PACC Committee Meeting

STANDING COMMITTEE ON PUBLIC ACCOUNTS

COMITÉ PERMANENT DES COMPTES PUBLICS

EVIDENCE

[Recorded by Electronic Apparatus]

Tuesday, October 30, 2001

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[English]

The Chair (Mr. John Williams (St. Albert, Canadian Alliance)): Good afternoon, everybody.

Pursuant to Standing Order 108(3)(e), today we will consider chapter 24, “Federal Health and Safety Regulatory Programs”, of the December 2000 report of the Auditor General of Canada.

Our witnesses today are, from the Office of the Auditor General of Canada, Mr. Alan Gilmore, Principal, and Mr. Douglas Timmins, Assistant Auditor General; from the Privy Council Office, Mr. George Redling, Assistant Secretary, Regulatory Affairs and Orders in Council; from Transport Canada, Ms. Janet Milne, Assistant Deputy Minister, Corporate Services Group, and Mr. Gordon Chapman, Executive Director, Regulatory/Inspection Secretariat; and from Health Canada, Ms. Diane Gorman, Assistant Deputy Minister, Health Products and Food Branch.

We have a number of opening statements this afternoon, so without further ado we will ask Mr. Timmins to present his points.

Mr. Timmins.

Mr. Douglas Timmins (Assistant Auditor General of Canada): Mr. Chairman, thank you for the opportunity to present the results of our audit of federal health and safety regulatory programs, as reported in chapter 24 of our December 2000 report.

With me today, as you've indicated, is Dr. Alan Gilmore, who is responsible for this chapter and for the general coordination of the health and safety regulatory audits reported in chapters 25 to 28.

Chapter 24 presents our principal concerns. Chapters 25 to 27 report our findings on specific programs in the Canadian Food Inspection Agency, Health Canada, and the Canadian Nuclear Safety Commission.

Your committee has already held hearings on chapters 26 and 27, and is planning one on Thursday, I believe, for chapter 25, which deals with the CFIA. Chapter 28 is a follow-up of previous recommendations made to various other regulatory agencies.

[Translation]

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.

The major challenges facing regulatory programs include the following: major reorganizations, resource reductions, or privatization; an increasing focus on the precautionary principle; an aging workforce, many vacancies, few recruits, and a high attrition rate in certain key areas; major concerns about scientific credibility in certain areas; and an increasing need for multi-departmental and multi-jurisdictional action.

In addition, one of the particular challenges regulatory programs face is determining the appropriate balance between protecting the public interest and responding to government initiatives related to client service.

[English]

We continued to find efficiencies in risk identification and management. Without sound procedures, some significant risks may not be identified and managed, and the resources may not be reasonably allocated. For example, in the Canadian Food Inspection Agency, we noted a lack of important information on the incidence of food-borne illness.

Similarly, assessments on the impact of regulations as required by government policy continue to need significant improvements. Without good assessments it is difficult for parliamentarians, ministers, and the public to have a reliable basis for understanding what the regulation will achieve and how much it will cost to implement.

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[Translation]

We also found continuing deficiencies in ensuring compliance with regulations. There was a pattern of problems with unclear objectives and inadequate inspection coverage. Reporting to Parliament on effectiveness also continues to be inconsistent or incomplete, and there is a lack of performance indicators.

[English]

Our recommendations focus on measures the government needs to take to significantly improve regulatory programs across the board. These recommendations raise the following questions:

(1) Who will be responsible for ensuring that action is taken on a sectoral basis rather than each agency on its own?

(2) When will information on government health and safety priorities and the balance that has been struck between protecting Canadians, serving industry clients, and addressing budget and economic objectives be provided?

(3) What steps will be taken to ensure that reliable information on risk is available and that surveillance systems are sound?

(4) How will the government ensure the credibility of science and impact assessments?

(5) What measures will be reported to ensure that resources are allocated based on risk?

(6) How will the government deal with the loss of expertise due to retirements?

(7) When will officials be assessed on the achievement of significant interdepartmental program objectives?

(8) When will Parliament receive annual sectoral reports on the effectiveness of health and safety regulatory programs that require significant interdepartmental cooperation?

We also believe Parliament needs to consider establishing a means to periodically scrutinize health and safety programs on a sectoral basis with respect to how they are responding to common key challenges, pressures, and improvement requirements.

Mr. Chairman, that concludes my opening statement. We would be pleased to answer any questions.

The Chair: Thank you very much, Mr. Timmins.

Now we'll turn to Mr. Redling.

[Translation]

Mr. George Redling (Assistant Secretary, Regulatory Affairs and Orders in Council, Privy Council Office): Thank you, Mr. Chairman, for inviting us.

With me are Hélène Quesnel and Jody Aylard, who are senior officers in the Regulatory Affairs Division, as well as Ms. Marie-France D'Auray-Boult from the Treasury Board Secretariat.

[English]

It might be helpful to outline the role of the Regulatory Affairs and Orders in Council Secretariat in the government's overall regulatory structure. I would also like to report on some current developments in priorities in our collective efforts to manage regulations in the best interests of Canadians.

The secretariat, for which I am the assistant secretary, supports the Special Committee of Council, the committee of ministers responsible for considering regulatory proposals that require cabinet approval. The secretariat assists the Special Committee of Council in developing and implementing the regulatory policy and providing substantive analysis and advice with regard to regulatory proposals.

Canada was one of the first countries in the world to adopt a regulatory policy and to define regulatory management standards as part of its administrative policy. Although not unique, our approach is regarded as being avant-garde by the Organization for Economic Cooperation and Development, or the OECD, which is currently carrying out its own review of Canada's regulatory system.

The report of the Auditor General is another useful review to improve our regulatory system. We have noted the Auditor General's recognition of good practices. As the government responded, it will build on this work by continuing to identify and disseminate best practices in such areas as managing risks; using advisory committees and a range of public policy instruments; measuring outcomes; and communicating and consulting with Canadians.

The government also noted that it believes the regulatory policy is sound. At the same time, the government has recognized the need to ensure that regulatory authorities have the capacity to meet expectations of the regulatory policy. Indeed, as the Auditor General noted, the government already had identified many of the issues raised and undertaken significant good work.

[Translation]

Let me conclude by describing three initiatives which respond to the Auditor General's recommendations.

[English]

First, I touched earlier on the OECD's review of Canada's regulatory management system. This is a rigorous examination of our policies and procedures against a template of best practices. We expect to see the OECD's report early next year, but informal indications are that the OECD sees the policy as being the most advanced in the world in terms of regulatory management. The OECD will no doubt have suggestions for improvements, which we will consider seriously, as we have the recommendations of the Auditor General.

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A second area of activity is risk management and the precautionary approach principle. The Treasury Board Secretariat, after extensive research and consultations, issued an integrated risk management framework to strengthen risk management in the public sector and to advance a more systemic approach.

[Translation]

During the last year the government has developed a framework for the implementation of the precautionary principle. The government plans to launch public consultations on the proposed principle-based framework. The results will enable it to determine whether the guiding principles allow for a more specific application.

[English]

Finally, as part of the government's overall emphasis on e-government, we are identifying methodologies and best practices in regulatory management. One of our capacity-building initiatives is the creation of online learning tools to assist regulatory organizations to better develop and consult about regulations.

Mr. Chairman, we're continually striving to enhance the regulatory process. We believe we are in the forefront as compared with other countries, but improvements remain to be made, and we're working hard to make them.

Thank you.

The Chair: Thank you very much, Mr. Redling.

Now we're going to turn to Ms. Janet Milne from Transport Canada.

Ms. Janet Milne (Assistant Deputy Minister, Corporate Services Group, Transport Canada): Thank you, Mr. Chairman and members of the committee.

I'm here to discuss some of the issues related to the management and health of the regulatory inspection community. I'm accompanied by Gordon Chapman, executive director of the Regulatory/Inspection Secretariat housed at Transport Canada.

[Translation]

In 1998, a committee of deputy ministers was convened to examine the state of the regulatory/inspection community, in departments with responsibility for protecting the health and safety of Canadians. The initial request was to examine the demographic profile of the community and to advise on actions that the government should be taking to sustain the capacity of this workforce to carry out its mandate. Five departments/agencies participated in the Review: Transport Canada as Chair of the group; Health Canada; the Canadian Food Inspection Agency; Environment Canada and Human Resources Development Canada. A number of others have joined recently.

[English]

The report of that committee, entitled A Public Trust—Keeping Canadians Safe and Healthy, ultimately extended well beyond demographics and looked at a range of the issues that affect the workforce, including recruitment, retention, and changing competency profiles, and a variety of management challenges. It concluded at that time that action was needed to recruit more aggressively, build competencies for inspectors, create better conditions for retention, and build a stronger sense of community and recognition amongst the various groups of inspectors. To ensure that we did this in a coordinated way across government, the secretariat was created at Transport Canada.

