorter, which is great, but what will often happen is that the CDA will make a decision about whether something is cost-effective and then it may take up to six months for the PCPA to be able to pick that file up.
Conservative
Matt Strauss Conservative Kitchener South—Hespeler, ON
If I'm a drug company and I'm like, “Oh man, this is going to take years. I don't even know if the CDA's going to pick up the file”, why don't I say, “I'll still put the application in to Health Canada. I might as well just get the ball rolling.”
Is there a financial cost? What is the cost of just getting the ball rolling and putting in the application in the first place?
Senior Director, Regulatory Affairs and Clinical Research Transformation, Innovative Medicines Canada
There is a fairly significant cost to starting the process. There are fees related to applying for Health Canada approval. There's staff time and there are investments that go into that. I think that's part of the challenge.
I think a lot of companies do try to launch medications even though they know that the process is going to take a lot of time. In the antibiotics space, what complicates it further is there's that complication related to the process, but then there's also the market issue itself.
A standard medication or treatment would get launched and then a lot of patients would use it. That's the typical model. In the antibiotics space, as I said earlier, we don't want people to use these unless they absolutely have to, so it's harder from a market perspective, which is why the pull incentives are so important. They make sure that we can protect and have appropriate stewardship of those medications, so that they are available when they're needed and then they don't themselves become resistant, which is what's happened with a number of the antibiotics that have been developed in the past. They've been—
Liberal
The Chair Liberal Hedy Fry
Thank you, Ms. Buckley.
We've just gone one minute and 15 seconds over time here. Because we only have three witnesses and we have time, I am letting a lot of this go over time, but can I ask committee members to be careful? If I give you a 14-second warning, you only have 14 seconds and not an extra one minute and 14 seconds.
I will allow this because we only have three witnesses. When we have a full slate of witnesses, it may not be possible.
We'll go to Ms. Jaczek for five minutes, but we'll go over if you wish.
Liberal
Helena Jaczek Liberal Markham—Stouffville, ON
Thank you to our witnesses. I've had the pleasure of having conversations with Dr. Salama and Ms. Buckley previously at the science and research committee on this very topic.
I really do appreciate the previous colleagues' questions because this is exactly what I would like to ask Dr. Salama. We've heard from Ms. Buckley in terms of the process with Health Canada and then Canada's Drug Agency and so on.
Would you recommend, or is part of the pan-Canadian action plan to push the federal government to look very seriously at this process with a view to, in some way, speeding it up?
Chair, Canadian Antimicrobial Innovation Coalition, Chief Scientific Officer, Fedora Pharmaceuticals Inc.
[Technical difficulty—Editor]
Liberal
Helena Jaczek Liberal Markham—Stouffville, ON
Dr. Salama, did you hear my question? It related specifically to the line of questioning that Dr. Strauss had in relation to the lengthy process of Health Canada and then Canada's Drug Agency, etc.
Is this part of the pan-Canadian action plan? Is this a gap that you would like to make a recommendation related to?
Chair, Canadian Antimicrobial Innovation Coalition, Chief Scientific Officer, Fedora Pharmaceuticals Inc.
I'm having some audio problems [Technical difficulty—Editor].
I'm sorry. Would you mind repeating the question?