HEAL Committee Meeting

37th PARLIAMENT, 1st SESSION

Standing Committee on Health

EVIDENCE

CONTENTS

Tuesday, June 4, 2002

Â

1205

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

Ms. Caroline Weber (Director General, Policy Planning and Priorities Directorate, Department of Health)

The Chair

Mr. Merrifield

Ms. Caroline Weber

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

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

Mr. Rob Merrifield

Ms. Caroline Weber

Mr. Rob Merrifield

Ms. Caroline Weber

Mr. Rob Merrifield

Ms. Caroline Weber

Mr. Rob Merrifield

Ms. Caroline Weber

The Chair

Mr. Rob Merrifield

The Chair

Mr. Rob Merrifield

The Chair

Ms. Caroline Weber

Mr. Rob Merrifield

Ms. Caroline Weber

Mr. Glenn Rivard

Mr. Rob Merrifield

Mr. Glenn Rivard

Mr. Rob Merrifield

Ms. Caroline Weber

Â

1210

Mr. Rob Merrifield

Ms. Caroline Weber

The Chair

Ms. Caroline Weber

The Chair

Mr. Rob Merrifield

The Chair

Mr. Rob Merrifield

Mr. Szabo

Mr. Rob Merrifield

Ms. Caroline Weber

Mr. Glenn Rivard

Â

1215

Ms. Caroline Weber

Mr. Rob Merrifield

The Chair

Mr. Réal Ménard (Hochelaga—Maisonneuve, BQ)

Ms. Francine Manseau

Mr. Réal Ménard

Ms. Francine Manseau

Mr. Réal Ménard

Â

1220

Mr. Glenn Rivard

Mr. Réal Ménard

Ms. Francine Manseau

Mr. Réal Ménard

Ms. Francine Manseau

Mr. Réal Ménard

Ms. Lise Lavoie (Senior Policy Analyst, Special Projects Division, Health Policy and Communications Branch)

Mr. Réal Ménard

Ms. Caroline Weber

Mr. Réal Ménard

Mr. Abbott

The Chair

Mr. Paul Szabo

Â

1225

Ms. Caroline Weber

The Chair

Ms. Caroline Weber

The Chair

Ms. Caroline Weber

Mr. Glenn Rivard

The Chair

Mr. Glenn Rivard

The Chair

Ms. Caroline Weber

Mr. Paul Szabo

Â

1230

Ms. Caroline Weber

Mr. Paul Szabo

Mr. Glenn Rivard

Mr. Paul Szabo

Ms. Caroline Weber

Â

1235

Mr. Paul Szabo

Ms. Francine Manseau

Ms. Caroline Weber

The Chair

Ms. Caroline Weber

The Chair

Mrs. Carol Skelton

Mr. Glenn Rivard

Mrs. Carol Skelton

Mr. Glenn Rivard

Mrs. Carol Skelton

Mr. Glenn Rivard

Mrs. Carol Skelton

Ms. Caroline Weber

Mrs. Carol Skelton

Ms. Caroline Weber

Mrs. Carol Skelton

Mr. Glenn Rivard

Ms. Caroline Weber

Â

1240

Ms. Francine Manseau

Mrs. Carol Skelton

Ms. Caroline Weber

The Chair

Mr. Paul Szabo

Ms. Caroline Weber

Mr. Paul Szabo

Ms. Caroline Weber

Mr. Paul Szabo

Mr. Glenn Rivard

Â

1245

Mr. Paul Szabo

Mr. Glenn Rivard

Mr. Paul Szabo

Mr. Glenn Rivard

The Chair

Mr. Réal Ménard

The Chair

Mr. Rob Merrifield

Mr. Glenn Rivard

Â

1250

Mr. Rob Merrifield

Mr. Glenn Rivard

Mr. Rob Merrifield

Mr. Glenn Rivard

Ms. Caroline Weber

Mr. Rob Merrifield

Ms. Caroline Weber

The Chair

Mr. Réal Ménard

Ms. Caroline Weber

Mr. Réal Ménard

Ms. Caroline Weber

Mr. Réal Ménard

Ms. Caroline Weber

Mr. Réal Ménard

Â

1255

Ms. Lise Lavoie

Mr. Réal Ménard

Ms. Lise Lavoie

Mr. Réal Ménard

Ms. Lise Lavoie

Mr. Réal Ménard

The Chair

---

CANADA

Standing Committee on Health

---

NUMBER 086

l

1st SESSION

l

37th PARLIAMENT

---

EVIDENCE

Tuesday, June 4, 2002

[Recorded by Electronic Apparatus]

  (1205)  

[English]

    The Chair (Ms. Bonnie Brown (Oakville, Lib.)): [Inaudible—Editor]

    Ms. Caroline Weber (Director General, Policy Planning and Priorities Directorate, Department of Health): Thank you, Madam Chair.

    I think we'll just turn to questions. There were only two issues I wanted to go back to, as we reflected on the discussion from last time.

