Skip to main content Start of content
Start of content

431-00179 (Health)

Petition to the House of Commons, the House of Commons in Parliament assembled, the Government of Canada, Prime Minister Justin Trudeau and Patty Hajdu, Minister of Health

WHEREAS

  • With the proposed changes to PMPRB, it is foreseeable that many companies will delay or even forgo the launching of new innovative medicines in Canada.
  • Trikafta, is a game-changing drug targeting the basic defect of cystic fibrosis. It can treat up to 90% of Canadians with Cystic Fibrosis.
  • TriKafta was approved for sale in the U.S.A., by the FDA in October 2019. Six months ahead of schedule. The FDA commissioner at the time of approval said: "...we used all available programs, including Priority Review, Fast Track, Breakthrough Therapy, and orphan drug designation, to help advance [Trikafta's] approval in the most efficient manner possible..."
  • This one drug alone has so much potential to help the majority of cystic fibrosis patients who previously had no other options to live longer and healthier lives... But due to the uncertain pricing environment in Canada, the chances of this treatment coming to Canada in the near future are slim to uncertain.
  • By Adopting a universal (legally binding) "value" index, namely an (Incremental Cost-Effectiveness Ratio) hereafter referred to as ICER; as currently recommended by PMPRB; of $60k/QALY for drugs for common conditions or $90k/QALY for a drug intended for a rare disease population, it would preclude consideration of many other factors, including severity of disease, other treatment options, challenges of administration, and, indeed, leaves no room for negotiation.

We, the undersigned, Cystic Fibrosis patients, family and friends of Cystic Fibrosis patients and other concerned citizens of Canada, call upon the House of Commons, the House of Commons in Parliament assembled, the Government of Canada, Prime Minister Justin Trudeau and Patty Hajdu, Minister of Health, to:

  • Rescind amendments to the PMPRB. They restrict Canadians from life saving medication (ie Trikafta);
  • Work with Provinces to immediately help and provide access to CF disease modifying drugs currently available in Canada to those who need them (such as CF drugs: Kalydeco, Orkambi and Symdeko);
  • Move quickly to improve and coordinate access to medicines and care for people with rare diseases by developing a separate pan-Canadian rare disease drug review and reimbursement approach to eliminate duplication in the system and ensure timely and equitable access to drugs for rare diseases like cystic fibrosis;
  • Take a leadership role in negotiating a price for gene modulators (Trikafta) for all provinces.

Response by the Minister of Health

Signed by (Minister or Parliamentary Secretary): Darren Fisher

The Government of Canada recognizes the importance of patient access to new therapies for serious or life-threatening conditions.  To date, Health Canada has not received a submission for Trikafta although the Department has been in contact with Vertex Pharma, the manufacturer of Trikafta, with regard to this product.

Any company that wishes to market a new drug in Canada must first obtain regulatory approval to do so. To obtain this approval, a company must file a drug submission to establish that the new drug meets the regulatory requirements relating to safety, quality and effectiveness. The price of a drug is not relevant in the process to obtain Health Canada’s regulatory approval to sell or advertise a new drug in Canada. While Health Canada encourages manufacturers to file drug submissions in Canada, it is ultimately up to a manufacturer to decide whether they choose to seek market authorization for their product in Canada.

In some circumstances, drugs not yet approved in Canada may be accessed through Health Canada’s Special Access Programme (SAP). The SAP provides access to non-marketed drugs to practitioners treating patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable or offer limited options. All requests are practitioner-initiated (generally by a physician) and considered on a case-by-case basis. Decisions are based on the information provided in the request, taking into consideration the severity of the condition, data supporting the use of the drug, other therapies considered and availability of the drug from the manufacturer. Although Health Canada has not received a new drug submission for Trikafta, as of June, 2020, 116 patients in Canada have accessed this drug through the SAP.

Prescription medicine prices in Canada are among the highest in the developed world. This influences Canadians’ access to important medications and the sustainability of Canada’s health care system. Current high prices in Canada strain the budget of public and private insurers and place a financial burden on those who pay out of pocket for medications. The objective of the recent regulatory amendments to the Patented Medicine Regulations is to ensure that the Patented Medicine Prices Review Board (PMPRB) has the correct tools and information to fulfill its mandate to protect Canadian consumers from excessive medicine prices.

Even with lower prices, Canada will remain an important pharmaceutical market and revenues from patented drug sales are expected to continue growing over the next ten years. Drug companies are expected to launch their products in Canada at the same rate as they do today. In fact, industry sponsored studies have found that many countries with lower prices than Canada have faster access to new medicines, including the Netherlands, Sweden, the United Kingdom and Norway. In general, new medicines are launched in all major markets within the same general timeframe, regardless of price.

It is important to note that, due to the COVID-19 pandemic, the Government of Canada has delayed the coming-into-force of the regulatory amendments by six months to minimize the imposition of new administrative burden on the pharmaceutical industry and provide stakeholders with a longer period in which to submit feedback to the PMPRB’s Guidelines consultation process. More information on the delay is available in the Regulatory Impact Assessment Statement (RIAS), published in the Canada Gazette Part II and accessible at the following link: http://gazette.gc.ca/rp-pr/p2/2020/2020-06-10/html/sor-dors126-eng.html

As it relates to specific Incremental Cost-Effectiveness Ratios (ICERs), the PMPRB recently issued revised draft Guidelines (https://www.canada.ca/en/patented-medicine-prices-review/services/consultations/draft-guidelines.html#submissions) that proposes new thresholds. The PMPRB is welcoming stakeholder comments on their revised Guidelines until July 20, 2020. We strongly encourage all interested stakeholders to take part in this consultation process.

We will continue to work with provinces, territories, and other partners to improve the accessibility and affordability of medications. For instance, we know that for many Canadians who require high-cost prescription drugs to treat rare diseases, the cost of these necessary medications can be astronomically high. That is why, as part of Budget 2019, the Government of Canada proposed to invest $1 billion over two years, starting in 2022-23, with up to $500 million per year ongoing, to develop a national strategy for high-cost drugs for rare diseases. This will enable Canadians to achieve better access to the effective treatments they need.

Presented to the House of Commons
Scott Reid (Lanark—Frontenac—Kingston)
May 12, 2020 (Petition No. 431-00179)
Government response tabled
July 20, 2020
Photo - Scott Reid
Lanark—Frontenac—Kingston
Conservative Caucus
Ontario

Only validated signatures are counted towards the total number of signatures.

Disclaimer regarding petitions