Question Period Note: Canadian Drug Agency

N/A

• The government is committed to creating a new Canadian Drug Agency (CDA, the Agency). The Canadian Drug Agency Transition Office (CDATO) is engaging provinces, territories, patients, and stakeholders to develop options for the mandate and functions of the new agency. The CDATO also supports work on other pharmacare-related initiatives (e.g., national formulary, drugs for rare diseases strategy, Canada Pharmacare Bill).
KEY MESSAGES
• Prescription drug prices in Canada are among the highest in the developed world.
• High prices and a patchwork of drug coverage leaves many Canadians facing significant barriers to getting the prescription drugs they need.
• The CDA will provide the structure and system coordination required to support efforts to make our drug system more accessible, sustainable, and prepared for the future.
• To inform options for the CDA, we have met with all provinces and territories and hundreds of stakeholders, including healthcare professionals, patient organizations, and industry.
• We are developing a principled approach that prioritizes respect for jurisdiction, builds on system strengths, and focuses on the continued involvement of patients and stakeholders.
IF PRESSED ON THE NEED FOR A CANADIAN DRUG AGENCY …
• Canada has internationally recognized pockets of excellence in pharmaceuticals management, including the regulatory approvals process within Health Canada.
• The CDA will focus on the system as a whole to address gaps, remove duplication, improve system coordination and enhance access and equity.
• The CDA will also provide the dedicated leadership and capacity that is needed to implement national priorities to improve the pharmaceuticals system.
• The CDA will not duplicate well-performing functions or organizations.
IF PRESSED ON RESULTS TO DATE …
• The Government of Canada is working closely with provinces and territories and key stakeholders as we consider options for establishing the Canadian Drug Agency.
• We have held over 300 meetings and roundtables to obtain advice from PTs and stakeholders on the potential scope and functions of a CDA, including input from patient organizations, pharmaceutical companies, insurers, healthcare professionals, academics, and others.
• This has informed the development of options for establishing the Agency, including its mandate and functions.
• We will continue to communicate as work progresses towards launching the Agency.
IF PRESSED ON RESPECTING PROVINCIAL AND TERRITORIAL JURISDICTION …
• Provincial and territorial healthcare systems, including public drug plans, are facing mounting pressure, exacerbated by the pandemic.
• Our approach will focus on filling gaps, improving access, and system sustainability.
• The CDA will respect provincial and territorial jurisdiction and will not duplicate well-performing functions and organizations.
• Federal, provincial, territorial collaboration is the cornerstone of our approach for establishing the CDA, and we will continue to work collaboratively with jurisdictions toward its launch.

Advisory Council on the Implementation of National Pharmacare
• Budget 2018 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 universal pharmacare over several years, including FPT collaboration to create a new arms-length Canadian Drug Agency with the following functions:
o Assessing the clinical effectiveness of drugs compared to other treatment options
o Assessing the cost effectiveness of drugs compared to other treatment options
o Deciding which drugs and related products (such as devices and supplies) should be on the national formulary
o Negotiating prices and supply arrangements with manufacturers
o Providing advice to prescribers, pharmacists, and patients on how best to use drugs
o Monitoring the safety and effectiveness of drugs in real-world use
Budget Commitments
• 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 proposed $35 million over four years, starting in 2019-20, to establish a Transition Office to support this initiative. 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 2020 Fall Economic Statement, Budget 2021 and Budget 2022.
External Perspectives
Media and Public Opinion
• Canadians are generally supportive of improving affordable access to prescription drugs but are also sensitive to cost considerations as government health-related expenses continue to grow, particularly in the context of COVID-19.
• Mainstream media coverage of the pharmaceuticals system focuses primarily on approval of new treatments, science-based innovation, clinical trail breakthroughs, and accessibility / affordability of treatments from a human interest perspective.
• Media reports are generally factual, and link the mandate letter and related federal Budget announcements. Select media emphasize Quebec’s unique approach to health.
• A May 2022 Fraser Institute poll following the federal budget, found that 79% of Canadians support universal national pharmacare with no costs attached. Support fell by almost half, to 40%, if the program was to be financed by an increase in the GST.
• An October 2020 Angus Reid study found that one quarter (26%) of Canadians had to pay for half or more of their prescription drug costs in the past year. Nearly nine-in-ten Canadians supported the idea (86%) of an affordable drugs program and more than seven-in-ten (77%) said increasing coverage should be a high priority for government.
Stakeholders
• The stakeholder ecosystem for the pharmaceuticals management system is very large and diverse, including patients, patient organizations, Indigenous representatives, healthcare professionals, prescribers, dispensers, scientists and researchers, employers and employees, and innovative and generic manufacturers.
• Some stakeholders, including brand name manufacturers and unions, have developed written input to share their perspectives on the mandate and role of a CDA.
• Industry emphasizes priorities such as accelerating approvals processes, support for innovation, a data-driven approach to technology assessment, value analysis, and assessing treatment outcomes.
Provinces and territories
• Through the Council of the Federation, provincial and territorial Premiers publicly and persistently call on the federal government to increase funding for healthcare through the Canada Health Transfer (CHT),
• Premiers sometime note pharmaceuticals among the priority areas, including in July 2022.
Pharmaceuticals Management Landscape
• In recent years, decisions related to system management have been driven by rapidly evolving system demands, new technologies, and evolving international market factors that have been challenging to reconcile with the traditional division of responsibilities and the provisions of the Canada Health Act.
• This has resulted in gaps, challenges, and inefficiencies particularly in relation to:
o Coordination across jurisdictions and throughout the life cycle of a drug
o Data, real-world evidence, and analytical capacity
o Health outcomes and appropriate use
o Negotiations, pricing mechanisms and sustainability

• Key reports on the future of the Canadian pharmaceuticals system recommended the creation of a new national drug agency that would build on existing provincial and territorial successes and take a coordinated approach to improving system management.
• The Canadian Drug Agency Transition Office was established in spring 2021 to work with provinces, territories and key stakeholders on options for a Canadian Drug Agency (CDA) supported by a Budget 2019 investment of $35 million over four years.
• In December 2021, the Prime Minister reinforced the commitment to creating the CDA in the Minister of Health’s mandate letter, stating the government would “continue engaging with willing provinces and territories towards national universal pharmacare, while proceeding with a national strategy on high-cost drugs for rare diseases and advancing the establishment of the Canada [sic] Drug Agency.”
• In March 2022, the Prime Minister elaborated on the mandate of the CDA in the Supply and Confidence Agreement with the New Democratic Party of Canada, announcing the CDA will “develop a national formulary of essential medicines and bulk purchasing plan by the end of the agreement” in 2025. This commitment was reiterated in Budget 2022.
• Work to develop a proposal for establishing a CDA has been informed by analysis of the current pharmaceuticals management system and significant engagement, including meetings with all provinces and territories, and hundreds of stakeholders such as healthcare professionals, patient organizations, and industry.