Health Committee on April 27th, 2023

[Jean-Yves Duclos, Liberal, Québec, QC]

Researchers and scientists are putting so much of their work and talent into providing better access and lower prices for large numbers of drugs, which I will be happy to give details to you on.

[The Chair, Liberal, Sean Casey]

Thank you, Minister.

The last round of questions for this panel will come from Dr. Powlowski, please, for five minutes.

[Marcus Powlowski, Liberal, Thunder Bay—Rainy River, ON]

I'm trying to understand the nature of the controversy and the timelines here.

The PMPRB issued draft guidelines on October 22 and they wanted to bring these into effect in December, right? There is a requirement for consultation.

It would seem to me that if you issue guidelines in October and you have basically the month of November, that isn't a lot of time to consult with various stakeholders. Does that not seem to be the case with you as well?

[Jean-Yves Duclos, Liberal, Québec, QC]

Yes. You correctly point to an important connection between the importance and the timing.

The regulations that were put into place on July 1, 2022, are significant regulations. We're changing completely the basket of countries to which we want to compare our drug prices in Canada. This is a fundamental change in the ability of PMPRB to decrease prices and increase the availability of drugs in the next years and decades.

That's why we know that PMPRB will need to take the time and put in the efforts needed to draft and to issue the guidelines that are essential to support those regulations.

It's correct to say that the PMPRB has a big responsibility to assume and considerable work to put into place. We have full confidence in them. However, as you pointed to, I issued a letter in which I encouraged the board to consider taking more time to get those guidelines right.

[Marcus Powlowski, Liberal, Thunder Bay—Rainy River, ON]

That wouldn't seem to me to be the wrong thing to do.

Where we're going from here in terms of.... I think we're focusing on one part, but this has been an ongoing process. In 2017, there were other guidelines issued. The issue went to court. The court decided that part of those guidelines weren't within the mandate of the PMPRB. They came out with these other guidelines. I think you probably quite correctly said that there ought to be more consultation on this process.

In this ongoing process, where are we going from here?

[Jean-Yves Duclos, Liberal, Québec, QC]

That's right. Again, the board is independent, quasi-judicial. It has the ability, the talent and the support needed to write those guidelines. How exactly it will do that is for them to decide.

If you are interested, you can probably invite any of them—I think you will be speaking to some of them today and next week—to ask them about the ways in which they want to proceed to get those guidelines right.

These guidelines, as I just said, are essential. We need to have them right if we want the regulatory power of the changes that were put into place in July 2021 to be maximized.

[Marcus Powlowski, Liberal, Thunder Bay—Rainy River, ON]

The Canadian public ought then to expect in the coming months or year that further guidelines will be issued and that there will be ongoing consultation before guidelines that everybody is aware of are arrived at, including the ministry.

[Jean-Yves Duclos, Liberal, Québec, QC]

That is correct. That's right.

It's a fair question to ask, and I would invite you to ask it to the appropriate board leadership.

[Marcus Powlowski, Liberal, Thunder Bay—Rainy River, ON]

This question is not necessarily for you, Minister.

In Mr. Herder's letter of resignation, one of the things he mentioned was that we failed to appeal the Quebec Court of Appeal decision that struck down certain parts of the guidelines. Can someone in your group answer as to why we decided not to appeal that decision?

[Jean-Yves Duclos, Liberal, Québec, QC]

It's a great question. I will turn to Mr. Abu-Zahra, who is here and very talented.

[T. Nessim Abu-Zahra, Counsel, Health Legal Services Unit, Department of Justice]

Thank you.

Just briefly, the decision as to why this appeal wasn't sought is quite well laid out in the regulatory impact analysis statement. That's the statement that traditionally accompanies the regulatory amendments.

In June 2022, when the Governor in Council repealed the amendments, the RIAS contained a nice explanation about why the decision was made at the time to not pursue the litigation. I direct people to that, but the high-level explanation is that, as is stated in the RIAS, the decision about the evolving pharmaceutical landscape was a policy decision that the Minister of Health made, certainly informed, as set out, by the court decisions. However, I think the Governor in Council's rationale for the repeal was focused on that evolving landscape, which, again, was really set out quite well in the RIAS, which I won't take you through.

