Last week Health Canada released a whitepaper outlining a proposed change to the availability of clinical information in drug submissions and medical device applications. Currently, this information is considered confidential business information. The agency proposes that once a final decision is reached on a drug submission, this information would be made public. This is in line with how the European Medicines Agency and the United States Food and Drug Administration Currently operate.
Health Canada hopes that by making this information public it will provide the following benefits:
Benefits for patients and health care providers:
- better inform health decisions; and
- promote appropriate use of drugs and medical devices.
Benefits for clinical trial participants:
- avoid duplication of research that unnecessarily exposes participants to harm; and
- advance the altruistic aims of individuals who enroll in clinical trials by further advancing medical science.
Benefits for medical research:
- avoid duplicative studies that are an inefficient use of health resources; and
- enable secondary analysis of clinical information for purposes different from the original study
Canadians are welcomed to provide feedback by May 26, 2017. The full whitepaper is available here.