HEAL Committee Meeting

37th PARLIAMENT, 1st SESSION

Standing Committee on Health

EVIDENCE

CONTENTS

Tuesday, June 11, 2002

Á

1105

The Chair (Ms. Bonnie Brown (Oakville, Lib.))

The Chair

The Clerk of the Committee

The Chair

The Chair

Mr. Réal Ménard (Hochelaga—Maisonneuve, BQ)

The Chair

Mr. Réal Ménard

The Chair

Ms. Maria Barrados (Assistant Auditor General, Office of the Auditor General)

Á

1110

The Chair

Mr. Ian Shugart (Assistant Deputy Minister, Health Policy and Communications Branch, Department of Health)

Á

1115

The Chair

Mr. Glenn Rivard (Senior Legal Counsel, Department of Justice)

The Chair

Mr. Gerald Chipeur (Lawyer, Individual Presentation)

The Chair

Mr. Rob Merrifield

Ms. Maria Barrados

Á

1120

Mr. Rob Merrifield

Mr. Ian Shugart

Mr. Rob Merrifield

Mr. Ian Shugart

Á

1125

Mr. Rob Merrifield

Mr. Glenn Rivard

Mr. Ian Shugart

The Chair

Mr. Gerald Chipeur

Á

1130

The Chair

Mr. Alan Gilmore (Principal, Office of the Auditor General)

The Chair

Mr. Paul Szabo (Mississauga South, Lib.)

Ms. Maria Barrados

Mr. Paul Szabo

Á

1135

Ms. Maria Barrados

The Chair

Mr. Ian Shugart

Á

1140

Mr. Paul Szabo

Mr. Ian Shugart

Mr. Paul Szabo

Mr. Ian Shugart

Á

1145

The Chair

Mr. James Lunney

Mr. Ian Shugart

Mr. James Lunney

Á

1150

Mr. Glenn Rivard

Mr. James Lunney

Mr. Gerald Chipeur

Mr. James Lunney

Mr. Ian Shugart

Á

1155

Mr. Glenn Rivard

The Chair

Mr. Alan Gilmore

Mr. James Lunney

Mr. Ian Shugart

The Chair

Ms. Judy Sgro (York West, Lib.)

Â

1200

Mr. Ian Shugart

Ms. Francine Manseau (Senior Policy Analyst, Health Policy and Communications Branch, Special Projects Division, Department of Health)

Mr. Ian Shugart

Ms. Judy Sgro

Mr. Ian Shugart

Ms. Judy Sgro

Mr. Ian Shugart

Ms. Judy Sgro

Â

1205

Mr. Ian Shugart

The Chair

Mrs. Carol Skelton

Mr. Ian Shugart

Â

1210

Mrs. Carol Skelton

The Chair

Mrs. Carol Skelton

Mr. Gerald Chipeur

Â

1215

The Chair

Mr. Glenn Rivard

The Chair

Mrs. Carol Skelton

The Chair

Ms. Hélène Scherrer (Louis-Hébert, Lib.)

The Chair

Ms. Hélène Scherrer

The Chair

Ms. Hedy Fry (Vancouver Centre, Lib.)

Â

1220

Mr. Ian Shugart

Ms. Hedy Fry

Â

1225

Mr. Ian Shugart

Ms. Hedy Fry

Mr. Ian Shugart

Mr. Glenn Rivard

The Chair

Mr. Rob Merrifield

Ms. Maria Barrados

Â

1230

Mr. Rob Merrifield

Ms. Maria Barrados

Mr. Rob Merrifield

Ms. Maria Barrados

Mr. Rob Merrifield

Ms. Maria Barrados

Mr. Merrifield

Ms. Maria Barrados

Mr. Rob Merrifield

Ms. Maria Barrados

Mr. Rob Merrifield

Ms. Maria Barrados

Mr. Rob Merrifield

Ms. Maria Barrados

The Chair

Mr. Ian Shugart

Mr. Rob Merrifield

The Chair

Mr. Paul Szabo

Ms. Maria Barrados

The Chair

Mr. Gerald Chipeur

Mr. Paul Szabo

Â

1235

Mr. Glenn Rivard

The Chair

Â

1240

Ms. Hedy Fry

The Chair

Mr. Glenn Rivard

The Chair

Mr. Rob Merrifield

Ms. Maria Barrados

Â

1245

Mr. Rob Merrifield

Mr. Alan Gilmore

Ms. Maria Barrados

The Chair

Mr. Rob Merrifield

Â

1250

Mr. Glenn Rivard

Mr. Merrifield

Mr. Glenn Rivard

Mr. Ian Shugart

Mr. Glenn Rivard

Mr. Ian Shugart

Mr. Rob Merrifield

The Chair

Mr. Rob Merrifield

Mr. Glenn Rivard

Mr. Merrifield

Mr. Alan Gilmore

Mr. Rob Merrifield

The Chair

Mr. Rob Merrifield

Ms. Francine Manseau

Mr. Rob Merrifield

Ms. Francine Manseau

Â

1255

Mr. Rob Merrifield

Ms. Francine Manseau

Mr. Ian Shugart

The Chair

Mr. Rob Merrifield

Mr. Paul Szabo

The Chair

·

1300

Mr. Ian Shugart

The Chair

Mr. Ian Shugart

The Chair

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CANADA

Standing Committee on Health

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NUMBER 088

l

1st SESSION

l

37th PARLIAMENT

---

EVIDENCE

Tuesday, June 11, 2002

[Recorded by Electronic Apparatus]

Á  (1105)  

[English]

    The Chair (Ms. Bonnie Brown (Oakville, Lib.)): It's a pleasure to call this meeting to order.

    Before we begin to hear from witnesses, you will see in front of you an operational budget, which we desperately need, because if we're going to continue to hear witnesses, we must have some money to pay their expenses. So I would be happy to accept a motion for the amount requested, which you see in the black box at the top, $29,500. It is moved by Madame Thibeault, seconded by Mr. Ménard. Are there any questions about this budget?

    Mr. Rob Merrifield (Yellowhead, Canadian Alliance): Is this to take us through this week? I see ten witnesses.

    The Chair: Yes. It's just to make sure--

    The Clerk of the Committee: There will be more than 10 witnesses, but quite a few of them don't have to be paid, because they're local.

    The Chair: They live in Ottawa.

    Mr. James Lunney (Nanaimo—Alberni, Canadian Alliance): That was my question, Madam Chair: is it enough?

    The Chair: Okay, I'll call the question.

    (Motion agreed to)

    The Chair: Mr. Ménard has given me a notice of motion.

[Translation]

    Mr. Réal Ménard (Hochelaga—Maisonneuve, BQ): I'm not asking for a debate. I just want to read the motion, then we can have a vote at the next sitting pursuant to our Standing Orders. I think we'll have a unanimous vote because this is a just motion.

It is moved:

That the Standing Committee on Health severely censure Minister Anne McLellan for her refusal to appear again before the Committee to defend her Department's estimates. In the Committee's view, this is a lack of respect for parliamentarians, a denial of ministerial responsibility and a sign of unspeakable arrogance.

That the matter be referred to the Speaker of the House.

    This is my motion. We will discuss it tomorrow.

[English]

    The Chair: On the very first part of it, Mr. Ménard, did you say we should send a letter to that effect? What form do you want this chastisement to take?

[Translation]

    Mr. Réal Ménard: We'll take a vote. It would take the form of a vote. However, you can communicate with the Minister.

[English]

    The Chair: It would result in a letter to the minister, the clerk tells me, if we passed this motion. Okay, thank you, Mr. Ménard. We'll put it on the agenda for Thursday. That was just a notice of motion.

    We'll move now to the regular business of our committee. You have your witness list in front of you. The first pair are Maria Barrados and Alan Gilmore from the Office of the Auditor General of Canada. I'll ask them to begin to comment on those clauses the clerk has advised them we want to hear about.

    Ms. Maria Barrados (Assistant Auditor General, Office of the Auditor General): Thank you very much, Madam Chair. Thank you for inviting us to assist you in your deliberations on Bill C-56, an act respecting assisted human reproduction.

    I have with me today Dr. Alan Gilmore, principal, who will be pleased to answer questions on regulatory matters. My remarks today will focus on accountability issues.

Á  (1110)  

[Translation]

    The Office of the Auditor General does not comment on policy matters, and it is not our practice to comment on specific items in draft legislation. We may, however, be able to assist members of the Committee with some of the issues related to Bill C-56, such as the accountability to Parliament of the new Assisted Human Reproduction Agency of Canada.