[Translation]

The report pointed out that while inspectors in different departments require very different technical expertise, and vary widely in the amount of experience and training required, many issues and challenges were common across the system. For example, the changing competency profile of inspectors and the need for increased focus on non-technical skills was widely viewed as a challenge, along with growing concern among inspectors about personal liability.

Other issues, for example the age profile of inspectors and the highly competitive market for skills in areas such as engineering and for pilot certification and experience, were more specific to individual departments. Therefore, in addition to collective action, individual departments are actively working to solve their own unique problems.

[English]

So progress is being made. Compensation issues have been addressed to some extent through the collective bargaining process, which until that time had been largely suspended during the program review period. Salaries have been improved and targeted allowances have been introduced for some of the higher-risk groups.

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Aggressive recruitment initiatives have been undertaken by a number of departments. At Transport Canada a major national recruitment campaign was mounted that initially targeted civil aviation and marine inspectors. We've added other groups since then. This included ads in all of our major national newspapers and some key professional journals along with development of an online recruitment system, which has now become a permanent recruitment tool with increasingly broad application.

As a result of these efforts and the salary improvements and allowances, vacancy rates for inspectors in Transport Canada have fallen dramatically over the last year and a half. Our retention rates have also improved. In fact, in the year 2000, recruitment exceeded attrition for the first time in a number of years. The time required to fill vacancies has also been significantly reduced.

[Translation]

Currently, the Secretariat is looking at ways to partner with the Joint Career Transition Council, a labour-management partnership, to participate in job fairs across the country.

In addition, there have been discussions with the Public Service Commission and Communications Canada to develop methods to get the word out to students and young people beginning their careers, to make them aware that there are interesting professions in inspection.

Recognition of the accomplishments of inspectors is also important, both to build inspectors' sense of identity and to communicate their accomplishments to Canadians. A website has been created, and an issue of the publication, A Day In The Life, published by The Leadership Network, featured inspectors and their activities.

[English]

Mr. Chairman, the regulatory inspection community, as we know, is comprised of a wide variety of different backgrounds in different departments—veterinarians, biologists, railway inspectors, fisheries officers, and medical doctors, to name just a few. To promote communication amongst the inspectors, the secretariat has held interdepartmental sessions on the report and will be holding a series of conferences across the country for inspectors over the coming year.

As we prepare for the rising number of retirements that we anticipate in the coming years, we're concentrating on identifying key knowledge that's held by individuals in this group and developing ways to transfer rapidly to the next generation. We had a pilot project in Transport Canada last year that focused on how to do this quickly and efficiently.

As well, we've launched common training programs that will provide inspectors from all departments with training in areas of common competencies. Team-building, report writing, leadership—all are skills that technical staff need and may not actually get in traditional technical training courses.

[Translation]

I would like to note that despite the numbers, the number of anticipated retirements, which was about 40% by 2008, has not been reached this year. We are still very concerned about retirements however as they will eventually occur, albeit at a slower rate than anticipated. We are monitoring our demographic profiles closely to ensure that our recruitment, retention and learning programs are on target to maintain the health of this important community.

I'd like to thank you again for this opportunity to speak to you.

[English]

The Chair: Thank you very much, Ms. Milne.

We'll turn finally to Ms. Diane Gorman from Health Canada.

Ms. Diane Gorman (Assistant Deputy Minister, Health Products and Food Branch, Health Canada): Thank you, Mr. Chairman and committee members, for inviting Health Canada to appear before the public accounts committee today.

I am pleased to be here with Elizabeth Nielsen, Director General of the Office of Regulatory and International Affairs, and Dr. Robert Peterson, Director General of the Therapeutic Products Directorate of the Health Products and Food Branch at Health Canada.

Science is yielding powerful new drugs, vaccines, and therapies to improve the health, and enhance the lives, of Canadians in ways that until recently were hard to imagine. Leading-edge technology is having a dramatic impact on people who face life-threatening or serious illnesses. However, with the fast pace of change and the complexity of the biological starting material, much is still unknown about some of these new and emerging products.

[Translation]

Health Canada, through its Health Products and Food Branch, regulates the safety and efficacy of many products in the Canadian marketplace and health system. The findings of this particular chapter are based on the results of an audit which focused on the regulatory regime of biological products of Health Canada.

Our goal as the regulator is to ensure that products available in the marketplace are safe, effective and of the highest quality. Along with an assurance of safety and quality, Canadians also expect to be informed on the appropriate use and the risks of these products. Canadians also expect to have accurate information in order to make their own informed consumer health decisions.

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[English]

Health Canada is well aware that although the area of biologics presents great potential, it may also involve risk. We have been working proactively to create a regulatory regime that can help Canada harness the potential while limiting the risk. Rapid advances in the field require a regulatory regime that is up to date and responsive to change.

The Auditor General has conducted a very useful audit of our regulatory program as it affects the area of biologics. The report complements our own evaluations of our processes and confirms that we are on the right track in meeting the regulatory challenges. Each responsible bureau within the Health Products and Food Branch works closely with partners and stakeholders, both internally and externally. We also have established and make broad use of expert advisory committees.

Health Canada acknowledges that the Food and Drugs Act and regulations have not always kept pace with scientific and technological advances. Health Canada is conducting a comprehensive review of its health protection legislation with a view to replacing outdated statutes with a new health protection legislative regime. The objectives of the legislative review are to modernize and strengthen the legislation and to provide policy direction in the area of health protection.

[Translation]

This new legislation would address some of the recommendations of the AG report, including the tenant for public scrutiny of government actions and co-operation among all affected parties without compromising the regulator's role and accountability to the people of Canada.

In July 2000, the realignment of Health Canada became effective. The purpose was to strengthen our scientific, policy, regulatory and management capacity to protect and improve the health of Canadians. The realignment included the creation of a new directorate, the Biologics and Genetic Therapies Directorate, to focus resources and efforts in this important area. We have also created the Office of Consumer and Public Involvement (OCAPI) to promote meaningful public and consumer participation in decision- making on priorities, policies and programs for the regulator.

[English]

In addition, we have established the Office of Regulatory and International Affairs, which has been created to improve the ability and the capacity of the branch to deliver its regulatory and international policies and programs and to further improve the consistency of our approach to regulation.

As well, we have just announced the establishment of a new body in our department to focus resources and efforts on post-approval surveillance and assessment of marketed health products.

As with any regulatory framework, the use of standards has benefits and limitations. The Auditor General has recommended that we establish more formal criteria to determine which approach is most appropriate. We are looking to a mix of approaches. We have established a departmental committee to address these issues and are communicating with a department-wide committee studying the best use of standards in regulation. We are also actively implementing our decision-making framework with a view to constantly strengthening our approaches to assessing risk and determining how to address it. Whatever the approach used, it will ensure that solid scientific evidence informs our regulatory decisions.

The Auditor General noted the need for the “credible use of science by government”. Health Canada recognizes that the scientists working within the department need the resources and support to conduct their important work. To this end we have created the Office of the Chief Scientist on the advice of our science advisory board, an arm's-length science advisory panel for Health Canada.

The demand for qualified workers in science-based programs is acute in both the public and private sector. We must compete aggressively with universities and industry for the knowledge workers we need. Teams of human resource officers, departmental scientists, and managers are working together on just such a human resource plan. They are coordinating their efforts to ensure effective recruitment and training strategies. Through a variety of programs, we are enhancing training opportunities for staff so they can keep abreast of new developments and enhance the skills they need to do their jobs.

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Through these efforts and others, Health Canada is establishing an exemplary regulatory program for the area of biologics. Our regulatory tools will be relevant and flexible. They will keep pace with technological advancements as much as possible. They will help ensure that all biological products regulated by Health Canada adhere to the highest standards and improve the quality of life for Canadians. The Auditor General's findings and recommendations will be very helpful to Health Canada as we continue to strengthen our regulatory regime of biologics. The Auditor General should be commended on the excellent work that has been done in this important area.

Thank you, Mr. Chair.

The Chair: And thank you, Ms. Gorman.

Now we'll start our first round.

Mr. Merrifield, eight minutes, please.

Mr. Rob Merrifield (Yellowhead, Canadian Alliance): Thank you very much.

It's a pleasure for me to be here to ask you some questions. I was actually pricked by some of the things that were mentioned by Ms. Gorman. Health and safety is first with Health Canada, I'm sure it is, but with drug safety it becomes a bit of a concern. I understand it takes approximately 734 days to approve a drug in this country. Is that true?

