PACP Committee Report
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INTRODUCTION Health Canada, through the Food and Drugs Act, regulates the safety, efficacy, and quality of all pharmaceutical drugs for use by humans 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. The Office of the Auditor General of Canada (OAG) conducted an audit covering the period of January 1, 2009 to December 31, 2010 to determine if Health Canada fulfilled its four main responsibilities related to drug regulation.[1] These responsibilities are:
On March 29, 2012 the House of Commons Standing Committee on Public Accounts (the Committee) heard from witnesses regarding Chapter 4 of the Fall 2011 Report of the Auditor General of Canada. From the OAG, the Committee heard from Neil Maxwell, Assistant Auditor General, and Louise Dubé, Principal. From Health Canada (HC), the witnesses were Glenda Yeates, Deputy Minister; Paul Glover, Assistant Deputy Minister, Health Products and Food Branch; and Marc Berthiaume, Director, Marketed Pharmaceuticals and Medical Devices Bureau, Marketed Health Products Directorate, Health Products and Food Branch. AUDIT FINDINGS During this hearing, the Committee asked Health Canada officials to provide details on how the department regulates prescription drugs to ensure that it is putting the health and safety of Canadians first. Deputy Minister Glenda Yeates responded that “this is done in a variety of ways. It's done before the drugs ever come to market by looking at the clinical trials. It's done as the drugs are submitted for approval. It's done as we put them on the market and continue to have surveillance mechanisms to ensure that we understand all the possible consequences of these drugs.”[3] Some examples provided by Ms Yeates included:
In addition to this, Ms. Yeates stated that the findings of the OAG were helpful, and that the department was using these as a foundation for improving services to Canadians.[5] The Committee was encouraged to see the commitment of Health Canada officials to improving services. However, some concerns remained and witnesses were questioned at length about the recommendations of the OAG, with Committee members asking for more detail about the problems identified by the OAG and how these would be dealt with by the department. The OAG made ten separate recommendations to Health Canada. To summarize the audit’s findings, the OAG stated in its report: “we examined key Health Canada responsibilities involving timeliness, consistency, transparency, conflict of interest, and risk-based post-market activities. We found that the Department has not adequately fulfilled most of these key responsibilities related to clinical trials, submission reviews, and post-market activities for pharmaceutical drugs.”[6] In response to the OAG’s findings, Health Canada created an action plan to address of each of the OAG’s recommendations within certain timeframes. This was shared with the Committee before the hearing and was updated on June 1, 2012 (see Appendix B). CLINICAL TRIALS Clinical trials are experiments involving volunteer participants that are used to determine whether a drug is safe and effective and what side effects are associated with its use. In order to conduct a clinical trial in Canada, parties must submit a clinical trial application to Health Canada, except for clinical trials on drugs that are already on the market and are being tested to treat conditions for which they were authorized.[7] At the time of the audit, the OAG stated that there was no definitive, publicly accessible source of information on clinical trial results authorized by the department. In the audit, the OAG recommended that, “Health Canada should fulfill longstanding commitments to enhance public access to information on authorized clinical trials, including the summary results of its clinical trial inspections.”[8] Neil Maxwell, Assistant Auditor General, commented on the progress of Health Canada in this area, stating that “I’m encouraged by the action Health Canada is taking, but a gap still exists today in the information Canadians have.”[9] When asked if Health Canada was committed to the establishment of a Health Canada administered database on authorized clinical trials in progress, Glenda Yeates responded that Health Canada was in consultations and exploring possibilities on creating this database because “we want to build something here. We want to go down the path that is most useful to Canadians.”[10] The Committee recognizes that Health Canada did in fact take steps to address Parliament’s 2004 recommendation, but strongly encourages Health Canada to complete work in this area. REVIEW OF NEW DRUG SUBMISSIONS Health Canada reviews pre-market submissions to determine whether claims made by industry regarding a drug’s safety, efficacy, and quality were supported by sufficient evidence. The Department received about 4,400 drug submissions in 2009 and 2010. In this area, Neil Maxwell, from the OAG, told the Committee that Health Canada was “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.”[11] In 2009 and 2010, Health Canada’s four review bureaus:
When members questioned Health Canada witnesses about these matters, Glenda Yeates responded that “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.”[17] She also said: We've strengthened the user fee proposal that was put through Parliament under the User Fees Act, which now supplies a substantially enhanced resource base to the department and rebalances the fees paid by industry in accordance with the support given by the public tax base, thus providing us with new resources. For example, we have virtually doubled the number of chemists who are able to work on the generic drug files. While we are up to date in meeting our performance standards and have eliminated the backlog for brand-name or new drugs, we are not yet meeting our performance standards for generic entities. That's why we've put these new resources in—to improve our performance in that area.[18] As adequate service standards and meeting performance objectives are essential for efficient and effective regulation, the Committee encourages Health Canada to resolve these issues identified by the OAG as early as possible. POST MARKET SAFETY ASSESSMENTS Health Canada monitors the safety of post marketed drugs by collecting, analyzing, and assessing domestic adverse drug reaction reports that are submitted by the pharmaceutical industry, health professionals, and consumers.[19] Ms. Yeates stated that: We are the only drug regulator in the world that has established performance standards on the post-market side for completing safety assessments when a drug is already on the market. Our international partners are very interested in talking to us to see if they can adopt this practice. Most drug regulators have only timelines and benchmarks for the review of drugs.[20] Some members questioned Health Canada officials on the issue of the response time of the department when safety issues are identified for drugs that are already on the market. In 2009 and 2010, the OAG found that Health Canada took at least one year to complete 34 of its 54 safety assessments.[21] In some cases, it took significantly longer, and the department missed meeting its own established performance measures by a significant margin. For example, five medium-priority assessments required more than two years to complete, and one of these five required more than three years to complete, even though Health Canada’s targets dictated that these were to be completed in 130 or 200 days.[22] Expressing concern over the potential dangers of not completing safety assessments in a timely manner, Committee members asked Health Canada officials if they could explain why the process took as long as it did, and whether it would be important for improvements to be made in this area. Dr. Marc Berthiaume of Health Canada, as part of his response, stated that: [W]hat's important is dealt with as a priority. Of course, we always want to do things as quickly as possible. However, when there is a significant risk for Canadians, we act as quickly as we can. I think that, in the past few years, the department has made considerable progress with respect to its ability to tackle the drug safety issues that arise. The department has increased its ability to respond; it has improved its response time; it has increased the number of issues that are analyzed. There are more resources. Everything has been done to be more and more efficient with respect to the department's response time to health issues that emerge when products are put on the market.[23] The Committee notes that while Health Canada’s response showed a desire to improve, the department should act quickly and actually demonstrate measureable efficiency improvements. The OAG found that “delays in approving new drug submissions mean that access to the potential health benefits of these drugs is delayed.”[24] CONFLICT OF INTEREST Members of the Committee, hearing that the OAG had encountered issues with transparency in the pharmaceutical regulation system, queried the department on issues of conflict of interest. The OAG reported that Health Canada’s conflict-of-interest guidelines are generally consistent with the government’s Values and Ethics Code for the Public Service. However, in 2010, the Department did not comply with the Code’s requirement to issue an annual reminder to employees of their conflict-of-interest obligations.[25] Also, at the time of the audit’s completion, the department 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 pharmaceutical review activities.[26] Mr. Maxwell stated to the Committee that “Our main concern was really the fact that we thought the department hadn't really assessed where the risks lie in terms of managing conflict of interest for its reviewers of drug submissions. And really, its processes were meeting Treasury Board requirements, but nothing more.”