    Clause 74 of the Bill adds the Agency to Schedule II of the Financial Administration Act. The Agency will be a departmental corporation, meaning that the Auditor has the full mandate for value-for-money audit, and would also be responsible for the financial audit of the Agency.

[English]

    The use of a board as a governing body is one of the main ways a department corporation differs from a department. The agency will be governed by a board of directors, whose members will work part-time and will be appointed by the Governor in Council to reflect, as far as possible, a range of backgrounds and disciplines relevant to the agency's objectives. Deputy ministers, or their designates, of federal and provincial health departments will also attend board meetings and be entitled to speak on any matter being considered.

    There is only limited mention of accountability provisions in the bill itself. However, because of the agency's designation as a departmental corporation in the Financial Administration Act, the agency will be subject to the various accountability mechanisms that apply to regular departments. These include the report on plans and priorities, the departmental performance report, and all Treasury Board policies that apply to entities defined as departments for the purposes of the Financial Administration Act. Likewise, the agency is being added to the schedules of government institutions to which the Access to Information Act and the Privacy Act apply.

[Translation]

    The Report on plans and priorities and the Departmental performance report, as estimates documents, contain important information on performance that is essential for effective parliamentary scrutiny of government expenditures. The Report on plans and priorities establishes performance expectations and outlines the general direction the Minister wants the department to take during the estimates year and the next two years. The Departmental performance report provides information on the results actually achieved in serving Canadians.

[English]

A good performance report tells the agency's performance story, tells Parliament the difference the agency has made for Canadians, by presenting a coherent picture of performance. Good performance reporting is fundamental to effective accountability to Parliament.

    As a starting point, it is important to be clear on the purposes and objectives of the organization. This provides the basis for producing a good performance report that should meet a number of requirements. It should clearly set out relevant information about the organizational context and strategic outcomes. With information on performance, parliamentarians should expect four things: clear and concrete performance expectations focusing on outcomes, that is, results for Canadians; key results reported against expectations, demonstrating the agency's contribution to reported results; that reliability of performance information is supported, ensuring accuracy; and that use of performance information is demonstrated, improving results.

    The new agency will operate within the well-defined accountability framework for government departments. However, like other departments and agencies, it must also meet the challenge of good performance reporting to Parliament.

    Madam Chair, that concludes my opening statement. We would be pleased to answer the committee's questions.

    The Chair: Thank you, Madam Barrados.

    We'll go now to the Department of Health, Mr. Shugart, assisted by Mr. Rivard.

    Mr. Ian Shugart (Assistant Deputy Minister, Health Policy and Communications Branch, Department of Health): Thank you, Madam Chair.

    In keeping with the last number of appearances here, we thought we would not take the committee's time with a lengthy statement on the issues of accountability. I don't really have much to add to what the Assistant Auditor General has said. It is true that the details of accountability are not spelled out in the legislation per se, for the reason Ms. Barrados has indicated. In schedule II of the Financial Administration Act those operating principles and accountability provisions clearly apply to the agency as it is proposed. So if it's acceptable to you, we'll simply remain in your hands for questions from the committee and be as helpful as we can.

Á  (1115)  

    The Chair: Thank you very much.

    Mr. Rivard, from the Department of Justice, did you want to add anything?

    Mr. Glenn Rivard (Senior Legal Counsel, Department of Justice): I'll simply say that I agree with the two previous speakers. The matter is covered by listing the agency in schedule II of the Financial Administration Act.

    The Chair: Okay, thank you.

    Mr. Chipeur, you have the floor, sir.

    Mr. Gerald Chipeur (Lawyer, Individual Presentation): Thank you very much. I'm here to answer any questions the committee may have at this time.

    The Chair: Okay.

    The general theme of this meeting is supposed to be places where the bill itself differs from the recommendations of the committee. I don't know if any of the witnesses have any comments in regard to that particular issue.

    Seeing none, I'll move to Mr. Merrifield. We're on equivalency agreements, accountability, and the agency.

    Mr. Rob Merrifield: Thank you.

    I have a couple of questions, because I think the agency is really what will take us forward into the 21st Century, in a way that will garner the trust of Canadians or not. Whether it's transparent enough and whether it's accountable enough are critical questions we have to examine now, and we have an opportunity at this stage where we can perhaps tweak it in a way that will help us towards that goal. I think that's the goal we, as a committee, have worked hard for the last year towards. That's the direction we want to go.

    When it comes to the differences between our majority report and what actually came out in the legislation, I like to look at it in two different ways. There's the agency and how it's set up, how it's made up, then once it's made up, there's how it performs the function we have charged it to do.

    When it comes to the makeup of this body, there's a considerable difference. We worked long and hard, because the initial draft was quite void in that whole area, to try to come up with what we felt was an accountable agency, an agency that would do what we wanted, be open, transparent, and garner trust. We looked at Great Britain's way, which is putting all the special interests around the table, so that they can be heard. Or there's the other area we recommended as a committee, which was to have a judge-style agency, where we would chose the wisest men and women of the land--50% would be women--and have recognition of the interests come before them. We felt that was a much wiser way to approach this agency.

    I want to get comments from, first, the Auditor General, because this is something you'd be looking at. I'd be quite interested in hearing the department's comments on why you went the way you did, rather than the way we suggested. And then I'd like Mr. Chipeur's comments about which would be the best way--and whatever comments you might have.

    Ms. Maria Barrados: As you know, we have, as an office, been making a lot of comments on the institution of agencies, and our concerns have been focused on the lack of accountability, lack of transparency, lack of access to information. But this agency described in the bill is not one of those creatures. This is established as part of the FAA, and all the policies and all the procedures with the estimates are covered. So we do not have the same concerns about accountability and transparency as we do for things like the millennium scholarship and the Foundation for Innovation, for example.

    I believe your question on how this works goes to the composition of the board, which is described in the legislation, and I don't really have any comments on that.

Á  (1120)  

    Mr. Rob Merrifield: I just wanted to get your take on it.

    Now it would be interesting to hear from the department why it's there in this form, rather than as what we recommended.

    Mr. Ian Shugart: My first point would be to stress that I'm not sure there is so different a perspective in the way the agency, the board in particular, would carry out that mandate. The language concerning the composition of the board is to reflect a range of backgrounds and disciplines relevant to the agency's objectives, not to represent a range of interests relevant to the agency's objectives. I think the expertise, the diversity of perspectives, is important to have with the board of the agency, precisely in order to have what is needed to make decisions on the issues that will come before it. The thinking was that in order to have well-informed, sensitive decisions rendered, it was necessary to have that range of perspectives, to combine the understanding of the science, the ethics, the law, international considerations, and so forth.

    The mandate of the agency, of course, is the issuance of licenses, and I don't want to press the point, particularly with my colleague from Justice here, that the agency has any quasi-judicial function, but in fact, in issuing a license, it is clearly a regulatory function. In that sense, it is hearing representations, making decisions, and so interests will come before the agency to have those decisions made.

    So I don't think it is as black and white as one model or the other. In fact, the rationale was that in order to have wise decisions rendered, it would be necessary to have the board composed of men and women with a range of views, so that they could reflect the diversity of the Canadian population, as well as of the different disciplines that are brought to bear. That distinction between backgrounds, disciplines, and interests being represented on the board was, in our view, quite an important distinction.

    Mr. Rob Merrifield: If that's the intent--and I take you at your word, and I think maybe it is--perhaps there's a way we can, in the legislation, spell out some of those differences that should be represented by the agency, so we know this is not solely driven by science and takes in multifaceted areas of concern, because this piece of legislation covers so many other areas. I think that's our discomfort. It was a concern of this committee how we could get all the people at the table, so that it was not driven solely by one area.

    Mr. Ian Shugart: I take the point, and my colleague may have some comments from a drafting perspective on that question. You're quite right, those disciplines and backgrounds are not enumerated. It would have seemed to us, I think, that the phrase “relevant to the agency's objectives”, spelled out as having to do with the ethical, health and safety, social, as well as scientific implications of these issues, is identified in the agency's mandate. But that will be for the committee to decide.

Á  (1125)  

    Mr. Rob Merrifield: But understand it from our perspective. You have an agency that is really struck by the minister, that reports back to the minister, that in essence, from clause 25, actually can be instructed by the minister to do anything he likes, and the appointments are by the minister. We must have some accountability and some transparency here, and this is, I think, the discomfort we're feeling with the formation of the agency. Somehow, we should be spelling that out. It's not that I think the bill goes against the intent, but we should have it in here, because this piece of legislation is going to go on for a number of years, and now we have an opportunity to get it right.

