HEAL Committee Meeting

STANDING COMMITTEE ON HEALTH

COMITÉ PERMANENT DE LA SANTÉ

EVIDENCE

[Recorded by Electronic Apparatus]

Tuesday, November 6, 2001

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[English]

The Chair (Ms. Bonnie Brown (Oakville, Lib.)): Good morning, ladies and gentlemen. This meeting is now called to order.

It is my pleasure to welcome our witnesses this morning. Up first, we have officials from Health Canada, and then we have a representative from the Faculty of Human and Social Development at the University of Victoria. Following him, we have people from the Office of the Auditor General, one of whom is not here yet.

See if you agree with this plan: I'm thinking of hearing from Health Canada, then the University of Victoria, and if the people from the Auditor General's office are not here by then, maybe we'll have one round of questions for the first witnesses.

[Translation]

Mr. Réal Ménard (Hochelaga—Maisonneuve, BQ): Madam Chair, I would like to clarify something. Are the people from the Office of the Auditor General here to talk to us about the draft legislation or the department's operation?

[English]

The Chair: They're here to talk to us about regulatory models. The Health Canada people are going to give us a summation of those models that they have investigated—isn't that correct, Rhonda?

Ms. Rhonda Ferderber (Director, Special Projects Division, Policy, Planning and Priorities Directorate, Health Policy and Communications Branch, Department of Health): It's close. We're going to do a broader presentation on the functions and the forms it could take as a regulatory body, and then we'll certainly answer questions on specific models if that is desired.

The Chair: Good, then let us begin.

[Translation]

Ms. Rhonda Ferderber: Good morning, members of the committee. We are pleased to have the opportunity to provide some details and perhaps some clarifications on the regulatory framework proposals pertaining to assisted human reproduction technologies.

[English]

I'm joined here today by Glenn Rivard, whom you've met—he's our senior legal counsel—and my colleague Michael Bryden, who really does hold the file when it comes to the details on models. We'll be pleased to answer your questions.

Over the last several weeks of testimony, you've heard many comments and suggestions about what a regulatory body and regime for the assisted human reproductive sector could look like or should look like. Today, we hope to perhaps provide a little bit of information on the department's thinking regarding a proposed regulatory regime for assisted human reproduction.

Certainly, we have long been aware of the range of views about what such a body could look like and could do. As with similar initiatives in other countries that have introduced legislation and regulations in this area, there are differing views with regard to the need for or nature of any government oversight to address the issues.

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There has always been a lot of discussion about how self-regulation could indeed take over. Or perhaps we just need to look at new standards or practices within the professions, or maybe at new industry-led initiatives on accreditation, for instance.

However, it would seem that in the experience of other countries, it has generally been the case that government involvement is necessary to coordinate, maintain, and ensure a comprehensive framework for AHR. That has certainly been expressed across our discussions with numerous players.

We have done a fair bit of preparatory work with some of the organizations involved. For instance, we've been trying to lead toward the development of a possible accreditation process. We've worked to develop potential performance indicators for IVF clinics.

While these kinds of initiatives certainly have their share of support, we can't honestly say we have a way of getting at the full involvement of everyone. That leads to still having some reluctance and unevenness, if you like, around whatever we might be able to do on a strictly voluntary basis. It certainly leads us to the conclusion that some form of national regulatory entity or organization needs to be put into place.

When the royal commission first released its report, that report contained a major recommendation that called for an independent body. The advice was that it be established at arm's length from existing institutions, but that it report directly to Parliament. That was the nature of the recommendation contained in the royal commission report.

The series of consultations that have taken place over a period of quite some time have been pursued. As recently as the winter of 2000, we went cross-country and talked to any number of stakeholders and provincial and territorial representatives. We were expressly asking them to assist us in how we might define and refine, if you like, a comprehensive legislative and regulatory framework. The input from that process has us understanding that stakeholders generally would agree along the following lines for functions of such a body.

The functions could certainly include a policy function that would monitor domestic and international developments and issues. It would develop and recommend appropriate changes to legislation, the regulations, or even existing policies, for consideration by the minister.

Another function that certainly gains support is this area of licensing and inspection. Here, they look to the body to issue licences to qualified persons or organizations for approved treatments or research, and would ensure compliance through inspections—and we've talked about inspections before.

Another area that has been obviously discussed at length is the collection of health information, and the need for information registries on donors and on persons born as a result of these treatments. There is also certainly a desire for information to be available on the outcomes of assisted human reproduction treatments and research.

A final area for possible functions of such a national-level body would be the area of communications, used in the broadest sense of communications. This would mean such a body could engage in consultations with stakeholders to resolve various issues or concerns that they might have. It certainly would be a body that could provide information to inform prospective clients of their choices in order to help them make informed decisions about how they want to proceed. It could be that centre of expertise in the area of assisted human reproduction. Finally, it could certainly have a responsibility to inform the Canadian public about these many issues, perhaps along the lines of what is emerging in terms of research, etc.

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Those were five main areas of functions around which we heard a fairly good consensus. We went then from functions to form, in that form should follow function. Once you know what you're supposed to do, you can try to start to understand how you need to be organized in order to perform those functions. So within the context of the proposed current draft of the legislation, there are elements of how those authorities for such a regulatory body could be developed to perform those functions.

However, as certainly Mr. Manning has observed, it is the use of the federal criminal law power that would allow our Minister of Health to actually bring into effect any federal level of oversight for such a sector. Many of the proposed regulatory and administrative functions in the proposed legislation are similar to the existing provisions contained in the recent Tobacco Act, and certainly to provisions in the Food and Drugs Act and its many regulations.

When we moved to addressing the form of the regulatory body that would oversee assisted human reproduction legislation and regulations, we did undertake a fairly extensive review of regulatory bodies and regimes in other countries, as well as regulatory models and examples that we have here in the Canadian context. We undertook a number of our own studies on various aspects of delivery models, best management practices, and recommendations for regulatory frameworks. We have tried to provide you with some background pieces describing the models that exist.

The consultations on those elements have certainly assisted us in determining what could be key design elements, if you like, for such a regulatory body. Loudly and clearly, we heard about broadly based representation being a very important area, and that this broadly based representation should be drawn from the relevant disciplines and expertise, to be used to promote thorough review and discussion, and hopefully to develop some consensus around the issues the experts would be faced with.

The regime should be responsive to addressing new developments, issues, or concerns. Obviously, it has to be effective in the delivery of its functions.

We've heard a lot about accountability. It has to be a regime that can be looked to in order to provide accountability for whatever its decisions, actions, and results could be.

Transparency is another key design element that came up.

The regime must be flexible in order to adapt the regulatory body's roles and functions to changing needs or conditions. Certainly, we've seen so much change in this sector that this will be an important area and design feature to build into whatever model we go for.

Government's efficiency in conducting its functions and business affairs must be considered. Indeed, sufficient resources must be allocated for the regime to perform its functions fully and effectively.

Certainly, there was a fair amount of concern with respect to the kind of relationship the regulatory body should have with the minister. There are definitely concerns that the minister should be responsible for the regulatory body. In other words, there should be some way through to the minister in whatever construct we give the regulatory body. The minister might consider having control over the strategic policy direction without necessarily being involved in the day-to-day functions.

When we added that all up, we came forward with a general consensus amongst external stakeholders, interest groups, and others, for an external regulatory body, a governing board or council with broadly based representation, reporting to the Minister of Health.

Most people certainly supported a national regulatory framework in order to avoid inconsistent application across the country, between provinces and territories. There was certainly a general consensus that provinces and territories must be able to undertake some or all of the regulatory activities if they desire to do so, but they should have to be consistent with a federal framework. When we spoke with the provincial and territorial governments, they had no difficulty with what kind of federal involvement our legislation would call for on the prohibition side.

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As for a regulatory body, though, the opinions of the provincial and territorial governments were split with respect to an external or an internal one. They were very clear, however, that no matter what regime is put into place, there will be concerns about any incurring of additional costs associated with the implementation or enforcement of regulations for assisted human reproduction.

As the legislation is currently drafted, this legislation would allow the Minister of Health to create a regulatory body that is internal to the Department of Health. That's why we're discussing this. Is this the way we want to go, or would we need to make changes vis-à-vis whatever regulatory model results from your deliberations?

