Thank you, Mr. Chair.
Thank you for this opportunity to present the results of our audit on regulating pharmaceutical drugs at Health Canada.
With me today, as you noted, is Louise Dubé, the principal responsible for audits in the health sector.
There are about 13,000 prescription and non-prescription drugs on the Canadian market. Pharmaceutical drugs play an important role in Canada's health care system and economy. Health Canada regulates the safety, efficacy, and quality of all pharmaceutical drugs in Canada before and after the products enter the Canadian marketplace.
The department does this through a combination of scientific review, monitoring, compliance, and enforcement activities. It aims to ensure that the public has timely access to safe and effective pharmaceutical drugs, and that those who need to know of safety concerns are informed.
For our 2011 fall report, we examined whether Health Canada fulfilled its key responsibilities for pharmaceutical drugs. These responsibilities involved timeliness, consistency, transparency, conflict of interest, and risk-based post-market activities.
We found that the department had not adequately fulfilled most of these key responsibilities related to clinical trials, submission reviews, and post-market activities.
In particular, we found that Health Canada had problems with the timelines and transparency of its activities.
Health Canada is not meeting its service standards for the timely review of most of the drug submissions it receives, thus delaying Canadians' access to the health benefits of new drugs. It is also delaying access to more affordable treatments.
Health Canada has established processes to identify potential safety issues for marketed drugs, but it is slow to act. It can take the department more than two years to complete an assessment of potential safety issues and to provide Canadians with new safety information.
In 2004, the House of Commons Standing Committee on Health recommended that this department create a public database to provide information on clinical trials in progress, abandoned and completed. Health Canada committed to enhancing public access to information about clinical trials. In the fall 2011 audit, we found that, despite this commitment, Health Canada had not taken action. This lack of information increases the risk that Canadians may be unaware of new treatment options or may unknowingly participated in an unauthorized trial.
The department is also not disclosing information on drugs that it rejects, drugs that the manufacturer withdraws from the review process, or drugs with conditions.
Health care providers have the discretion to prescribe a drug for conditions that the drug has not been authorized to treat. Therefore, it is important that health care providers be informed when the department rejects a marketed drug for a new use, so they understand the department's concerns.
We reported very similar findings in our June 2011 report on the regulation of medical devices about a lack of timeliness to review submissions related to those devices. We found that Health Canada was not making use of assessment work done in other jurisdictions, as part of its own assessments of the safety and efficacy of medical devices that could lead to program efficiencies. Health Canada has recently launched an initiative to make greater use of this information for medical devices and pharmaceuticals.
We are pleased that Health Canada has agreed with our recommendations from both reports and that it has developed action plans to address them.
The regulation of pharmaceutical drugs is important to Canadians. With an aging population, the role of pharmaceuticals is expected to grow as researchers come up with new therapies to replace earlier treatments or provide new options where no treatment existed before. The committee may wish to obtain the assurance and commitment from Health Canada to implement our recommendations in a timely manner.
Mr. Chair, that concludes my opening statement. We would be pleased to answer your committee's questions.