    Mr. Glenn Rivard: If I could just comment on the question of transparency in appointments, in fact, appointments are made by the Governor in Council. Those appointments are made public, so it will be possible for everybody to know who's been appointed and to examine their backgrounds, expertise, etc., to determine if the statutory criteria Mr. Shugart referred to have been met, in short, that a variety of expertise is brought to the board.

    Mr. Ian Shugart: Madam Chair, I wonder if I could go a little further in my answer with respect to the composition of the board. It relates to the federal deputy minister and one of the provincial deputy ministers of health. You asked us to focus on any areas of variance with the committee recommendations. There again I think the outcome as recommended in this bill is not black and white. We felt, and in our discussions with provinces it became clear, that given the importance of this area of jurisdiction's not crossing the line into provincial jurisdiction, it would be important to have some linkage, some flow of information, at board deliberations between federal and provincial governments, but that they not be voting members of the board. That was the rationale for inclusion of those two deputy ministers of health or designates as, in effect, observers, but not voting members of the board. I thought, since it does relate to composition, I would mention that at this stage.

    The Chair: Mr. Chipeur.

    Mr. Gerald Chipeur: I think this discussion highlights one of the problems I noted last time, and that is the question of crossing that jurisdictional line. It's a serious issue if, for example, we find that instead of having one national body, we have a national body that we had nine provinces opt out of, so then you would be left with a national body for just one province. And to go to the issue of identifying the kinds of appointees you're going to place on this agency board, what is their job? If their job is quasi-legislative, just to determine what will be exempted and licensed, and therefore not become a criminal offence, all the Parliament's done is delegate its responsibility to make up the Criminal Code of Canada.

    If this body is, instead, intended to get into issues that should be decided by local hospital ethics boards, it's crossing the jurisdictional line and getting into the provincial area of jurisdiction, and the fact that we have two deputy ministers on it just further highlights the point I was making, that this law is fundamentally flawed, because it does not address the issue of whether or not there is a national concern. If there's a national concern here and the federal Parliament decides it must act, it cannot constitutionally provide an exemption. So either you have fish or fowl, but what you've done here is create something like Banff's merman. You have a combination, and that's not contemplated in our constitution.

    This discussion here today highlights the problems this agency is going to face as it tries to carry out its mandate in the future. I think you do need more clarity with respect to the kinds of people who are going to be on this agency and their responsibility. Otherwise, you are going to have the jurisdictional problems, both on the Criminal Code side and on the provincial-federal jurisdiction side.

Á  (1130)  

    The Chair: Mr. Gilmore.

    Mr. Alan Gilmore (Principal, Office of the Auditor General): On a similar theme, but getting more into the nuts and bolts of the legislation, based on our experience with regulatory agencies, the legislation allows for appointments part-time. You've got a regulatory agency that has significant responsibilities, and the appointments are not to exceed three years, even though there's an overlap in that. They serve during pleasure. If you're concerned about independence of a regulatory agency, generally speaking, regulatory agencies would have full-time members, they would serve for longer periods of time, and they would serve during good behaviour. Reduced independence arises when you have part-time people serving for a limited number of years, eligible for reappointment, then serving at pleasure.

    I would also add, one thing you may or may not be aware of is that the conflict of interest guidelines for Governor in Council appointees formally apply only to full-time appointments. My understanding is that the ethics counsellor does extend the ambit of those guidelines to part-time employees, but for your information, it's not formally within the guidelines, as I understand it.

    The Chair: Food for thought.

    Thank you, Mr. Merrifield.

    Mr. Szabo.

    Mr. Paul Szabo (Mississauga South, Lib.): Thank you.

    Ms. Barrados, in your statement you outlined that the agency will be appended to schedule II of the Financial Administration Act, the Auditor General has the mandate for a value-for-money audit, and will also be responsible for the financial audit of the agency. I think we understand the audit from the financial side, but in conducting that audit, is part of your job also to ensure that the agency's mandate is being fulfilled or operated within and that it has the tools and the expertise to discharge that mandate?

    Ms. Maria Barrados: As you know, value-for money audits are very broad in scope. We look at an organization, we do an assessment of risks, and we do detailed analysis on those risks. All those areas you mentioned, compliance, whether there are the tools in place, efficiencies, effectiveness, any issue we think is important in the operations, with the exception of the policy itself, would be in the ambit of our audit.

    Mr. Paul Szabo: Thank you.

    In subclause 40(2) of the legislation, referring to the agency's administration, it says:

A licence authorizing the use of an in vitro embryo for the purpose of research may be issued only if the Agency is satisfied that the use is necessary for the purpose of the proposed research.

I stress “satisfied”. In the committee's report on the draft legislation one of the recommendations was more specific: generally stated, no licence shall be issued unless it can be clearly demonstrated that no other non-embryonic source could achieve the same research objective. It's a matter of the definition of what is termed necessary. Also, in the speech from the minister on second reading, she indicated that:

Regulations would require researchers working with embryonic stem cells to obtain a licence from the regulatory authority for each of their research proposals. They would also need to obtain approval from a reputable ethics board for any project proposal and demonstrate that no other source would be adequate for their needs.

    There appears to be some reconciliation in the legislation, being satisfied that it is necessary, as opposed to “shall do this”. In fact, the minister's statement suggests that the decision of whether it is necessary may be made by a local research ethics board and that the responsibility of determining whether it's necessary is being seconded to another jurisdiction. Do you believe that in order for you to be able to discharge your responsibilities with regard to its mandate, you need a better understanding of what is meant by being “satisfied” that the use is “necessary”?

Á  (1135)  

    Ms. Maria Barrados: Mr. Szabo, I'm not really in a position to get into the details of that argument, I'm not sufficiently informed, but as a general principle, in all the work we do it assists us a great deal if there is clarity of intent in both what an organization is to do and the specific requirements that may have debate and controversy surrounding them. In our work we look very closely at the legislation. We will also look at discussions and deliberations on that legislation, because we don't make up the criteria, we rely on what Parliament has given us. So the greater the clarity, the better, from our point of view.

    The Chair: Mr. Shugart wants to comment on that.

    Mr. Ian Shugart: The intent here was to achieve the objective of non-reliance on the more ethically problematic material, if I can use that term. So the intent is that of the committee. We combined that policy intent with language that was as close as we could get to that used in the U.K. legislation. We felt it would be helpful to look at what that comparison showed from a ten-year track record of working in this area. In effect, we borrowed that language to achieve that policy intent.

    With respect to the connection of the agency's responsibility and the REBs', the way this would normally occur is that a proposal or an application for a licence would not even come to the agency or go to a funding agency, for example, for funding until it had gained local research ethics board approval at the institution. In some institutions you may even have a couple of REBs. For example, at a teaching hospital there might be an REB for that hospital and then one for the faculty of medicine at the academic science centre. The funding agencies will not entertain an application for funding unless there is certification of REB approval for that application. The agency is not delegating to an REB. Indeed, in making its decision, it would almost certainly take into account the deliberations of the REB on that particular application. It doesn't mean that if the REB approved, it would be approved and a licence granted, but undoubtedly, it would take that into account.

    Glenn may want to comment further, but there's no intent, and I don't see in the bill any provision, for delegation of that responsibility to any other organization.

Á  (1140)  

    Mr. Paul Szabo: Okay, the bottom line is that all research, in the normal course, has to go through an REB. That's been going on in the past and will go on in the future, and it will be taken into account. If they said no, it would never even get to the agency. But how does the agency discharge its responsibility, i.e., satisfy itself? What else does it do to satisfy itself that the research is necessary, that there is no non-embryonic source that would achieve the same research objective? The REB does not address that question. Somebody must address the question, so who is it?

    Mr. Ian Shugart: The agency is the bottom line. The agency must be satisfied, whether or not the REB raised that question. Given that the prevailing research and ethics guidelines do, in fact, speak of the same principle, that where there is material that is more freighted with ethical difficulty, one would take the path of least ethical problem, that principle ought to be employed by an REB in their scrutiny. I would think that they should, in their own right, to discharge their duty. If they don't, you're quite right, the agency explicitly has to be satisfied on that score. If the research ethics board has examined that question, they may not come to a different conclusion.