While our minister has certainly identified an external regulatory body as an option, we still need further advice. We look to you for that advice, bearing in mind that the creation of a new or external federal regulatory body for assisted human reproduction would be a machinery-of-government issue. That falls under the prerogative of the Prime Minister, of course, so we have discussions to pursue in that area.

As I've said, we've worked extensively with a number of external stakeholders, and we are generally coming up with support for an external federal regulatory body. The responsibilities would have to include any number of the functions I've identified, but an internal body could also cover those functions.

The shared model that would involve the key stakeholders has also been an area that has received a fair amount of interest, wherein you would have various medical colleges and associations being involved in a way, through certification, if you like, of those medical practitioners who are specializing in AHR. They would certainly be involved in the development of standards of practice, of which some can certainly be referenced in our regulations. The professional accreditation bodies have been very involved in expressing what they might be able to do to take on responsibilities in this very important area.

I'll address the costs now, if I may, and say just two words on that. Certainly, we have been trying to—depending upon where we land on this—get a handle on what resources would be required to establish and operate a regulatory body. We have recent estimates that put it somewhere around $7 million to establish it, and then $7.5 million to operate it on an annual basis.

Some of these rather significant costs obviously involve the development of initial business and transition plans for the regulatory body and the sector writ large. Certainly, the development and maintenance of regulations will be a major task, as will the development of the information registry discussed in the legislation, and the setup of the body with its appropriate staff and other resources. With those numbers, we are also aware that, external or internal, the costs are going to run fairly similarly.

That was all I was going to provide in the way of an overview presentation of the functions, form, and considerations we have been given. When the time comes, though, I would be happy to talk more specifically about models. We do look forward to receiving your input.

Thank you.

The Chair: Thank you very much.

We'll move on to Professor Michael Prince, a professor of social policy at the University of Victoria.

Professor Michael Prince (Lansdowne Professor of Social Policy, Faculty of Human and Social Development, University of Victoria): Thank you, Madam Chair.

Good morning, everyone. It's a pleasure to be invited to address the Standing Committee on Health on the issue of assisted human reproduction.

I believe a paper was circulated, containing the full remarks I would like to share with the committee. I would just like to stress that these are my own views. This paper has not been commissioned or paid for by anyone. This is my own independent thinking as an academic and observer of public policy and public administration in Canada over a number of years.

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I think a number of my comments happily echo or reinforce some of the thinking that Health Canada has been working on, and those of many of the stakeholders who have been consulted over the past few years. That indicates to me that a consensus is emerging in the country over how to proceed, and over what role the federal government should play in that consensus.

In the paper, I begin with some preliminary observations, which I'll just briefly note. One is prohibiting, licensing, and monitoring the use of assisted human reproduction. All of these are fundamentally important and critical public policy issues, and they therefore suggest to me that government—particularly the federal government—has a fundamental role to play in this area. Having said that, it immediately suggests a need to ensure direct scrutiny by Parliament of this role, and a strong emphasis on ministerial responsibility to Parliament for that role.

A second observation is that, as you all well know, multiple values are at stake in this area, involving several value tensions and trade-offs. I outline a number of these in the paper, in box 1. All of them are important. All of them are ever present. All of them are unavoidable. The values and the balances that we strike in achieving them in practice have implications for how we design a regulatory framework, so I would suggest that when we review and look at the draft legislation, we pay attention to what values are being addressed in the legislation, and to what sorts of balances are being struck or have been overlooked in the legislation.

Thirdly, policy debates in the country often have more shades or degrees of regulation than we acknowledge. Regulations are not simply rules found in legislation. They are also in intergovernmental agreements, delegated legislation, agency or departmental guidelines, and professional standards and codes of practice. In this area in particular, I think professional standards and codes of practice do play and will play a critical role in any policy framework.

The fourth observation is that rarely, if ever, is it the case that a single regulatory body has total control over an entire system of regulation in a policy field. What we need to be talking about is a regulatory regime or governance system, and one that's a shared model of governance. I think that's the theme we're hearing from the Health Canada officials as well.

In my paper, I also identify a range of major functions that could be contemplated as being part of a regulatory regime. My list is longer than Health Canada's list, but it doesn't really matter. It's just a suggestion on how to think about the range of activities a regulatory body and other stakeholders can or perhaps ought to play in such a sector as this.

Again, it's a checklist that is useful to thinking about the extent to which the draft legislation addresses each and any one of these functions. Is it giving attention to these or not? Has it overlooked some of these? To what extent should the legislation address each of these in any detail? To what extent should we leave their development to the regulations or statutory instruments delegated under the law by a minister or by a body?

Let me turn to the question of who should perform each of these functions.

A number of these are already being done in the country in some fashion by certain governmental or non-governmental organizations, though not perhaps specifically for assisted human reproduction. Health Canada has a role already, as do a variety of non-governmental organizations, such as the Infertility Awareness Association of Canada. The federal research councils are involved in articulating policy on ethical research on humans. A number of other professional bodies, medical associations, and colleges are also involved. That tells me that whatever regulatory regime the federal government decides to select, it will be one that has to be situated within a network of already existing organizations, governments, families, and community sector organizations. Coordination and linkages will be critical.

Other reasons for the specialization of roles, and therefore for the creation of new structures, are to enhance citizen participation and stakeholder representation in this process; and, secondly, to avoid real or perceived conflicts of interest. That would be why I would not recommend an internal regulatory body located within Health Canada. I think that would generate real concern about real or perceived conflicts of interest within that portfolio. In the paper, I explain that perhaps in a bit more detail.

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Let me just spend a few minutes outlining what I would propose as a particular regime at the level of the Government of Canada. That's my focus here. I realize provincial governments have a central role to play. I realize medical colleges and professional societies have a central role to play. But my focus here this morning is on addressing the Government of Canada.

Some of these machinery-of-government questions have already been mentioned. First, the Minister of Health and Health Canada should be the lead federal minister and lead federal department for assisted human reproduction. I don't think there's much dispute, discussion, or contention around that. Secondly, a separate regulatory agency external to the department, yet part of the health minister's portfolio, should be established and should report directly to the minister. Thirdly, an advisory council should be established, with broad representation from family, medical, scientific, and women's organizations, among others, reporting directly to the minister. In my paper, you'll see table 1, in which I outline a possible distribution of the major functions to each of these three components in the regime.

Let me address each of the three main components, beginning with the Minister of Health and Health Canada. Under the Department of Health Act, a number of functions and responsibilities are already enumerated. When we think of this area, they nicely dovetail with the assisted human reproduction area. Powers and duties are already assigned to the Minister of Health with respect to the promotion and preservation of the physical, mental, and social well-being of the people of Canada; the protection of the people of Canada against risks to health; research into public health; collection, analysis, and distribution of information; etc. But with respect to assisted human reproduction in particular, the roles of the minister outlined in this draft legislation could include coordination of policies for the Government of Canada, as the lead minister; responsibility for and overall direction of the regulatory agency; responsibility for establishing policies and standards relating to assisted human reproduction; authority to enter into equivalency agreements with any provincial or territorial government that would so choose and would then have the ability to substitute provincial or territorial laws for the federal laws and regulations in the jurisdiction; and, finally, assigning to the Minister of Health responsibility for assessing the effectiveness of the regulatory agency's activities. I would suggest those as an addition to the draft legislation in this area.

The legislation itself should give formal expression to the principle of a checks-and-balances relationship between Health Canada and the minister on the one side, and the regulatory agency on the other. The legislation could specify that the Minister of Health is responsible for establishing policies and standards relating to the safety and efficacy of reproductive and genetic technologies in Canada. As well, the minister could be designated as responsible for auditing and assessing the effectiveness of the inspection and enforcement activities of the agency, to verify that they're in compliance with the health and safety standards and policies. The Minister of Health and the department would not, however, participate in the ongoing daily operations of the agency.

Secondly, I recommend a new regulatory body. By that, I mean a semi-independent, statutory-based, federal organization with an executive head and board of directors who report directly to the Minister of Health.

Looking at the draft legislation, a number of possibilities are already contemplated or anticipated for intergovernmental agreements and for partnerships with medical and scientific professional organizations. This suggests the need for incorporating flexibility and responsiveness into the organizational design of the regulatory body. It has to come out from under the usual bureaucratic controls of a line department, in order to be able to pursue and achieve these kinds of flexible and innovative arrangements. In the paper, you'll see that I outline several key features of what I would envisage to be a national regulatory agency.

