Evidence of meeting #13 for Health in the 43rd Parliament, 2nd Session. (The original version is on Parliament’s site, as are the minutes.) The winning word was pmprb.

A recording is available from Parliament.

On the agenda

MPs speaking

Also speaking

John Adams  Board Chair, Best Medicines Coalition
Annie Beauchemin  Executive Director, Patient Access, Pricing, HealthCare Affairs Solutions, Boehringer Ingelheim Canada Ltd.
Mehmood Alibhai  Director, National Policy and Patient Access, Boehringer Ingelheim Canada Ltd.
Stephen Frank  President and Chief Executive Officer, Canadian Life and Health Insurance Association
Colleen Fuller  Representative, Independent Voices for Safe and Effective Drugs
Clerk of the Committee  Mr. Jean-François Pagé

1:40 p.m.

President and Chief Executive Officer, Canadian Life and Health Insurance Association

Stephen Frank

Thank you for the question. I'll make a couple of points.

Drug costs are borne by the employer, so any savings on the price of the medications will flow directly through to the employer and ultimately to the employee. It's sort of a pass-through cost, from our perspective. The savings there would accrue directly to Canadians.

If I may just comment quickly on one of the other elements I heard earlier, I think it is correct to say that there are pricing negotiations occurring within the public system with manufacturers, but those do not apply on the private side. One of the advantages of an approach that would apply to everyone, and one of the things we find attractive about this, is that PMPRB pricing does apply to all Canadians equally. This is an important piece for us.

1:40 p.m.

Conservative

Chris d'Entremont Conservative West Nova, NS

Thank you.

I see that Mr. Adams is back, and I'm hoping he heard the question.

With your partners within your coalition, can you give us a couple of examples of research projects or drugs that might not be available because of these changes? The majority of the presentations we have received—or at least the briefs we have received—have been very negative towards the changes. I think your group is a good representation of that.

1:40 p.m.

Board Chair, Best Medicines Coalition

John Adams

Among our members, we have two patient organizations in the cystic fibrosis space, but I'm going to speak about my direct personal knowledge.

I have a son with a rare condition, which is PKU, or phenylketonuria. He is on the first pharmaceutical and doing extremely well with that one. There is a second pharmaceutical for PKU because the first one doesn't work for everybody. The second one was approved in the United States in 2019 and in Europe in 2020. There's no sign of an application in Canada.

The same drug developer is taking that rare disease seriously. They have launched a clinical trial in Europe and in America—but not in Canada—for the first gene therapy for PKU. There's tangible evidence of at least a delay, if not a complete lack of access, to, frankly, breakthrough therapies for the rare disorder. It affects about 2,500 Canadians, but it's one that I'm intimately familiar with. There's no sign that this drug company is going to make an application for a clinical trial for the gene therapy, for the second drug or for the gene therapy, if and when it appears to be safe and effective.

I would be delighted to do a follow-up with the committee with other tangible examples. It's not the only one, but it's the one that's very near and dear to my own heart.

1:45 p.m.

Liberal

The Chair Liberal Ron McKinnon

Thank you, Mr. d'Entremont.

We go now to Mr. Kelloway for six minutes, please.

December 11th, 2020 / 1:45 p.m.

Liberal

Mike Kelloway Liberal Cape Breton—Canso, NS

Thank you, Mr. Chair.

To you, my colleagues, the witnesses, the analysts, the clerk and all staff, merry Christmas. Hopefully you have a great holiday. Thank you for all the work you do, by the way.

I'm going to start with Ms. Fuller.

Ms. Fuller, I've often heard the claim that lower drug prices will lead to a loss in R and D and manufacturing in Canada. In fact, the countries that receive some of the highest rates of industry investment also have relatively low drug prices. For example, Belgium receives 13 times the investment levels of Canada, despite average prices being 20% or a little lower. In comparison, pharmaceutical investment levels in Canada have been falling for the past 15 years or so, with Canada now having some of the lowest R and D investment and manufacturing activities in the developed world.

Could you comment on that and could you comment on whether there's any evidence to suggest a correlation between affordable drug prices and reduced R and D investments?

1:45 p.m.