    One was the importance of licences. We're not sure it came across well enough that without a licence, controlled activities under Bill C-56 would be prohibited. The discussion we were having around import and export is a good one to go back to. No one can import gametes without a licence, and the onus would be on the agency to determine the safety of the supply before granting a licence. Without that evidence, a licence would not be issued.

    We also wanted to touch on the transparency provisions associated with the agency. Paragraph 19(a) provides that all ministerial directives and all information associated with licensing would be made public--all licence applications, notices of proceedings, all information provided to the agency with respect to licences and decisions.

    We also just wanted to note that we had been requested to bring forward an analysis of family law and adoption provisions. We have that material, but it's in translation right now, so we'll be bringing it or sending it on Thursday.

    The Chair: You'll recall that Ian Shugart made quite a presentation at the last meeting, and we essentially asked these witnesses to come back to answer questions.

    So we'll move right to questions and begin with Mr. Merrifield.

    Mr. Rob Merrifield (Yellowhead, Canadian Alliance): Thank you for coming back to review the bill with us.

    From your information on importing and exporting, and just to get it straight in my mind, do we import gametes right now, or is it just sperm?

    Ms. Caroline Weber: Absolutely.

    Mr. Rob Merrifield: We do both.

    The Chair: Yes.

    Mr. Rob Merrifield: Just sperm?

    Ms. Francine Manseau (Senior Policy Analyst, Health Policy and Communications Branch, Department of Health): Yes, mainly sperm.

    Mr. Rob Merrifield: Not ovum?

    Mr. Glenn Rivard (Senior Legal Counsel, Department of Justice): There's no prohibition against importing ovum, but because it's not regulated, we don't really know whether it actually happens.

    Mr. Rob Merrifield: So you're saying the identification of that and the criteria behind the importation of it will be prohibited in this bill or--

    Ms. Francine Manseau: Regulated.

    Ms. Caroline Weber: There are prohibitions on commercialization, so I'm not sure of the question.

    Mr. Rob Merrifield: Commercialization means we're not going to be buying or selling any of....

    Ms. Caroline Weber: Correct, and no one--

    Mr. Rob Merrifield: Would they need to meet the same regulations as ours before we'd import them? Would imported sperm or ovum from another country have the same regulatory regime as we would have in Canada? That's my question.

    Ms. Caroline Weber: Yes. The regulations would reflect the legislation that gametes cannot be obtained commercially. You can't purchase their donation.

    Is that what you were asking?

    Mr. Rob Merrifield: That's part of it. We'll probably get into the other part, so I don't know if it's worth going into it right now, on identifying donors and gametes. Right now they're anonymous, right?

    Ms. Caroline Weber: Yes. That's a good point. The same regulations would have to apply that you'd need to have identity attached to them. So that would have a huge impact on what was importable.

    Mr. Rob Merrifield: Exactly.

    Let's get into another area before my time's gone.

    The Chair: You have lots of time.

    Mr. Rob Merrifield: Do I have lots of time today?

    The Chair: Are you going to use five minutes or ten minutes?

    Mr. Rob Merrifield: What if I take ten minutes?

    The Chair: You usually have ten, but if you want to share with Ms. Skelton you can only take five.

    Mr. Rob Merrifield: We're arguing. We just lost a minute.

    Mrs. Carol Skelton (Saskatoon—Rosetown—Biggar, Canadian Alliance): Take ten.

    Mr. Rob Merrifield: Okay.

    On the agency, I asked a question about clause 25 the last time you were here. I think Ian Shugart answered, but we didn't get an answer for why clause 25 was there.

    In it the minister has sweeping control to give direction to the agency, and the agency must comply. Will that be a transparent directive or not? It's certainly not implied there, and it has sweeping controls by the minister to a regulatory body that is supposedly arm's length.

    Ms. Caroline Weber: From a policy perspective, part of the issue is that the minister and the department retain strategic policy development responsibility. If that changes, if in the broader sweep of things the strategic policy direction is changing, then the minister has to be enabled to give that direction to the agency. That's my policy understanding of that.

    I'm going to turn it over to Glenn to comment on the finer legal points of it.

    Mr. Rob Merrifield: Our nervousness comes from the fact that when you have a clause like this, it gives sweeping control, an opportunity for tremendous abuse--potentially. When you're doing law you think of worst-case scenarios, and the worst-case scenario is that this could be an absolutely terrible clause in a piece of legislation, one that could be abused unbelievably.

    Ms. Caroline Weber: Again, I think paragraph 19(a) ensures that this will be transparent, but I'll pass that over to our legal counsel.

    Mr. Glenn Rivard: Under clause 19 the agency is required to make public any policy directions the minister provides under clause 25. These policy directions will be public, and that process will therefore be transparent.

    As to clause 25 itself, it really is a product, if you will, of clause 20, which provides that the minister is the accountable minister for policy in this area and is accountable for the agency. This therefore assures ministerial responsibility in front of Parliament. The reverse side is that the minister needs some power to direct the agency if need be, if the minister is not happy with the direction being taken by the agency. That's the balance that is struck in the bill.