The remarks I'm now going to be giving could either be folded into the draft legislation as a major new section of the bill, or they could form the basis for a separate statute. I'll leave it to the committee to reflect on that.

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A “departmental corporation” is defined under the Financial Administration Act as having: a mandate; a corporate board of management with more autonomy than a regular department; a CEO or president appointed by the Governor in Council for a five-year term, with the rank of a deputy minister who would direct the daily operations; a board of directors, but not a large one—perhaps five to nine members, appointed by the Governor in Council, after consultation with the provinces and territorial governments; accountability reporting directly to the Minister of Health; a requirement to submit an annual report and strategic plan, at least every five years, to the minister for approval, with both of those regularly tabled in the House of Commons and the Senate; and a budgetary base largely, if not exclusively, from Parliamentary appropriations. This gets to the funding issue.

The draft legislation makes no mention of fees or any cost recovery policy. It needs to be in there. Something needs to be addressed around the funding and the financing. My own view would be that the agency would perhaps cover some costs with fees, but that the large bulk of their budgetary financing would come from appropriations regularly voted by Parliament.

My third element in a proposed regime is a Canadian advisory council on assisted human reproduction. An arm's-length council is worthwhile for several reasons: to recruit expertise, to raise the profile of this field, to ensure wide representation of public interests and value perspectives, and to support a responsiveness of policy-makers to the developments and trends in this rapidly and ever changing field.

Because assisted reproductive technologies are a public good with profound social and ethical implications, the advisory council should be government-sponsored and funded. I do not see this as some non-profit foundation or some public-private partnership organization. Too much of a public interest is at stake. In many countries, governments have established such structures to deal with social and ethical principles. They typically are separate from the regulatory process. The regulators are not also the advisers and the ethicists.

One might think some existing advisory bodies at the federal level could play this role if they were adapted somewhat. My own view is that, even in a recast form, bodies such as the Canadian Biotechnology Advisory Committee simply aren't suited to this sort of function. They are already large enough and have a big enough mandate and responsibility of their own. I've come to the conclusion, therefore, that a new, permanent advisory council is required to perform a number of functions: to provide advice to the minister, government, and Parliament, on the health, safety, ethical, social, cultural, and scientific aspects of these technologies; to provide a voice for groups that are traditionally marginalized in policy-making; to raise public awareness and understanding; and to promote the participation and involvement of all Canadians in discussions on these critical issues.

Again, I outline in the paper a number of features of what the national advisory council might look like. I would suggest that it be mandated and included in the legislation, with a statutory base, that it report directly to the minister, and that all of the reports, work plans, and research studies made in the commission be publicly available, in plain language as much as possible.

It would be a multi-member council of at least twelve people, but perhaps with upwards of eighteen. The council membership should embody a number of representational dimensions, including perhaps representation from infertile people, persons—or their advocates—born of reproductive and genetic technologies, interested lay people, ethicists, research scientists such as geneticists, medical and health clinicians such as nurses, obstetricians or gynaecologists, persons with disabilities, women's consumer groups in these technologies, and faith communities.

I see these council members not functioning as advocates for their corner, but as informed individuals from various segments of Canadian society with different disciplines, expertise, and life experiences, who are committed to serving the public interest as expressed in parliamentary law. I would suggest this kind of language about a council and a representation section be included in whatever legislation is recommended.

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Let me just offer some summary remarks, Madam Chair.

Reproductive and genetic technologies are obviously shaped by far more than machinery-of-government questions, but we live in an organizational society and we live in a society in which institutional designs do matter. They matter in terms of what ethics or values are promoted, how different kinds of knowledge and ways of knowing are treated and managed, what kinds of accountability relationships are forged, and how public perception and confidence are affected in the policy area.

In light of public expectations in Canada, in light of scientific and medical capacities and trends, and in light of international practices, workable and acceptable models are available for designing a regulatory regime in Canada for assisted human reproduction. The determination of what are permitted and what are prohibited activities can be based on up-to-date science and medicine, and should also be based on up-to-date ethical review and up-to-date public input and discussion.

I've outlined a regulatory regime, Madam Chair, with three main components: an important role for the minister and Health Canada; a new regulatory agency; and a new national advisory council. While the proposed agency is separate from Health Canada, I believe it is conditioned or ought to be conditioned by the requirements of ministerial responsibility and parliamentary oversight. The work of both the agency and the advisory council that I envisage would help to connect the federal government with the roles and responsibilities of the provinces, of professional associations, of other groups, and of families.

As committee members well know, none of what I've just talked about is in the draft legislation. Some version of this needs to be included in it or in a separate piece of legislation expressly intended to establish the regime.

Thank you very much.

The Chair: Thank you, Professor Prince.

I'll now ask the representative who is here from the Office of the Auditor General for his best advice. Dr. Gilmore, were you going to give the presentation, or was Mr. McLaughlin doing so?

Dr. Alan Gilmore (Principal, Office of the Auditor General of Canada): It was our intention to divide the presentation. I can address the subject matter and various parts of our opening statement. Perhaps that would be useful.

The Chair: Yes, I think so.

Dr. Alan Gilmore: I should begin by apologizing on behalf of the office and Mike McLaughlin. He was called away to a funeral this morning. It was our understanding that the presentations were going to be sequential, so he was planning to arrive at noon. I apologize for him not being here.

My name is Alan Gilmore. I was responsible for chapter 24 of the Auditor General's report to Parliament in December 2000. Chapter 24 discussed the results of our audit of federal health and regulatory programs. I was also responsible for the coordination of the other chapters associated with that, which were chapters 25 to 28.

Chapter 24 identifies the major challenges and strengths faced by regulatory programs, as well as the measures that could be taken to make significant improvements. We focused on sector-wide issues affecting the programs. That is, we were not interested specifically in a specific program and what was happening in that specific program, we were trying to look at the patterns across federal health and safety regulatory programs.

For the purposes of the committee, when we do audits, we have a set of audit criteria that we use to assess whether or not programs are working efficiently, economically, and effectively. In a way, these criteria are really benchmarks for what makes for good programs.

From the chapter, we can draw a set of principles that form the foundation for good regulatory regimes. It might be useful for me to outline for the committee the principles that we believe should be taken into account in deciding on an approach to regulation, particularly in a controversial and scientifically emerging area.

Regulatory approaches to health and safety generally use traditional models of regulation—for example, Health Canada's administration of the regulatory regime for drugs, or the administration of regulations by separate agencies such as the Canadian Nuclear Safety Commission or the Canadian Food Inspection Agency.

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The use of government agencies reflects the serious nature of the risks to health and safety and the responsibility of government to protect the health and safety of its citizens. However, alternative approaches can be assessed to determine if they would work better to address a specific regulatory need. We suggest such an assessment should be based on evaluating how the regimes would meet the requirements of key principles for sound regulatory regimes, and how responsibilities would be allocated to ministers and officials.

The principles include the following: ensuring accountability to Parliament; defining clear values, ethics, and codes of practice; ensuring sound assessment of risk; establishing effective inspection enforcement regimes; and reporting to Parliament fully on performance, using relevant indicators. The appendix to our opening statement has a more complete list of the criteria we used when we conducted our audits.

Our suggestion to the committee is that you might consider requesting the responsible government departments—in this case Health Canada, and if you're moving into machinery-of-government issues, the Privy Council Office—to provide the committee with an analysis of alternatives, using these principles as criteria. What would work under one? Who would be responsible for what? For example, it may be just as simple for your committee to ask for a spreadsheet that would readily provide summary information against the principles that we've identified. This would allow members to determine where they need more detailed information, while enabling them to ask specific questions on how a particular approach would work when it is compared to others.

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

Madam Chair, this concludes our opening statement. I'd be happy to answer any questions the committee may have.

The Chair: Thank you, Dr. Gilmore.

Ladies and gentlemen, we have had three presentations. We'll begin the questioning with Mr. Manning.

Mr. Preston Manning (Calgary Southwest, Canadian Alliance): Panellists, I'd like to thank you for your presentations. As several of you pointed out, this is a subject that is really not dealt with extensively in the draft legislation, so it's an area in which we have to plough some new ground.

