Summary basis of decision in context.(Correspondance)(Letter to the Editor)

In their analysis of Health Canada's Summary Basis of Decision (SBD) initiative, Joel Lexchin and Barbara Mintzes (1) raise important issues about transparency, but they do not discuss the unique Canadian legal context within which manufacturers submit their information for review.

The confidentiality of drug submissions is anchored in Canadian common law, federal statutes and international trade obligations. Drug manufacturers can usually argue successfully that data kept in trade confidence by the manufacturer and submitted to Health Canada in confidence are excluded from disclosure under the Access to Information Act. The recent Federal Court of Canada decision in the Singulair case (2) may impose further limits on the release of review information under access legislation. In the interests of public disclosure, Health Canada has appealed that decision.

With some exceptions, the North American Free Trade Agreement and the World Trade Organization's Agreement on Trade-Related Aspects of Intellectual Property Rights also require member countries, including Canada, to take steps to protect data filed with a national authority as a condition for market authorization.

Lexchin and Mintzes contend that the US Food and Drug Administration (FDA) routinely posts detailed information submitted by the drug company, along with FDA reviewers' analyses. In fact, the FDA ceased publication of Summary Basis of Approval documents in 1994, opting to publish hundreds of pages of review information, with confidential commercial information severed. The FDA was subsequently criticized by the US inspector general for not providing summary information; (3) that criticism was based on concerns about the readability of the full reviews for many segments of the public.

The SBD provides concise public information on the quality, clinical efficacy and safety elements of a drug submission, including summaries of clinical trial design and premarketing adverse events. Our consultations indicate that this is a major step forward, particularly for consumer associations and health care providers.