[The Chair, Liberal, Sean Casey]

Thank you, Dr. Powlowski.

To you, Minister and to your officials, thank you so much for being here with us today.

I know the format is difficult, but time is the currency of Parliament, and it's hard to divvy up currency in a manner that satisfies everyone. We appreciate your patience and we appreciate your service to your country. We thank you very much for being with us.

Colleagues, we're going to suspend while we allow the witnesses to take their leave and we bring in our next witness of the day.

Thank you all. The meeting is suspended.

[The Chair, Liberal, Sean Casey]

We are now reconvening the meeting.

In the second part of the meeting, we are welcoming Ms. Mélanie Bourassa Forcier.

Ms. Bourassa Forcier, thank you for having taken the time to appear before us today. You have five minutes for an opening address. I know that you were in attendance during the appearance of the last group of witnesses, and so I trust that you are comfortable with how we operate here.

You have the floor.

[Mélanie Bourassa Forcier, Full Professor, As an Individual]

Thank you, Mr. Chair.

I'd like to thank the members for having invited me to testify here today.

My name is Mélanie Bourassa Forcier. I'm a lawyer and a full professor in law at the Université de Sherbrooke. I have a Masters degree in international health policy, majoring in pharmacoeconomics and health economics. In the course of my studies, I focused on several international models for the regulation of innovation and for controlling medicine prices.

I also have a doctorate in law, and my thesis was on Canada's pharmaceutical patents policy. I studied the theory of rational choice and how this interest affected the formulation of public policy and the behaviour of interest groups. Also in my thesis, I addressed various innovative pharmaceutical industry policy strategies, which among other things made it possible to amend the Patent Act on two occasions.

As a professor, I give courses on pharmaceutical law and policy, on health systems governance and on accessibility challenges, particularly among Canada's indigenous communities. As a researcher, I am directing several research projects, one of which is on the social responsibility of the pharmaceutical industry, and on equitable access to patented medicines and vaccines in a pandemic. I have also worked on several occasions on governance, ethics and listening to stakeholders.

I was an ethics and regulatory commissioner for Quebec's Commissaire à la santé et au bien-être, an independent body that is part of Quebec's ministère de la Santé. I am also a member of the Commission de l'éthique en science et en technologie du Québec.

I am here before you in my capacity as a former member, vice-chairperson and acting chairperson of the PMPRB. I was appointed to this position by the Governor in Council in June 2019. I resigned on December 5, 2022.

I'd like to use these few minutes available to me to give you my vision of the board and to make a few recommendations that we might discuss during the round of questions.

I believe that the board is a key organization. Its impressive research division does thorough work. The studies from this division are an excellent source of information for the scientific community.

My view is that the board's quasi-judicial role should be completely separate from its operational role. Its members should only deal with the quasi-judicial sphere, which in turn should be limited to reviewing excessive prices for patented medicines.

As the chairperson is the only person in contact with staff, the minister and the stakeholders, he ought not to sit during hearings. The operational role of the board should be more flexible and allow for innovations in both policies and practices.

The board's mandate should also be clarified. I would ask you the following question: is its only mandate to control excessive pricing of patented medicines, or is its role to ensure accessibility to patented medicines for Canadians?

To ensure effective governance, a serious review of the internal operating rules is required. The board should establish clear and transparent operating procedures for itself. It should also, moreover, provide independent external protection and support for members appointed to the body.

With respect to guidelines, if the board were to keep its mandate as it is, its members should have timely access to the contents of submissions presented in consultations.

More comprehensively and broadly, in terms of innovation and accessibility to medicines, I recommend creating a registry that would monitor the rate of penetration of medicines in Canada as compared to other countries; to review the definition of research and development and to promote research and development being carried out in Canada; and to promote medical innovations, with a capital "I". I further recommend that the Government of Canada maintain a public registry of innovations resulting from public funding, whether solely or in partnership with industry, and that it ensure that what it is funding becomes available in the Canadian market. I further recommend that it establish a fund that will could provide independent financing for groups of patients.