    Mr. Paul Szabo: I'm going to presume that it would not have the experience or expertise to make that determination itself, because the people are not involved in day-to-day research, so as to know what else is going on. How would the agency find out whether or not there was a non-embryonic source of stem cells that could achieve the same research objectives? Who would they ask who would be independent and have the basis for opinion on that question?

    Mr. Ian Shugart: They would need to have sources with respect to the general question. In other words, they would need to develop the expertise or the sources of expertise in the general case. They would have to stay abreast of the science in that area and have access to it, almost on a standing basis. Then they would have to bring expertise to bear on the specific application, the specific case before them. The current debate in scientific circles about the plasticity of embryonic and adult stem cells I think is the best way to illustrate this. There will be different viewpoints on both sides of that scientific divide. I think it would be quite evident that the agency had not been diligent if it consulted and had, as part of its source of expertise, leading researchers on one side of that scientific debate. If they had recourse only to one particular perspective, it would be apparent that they were looking for a particular outcome.

    It's true that they will not themselves be leading practitioners of science, because then we would be running right into the committee's concern about having leading researchers right at the table rendering these decisions. So they'll need to have access to it, they'll need to have it on a continuous basis, and they'll need to have methods, provisions, and process for building it in. To some extent, they have to do the same thing if there is a lack of expertise on a particular question in ordinary peer review of grant applications. Whether it's the funding decision or the ethics review, it is standard practice to go outside the panel and get a second reader or an expert reviewer who's known to be leading in that field to bring their views to bear. So that, I think, is how it would work, Mr. Szabo.

Á  (1145)  

    The Chair: Thank you.

    Mrs. Skelton.

    Mrs. Carol Skelton (Saskatoon—Rosetown—Biggar, Canadian Alliance): I'll let Dr. Lunney go now, because he has to leave.

    Mr. James Lunney: Thank you.

    I've a few questions, and one of them--and I think this still does fall under the accountability section--is the sale of gametes, or the import of gametes across the border. I am concerned about this for a number of reasons. We did hear some discussion about it from our witnesses. We have a problem with cross-border drug control, with drugs being ordered over the Internet, Propulsid and other drugs banned in Canada or controlled drugs, and coming in by mail. First, why are we allowing the import of gametes? Second, how does the department envisage controlling that?

    Mr. Ian Shugart: As to the why, Mr. Lunney, it's simply a matter of supply to facilitate conception by infertile couples. The overlay this bill would provide is the regulatory authority to ensure that gametes from whatever source meet the health and safety standards set by regulation. Policing and enforcement of any area involving health and safety present an ongoing challenge for any regulatory department, and Health Canada is no different in that regard. In the main, of course, it will be fertility clinics that will be involved in the handling of gametes for the needs of infertile couples, and the information provisions of the bill would ensure that the agency knows where those clinics are, they're registered, and all that kind of thing. They themselves must be licensed, and in order to be licensed, they themselves must meet the health and safety tests. So the normal dealings with patients and the clinics, including sources for import, are going to be transparent to the agency because of the licensing and regulatory provisions the agency operates under. And then, through the inspection provisions, the audit provisions, if you will, the agency has with respect to those clinics, verification of health and safety standards for the gametes can be followed through.

    Mr. James Lunney: Thank you.

    I want to ask Mr. Chipeur's opinion, but let me throw something else in here. One of our big concerns is about commercialization and commodification of reproductive materials. I can see we have some ability to control what goes on within our own borders, but if we get an agency in some other country that wants to import sperm from a Robert Redford or ova from some fashion model at a tidy fee to Canada, to produce designer babies on this side, how on earth are we ever going to regulate or control that if we're bringing reproductive materials over our borders?

Á  (1150)  

    Mr. Glenn Rivard: I would just point out that an importer will have to be licensed under the act, and therefore will have to meet the regulatory requirements, including requirements for information on the source of the sperm or ova, the identity of the donors, the method of collection, whether there was payment or not. All this additional information will have to be provided and can be checked or inspected by the department under the act for accuracy and completeness.

    Mr. James Lunney: So we'd be able to go down to Costa Rica where there's a clinic set up and just examine their records and make sure... How on earth are you ever going to determine where the sperm or ova came from if their records say one name? How on earth are you ever going to do genetic tests on their materials to try to prove that this is a this or this is a that? I can see a terrible snare here. I wonder, Mr. Chipeur, if you have any comment on this subject.

    Mr. Gerald Chipeur: I agree with my friend from the Department of Justice that the provisions in the act will apply to all importers and will give the federal government the same kind of hammer it would have with respect to a local distributor. My view would be that your difficulty in regulating and controlling domestic providers, if you want to use that word, is going to be just as difficult as with any international organization. Once you have the product, you have the product, and you're going to have the same kind of DNA trail you would have to follow if you were going to try to convict in that case. I agree that it's an issue, enforcement is always an issue, but the legislation does a good job of addressing it. In fact, the federal government is the only level of government that can actually regulate this kind of importation. The provinces would not have this jurisdiction. If there is any area where the government should be acting, it's this area.

    Mr. James Lunney: Finally on this issue, what safeguards really are there to prevent the scenario I've just described happening? It's all there in words, but if enforcement is an issue, are we going to send the RCMP down to investigate a lab in some foreign country? Would we send the CFIA down to Brazil, for example, on mad cow disease? That is not a normal practice, and it's well beyond our budgetary constraints. What kind of snares are we creating here? That's really what I'm asking. If indeed you can't control it, are we not better to say, reproductive material should come from within our own borders, we're not all infertile within Canada, surely we have a good natural resource still available to us?

    Mr. Ian Shugart: I'm not sure I can go beyond what we have said. For example, the failure to provide the information that is required to give assurance as to the safety of gametes could be used as the basis for not issuing a licence to that importer. The agency is not under any obligation, in discharging its regulatory responsibilities, to issue a licence. In fact, not issuing a licence is one of its major instruments for enforcement. One would anticipate that it puts a premium on the interactions being with the reputable organizations, whether they are in Canada or offshore.

Á  (1155)  

    Mr. Glenn Rivard: I would just add that the bill does provide for the full range of enforcement inspection authorities that is available to regulatory authorities. In any industry that is regulated by any government anywhere in the world there is always the potential that the body being regulated will commit fraud, and that's really what would have to happen to get around this scheme. I would simply point out that the bill provides for very significant penalties in this event, up to five years imprisonment.

    The Chair: Mr. Gilmore would like to comment on this.

    Mr. Alan Gilmore: Prohibition versus regulation is a classic problem in regulatory areas. If you prohibit something, you create the possibility of a demand for what you're trying to prohibit. So you're always faced with whether you want to try to regulate it or you want to try to prohibit it. The risk here is that if you prohibit the importation of material from other countries, you create an underground market for exactly what you're trying to prohibit, which will create a whole different kind of regulatory and enforcement problem. Based on rather diverse experience, it's really hard to choose, but I think my personal preference would be to regulate something and try to control it, rather than prohibit it and create an underground market for it. That's a personal view based on what we can read in the literature and what we can see.

    Mr. James Lunney: To go back to the regulatory body and the composition of the members, we talked about the different models with the experts around the table. Many of the licensing boards, for our health professions in particular, have lay people mandated as part of their composition. I think that is spelled out in regulations in many of the health professions. We don't see anything like that here. Is there a possibility of simply amending this to include a number of people who are not directly related to the industry, who have expertise or experience or wisdom, but are not directly related? We are concerned about conflicts of interest.

    Mr. Ian Shugart: Mr. Lunney, as always, we're in the committee's hands with respect to the question of changes. In research ethics boards, for example, it is now an accepted practice, and the best research ethics guidelines insist that research ethics boards have lay members. There's certainly nothing that would prevent that here. The issue is only whether the diversity I referred to is enumerated with respect to the backgrounds and perspectives or is left as that general statement, but I would anticipate that a representative of the general informed populace not having an interest could easily be included in that number.

    The Chair: Thank you, Dr. Lunney.

    Madam Sgro.

    Ms. Judy Sgro (York West, Lib.): Thank you very much.

    Dr. Shugart, how big a problem is it when it comes to having sufficient gametes in Canada? When we had our witnesses previously, when we had draft legislation, I got the feeling that some of these issues aren't major issues in Canada, that there are not huge waiting lists for people in need of the gametes, and so on.

  (1200)  

    Mr. Ian Shugart: The numbers are not large when one compares them with other fields of clinical practice, that is true. Within those aggregate numbers it's a question of proportion and whether there is enough to meet the needs of those relatively smaller numbers.

