Improving Timely Access to Medicines

Regulatory Review of Drugs and Devices in Canada

Megan Bettle
Regulatory Review of Drugs and Devices Biologics and
Genetic Therapies Directorate, Health Canada


oles and responsibilities in the Canadian healthcare system are shared between different levels of government.

The federal government’s role includes setting and administering national principles, while direct health and social service delivery for most citizens is primarily the role of the provinces and territories. In 2016, Canadian provincial, territorial, and federal health ministers committed to work together to improve the affordability, accessibility, and appropriate use of prescription drugs.

What are the access issues?

While the single-payer public healthcare system provides universal healthcare, including drugs used in hospitals, costs for drugs used outside of hospitals may not be covered. Provincial drug plans pay for many medicines and devices for specific populations, while other Canadians have a significant portion of drug and device costs paid for via private health insurance, or have no drug plan coverage at all and therefore have to pay out-of-pocket. Additionally, the interplay between federal and provincial/territorial roles in Canadian healthcare requires a multi-step process to get drugs from development through regulatory approvals, health technology assessment, price negotiation and payment decisions, and finally to the patients who need them. This process, with independent stages of review by different organizations, can mean that from the time a new drug regulatory submission is received, it can be two years or longer before a patient receives the drug and has it paid for under a public or private health plan.

The government commitment to improving drug access has been reinforced by significant funding in the 2017 federal budget to Health Canada (the federal drug regulator), the Canadian Agency for Drugs and Technologies in Health (a health technology assessment organization), and the Patented Medicines Price Review Board (which ensures that prices on patented medicines are not excessive). Part of this investment is driving a large-scale transformation, over the next five years, of how the various systems and players work together to bring therapeutic products to market. This initiative, called the Regulatory Review of Drugs and Devices, consists of regulatory and policy changes to improve timely access to safe drugs for patients, including accelerated market access to innovative technologies coming to market. This initiative began in 2017, and a variety of projects attacking the problem of drug access have been developed.

Some of these projects include:

  • Examining possibilities to share work with other regulators, or, in certain circumstances, to rely on the decisions of other regulators.
  • Creating a new unit dedicated to the review of digital health technologies, and enhancing support for medical device submissions.
  • Investing in additional scientific review capacity, particularly to support evaluations of generic drugs and biosimilars.
  • Identifying regulations that must be updated to support the complexities of the current drug development space, and processes to be modified in order to streamline how the regulator interacts with industry, patients and prescribers, and other parties.

One project with significant internal and external interest is a re-examination of the criteria used to determine if a drug will receive priority review. The established priority review pathway currently allows for a 180-day review target for a drug that meets an unmet medical need for a serious, life-threatening or severely debilitating disease, compared to a 300-day target for the review of a standard drug submission. Consideration of “healthcare system need” as a factor in this decision-making would provide a mechanism to accelerate review for the right drugs at the right time, including drugs which are regulated under orphan drug frameworks in other jurisdictions. However, defining exactly what would be considered as a healthcare system need, and the mechanisms for making these decisions, will require considerable consultation and analysis before this could be implemented.

Another exciting initiative already demonstrating concrete results has Health Canada working more with health technology assessment organizations to share information, reduce overlap, and, wherever possible, better align review processes. This work builds on a successful pilot that overall has saved time with getting products to market.

As we look back at 2017, we can be confident that in this first year of the initiative, Health Canada and interested health partners have begun to establish effective relationships and a clear path forward for working together through some of the regulatory and systemic issues which can contribute to delaying access to needed drugs. Health Canada will continue to work closely with all those affected by changes in the system in order for these initiatives to be implemented effectively and for the benefit of patients.

Watch this space for further updates on our challenges and successes.

References available upon request.