Auditor-General slams regulatory regime

Health Canada's management of its 3 primary regulatory programs is so haphazard that it is impossible to ascertain whether “it is fully meeting its responsibilities as the regulator of drug products, medical devices and product safety,” Auditor-General Sheila Fraser says.

Moreover, the department's process and principles for oversight of the 3 regulatory programs is so incoherent that it hasn't even “determined the level of activities the programs must carry out to meet the Department's regulatory responsibilities, or the level of resources they would need to do so,” Fraser said in a Nov. 28 report to Parliament.

The inevitable consequence is inadequate protection of Canadians' health and safety, which even program managers admit is likely now at risk, and sets the stage for “increased risk of liability to the Crown,” Fraser noted. “The Department needs to decide what it is trying to achieve, what its priorities are, and direct resources toward programs and services that help Canadians.”

While casting all aspects of Health Canada's regulatory process as generally lax, the report sketches a lengthy list of areas in which oversight is particularly deficient, including conducting suitable risk assessments of products; issuing “timely and accurate” health warnings to the public; conducting inspections of drug ingredients and manufacturing practices; and virtually all aspects of post-market surveillance, whether investigations of consumer complaints or tracking of adverse events.

Among the endemic structural flaws identified by Fraser were: inadequate assessment of the resources required to achieve objectives; shoddy or non-existent operational and financial plans; non-existent “performance measures with targets for expected results”; as well as violations of the Financial Administration Act, which require full cost recovery for the Drug Products and Medical Devices program services through user fees. For example, oversight of medical devices costs $21.8 million but user fees account for only $7.4 million.

Fraser urged 10 specific recommendations as part of a massive overhaul of Health Canada's oversight of regulatory programs. In response, the department agreed to implement reforms by the end of fiscal year 2007/08. — Wayne Kondro, CMAJ