Ms. Diane Gorman: I'm going to ask Dr. Peterson to join me at the table.

I just want to define, as well, Mr. Merrifield, in terms of the response to the particular audit, that this audit was with regard to the approval of biologics in Canada. It did not deal with our therapeutic products more broadly. It was limited to biologics.

Mr. Rob Merrifield: Okay. I guess maybe that was an inappropriate—

The Chair: Just a moment, Mr. Merrifield.

Can you introduce yourself, Dr. Peterson, please?

Dr. Robert Peterson (Director General, Therapeutic Products Directorate, and Acting Director General, Biologics and Genetics Therapies Directorate, Health Canada): Certainly. I'm Dr. Robert Peterson, Director General of the Therapeutic Products Directorate and Acting Director General of the Biologics and Genetics Therapies Directorate.

The Chair: Thank you very much.

Sorry, Mr. Merrifield.

Mr. Rob Merrifield: Perhaps I should become a little more focused in my question, and you can tell me whether or not you can answer this.

The drug Cipro in particular is not an approved drug right now in Canada. Health and safety is number one. Can you tell me, is that a...?

Maybe I'm wrong here.

Ms. Diane Gorman: Perhaps I can just clarify, Mr. Chair, that Health Canada is here today to deal with the response to the Auditor General's report. There have been other fora where this issue has been discussed. Mr. Merrifield was part of a discussion last week at the Standing Committee on Health.

So I'd like to know whether we should be limiting our questions here to the Auditor General's report with regard to biologics.

The Chair: I think Mr. Merrifield is entitled to ask the questions he feels are appropriate.

Mr. Rob Merrifield: I'm not trying to blame anyone here. I'm trying to get to the bottom of the health and safety of Canadians, and this is what I believe your department is in charge of.

Cipro is a drug that, as I understand it, is not approved now, and I would assume it's going to be approved very shortly. I'm just trying to get to the bottom of this. Can you answer me as to whether it's going to be approved?

Ms. Diane Gorman: Certainly we can answer that question. The drug is approved for use in Canada. It was approved some years ago, and has been used widely in Canada. There has been some question as to whether or not it has been approved for the indication of anthrax.

As you can imagine, a process that would bring you to approve a product for anthrax that might involve clinical trials might be outside the normal process. But it has been approved, and has been used widely in Canada for other indications.

Mr. Rob Merrifield: But never for the use of anthrax.

Dr. Robert Peterson: There are no products approved in Canada at the present time for the treatment of anthrax. Again, current regulations require clinical trials, and clinical trials against weapons of mass destruction are not ethical. So we are currently engaged in looking at the manner whereby we can bring these products through approval, upon application by the sponsor.

Mr. Rob Merrifield: Can you tell me how soon that would take place?

Dr. Robert Peterson: It would depend on the timing for a regulatory change.

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Mr. Rob Merrifield: I guess my question is based on the fact that we've amassed a considerable amount of this product for the potential onset of anthrax, and if it has to be used, it's quite important that we know whether it's going to be approved and what the time lines would be.

But fair enough. I have only eight minutes, and I don't want to waste it all on this.

The Chair: You have four minutes yet.

Mr. Rob Merrifield: Okay.

Ms. Diane Gorman: Health Canada ensures that the products in the marketplace are both safe and effective. The fact that Cipro has been used for other indications, quite safely, for many years is a factor here. As you know, many drugs in Canada are prescribed “off-label”, as we call it, by doctors who feel, in their judgment, this is the appropriate treatment for a patient.

Mr. Rob Merrifield: So what you're saying is, they could be used immediately if a doctor deemed them necessary. Is that what you're saying?

Dr. Robert Peterson: That's absolutely correct. The consensus opinion of medical specialists in the treatment of anthrax specify Ciprofloxacin as one of the drugs of choice for that infection.

Mr. Rob Merrifield: So approval's not necessary. That's really what you're saying.

Dr. Robert Peterson: The indication for anthrax requires submission of an application by a sponsor for that. This is a drug that has been approved for other respiratory infections, including infections similar to that produced by this bacteria.

Mr. Rob Merrifield: Okay.

I'd like to shift my next question a little bit, although it's on the same vein. There's been a report made by the department with regard to defence against terrorist attacks. I understand the minister, as suggested a few minutes ago.... This report, published three years ago, suggested that the cost of an attack in Canada would be potentially $8.5 billion, with 30,000 deaths, if the appropriate defence is not taken.

When we have a report that is published, and brought by the department, why would it take until now before any action is taken? Is that normal?

Ms. Diane Gorman: Mr. Merrifield, I would make the same comment I made before, that the purpose behind my appearing before the committee today is to respond to the Auditor General's audit with regard to the health and safety regulatory framework, and, more specifically, the chapter on Health Canada's biologics program.

To answer your question, I have no knowledge of that report. I have no personal knowledge of that report, and I therefore cannot respond to your question.

Mr. Rob Merrifield: In general, when a report coming from Health Canada, produced by Health Canada, with regard to the health and safety of this country is not acted on, is that normal process?

Ms. Diane Gorman: I'm sorry, I can't answer that question. I have no knowledge of that particular report. To answer would be pure conjecture, and I don't think the committee wants anything but fact before it.

The Chair: Mr. Merrifield, do you have the name of that report?

Mr. Rob Merrifield: I don't have it in front of me. It's in my office. I can certainly give it to the committee.

The Chair: If you can get the name of the report before the end of the meeting, we can ask Health Canada for a written response to your question.

Mr. Rob Merrifield: Absolutely. That would be appreciated.

The Chair: Any more?

Mr. Rob Merrifield: No, that's fine.

[Translation]

The Chair: Mr. Perron, eight minutes, please.

Mr. Gilles-A. Perron (Rivière-des-Mille-Îles, BQ): Good day, Mr. Chairman. Good day, ladies and gentlemen, and thank you for being with us.

In your statements, you referred to the precautionary principle. Can you give me the government's definition of that principle, and explain to me how it is implemented in regulatory programs for health and safety?

Mr. George Redling: Mr. Chairman, may I ask my colleague Hélène Quesnel to answer that question? She has worked extensively with other departments on the precautionary principle.

[English]

The Chair: Perhaps I can ask you to introduce yourself, please, before you speak.

[Translation]

Ms. Hélène Quesnel (Policy Analyst, Regulatory Affairs and Orders in Council Secretariat, Privy Council Office): Of course. My name is Hélène Quesnel and I am a senior analyst in Mr. Redling's organization, the Privy Council Office secretariat.

If I understood your first question correctly, Mr. Perron, you were asking for a definition of the precautionary approach in the context of a federal initiative.

As you know, we have spent a year trying to come up with an agreement on a description that would be acceptable for all regulatory programs of a scientific nature in the fields of health, the environment and natural resources. We have come to the conclusion that the precautionary approach is an approach used in the context of risk management. It is an approach that is used when it is necessary to take a decision in a situation where there is a risk of serious or irreversible danger and where there is a high level of scientific uncertainty.

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Therefore, in this context, there are basically three elements: decision, danger and scientific uncertainty.

Mr. Gilles Perron: Am I to understand that there is no consensus among the various departments as to the vision of the precautionary principle?

Ms. Hélène Quesnel: No, on the contrary, there is a consensus among all the departments. On the other hand, the precautionary principle, just like the precautionary approach, is defined or described in different ways in different instruments. In some federal initiatives, it is a precautionary principle and a certain language is used, whereas in other international, national or provincial instruments other terms are used. Depending on the context, public servants have come to realize that there are many descriptions. We therefore arrived at the identification of the three critical elements: decision, danger, uncertainty.

Mr. Gilles Perron: I still don't understand what the precautionary principle is.

Ms. Hélène Quesnel: The precautionary principle is an approach to decision-making. It is a risk management approach to reach a decision. It is an approach that is used when the problem contains the three elements that I mentioned.

If a public servant faces a situation where he must make a decision, where there is a great deal of scientific uncertainty and where there is serious or irreversible danger, the precautionary approach is used to make the decision.

Mr. Gilles Perron: It has a Québécois flavour.

You talk about risks. Your answer puts me in mind of comment 24.121 of the Auditor General's Report, where it says that the government must explain its regulatory policy clearly to Canadians. Do you agree? The Auditor General says:

Solving health and safety regulatory problems requires more citizen engagement.

Could you explain your goal further? Do you agree with the Auditor General's statement?

Ms. Hélène Quesnel: In the implementation of the precautionary principle or in general?

Mr. Gilles-A. Perron: Well, in general. The Auditor states that the government must explain its regulatory policy clearly to Canadians. Do you agree with that?