    These sorts of provisions exist in other federal legislation. Typically, they're exercised by exception. In other words, the minister uses this sort of power relatively rarely, only if he or she feels that the agency in question is not acting appropriately. But generally speaking--

    Mr. Rob Merrifield: Excuse me for breaking in. Can you give me a case where the minister might exercise clause 25? What would an agency do that would compel the minister to give this kind of--

    Mr. Glenn Rivard: It's a bit difficult to speculate. For example, if the agency developed a routine where inspections didn't occur often enough--perhaps they decided they would inspect facilities only every four years--the minister might take the view that it was not enough to assure compliance with the act and might direct that the facilities be inspected once a year.

    Mr. Rob Merrifield: Wouldn't that be in regulations?

    Ms. Caroline Weber: Yes, it would. I'm having a very hard time imagining such a case, probably because we're too close to it and we think we've built in all these checks and balances. It's more in the instance where something is shifting dramatically. Because this is such a new area and it is hard to predict exactly where it's going to go, it's just hard....

  (1210)  

    Mr. Rob Merrifield: You see, that's what makes me so nervous about it. When you put this in here, in a bill that is under mandate to be reviewed in three years, it just seems as if it gives sweeping control where that's unnecessary. It makes me very nervous to say we're going to allow this kind of control. I can't think of an instance or a situation where it would apply appropriately.

    Ms. Caroline Weber: Again, I think it's hard to anticipate or imagine right now. I think of it in the context of rapidly changing science, of understanding materials and potential, and of what's necessary and what's not.

    The Chair: That's making it more and more.

    Some hon. members: Oh, oh!

    Ms. Caroline Weber: I see that.

    The Chair: It's a rapidly changing science when, for example, we have prohibited activities in the bill. But Rob, it couldn't be changed by a phone call anyway. There would have to be legislative change to bring in something like approval for therapeutic cloning or something like that.

    Mr. Rob Merrifield: Oh yes, in that case, but just think that clause through.

    The Chair: What are you thinking of? Which change?

    Mr. Rob Merrifield: I can't think of--

    Mr. Paul Szabo (Mississauga South, Lib.): Unless the bill is silent on the issue, in which case it's moot.

    Mr. Rob Merrifield: Yes, that's right. I just can't imagine a place where this clause would apply. I think it's put there as a safeguard. I hope that's the intent. But with a piece of legislation as sensitive as this, with a three-year review, it's an overkill, in my mind. Actually, it is a real sticking point to the piece of legislation, especially if you're wanting an agency that is going to garner the trust of Canadians on very difficult ethical issues such as this. This clause doesn't garner trust and confidence by transparency and openness. That's my concern with the clause.

    Ms. Caroline Weber: Madam Chair, what about equivalency provisions? If an agreement were signed, how would that be translated to the agency? Because the minister has responsibility for this, if the minister approved an equivalency agreement, how would the information be communicated to the agency that they should cease and desist inspections, for example, because the provincial legislation was going to...?

    Mr. Glenn Rivard: I think that more general level of issue wouldn't be an issue because it follows logically from the provisions in the act, but you could see more particular problems arising. For example, even where an equivalency agreement is signed, the act provides that the clinics must still collect the information required under the act and it must flow through to the agency. There may be problems at an operational level in terms of assuring compatibility and a good working relationship between the agency and the province or the clinic involved in that type of scenario. The minister may want to use this sort of authority to direct the agency to operate in a particular fashion, if need be, in order to facilitate the flow of that information. That is possible.

  (1215)  

    Ms. Caroline Weber: Again, we're just touching back to why we did this. We did this because of the minister's strategic policy responsibility in this legislation. In response to your question about whether we can describe the scenario, we're having a hard time again because we think we built it with lots of checks and balances.

    Mr. Rob Merrifield: So if this committee saw this as being a difficult point or a sticking point in the bill, is it a make or break situation?

    Ms. Caroline Weber: I really can't say.

    Mr. Rob Merrifield: If you can't, we're in trouble.

    The Chair: Mr. Ménard.

[Translation]

    Mr. Réal Ménard (Hochelaga—Maisonneuve, BQ): Thank you, Madam Chair.

    What does the bill say about genetic screening tests? According to my information, genetic screening in hospitals might be an infringement of the Patent Act, inasmuch as it requires taking a sample of DNA that should be protected by copyright. Nonetheless, this is widely practiced. This does not concern our committee. The Patent Act must be amended, but this involves the industry committee.

    I want to know whether our bill is expected to make a link with the issue of genetic screening tests?

    That was my first question; I have four questions.

    Ms. Francine Manseau: With regard to genetic screening tests, the bill could perhaps apply in cases like pre-implant genetic testing. Some persons might want to have access to such services because they bear a gene that might cause a serious genetic illness, for instance. I imagine that it would apply especially to that kind of case.

    Regulations would be devised to ensure that the tests are accurate. But I do not see any other situation where this could happen. It would most likely be in more specific cases, for instance when people want to access in vitro fertilization because they carry a gene and they want to ensure that the transferred embryo does not carry the same gene.

