HEAL Committee Meeting

STANDING COMMITTEE ON HEALTH

COMITÉ PERMANENT DE LA SANTÉ

EVIDENCE

[Recorded by Electronic Apparatus]

Wednesday, September 26, 2001

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[English]

The Chair (Ms. Bonnie Brown (Oakville, Lib.)): I'd like to call this meeting to order, ladies and gentlemen. I apologize for the delay.

To the witnesses, we have a little procedural matter to deal with first. At the end of yesterday's meeting I promised the members that the question left over from that meeting would be dealt with at the beginning of today's meeting.

You will recall that we had a motion to defer from Mr. Dromisky. I declared it to be non-debatable and votable and was trying to call the question when several members of the opposition questioned the validity of that interpretation. Mr. Ménard, who was here yesterday, suggested that he didn't want to accept that unless the clerk could prove to him that's what the book said. Because the clerk didn't have his book, I suggested that we conclude the meeting, ask the clerk to research the issue, and I would present that research to you at the beginning of the meeting, which is what I am going to do.

The clerk of the committee, Gary Sokolyk, has given me a letter signed by him. It says:

As instructed, I have researched the procedural admissibility of a motion to defer/postpone consideration of a question before the Committee.

The pre-eminent authority on Canadian Parliamentary Procedure is House of Commons Procedure and Practice by Robert Marleau and Camille Montpetit. “Beauchesne”, “Bourinot” et al. are now treated as secondary authorities.

The motion in question is called a superseding motion. That is, it is one which is moved for the purpose of replacing the question before the Committee. Marleau and Montpetit, on page 456... state that, among superseding motions, only the motion “that this question be now put” cannot be moved in Committee.

As indicated above, superseding motions take precedence over and set aside the question under debate.

Again, that's page 456.

Among the superseding motions which the Standing Orders permit in Committees are those “to adjourn debate” and “to postpone consideration of the question until a later date”.

Therefore:

A motion to defer debate is votable and non-debatable, and takes precedence over the question under debate.

Are there any questions about that?

Seeing none, I will now ask the clerk to read the motion and I will call the question.

Mr. Rob Merrifield (Yellowhead, Canadian Alliance): Could we have a recorded vote?

The Clerk of the Committee: The motion, as proposed by Mr. Dromisky, was that the debate on the motion be deferred until a later date.

The Chair: Thank you.

Everyone is clear on the motion?

We'll have a recorded vote, Mr. Clerk, please. It's been requested by the opposition.

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(Motion agreed to: yeas 8; nays 6)

The Chair: That motion carries, setting aside the other motion that was before us.

We are now free to proceed with today's agenda, which as you will recall is a carrying forward of our meetings with Health Canada officials. I once again welcome them. We were working our way through questions that needed clarification based upon our first set of witnesses and hearings.

I'm just trying to remember where we were in this document. The document, called “Briefing Notes”, was prepared for us for the meetings of September 18 and 20. We worked our way into this. I think we were on...

Mr. Jeannot Castonguay (Madawaska—Restigouche, Lib.): Item C.

The Chair: Were we finished with “Prohibited Activities”?

Mr. Jeannot Castonguay: Yes.

The Chair: We're moving forward, in the English version, to page 4, item C, “Controlled Activities”. My colleagues will remember that this whole differentiation between prohibited and controlled activities is essential to the structure of the legislation as proposed.

Madam Ferderber, are you going to lead off?

Ms. Rhonda Ferderber (Director, Special Projects Division, Policy, Planning and Priorities Directorate, Health Policy and Communications Branch, Health Canada): I am indeed.

The Chair: Good. If you could begin by trying to answer those questions under section C, that would be helpful to us.

Ms. Rhonda Ferderber: We're pleased to be here to indeed continue the discussions we started last week. However, perhaps I could insert one small note for your consideration. I'm aware that there is a number of continuing concerns around the issues regarding research, particularly chimeras and research involving animals, etc. I wanted to make sure it was understood by you and your committee that Health Canada continues to see that as an issue under active review for us. It's our intention to meet with some scientists further and to bring back that kind of information for your further knowledge, edification, and consideration.

So that's very much an issue on our plate. I know concerns have been expressed by a number of you, and I just wanted to flag that in case it wasn't perfectly clear from testimony of last week.

The Chair: Thank you.

Ms. Rhonda Ferderber: With respect, then, to undertaking today the discussion under “Controlled Activities”, and the balance of the questions, we're certainly prepared to proceed, welcoming any further questions to those that are actually itemized.

As the chair indicated, controlled activities are very much a part of this proposal. Essentially, they are those activities that will be permitted only with a licence. Any licence obviously will set out the terms and conditions as per what the regulations, yet to be developed, would declare are necessary.