I think a lot of us, as members of the committee, have heard the need for independence for this regulatory tribunal, which suggests an external tribunal. I think there are good reasons for that. I'm conscious that the greatest abuses of reproductive technology and genetic science in the 20th century were done by governments, not by the private sector. I think that's a caution to us all that this body has to be able to regulate government and government labs, as well as the private sector.

Assuming that independence is a big feature, I think the question with a lot of us is how you get accountability. In a sense, the two are at opposite ends of the pole. You set up this body that is independent of the minister to some degree, but how do you then get accountability, and particularly accountability to Parliament?

We've had instances now with so-called quasi-judicial independent regulators. When you ask the minister questions about it, he says, “Wait a minute, you set this up as an independent, arm's-length body. Don't come asking me why it did this and that.” So I wonder if you could perhaps help us by cataloguing the total array of tools that you can use to hold an independent regulatory body accountable to Parliament and to the people of Canada.

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Dr. Alan Gilmore: The two models that exist that people most often use are things in health and safety. You have the Canadian Nuclear Safety Commission, which is essentially what is being described. It's a separate agency. It has the power to make regulations, although the regulations have to be approved by Parliament and are subject to the joint scrutiny committee of the House and the Senate. It has a board, it has an advisory council, it does its own risk assessments, it does its own compliance and inspection, and it's expected to report to Parliament.

The mechanisms that you would use as a parliamentary body are issues relating to what kind of information you want—but maybe I should go back.

The responsibility of ministers for departmental corporations or separate bodies is a point that has been debated for a while. It might be that you want to consider stating in the legislation the responsibility of whichever minister you have, whether it be the Minister of Health or joint responsibility with some other minister. Say what the responsibilities of that minister will be.

In terms of a parliamentary approach, as people have mentioned earlier, the tools that are available are specifying when you want a report, what kind of report you want, and what assurances you want that the report is accurate. For example, in the Canadian Food Inspection Agency, the Auditor General is required to give an opinion on the performance report of that agency. We're not required to do that for most agencies.

You might want to consider that you would be able to call...you would set up a regime in which, every three or five years, an automatic review would be held. Both Parliament and the agency would be looking forward to those points—which will be specified in legislation—and to getting the information. You would ask for or seek the performance report or the strategic plan and the assurances that you wanted on those plans before the committee met.

Mr. Preston Manning: Maybe you don't have to answer this now—the department might be able to send us back a two-page memo with a list—but we're all familiar with the standard mechanisms for holding people accountable, like who can appoint the members of it, reports to Parliament, or subjecting it to the Auditor General. Those are the standard things. But I'm wondering if some extraordinary things can be considered, because this regulatory tribunal is dealing with one of the most sensitive areas. You're talking about human life and its transmission to the next generation. Are there special instruments? I noticed that for the British regulatory tribunal, its code of practices has to be approved by the minister. If I understand it right, the British Parliament has to pass an authorizing resolution with respect to some of its regulations and can veto some of its regulations.

Maybe we don't want to get into it now, but I think it would be helpful for us to have a list showing all the ways in which you can hold an independent tribunal accountable to the Canadian public—and not just the standard ones, but maybe some extraordinary measures, given the extraordinary nature of the body.

Dr. Alan Gilmore: I might mention that the joint committee of the House and the Senate, if it were to scrutinize regulations on this matter, could recommend modifications to it.

The question is whether you can have extraordinary measures. That could be done. If you're going to suggest to the Health Canada people to seek them, they might want to also take a look at the existing measures and how they could be used. Parliament has a number of existing measures that may not be as fully utilized as they could be.

That would be my only comment. I would expand it, if I might suggest that.

Mr. Preston Manning: You've listed in your presentations a number of the distinguishing characteristics that this regulatory body has to have—independence, accountability, transparency, technical competence, and a list like that—but it seems to me that one of the special characteristics this body has to have is ethical integrity and authority. It's going to be making decisions on questions the public is going to see as being right or wrong, because they get into all these moral questions. Therefore, I think we have to give this special attention. How do you vest a regulatory authority with ethical integrity and authority? It's a really difficult question.

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I just wonder if you have any suggestions on what can be included in the authorizing statute to confer that kind of authority. How can you give standing to ethical perspectives and faith perspectives? We're conscious that a B.C. court, on the pornography case a couple of years ago, dismissed faith-based arguments against pornography by citing the former Chief Justice of the Supreme Court saying that Canada was a secular society. This group had technical standing before the court, but had no real standing. Could you suggest to us if there are ways, in the statute, of conferring moral and ethical integrity and authority on the regulatory body, and actually ensuring standing for ethical and moral perspectives in front of that tribunal?

Prof. Michael Prince: Professors might take a crack at that, but the officials might be a little reticent.

Mr. Preston Manning: It's a professorial question.

Some hon. members: Oh, oh!

Prof. Michael Prince: I have tenure, so I can...

Some hon. members: Oh, oh!

Prof. Michael Prince: As you probably know, the legislation in Victoria, Australia, has some discussion in its law about representation criteria. The British legislation is a little more vague on that, but there is a way, depending on the comfort of both the government and Parliament in terms of how far you want to push a clause in the legislation. Such clauses are already in other federal laws setting up other bodies—the space agency, the food inspection agency, or others—with shorter or longer representation clauses. They describe them perhaps as suggestive, not exhaustive. They give guidance to the minister and to the Governor in Council on what the statutory expectations are, not obligations, in terms of the kinds of groups, but not limiting them. Perhaps Parliament will have a healthy debate over including faith communities as one such group. I think that needs to be put on the table for discussion.

My view is that a national advisory council would be a major place in which you could have a strong element of an ethical, legal, and spiritual input. As I conceive a board, a regulatory board would be a smaller management board, although that doesn't mean one of the five to nine directors on the board is not also a highly respected scientist and/or ethicist or what have you, in addition to those with the financial and administrative skills needed to run that organization.

Mr. Preston Manning: Could you elaborate on why you prefer the advisory council model? The other model is to create a regulatory body and create a regulatory arena out in front of it, where all the interests—ethical, technical, scientific—have standing, and they come to argue in front of the group, as distinct from an advisory council on which you try to get balanced representation. I gather you favour the advisory council model ahead of the creation of an open regulatory forum.

Prof. Michael Prince: I wouldn't see them as exclusive choices. I wouldn't put all my eggs in the one basket, because again those are fairly standard 20th-century models, too. I think this is a policy field with a heavy requirement for greater transparency and openness in an ongoing way. I don't see it as being for just when an application is going through and triggers those groups with standing, but as an ongoing process.

I think the royal commission concluded that after its many years, and they recommended that the body report to Parliament. I'm not opposed to that. I'm suggesting that it report to the minister, but that might be another way of getting at your idea of empowering Parliament more in the accountability regime.

I see a regular role for communication and public awareness on this. That body can do this, whereas a regulatory board could get into trouble. Again, conflicts of interest could be perceived. Food agencies run into this. When does its information start to be seen as promotion? When is it seen to be advocating biotech methods or genetically modified foods when Canadians are thinking it's really policing the sector, not just promoting it?

• 1205

So in giving it all to the regulatory board, you can run into some real or perceived conflicts of interest, either for that reason or for the reason of public profile and awareness promotion.

Again, these are choices to be made, but that's where my orientation lies.

The Chair: Mr. Lunney.

Mr. James Lunney (Nanaimo—Alberni, Canadian Alliance): We've certainly heard some interesting models presented here today, starting with Health Canada talking about an internal model within the department and talking about an external model, and going to the development of the three-part program Professor Prince has pointed out to us, beginning with the minister and his responsibilities, the separate regulatory body, and the separate advisory committee.

In addition to the questions that Mr. Manning has already raised, a question was raised earlier about the costs, whether the model is internal or external. You were talking about $7 million to establish and then about $7.5 million to operate.

Professor Prince, you have suggested that, in addition to a regulatory body with an advisory committee, this should also be funded by the taxpayers, in the form of a much larger body of maybe up to twelve to eighteen people. What might you consider to be the costs of running a second organization, and how might the taxpayer feel about that?

Prof. Michael Prince: I'm conscious of the fact that I have a person here from the Auditor General's office, and they probably have answers and thoughts on this.