    Mr. Réal Ménard: Is Health Canada informed about the fact that three or four private companies might hold a monopoly on detection, genetic testing and pre-implant diagnostics, and that finally this monopoly might make this very expensive for those who want to use it? Have you any information that you could share with the committee about this matter? I know that there is a link with the Patent Act, but this also concerns us to some extent.

    Ms. Francine Manseau: Personally, I do not have that information, but that does not mean that Health Canada does not have it.

    Mr. Réal Ménard: If you ever come across it, I would be very interested in it. Nothing says that the committee may not work on that at some time.

    Now let me put another question. Mr. Rivard gave a very convincing and articulate answer at the last session regarding the fact that if the committee went too far with compulsory disclosure, this would bring us head first into family law and matters that are up to the provinces to legislate. This has shaken the rather interventionist opinion that I held when we began this work. So, as my colleague Ms. Scherrer said, I toned down my enthusiasm somewhat, but if ever, in the bill, there was a provision...

    Is there no legal formula that would allow us to meet the committee's objective, namely to disclose the information to the child in case it might want to get in touch with the donor later on, while ensuring that this does not create any obligations under family law? In your opinion, Mr. Rivard, is there any provision or legal formula that could be included in the bill in order to prevent this, so that the provinces do not have to do this for themselves?

  (1220)  

[English]

    Mr. Glenn Rivard: The short answer is no. We have examined really just how far we can go legitimately under the federal powers in the Constitution and there's no doubt that we really could not address these sorts of issues. I agree that it would make things simpler in this instance, but, nonetheless, it's really not an authority that the federal government has.

[Translation]

    Mr. Réal Ménard: All right. With my second last question, I want to make sure that I have understood things correctly, and I am sure that Mr. Szabo will follow up on my question soon to make sure that the committee has understood this well.

    When someone comes to a fertility clinic to get treated for infertility and undergoes an ovarian stimulation cycle, when three or four ova are engendered by the stimulation, some ova are kept and others could be given to research with enlightened consent.

    Ms. Francine Manseau: These are not ova but embryos.

    Mr. Réal Ménard: These are embryos, excuse me.

    Ms. Francine Manseau: They are about to be created. That is what they are.

    Mr. Réal Ménard: Embryos are about to be created. Let's say there are four of them. Then, one embryo will be used...

    Ms. Lise Lavoie (Senior Policy Analyst, Special Projects Division, Health Policy and Communications Branch): With four ova, they will probably try to create four embryos. Thus, you will have four embryos. Please continue.

    Mr. Réal Ménard: Basically, some of the embryos that are the result of treatment in fertility clinics might be given to research with free, informed and voluntary consent.

[English]

    Ms. Caroline Weber: Just to be very clear here, the ovum and the embryos would have been created for the purposes of reproduction, first and foremost. So in the first instance, the objective is reproduction. And it is only after a determination has been made that they built the family they wanted, or it's not going to work and there are still viable embryos, that the decision is made to consent for other purposes.

[Translation]

    Mr. Réal Ménard: But some embryos are kept frozen. Once the couple has reached its goal and has a child, the embryos that are kept... During a scrum, the minister told a journalist that they would throw those embryos away and this was broadcast on the news. So I would like to ensure that fertility clinics can give embryos to research when there is consent. We agree on that point.

    Ms. Francine Manseau: As Caroline was saying, usually, when embryos are produced, consent is first given for producing extra embryos besides the one the couple needs; usually, these embryos are frozen and kept for later use.

    But when a couple says it does not want to do any more testing, because the procedure has worked or, on the contrary, because it did not work, it has three options: to give the embryos to another couple for reproduction, to give them to research, or to destroy them.

[English]

    The Chair: Thank you, Mr. Ménard.

    Mr. Szabo.

    Mr. Paul Szabo: In the minister's speech at second reading she said, for example, the regulations would require researchers working with embryonic stem cells to obtain a licence from the regulatory authority for each of their respective proposals. They would also need to obtain approval from a reputable ethics board for any project proposal in order to demonstrate that no other source was adequate for their needs. The legislation says that the agency has to satisfy itself that the use is necessary for the purpose of the proposed research.

    I'm not sure what the intent of the legislation is, if it is to have a local REB do the assessment if necessary, because the minister's statement seems to indicate that.

  (1225)  

    Ms. Caroline Weber: As normal procedure in research, researchers take their work to a research ethics board and usually cannot do anything in any institution until they have their approval from a research ethics board.

    The way we handle research ethics boards now is that they are either in policy statements, such as the tri-council policy statement, or they're in regulations, such as Health Canada's regulations for drug approvals. We left the regime that way. The presumption is that research ethics boards will be identified in the regulations or as part of the process of the agency defining what is necessary.

    The Chair: Can you just clarify that? Who is going to make the decision as to what's necessary? Is it somebody in Ottawa?

    Ms. Caroline Weber: It's the agency.

    The Chair: Are they going to be advised by a local ethics board, or is the ethics board an additional process the proposer has to go through to get permission to do it in that institution?

