Health Canada is fulfilling certain key responsibilities in regulating pharmaceuticals, but is struggling with the timeliness and transparency of some of its activities, Canada’s Parliament has been told.
A report presented by John Wiersema, Interim Auditor General of Canada, in the House of Commons – examining key Health Canada responsibilities involving timeliness, consistency, transparency, conflict of interest and risk-based post-marketing activities – finds that the agency has not adequately fulfilled most of these key responsibilities related to clinical trials, submission reviews and post-marketing activities for pharmaceuticals.
While the agency has increased the amount of information it discloses on approved drugs, it does not provide information on rejected admissions, on drugs withdrawn by manufacturers from the review process or on the status of drugs approved with conditions, the report states.
Nor has Health Canada delivered on its long-standing commitment to disclose more information about clinical trials, or determined what measures are needed to address the potential for conflicts of interest in its reviews of drug submissions, Mr Wiersema adds.
“Although Health Canada has a risk-based clinical trial inspection strategy, it does not have all the information it needs to make comparative risk-based decisions about which sites to inspect, and it does not regularly report on its clinical trial inspection activities. The department has also not met its clinical trial inspection target in 2009 and 2010,” says the report.
“Furthermore, the department does not document its approach to monitoring adverse drug reactions in clinical trials to ensure that it focuses on the trials that posed the greatest risk. It did not fulfill long-standing commitments to increase the transparency of authorised clinical trials,” it adds.
On conflicts of interest, the Interim AG’s report finds that Health Canada’s guidelines in this area are consistent with the government’s Values and Ethics Code for the Public Service, but last year it had not complied with the code’s requirement to issue an annual reminder to employees of their conflict-of-interest obligations. At the time of the audit, it had not yet issued this reminder for 2011, nor had it determined the necessary measures to address the conflict-of-interest risks specific to its review activities, it adds.
The report also finds that while the agency is actively monitoring the safety of drugs already on the market, it is slow to assess the potential safety issues which it identifies – it sometimes takes more than two years to complete an assessment and provide Canadians with updated safety information, it says.
“Health Canada is slow to act on potential safety issues related to drugs already on the market. It needs to get safety information out to Canadians more quickly and address the potential for conflict of interest,” commented Mr Wiersema. However, he added that the agency had responded to his report and that it “agrees with all our recommendations.”