I don't see this as a high-cost council. I see this as a council that would meet only two or three times a year. I don't see this as a huge bureaucracy. A small secretariat would support this.

I'm also not averse to the possibility that once the regime is set up and we get some experience with it, we would rethink the funding arrangements. Some provinces may opt in with some equivalency agreements. There should be a quid pro quo with medical colleges and professional and scientific societies. If they want a major role and a voice in policy development, maybe they need to contribute some funding to the process as well. That should be part of the partnership of discussion.

Ten years from now, the funding mix may be very different from what I'm thinking it might be to start it up. Again, some general wording may be needed in the legislation to accommodate that kind of evolution of the regime. Or if there was a five-year review, as Dr. Gilmore suggests, that could be part of the discussion. Where are we now? How can we fund it? Who is in fact playing a role? What is the actual interest, capacity, and involvement of the medical colleges and the professional and scientific bodies in this country, be it on the accreditation side or others?

The Chair: Ms. Ferderber would like to comment on this question.

Ms. Rhonda Ferderber: Thank you.

I was especially struck, Professor Prince, by the similarity and complementarity of many of your remarks, so in answer to the question, I would want to suggest that our calculation of around $7.5 million in ongoing operating costs on an annual basis did involve the potential for an advisory council to be part of whatever the regime that is set up might be. As to the actual number, etc., we differed a little bit in our calculations. We were a little bit bigger. But as we played out the option that could involve an advisory council in terms of seeing the merits of having that kind of advice provided, we certainly did calculate it into the ongoing $7.5 million.

Mr. James Lunney: Did your calculations include contributions from the industry to be self-supporting through fees and licences, at least in part, or was that totally tax-funded?

Ms. Rhonda Ferderber: It's mostly within taxes, although there are discussions around this whole issue of cost recovery. But at this stage in the development of the costs, and to get a real sense of the costs, it was limited to what the federal government might have to provide.

Mr. James Lunney: With the constraints on budgets that all government are facing now, nobody seems keen to pay more taxes. We're certainly under a lot of restraint, but the public is really keen to see dollars spent on services they actually consume, so I think we're going to have to look at these agencies being self-supportive as much as possible.

• 1210

Just to take it in a different direction, Dr. Gilmore brought up a suggestion that we hadn't seen before or perhaps hadn't considered in committee, and that was how we could possibly scrutinize a regulatory regime. He mentioned some questions that we could consider, including that of a sunset clause requiring a full parliamentary review after a five-year period.

Another was consideration of some of the controversial aspects of the bill that we're looking at, particularly with respect to embryonic research. We see exciting developments taking place with the use of adult stem cells. Some breakthroughs weren't conceivable six months or a year ago, like Dr. Freda Miller's work with skin cells and so on. Cells they used to think were not so flexible are showing tremendous promise, and perhaps you've presented a venue in which the committee could consider dealing with this. Perhaps we should look at a sunset clause on prohibiting certain types of research, in order to advance dollars going into the area with the most promise in terms of adult stem cells. I think you've raised an interesting question.

Could you comment on your intention when you mentioned a sunset clause? Or was that just a broad stroke?

Dr. Alan Gilmore: If I may, I'll just make several comments.

To go back to an earlier point made about ethics and values and how you build them into organizations, we did a chapter on values and ethics in the public service in May 2000. It describes the kinds of procedures and policies that can be put in place in an agency to ensure values and ethics. For a regulatory agency of this nature, we might want to consider actually having a code of ethics built into the legislation, along with a requirement for a code of practice that is put into the legislation and would come before a parliamentary committee for approval. We did a whole chapter on this. I don't want to get into it, but I want to refer you to it.

In terms of costs and cost estimates, the guts of agencies are making regulations, consulting, doing inspection and compliance, and performing risk assessments. If you don't know how much money is being put into these areas, you won't know whether the amounts being calculated are accurate. There are trade-offs. If you want a level of assurance that things are okay, it's going to take a certain amount of expertise and money to do the surveillance and risk assessments. It will take the same amount of money to do the inspections. In our chapter, we have identified time after time that when the risk assessment isn't sound, the inspection and enforcement regimes are not adequate.

The closest thing to this that you're talking about here is the semen regulations that Health Canada already administers. When we audited that for the December 2000 report, we found major problems that had gone unnoticed for quite a bit of time. It's true Health Canada caught up with them over a period of time, but there were major problems. So it is an area that is close enough to give you a sense of what can go wrong.

In terms of reviewing things on a sunset basis, if you were to require in the legislation a regulatory plan—that is, what regulations are going to be made and what their impact is going to be—if you were to require that the risk assessments be tabled, and if you were to require that an enforcement and compliance regime be tabled along with an evaluation of whether those things are working or not, you would at least get the information that would start you off. If you wanted to include pieces to sunset, in a way, in terms of what pieces of information you would need leading up to a five-year total review, those are the kinds of pieces you are going to need.

[Translation]

The Chair: Thank you very much.

Ms. Thibeault, you have the floor.

Ms. Yolande Thibeault (Saint-Lambert, Lib.): Thank you, Madam Chair.

Good morning, ladies and gentlemen. Mr. Lunney has already asked the question that I wanted to put to you. However, I would still like to pursue the matter.

Mr. Lunney has used the word "industry", probably because, just like me, he has heard many witnesses tell us about the industry.

• 1215

That industry obviously expects to make profits. In fact, it is a very profitable industry, according to them. At least, they hope it will be. That industry will offer services, for all practical purposes, to a very small fraction of the population, those who will be able to afford these new technologies in the near future.

That is why I am wondering if it would not be wise to ask that industry to bear at least a great portion of the costs that would be incurred by such an agency.

Ms. Ferderber, you said that there were apparently some consultations with the provinces. According to you, the provinces are in agreement with all of this, providing that it doesn't cost them anything. Which brings me to ask you whether you have the feeling that some provinces would be interested in having their own regulatory agency.

Ms. Rhonda Ferderber: Only three provinces have a significant industry. British Columbia, Ontario and Quebec are the provinces that are involved in a significant way. The others are interested and do have some clinics, but only a few of them. The majority of clinics and activities are located in those three provinces.

During our consultations and discussions with them, the provinces indicated that they were prepared to consider entering into some agreements, but they had not yet seen the proposed legislation. We are still waiting for their reactions to the draft legislation. At the present time, no province has indicated that it is specifically interested.

[English]

We are certainly not able to say with certainty that the provinces would like to enter into their own level of regime. However, there certainly is an interest on their part in being involved in the development of the regulations, and I think once the area those regulations will cover is clear to them, this will also help them to understand what part they want to play, and what part they feel they need to play, given their own sense of jurisdiction. As well, we'll all have a better sense of the issues around the costs of implementation and maintenance. So it's certainly still very much a point of discussion with the provinces and territories.

Ms. Yolande Thibeault: Thank you very much.

The Chair: Thank you, Madame Thibeault.

[Translation]

Mr. Ménard, you have the floor.

Mr. Réal Ménard: Thank you, Madam Chair.

You know that the bill has four goals: to authorize certain activities, to prohibit some others, to maintain a national registry of donors and to provide information to the Canadian public.

Our researcher has prepared an inventory and his document is quite interesting. It gives an overview of various types of regulatory organizations. I believe there are two models that we might consider and some others that we must reject.

For example, the Patented Medicine Prices Review Board is an organization that has quasi-judiciary powers and the mandate to review the prices of medicines based on international comparisons.

Recently, the Environment Committee has reviewed the PMRA, the Pest Management Regulatory Agency. If my memory serves me right, the main recommendation in that report was that there should be an independent organization separate from Health Canada, even though the PMRA reports to Health Canada in the end.

• 1220

Given the four goals of the bill, is the majority of the panelists of the opinion that there is a need for an organization that would be totally separate from Health Canada? And why should it be separate from Health Canada? Because there is the possibility of a conflict of interest. The department, which must apply a legislation that determines whether certain activities are prohibited or not, cannot be also the watchdog.

That is my main concern. In itself, this argument should, in my view, persuade us, as parliamentarians, to avoid making the same mistake that we made in the case of the PMRA, for example. Many people in environmental field are now questioning the fact that the Pest Management Regulatory Agency is integrated to such an extent within Health Canada, because with respect to biological control agents, it does not have the capacity to control or criticize.