Mr. George Redling: If you will allow me to respond, Mr. Chairman, I will say that I agree with that comment or suggestion. The government can explain the direction it is taking in many ways. There is the Speech from the Throne. There are also Cabinet deliberations. There are also the annual reports on departmental performance. There are many ways to express that direction and explain the balance that must be created by the government.

In the context of the precautionary principle, I can add that we have worked hard with the other departments involved to develop a policy, a perspective on the precautionary principle. Our work is done and it will be ready for publication and public discussion. We want to have a dialogue with the public on this principle.

Mr. Gilles Perron: When will it be ready?

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Mr. George Redling: I expect that we will be able to publish it in a month or two.

Mr. Gilles Perron: When and how will the government provide Canadians with information on the following points: the nature of the risks, the definition of risk management and the way the precautionary principle is implemented? I am raising the precautionary principle again because it is not clear.

Ms. Hélène Quesnel: As to the nature of the risks, I believe it would be appropriate for you to direct your questions to our Department of Transport colleagues.

Mr. Gilles Perron: My question is directed to anyone who wants to answer.

Ms. Hélène Quesnel: Very well. I can answer the question about the way the government implements the precautionary principle or approach.

As Mr. Redling indicated, the federal initiative has led to a discussion paper in which we have developed guidelines. Even if there is scientific uncertainty, there has to be a basis for decision-making. How do we develop this basis?

We expect these guidelines to be ready in a few months so that we can have an open consultation both here and internationally.

Mr. Gilles Perron: I had two or three related questions, if you recall. I would like an answer if possible, Mr. Chairman. I would like the definition of risk management.

Ms. Hélène Quesnel: Mr. Perron, you will find the definition of risk management in A Management Framework for the Government of Canada, which was published in April of this year by Treasury Board. I would be pleased to send you copies if you wish.

Mr. Gilles Perron: We should have a copy for each member of the committee.

The Chair: Yes, that's possible.

[English]

Can you deliver a copy to the committee clerk for distribution?

[Translation]

Ms. Hélène Quesnel: Yes, very well. I will send a number of copies.

The Chair: Thank you very much.

Ms. Hélène Quesnel: Regarding the nature of risks, Ms. Gorman or Ms. Milne can answer.

Ms. Janet Milne: I don't know if it is a question of identifying precisely the nature of risks. Here at the Department of Transport, there is a risk management process that is well developed, that involves a whole range of expert committees. These experts examine the facts and the data and we discuss the implications of this scientific or technical data with them.

Mr. Gilles Perron: The purpose of my question is to find out how Canadians are warned about the risks. It's very nice to discuss that behind closed doors with experts and scientists, but how do you warn Canadians about the possibilities of risk?

[English]

The Chair: Monsieur Perron, I think we'll come back to you. We'll follow through on that line of thought.

[Translation]

Mr. Gilles Perron: Excuse me, Mr. Chairman.

[English]

The Chair: I'll now turn to Mr. Bryden.

Mr. John Bryden (Ancaster—Dundas—Flamborough—Aldershot, Lib.): Thank you, Mr. Chairman.

The report that Mr. Merrifield referred to is entitled Bioterrorism in Canada: An economic assessment. It appeared in the latest issue of the Canadian Journal of Infectious Diseases, and it was co-authored by Ronald St. John, head of Health Canada's Centre for Emergency Preparedness and Response.

In my view, Mr. Merrifield's questions are entirely in order, because I believe this report was irresponsible. It was not proper for the head of a sensitive agency, even before September 11, to be co-authoring such a document. The problem is that it relies exclusively on American documents and fails to seek the advice of Canadian defence officials, who would have been able to inform the authors that perfect conditions for bio-terrorism, or the mass use of anthrax or any other biological weapon, do not normally exist. By creating a scenario based on perfect conditions, an article has appeared, picked up by the news media, that is certainly frightening, and I think a proper reason for comment by members of Parliament.

• 1620

I do not think it properly reflects the nature of the actual threat out there in the sense that, basically, the content could have been written any time in the last 50 years. This technology for the mass dispersal of biological agents has been with us for 50 years. We didn't need this report at this time.

That said, Mr. Chairman, I'd like to actually ask relevant questions along this line, if I may. One of the issues I would like the witnesses to comment on is that in the context of this current fear we are facing, there is a regulatory problem. One of the witnesses alluded to it—namely, the question of how we can rapidly bring on stream remedies, or prophylactics, if you will, that have not been cleared by clinical trials. I'm thinking here of anthrax vaccines, for example. There are certain médicaments that are useful for chemical poisoning.

Is Health Canada looking at a way in which we can get those things on stream and make them available to our officials as quickly as possible?

Ms. Diane Gorman: Thank you for the question, Mr. Bryden. I'd like to answer it in several ways.

Even prior to September 11 the department was looking at what its proper mandate and response should be in the event of a national emergency. So we did have processes in place very broadly in that regard. Since September 11, we, and all Canadians, have been looking at what are those unanticipated threats to our national security. We have been putting a number of measures in place in that regard. Some of those are with regard to leadership that Health Canada should provide.

I won't give a full response there, but to come to your specific question, we have been looking at what are the regulatory or legislative authorities the Minister of Health might need in the event of an emergency, and what, under other circumstances, might not provide us with sufficient flexibility to deal with the kind of issue you are raising. In fact, Dr. Peterson was alluding to an analysis we have conducted and have sought legal advice on with regard to what regulatory flexibilities might be needed in an event such as you describe.

I could ask Dr. Peterson to provide a bit more detail about the particular circumstance you raise, because I think it's an excellent example of where one would not normally expect to have the types of threats that we now know are possible. Our regulatory regime had not anticipated having to approve drugs and release drugs under those circumstances.

Dr. Robert Peterson: There are two additional mechanisms that do exist in regulations at this point in time for an emergency response such as has been alluded to. One is under the provisions of the special access program the Health Products and Food Branch organizes and has run for many years. This allows for a practitioner to request the availability and the marketing of otherwise unapproved substances for a particular purpose under extraordinary conditions. The special access program has been looked at in the past and used for purposes not in the context of the emerging threats that we are potentially facing today but in other medical circumstances that are equally a risk to the health and well-being of Canadians.

The other instrument that is available to us comes under the regulations that are related to clinical trials in Canada, and that is the opportunity to rapidly approve, within a 30-day default period, a clinical trial application that would provide for a rather open and widespread use of a new therapeutic agent, given appropriate controls, in order to undertake surveillance and measurement of effectiveness of the product.

The earlier allusion to the necessity of revisiting regulations with regard to the actual approval process of drugs that otherwise could not be tested in standard clinical trials in humans was in response to the specific question of whether there was a drug approved for the treatment of anthrax at this time in Canada.

Mr. John Bryden: Are you confident, then, that you are moving as rapidly as you can on that particular file? Because it's an awkward file, and it does fall right within your bailiwick, I would have thought.

Ms. Diane Gorman: We are, and thank you for your support.

• 1625

Mr. John Bryden: Can I ask another question, Mr. Chairman?

The Chair: Sure, two minutes.

Mr. John Bryden: There's another area of concern for me with respect to Health Canada and this particular problem. Are you liaising now in any changed manner with the Department of National Defence and with Environment Canada, who happen to have expertise in the very areas we're dealing with here? I'm just not sure whether there is, shall we say, cooperation. I'm hoping there is.

Dr. Robert Peterson: We've been in discussions with the Department of National Defence for a period of years with respect to their expectations and anticipatory needs of agents such as these. Again, they have in the past been made available under investigation of new drug protocols as well as under the special access program. The provisions we are currently engaged in with regard to revisiting the regulations would indeed cover the anticipated needs that DND would have as well.

Mr. John Bryden: Just as a small comment, one of my concerns about the particular article was the fact that it seemed to indicate there wasn't consultation with defence scientists, who perhaps could have put things in a bit better perspective. So I would hope there is the kind of liaison there should be now, in this situation, with other ministries.

Ms. Diane Gorman: Again, I can't speak to that report, because I have not personally seen it.

Mr. John Bryden: I understand that.

Ms. Diane Gorman: Across government we are collaborating in many ways. Dr. Peterson mentioned some ways. We are also looking at scientific capacity and laboratory capacity across government so that we can both respond and know where the nodes of response are in the event we need to call upon them.

Mr. John Bryden: Excellent.

Thank you, Mr. Chairman.

The Chair: Thank you, Mr. Bryden.

We'll now move on to the second round, which is only four minutes.

Mr. Jaffer, four minutes, please.

Mr. Rahim Jaffer (Edmonton—Strathcona, Canadian Alliance): Thank you, Mr. Chairman.

I'm going to shift gears a little bit from what my colleague was asking questions about.

