Thank you. Mr. Chair.
I'd like to thank the committee for this opportunity to speak about what the government is doing to improve Canadians’ access to quality and affordable medicines.
With me today from the Department of Health are Mr. Stephen Lucas, Deputy Minister, Mr. Eric Bélair, Associate Assistant Deputy Minister, Strategic Policy Branch, as well as Mr. Nessim Abu-Zahra, counsel, from the Department of Justice Health Legal Services Unit.
Canada has among the highest patented medicine prices in the world, and these high prices can impact the ability of patients to access new medicines. This is unacceptable.
The Government of Canada supports and respects the role of the Patented Medicine Prices Review Board, the PMPRB, as a strong, independent quasi-judicial body that protects the interests of Canadian consumers by ensuring that the prices of patented medicines sold in Canada are not excessive.
Today, I will begin my remarks with a few words about my role with respect to the PMPRB, the role of PMPRB itself, as well as the role of Health Canada.
The PMPRB is an independent, quasi-judicial body that carries out its mandate at arm's length from the Minister of Health and operates independently from Health Canada.
As Minister of Health, I am responsible for the patented medicine pricing provisions of the Patent Act. These sections of the act establish the PMPRB and its authorities, as well as my responsibilities with respect to the board.
The patented medicines regulations fall under my responsibility as Minister of Health. In fact, the Patent Act sets out that certain regulations can be made by only the Governor in Council, based on my recommendation, following consultation with stakeholders, including provinces and territories, consumer groups and the pharmaceutical industry.
It is also subsection 96(4) of the Patent Act that gives PMPRB, after consultation, the authority to issue non-binding guidelines.
You will recall that following the initial publication in 2019 of the proposed amendments to the patented medicines regulations, the validity of the amendments was challenged in the Federal Court and the Quebec Superior Court. Although aspects of the amendments were held to be valid, important elements were struck down. In particular, the Quebec Court of Appeal found that two elements were unconstitutional.
On July 1, 2022, revised amendments to the patented medicines regulations came into force to provide the PMPRB with new tools to protect Canadians from excessive prices. To operationalize these amendments to the patented medicines regulations and to modernize other aspects of its existing guidelines, the PMPRB proposed new guidelines in October 2022 and posted them for a 60-day consultation period.
Subsection 96(5) of the Patent Act states that the PMPRB must consult with various parties, including the Minister of Health, before the issuance of any guidelines. This requirement to consult and who must be consulted were also highlighted in the letter published on March 3, 2023, by the former acting chairperson.
It is in that context that I provided a letter to the chairperson of the PMPRB, sharing my views with respect to the consultations on the proposed guidelines. In this letter, I respectfully invited the board to consider pausing the consultation process to allow more time for stakeholders, including provinces and territories, to fully understand the short- and long-term impacts of the proposed new guidelines.
In the interests of transparency, this letter has also been made public.
In my role as Minister of Health, I meet regularly with a wide range of stakeholders on many issues that touch the health of Canadians. That's also what I'm doing here. I've heard the views of industry. I've also listened to the concerns of patients, health care professionals and other stakeholders, including my counterparts across the country, about access to medicines.
It is with this in mind, in view of the importance of this issue, that I asked that the PMPRB consider a pause as a way to allow all stakeholders to engage meaningfully in the consultation process.
Our government has undertaken an ambitious pharmaceutical, biomanufacturing and life sciences agenda. That includes moving ahead with the regulatory amendments to the patented medicines regulations, improving access to medications, accelerating innovation and streamlining regulations and having a national strategy for drugs for rare diseases, all while supporting a vibrant biomanufacturing and life sciences industry.
We are also making progress towards establishing a Canadian drug agency, and we remain committed to tabling a pharmacare act.
To conclude, I want to underscore the fact that our government is firmly determined to improve accessibility to medicines at more affordable prices. The PMPRB will continue to play an important role in exercising its authority as an independent body to oversee the prices of patented medicines in Canada.
I'd be happy to answer your questions.
Thank you.