Thank you, Mr. Chair.
We thank you for the invitation to participate in your study on post-market surveillance of pharmaceutical products. As you mentioned, I'm accompanied by Neil Maxwell, assistant auditor general. I believe that some of our past findings on regulatory and post-market surveillance activities at Health Canada would be useful to the committee in its study.
In my presentation, I will highlight some of our findings on the drug products program discussed in our 2006 chapter entitled “Allocating Funds to Regulatory Programs--Health Canada”. I am also pleased to talk about two other audits, where we examined programs similar to pharmaceutical products. We reported these findings in our 2004 chapter on regulation of medical devices and our 2000 chapter on the regulatory regime of biologics.
I will start with our 2006 Chapter—Allocating Funds to Regulatory Programs. In this audit, we examined issues related to the allocation of financial resources in three regulatory programs.
These programs regulate the safety and use of consumer products, medical devices and, what is of more interest today, pharmaceutical products. It is important to note that the audit was on the allocation of financial resources and how this affected that Department's ability to carry out its regulatory responsibilities.
We did not examine other aspects of pharmaceutical products, such as post-market activities. We concluded that Health Canada did not know if it was fully meeting its regulatory responsibilities for the Drug Products program.
First, Health Canada needed to determine the activities that must be carried out in order to meet the Department's regulatory responsibilities. Program managers for Drug Products indicated that they considered the level of post-market compliance and enforcement activities to be insufficient. This could have consequences for the health and safety of Canadians, such as exposure to unsafe, ineffective or dangerous products.
Second, we found that Health Canada needed to determine performance targets for the activities.
Third, Health Canada needed to determine the level of financial resources required to carry out the activities necessary to meet is regulatory responsibilities. We found that the demands on regulatory programs were increasing while the funding remained constant, making it difficult for program managers to fully meet the Department's regulatory responsibilities. Although the funding remained constant, the core funding for the Drug Products program had decreased 32% over three years, if all sources are considered.
Furthermore, most of the additional funding that Health Canada received had been allocated to pre-market activities, and funds that were meant for the Drugs Product program were reallocated to other programs. For more details about funding, please refer to the table we distributed.
In its responses to our recommendations, Health Canada stated that it planned, among other things, to improve the operational planning process; review the funding, including core funding allocated to regulatory programs; work on a cost recovery strategy and regime, including the establishment of a full costing model; introduce a budget management framework with guidelines on resource allocation and monitoring of Treasury Board decisions; and improve performance measurement.
Health Canada also promised to conduct comprehensive reviews that would serve to establish program baselines by defining the required level of activities that the program must carry out, identify the targeted performance for these activities, and identify the resources needed to carry out these activities.
Health Canada promised to make these changes by March 31, 2008, or earlier. The department's next progress report is scheduled for the end of April, and your committee might wish to examine what progress has been made, especially concerning the baseline study for pharmaceuticals.
The two other audits were about programs similar to pharmaceuticals. We found similarities in the findings related to post-market activities. We would ask you to note that these audits are dated, and we have not conducted recent audits to see if our concerns have been resolved.
Post-market activities were a concern in our 2004 audit on the regulation of medical devices. We found that health Canada did not carry out any inspection activity at the post-market phase and did not know the extent to which the regulations were being respected.
The Department had made it mandatory for the manufacturers to report serious adverse events, but had done little work to increase the number and quality of reports received from health care professionals. The rate of reporting on adverse events was significantly less for Canada compared with the US and the UK. In addition, there were weaknesses in the analysis and interpretation of adverse events, and there was no proactive system to identify patterns that could signal a serious safety concern.
We also noted that Health Canada had never developed a communications plan or strategy for medical devices to ensure that Canadians were fully aware of risks.
In addition to recommending that Health Canada address these weaknesses in post-market activities, we also recommended, due to the weaknesses also found in pre-market activities, that Health Canada make a choice: either provide adequate human and financial resources to deliver the program as designed, or redesign the Medical Devices program and the Regulations to manage risks in a way that requires fewer resources.
Finally, in our 2000 audit on the regulatory regime for biologics, we found that Health Canada had difficulty managing the workload of pre-market and post-market activities. Officials told us they had trouble staffing positions. We recommended that sufficient databases be implemented to adequately process, analyze, and disseminate information on adverse reactions and events for biologics.
As you can see from these three chapters, we have had concerns about resource allocation and post-market surveillance for several years now. It seems that the emphasis has been on pre-market activities, to the detriment of post-market activities.
As you know, I cannot comment on the policy approach, but I am encouraged to see that some of the issues raised in our reports, such as problems with post-market surveillance and under-reporting of adverse events, are included in the government's Blueprint for Renewal: Transforming Canada's Approach to Regulating Health Products and Food.
I would like to take this opportunity to update the committee on other work we are conducting. We have a chapter on infectious disease surveillance in our report to be tabled on May 6. We would be pleased to meet with you again after tabling to discuss that.
We are also beginning an audit on electronic health records, and we plan to provide this report to Parliament in fall 2009. Several provincial auditors general will concurrently carry out audits on the same subject matter, leading to a comprehensive look at the implementation of electronic health records in Canada.
Lastly, we will soon begin developing a plan identifying the audits we will conduct over the next five years. We would be pleased to discuss our plan with you at a future date.
I hope our comments today will help your study on post-market surveillance of pharmaceutical products. I look forward to reading your report and the government's subsequent answer to it.
Mr. Chair, that concludes our opening statement. We would be pleased to answer any questions the committee members may have.
Thank you.