    Ms. Caroline Weber: It would be an additional process. I would anticipate that it would be part of the submission to the agency as they're seeking the licence. In addition to showing their research proposal and a variety of other things, the trail of purpose in the research, they also have to have a certificate, a letter, or whatever the form is from a research ethics board that says this research has been reviewed and approved by a valid research ethics board. It would be part of the submission process and also a condition of approval.

    Mr. Glenn Rivard: If I could, I'll just draw a parallel to the existing good-clinical-trial regulations for drug approvals. Again, the requirement for a research ethics board is a precondition set out in those regulations. There must be an attestation filed with Health Canada that an REB approval has been attained. Health Canada still makes the assessment as to the health and safety issues associated with that clinical trial proposal and can either deny the approval or grant it. The REB approval is simply a precondition, one of many preconditions, that must be met before Health Canada examines and makes its own determination.

    The Chair: You said health and safety is decided at Health Canada. You didn't say it includes ethics.

    Mr. Glenn Rivard: This is under the Food and Drugs Act, and that authority is limited to health and safety.

    The Chair: What Mr. Szabo and I are trying to get at is whether this agency will have the capacity to make the ethical judgment no matter what a local research ethics board says or whether it will be a matter of rubber-stamping it because some university research ethics board has said, “This looks good to us”.

    Ms. Caroline Weber: No. The research ethics boards operate under different policies and guidelines and wouldn't necessarily be paying attention to this act--although they should. The agency would of course have the act as its framework for making that determination.

    Again, as Glenn has said, I anticipate that it will be the agency that reviews the proposal. Research ethics boards in that kind of context usually provide reassurance that the researchers actually have the skills and facilities to do what they're proposing, and by consulting with community representatives, ethicists, etc., they ensure that from their perspective no harm is done.

    It's one more piece of information in the application, but it's not anticipated at all that it will be the answer or even the full determination in any way, shape, or form.

    Mr. Paul Szabo: I'm sorry, but I don't think the issue has been addressed. One of the most significant recommendations in the health committee's report was that there should be a determination that no other non-embryonic source could achieve the same research objectives.

    The minister in her speech said that a reputable ethics board for any project would “demonstrate that no other source would be adequate for their needs”. The minister's statement seems to closely reflect the report of the health committee, but not the legislation. The intent here is crucial. Who is going to make the determination whether there is no other source that would be adequate for their research needs?

    Ms. Caroline Weber: The agency.

    Mr. Paul Szabo: The chair's question was, “Are they going to have the capacity and the knowledge and the tools to be able to make that determination?”

  (1230)  

    Ms. Caroline Weber: Yes, the agency has been adequately resourced. The proposal for the agency is robust.

    Mr. Paul Szabo: Okay. Madam Chair, I know it's taken a little bit of time. I have a couple of other quick....

    I understand both researchers and fertility clinics are going to be licensed.

    Ms. Caroline Weber: Yes.

    Mr. Paul Szabo: In terms of the commercialization implications, a fertility clinic may have surplus embryos, but it will now have this responsibility at first contact to do free and informed consent and full disclosure, etc. I don't know how the relationship between researchers and fertility clinics exists now; I'm going to have to learn more about how they talk to each other. But it would seem to me there is no incentive for fertility clinics to get involved with this substantive legal and administrative process--to be able to carefully transmit stored embryos to researchers--without some sort of cost recovery. I read the bill. It appeared to me there was a possibility that fertility clinics would be able to recover direct costs associated with providing those, but not to make a profit. Is that so? The legislation says they must submit receipts, and I don't know how a fertility clinic submits a receipt for its hydro, its insurance. This could be an administrative nightmare for fertility clinics.

    Mr. Glenn Rivard: On this particular point, subclause 12(1)(b) provides an authority whereby, for example, a clinic could obtain a licence to be reimbursed for an expenditure incurred in the maintenance or transport of an in vitro embryo.

    Several points are key here. Again, a licence is required. Second, it is an expenditure. That means it must be an out-of-pocket expense that has actually been incurred by the clinic, for example, and they can only be reimbursed for that amount. They must also provide a receipt, and lastly, pursuant to clause 65, it can only be the sort of expenditure that has been provided for in the regulations. It's a very tightly controlled regime.

    Mr. Paul Szabo: I suspect this is the last question I'm going to have an opportunity to put. The CIHR guidelines basically said at the point of first contact you have to make the decision, and that means the fertility clinic is going to be the point of first contact with the potential donor and that they will have to go through this process prescribed under the regulations and the legislation. But there is no possibility for them, according to what you just said, to get any recovery for all the work they have to do to get a legal agreement for the donation of their embryos--

    Ms. Caroline Weber: Can I try to break this down a little bit?

    Mr. Paul Szabo: Sure.

    Ms. Caroline Weber: There are lots of relationships here and lots of licences. The clinics need to have a licence just to store the material, etc., but they would not be anticipated to be pursuing a licence for research, which is I think the point you're trying to make: that there is this kind of transfer between the clinic and a clinic somehow getting involved in the research activity, or that whole kind of change of--

    A voice: There would be different licences.

