e-3787 (Health)

As the federal drug regulator, Health Canada assesses and monitors the safety, quality, and efficacy of drugs made available to people in Canada. To support this work, Health Canada charges industry fees to cover a portion of the costs of its regulatory services, which is consistent with international practices. These fees represent only a small portion of the costs of bringing a drug to the market.

Improving access to medications for children in Canada is a global and multi-faceted issue. Health Canada has been analyzing ways to encourage companies to submit pediatric data on health products to Canada. In 2020, it established the Pediatric Drug Action Plan (PDAP), with the goal of improving children’s access to safe and effective health products. The PDAP focuses on three main areas: increasing the development of pediatric medicines and formulations; improving access to pediatric medicines and formulations; and, providing more information to Canadians.

To address the goals of the PDAP, Health Canada is working across government departments and with external national and global partners on key initiatives. Full implementation of the plan will take a number of years; however, several initiatives are currently underway. For example, the Department is in the process of developing pediatric provisions (regulations) similar to those that exist in other jurisdictions such as Europe and the United States, which will compel the submission of pediatric information to the regulator. This is expected to increase approvals of pediatric indications, and their corresponding formulations in Canada. Health Canada is aiming to implement the pediatric provisions in policy to encourage industry to submit pediatric information to Canada in early 2023 while continuing work towards implementing amendments in regulations.

Health Canada is also examining incentive-based tools to determine if any new incentives should be explored to help increase the availability of medications for Canadian children. Any new tools developed through this initiative will complement the existing incentive in Canada’s Food and Drug Regulations that confers an additional six months of data protection for innovative drug manufacturers who submit results from clinical trials for the purpose of increasing knowledge about the use of their product in pediatric populations. Health Canada is also currently working with pediatric stakeholders across Canada to develop a National Priority List of pediatric products that are urgently needed in Canada. As part of this process, Health Canada will identify the regulatory pathways and flexibilities that can be offered to bring these products to Canada, and will work with industry to bring those products to Canada once the priority list is consulted upon and posted publically (expected by early 2023).