Question Period Note: Accelerating Access to Drugs

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KEY MESSAGES
• The drug access system is a shared responsibility, involving multiple steps and institutions (Health Canada, Canada’s Drug Agency, pan-Canadian Pharmaceutical Alliance, and provinces and territories). We are committed to collaborating with provinces and territories, and partners on improving access to drugs, and ensuring that the federal government contributes directly in this area by upholding its responsibilities for timely regulatory approval.
• The Department’s drug review upholds the highest standards and our approval timelines are comparable to leading regulators worldwide and in some cases, such as for generic drugs, faster than in other jurisdictions.
• Companies’ business decisions on where and when to submit regulatory packages can be influenced by a variety of factors that are most often outside of Health Canada’s control.
IF PRESSED
Q1 : If pressed on the timeliness of drug access in Canada.
A1 :
• We know that Canada’s overall time to patient access to medicines through public plans may lag international peers for certain products.
• Shortening the time to access for drugs is a priority.
• We are committed to collaborating with provinces and territories on improving access to drugs, and ensuring that the federal government contributes directly in this area by upholding its responsibilities for timely regulatory approval.
Q2 : If pressed on strategies to improve timely drug reviews
A2 :
• The Department is implementing several efficiencies to reduce burden on internal resources and industry, including examining internal processes, which are expected to reduce volumes of certain low risk submissions and support increased access.
• The Department is continuing to engage with industry stakeholders in a series of regulatory workshops to develop solutions to manage submission backlogs, and is developing a backlog action plan.
• Health Canada engages the industry to provide guidance and workshops on improving submission quality, as improving approval rates of generic drugs would help address submission backlogs and facilitate faster access.
Q3 : If pressed on generic drug review performance
A3 :
• Health Canada’s human generic drug review program has the fastest review performance standard of our international regulatory partners -- 180 days versus 300 days in the US & Europe, 330 days in Switzerland and 350 days in Australia
• Over the past decade, generic filings have surged – up 43% for new generics and over 200% for changes to marketed generics. The department has boosted its decision rate to keep pace and remains committed to meeting demand as the workload grows.
• Due to year over year increases in the number and complexity of submissions coupled with ongoing hiring restrictions, the Department currently faces a backlog of generic submissions. In this space, operational efficiencies, international work-sharing, and strategic collaborations have helped to increase the output of monthly decisions issued.
Q4 : If pressed on delays in getting new treatments
A4 :
• As a smaller market for pharmaceutical drugs, Canada may receive drug submissions later than other regulators, yet still continues to perform competitively once a product is submitted.
• Pharmaceutical companies determine when and where they will submit a drug to a given jurisdiction, which can lead to a gap between when a drug is submitted for review in Canada versus in other countries.
• Many factors are in play, such as price and profitability forecasts, the relative size of the market, and international regulatory alignment considerations.
• The number of drug submissions and submission complexity have increased substantially, increasing review workload.
Q5 : If pressed on accelerating drug reviews
A5 :
• A sponsor may seek a shortened Priority Review for a serious, life-threatening or severely debilitating condition for which there is substantial evidence of clinical effectiveness.
• A sponsor may seek a shortened review pathway for promising new drugs for serious, life-threatening or severely debilitating conditions, where clinical trials could be used to confirm the drug’s benefit after its approval.
• The expedited review of a drug submission is another tool used to accelerate access to drugs in case of a drug shortage, which takes into account the medical importance of the product as well as the availability of alternative products on the Canadian market.
• Health Canada is developing a reliance order for expanding the use of foreign reviews and reliance with similar minded regulators.
Q6 : If pressed on collaboration
A6:
• Health Canada offers the option of aligned reviews with its downstream health technology assessment organizations, Canada’s Drug Agency and INESSS. This allows a portion of Health Canada's drug review to be conducted in parallel with the health technology assessment review, thereby reducing potential delays between Health Canada’s market authorization decision and the reimbursement recommendations.
• Health Canada also works closely with international regulatory partners to share information and align on evidence-based approaches.
• It strengthens our ability to assess new treatments efficiently and maintain high standards of safety and effectiveness, while reducing barriers to access to medicines.
• In contributing to and adopting internationally aligned approaches, and undertaking successful collaborative reviews with other jurisdictions, Health Canada makes it more attractive for companies to submit their drug applications in Canada.

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• In 2024-25, the Department delivered strong on-time performance, completing 97% of new drug reviews and 84% of generic drug reviews, within established timelines.

• For priority reviews – used to fast-track drugs that address serious conditions - Health Canada leads globally with a median approval time of just 223 days, compared to six major regulators whose timelines range from 244 to 251 days.

• Canada sets one of the fastest generic drug review targets internationally – 180 days versus 300 in the U.S. and 350 in Australia – driving quicker access to affordable medicines and reinforcing its reputation as a top-tier regulator.

• Canadians can face slower access to some drugs compared to international peers. The average total time from first global approval to public reimbursement in Canada was 926 days (2012-2018). Regulatory approval timelines are competitive