In your brief, Madam Gorman, there's one part where it says:

Health Canada acknowledges that the Food and Drugs Act and Regulations have not always kept pace with scientific and technological advances.

I know that your report, as you've said here, focuses specifically on biologics, but this raises a larger question, especially considering what my riding is, Edmonton—Strathcona. I have the University of Alberta located there. In a case not too long ago, there was a doctor, Dr. Russell, who had been doing some work—clinical trials and a lot of research—on specifically an arthritic drug that was helping a lot of people. I guess it was more therapeutic by nature, but it was helping a lot of people.

The concern here—I've also raised this in the House—is around the approval times for drugs like that, where they're actually serving a purpose. They've gone through rigorous testing and clinical trials, but often when they get to the Health Protection Branch, it unfortunately takes far too long for the drug approvals. People who could actually be helped in the process from the testing that goes on within universities and other institutions are unfortunately held back from getting access to those drugs while the Health Protection Branch takes longer to approve them.

I'm wondering if you can address that issue, because that's been a great concern on a few other drug approval times as well.

Ms. Diane Gorman: Thank you for your question, Mr. Jaffer.

I'll start at the level of the legislative framework, which is where you began your question. As you probably know, the Health Protection Branch began broad public consultation with regard to its legislative framework, which goes back now about four years. We are working with legislation that in some cases date from the 1950s. The science and technology that exists now—and certainly we know the future potential for it to exist—was not contemplated at the time of some of that legislation. So we are having to use existing legislation to deal with some very complex emerging scientific issues.

That was why I mentioned our legislative framework, which we have recognized as being outdated. We have consulted broadly with Canadians, and we do have very good input as to where Canadians would like to see health protection legislation go in the future. We are actively working on that. However, that doesn't negate the importance of safety, and that always is principal in our minds. Dr. Peterson has talked about a number of mechanisms that are used within the drug approval process and that provide early access and priority drug reviews. He could speak to that in more detail, if you like.

• 1630

To go back to Mr. Perron's question on the precautionary principle, it's a very important element for us that we find the right balance between the safety of the product and access by the Canadian public. We do have a number of mechanisms by which the Canadian public can access products if they are in a particular circumstance, either through special access or participating in a clinical trial, prior to the drug itself being approved. If you'd like more detail, Dr. Peterson could respond.

Mr. Rahim Jaffer: Maybe you would want to expand there, because I do have one other quick question in line with that. One of the concerns raised at the time of this particular drug, and the clinical trials involved with it, was that in some cases other markets are approving similar drugs. Is there some collaboration being done with other countries when it comes to research and development of certain drugs that may be taking place here as well in order to facilitate perhaps a sharing of research information?

Unfortunately, what often happens is that if the drug is being held up here, then people are accessing it illegally from other markets. If it helps their pain or suffering, obviously it's hard to blame them for doing so.

What can be done on that front to integrate systems internationally, to some extent, for research especially? That's something I think many Canadians are concerned about.

Ms. Diane Gorman: Again, thank you for the question.

This is not a simple issue. To go to your point on harmonization, Canada does work very actively with a number of different countries—for instance, the International Conference on Harmonisation will establish, as a first infrastructure, that submissions received by a number of these member countries will have the same technical requirements. So at least that lays the foundation for us in terms of a platform in the future to share information.

We also have a number of mutual recognition agreements with other countries with regard to manufacturing practices and establishment licensing for those industries who produce products in other countries. So we are working on that front as well.

We are also working with regard to post-market surveillance and sharing information, especially with the USFDA. Given that we are such a small population, and given the demography we've dealing with, the trigger for an adverse drug reaction may not be apparent in Canada as opposed to the United States.

So we are working on all of those fronts, and expect to make even more progress in the future, but it is not a simple issue. Companies do not necessarily file in Canada at the same time as they file in other countries, so by the time we are reviewing the application we might have more information. There might be more adverse reactions than one would have seen in a clinical trial that is very closely managed. It's not a simple issue.

I don't know whether Dr. Peterson has anything to add.

Dr. Robert Peterson: Not really. That's a very comprehensive answer to the question.

[Translation]

The Chair: Mr. Perron, four minutes please.

Mr. Gilles Perron: Thank you, Mr. Chairman.

I'd like to get back to the question of communications. The Auditor General believes that the government must emphasize information about risks. In your departments, do you have a communications plan regarding risks?

Mr. George Redling: Mr. Chairman, the document to which Ms. Quesnel alluded is a document that helps departments identify, analyze, manage and communicate risks. We can give you specific examples of how departments do that.

Ms. Janet Milne: In the Department of Transport, we have a very active communications program for problems and specific risks that we identify.

For example, a year ago we identified a serious risk, the one that occurred if infant car seats were not installed properly. We therefore launched a major campaign to make Canadians aware of the danger and inform them about the best way to install the seats.

Secondly, on our Web site we have a page that gives a list of all the vehicles that have been recalled. We provide information about that. One of our priorities is to publish information about problems and facts that the public should be aware of.

• 1635

Ms. Diane Gorman: At Health Canada, we believe that there are two parts to effective communication: the public, that provides us with information, and the department, which is responsible for providing information to the public. As I mentioned in my remarks, we have created the Office of Consumer and Public Involvement, whose mandate is to consult the public in order to ensure that we understand its concerns and needs well, and to make the public understand that it has a role to play in setting our priorities and policies. It is a way of involving the public, but there are others. It's the part about receiving information.

To communicate our decisions or the risks associated with products, we have many ways of communicating with the public and the people who are part of the health system, especially doctors and pharmacists. We have documents such as Dear Health Care Provider Letters, the public advisories and It's Your Health. The Health Products and Food Branch also has a Web site that provides information to the public.

The Chair: That is a very lengthy answer, Mr. Perron, but...

[English]

Mr. Gilles-A. Perron: Don't blame me.

Voices: Oh, oh!

The Chair: Madam Phinney, four minutes.

Ms. Beth Phinney (Hamilton Mountain, Lib.): I note that Mr. Redling, in his two-page comments, a couple of times mentioned the OECD, and that you're anticipating glowing remarks from them about Canada's regulatory system.

I've been there, and I know this is a think-tank. Normally they take on a project when they're asked by some country to study it for some reason. Why are they doing a review of Canada's regulatory system right now?

Just a short answer, please.

Mr. George Redling: The short answer is that they look for volunteers. We volunteered.

Ms. Beth Phinney: They look for volunteers for what?

Mr. George Redling: To have their regulatory processes and policies, for example, reviewed.

Ms. Beth Phinney: Was some other country asking for this?

Mr. George Redling: Other countries have volunteered. All of the G-7 countries up to this point, I believe, have volunteered. France and Germany still have to confirm their participation, but it's expected soon. Canada was one of the first five to volunteer for the program.

Ms. Beth Phinney: Okay. Thank you very much.

The Auditor General mentions the importance of good surveillance systems in identifying areas of risk and providing data, etc. In 1999 the audit found there were weaknesses in the national surveillance of diseases and injuries, and the Auditor General made some recommendations. Health Canada agreed to implement them all, and then this committee made some suggestions.

I'm just wondering if you could tell us what progress has been made in this area. Does Canada have a risk communication strategy, and is the data from the system being used to guide resources?

The Chair: Who are you directing your question to, Ms. Phinney?

Ms. Beth Phinney: To Ms. Gorman.

Ms. Diane Gorman: Do you want to start with that, Robert?

Ms. Beth Phinney: Or Dr. Peterson, yes.

Dr. Robert Peterson: Certainly.

We have a number of areas where we look at health surveillance. Again, specifically to the biologics area today, we have surveillance systems we use in coordination with the population and public health branch with regard to surveillance of the blood system as well as vaccine surveillance, as an example. In both instances, those are directly tied to disease surveillance mechanisms insofar as the effectiveness of the vaccine and the utilization of the vaccine is in the public health domain. Therefore, the provincial public health departments cooperate with us in those surveillance systems.

• 1640

The same type of surveillance system is now presently being developed for blood, where there is a pilot project across a number of provinces. Major hospitals are reporting to us instances of transmission of infectious diseases through blood transfusions and other blood products. This is a new surveillance system that has followed recommendations from Justice Krever.

Ms. Beth Phinney: I think each time you come to this committee we ask for performance reports. Are you giving us the regular reports? Are you keeping us up to date on this in your performance reports?

Dr. Robert Peterson: We publish performance reports on a quarterly basis. I myself am not confident as to how they are transmitted to this committee.

Ms. Beth Phinney: Are you keeping track of this, or identifying this, in your performance reports that you make four times a year? Are you recording how successful you are with your surveillance system?

