Question Period Note: PHARMACARE

• The Government has committed to implement national pharmacare, including a Canadian Drug Agency, a national formulary, a national strategy for drugs for rare diseases, and a Canada Pharmacare bill.

• No Canadian should have to choose between paying for prescription drugs and putting food on the table.
• The Government of Canada is committed to continue working with willing provinces and territories towards national pharmacare. This will include tabling a Canada Pharmacare bill and working to have it passed by the end of 2023.
• We have established a Canadian Drug Agency Transition Office and are taking steps to develop a national formulary, while moving forward with developing a national strategy for drugs for rare diseases in collaboration with provinces, territories, stakeholders, and the public.
• We have signed a first agreement with the Government of Prince Edward Island to improve access to medications for Island residents and inform the advancement of national pharmacare.

IF PRESSED ON THE GOVERNMENT’S COMMITMENT TO IMPLEMENT NATIONAL PHARMACARE …
• The mandate letter from the Prime Minister reiterated the Government of Canada’s commitment to continue engaging with willing provinces and territories towards national pharmacare, while proceeding with a national strategy for drugs for rare diseases and advancing the establishment of the Canadian Drug Agency.
• The agreement to bring forward a Canada Pharmacare bill builds on this commitment.

IF PRESSED ON THE CANADA PHARMACARE ACT …
• We look forward to working with all Parliamentarians to ensure that Canadians have better access to the drugs they need.

IF PRESSED ON STATUS OF THE NATIONAL STRATEGY…
• We recognize that for many Canadians who require prescription drugs to treat rare diseases, the cost of these medications can be astronomically high.
• To help Canadians get better access to effective treatments, we are working with provinces, territories and other partners willing to move forward to develop a national strategy for drugs for rare diseases.

IF PRESSED ON THE AFFORDABILITY OF PRESCRIPTION MEDICATIONS…
• We have already taken action to improve accessibility and affordability of prescription drugs. For example, we modernized the way patented drug prices will be regulated in Canada, which will help Canadians afford the prescription medicines they need, improve the health of Canadians and better meet health care system needs.

IF PRESSED ON THE CANADIAN DRUG AGENCY TRANSITION OFFICE…
• The Canadian Drug Agency Transition Office is working closely with provinces and territories, partner organizations, patients, care providers, and stakeholders to develop an approach that addresses shared objectives for better health outcomes for patients and a more sustainable pharmaceuticals management system.

IF PRESSED ON THE DEVELOPMENT OF A NATIONAL FORMULARY AND BULK PURCHASING PLAN …
• Work is already underway to develop a national formulary. Following public consultations this winter, a multidisciplinary national panel will provide its recommendations this summer. The panel’s work was overseen by the Canadian Agency for Drugs and Technologies in Health (CADTH), at the request of Health Canada.
• We will continue to work with all provinces, territories, and stakeholders to lower costs and improve access to the safe, high-quality drugs and vaccines Canadians need.

Supply and Confidence Agreement
The agreement announced on March 22, 2022, committed to continuing progress towards a national pharmacare program by passing a Canada Pharmacare Act by the end of 2023 and then tasking the National Drug Agency [Canadian Drug Agency] to develop a national formulary of essential medicines and bulk purchasing plan by the end of the agreement (June 2025). This commitment was reflected in Budget 2022.

Private Member’s Bill on Pharmacare
On February 24, 2020, NDP MP Peter Julian tabled Private Member’s Bill C-213, An Act to Enact the Canada Pharmacare Act, in the House of Commons. This bill would provide for a legislative framework for a public single-payer drug coverage system in Canada. On February 24, 2021, Bill C-213 was defeated on second reading with a vote of 295 against and 32 for.

Opposition Motion on Pharmacare
On March 13, 2020, the House of Commons unanimously adopted a motion from NDP MP Don Davies (Vancouver Kingsway, BC) that called on the government to negotiate with the PTs to establish a dedicated fiscal transfer for single-payer, public pharmacare. The motion was passed with the Government’s support.

Text of the motion:
(a) acknowledge the government’s intention to introduce and implement national pharmacare;
(b) call on the government to implement the full recommendations of the final report of the Hoskins Advisory Council on the Implementation of National Pharmacare, commencing with the immediate initiation of multilateral negotiations with the provinces and territories to establish a new, dedicated fiscal transfer to support single-payer, public pharmacare that will be long term, predictable, fair and acceptable to provinces and territories;
(c) urge the government to reject the U.S.-style private patchwork approach to drug coverage, which protects the profits of big pharmaceutical and insurance companies, but costs more to Canadians; and
(d) recognize that investing in national pharmacare would help stimulate the economy while making life more affordable for everyone and strengthening our health care system.