Do you share that point of view? I am addressing my question particularly to the Office of the Auditor General, but to the university professor as well. Should we have a totally independent organization?

[English]

Dr. Alan Gilmore: You're asking us to step out of our role a bit. I'm not sure I'm totally comfortable in doing that, because we're not a policy-making body.

Let me try to address the question you are asking by looking at the kinds of reviews we did for chapter 24. Take something like the National Energy Board, the Canadian Nuclear Safety Commission, or the biologics regime. The biologics regime is within Health Canada, the National Energy Board is a branch of the public service, and the Canadian Nuclear Safety Commission is a departmental corporation.

In our audits across the board, the same patterns were found in these agencies. We were concerned about risk assessments, we were concerned about effective enforcement, we were concerned about codes of ethics, and we were concerned about trade-offs between the public interest and service to industry. If you go into any form of cost recovery, the government's cost recovery policy requires, in part, that you're providing a service. We were concerned about the conflict of interest that may give rise to.

[Translation]

Mr. Réal Ménard: In your last report, you were very critical of cost recovery measures. There is a link with Ms. Thibeault's question. It does not appear, in terms of the public interest, that cost recovery is necessarily always positive.

[English]

Dr. Alan Gilmore: It obviously depends on how it's implemented and on the safeguards you put around it. It may be appropriate in certain areas. It's for the committee to decide whether or not, for human reproductive issues, you want to have cost recovery and the implications that go along with it. That's really a public policy decision, but we've outlined for you all the advantages and disadvantages of that. There clearly are advantages, and there clearly are disadvantages, and how you decide which outweighs the other in this area is a decision for you, the committee, to make. The issue I'm trying to bring to the floor is that whatever agency or whatever mode of delivery you choose, when we audit across these different modes of delivery—be they within the department, a separate agency, or some branch of the public service—we find the same problems.

The structure itself is not going to save the day. It will make a difference, for sure, but it won't make the definitive difference. You have to build into the structure the accountabilities for doing certain things. If those accountabilities aren't there, it doesn't matter what structure you use.

If you take something like the Canadian Nuclear Safety Commission, it would have all the powers...in the form you're creating or the form you're discussing, it has many of the same features. When we audit that agency, we find many of the same problems we found when we audited Health Canada's regime for biologics, and many of the same characteristics that we found when we audited the National Energy Board, which is a slightly different model.

My concern would be that focusing on structure without focusing on the guts of what the agency does and how it's going to do that, is going to give you a false sense of assurance. I would urge the committee to take a look at how the guts of the agency are going to work, and at how you're going to get assurance that it is working, rather than focusing on the form as a sole focus.

• 1225

Prof. Michael Prince: I'd like to respond to the comments made by both Monsieur Ménard and Madame Thibeault.

On cost recovery, the legislation in the U.K. actually specifies a 70% cost-recovery target. The authority in the United Kingdom has specific direction from Her Majesty's Treasury of the British Government. I wouldn't want to go that high, quite frankly.

To give a Canadian example, 80% of the Canadian Food Inspection Agency's money comes from Parliament, and 20% comes from industry. There are two things there. One, industry doesn't want it any higher, because it upsets trade flows with U.S. meat producers, poultry producers, and so forth. Two, it starts to challenge what the public interest is and the public row, in terms of what the balance is between public and private interest. In this area, the question is how much of the reproductive technology, in vitro fertilization, or whatever, is a personal benefit the person or the family should pay for, and how much of it is a public good. How much of it do we want to pool our risks for, as we do in so many areas of social policy in Canada?

The bigger question for this committee and the government is whether or not this is going to be under the Canada Health Act as an insured service. I don't think they'll want to touch that question, because they'll see it a a big cost driver.

On your other question about independence, I was suggesting in my paper what I would call checks and balances. I would not want to see an agency internal to Health Canada, one in which the department and the minister set the rules, enforce the rules, then audit themselves as to how well they've been following the rules. We want different institutions. That's internal, but we also have the Auditor General and Parliament. But that's why we've set up departmental corporations. I think structure isn't the answer, but it does matter. That's my point. I would see a clear distinction between the responsibilities of the minister and the agency. Create some space between the agency and the department bureaucracy.

Rather than calling it sunset, I'd prefer to call it sunshine. You want the light to shine in on these laws. Quite frankly, I think Canadians would be frightened to think that if a law was theoretically going to self-destruct in five years in this area, too many families would be counting on these sorts of procedures and treatments in year four to think this could possibly go poof in year five. That's kind of silly. What we need to say is that we want sunshine provisions like mandated reviews, but don't use terms like “sunset”. I don't think that's appropriate, particularly in an area of such deep personal and moral decisions.

[Translation]

Mr. Réal Ménard: You know that the present legislation provides for a five-year review of the legislation. It is one of the provisions of the bill.

One thing concerns me, and I shall close with this, Madam Chair.

[English]

The Chair: This is your last one.

Mr. Réal Ménard: The last one, yes.

[Translation]

We find, in the case of the PMRA and the biological control agents, that when we are clearly focussed on cost recovery, the issue of profitability takes precedence over the public good. That scares me.

The overarching goal of reproductive technologies is to help the persons who have infertility problems, and not to fill the coffers of governments.

That was my comment, Madam Chair, and that will end my intervention.

[English]

The Chair: Thank you, Mr. Ménard.

This is the first day on which we've been talking about cost recovery. While I know it's a principle of management boards, we have so far managed to keep our topic away from it, and we may have to get an exemption from Treasury Board.

I can't believe I'm hearing this. To me, it's a hangover from the previous regime. This whole idea that you have to keep collecting money from people for something as intrinsic to their sense of self as reproduction seems to me to be highly inappropriate. But pardon me for the editorial comment.

Mr. Dromisky.

Mr. Stan Dromisky (Thunder Bay—Atikokan, Lib.): Thank you very much.

I'm very optimistic regarding the model we will probably support in the long run. Of all the regulatory models that governments in the past have created and those that are in existence at the present time, I think the model pertaining to this area of concern will probably be one of the most important, if not the most important regulatory structure that we will create for the future of Canadians. I have no doubt in my mind about that. However, I do have a concern.

• 1230

You talked about sunshine, and I appreciate the comments Dr. Gilmore made regarding integrity and so forth. But I always think of President Nixon's tapes that have that block, that period in the tapes where there's no information, just silence. With all regulatory bodies, when they report, I think there's something suspect in every one of the reports, because a regulatory body has the option of giving or hiding. In other words, they're not confessing, they're not giving all the information.

I would like some opinions regarding the whole question of transparency. Where do we put in controls, and what kinds of controls, what kinds of directives. Just give some general comments pertaining to transparency, so that we don't end up in the situation that we have ended up in with so many other reports pertaining to regulatory bodies. Transparency's the question. How much? Anyone?

Dr. Alan Gilmore: In terms of mechanisms for transparency and concerns about what is reported and what is not reported, various government policies require things to be reported. It's not a vacuum out there. For this area, the question becomes one about what information the committee or Parliament wants.

You could request various kinds of information. You could seek to have proposals on the performance indicators that would be most appropriate for this area. You could ask for ongoing operational reporting, and you could ask for those reports to be attested to in terms of accuracy and completeness.

There are mechanisms that can be used to get the information out, and mechanisms for identifying what information you want. They would be part of what the committee might want to consider obtaining from Health Canada or other experts in this area. What would the performance indicators be? What would the effectiveness indicators be? What would the level of assurance on inspections be?

For example, if you were going to have x number of licencees, what level of inspection is appropriate, how often should it be made, who is going to do the inspection, and who is going to set the standards? These are the things that make regulatory agencies work. When you get that information in a package, you can then have some assurance that it's working, but it means specifying what you want. Otherwise, you will get what they give you.

Mr. Stan Dromisky: That's right.

Does anyone have any other comments?

Prof. Michael Prince: Something else Dr. Gilmore said earlier was a very good thought. The legislation could specify in some detail what kinds of reports, what kinds of information, and what kinds of indicators you are seeking. The federal books of laws already contain examples that specify, in more detail than in other laws, what exactly needs to be reported. It's a question of level of detail, but that has to be balanced on some of the information, such as, obviously, individual applications, confidentiality, and privacy. But you could require that they report on the guidelines, the codes, and the templates for decision-making, so that the specific cases are dealt with and you get some assurances as to what the systems are in decision-making.

