Health Committee on Nov. 27th, 2020

[Douglas Clark]

I think a one-stop-shop would be ideal, but when you break down many of the dysfunctional and intractable issues in Canada, a big part of the reason we sometimes can't overcome them is that we're a federation. That's my own personal opinion.

I do think there's a lot of goodwill out there, and you've certainly seen different regulatory bodies in the space and different jurisdictions co-operating and collaborating in a way that we've never seen before, because they have to and because of the cost situation they're confronted with. I think it's an opportune time to capitalize on that goodwill and try to take that further and formalize that co-operation and collaboration.

[Mike Kelloway, Liberal, Cape Breton—Canso, NS]

That's fantastic.

This is another question for both of you or one of you.

Price is considered to be a poor determinant of where new medicines are first launched. Many countries with lower drug prices than Canada, including the Netherlands, Sweden, the U.K. and Norway, have obtained earlier access to new medicines. I think this is an important question for all of us, but for Canadians watching, can you explain how the new guidelines will encourage further pharmaceutical innovation in Canada?

[Douglas Clark]

I don't think we're making that assertion or that claim. We don't have a policy responsibility to encourage innovation. We're an economic regulatory body that ensures that prices of patented medicines aren't excessive. There are a lot of other things going on within government, both federally and provincially. Quebec in particular has an organization, a public-private partnership, called Catalis. They're doing amazing work to try to bring in more clinical trials in that province.

I don't think it's the purview of PMPRB to ensure that its guidelines, regulations and regime in its totality encourage R and D. It would be nice if it did, but we don't have that mandate.

[Mike Kelloway, Liberal, Cape Breton—Canso, NS]

That's fair enough.

Let me go to a third question, if I have time. How much time do I have, Chair?

[The Chair, Liberal, Ron McKinnon]

You have five seconds.

[Mike Kelloway, Liberal, Cape Breton—Canso, NS]

Well, stay tuned for the next edition. I'll pass.

Thanks so much.

[The Chair, Liberal, Ron McKinnon]

Thank you, Mr. Kelloway.

We now go back to Mr. Kmiec. You have five minutes, please.

[Tom Kmiec, Conservative, Calgary Shepard, AB]

Thank you again, Mr. Chair.

Just to go back, I was looking this up online. According to ISED's website, we have 2% of the world's pharmaceutical market, but we attract 4% of clinical trials. Clinical trials, though, are a really important way for patients to get access to drugs that are not approved in Canada or are not for public reimbursement.

Has the PMPRB done any work, or any internal analysis, on what the expected drop in clinical trials will be—over the next, say, one to five years—if these regulations go through, or are they expected to increase? Have you done that analysis? Also, what will the impact be on patients and patient access to some rare-disease drugs, like rare oncology drugs, in Canada?

[Douglas Clark]

It's true that we are 2% of the world market, but that's not a negligible amount. That makes us a top 10 market, so it's not surprising that we would account for a significant amount of clinical trial development. I will say that pharmaceutical patentees, from the industry, account for a small minority of those clinical trials in Canada. They are the exception. It's mostly other organizations within the health care system that conduct those clinical trials.

I can't say that you reduce the price to this or that amount and it will equal this or that number of clinical trials. I just don't think there's a formula that lands you there magically. All I can say is that we are unable to discern a strong correlation between price and clinical trial intensity. In fact, we see the opposite.

[Tom Kmiec, Conservative, Calgary Shepard, AB]

I have a question, then, about the regulations that are to be introduced January 1. Is there any mechanism within the PMPRB that's being planned, or is already set up, that is going to assess the impact of these new regulations, not on price, but on patient access to drugs? Is it going to look at things like how many Canadians are going to the United States or Mexico to get access to drugs? Is it going to look at the number of situations where people go on a GoFundMe page in order to finance a drug that perhaps is approved in Canada but is not up for reimbursement?

What are the metrics that are going to be used, specific to patient access?

[Douglas Clark]

That's an excellent question.

We're working very hard on what we're calling a guidelines monitoring and evaluation plan. It's a very audacious, ambitious plan. We are going to be reaching out. It has four different buckets of things that we'll be looking at and evaluating. There are many metrics falling into each of those buckets, but the things that you've just talked about do squarely fall into them.