    Francine, could you give us a sense of the extent of the problem?

    Ms. Francine Manseau (Senior Policy Analyst, Health Policy and Communications Branch, Special Projects Division, Department of Health): It depends on whether you're talking about sperm, eggs, or embryos. For reasons we don't know exactly, about 80% of the sperm comes from the States right now. The exception would be in the province of Quebec, where they seem to be getting their own donors. Years ago that was not necessarily the situation, and as to why it evolved to that, I think you would have to ask the people. With eggs, I think there is a shortage. The waiting list is very long in most of the clinics in Canada, and not all of them are doing it anyway. With embryos, it's even more so. There is a shortage of eggs and embryos, with sperm, it depends. If you talk to some clinics, they say the restrictions with health and safety and the testing that needs to be done have had an impact on the sperm available in Canada.

    Mr. Ian Shugart: I would supplement that by saying we should not give you the impression that we have hard data to answer your question. In the future, as a result of the general registry and the collection of data in this area, we will have harder numbers, but from our understanding of the field and watching the discussion at the committee earlier, it's the clinicians in the field who are at the moment the primary source of information about the nature of the problem at the clinical level.

    Ms. Judy Sgro: Infertility is a big problem, then, from what I would guess. If we're importing a variety of these things, there must be a huge demand here, much more than I was aware, when it comes to the infertility issue.

    Mr. Ian Shugart: There is, and it is, I think, a particularly poignant kind of demand for the families involved. Our best information is that it is a growing demand, for a variety of sociological reasons, as well as because of some epidemiological factors related to sexually transmitted diseases and so on. Again, if you compared the total population of infertile couples to other fields of medicine, cardiology or orthopedics, you'd be dealing with relatively small numbers. But within that community it is a significant issue and is projected to grow, which is why provisions in the bill that would disproportionately affect the infertile couple are balanced against the desire, the policy, that there not be commercialization in this field. There is, without question, a balancing act there, precisely because of the nature of the infertile couple community.

    Ms. Judy Sgro: But we can't actually say how many?

    Mr. Ian Shugart: Not in hard numbers.

    Ms. Judy Sgro: On when the researcher has to go to the agency and say he needs to do his research on the embryonic cells, run me through that process again, because it's an issue I'm still wavering on. Will he have to prove to you and have evidence to show you that there is no other biological material he can do his research on?

  (1205)  

    Mr. Ian Shugart: Yes, that is the idea. Take, for example, Freda Miller at McGill, who works in adult stem cells and is reported in the news today to be moving from McGill to Sick Kids in Toronto to pursue her work there. Any research protocol she might bring forward would have to go through research ethics review by the research ethics board at Sick Kids, at a minimum. With respect to that research, because there's no embryonic material involved, that's the end of it, assuming approval. Another researcher using embryonic stem cells would need to submit the same kind of research protocol to the local board. It would be reviewed. Is it generally ethical? Is the objective of the exercise and the purpose of the experiment ethical in its own right? If yes, then gradually the reviewers would come to the question of the material being used in the research, and because embryonic and adult stem cells are very different with respect to ethical implications, there's a specific set of questions by which that researcher will be put through his or her paces. Why do you need to go to the embryonic material? Why could you not use stem cells, period? The researcher is perhaps going to try to understand the extent of the plasticity of the stem cell, because some of the literature demonstrates that researchers working with adult stem cells in that particular area have come up against a dead end over and over, they can't take it any further.

    The problem, Ms. Sgro, is that it can never be absolutely proven that something is not possible, and yet it can be demonstrated that something is necessary. It's a bit of a logical dilemma, it's unquestionably a paradox, but the test is exactly the same. We want to ensure that embryonic cells are not used trivially; if there is another road that leads to Rome, that road should be followed in preference to embryonic stem cells. If all the evidence suggests that all those other roads to Rome are blocked and there is no other way of getting there, the bill requires the agency ultimately to be satisfied that is indeed the case.

    We're dealing, as always in matters of science, with uncertainty. Some aspects cannot be known, and there are members of the committee who know, from their own careers, better than I that such is the case, but that is the test. If the research ethics board at the local level says, okay, we're persuaded, that's justifiable, it then goes to the agency, and the agency has to be satisfied itself on that same issue, whether or not the REB has dealt with it fully. If it has, that will undoubtedly be used as evidence. If it hasn't, it has to be satisfied itself.

    The Chair: Thank you.

    Ms. Skelton.

    Mrs. Carol Skelton: In researching this whole issue, I've spoken with some researchers at a Canadian university, and the one point they raised was on intellectual property rights. If a donor allows research to be done on their donated embryos and a cure, let's say, is discovered through that research, is there anything to prevent the donor from seeking a portion of the profits from that cure? In the legislation there seems to be nothing that disallows the person that.

    Mr. Ian Shugart: The reason for that, Ms. Skelton, would relate to the scope of the bill and the fact that its subject matter does not extend to the law governing intellectual property. If there is any body of legislation that would shed light on that question, it would be the Patent Act and intellectual property regimes that flow from that. In the normal case, of course, any sharing of royalties or benefits flowing from intellectual property would be spelled out in fairly exhaustive legal agreements prior to any real benefit flowing. Certainly, in situations where there is academic-industry collaboration on research or there are a number of research agencies or sites, different academic institutions, sharing, those agreements are exhaustively worked out before the research is actually entered into. So it would be the Patent Act that would rule on that kind of question.

    Second, in practice--although I don't want to be categorical here--I would think it highly improbable that after the event someone could register a claim if it had not been established as part of a royalty agreement at the outset. If that happened, the provisions of this bill would kick in, because there is a prohibition against any consideration, monetary or otherwise, present or future, in exchange for the donation of an embryo or gamete.

  (1210)  

    Mrs. Carol Skelton: Do the rest of the witnesses agree with that?

    The Chair: I think that is beyond the scope of the bill, Ms. Skelton, patenting and profits and all that sort of thing.

    Mrs. Carol Skelton: Well, it's a question that was raised with me by a researcher.

    Mr. Chipeur, you mentioned that the bill didn't address a national concern. Would you tell us more about that, please?

    Mr. Gerald Chipeur: In the theory of the Canadian Constitution the provincial governments are given responsibility for local matters, and health care is generally a local matter. The federal government is given responsibility, for example, for criminal law. Many of the prohibitions in this legislation are criminal law. If the federal government has a concern under one of the headings given to it under the Constitution and desires to address that concern through legislation that incidentally goes into the area of provincial jurisdiction, let's say health care, the courts will uphold that incidental impact on the provincial government's right and responsibility to regulate health care if it's part of a national scheme that is necessary to achieve the objectives the federal government rightly has under the Constitution. The problem with this legislation is that it allows provincial governments to exempt themselves from the scheme, which logically, in my mind, takes away the very basis for the argument a Parliament could make that they needed to incidentally affect health care in order to achieve their objective. This argument doesn't have any impact on the prohibitions in the statute. All the prohibitions are proper criminal law prohibitions. The problem comes when you set up an agency that makes decisions with respect to health care. That's where, in my view, this legislation falls short.

    If this is necessarily incidental to the exercise of some federal jurisdiction, it would seem logical that one would not create an exemption. Otherwise, as I said, we could have the illogical conclusion that only one province... For example, under the child support guidelines, provinces are allowed to opt out, and Quebec has opted out. We could see the exact opposite here. We could see, let's say, every province except Quebec create its own equivalent agency, and then the entire attempt by Parliament to regulate in this area would be frustrated. That is the fundamental flaw I see in this legislation with respect to that question.

  (1215)  

    The Chair: Mr. Rivard, would you like to comment?

    Mr. Glenn Rivard: I would just say the view of the Department of Justice is not the same. We're quite satisfied as to the constitutionality of the legislation. I would point out that the equivalency provision requires an assessment that there is equivalent protection for those who would undergo these procedures in a province that has signed an equivalency agreement with the federal government. As well, it's not quite true to say there is a complete opting out. In fact, the bill specifically requires a continual flow-through of information to the federal government. The emergency power under the bill is still applicable and can be exercised by the federal government. Finally, it is always within the power of the federal government to cancel the agreement and reassert jurisdiction under the bill. I'm not aware of any case law that would uphold the contrary view on this point, and as I've said, we remain satisfied that it is constitutional.

