Markwell Clarizio LLP

Announcement of a new Canadian Drug Agency by the Government of Canada

On December 18, 2023, the Government of Canada announced the creation of the Canadian Drug Agency (“CDA”) built from CADTH in partnership with provinces and territories. The implementation of CDA is supported by an investment of $89.5 million over 5 years.  

The creation of the CDA has been in the works for many years. In February 2018, the government created an Advisory Council on the Implementation of National Pharmacare to “ensure every Canadian has access to the medicine they need” and to “make prescription drugs more affordable and accessible”. This led to a sweeping report in 2019 which held that the amount Canadians currently spend on prescription drugs is “unacceptable” and that the federal government should “work with provincial and territorial governments and stakeholders” to establish a universal, single-payer, public pharmacare system. At that time, the government said that this new programme would comprise a Canadian Drug Agency to negotiate prices on behalf of public payors, a national formulary of “essential medicines”, and a national strategy for access to expensive drugs for rare diseases.

In the spring of 2021, the Canadian Drug Agency Transition Office (CDATO) was implemented to work with provinces and territories as well as interested stakeholders on a vision, mission, and mandate for the  CDA.  Since that time, the CDATO has met with and received guidance from provinces, territories, partners and stakeholders to establish the overall scope and function of the CDA.

The precise scope of the CDA has not been revealed publicly. However, the government says in this most recent announcement that the CDA will build on CADTH’s existing mandate and functions of health technology assessment, post-market safety and effectiveness and it will also expand to include the following new mandates:

  • “Improving the appropriate prescribing and use of medications, for better patient health and to support system sustainability”;
  • “Increasing pan-Canadian data collection and expanding access to drug and treatment data, including real-world evidence data, to better support patients, inform health decisions and enable robust system data analytics”; and
  • “Reducing drug system duplication and lack of coordination”.

We will be watching with interest in 2024 to better understand the role that the CDA will play in regulating drug process and market access, and how the government proposes to implement its proposed measures at a federal level without exceeding its legislative authority under s. 91 of the Constitution Act, 1867.