Around the Globe CANADA

Funding Established for Canadian Drug Agency Transition Office
Judith Glennie
JL Glennie Consulting Inc.

he September 2021 federal election represented a second trip to the polls for Canadians in the last two years, resulting in another minority government for the incumbent Liberal Party. From a pharmaceutical policy perspective, the party platform mirrored the federal budget tabled in April 2021 and affirmed previous direction on files related to this sector. In the context of this renewed mandate, it is worth reviewing recent developments in the Canadian pharmaceutical policy space and how they might move forward in the future.

Canadian Drug Agency

As noted in the September 2021 Global Forum, the creation of a National Pharmacare program has been a focus of the Federal Liberal government since their election in 2015. The government has started to advance some of the recommendations made by the Advisory Council on the Implementation of National Pharmacare. Specific to the proposed Canadian Drug Agency (CDA), Susan Fitzpatrick, head of the CDA Transition Office within Health Canada, recently gave an update on the work being done by her group.

The federal government established funding in the amount of $35M over four years for the Transition Office to establish the CDA. Ms. Fitzpatrick’s mandate is to bring forward viable options to the federal government for the structure and governance of the agency. Principles underpinning the Transition Office’s work include:

  • Make sure that the CDA does not interrupt functions that are already working;
  • Put a focus on bringing existing programs together and/or aligning their activities;
  • Avoid duplication and determine value-added areas and/or gaps where the CDA can contribute; and
  • Consider the value of bringing national coordination to various activities (e.g., data analytics, appropriate use initiatives, drug shortages, etc.).

The office has undertaken consultations with a broad range of stakeholders, both nationally and internationally. There have been 120 stakeholder meetings to date, with the early focus on the following groups: provinces and territories; agencies focused on pharmaceuticals; medical institutions, academia, and research organizations; and industry, healthcare professionals, pharmacy, private insurance plans, and distributors. The Transition Office intends to continue these activities through Fall/Winter 2021.

The office is in the process of compiling the inputs from these consultations. Several learnings have emerged from discussions to date (see below). These insights speak to an opportunity to build on existing activities and work toward greater national cohesion.

  • High level of interest in and desire for engagement with the agency
  • Achievements thus far by the provinces (via the pan-Canadian Pharmaceutical Alliance [pCPA]) in improving drug pricing and leveraging bargaining power
  • Established alignment efforts between Health Canada and health technology assessment (HTA) bodies.

In addition, stakeholders have identified data infrastructure and analytics as areas that the CDA could address. Canada has tended to be a country rich in health data but poor in terms of its systematic use of information gleaned from those sources. For instance, national organizations such as the Canadian Institute for Health Information and Statistics Canada and province-specific data sources (e.g., the Institute for Clinical Evaluative Sciences in Ontario) represent but a few of the myriad of health data resources available. Unfortunately, systemic challenges have prevented the timely and trusted collection, sharing, and use of data to inform policy decision-making. A recent report from the Expert Advisory Group for the pan-Canadian Health Data Strategy will hopefully move us toward “the effective creation, exchange, and use of critical health data for the benefit of Canadians and the health and public health systems” as the strategy envisions. The CDA could provide real value by focusing on data and analytics specifically related to pharmaceuticals, which could, in turn, feed into efforts to address health system sustainability. Alignment with the broader health data strategy would be important.

While Ms. Fitzpatrick noted that she does not yet have a specific vision for the components of the agency, she indicated that collaborating with provincial/territorial governments, patients, and other stakeholders would be a strong theme. She also noted that Canada must be future focused and benchmark itself as a high-performing, comprehensive pharmaceutical “system,” an additional factor that should be considered as part of the Transition Office’s work.

DSEN Transitioning to CADTH

In August 2021, the Canadian Institutes of Health Research (CIHR) and Health Canada announced that they intend to give the Canadian Agency for Drugs and Technologies in Health (CADTH) responsibility for the Drug Safety and Effectiveness Network (DSEN) as of Fall 2022.

DSEN was an initiative announced by the federal government in July 2008, as part of its commitment to drug safety and effectiveness under Health Canada’s Food and Consumer Safety Action Plan. The network was established in 2009 by Health Canada and CIHR to increase the level of national research on the safety and effectiveness of drugs used by Canadians, to be achieved by:

  • linking researchers through a new virtual network;
  • helping to coordinate a national agenda of research based on priorities identified by decision-makers;
  • funding independent research on the safety and effectiveness of drugs in the marketplace; and
  • assessing the risks and benefits of drug products that are on the market.

As its work has evolved, DSEN has become a key tool for filling information gaps for federal, provincial, and territorial decision-makers regarding the safety and effectiveness of drugs used in real-world settings. DSEN has also significantly increased Canada’s capacity to undertake high-quality post-market research.

The shift of DSEN from CIHR to CADTH provides the latter with the opportunity to fulfill one of its strategic objectives relating to enhancing its expertise and capabilities in drug lifecycle management. CADTH has been involved in a range of activities and discussions related to real-world evidence (RWE) generation for some time. Consolidation of this expertise within CADTH could be quite complementary to any future models for the broader CDA noted above.


Many of the pieces envisioned within the 2019 recommendations of the Advisory Council on the Implementation of National Pharmacare have started to move ahead within the past year. While a full-fledged National Pharmacare program is still likely many years away, the momentum seen with various initiatives—including the move of DSEN to CADTH—is not likely to slow down given the government’s renewed mandate.

One key challenge in moving the CDA ahead is that existing component parts (particularly CADTH and pCPA) were developed by and have formal reporting relationships to provincial and territorial governments. The degree to which these jurisdictions might be willing to cede control over the governance of these bodies remains to be seen. In addition, if the CDA is intended to be national in scope, it is not clear what the implications are for INESSS and its activities in Quebec.

It also remains uncertain as to whether and how the federal government will start to better align its pharmaceutical policy efforts with its 2021 Budget investments in innovation, particularly as it relates to the Patented Medicines Regulations and final PMPRB Guidelines. Full congruence across all aspects of the Canadian pharmaceutical policy system could foster a more vibrant therapeutic product innovation ecosystem. Conversely, lack of policy alignment is sure to result in Canada falling behind other developed countries, with Canadian patients suffering in the long run. Let us hope that the champions of congruence win!