You might do what some provincial ombudsmen's offices do, which is include vignettes, summaries, or camouflaged actual decisions or cases that they've dealt with, to communicate to Canadians the human dimension and the actual, real world that the agency is dealing with. That way, it's not just techno-jargon and lots of scientific language that will befuddle or intimidate Canadians. It's something that actually reminds us that we're talking about people who want to have children, who want to have a family, who want to have a future.

• 1235

The Chair: Madame Picard, did you want to ask a question? No?

Ms. Sgro.

Mr. James Lunney: Ms. Ferderber had a comment she wanted to make.

The Chair: Okay.

Ms. Rhonda Ferderber: It's in response to the last question, Madam Chair.

I was just thinking in terms of transparency. When we are talking of it in our discussions, we certainly do talk about needing to build in these reporting requirements and just exactly what would be featured in reports. But we also talk about it in terms of how we see the body actually operating and how it will obviously be visible, perhaps through participation on the advisory council by folks who come from any number of different disciplines, etc. They have their ways and means both of bringing perspectives so that they can be discussed, and of taking out and away what they will from such discussions.

We think of transparency as coming also in that form of a communications function that would indeed share, more broadly than is the case now, the kinds of information around this sector. Some of the notion of transparency is also captured in those types of perhaps less tangible reporting performance indicators, but those indicators are still a body that is accessible, a body that will respond to questions and give out information, etc.

The Chair: Mr. McLaughlin, welcome, sir.

Mr. Michael J. McLaughlin (Deputy Auditor General, Corporate Services Branch, Office of the Auditor General of Canada): Thank you, Madam Chair.

I thought we would be remiss if we didn't point out the potential audit role in all of these activities. In terms of the role the auditors can play, there are three models that currently exist.

The first is our traditional value-for-money audit work, which you're examining today as well.

Secondly, with the new agencies that have been created—the CFIA, the revenue agency, and the parks agency—we have a responsibility to do an assessment of their performance report. In that way, we can give some degree of comfort in terms of the completeness of the report and the soundness of the procedures behind the report. The committee might consider that kind of activity.

Thirdly, in the crown corporation domain, if a body gets that far away from Parliament, a regime is set up for us to do a special examination of the systems and procedures every five years, to ensure that the crown corporation is being run with due regard for economy and efficiency, and to ensure that it is effective in its mandate.

So different models are available from the audit side that could be brought to bear to increase transparency. We would therefore certainly be ready to—and believe we should—play some type of role with this kind of regulatory agency.

The Chair: Thank you, Mr. McLaughlin.

I'll move on now, if you don't mind. Five answers to one question is a bit much.

Ms. Sgro.

Ms. Judy Sgro (York West, Lib.): Thank you, Madam Chair.

Before I forget, Dr. Gilmore, if you could get us a copy of that report you did on the code of ethics and morals—

Dr. Alan Gilmore: Sure.

Ms. Judy Sgro: —I think it may help us deal with some of the challenges we're trying to cope with while we deal with this legislation.

Madam Chair, I don't know how we decide who comes before us, but after dealing with the scientists, mothers, and young people who are the product of so many scientific events, we're now back to reality and to talking about cost recovery. I thought I was back in finance committee or something like that.

I've always talked about cost recovery, but I find it absolutely appalling to talk about cost recovery when we're so tied up in the emotional issues we're trying to deal with. It's not that cost recovery is not important, but compared to what we've been learning on this issue, it's not important at all. It's more important that we make sure we protect Canadians and do the right thing.

You've added another dimension that I don't want to deal with yet, frankly, because we're still trying to deal with how to deal with the complexities of all this other legislative stuff that's very difficult.

One of the other issues we're dealing with is the whole issue of the ability to enforce whatever legislation we bring in. I feel much more comfortable putting issues of enforcement into criminal codes and all that—so I'm still there—versus a regulatory regime that doesn't make me feel comfortable. I don't feel it's strong enough or that it's going to make sure certain things are prohibited and monitored.

• 1240

On this whole issue of a regulatory regime, is there a particular model that would still be called a regulatory regime but would somehow have some teeth to it? Or does it all boil down to how much money is on the table and how many people we employ for enforcement of the rules?

Ms. Rhonda Ferderber: We're very conscious of the fact that whatever we bring forward for consideration will have to have teeth. That is certainly what the clientele and those who are part of this are looking for. They are looking for a place in which they know they will find the necessary assurances that the treatments are going to be safe, and that certain types of information along the lines of what we've been talking about can indeed be accessed. A number of models that could either be considered external or at arm's length—whatever you want to use by way of terminology—could have teeth, for certain.

Again, in talking about it becoming the oversight for a piece of legislation, that would require that the body have the necessary capacity, structure, form, and function to be able to properly provide such oversight. Perhaps I'll ask my colleague Michael to comment on one or two possible models that could have those teeth, if you like, as a way of assuring you.

Mr. Michael Bryden (Senior Planning Adviser, Special Projects Division, Policy, Planning and Priorities Directorate, Health Policy and Communications Branch, Department of Health): In terms of some of the models available, a range have been mentioned in this morning's presentations, as well as in some of the documents that have been provided to the committee.

The Chair: I'm wondering if a verbal description of models is as efficient as you giving us chart-like descriptions of these different models on paper. Professor Prince has given us one little thing that is very simply done in a square. We hear a lot of words here. If you'd like to try to be succinct, that's fine, but I think it would go into our heads a little better if we had it in some kind of chart showing who does what.

Mr. Michael Bryden: We prefer two models. We have provided the committee with a document that has a couple of appendices that are an overview of a proposed model that would follow basically the term that Professor Prince has used, that being a departmental corporation. That is one in which an array of levels of bodies would be involved, with the minister at the head and responsible and accountable for this organization. A board of directors could be based upon broad representation, with upwards of fifteen to twenty members. A secretariat or regulatory body could actually perform the functions that are assigned to this organization. So there is that particular model of the departmental corporation.

Another model that has been identified as a potential one—again having teeth, as Rhonda mentioned—would be one that is called the separate statutory agency, also sometimes called a branch within a department. Again, this organization is another model in which the minister is held accountable directly for the agency. Again, the agency functions as a separate entity outside of the department, but it basically has the same status, if you will. As Professor Prince mentioned, there could be an advisory committee or council that would be assisting in the regime, providing advice to the minister and/or the agency.

So from our standpoint, two models have a lot of teeth, and those are essentially the departmental corporation and possibly a separate statutory agency.

The Chair: Thank you.

Is that enough, Ms. Sgro?

Ms. Judy Sgro: Yes.

Dr. Castonguay.

[Translation]

Mr. Jeannot Castonguay (Madawaska—Restigouche, Lib.): Madam Chair, I wanted to pursue the same topic.

• 1245

It is important to know what relationship there will be between the two organizations. I understand that the national advisory committee will be comprised of people from various disciplines, be they ethicians or women who are often on their own and who are very involved in these issues.

The regulatory agency, if I understand correctly, will be made up mostly of researchers. How do we know for sure that the advisory committee will really have some influence? Can we have any assurance of that? If not, I believe that it would be an exercise in futility. Is there any way of ensuring that these models...

[English]

Prof. Michael Prince: That's an excellent question, and I don't adequately address it in this brief paper. I have more concerns about your question than I did about Mr. Manning's one about accountability. I think a number of mechanisms exist, but other ones could be added. I think this is the key question.

If you're attracted by the idea of a national advisory council, I think this is where the committee has to think harder. I'll think about this with you if you want. I'll provide my best thinking, but I think this is where some additional... We all know about royal commissions, advisory councils, or task forces that do reports. Those reports don't go too far, they don't get picked up.

I think this is where, in the legislation, there must be some obligations of reporting. Again, I'm open as to whether or not this council could or should report to Parliament directly. That's what the royal commission suggested for the regulatory body. I don't think that's appropriate for the regulatory body, but it is for the national advisory council.

There's also dual reporting. That might complicate it in some people's minds, but it might also ensure... But you're right. There is a need for stronger linkages. The fact that their reports and proceedings would be public is like the power of an auditor, an ombudsperson, or investigator. It's the power of publicity. They would have incredible legitimacy in their representation.