    Ms. Caroline Weber: There would be different licences; okay. There are licences for research separate from licences for operating, separate from licences for importation, so there are lots of licences alluded to here.

    The other thing is I don't see, I guess, what the costs are to the clinic, except that once a family has decided they are through with the services of the clinic, they have to get something in writing from their patients, from their clients, in terms of the disposition of the material and--

  (1235)  

    Mr. Paul Szabo: You can help me out greatly if you could tell me what fertility clinics do today with regard to getting an embryo to a researcher. Do they get paid for providing the embryos to the researcher?

    Ms. Francine Manseau: I think you should be asking a clinic those questions.

    Mr. Paul Szabo: Don't you know?

    Ms. Francine Manseau: What I could say is right now embryos are kept in a freezer. Usually it's the couple who pay a fee to the clinic for the clinic to keep that embryo. It will be very different from one clinic to another.

    Ms. Caroline Weber: That's right. Again, because there's no regulation, we don't know. Some of them may get consent. Some of them maybe don't. We don't know the disposition of all of the material. The other thing is, it's our understanding that there's very little research going on with embryos right now in Canada and that some of it has even been obtained from the United States. It's a small subgroup at this point.

    The Chair: Following up on that one little question, some of these things have puzzled me about the way a fertility clinic works, considering that in Ontario, at least, the doctors cannot charge OHIP. Do you think there might be any way we could get a look at the books of one of these places to see all these kinds of costs and exchanges of money that are taking place? You obviously said you don't know the answer to several questions, so....

    Ms. Caroline Weber: I think we'd have to ask the clinic, and it would be on a voluntary basis since we don't have jurisdiction.

    The other thing we learned last week, because we did visit the Province of Ontario to brief them on this bill, is there are some clinics operating in hospitals where actually the province does provide those services, so it's not even consistent within Ontario.

    The Chair: Thank you.

    Ms. Skelton.

    Mrs. Carol Skelton: I have concerns about the agency you're talking about that is going to be in charge of this. Are you envisioning that this new agency would be patterned along, let's say, a type of Canadian Blood Services agency or directorate?

    Mr. Glenn Rivard: Canadian Blood Services is actually a provincial agency. It's a consortium, if you will, of the provinces.

    Mrs. Carol Skelton: Put together--

    Mr. Glenn Rivard: This is an agency of the federal government.

    Mrs. Carol Skelton: I was under the assumption that the Canadian Blood Services was an arm of the federal government.

    Mr. Glenn Rivard: No, in fact a result of the Krever inquiry is that because the federal government regulates the provision of blood, the provider, if you will, Canadian Blood Services, is arm's length from the federal government. It's a consortium of the service providers, which are the provinces. This agency is akin to Health Canada in the sense that they are both regulatory bodies. It doesn't provide the service. The Canadian Blood Services provides the service of collecting and distributing blood products.

    Mrs. Carol Skelton: On your research ethics boards that are going to be set up, who's going to set these up?

    Ms. Caroline Weber: They're not our research ethics boards. Research ethics boards currently are either associated with institutions or they are done on a for-profit basis. There are companies out there running research ethics boards and supplying that service to institutions. They do this because it's very labour intensive, and, in general, at least within research institutions such as universities, there is a perception of lack of support for the activity. It's committee work. You don't really get rewarded for it and yet it's very time consuming.

    Researchers who have sufficient funds can purchase a research ethics board review, but we would not be setting up research ethics boards, nor does Health Canada do that for drug approvals now.

    Mrs. Carol Skelton: My final question is, why is there no provision for an annual report to Parliament?

    Ms. Caroline Weber: That's not true. There is a provision for an annual report to Parliament, but I'll let Glenn run down the requirements for this agency.

    Mrs. Carol Skelton: Where is it?

    Mr. Glenn Rivard: Again, the agency, being an arm of the federal government, is subject to the Financial Administration Act and reports on the same basis as any department.

    A voice: Do you remember what section it is--

    Ms. Caroline Weber: It is in the bill.

  (1240)  

    Ms. Francine Manseau: It's clause 74. It mentions the Financial Administration Act. One of the requirements is that they provide an annual report.

    Mrs. Carol Skelton: Clause 19 says: “The Agency shall make available for inspection by the public”. What type of inspection were you envisioning?

    Ms. Caroline Weber: This is an information provision clause. In the first instance, we're thinking about a website where much of this information is posted, but there would also be print forms available. So it's a variety of media.

    Mrs. Carol Skelton: Okay, thanks.

    The Chair: Thank you.

    Mr. Szabo.

    Mr. Paul Szabo: If this bill got royal assent today, do you have any idea how long it would take to implement fully?

    Ms. Caroline Weber: We're anticipating about two years to go through all the regulations. We are also anticipating, though, that we could do a number of sets of the regulations. We've been grouping the material that's described here in terms of coherent units. I think we've identified 11 or 12 units. We take a risk management approach to that and go with the things where we think there's the most risk and start with those first. I think we could get through a number of substantial elements in the first year.