Advisory Council on the Implementation of National Pharmacare
In Budget 2018, the Government announced the creation of the Advisory Council on the Implementation of National Pharmacare, chaired by Dr. Eric Hoskins. The Council engaged with Canadians, patients, provincial, territorial and Indigenous leaders, health care experts, and stakeholders through regional roundtables, town halls, an online questionnaire, and written submissions. On June 12, 2019, the Council’s final report was tabled in Parliament, recommending the implementation of national pharmacare over several years.

Budget 2019 Commitments
Guided by the recommendations of the Advisory Council, Budget 2019 announced federal investments to move forward on three foundational elements of national pharmacare:
o Creation of a Canadian Drug Agency to take a coordinated approach towards assessing effectiveness and negotiating drug prices;
o As part of the work of the Agency, development of a national formulary to promote more consistent coverage across the country; and,
o Creation of a national strategy for drugs for rare diseases to help Canadians get better access to the effective treatments they need.

Budget 2019 announced $35 million over four years, starting in 2019-20, to establish a Transition Office to support the creation of a Canadian Drug Agency and national formulary. It also announced an investment of up to $1 billion over two years, starting in 2022-23, with up to $500 million per year ongoing, to help Canadians with rare diseases access the drugs they need.

These commitments were reiterated in the Speech from the Throne, Fall Economic Statement and Budget 2021.

Prince Edward Island Initiative
On August 11, 2021, the Government of Canada announced the signing of the first agreement with the Government of Prince Edward Island (PEI) to inform the advancement of national pharmacare. Through this agreement, PEI will receive $35 million over four years in federal funding to add new drugs to its list of covered drugs, and lower out of pockets costs for drugs covered under existing public plans for Island residents. The Government of Canada will use early lessons from PEI’s efforts to inform its ongoing work to advance national pharmacare.

Modernization of the Patented Medicines Regulations
On August 21, 2019, the Government modernized the Patented Medicines Regulations (‘Amendments’) to ensure the Patented Medicine Prices Review Board (PMPRB) has the tools and information to fulfill its mandate to protect consumers from excessive patented medicine prices. However, the brand-name pharmaceutical industry, and some patient groups, have expressed concerns that the amendments could result in reduced pharmaceutical investments and access to medicines.

The Government has delayed the coming into force of the amendments four times due to considerations associated with the COVID-19 pandemic. The most recently delay of the coming into force date to July 1, 2022, also allows the Government to further engage stakeholders on the application of these amendments within the changing pharmaceutical landscape.

The Amendments have been challenged in the Federal Court and Superior Court of Quebec by Innovative Medicines Canada (IMC) and sixteen subsidiaries of brand-name companies. On June 29, 2020, in the ruling of the case IMC v Canada, the Federal Court upheld most of the regulatory amendments, but struck down the collection of confidential rebate information. On December 18, 2020, a similar decision was issued by the Quebec Superior Court in Merck et al vs the Attorney General of Canada to uphold the constitutionality of the existing regime and regulatory amendments. Following this, the Court of Appeal of Québec on February 18, 2022, upheld the constitutionality of the existing regime and the validity of the updated basket of comparator countries, but found that the three new price regulatory factors in addition to the collection of confidential rebate information to be invalid.

KEY FACTS
• In Budget 2018, the Government announced the creation of the Advisory Council on the Implementation of National Pharmacare, chaired by Dr. Eric Hoskins. On June 12, 2019, the Council’s final report was tabled, recommending the implementation of national pharmacare.
• Budget 2019 announced $35 million over four years, starting in 2019-20, to establish a Transition Office to support the creation of a Canadian Drug Agency and national formulary. It also announced an investment of up to $1 billion over two years, starting in 2022-23, with up to $500 million per year ongoing, to help Canadians with rare diseases access the drugs they need.
• On August 11, 2021, the federal government announced an agreement to provide Prince Edward Island with $35 million over four years (from 2021-22 to 2024-25) to support the province’s efforts to provide its residents with more affordable access to prescription drugs.
• Budget 2022 announced that the federal government will continue its ongoing work towards a national pharmacare program. This will include tabling a Canada Pharmacare bill and working to have it passed by the end of 2023, and then tasking the Canadian Drug Agency to develop a national formulary of essential medicines and bulk purchasing plan.