I would think you would have some experts on that. These would not just be lay people. They would wear many hats. You could have a woman who is also an ethicist, and who is also whatever. People could have multiple dimensions here.

But I think you've hit on a key question that I would urge the committee to think harder about. I can't give you immediate answers right now, but I think this is worth addressing, and worth addressing in the legislation. That way, it's not left to the whims and wishes of a bureaucracy or a minister, with respect, down the road.

[Translation]

Mr. Jeannot Castonguay: Mr. Prince will obviously ponder over that issue. I greatly appreciated your presentation. If you have any other ideas to express on this issue, the members of the committee will be pleased to hear them.

Thank you, Madam Chair.

[English]

The Chair: Thank you.

If I may, colleagues, I want to challenge Professor Prince on the particular model that he has picked.

I look at these advisory councils somewhat differently than you do. Having probably served on one, you're aware that reports often get shelved, not implemented.

Prof. Michael Prince: Yes.

The Chair: I want you to put your feet in the shoes of the minister for a minute. If, as your paper suggests, all the money for this does in fact come out of the tax base, it is then up to the minister to secure the funds in the bargaining that goes on at cabinet and with the Minister of Finance. The minister has to get the money. He then transfers it to the agency you describe. The agency has to make decisions about how the money going to be spent. How much will be spent on policy development, as opposed to inspection and enforcement, for example?

Within the discipline of the budget it is given, the agency makes the best decisions it can. In the meantime, it's not quite as perfect as the advisory council would like. The advisory council then puts out reports that mainly castigate the agency for not doing what the council wanted the agency to do. The agency says it's not its fault, because the minister didn't give it enough money. You immediately set up a system whereby the public has a barrage of reports in the newspaper, saying that the advisory council is mad at the regulatory agency, which in turn has blamed the minister.

In the same way, the broadly based advisory council represents a variety of interests. We know from our hearings that the scientists are the ones who always use the word “flexibility” the most. Whatever avenue is opened up in science, they want to be able to pursue it as quickly as possible. If it's not moving fast enough for them...suppose the regulatory agency decides it really cannot afford to license, inspect, and enforce the rules on some new activity. Therefore, for reasons revolving around being responsible with the money, it delays that. Well, the scientists are all screaming, and again they blame the minister.

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I think this is of interest to all of us, because the political end winds up taking the heat for everything that goes wrong, no matter which party is in power. For the opposition members, it might be fun for a while, while they have this minister and this government, but if they ever had the chance of taking over, it would become a nightmare.

Somehow or other, we have to do something that is fair to everybody, but I find the advisory council is just absolutely a nightmare. We had experience with it with the Secretary of State for the Status of Women. When we first came to power, there was an advisory council. The advisory council had a larger bureaucracy than the minister, and it did research and wrote reports saying why the minister and the government were no good.

That's how I see advisory councils. I see them as solely troublemakers. Why would I vote for funds to fund a group whose main role is to beat me over the head?

Maybe you would like to respond to that.

Prof. Michael Prince: I'm glad you asked such a neutral question.

The Chair: No, I told you what I really think. That gives you the opening to tell me what you really think.

Prof. Michael Prince: This is good.

I think you're right. We're into the real politics of regulation. Regardless of the forum and whether you like my model or another, this is the forum in which the heat will come back to a government and the heat will come back to a minister, as it does in food safety.

We have the Canadian Food Inspection Agency. It has 4,000 people working for it. It has incredible criminal powers. But if there's a real crunch about grapes, raspberries, or this or that at the border, will there be questions in the House? Yes. Is the fire at the feet of the agriculture minister? Yes, it is, and perhaps it should be even with this huge bureaucracy. I'm thinking of a perhaps smaller agency here, but it's inevitable that it's going to be part of the real politics.

You're right. I think you might get around part of that by separate votes and line items for appropriations directly to the council. That still doesn't finesse the Treasury Board, so you identify the council and don't just lump it in with the agency for budgetary appropriations. You instead identify it as a specific line item in the federal budget every year. You might even be so bold—Treasury Board will go nuts on this—as to strongly suggest a base budget. It's unheard of, I know.

I'm well aware that the royal commission itself imploded over issues. So did the advisory council on the status of women in the eighties. There are lots of precedents. I don't think we should stop trying, though. The level of public awareness is low in this area.

The fragmented and divergent interests aren't going to go away. In fact, if anything, they'll strengthen. I think this is an area that should not be dominated by the science and the technology. This is ultimately a social policy. It's a health policy. It's a family issue in which tremendous values and morality are embedded. That's going to happen if it's—

The Chair: I agree with that. The thing is, why wouldn't the board that has to make the decisions and live with them, even if the minister does end up taking flak... That happens inevitably, as you say. But if you had a board that has to make its decisions within the discipline of the various voices at the table—from the faith groups, from the ethical perspective, from the science but not dominated by science—it seems to me that it's better than having the outside group loosing arrows at them all the time because they're not perfect. I really fail to see the wisdom or the value of this advisory council.

If you fund the agency well enough, it can do the public hearing function, and the parliamentary committee can assist. The committee can look at how the public is reacting to the agency. On our budgets, we can go travelling a bit—even though we haven't managed it so far. You just haven't convinced me that the advisory council is that important.

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Prof. Michael Prince: Just as one final comment, you could have a regulatory agency with a board of directors of twenty to do it. There, though, I worry about embedding a conflict of interest within the agency, particularly on individual applications for treatments, services, licensing, or the revocation of the licence of an individual clinic. You will have embedded too many interests. You want an impartiality and independence of that quasi-judicial or adjudicative function. That's not where you want to have your twenty people having a good brouhaha over the values, ethics, and policy questions of reproductive and genetic technologies. You want their voice—

The Chair: But how could you possibly give the money to a group that didn't reflect those conflicting opinions? The usual thing with a group like that is that two members are from a certain sector. They put forward their view. If it's not practical, the rest vote that down. That's the reality of sitting on a board. A hospital board is run very much that way. Almost every board I've ever served on has all those interests at the table. Therefore, in my view, the governance that comes out of it is pretty good.

I don't want a bunch of technocrats running this agency, pretending they don't have views. Every single individual in this room has views about this subject. They may not have views about food inspection, about the Canadian Food Inspection Agency board. But when you're talking about life, birth, and death...and education is actually another one. Every single person in the room has a view about it because we all experienced it.

Prof. Michael Prince: I've sat on hospital boards too, but we didn't have criminal powers. We didn't have the Criminal Code of Canada. I would like to see this bill have teeth. It does have teeth. You want the people in charge of the teeth to be impartial, independent, and to make the best possible decisions. That's not done with a council of twenty people sitting on a board of directors.

The Chair: They're setting policy, though. Wouldn't it be the staff that implements?

Prof. Michael Prince: I see the minister setting the policy and the national policy framework. The council and the agency provide input, but the policy-maker is the minister accountable to Parliament. The agency is more the implementer and administrator of the laws and standards that are set by the minister and Parliament and that are embedded in the legislation. That's again to avoid conflict of interest and blurred roles.

I see the agency as implementing the licensing rules, implementing the inspection function, and perhaps engaging in accreditation agreements with medical colleges or other societies that are already doing that. Why repeat that? The agency could articulate perhaps a code of practices that is a guideline for clinics, but that would be informed by both the national framework and by input by the advisory council.

I see the agency as very narrowly based, and focused on enforcing and administering the licensing, inspection, and compliance functions of the laws that have been spelled out by the minister and by Parliament. But I'm glad we've had this debate, because these are good, hard choices to have to talk through.

The Chair: I would just like to thank Dr. Gilmore for pointing out the fact that, wherever the mini-bureaucracy is that does this work for us, to me it doesn't really matter. To me, it's more important that the ideas be clear in the legislation and in the regulations. I don't think the question is where it's placed, whether it's supposedly at arm's length or not, whether it's inside Health Canada or not. The question is how precise we can be about Parliament's instructions to whoever takes on this responsibility. As Dr. Gilmore has pointed out, what mechanisms can we put in that give us measurable results and somebody to measure them on a regular basis?

Anyway, thank you very much, everybody. It's one o'clock.

I thank the department officials, who are so patient with us and come regularly, with great patience and charm. Thank you, Professor Prince, and thank you, Mr. McLaughlin and Dr. Gilmore. You've been really helpful, and we may call you back.

This meeting is adjourned.