    The Chair: Madam Skelton, since the publication of the royal commission in late 1993 nine years have gone by, and no province has rushed in to fill this void. As a matter of fact, I think they're probably going to be quite happy that someone else is carrying this particular responsibility, because of the ethical overtones and the conflicting opinions about these subjects. So I don't think they're all going to rush to set up their own agencies and opt out and all those things.

    A voice: Except Quebec.

    Mrs. Carol Skelton: But if it's in the law, that's my concern about it.

    The Chair: Madam Scherrer.

[Translation]

    Ms. Hélène Scherrer (Louis-Hébert, Lib.): Thank you very much, Madam Chair.

    There's an issue that is of special concern to me. It's once more about confidentiality. I remember that we recently talked about a very specific framework for confidentiality. We particularly talked about communication of medical information. It was mentioned that if someone made a specific application at age 18 in order to know the identity of his or her biological parents, that the application could be considered.

[English]

    The Chair: Excuse me, Madam Scherrer, the whole thing about anonymity is on the agenda tomorrow.

[Translation]

    Ms. Hélène Scherrer: All right.

[English]

    The Chair: Okay, thank you very much.

    I'll move quickly to Madam Fry.

    Ms. Hedy Fry (Vancouver Centre, Lib.): Thank you very much, Madam Chair.

    I have just two little questions, clarifications more than anything else. Obviously, the CIHR and other bodies will be granting research funding for people who apply to do research on any one of these issues. You've been explaining this at some length, and it's becoming less and less clear to me. I thought it was clear, but it's now less and less clear. Is the agency going to undertake day-to-day micro-management in looking at a piece of research that goes to the CIHR, for instance, or a federal or a provincial research body and making a decision? Are they supplanting the work of these bodies, are they duplicating the work of these bodies, or are they only going to come in when they think there is something questionable going on? That's my first question.

    The second question has to do with confidentiality, but of a different type. Under clause 47 an inspector can come into any one of these areas. These are not all going to be research, in vitro kinds of places. There are going to be fertility clinics, there are going to be clinics that are actually doing some of this work on real people. There's going to be the in vitro component of it. My concern is whether, when they are demanding information, there is going to be some sort of doctor-patient confidentiality, so that the names of the people this work is being done on will be not so easily accessible. Many of us physicians have fought very hard in cases of motor vehicle accidents and others not to have some lawyer suddenly decide they must get our charts; we would need to have some sort of subpoena to give the information we don't think is pertinent. So I'm concerned about somebody coming in and suddenly getting 600 charts to look at out of a clinic and knowing all the names of the people who've been seeking advice and counselling. This throws doctor-patient confidentiality out of the door.

    Perhaps you can explain both of those to me.

  (1220)  

    Mr. Ian Shugart: I'm going to ask Glenn to speak to the privacy provisions in the bill. I would mention that again, the scope of the bill is the in vitro embryo only, so other clinical interventions or dealings with respect to the in vivo situation are automatically outside. I realize that in the context of the clinic, that's not always quite so clear, so I'll ask Glenn to follow up on that.

    The research context is complicated. The short answer to your question is that the agency would not be involved in the micro-management of the science. I think it needs to be mentioned that the research coming before the agency concerns only those areas where a licence must be issued, in other words, the embryo, the research on the gametes, and so on, which automatically involves, certainly in the Canadian context, a relatively small number of researchers. That is why we don't anticipate that there would be the volume of activity, if I can put it that way, to justify full-time membership on the board exercising that regulatory function, any more than with the members of the patented medicine prices review board, who are regulators, in effect, and part-time members as well.

    There is obviously a connection between CIHR and the agency in a variety of ways. CIHR may choose, on grounds that have nothing to do with the ethics, not to fund an application, which is then a dead letter, there's no need. So the researcher community in this area is going to be relatively small, and the mandate of the agency is related only to those aspects that relate to the issuance of a licence. Funding decisions and the development of research ethics guidelines that govern research ethics boards and so on are outside the purview of the agency.

    Ms. Hedy Fry: For argument's sake, let us suggest that embryonic stem cells could be used for something else. What if the research is, in fact, looking solely at embryonic stem cells to find further properties, to find out what embryonic stem cells can do that we still don't know? How would that kind of research be viewed? That would be purely, again, in vitro research looking at what it is we don't know currently about embryonic stem cells and comparing them, say, with adult ones or just looking at them on their own.

  (1225)  

    Mr. Ian Shugart: You would have to ask someone who is trained in bioethics to go into depth on that question. The first thing ethics review would watch for is any triviality or lack of focus. Much is known. Researchers in any human material, where's there's human experimentation involved, have to be pretty precise about what it is they need to know and why they need to know it. It's a fairly high bar. Can I say that line of inquiry itself would be ruled out? No, I can't, but even that line of inquiry would contain within it standards of expectation by ethicists, it would not be entered into trivially.

    Ms. Hedy Fry: I'm glad you say you couldn't rule it out, because for me, the only reason we know what embryonic stem cells can do and what the properties are is that somebody did research on them originally. One has to be very careful, when one is balancing off the progression of knowledge, that one doesn't close the door to that continuing progression. There are things we thought we knew about the brain, and we now realize we don't know two-thirds of what the brain does. So we need to continue to push those borders. Doing it in an ethical manner is obviously going to matter. I hope you have bioethicists on your agency board.

    Mr. Ian Shugart: I am again convinced that such would be included in the definition of range of backgrounds and disciplines relevant to the mandate of the agency.

    But perhaps Glenn could follow up on your question on privacy.

    Mr. Glenn Rivard: I would just make a couple of points. One is simply that the authority to inspect really pertains to assuring compliance with the provisions of the act, and so it's not an open-ended licence given to health inspectors to go in and search for anything and collect any sort of information. If, for example, you're a doctor with a licence to practise, licensed under this act, providing in vitro fertilization, but you also provide medical services, the legitimate scope for the inspection pertains to those activities that are licensed under this act.

    The other thing I would point out is simply that the legislation has very limited grounds for disclosure of information beyond the agency, and it would be very difficult to think of a situation in which actual patient names would be disclosed if you look on those grounds. One possibility is if there is an actual court order requiring disclosure, although I find it difficult to imagine a situation where that would come about. The basis for disclosure of any information is significantly more limited than under the federal privacy act, for example.

    The Chair: Thank you, Madam Fry.

    The people from the Auditor General's office have to go very shortly. Mr. Merrifield has a question for them, and so does Mr. Szabo. So we'll get your question out of the way, Rob, and then we'll move to Paul.

    Mr. Rob Merrifield: Your department will likely be the ones who will be doing a review of this agency. What disturbs me more than anything is that I don't see a mandatory requirement for reporting directly to Parliament; it's just to the minister, then, at her will, the department. Is that something, from an auditor's perspective, looking for openness and transparency, you're comfortable with, or would you prefer to see something coming directly to Parliament?

    Ms. Maria Barrados: Under the FAA there is a requirement that the report on plans and priorities be prepared and presented as part of the estimates process, and a performance report is prepared and presented as part of that process. Putting this agency on that schedule brings with it those requirements, so there is a reporting to Parliament.

  (1230)  

    Mr. Rob Merrifield: Just through the estimates process?

    Ms. Maria Barrados: There are two big reports, and you have a lot of scope in those reports.

    Mr. Rob Merrifield: Is the scope, from your perspective, through the estimates more on the use of dollars for the agency, or is it anything deeper than that?

    Ms. Maria Barrados: Those reports expect both, accountability on the financial performance and program performance.

    Mr. Rob Merrifield: And they will be yearly reports?

    Ms. Maria Barrados: That's right.

    Mr. Rob Merrifield: So every year your department would go in.

    Ms. Maria Barrados: No. The reporting requirements that are part of the estimates process are annual. We will do a financial audit every year. It's not clear what kind of financial audit, but if there's a separate financial statement, as in the case of an agency like CIHR, we would audit that. We would do the financial audit. Or it may be part of the public accounts, and we would do that financial audit, and that's on an annual basis. On the value-for-money audit side, we are not in every year. We do a risk assessment, and we are selective as to the programs and activities that would--

    Mr. Rob Merrifield: Can you tell me what would trigger that?

    Ms. Maria Barrados: We work off a number of things. First we have the Auditor General's priorities in the value-for-money area. Health and safety is one of her priorities, which means we look, as an office, at the whole health and safety area, at what we call the risks, at where we have been and where we have not been. We also make an assessment about what value we can add to doing an audit. If we have something we view as risky, if we have something we have not been in, if we have something we can add to, it's definitely high on the list, and then we make resource allocation decisions.