[27] In its audit, the OAG stated: The government’s Values and Ethics Code for the Public Service requires that departments establish measures to manage conflicts of interest. To determine whether Health Canada had systems to manage conflict-of-interest risks to the drug submission review process, we examined its Code of Conduct and its conflict-of-interest guidelines, and interviewed key entity officials. The audit was not designed to find cases of officials being in a conflict of interest, and we did not find any such cases.[28] The OAG pointed out in the audit that some federal government departments (as well as a different international regulator of pharmaceuticals) have developed additional measures to manage conflict-of-interest possibilities for particular activities that employees undertake in their area of work that may not be covered under the general government-wide application of the Values and Ethics Code for the Public Service.[29] For example, this may include developing conflict-of-interest measures for Health Canada employees working closely with publicly traded pharmaceutical companies on new drug approval matters who would be in a position to profit from knowledge gained in their work. As such, the Committee agrees that Health Canada should develop specific conflict-of-interest guidelines that apply to pharmaceutical regulation work at Health Canada. Guidance could be drawn from the OAG’s Fall 2010 Report on “Managing Conflict of Interest.” RECOMMENDATION The Committee has reviewed the ten separate OAG recommendations that touch on varied areas of pharmaceutical regulation at Health Canada. Based on the OAG’s findings, the Committee feels that Canadians, while generally well-served, should receive improved services from Health Canada. The Committee is encouraged to see that Health Canada has created an action plan that addresses each of the OAG’s recommendations separately, and that includes timelines for completion. The Committee intends to monitor the progress of Health Canada in implementing the action plan that was provided to the Committee one day prior to the hearing and updated on June 1, 2012, and recommends: RECOMMENDATION: That Health Canada provide to the Public Accounts Committee by March 31, 2013 a detailed progress report on its June 1, 2012 action plan items so the Committee may appraise the progress of Health Canada regarding its commitments to address the OAG’s recommendations. This update should provide evidence of substantive, measurable progress, especially for action items that are to be completed by March 31, 2013. CONCLUSION During the hearing, the Committee expressed its satisfaction with the work of the OAG noting that: The Auditor General examined many important areas of regulating pharmaceutical drugs, including transparency and timeliness in communicating information about clinical drug trials, conflicts of interest, timeliness of safety assessment recommendations for marketed drugs, and how Health Canada applies risk-based standard operating procedures. Along with Health Canada's other drug regulation activities, these are all important areas to Canadians and to Canadian drug manufacturers and suppliers.[30] The Committee reaffirms that effective pharmaceutical regulation is key to ensuring the safety of the many Canadians who rely on these drugs, and notes that Health Canada has shown progress in its regulatory program. However, the Committee also notes the findings of the OAG, and asks that Health Canada respond without delay to the recommendations of the OAG and to work toward meeting the commitments made within the timelines set in the action plan that was provided to the Committee on June 1, 2012. [1] Auditor General of Canada, Fall 2011 Report, Chapter 4, “Regulating Pharmaceutical Drugs—Health Canada,” Ottawa, 2011. [2] Ibid, paragraph 4.11. [3] House of Commons, Standing Committee on Public Accounts, Evidence, 1st Session, 41st Parliament, March 29, 2012, Meeting 36, 900. [4] Meeting 36, 900. [5] Ibid, 905. [6] Chapter 4, paragraph 4.115. [7] Ibid, paragraph 4.16. [8] Ibid, paragraph 4.41. [9] Meeting 36, 1030. [10] Ibid, 1035. [11] Ibid, 850. [12] Chapter 4, paragraph 4.48. [13] Drug review responsibilities are divided among four review bureaus based on the type of review required – 1) new drugs, 2) generic drugs, 3) over-the-counter drugs and 4) post-market changes. [14] Chapter 4, paragraph 4.56. [15] Ibid, paragraph 4.59. [16] Ibid, paragraph 4.62. [17] Meeting 36, 900. [18] Ibid, 900. [19] Chapter 4, paragraph 4.71. [20] Meeting 36, 900. [21] Chapter 4, paragraph 4.83. [22] Ibid, paragraph 4.84. [23] Meeting 36, 910. [24] Chapter 4, paragraph 4.52. [25] Ibid, paragraph 4.66. [26] Ibid, paragraph 4.67. [27] Meeting 36, 925. [28] Chapter 4, paragraph 4.65. [29] Ibid, paragraphs 4.67-4.69. [30] Meeting 36, 900. |