    Mr. Paul Szabo: Two years to get all the regulations and everything--the agency set up, all the fertility clinics properly informed about the documentation and all the things they have to do to be fully compliant with the act and the regulations, etc. Two years. That's a long time.

    Given how quickly things happen and that there is privately funded research that can go on until this occurs--and the CIHR said they would suspend or withhold funding until April 2003--has Health Canada considered placing a moratorium or a ban on certain of these activities that are clearly a consensus, simply to ensure that cloning doesn't go on, or genetic alteration, etc.? It makes some sense to me that to do this bill properly, and for you to be able to do all your work, which was going to take two years after royal assent, that's an awfully long time to leave the....

    Ms. Caroline Weber: Partly we're waiting to see what happens here, but upon proclamation, all the prohibitions are immediately in effect.

    Mr. Paul Szabo: Yes, but some of the proclamations, like cloning.... I'm pretty sure there will be a witness who will say the cloning provisions don't cover all types of cloning and stuff like that, because of definitions. But I won't get into that.

    Which act of Parliament do we work with for the concept of free and informed consent? I think the bill referred to somewhere else.

    Mr. Glenn Rivard: I think what you're referring to is the definition of consent in the bill, which says “given in accordance with the applicable law governing consent”. What we're really referring to there is the applicable provincial law.

    What we're trying to do is create a situation where, say, medical doctors who are working in a clinic and are therefore used to obtaining consent under the law of their particular province would apply the same standard. We feel comfortable doing this because our review of provincial law indicates that they all have essentially the same requirements: there must be mental capacity; the person must be fully informed and given the opportunity to consent or not to consent. These are the fundamental requirements. Some provinces may have additional reporting requirements for medical practices.

    In this sense, we can be assured that the fundamental standards will apply throughout Canada. Then those who are practising medicine in a particular province will not have to learn a different set of standards just for this bill. They will be able to apply whatever additional standards may exist in their province.

  (1245)  

    Mr. Paul Szabo: I have the Ottawa fertility clinic information, and it has patient information and a whole bunch of.... It's quite extensive. But if it's provincial, will the legislation, or at least the regulations, give guidance as to the minimum disclosure for donors?

    Mr. Glenn Rivard: Yes.

    What I was referring to was the legal standards, but one of the fundamentals of consent is that it be informed. The regulations, then, will outline what information must be provided at a minimum by the clinic to ensure the patient is fully informed of the consequences before they sign consent.

    Mr. Paul Szabo: I think I have to think about this one a little further.

    This is my last question, Madam Speaker.

    The legislation profile is to provide a list of prohibited activities as opposed to permitted activities. Science is mystical, and things happen that you can never contemplate.

    Should this bill not specifically prohibit something that would defeat the intent, is there any way we can have something like what they have in the Income Tax Act, a general anti-avoidance provision, so that notwithstanding that it's not in there, you're still violating the spirit of what we intended in this legislation, and therefore it should be covered? Or, strategically, should we turn this on its head and say what we should do is be clear and list permitted activities?

    Mr. Glenn Rivard: Essentially, I guess, in a democracy everything is permitted unless the law states otherwise. We don't have a system that works in the opposite fashion. We don't have a system in which people can do only what the law allows them to do. That's at least part of the response on the broadest, most philosophical basis.

    On a somewhat more narrow basis, but certainly consistent with that, this legislation is founded upon the criminal law power of the federal government, and constitutionally, in order to qualify as criminal law, it must consist of prohibitions and associated penalties, which is what we have in this legislation.

    So it's not really possible to take an approach of saying everything is prohibited except the following.

    The Chair: Thank you, Mr. Szabo.

    Mr. Merrifield.

    Mr. Réal Ménard: Excusez-moi, I don't understand why we returned to the Alliance canadienne. Moi, je n'ai pas encore posé de question.

    The Chair: Because Mr. Merrifield asked first and you asked second, and--

    Mr. Réal Ménard: No, no, I asked before.

    The Chair: No, he had his name in well before that, before you nodded.

    Mr. Rob Merrifield: My question--and maybe Mr. Ménard would be interested in this one, because it goes back to the equivalency agreements--is if you have a province or a provincial jurisdiction that has made say a more conservative ruling with regard to what's covered under the act, which one takes precedence? I'm thinking of how in January, Quebec banned embryonic stem cell research.

    That's not true?

    Okay, that's what my understanding was, or maybe their intent was to do that. I'm sure it was reported in January that this was their intent. But double-check that, because I'm sure there's something there.

    Nonetheless, if that were to happen, which would take precedence?

    Mr. Glenn Rivard: The general constitutional principle is called the paramountcy rule. Essentially it says that where a federal law and a provincial law are in conflict, assuming that both are valid laws under the constitutional powers, the federal law will carry the day and will, in effect, override the application of the provincial law.