    Mr. Rob Merrifield: It's your call, then.

    Ms. Maria Barrados: It's our call, with one exception. If there is a majority request from a parliamentary committee, we try always to meet it.

    Mr. Rob Merrifield: So this committee could initiate that?

    Ms. Maria Barrados: As long as it's a majority request.

    The Chair: Mr. Shugart.

    Mr. Ian Shugart: I would just add that simply by virtue of the estimates process, parliamentarians can call the agency to committee to defend the estimates and so on. That's an additional implication of the process.

    Mr. Rob Merrifield: I hope the agency will be more responsive than the minister, or we are in real trouble.

    The Chair: Mr. Szabo.

    Mr. Paul Szabo: My question relates to the issue of free and informed consent, which is a very big part of the relationship between donors, researchers, and infertility clinics. The definition refers to consent “that is given in accordance with the applicable law governing consent”. I don't recall which law that is. In your experience, are there other pieces of legislation or other precedents where there has been an amplification on what constitutes free, full, informed disclosure and consent with regard to a particular undertaking or contractual arrangement, depending on what the bill might be relating to it?

    Ms. Maria Barrados: I'm sorry, we can't add anything on that.

    The Chair: Mr. Chipeur.

    Mr. Gerald Chipeur: The common law is clear. That's the classic definition of consent a physician must obtain. So the courts would have no problem enforcing that, and it would require all the usual tests, such as providing the client with all the options, the consequences of choosing those options, including the cost of those options. All those things would have to be disclosed. That is a classic definition of consent, and I think it is properly used.

    Mr. Paul Szabo: But are you presuming the provisions, for instance, that were laid out in the guidelines adopted by CIHR, which included such things as, you consent that you will not participate in any future commercialization of materials flowing from that donation, and you will also be getting a conflict-of-interest statement from the researchers using your gametes? I think there are also copies of contracts you will get to look at, contracts between the researcher and the institution or any other parties they have contracts with. There are a lot of specifics with the CIHR. I'm not sure whether it's contemplated that the regulations would detail exactly what they're giving up, what they're entitled to see, whether or not they have rights of withdrawal at all times, etc. It seems to me that most people would understand this process of free and informed consent as a general principle, but in this regard there is tremendous detail on that “informed” part. It's not specific here, and I'm not sure whether the regulations are going to flesh that out.

  (1235)  

    Mr. Glenn Rivard: Maybe I could just comment on that. As Mr. Chipeur has indicated, there are certain fundamentals in the law with the principle of consent that apply in every jurisdiction in Canada. The benefit of relying on the concept of consent is that you, in effect, gain the benefit of all that case law and that interpretation and the protections that go with it. It is also the case that in certain jurisdictions, in the medical field, the province has legislated the information requirements that must be met in order to assure a fully informed consent. So the definition in the act is constructed to ensure that where a province has specified in legislation the information requirements, they would be applicable. The major advantage then is that a doctor working in the province of Ontario, for example, does not have to apply two different standards for a medical practice licensed under this act and general medical practice.

    The Chair: Paul, this concerns me, because we're leaning on an old definition or practice called 'informed consent', as it applies in a doctor's office, for example. It would seem to me that the list Mr. Chipeur put forward of the options, the possible consequences, and all those kinds of things is totally appropriate, except that it probably would be restricted to the medical options of going forward or not going forward. The choice among the options of going forward, the possible side-effects and repercussions, would be on the physical side. I would agree that the province has the right to legislate in that area for its doctors in medical practice, but it seems to me that this whole field is much broader than that.

    We had one of the very excellent clinics represented, the London Health Sciences Centre, and the social worker testified that in some cases, as the client went through the medical interview, the doctor in charge discharged his duty on informed consent, but for that clinic that's not enough. That person has then to go to the social workers and talk about things like family history, their plans for the future, how many children they might want to have, and all kinds of things. She told us, quite frankly, that a number of people had changed their minds based upon the longer-term implications seen in that kind of interview. In some cases there were two or three sessions, because the medical doctor in charge, though satisfied with the physical situation, was not satisfied that these people had really thought it through for long-term implications.

    So in my view, the medical licence that requires a certain kind of informed consent in this case, when we're building families and it's essentially a societal question, really isn't sufficient. That's why we kept talking about it. We knew informed consent was already defined and already in practice and, if you recall our report, that is exactly why we didn't use the phrase informed consent, but said we wouldn't mind using it if it was “informed consent and informed choice”, because we wanted to expand the parameters.

    We heard of the case of a woman who wanted to conceive, was very ill and couldn't, and wanted to have a surrogate, but the prognosis of the person who would be the caregiver mother was so bad that it looked as if she would not last very long into the child's life. There are all these other things. Sometimes people are pretty blinded by this tremendous desire to have a child, even though the best interest of that child might not be foremost in their minds. Dr. Fry wasn't here at the time, but we heard some quite blood-curdling tales about people who were desperate and absolutely determined, but every factor in their case suggested that it was not really in the potential child's best interest.

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    Ms. Hedy Fry: Madam Chair, I really would like to make a comment on that. I have done this for 23 years, and usually when a person goes to a clinic, including the clinic you're talking about, they have gone through their general practitioner first, and the general practitioner usually doesn't discuss the kinds of things you're talking about, but they do talk about those long-term implications. They would have talked to that woman about her short lifespan and whether this was an appropriate thing or not. So there is a place through which those discussions go to a different kind of informed consent, because the general practitioner refers the patient to something like that. Usually, the general practitioner's informed consent is very different from the clinic's informed consent.

    The Chair: But we heard that these very people, maybe because the doctor didn't want to get into long-term discussions, were referred to the clinic, in the hope that it would happen there.

    Mr. Glenn Rivard: If I may, I'd like to comment on that concern. In answering the specific question on consent and the definition of consent, I didn't wish to imply that there is no authority under the legislation either to require the provision of information or to provide a great deal of information to people undergoing these procedures. That authority does exist under the legislation, and further, it also provides for an offer of counselling services, all of which is designed to address exactly the sorts of concerns you've raised.

    The Chair: Mr. Merrifield.

    Mr. Rob Merrifield: That's a very good discussion, and I think it's maybe something we need to examine a little further, perhaps on another day with other witnesses.

    But my question that maybe the Auditor General, who's still here, would like to comment on concerns the difference between what our majority report said and what came out in the legislation. That's talking about setting out the principles of a statutory declaration of the regulatory body's mandate, as well as then developing a code of ethics for that. Regular reporting to Parliament is something we talk about a little, and a strategic plan for three years that the minister and Parliament would approve.

    Ms. Maria Barrados: We reviewed the material that came from the committee and we asked ourselves whether the accountability provisions suggested in different places through the recommendations were taken care of, Because it is part of the FAA, we felt that the main questions on accountability for this kind of agency were taken care of in that way. The result is that when you read the legislation, you have to read it with all the other detail that goes with the FAA, because it is not in this piece of legislation, but in other pieces of legislation. Its addition to the schedule of the FAA brings all those other things in.

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    Mr. Rob Merrifield: But it's more specific. If there's a code of ethics laid out for the regulatory body to follow, you will audit based on that code of ethics, I would imagine.

    Ms. Maria Barrados: Yes.

    Mr. Rob Merrifield: Thank you.

    Mr. Alan Gilmore: I think you have to distinguish between the costs and benefits of something being within the framework of the FAA and its being under the government's general policies, Treasury board directives, and PCO directives. There are implicit choices made by putting an agency within the framework of the Treasury Board and PCO. For example, you're implicitly saying, by having this agency here as a departmental corporation, it will be subject to the Privy Council Office regulatory policy. That has a series of policy guidelines. It tries to balance public interest with economic interest and individual interest, tries to perform a balancing act. Where that balance is varies over time. So you have to understand that it's part of the context within which the agency will operate. The more definitive you want to be in the legislation, the less that policy holds sway, because the legislation, obviously, is more important than a policy. But if it's not in the legislation, the policy applies. Then the agency and the PCO and the Treasury Board begin to try to balance that out.

    For example, in concrete terms, the PCO is wrestling with how the precautionary principle will apply to regulatory agencies. The precautionary principle appears in certain pieces of legislation that already exist and it's part of international agreements the Canadian government has accepted. Implicitly, the precautionary principle, in some form or other, will apply to this regulatory agency, unless you modify that. How it will apply will have to be worked out by the parties, but if the PCO finally comes to its idea of what the precautionary principle will be, then it will apply. The precautionary principle isn't in this legislation, so it's within the context of the government policy.