We're going to be reaching out very soon to our provincial and territorial colleagues and counterparts to help us formulate an initial framework, and then we're going to be going to patient groups and academics. We're going to be engaging everybody to help us come up with a very exhaustive, comprehensive plan to make sure that if there are any—

[Tom Kmiec, Conservative, Calgary Shepard, AB]

When will it be complete?

[Douglas Clark]

By the end of fall 2021. Before any impact of these guidelines and regulations makes itself felt, we'll have that plan in place. I can assure you of that.

[Tom Kmiec, Conservative, Calgary Shepard, AB]

You're saying the expectation from your agency is that the impact will not be felt between January 1, 2021 and the fall of 2021, before you have this evaluation plan in place.

[Douglas Clark]

No price changes can take place as a result of the new regime until January 2022. I think that's what I'm saying.

[Tom Kmiec, Conservative, Calgary Shepard, AB]

Will you also do an analysis? There's going to be a year lead time going into it, so some companies will obviously be making decisions, and patients are going to be waiting for some of these drugs. They're seeing their friends and people they know travelling to America. Trikafta is a perfect example, because it happens all the time. I just spoke with a patient who is on Trikafta through SAP in Canada, and it's a life-changing experience for her.

How are we going to track situations like hers, where people can't get access to SAP or, after it's approved—if it is approved—are not eligible for it? How will you track that? Will they be part of those metrics showing that these people didn't get access to it?

[Douglas Clark]

Yes, they absolutely will.

There are 4,300 people in Canada who suffer from this awful disease, and Canada is renowned because of CF Canada's very comprehensive and exhaustive database of all of those patients. That's a great tool for us to rely on in being able to track those things, so absolutely, we will.

[The Chair, Liberal, Ron McKinnon]

Thank you, Mr. Kmiec.

We will go now to Mr. Van Bynen, for five minutes.

[Tony Van Bynen, Liberal, Newmarket—Aurora, ON]

Thank you, Mr. Chair, and thank you to our witnesses for joining us again today to share their expertise on PMPRB.

We're living in a world where information is easily accessible to everyone at any time, in any form and anywhere. As a consequence, disinformation is easily accessible. It's often said that disinformation will be halfway around the world before the truth has put its shoes on.

Many if not most of us are not familiar with PMPRB. I'd like to take this opportunity to ask what is fact, what is not, and to elaborate where possible.

With this in mind, could you tell the committee whether the following statement is a myth or a fact: “Lower drug prices will lead to a loss of research and development and manufacturing”?

[Douglas Clark]

There is no empirical evidence to back up that statement, and to the extent that there is empirical evidence, it would suggest a contrary conclusion.

[Tony Van Bynen, Liberal, Newmarket—Aurora, ON]

Thank you.

What are your thoughts on the following statement: “Canada's approach is out of step with that of the rest of the world”? Is this a myth or a fact? How does our approach compare to the rest of the world?

[Douglas Clark]

It's both a fact and a myth. As I said, no two regimes are alike. Canada is the only country with a universal health care system that doesn't include prescription drug coverage. Therefore, the idea was that we would try to approximate what we would be able to secure by way of our monopsony power, if we were buying on behalf of the total population, by creating a ceiling price regulator.

There is no other country that has a ceiling price regulator in this sector like Canada does, but the new economic factors that we're adopting as part of these regulatory changes are based on pharmacoeconomic value, market size/affordability and based on best practices internationally. I'm not aware of any country where these things are not given prominence in the process for determining whether to reimburse a drug and at what price.

[Tony Van Bynen, Liberal, Newmarket—Aurora, ON]

Thank you.

During these challenging times, something that is on everybody's mind is their job. Is the statement “Some drug manufacturers may be forced to cut jobs in Canada” a myth or a fact? Could you elaborate on that?

[Douglas Clark]

I think that question should be directed at the companies. I know there's been a lot of attrition in the pharmaceutical industry footprint in Canada in the last 10 or 15 years. I believe the Prime Minister spoke to that in question period a few days ago. Whether this will exacerbate that is not for me to say.

[Tony Van Bynen, Liberal, Newmarket—Aurora, ON]

It sounds to me like the major differentiator is the fact that we're lacking significantly in homegrown manufacturing.