Lastly, this consultation being carried out as part of your study pertains to the quasi-judicial functions of this organization, as well as the rules and decisions of its members acting in that capacity.

Although these members are subject to confidentiality requirements, I will make an effort to answer your questions to the best of my knowledge, with due regard to these requirements.

Thank you.

[The Chair, Liberal, Sean Casey]

Thank you, Dr. Bourassa Forcier.

We will now begin with rounds of questions, starting with the Conservatives for six minutes.

Go ahead, please, Dr. Kitchen.

[Robert Gordon Kitchen, Conservative, Souris—Moose Mountain, SK]

Thank you, Mr. Chair.

Thank you, Madam Forcier. I apologize if I pronounced that wrong.

I only speak a little French.

[Mélanie Bourassa Forcier]

That's okay.

[Robert Gordon Kitchen, Conservative, Souris—Moose Mountain, SK]

Anyway, thank you.

I appreciate your comments, and thank you. We have your letter, which is in front of us. We've had a chance to review it.

I'm wondering if you could, just for those who are watching.... Ultimately, your role basically was as vice-chair and then acting chair. Mr. Herder was chair, but there is a bit of a difference. Can you explain briefly what those differences are between the two?

[Mélanie Bourassa Forcier]

In fact, I was appointed by the Governor in Council as a member and vice-chairperson of the PMPRB. The board has five members appointed by the organization, and they are the vice-chairperson, the chairperson and three other members.

Mr. Herder was one of these members. So I was the vice-chairperson and member, and there was the chairperson, who left that position at the end of the term. Accordingly, it remained unfilled until there was a new appointment. I want to point out that I never put my name forward for the position of chairperson; I acted on an interim basis while waiting for a new chairperson to be appointed.

[Robert Gordon Kitchen, Conservative, Souris—Moose Mountain, SK]

Thank you for that.

With regard to the roles, basically there are members of the PMPRB who do the investigation, correct? Then we have members who are the five who sort of “overview” things, correct?

[Mélanie Bourassa Forcier]

It's a complex organization. If you look at the organization chart, There's the personnel side, which includes an investigation division and a research division, which I spoke about. The investigation division is responsible for reviewing the prices of medicines. When the investigation division concludes that the price of a patented medicine may be excessive, the pharmaceutical company is advised, and it can challenge the determination. In the event of a challenge, there may be a hearing, which would be attended by two members of the board, appointed by the Governor in Council.

So that's one of the roles of the members. As Mr. Davies mentioned earlier in exchanges with the minister, another role of the members is to work on developing guidelines and to handle the consultation process, as provided in section 96 of the Patent Act. That applies only to the members.

[Robert Gordon Kitchen, Conservative, Souris—Moose Mountain, SK]

Thanks for that clarification.

The minister—who is separate, whoever that minister may be—is there to.... Ultimately, it's the issue of transparency and making certain that they are transparent as they move forward, but ultimately, the minister needs to know what the PMPRB is doing, correct?

The minister indicated earlier today that he has met with lots of pharma companies but that he has not met with the PMPRB. Is that unusual?

[Mélanie Bourassa Forcier]

I did that in an acting capacity starting in November 2021. All I can tell you is that I never met the minister during that period. There were times when I would have like to meet him, but having already worked at the provincial level, I'm well aware of the fact that the reporting structure within government organizations must also be complied with.

I was told that to meet the minister, I would have to wait for him to invite me. I therefore never met him because I never received an invitation.

[Robert Gordon Kitchen, Conservative, Souris—Moose Mountain, SK]

Thank you.

You never received an invitation. Mr. Herder has stated that the PMPRB made repeated attempts to reach the minister's office using other channels, yet they never got any answer back. Would you find that unusual from any minister, with the years that you've been there?

[Mélanie Bourassa Forcier]

Once again, I think it's a matter of following the government reporting structure. Mr. Bélair talked about that. I joined in 2019, and was the most recent PMPRB appointee.