    There are other pieces of policy you have to be aware of. There's been an ongoing debate for several years on public interest versus service to the regulatee, that is the agent, the entities, or the bodies that are being regulated. Inspectors in the regulatory community are in some sense torn between providing a service to the people they're regulating, an educational service, a persuasion service, and being a regulator. So the difference between the black hat and the white hat kind of role has been a subject of discussion. A report by a senior committee of government has raised that concern. If it's not specified in the legislation, the government policies make the context.

    Those are the kinds of things you have to be concerned about. The bill doesn't state whether the government's cost-recovery policy applies. That goes along with the package. Do you want it to apply or not? That's part of the government policy. That doesn't mean the agency will be made to recover its costs, it just means it applies and that gets worked out within the innards of the government. The more specific you are in the legislation, the less the policy guidelines apply. The less specific, the more the overall context of government policy and Treasury Board policy and PCO apply. That's the balance to be weighed when you put together a piece of legislation. You have to keep that in mind when you think about it.

    Ms. Maria Barrados: I wonder if I could be excused.

    The Chair: Certainly. I've been trying to indicate that for about 20 minutes now.

    Thank you very much.

    Mr. Rob Merrifield: I'm wondering, at the department, when you laid out the legislation, why you ignored the recommendations from this committee on a code of ethics for the agency?

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    Mr. Glenn Rivard: I think the intention was always that the specifics as to the criteria to be applied in assessing any licence application would be set out in the regulations and it could be drafted in the form of a code of ethics or a code of practice and incorporated into the regulations.

    Mr. Rob Merrifield: But then there is no mention anywhere. Wouldn't it be a wise thing to put in a piece of legislation that we're referring to a code of ethics, which would be worked out in the regulations. It's not there. It's something that surprised me when I saw the legislation, especially after our recommendation. We were pretty thorough on that.

    Mr. Glenn Rivard: I guess the approach in Canadian legislation is to indicate in regulatory power the things that can be regulated, but not to put a label on what that document might look like. This bill does also contain a broad power to incorporate documentation, including a code of ethics. It's in keeping, I guess, with the normal approach to the creation of a regulatory authority.

    Mr. Ian Shugart: That doesn't rule it out.

    Mr. Glenn Rivard: It certainly does not rule it out.

    Mr. Ian Shugart: It's more a question of drafting.

    Mr. Rob Merrifield: What section would you recommend putting it in, then?

    The Chair: Our recommendation is just that a code of ethics for the agency be developed from the principles outlined at the beginning of the bill. Wouldn't you just need a clause that said that?

    Mr. Rob Merrifield: That's what I'm saying. Where would it be, and what language would there be? That's my question. Maybe that's too specific a question right now, but perhaps you can get back to us on that recommendation.

    Mr. Glenn Rivard: I'm not sure this is a full answer to your question, but I would point out that clause 22, on the objectives of the agency, speaks particularly about an obligation “to foster the application of ethical principles”, and in clause 23 it basically says the agency must be governed by the principles set out at the beginning of the act. There is already in the bill an ethical framework for the agency.

    Mr. Rob Merrifield: It's pretty weak language. I was wondering if that was what you were going to come up with on it. That's fine. Perhaps there's a comment here from the Auditor General.

    Mr. Alan Gilmore: Within the context of the government, there is a requirement for agencies to have codes of ethics under Treasury Board policy and to have vision statements. The difficulty with those in the past has been that while the intention is there, the statements tend to be vague and at times subject to various kinds of interpretations. So if you do not have a code of ethics within the legislation or a requirement that it be explicit and clear, you're going to be within the Treasury Board rules and you'll have to deal with it within that context.

    Mr. Rob Merrifield: Our intent was based on how important it was to have that in the legislation.

    Are there more comments from anyone else? If not, I have another question.

    The Chair: Mr. Szabo has another question too.

    Mr. Rob Merrifield: I have a quick one, just for verification.

    The Chair: You've had 10 minutes, you know, Rob.

    Mr. Rob Merrifield: I can't help it. They took a long time to answer.

    Francine mentioned earlier that we actually have a shortage of sperm donors and eggs and embryos in Canada.

    Ms. Francine Manseau: What I said is that from the information we can gather right now, which, as Ian was saying, is maybe not as complete as all that, about 80% of sperm comes from the States.

    Mr. Rob Merrifield: There is a shortage in Canada.

    Ms. Francine Manseau: One assumes so. And for eggs, what we have been hearing from the clinics and the patients is that there are long waiting lists for people who need to have an egg from a third party donor, and it is the same thing for an in vitro embryo--people who are in need of an egg sometimes will try to get an in vitro embryo. That's what we're hearing.

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    Mr. Rob Merrifield: You're saying, for the purpose of reproduction, they're having a difficult time having people release in vitro embryos as donations.

    Ms. Francine Manseau: Yes, having couples decide to donate their in vitro embryo to another couple for the purpose of reproduction.

    Mr. Ian Shugart: That isn't necessarily the case for all time, and it may well be that the agency has a role in public education related to that and donation generally. But at the moment that's true.

    The Chair: The other thing is, one person's shortage is another person's abundance. In other words, the people reporting the shortage are the people who want to have lots to work with in their business. These fertility clinics are businesses, and they like to have lots of supply guaranteed. The reason we have so much coming from the States is that it is a business there. Those people are paying the donors and then charging big money to the Canadian places that buy from them. We're trying, in a sense, to turn the system on its head here. We're trying to say to Canadians, if you believe people need eggs and sperm, in a way similar to people who need organs and need blood, if not so critically, you are going to have to donate. Canadians will make a decision about that and how generous they want to be, so the public debate about this will land right in Canadians' laps.

    Mr. Rob Merrifield: But what's up for debate is that we have all these embryos that are just going to be destroyed, and so we need legislation to allow them to be used in research. It's really quite interesting when we're saying we actually have a shortage of people who are willing to give those up for reproduction. It's a little surprising.

    Mr. Paul Szabo: Madam Chair, we're almost out of time, so maybe I'll just state my request. I really hope we're going to be able to better understand. The committee report included a fairly large recommendation with regard to placing interest in storing ova, not restricting the number of eggs that are harvested, and other things like that. These things all relate to fertility clinics. These things all relate to the initial authorization by the tri-council policy statement that it's okay to do research on embryos. That was never ratified by legislation of Parliament. It also presumes that in vitro is a good process, notwithstanding that Dr. Baylis has put on the public record that 50% of embryos will never survive the cryogenic process. There are no thresholds. I don't understand what the relationship is between fertility clinics and researchers now. Presumably, they sell the embryos to researchers, which they won't be able to do. I don't know how they get swept into this and also become the agent on behalf of someone to make the first contact to get this informed consent. I really need to know lots more about that.

    The other part is what happens when the committee says we should concentrate or encourage research on the storage of ova, and in the event that ova could be stored, that would supercede the whole question on the embryonic side, simply because you would be storing ova rather than embryos.

    So these are questions, Madam Chair, where I don't know if we'll have another opportunity to explore how much this has to be amplified. But it would be of interest to me, and maybe to other members.

    The Chair: There is a question about the regulations. We kind of understood that some of the details, like the number of times a person can donate sperm, would probably be in regulations, and we hope the regulations will come here. Certainly, they would be gazetted, but there's something strange when clause 66 calls for proposed regulations to be laid before both houses of Parliament for a maximum period of 60 calendar days. That is unusual. It's more usual to have 30 sitting days, during which time parliamentarians in both houses would have a chance to look at them. But 60 calendar days could be July and August. So why was that particular strategy put in?

·  (1300)  

    Mr. Ian Shugart: I don't know for certain. I know there is a concern with respect to some of the regulations that relate to health and safety and there is an imperative in some circumstances to move forward when there is a requirement to act. I don't know if any of my colleagues here can add more information.

    The Chair: That wouldn't fall into this category.

    Mr. Ian Shugart: Then we'll respond to that.

    The Chair: Okay, thanks.

    As I see no further questioners, it's my pleasure to thank the witnesses for coming today and trying to assist us. The closer we come to the end, the more confusing sometimes it gets to us. It becomes layer upon layer of complication. But I really am most appreciative that you came on such short notice to help us out and help us through this particular set of issues.

    It's my pleasure to adjourn the meeting.