Dr. Robert Peterson: Well, certainly, we are. With regard to the products we regulate, we are actively engaged in reporting the number of adverse drug reactions entered into our own adverse drug reaction database. As well, a number of advisories sent out to either health care providers or the general public will appear on our website.

Ms. Beth Phinney: Do you feel your system is up to the level the Auditor General is expecting?

Dr. Robert Peterson: In the past year and a half we have begun several initiatives that are at present either in pilot phase or in a phase of alteration, based on experience in the early phases of these new surveillance programs. In addition to that, we are seeking international cooperation that will give us access to larger databases in recognition of the fact that the Canadian experience with therapeutic products represents approximately 2% of the world experience, and we can gain access to larger databases through cooperative efforts.

The Chair: Mr. Timmins, do you have anything you'd like to say in response as well?

Mr. Douglas Timmins: Yes, Mr. Chairman, perhaps I can just clarify a little bit. I think the initial question started with the audit done in 1999, and the answer to some degree dealt primarily with the biologics and the current chapter.

I would point out that the 1999 chapter dealt with diseases and injuries and the surveillance in that regard. Our normal practise would be to conduct follow-up work about two years after that, so that's under way. I think there will be further information available.

I personally cannot comment on the progress and the response to date, but I would point out that the 1999 chapter then did not look at regulated products and the surveillance systems related to regulated products. We do have comments in the biologics chapter, chapter 26, raising concerns about the surveillance practises. Those are specifically in paragraphs 26.38 to 26.40. We found a numbers of problems in those areas, such as little post-market surveillance of biological drugs supported by comprehensive data.

That was our current audit, but some of the discussion is related to progress that's been made since 1999.

The Chair: Thank you very much.

Mr. Grewal, s'il vous plaît, for four minutes.

Mr. Gurmant Grewal (Surrey Central, Canadian Alliance): Thank you, Mr. Chair.

My concerns are related to the regulatory policy and process, so I will direct my questions to Mr. Redling.

First, just for our information, are there any quasi-government agencies in health and safety that are delegated the regulation-making power?

Mr. George Redling: I'd have to turn to Ms. Gorman to answer that. I'm not aware of any that have delegated regulatory powers at Health Canada.

Mr. Gurmant Grewal: Very quickly, does anyone else know?

Ms. Diane Gorman: I can just speak for our department; we do not.

Mr. Gurmant Grewal: Okay.

My second question relates to page 24-19, where the regulation-making process and responsibilities are spelled out. The last point is that the Standing Joint Committee for the Scrutiny of Regulations feels the regulation should be repealed.

Would Mr. Redling agree that at the moment in the Canadian Parliament, after the last 15 years, the death allowance procedure is not on statutory footing? Would Mr. Redling recommend that the death allowance procedure in the Canadian Parliament should be on statutory footing?

• 1645

Mr. George Redling: Mr. Chairman, I'm not sure if I can make a recommendation as to what legislation should be passed. I think that has to be up to the government. I can say, however, that there is a procedure under parliamentary procedure to repeal regulations that are found by the standing joint committee to be, for example, ultra vires of the legislation under which they are purportedly made. There have been instances where such regulations have in fact been repealed.

So I am not quite certain about the statutory need for that authority. That authority seems to be already exercised by Parliament.

Mr. Gurmant Grewal: Since the time is short, I'll move on to another area.

The regulatory authorities, according to the Auditor General, should expand the use of independent expert scientific advisory committees. I see that there is some consultation, but not with the scientific advisory committees. Would you recommend—or is anything being done on this—that the advice of those scientific advisory committees will be sought for regulations on safety and health issues?

Mr. George Redling: In fact, Mr. Chairman, many expert advisory committees now exist. Some of them may have come into existence since the Auditor General's report—I'm not sure of the timing on each—but I know that most regulatory, certainly science-based, departments have expert advisory committees. Both of my colleagues have them in their departments. The CFIA has it. There's a Canadian Biotechnology Advisory Committee.

So these are being used more often. Not only that, there is more peer review of science being done by departments.

Mr. Gurmant Grewal: Okay.

How objective are the regulatory impact assessments? As well, how objectively are the cost-benefit analyses done in the department? Are you satisfied, or do you think there's more room for the impact analysis, as well as the cost-benefit analysis, to be done, including looking into the alternatives for regulations?

Mr. George Redling: Mr. Chairman, the regulatory process management standards, which came out in 1995, asked departments to put in place certain standards to be met—with, for example, cost-benefit analysis. Many departments, in following and putting in place those kinds of standards, have hired more staff, for example, to be able to do cost-benefit analysis.

Another element of objectivity, however, is the fact that the regulation-making process in Canada is a very transparent one. The cost-benefit analysis and the methodology a department uses is made public. In fact, the regulatory impact assessment statements will refer to them. The public has a right to see that methodology, and also to comment on it.

Mr. Gurmant Grewal: Thank you, Mr. Chairman.

The Chair: Right on the button, Mr. Grewal; four minutes to the second. That was absolutely wonderful.

Mr. Shepherd, four minutes. Can you do the same?

Mr. Alex Shepherd (Durham, Lib.): Well, get the clock going and we'll see what we can do.

I guess I want to hit on the macro thing, and maybe transport, because we're looking at transport safety these days and so forth, and the framework in which the regulatory process unfolds. It seems to me you really need to be involved with the industry more.

Some of the things that are coming out of the transport committee these days are that things are evolving and changing very quickly, very rapidly, and the whole concept of finding best practices for things that were not predicted, maybe prior to September 11, and that are now more predictable. We have to find a way to react to those things, and find out whether in fact the machinery of government is flexible. I think somebody used the term “flexible regulations”, which to me was an oxymoron, quite frankly.

So that's the macro, but on the flip side of that, I have a micro example. I'm sure other members of Parliament have run into this. One of my constituents, a Canadian, moved to the United States. He has a Harley-Davidson motorcycle, and has lived in New Jersey for most of his life. During that period time he had to change the frame of his bike; it broke or something. He put another frame on. When he came back into Canada, he could get everything else he had across the border. But they looked at the Harley-Davidson and saw it didn't have a Harley-Davidson frame on it. The Harley-Davidson frame is where the serial number is put.

So he took it home, and he got a letter from Transport Canada telling him to get that thing out of the country, because it wasn't safe to drive in Canada. He told them he'd have it safetied by the Province of Ontario.

• 1650

We allow these frames to be imported into Canada. Many of these bikes in Canada have these frames on them, and are licensed, and are perfectly safe. The reaction of Transport Canada was “Take the bike, but keep it registered in New Jersey and drive it with New Jersey plates”.

This is the kind of thing that irritates people. Why can't we get that kind of thing dealt with? Why are we accepting the manufacturer, Harley-Davidson of the United States, as being the be-all and end-all to determine safety features in Canada?

Ms. Janet Milne: I would not presume to try to deal with the specific instance you were describing here. I guess you started off with a more broadly based question about how we deal with committees....

Sorry, would you just repeat the front end of your question?

Mr. Alex Shepherd: I guess what I was looking at there was the evolution of a regulatory environment, especially in the process of change. You know, it's always seen that there are these mandarins up in Ottawa making all these rules and regulations, but in fact the people down in the airport, running the airport, and the people in the security business have a lot of good ideas about how this thing should change.

Ms. Janet Milne: I remember your question now. Let me just come back to that, because I think it's important that you do understand that a whole array of consultative committees are brought into the regulation development process.

In the aviation area, for example, there's a committee structure with an overseeing umbrella committee called CARAC, the Canadian Aviation Regulation Advisory Council. Underneath that are a whole lot of technical committees. These committees exist in marine as well. All have not just technical experts but also union members, industry people, and a whole range of people from the industry side of whatever it is you're dealing with. They are all very intimately involved in the development of all of these regulations.

During the RIAS process that has been described, any regulation being proposed by Transport Canada will be reviewed in detail by all of these committees, and recommendations will be made as to whether or not they should be put in place.

So in the regulatory process there is really quite extensive consultation and involvement, as I say, not just of the technical experts but also of a whole range of other people in the community who could be affected by those things.

Mr. Alex Shepherd: I understand what you're saying—

The Chair: Mr. Shepherd—

Mr. Alex Shepherd: —but what I'm saying is, here is a disaster that has happened, and how do we change the regulatory framework tomorrow to address it rather than all this study that goes on for a couple of years?

Ms. Janet Milne: Let me put it this way: I don't think we have changed the process for creating regulations in response to the situation we're facing right now. I think we feel that it's important to have good data before you make regulations. Now, we can respond very fast when we see difficulties emerging, and we have done that in many cases.

The Chair: Thank you very much.

Monsieur Bertrand, s'il vous plaît.

Mr. Gurmant Grewal: Mr. Chairman, I have a point of order, or perhaps a point of information.