Representative, Independent Voices for Safe and Effective Drugs

Colleen Fuller

I think your preface to the question sort of answers the question. Companies invest in countries for, I'm sure, lots of different reasons, including the profit that they can make in that country.

The pharmaceutical industry undertook certain obligations in the North American Free Trade Agreement, as I'm sure you know, regarding their investment in Canada, and they have never reached the level of commitment that they made in the agreement. I don't know all the reasons why they do or don't invest in a country.

I think there are reasons that have to do with their profit levels. I know that in some countries in Europe, companies such as Sanofi, for example, have pushed back against regulations in price controls and have threatened to pull their production out of those countries. They haven't done it, so in spite of the fact that countries will implement stronger regulations and guidelines, they continue to invest. I think it has to do with lots of different considerations, and I'm not saying that I know what they all are.

What I do know is that Canada has the capacity within our own country.... We have the scientists. We have the capacity within our academic sector and scientific sector to do the type of research that's needed to support the development of drugs. I'm not saying that we have to do it without the pharmaceutical industry, but I think that we have the capacity to do that. We frame the question as if we will not be able to do it if the pharmaceutical industry doesn't invest. I question whether that's the case.

1:45 p.m.

Liberal

Mike Kelloway Liberal Cape Breton—Canso, NS

Thank you, Ms. Fuller.

I'm going to stay with you, if that's okay. In written submissions to the committee, some stakeholders have expressed concern that the implementation of the amendments to the patented medicines regulations and the PMPRB guidelines will result in fewer innovative medicines being launched here in Canada. Nineteen pharmaceutical companies have further suggested that the PMPRB guidelines are complex and confusing, which is leading to uncertainty in their decision-making.

As a stakeholder, what steps has the PMPRB taken to ensure that its guidelines can be clearly understood by stakeholders and, for that matter, by the general public?

1:50 p.m.

Representative, Independent Voices for Safe and Effective Drugs

Colleen Fuller

I agree that the guidelines are difficult to understand when you just read through them. I think that the period of consultation that was undertaken by the price review board really enabled people who were involved in those consultations or who were observing them to understand what the impact of the guidelines could possibly be and what the rationale was behind the guidelines. I think that the price review board did its due diligence to help people understand what the guidelines are intended to do.

The pharmaceutical industry, including the companies that you just referred to, have entire legal departments at their disposal to help them understand what obligations they would be required to undertake if they complied with the guidelines.

1:50 p.m.

Liberal

Mike Kelloway Liberal Cape Breton—Canso, NS

Thank you so much.

I'm going to make it three for Ms. Fuller.

Ms. Fuller, how will the updated guidelines make the process of industry stakeholder engagement a more transparent, equitable and accessible process?

1:50 p.m.

Representative, Independent Voices for Safe and Effective Drugs

Colleen Fuller

I'm sorry. I didn't quite understand your question. I'm sorry to take so much time.

1:50 p.m.

Liberal

Mike Kelloway Liberal Cape Breton—Canso, NS

That's okay. I'll repeat it.

How will the updated—and I don't think I said this in my question so that might be the confusion—PMPRB guidelines make the process for industry stakeholder engagement a more transparent, equitable and accessible process?

1:50 p.m.

Representative, Independent Voices for Safe and Effective Drugs

Colleen Fuller

I think that some of the guidelines on transparency will certainly, from my point of view [Technical difficulty—Editor] enable me to understand a lot better what the rationale is on the part of the industry and in the assessment on the part of the board to either approve a proposed introductory price or not. I think that area of transparency is very important to bring some understanding to that.

One of the things I'd like to see on the part of the price review board, however, is a much more vigorous engagement with the Canadian public about the work that they do, what their intentions are and what their mandate is in order for Canadians to better understand it.

1:50 p.m.

Liberal

The Chair Liberal Ron McKinnon

Thank you, Mr. Kelloway.

1:50 p.m.

Liberal

Mike Kelloway Liberal Cape Breton—Canso, NS

Thank you, Ms. Fuller.

1:50 p.m.

Liberal

The Chair Liberal Ron McKinnon

We'll now go to Mr. Thériault.

Mr. Thériault, you have six minutes.

1:50 p.m.

Bloc

Luc Thériault Bloc Montcalm, QC

Thank you, Mr. Chair.

