Will Open Government Make Canada’s Health Agencies More Transparent

Paul C. Hébert MD, et. al. | CMAJ | March 21, 2011

On Mar. 18, 2011, the Harper government in Canada announced its “Open Government” strategy. Although it appears to have been borrowed from President Barack Obama’s 'Open Government' directive, the piecemeal and toothless approach adopted in Canada falls short of the openness that has become the default position of all government departments in the United States. To follow the US example, openness in health information would require directing Health Canada and the Public Health Agency of Canada first to be part of the approach and then to develop and report on how they will concretely achieve more “open government.”

The opacity and culture of secrecy of some of Canada’s federal health agencies must be addressed. As far back as 2000, Dr. Roberta Bondar, chair of Health Canada’s Scientific Advisory Committee, said that the drug approval process had become more efficient, but she harshly criticized the department “for a level of confidentiality that is inconsistent with public expectation and contributes to public cynicism about the integrity of the process.”

The committee had good reason to complain. The federal approach to overseeing pharmaceuticals and devices demonstrates the lack of transparency at Health Canada. Neither research evidence nor details of company submissions to launch new medications and devices are publicly available. Health Canada does not announce dates for approval hearings, provide the relevant information or offer the public reasons for its decisions. It defends this approach by saying commercial interests supersede the need for disclosure.

In contrast, the US Food and Drug Administration (FDA) announces topics it is examining, posts timetables for hearings and invites public submissions. When a regulatory decision is reached, the FDA will post the evidence considered, who provided opinions (and their competing interests), the value it placed on different patient outcomes and, ultimately, a detailed rationale for the decision.

Such clear and transparent descriptions ensure that the public can readily understand the rationale for complex decisions — such as that behind granting market approval for a new drug that dramatically reduces symptoms of a disease but increases rates of death. A recent example of transparent disclosure on a complex decision is the removal of the indication for use of monoclonal antibody bevaci zumab for breast cancer. The FDA produced a podcast to explain its position clearly; Health Canada still remains silent on recent postmarket research involving this drug.