Opening Statement to the Standing Committee on Public Accounts

Health Canada - Regulatory Regime of Biologics
(Chapter 26 - December 2000 Report of the Auditor General), and Canadian Nuclear Safety Commission - Power Reactor Regulation
(Chapter 27 - December 2000 Report of the Auditor General)

Madame Chair, thank you for the opportunity to present the results of our audit on biologics, reported in Chapter 26, and our audit on power reactor regulation, reported in Chapter 27. With me today are Ronnie Campbell, who was responsible for the audit on biologics, and Crystal Pace, who was responsible for the audit on power reactor regulation.

These two chapters were part of a set of five audits on federal health and safety regulatory programs, reported in our December 2000 Report. Chapter 24 presented the results of a decade of audits of federal regulatory programs and our principal concerns. In summary, we recommended that the government:

• explain to Canadians its priorities and the balance it has struck between protecting Canadians and addressing budget and economic objectives;
• ensure that reliable information on risk is available and that this information be used to determine priorities;
• allocate sufficient resources based on risk; and
• report annually to Parliament on the overall effectiveness of health and safety regulatory programs that require significant interdepartmental co-operation to work.

I will now present the key results of these two audits. Each audit addresses different aspects of our broader findings and each organization operates in quite different regulatory environments.

We found that Health Canada is taking a reasonable approach to developing and implementing frameworks and approaches for regulating different biologics. The responsible bureau works closely with others, both internally and externally. It maintains expert advisory committees, allowing it to be proactive, where necessary, in its interventions.

However, while the Department has recognized that a variety of approaches are necessary to deal with a wide spectrum of risks, it has not developed the necessary guidance to help its officials decide on the most appropriate approach for a given situation.

Health Canada acknowledges that the Food and Drug Act and Regulations have not kept pace with scientific and technological advances, and has begun to implement approaches based on standards, which it hopes will offer greater flexibility.

Under this concept, standards can be developed by recognized standards development organizations or professional bodies and can be referenced in Regulations. The government remains accountable for the effectiveness of the regulatory regime.

Lessons learned from using this concept should be applied to future standards-based regimes as appropriate.

The Department has had difficulty in staffing important scientific positions. In addition, it has had difficulty in implementing sufficient databases to adequately process, analyze and disseminate information on adverse reactions and events.

I will now turn to the audit of power reactor regulation. The Canadian Nuclear Safety Commission reviews operations of power reactors on a continuous basis. Commission staff at each power reactor site, along with specialists from Ottawa, monitor compliance with regulations and license conditions. Nevertheless, our audit found that improvements were needed to ensure that the Commission continues to protect the health and safety of Canadians.

First, the Commission's regulatory approach relies on the competence and professional judgment of knowledgeable staff. This pool of expertise will begin to disappear as staff retires. At the time of our audit, there were a number of lengthy vacancies in important positions. As a separate employer, the Commission has the flexibility to better manage its human resources.

We found that the Commission also needs to improve its review process for power reactors by using a risk-based approach that incorporates quantitative measures of performance. In addition, the assessment of performance as "acceptable", "conditionally acceptable" or "unacceptable" needs further elaboration so that the Commission licensees and the public have a clear understanding of both the adequacy of safety performance and of what needs to be done to improve it.

Also, the Commission had not completed key regulatory documents, particularly for the compliance regime. Given the shortages and expected turnover of staff, it is particularly important that the regulatory regime be clear and well understood.

Both Health Canada and the Commission were responsive to our Report. In addition, the Commission posted a more detailed action plan on its Web site that, when implemented, should address our concerns.

Madame Chair, this concludes my opening statement. We would be pleased to answer any questions.