It was mentioned earlier that OECD is preparing a report on regulatory reform, and Canada volunteered. Do we have access to that report? Can that report be tabled at the committee?

Ms. Janet Milne: Which report are you talking about?

Mr. Gurmant Grewal: On regulatory reform done by the OECD.

Mr. George Redling: That report is likely to be ready sometime in the late spring, Mr. Chairman, and it will be a public document.

The Chair: Okay. Perhaps you can forward it to this committee and to the scrutiny of regulations, too, when it's available.

[Translation]

Mr. Bertrand.

Mr. Robert Bertrand (Pontiac—Gatineau—Labelle, Lib.): Thank you very much, Mr. Chairman.

A few of the questions I wanted to ask have been answered, but I will first address myself to Mr. Timmins.

In your presentation this afternoon, you talked a lot about the new challenges in regulatory programs and you listed them. I am interested in the last one: “an increasing need for multi- departmental and multi-jurisdictional action”. I agree with you completely but one thing surprised me: you did not include the participation of certain provincial departments and agencies.

• 1655

Let's take the example of the Canadian Food Inspection Agency. I assume it works in co-operation with the corresponding agencies in the provinces. Do you work with the provincial auditors general to harmonize the practices of these agencies or different departments?

[English]

Mr. Douglas Timmins: Mr. Chairman, we do work extensively with the provincial audit offices, although more on a specific project basis, specific audits. That takes a lot of lead time, because they all are conducting their work at different times. So to negotiate a joint audit, as we would call it, would require a fair amount of lead time, and their resources are rather limited most of the time. So we have done it on occasion, but in this particular case the work we did was not joint with any of the provincial offices.

[Translation]

Mr. Robert Bertrand: But as you mentioned so aptly, there are now many more departments working together. You said it very clearly. As I said earlier, I agree with that 100 per cent. But I also said, and I may be the only one, that there is a lot of work being done in co-ordination with the provinces. I know we are not studying it at this time, but I am thinking about labour, which Human Resources Development has transferred to the provinces. There are audit practices in Human Resources Development and I wonder if you are looking at the way Quebec administers its program. Is there a certain co-ordination between the provincial and federal governments?

[English]

Mr. Douglas Timmins: Mr. Chairman, as I indicated, yes, we have joint meetings with the provincial auditors general, and there is certainly discussion of processes and approaches and areas of interest. In a program such as this, our mandate is limited to the federal role. So what we look at would require discussion with each individual provincial audit office to coordinate that work to a level....

As I say, we've done it on occasion. It is difficult to do that on every audit. Not all of the provincial audit offices are interested in pursuing the same issues that we feel are relevant and that we pursue. We would certainly look at the role the federal government takes in handling that coordination, because they have to do it. Whether it is really required to have a joint audit is something we do look at occasionally, but it's not something we do all the time. And in this case we didn't do that.

[Translation]

Mr. Robert Bertrand: Thank you very much.

I have a quick question for Ms. Milne.

In your presentation you spoke about a national recruitment campaign and, if I understood correctly, you mentioned that this campaign had been very successful. Have you noticed an increase in the number of applications since September 11? Has there been an increase since the events of September 11?

Ms. Janet Milne: An increase in the number of applications for jobs as inspectors?

Mr. Robert Bertrand: For jobs as inspectors and for other jobs.

Ms. Janet Milne: We have a program. We are in the process of increasing the number of security inspectors. Is that what you want to talk about?

Mr. Robert Bertrand: Yes.

Ms. Janet Milne: We are still adding security inspectors at this time. Since June, 34 more people have applied for jobs in the department. There seems to be some interest in this area.

Mr. Robert Bertrand: Since June?

Ms. Janet Milne: Yes.

Mr. Robert Bertrand: And since September 11?

Ms. Janet Milne: No.

Mr. Robert Bertrand: Thank you very much.

The Chair: Thank you very much, Mr. Bertrand.

• 1700

[English]

Mr. Bryden, four minutes, please.

Mr. John Bryden: Thank you, Mr. Chairman.

I wonder, did the auditor look at the adequacy of regulations dealing with the transfer of possibly dangerous biologics to individuals? It's a security issue that perhaps we weren't sensitive to before September 11 but we're sensitive to now. Is that something the Auditor General looked at?

Mr. Douglas Timmins: Mr. Chairman, I'm not absolutely sure about that. I might have to call one of my colleagues from the office, who is responsible for that audit.

Mr. Campbell, do you...?

The Chair: Mr. Campbell, perhaps you can come forward and introduce yourself before you start.

Mr. Ronald Campbell (Principal, Office of the Auditor General of Canada): I'm Ronald Campbell, a principal with the Office of the Auditor General.

The Chair: Very good.

Mr. Ronald Campbell: The short answer is no.

Mr. John Bryden: All right. That's fine. We appreciate that the circumstances have changed. I guess the question, then, would go to Health Canada.

In light of September 11, with regard to the regulatory issue, is Health Canada now looking at the security question of the transfer of biologics? As well, is Health Canada considering at all some sort of input on the publication of papers dealing with biologics that might contain information that may be dangerous to the public interest?

Ms. Diane Gorman: I can answer the first part of your question. I do not have knowledge with regard to the second. Unless Dr. Peterson does, that may be something we'll have to come back to you on in a written response.

With regard to the first, we have examined what we think might be products in Canada that have potential risk or threat, certainly in terms of what is now maintained in laboratories, and what we know has been imported into Canada and so on. We have written—Health Canada has, not our branch—to a number of academic facilities, industries, and so on to ask them to be particularly vigilant with regard to the security of those chemicals and biological agents.

With regard to the transport of those, I know that is something we have looked at. I don't know whether Transport Canada can respond in that regard.

Mr. John Bryden: It wasn't the transport but the transfer.

My corollary question, then, is I would trust that Health Canada is liaising with the Solicitor General's office, for example, on that particular issue.

If I may, I would quickly like to clarify my second point, because it's a very delicate point that has to do with academic freedom and that type of thing. I think my concern is that in the field of biologics, advances are made that can have profound implications, dangerous implications. If Health Canada isn't already considering this problem—and I don't pretend to know the answer here—I would hope it is looking at how it might address this whole question of the publication of papers that may have implications that they should have some oversight on.

Ms. Diane Gorman: Thank you for that question. We're not able to answer that now, and I'm also wondering whether or not that is not more rightly the responsibility of the Solicitor General or some other organization that might be looking at intelligence rather than Health Canada. But we will look into it and come back to the committee with a written response.

Mr. John Bryden: Thank you.

The Chair: Thank you, Mr. Bryden.

Mr. Redling, I was looking at your opening statement, and you tended to gloss over the issues raised by the Auditor General, even though the other departments did acknowledge that they have staffing problems or that they haven't always kept pace with scientific and technological advances.

Now, as the core department, does the Privy Council have a plan, or have you developed a plan, to deal with the problems and concerns raised by the Auditor General in his report?

Mr. George Redling: Mr. Chairman, could you please elaborate on what specific plan you're referring to?

The Chair: I'm saying, the Auditor General has raised a number of concerns in his report. In your opening statement you didn't address one concern or even indicate that you are addressing the concerns. I'm asking, do you have a plan to deal with the concerns raised by the Auditor General?

Mr. George Redling: I think quite a few of them have been responded to, or are in the process of being worked on, Mr. Chairman.

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For example, one of the comments made by the Auditor General is that there is a lack of risk identification in management ability in government. A number of initiatives have been taken by the government interdepartmentally to develop an integrated risk management framework; to develop a perspective and a position on the precautionary principle to assist that risk management framework; to develop a legal risk management strategy as well to help minimize the liability of the Crown, to help identify areas where legal risk can be minimized—

The Chair: But I don't think, especially after September 11, we're into talking about the Crown minimizing its legal risk. I'm looking at paragraph 24.94, where the Auditor General says:

The federal government should explain to Canadians and the government's regulatory and inspection community its priorities for health and safety regulatory programs....

Paragraph 24.104:

The federal government should ensure that regulatory authorities have a sound capability to identify risks to health and safety....

Paragraph 24.105:

The federal government should strengthen health and safety regulatory programs by basing the allocation of funding and staffing on risk assessments.

Paragraph 24.106:

The federal government should take major steps to help regulatory authorities manage the difficult human resource issues that they face.

These is a list of specific, quantifiable, identifiable concerns raised by the Auditor General. To you as the core department of government, I'm saying, what have you done to deal with these concerns, especially after September 11?

Mr. George Redling: They are serious concerns, Mr. Chairman. As I was indicating, there are a number of frameworks in place to help departments better deal with these types of issues, and I was referring to each one of them in turn.