I'd like to welcome all the witnesses and all my colleagues who have worked relentlessly over the past weeks and months. I wish everyone a merry Christmas, a prosperous New Year and a vaccination in 2021. That would be a great gift.

Mr. Adams, first of all, your organization represents many other patient organizations. I would like to point out that you support the principle of drug price reform, “in particular by lowering their prices so that they are in line with those of similar countries”, and therefore more affordable for patients.

Your first recommendation has two parts. In the first recommendation, titled “Phased implementation to immediately lower prices”, you state:

We urge the standing committee to request that the application of the new basket of comparator countries should proceed as planned to bring down prices … for all patients …

You also state:

We urge the standing committee to recommend that the federal government, through cabinet, direct a stay of implementation on parts of the regulations, deferring the application of economic factors in the determination of price to a second stage, pending further study and consultation.

Why do you say that?

1:55 p.m.

Board Chair, Best Medicines Coalition

John Adams

Quite simply, on the first point, the people who are most suffering from drug prices are the patients who are paying out of pocket. That represents about 21% of the total spend on prescription drugs in Canada. They don't have an ability to negotiate a better deal.

The second group of people—and they're represented here most ably by Mr. Frank—are the private insurance carriers. When they choose to, they have an ability to negotiate price on behalf of their plan sponsors.

The third group is the government drug programs which, after 60 years, have done the right thing and are bargaining collectively with drug providers through an informal organization, the pan-Canadian pharmaceutical alliance, which all the governments of Canada are participating in. The government drug plans are looking after themselves and they're doing a good job of it.

The problem is the new factors. The simple truth of it is that there is no other jurisdiction in the world that is using those economic factors for the purpose of price controls on drugs.

Let me make the distinction between price controls by regulation versus price negotiations, where individual patients don't have that clout. That's why we are in favour of the proposal and the regulation to change the comparison among countries to countries that are of a similar capacity to pay—gross domestic product.

The economic factors.... Frankly, if the committee and its analysts could take the time to go back to the six case studies of six different kinds of drugs that the PMPRB staff put forward back in 2008—which have not been updated with the final version of the regulations or the guidelines—you will see the problems there. I would invite a deeper dive by the committee and its analysts. I would be happy to help and point to the right documents.

It would be wonderful if the PMPRB had enough confidence in the rest of us that they would actually open their kimono and show us the details of their spreadsheets, their assumptions and their analysis, so that we could be happy to verify or be happy to dispute. There has been a lack of disclosure by the PMPRB staff of what the assumptions are and what the actual details of their analyses are on those case studies.

With all due respect, colour me skeptical when there is a lack of disclosure. Those are the reasons we are concerned about the significant risk that the government and PMPRB are taking by proceeding with all of the changes at the same time.

For my last point, let me use an analogy of a patient and a doctor. No doctor worth his salt would knowingly start a patient on four new drugs at the same time, because if something works, you don't know what is working. More importantly, if something does not work, you don't know what is causing the problem. The problem with these regulations and guidelines is that they're trying to do four different things at the same time. If something goes wrong, what is actually the central cause of the problem?

We ask for them to pause and reflect. Proceed with the change of basket of comparison countries and let's take a deeper dive into the more likely impacts of each of the three additional new economic factors. This is an experiment in public policy that has not taken place anywhere else in the world.

1:55 p.m.

Bloc

Luc Thériault Bloc Montcalm, QC

Thank you, Mr. Adams.

1:55 p.m.

Liberal

The Chair Liberal Ron McKinnon

Thank you, Mr. Thériault.

1:55 p.m.

Bloc

Luc Thériault Bloc Montcalm, QC

I think I have a minute left.

One of the central principles—

1:55 p.m.

Liberal

The Chair Liberal Ron McKinnon

No, you don't have any time left.

1:55 p.m.

Bloc

Luc Thériault Bloc Montcalm, QC

None at all?

1:55 p.m.

Liberal

The Chair Liberal Ron McKinnon

No, I'm sorry.

2 p.m.

Bloc

Luc Thériault Bloc Montcalm, QC

Does anyone want to give me their time?

2 p.m.

Liberal

The Chair Liberal Ron McKinnon

We go now to Mr. Davies, please, for six minutes.