Summary Basis of Decision in context

Diane Gorman maintains that Canadian federal statutes prevent Health Canada from releasing clinical information about safety and efficacy without the consent of the company submitting the data. In doing so, she ignores a section of the Access to Information Act that allows the release of such information if it “would be in the public interest as it relates to public health.”1 To our knowledge, Health Canada has never chosen to use this clause to disclose information.

Health Canada's Science Advisory Board examined whether the North American Free Trade Agreement created a barrier to disclosure of premarket clinical trial data and concluded that “Measures to require transparency for the protection of the public are not a violation of this treaty obligation.”2

Ms. Gorman points out that the FDA stopped posting Summary Basis of Approval documents in 1994, but that was because of the workload involved, not because of the North American Free Trade Agreement. The redacted review information still contains detailed reports of methods and results of the clinical trials that the companies performed. As we pointed out in our commentary,3 that information is not available in the SBD.

Finally, Ms. Gorman says that Health Canada's consultations show that consumer associations and health care providers find the SBD a major step forward. She fails to mention the statement issued by those attending the Health Canada SBD consultation, who endorsed the goal of transparency but stated firmly that “the model for a Summary Basis of Decision put forward at this consultation does not meet these common goals.” Groups signing the statement included the Canadian Organization for Rare Diseases, Doctors for Research Integrity, the Hospital Employees Union, the Society for Diabetic Rights, Women and Health Protection, PharmaWatch and the BC Persons With AIDS Society.