It is then up to departments, in terms of their own statutory responsibilities, as to how they apply the framework that's been developed, essentially, how they then identify the risks, with the assistance of these frameworks, and then how they allocate resources to that.

The Chair: Do you have a monitoring process to monitor these plans?

Mr. George Redling: The departments would have monitoring processes in place. Perhaps my two colleagues could refer to it, as to the type of surveillance—

The Chair: And you as the Privy Council are not monitoring what the departments are doing?

Mr. George Redling: The Privy Council, the Treasury Board, would put in place frameworks to assist them in doing that, but it would be departments themselves who would have the primary responsibility as to how that is being done within those frameworks.

The Chair: I appreciate that they have the primary responsibility, but you have the primary responsibility for across-government programming. We have Transport Canada here, we have Health Canada here. Nuclear safety has to be involved in some issues, and other kinds of departments are involved, all to deal with safety, which has become a major concern of Canadians and North Americans, indeed everybody in the free world since September 11.

Your department is the department that looks at this across the board. Are we all marching down the same road? Do you have a plan that is monitoring the departments to see that they're all doing what they're supposed to be doing?

Mr. George Redling: As I was mentioning, Mr. Chairman, there are these frameworks that have been developed in response to the deficiencies or the issues identified by the Auditor General. Cabinet plays a role in that in terms of the sectoral allocation of what the priorities should be and what resources should be applied to them. Departments and ministers have a responsibility in that regard.

There is a general oversight function—Cabinet shares in that, and the Privy Council, the Treasury Board—as to how those are being met by departments.

The Chair: And I come back to my question: Based on the concerns raised by the Auditor General that have now been public for 10 months, have you developed a plan, a coordinated plan across government, to deal with these concerns?

Mr. George Redling: And I think the answer to that is yes, Mr. Chairman. I had indicated the kind of frameworks that have been developed to respond to that.

The Chair: How do you feel, Mr. Timmins?

Mr. Douglas Timmins: Well, I share your concern, Mr. Chairman. I too would like to see a more formal plan with specific dates or specific actions that are indicated as to what's taking place. As we have pointed out, I think there is room for perhaps Parliament to play a greater role on a sectoral basis to look for that reporting. Maybe some sort of reporting on it would force the action. I also suspect that your committee will continue to follow up and ask for follow-up on recommendations, as you've done in the past. That, too, might help in that regard.

The Chair: Mr. Redling.

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Mr. George Redling: Perhaps I could just add to that somewhat, Mr. Chairman. I mentioned earlier the departmental performance reports that are filed annually with Parliament. The Treasury Board this year has come out with new guidelines on how those reports should be done. They are more performance- and results-oriented than before, rather than just on inputs. They are to report also on how resources are linked to the priorities being set and the risks being assessed, and also identifying the methodologies being used to give the public more confidence in how these programs are being run.

So a number of concrete steps have already been taken in response to what the Auditor General has identified. The Treasury Board in general has, I think, many programs in place to look at program management, at results reporting, at the allocation of resources, and also at the verification of program integrity.

The Chair: Well, I'm still not totally reassured, Mr. Redling. You know, it's reassuring to say that Treasury Board is now saying the performance reports are to report performance, which I've been calling for since a long time. But when I look at paragraph 24.137 of the Auditor General's report, it says:

The federal government should submit an annual report to Parliament on the overall effectiveness of health and safety regulatory programs and the extent to which they have the necessary financial and human resources.

In other words, whether they actually have the capacity to do what they want to do and whether they can actually do what they intend to do.

This report should include an assessment by lead regulatory authorities on the achievement of objectives that require significant interdepartmental co-operation.

Now, this “interdepartmental co-operation” is where you come in at the Privy Council, to ensure that as each departments writes its own performance report, be it Transport Canada, be it Health Canada.... Health Canada is not going to write on transport or nuclear safety or whatever; it's for you at the Privy Council to link it all together, as a multi-departmental report. Do you intend to do that?

Mr. George Redling: To some extent we already do that, Mr. Chairman. We have a challenge function at the Privy Council Office. When initiatives come forward, one of those challenge functions is what interdepartmental coordination and consultation has taken place. The departmental performance reports also require that the interdepartmental consultations and coordination be reported on by departments as well.

The Chair: But what we're trying to say is, you're the core department that's responsible for this interdepartmental coordination. You just told me about the new Treasury Board guidelines where you have to report on results. The Auditor General is saying you should be reporting to Parliament your results and the resources you have to achieve these results. So let me ask you specifically, will you put in your performance report, the Privy Council performance report, that you have the necessary financial and human resources to achieve this across-the-board regulatory and safety protection of Canadians, and that it is working? That's what we want to know. Are we going to see that in the Privy Council report?

Mr. George Redling: There are a number of reports already filed annually, Mr. Chairman, including the departmental—

The Chair: Yes, I know, but we're talking the performance reports.

Mr. George Redling: If the method of reporting is to be changed—

The Chair: No, no, we're talking about the annual performance reports that everybody reports. You just told me you got new guidelines from Treasury Board to say, yes, you have to put performance in your performance reports. I'm asking, will you put performance in the Privy Council performance reports, saying, yes, we are ensuring and monitoring this across-the-board coordination to ensure that regulatory and safety programs are there for Canadians? Will I be able to read that in your report?

Mr. George Redling: Mr. Chairman, I'm not sure if I can commit to that. Each department has its own responsibility with respect to the performance.

The Chair: What are your responsibilities, then?

Mr. George Redling: My responsibilities include supporting the Special Committee of Council. They include looking after how departments are meeting the regulatory policy requirements. They involve doing the challenge function that is necessary to do those things.

The Chair: And therefore you'll be reporting that in your report.

Mr. George Redling: I think that is already being done in the annual reports.

The Chair: I've been quite critical of all performance reports on a general basis, because they tend to be more input-oriented rather than performance-oriented. You just said the Treasury Board is trying to improve that from here on in.

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But I don't think we're getting too far on this particular line of questioning. I just think that after September 11—and I think all members of Parliament would agree with me—we have a heightened responsibility to do the best we can to anticipate what may or may not happen to Canadians, to think the unthinkable. Who would have thought, before September 11, that what actually happened on September 11 could have happened?

I don't envy you having to try to think these unthinkables and provide plans to try to be in the right place at the right time for something that few could ever foresee. But if it does actually happen, the question is going to be asked, why weren't we prepared? I don't underestimate the complexity and the difficulty of trying to go through that planning exercise, but we're not absolved from the responsibility of trying, and we're not absolved from responsibility of ensuring that Canadians know we are doing everything we can, as government, both in the civil service and as members of Parliament, to ensure that we are doing what we can to make sure this is a safe world for a country like Canada live in.

That is always the fundamental focus when we're talking about these types of issues, be it car safety—in more innocent times—or be it planes falling out of the sky, being aimed directly at buildings, in the terrible times we live in. We are here to try to serve Canadians and ensure that the environment is there for them.

So I do take it quite seriously, Mr. Redling, that you, as a core coordinating department of government, have a responsibility to respond to paragraph 24.137. We'll be looking for that.

I'm saying, then, take your responsibilities seriously, because we do. With these performance reports, on a general basis I've been highly critical. I really want to elevate these standards so that when we read them, we can feel that we understand what departments are trying to do, the problems they're having, and the assistance they may or may not need from Parliament.

I remember one particular department who complained about having no money, but there was nothing in the report about having no money. How could we respond as parliamentarians when we had no idea of what their problems were? Performance reports are a means of communicating to Parliament what you want to tell us on an annual basis. We look forward to them. They are reviewed. If you tell us everything is fine, you'll be held to that. If you say you have problems and you need assistance and help from the members of Parliament, then it's our obligation to come to your aid.

Does anybody have anything else to say?

Mr. Timmins, do you have anything to say?

Mr. Douglas Timmins: Mr. Chairman, I would just conclude by indicating that I think we've heard today about the risk management framework that Treasury Board has introduced. That is fairly recent, and we would in all likelihood be looking at auditing aspects of that into the future. That may be of interest to the committee. It will come at some point in the future.

On the point raised about communicating risks, what I heard was mainly communication of risks dealing with specific risks. One of the things we did touch on in the chapter is the need to communicate the choices that are made, the balance that is chosen, between the nature of risk after you've identified it and things like the pressures of client service, industry pressures, economic pressures, trade pressures, and costs. There are many facets to the aspect of what needs to be communicated to the public, and I think this was an important point that was discussed today.

The final point you raised in terms of annual reporting I think is also equally important to pursue.

Thank you.

The Chair: Thank you, Mr. Timmins.

The next meeting is scheduled for Thursday, November 1, 2001.

This meeting stands adjourned.