Thank you very much, Mr. Chair, and good morning to you and members of the committee.
Thank you for the opportunity to appear before the committee to discuss chapter 4 of the Auditor General's report dealing with the regulation of pharmaceutical drugs in Canada. I am joined here today, as was noted, by Paul Glover, assistant deputy minister of the health products and food branch, and Dr. Marc Berthiaume, director of the marketed health products directorate.
Canada has one of the safest and most rigorous drug safety systems in the world. At Health Canada, we take our regulatory role in support of the drug safety system very seriously and carry it out in a scientifically rigorous and independent manner. We know, however, that there is always room for improvement.
In this spirit, I would like to thank the Auditor General for his work. As the Auditor General noted, we need to improve the timeliness of our reviews; we can better document and accelerate the process of identifying potential safety issues; and we can increase the amount of information available to Canadians about our processes.
We do, Mr. Chair, as was noted, have a detailed action plan, which has been tabled with the committee. I can assure the committee of our commitment to carry out these actions as part of our ongoing process to improve how we protect the health and safety of Canadians.
I am pleased to report that as of April 1, 2011, we have significantly more resources available to fulfill our mandate as a result of our new cost-recovery program.
As was supported by the Auditor General in a previous audit, we have now increased fees that are charged to industry in support of drug applications, thereby returning us to a more historically balanced funding model. As a result, Canada is now much more in line with comparable international regulatory agencies such as the United States Food and Drug Administration and Europe's European Medicines Agency.
These fees are expected to generate, and in fact, are already generating significant new revenues. These incremental resources have already enabled us to hire 160 new staff, strengthen our capacity to improve our processes, and upgrade things like our computer systems.
Now I would like to briefly describe some of the specific actions that either have been taken or are under way to improve the safety, transparency, and timeliness of our systems.
At Health Canada, there is no higher priority than safety. The department reviews all drugs for safety, efficacy, and quality. Canadians can be confident that the drugs approved by Health Canada have undergone a rigorous assessment against these criteria.
The Auditor General recommended that Health Canada strengthen its risk-based approach to monitoring clinical trial sites and adverse drug reaction reports during clinical trials. This past September, we introduced a risk-based approach for monitoring and assessing clinical trial adverse drug reaction reports, and we have already completed and begun to implement an updated risk-based selection process for inspection of clinical trial sites.
Moving on to transparency, Mr. Chair, we recognize that the work we do is of great interest to Canadians, and that we have a duty to make information about the safety and effectiveness of drugs available to them. As I said, we take this duty very seriously.
The department is improving transparency with respect to marketed health products with the launch of phase II of the summary basis of decision project in June. These reports will provide information in a much clearer manner so that it can be understood by Canadians.
We are improving public access to information about clinical trials by publishing summary reports about clinical trial inspections. The first of these reports was published a few days ago.
We are also making important health information more easily accessible to doctors and patients. We are working with stakeholders to make labels more understandable to Canadians, and we are posting all authorized drug labels on Health Canada's online drug product database.
We will continue to take steps through policy guidance, and if necessary, regulatory proposals to improve transparency.
We are doing a number of things to improve timeliness in our core regulatory activities.
We believe that we are making significant progress in addressing the Auditor General's concerns about the pace of assessment of potential safety issues.
We are working with the United States and some European countries to streamline our drug-submission system and share information about inspections and adverse reactions. Moving forward, we plan to expand our cooperation with other countries.
With regard to evaluating drug submissions, I am pleased to report that we are making progress. The backlog for new drug submissions was eliminated in December 2011. We do still have a challenge in meeting our performance targets for generic drug reviews and we have devoted significant new resources to tackle this area.
In summary, the Auditor General's report has been helpful in guiding some of the changes that we need to make to continue to perform our regulatory responsibilities to protect the health and safety of Canadians. We have one of the most rigorous drug safety systems in the world, and Health Canada is consistently and constantly looking for ways to strengthen it, which is why we're taking the findings of the Auditor General very seriously.
My colleagues and I would be pleased to take your questions.