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Macdonald-Laurier Institute

Waiting for new drugs for rare disorders in Canada, part 7 – Canadian Drug Agency: Nigel Rawson and John Adams for Inside Policy

Canadians need a transparent and accountable drug agency, not another overlapping bureaucracy.

August 23, 2023
in Domestic Policy, Inside Policy, Latest News, Columns, Health, Waiting for new drugs for rare disorders in Canada, John Adams, Nigel Rawson
Reading Time: 3 mins read
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Waiting for new drugs for rare disorders in Canada, part 7 – Canadian Drug Agency: Nigel Rawson and John Adams for Inside Policy

This article is the seventh part of an 8-part series from the authors. The series, Waiting for new drugs for rare disorders in Canada, is an in-depth look at the disadvantages faced by Canadians with rare disorders in accessing needed, innovative drugs.

By Nigel Rawson and John Adams, August 23, 2023

In earlier articles in our series, we considered issues that can lead to delays in patients accessing drugs for rare disorders, and discussed national pharmacare which many Canadians think will offer a solution to the delays and the variability in access across Canada. In this article, we examine a development that some believe will also improve access to medicines – this is the establishment of a Canadian Drug Agency (CDA).

Over the past 20 years, a private member’s motion in Parliament and other calls have proposed an independent agency that would evaluate and warn about potential drug safety issues. However, nothing came of them. The idea of the CDA was introduced by the Liberals in their 2019 election platform for an agency that would both assess the effectiveness of new prescription drugs and negotiate drug prices on behalf of some or all of Canada’s government drug plans.

This objective implies that the CDA would incorporate the present health technology assessment agencies and the federal, provincial and territorial collective drug price bargaining organization and perhaps some regulatory roles.

The federal government’s 2019 budget provided $35 million over four years to establish the Canadian Drug Agency Transition Office (CDATO). The CDATO began in the spring of 2021 and is responsible for developing options for a vision, mandate and plan to create the CDA.

The CDATO’s initial activities include:

  • Consulting with provinces, territories and a wide range of stakeholders to ensure many points of view are included in developing and implementing the CDA.
  • Working with partners to determine how the CDA can support government drug plans and helping to standardize and improve access to drug and health data and analysis.
  • Partnering to build a CDA well-positioned to adapt and evolve to address the pharmaceutical landscape.
  • Collaborating with leaders in the appropriate use of medicines to improve health outcomes and ensure patients are prescribed the safest and most effective treatments for their conditions.

This is the typical Canadian bureaucratic approach of consulting stakeholders, although it doesn’t always impact the direction in which government wants to go.

The partners are provincial and territorial governments, the Canadian Institute for Drugs and Technologies in Health (CADTH), the Canadian Institute for Health Information, Canada Health Infoway, health care professionals and other stakeholders in the health sector and academia, patients and their families and advocates, and the biopharmaceutical industry. Some partners seem to be more senior than others. Over 300 meetings have taken place between the CDATO and its partners that emphasized the need for improving the pharmaceutical landscape for the benefit of all Canadians.

A cornerstone of the plans for the CDA and national pharmacare is the development of a national formulary (list) of prescription medicines. To recommend principles and a framework for developing a national formulary of medicines that government drug plans would be willing to insure – one that could eventually replace the list each government plan already has – the government established the pan-Canadian Advisory Panel on a Framework for a Prescription Drug List.

The reason for developing a national list is to try to introduce consistency and conformity in access across Canada. This sounds reasonable. However, we don’t know whether the intention is to develop a bare-bones list of so-called essential medicines for a small number of common diseases, or a comprehensive list of medicines in line with the best provincial formularies or, even better, like the benefit lists of private insurance companies.

Fundamental elements of how the cost of implementing a national formulary would be paid for and what patients’ out-of-pocket costs would be were deemed out of scope for the advisory panel. This is ducking key questions and nonsensical for patients because being able to access a covered medicine is not simply a matter of whether it’s on the list. Access also depends on whether patients can afford any required copayments and satisfy the often highly restrictive patient access criteria.

Moreover, the advisory panel intends to begin with cardiovascular, diabetes and psychiatric drugs for which the consistency of coverage by existing government formularies is already comparatively good. Instead of addressing medicines, such as rare disorder drugs, where inconsistency exists among government plans, the panel is starting with those that need the least attention.

CDATO actions so far point to the CDA being developed just as CADTH and the pCPA have – as non-transparent and unaccountable to patients and health care providers and far removed from parliamentary scrutiny. Patient engagement within CADTH is largely tokenism and not genuine participation. Real discussions take place behind closed doors, unlike other countries. Canadians need legislation that the CDA will guarantee transparency and accountability to them, not just to federal, provincial and territorial governments as CADTH and the pCPA are.

Nigel Rawson is a Senior Fellow with the Macdonald-Laurier Institute and an Affiliate Scholar with the Canadian Health Policy Institute. John Adams is cofounder and CEO of Canadian PKU and Allied Disorders Inc., a Senior Fellow with the Macdonald-Laurier Institute and volunteer board chair of Best Medicines Coalition. 

The views expressed are the authors’ own and do not necessarily represent those of organizations with which they collaborate.

Tags: Canada health policy
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