e-2971 (Human diseases)

The Government of Canada recognizes the importance of patients having access to drugs that may help treat their serious or life-threatening conditions, including those with rare diseases such as Amyotrophic Lateral Sclerosis (ALS), and is committed to supporting Canadians’ access to safe and effective health products.

In Canada, the management of pharmaceuticals is a shared responsibility among the federal, provincial and territorial governments. The federal government is responsible for assessing the safety, efficacy and quality of drugs before authorizing them for sale in Canada. The provincial and territorial governments are responsible for the delivery of health care for their residents, including determining which drugs are reimbursed and under what conditions for their eligible populations.

The Government of Canada has made a commitment to improve access to medications. The Regulatory Review of Drugs and Devices Initiative, and now the Regulatory Innovation Agenda, will make regulatory processes more efficient and better able to meet the needs of the health care system.

This plan includes providing more timely access to drugs by:

• expanding the priority review process, to decrease review time for products needed by the health care system, including drugs for rare diseases;
• renewing the Special Access Programme to improve access to products that are not now authorized for sale in Canada;
• improving access to generics, biosimilar drugs and biologics by ensuring more timely review of these products;
• modernizing clinical trial regulations;
• enabling advanced therapeutic products;
• enacting agile licensing for drugs and medical devices; and,
• enhancing the way Health Canada provides health information to Canadians on mobile.

Moving forward, we will continue to engage with stakeholders and Canadians, build on lessons learned from the temporary agile measures in place, and consult on all proposed policy and regulatory approaches as they are developed.

Once approval for sale has been issued by Health Canada, provincial and territorial drugs plans then decide if the drug will be eligible for public reimbursement. To help inform this decision, public drug plans use the recommendations and advice of the Canadian Agency for Drugs and Technologies in Health’s (CADTH) Common Drug Review and, in Quebec, the Institut national d’excellence en santé et en services sociaux (INESSS). Health Canada, along with CADTH and INESSS, has introduced an option for sponsors to seek aligned reviews for submissions. This aligned review process reduces time lags between the market authorization of a drug and the Health Technology Assessments (HTAs) performed by CADTH and INESSS which support its listing on a public plan.

Budget 2019 proposed to invest up to $1 billion over two years, starting in 2022-2023, with up to $500 million per year ongoing, to help Canadians with rare diseases access the drugs they need. We recognize that, for many Canadians who require prescription drugs to treat rare diseases, the cost of these medications can be astronomically high.

To support the development of a national strategy for high-cost drugs for rare diseases, a public and stakeholder engagement process was launched in early 2021 and concluded on March 26th, 2021. A What We Heard report summarizing key themes and feedback that emerged during the public and stakeholder engagement will be published in spring 2021.

The Government of Canada will continue working with provinces, territories and other partners to lower the costs of medications and improve access.