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Opening Statement to the Standing Committee on Health

Protecting Health and Safety: Federal Health and Safety Regulatory Programs

(Chapter 24 - December 2000 Report of the Auditor General)

6 November 2001

Michael J. McLaughlin, CMA
Deputy Auditor General

Alan Gilmore, Ph.D.

Madam Chair, thank you for the opportunity to discuss the results of our audit of federal health and safety regulatory programs reported in Chapter 24 of our December 2000 Report. With me today is Dr. Alan Gilmore, who was responsible for this chapter and for the co-ordination of the health and safety regulatory audits reported in chapters 25 to 28.

Chapter 24 identifies major challenges and strengths and weaknesses faced by regulatory programs, as well as measures that could be taken to make significant improvements. Dr. Gilmore will address these issues in his remarks to you.

I understand that your committee is interested in the question of maintaining parliamentary oversight of regulatory programs should separate non-governmental entities deliver the program. Dr. Gilmore will address questions related to regulatory programs and their oversight. I am prepared to respond to broader questions related to work the Office has conducted in reviewing alternative program delivery arrangements.

Some of these arrangements challenge the tradition of ministers answering to Parliament for policies and programs, and through Parliament to the Canadian public. Accountability becomes more complex. Often, little is reported to Parliament on the performance of delegated arrangements. In our view, Parliament needs to have the proper mechanisms in place to be able to exercise its oversight function.

Madam Chair, this concludes my remarks. Dr. Gilmore will now take you through some of the key principles to consider in ensuring an appropriate regulatory framework.


Madam Chair, thank you for inviting me to attend your meeting on regulatory regimes to govern assisted human reproduction. Our audit of federal health and safety regulatory programs focussed on key sectoral-wide issues affecting these programs.

The chapter identified major principles that form the foundation for sound regulatory regimes. It might be useful for me to outline for the Committee the principles that we believe must be taken into account in deciding on an approach to regulation, particularly in a controversial and scientifically emerging area.

Regulatory approaches to health and safety generally use traditional models of regulation— for example, Health Canada’s administration of the regulatory regime for drugs, or the administration of regulations by separate agencies such as the Canadian Nuclear Safety Commission or the Canadian Food Inspection Agency. The use of government agencies reflects the serious nature of the risks to health and safety and the responsibilities of government to protect the health and safety of its citizens.

However, alternative approaches can be assessed to determine if they would work better to address a specific regulatory need. We suggest that such an assessment should be based on evaluating how the regimes would meet the requirements of key principles for sound

regulatory regimes and how responsibilities would be allocated to ministers and officials. These principles include the following:

  • ensuring accountability to Parliament;
  • defining clear values and ethics and codes of practice;
  • ensuring sound assessment of risk;
  • establishing effective inspection and enforcement regimes; and
  • reporting fully on performance to Parliament using relevant indicators.

The Appendix to this statement presents the full list of principles.

We suggest that your Committee consider requesting the responsible government departments to provide the Committee with an analysis of alternatives using these principles as criteria. For example, your Committee may wish to ask for a spreadsheet that would readily provide summary information. This would allow members to determine areas where they need more detailed information as well as enable them to ask specific questions on how a particular approach would work compared with others.

We also believe that your Committee may want to consider recommending how Parliament could best scrutinize the regulatory regime. Some questions to consider include the following: Should there be a sunset clause requiring a full parliamentary review after a five-year period? What kind of performance report would be most useful to parliamentarians—what information do you want, from whom do you want it, and what assurance do you want that it is accurate?

Madam Chair, this concludes our opening statements. We would be pleased to answer any questions.


List of Key Principles for Regulatory Regimes

  • ensuring accountability to parliament;
  • establishing clear administrative accountability of officials;
  • defining clear values and ethics and codes of practice;
  • defining the balance that will be struck between protecting health and other goals of the government’s regulatory policy, such as economic development, trade, service to industry, and cost recovery;
  • ensuring sound assessment of risk;
  • conducting objective impact analysis of proposed regulations;
  • promoting a responsive regulatory regime;
  • maintaining the credibility of the scientific advice;
  • ensuring the availability of needed expertise;
  • consulting meaningfully with stakeholders and reaching out to engage citizens;
  • developing a reasonable cost-recovery policy, if applicable;
  • developing a sound legal liability strategy;
  • establishing effective inspection and enforcement regimes;
  • reporting fully on performance to Parliament using relevant indicators; and
  • ensuring cost effectiveness.