Public Access to Clinical Information on Drugs and Medical Devices
March 15, 2019
OTTAWA: Jim Eglinski, Member of Parliament for Yellowhead, wishes to inform constituents that Health Canada will publish on March 20, 2019, the final regulations allowing for the public release of clinical information on drugs and medical devices. This will give Canadians greater access to reliable information that will enable them to make well-informed decisions about their health and that of their families. The data that companies provide when requesting authorization of these products will include study reports and clinical trial results. These regulations are one of key transparency measures introduced under Vanessa’s Law. The Department will consult manufacturers to ensure that confidential and personal information is removed before it releases any data.
Clinical information will be made available to Canadians through Health Canada’s new Clinical Information Portal as of March 13, 2019 and will include clinical information on a small number of products provided by volunteer companies in advance of the final regulations.
Proactive disclosure for medical devices will start in 2021, to coincide with steps the European Union is taking to increase the transparency of clinical information for medical devices, and to reduce the burden on stakeholders by aligning approaches. Health Canada will also make information about drugs and medical devices already on the market available upon request and add this information to the portal. Health Canada consulted extensively with academic researchers, health care professionals, patient groups and industry on this approach to determine what information should be shared and in what form.
“This will help researchers tap into and use to benefit the health and safety of Canadians,” concluded MP Eglinski.
For more information please go to: https://www.canada.ca/en/health-canada/services/publications/drugs-health-products/medical-devices-action-plan.html