    What has to be noted, though, is first we have to be talking about two conflicting laws, and each of those laws must be constitutionally valid itself. And the courts have a particular understanding, if you will, of what is meant by a conflict. Essentially, they are saying it's only a conflict if a person cannot conform to one law without breaking the other law. Then you have a conflict and the federal law would predominate.

    However, it is quite possible for both jurisdictions to legislate in the same area. Say the federal government creates a certain set of standards, if the provincial government added to those standards, then the provincial law would remain valid as long as the person could comply with both sets of standards without breaking the federal law.

  (1250)  

    Mr. Rob Merrifield: Yes, that's a really difficult issue, one that depends on which side the provinces go on some of the delicate issues we're talking about.

    Mr. Glenn Rivard: What I would say as a general principle in the context of this bill.... Obviously, through the act and the regulations the federal government will be creating a number of standards and regulations around any given activity such as in vitro fertilization. It remains quite possible for a province to add additional safeguards to that. As long as an individual can comply with those without breaking federal standards, then you don't have a conflict in a constitutional sense.

    Mr. Rob Merrifield: Let's go back to the other one. Suppose the provinces had a ruling and a law in place saying there'd be no embryonic stem cell research and the federal government said there would be. You're saying that this federal law would take precedence.

    Mr. Glenn Rivard: No. In that instance it would be just the opposite because it would be possible for a person to comply with the provincial law without breaking the federal law. The federal law does not say you must allow research. It says that if you do it, you need a licence.

    Ms. Caroline Weber: The point is, it's okay as long as you're not violating any other law. If you're narrowing the scope in this instance, then the provincial law predominates.

    Also, the provinces, just in our limited consultations--only a few came forward--haven't really raised this issue.

    Mr. Rob Merrifield: I'm sure there's something in Quebec, whether it's enacted yet... probably not yet, but I know it was talked about.

    I have another question. When it comes to your definition of human cloning, you're talking about the embryo having the same nuclear DNA, and I think that's the definition we have. But there's a situation where not all of that DNA is there; maybe there's only 97%. I'm a little nervous about that definition of human cloning. Is this a loophole that could be exploited?

    Ms. Caroline Weber: Ontario expressed the same concern on Friday. They are going to give us some other language, and we'll be having a look at that. Yes, it's a good point, one we need to revisit and think about again.

    The Chair: Thank you, Mr. Merrifield.

    Mr. Ménard.

[Translation]

    Mr. Réal Ménard: I would like you to give us a very concrete picture of the entire authorization procedure. You say that the decision is made by the agency. As far as I'm concerned, I thought I had understood that the minister was the one who gave the authorization and that the minister should publicly disclose the authorizations that have been granted.

    During the last meeting, when I asked you the question about whether the minister should publicly disclose authorizations, you told me that that was the case. You should give us a concrete definition of the roles of the agency and of the minister. I would like you to show us a diagram showing the different kinds of authorization, under what conditions they can be obtained, and I would like you tell us concretely what the difference is between the role of the agency and that of the minister.

    You do not have to answer right away, but I want the information before we vote.

[English]

    Ms. Caroline Weber: In a very general sense, the minister is responsible for directing the agency and has responsibility for strategic policy and for the development of regulations within that strategic policy responsibility. The agency is responsible for licensing, inspections, enforcement, education, dissemination of information, maintenance of the registry--

[Translation]

    Mr. Réal Ménard: The minister has nothing to do with the authorizations.

    Ms. Caroline Weber: No.

    Ms. Francine Manseau: No, it is the agency.

    Mr. Réal Ménard: When I asked you this question the last time, you did not give the exact same answer.

[English]

    Ms. Caroline Weber: We'd be happy to provide you with a table laying that out.

[Translation]

    Mr. Réal Ménard: All right. It must be clear.

    Secondly, as we are speaking, considering the ongoing consultations with the Quebec government, do you feel that the Quebec government agrees with this kind of bill?

  (1255)  

    Ms. Lise Lavoie: The Quebec government representatives were completely silent. We did not get any comments from the persons responsible for this in the Quebec government.

    Mr. Réal Ménard: But in the consultations you carried out, were you sufficiently active in approaching Quebec?

    Ms. Lise Lavoie: Yes. Two years ago, we met with representatives of every province and territory, and at the time, the Quebec government representatives told us, and I can quote them, that they could not oppose the prohibitions, and so there was no problem. We had yet to see how the regulations would go, but since then, we have had no official answer from the Quebec government.

    Mr. Réal Ménard: But did you communicate this to all the provinces?

    Ms. Lise Lavoie: Yes. They got the draft bill last year, and at the minister's and deputy minister's level, they got the bill this year. Moreover, at least twice a year, we make a report about the most recent developments to the federal-provincial-territorial advisory committee on health infrastructure.

    Mr. Réal Ménard: Thank you.

[English]

    The Chair: Thank you.

    Seeing no further hands, on your behalf I want to thank the witnesses for coming. I reserve the right to ask them to come again. I think we got into some new areas today, and some of us may have to think a little bit about them.

    Thank you very much.

    The meeting is adjourned.