You were asking a question around what kinds of activities or criteria we engaged in when we specified what would be prohibited versus this set of controlled activities. Very simply, all the prohibitions are grounded in ethical principle. That was a key criterion in helping us decide what would be on the list of prohibited activities. These are the principles of human dignity and integrity of the human genome, and issues in opposition to the commercialization of reproduction.

Of course, some of the other prohibited activities might also involve safety concerns, such as prohibition around germ-line alteration. Some of the other prohibitions have less health and safety concerns but still very much ethical concerns, such as the purchase of donor gametes. Then there's the prohibition around the 14-day limit, but that one was certainly informed by the existing international standards.

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That takes us to the controlled activities. These are the activities that do involve any number of health concerns. In effect, regulations are there to protect the health and safety of women undergoing treatment and the children born from these. These would be some of the areas we would want to control.

You were also asking if we could give you a fairly significant and substantial list of the activities that will be controlled. I do want to provide the clerk, and will do so in the next day, with a list attempts to provide you with some details on what regulations could be developed, cross-referenced to the sections of the bill. I'm hoping when you see it outlined in that kind of listing that you'll perhaps see how the legislation does indeed give a fair bit of information on those activities that could be controlled. There is a significant amount of information throughout the legislation on this issue. However, it's sometimes hard to pick out when you're reading it. I'm certainly aware of the challenge there.

In addition, I thought it might be helpful if we provided you with a copy of the code of practice the United Kingdon has established, which is from the Human Fertilisation and Embryology Authority, or HFEA. You've probably been hearing a lot about the U.K.'s experience. Their code of practice details in quite some depth various areas that they use and the range and type of activities covered in their code. I think this might help add to your understanding of how regulations will eventually evolve and what they will address.

With respect to what activities would actually be regulated, we're certainly going to have a similar range. They'll involve issues around the use of reproductive materials, in the in vitro fertilization process, with respect to intracytoplasmic sperm injection—ICSI, as it's sometimes called. They'll certainly address collection and storage of gametes, all research involving human embryos, the import and export of gametes and embryos, and licensing of premises and facilities for laboratories. As you can see, quite a wide range of activities will need to have a set of regulations developed around them.

A very important set of regulations would focus on the information needs of persons using assisted human reproduction. As an example, there is going to be within the legislation, and therefore regulation, a call for the collection of information on sperm, egg, and embryo donors, thereby making it possible for children conceived with donated reproductive material to learn the medical history or background of their genetic parents. That's a very important area.

You've heard a lot about the informed consent provisions within the context of the legislation. That's one of the pillars and certainly an area that will have to be quite elaborated on in order to fulfil the requirements of the legislation for a free and informed consent provision.

With those remarks, I was thinking that I will have addressed the essence of your questions in items C(1) and (2).

The Chair: I think you have two more items to do in C before I start with questions.

Ms. Rhonda Ferderber: Okay. I'll ask my colleague, Francine, to address the next two.

The Chair: It may sound weird, but some of our witnesses have suggested that if a couple has a certain number of embryos created, use only three, say, and a few are left, they could actually consent to give them to the clinic. Then the clinic would sort of have ownership and the clinic might consent. That's all very mushy, in our minds.

Ms. Rhonda Ferderber: Francine will... Those are good questions to clarify.

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Ms. Francine Manseau (Senior Policy Analyst, Health Policy and Communications Branch, Special Projects Division, Health Canada): The clinic does not have not the authority over an embryo. The couple for whom the embryo has been created are the only ones who can provide consent to say what's going to happen to that embryo, whether it be provided to another couple for their own reproduction, destroyed, or given for research. Only the couple for whom the embryo has been created can allow that.

Now, the research might not be happening in the fertility clinic. It could be happening somewhere else. But it's going to be clear on the consent that they're allowing that research. In some conversations we've had, people were saying a clinic might have a tendency to put pressure—I don't know whether “pressure” is in fact the right word—to try to create more embryos to maybe then have access to embryos for research. I think regulation would be drafted in such a way to ensure that maybe the people getting the consent from the couple are not the same ones doing the research at the end of the day, so that there be some differences. The couple for whom an embryo has been created are the only ones who can give the authorization or the consent for what happens to that embryo if they don't use it for their own reproduction.

The Chair: In the definitions section, it says that the meaning of “donor” is left to the regulations. Could we have that in the bill instead of in the regulations? That way it would eliminate the clinic, which has a...

Ms. Francine Manseau: If you look at the gamete donors, it's very clear that the person from whom the gametes come provides the consent. We did that for embryos because there could be instances where the embryo has been created from donated gametes.

Let's say a couple goes in for pituitary treatment and they need to have sperm provided by an anonymous donor. What we are saying here is that once an embryo is created, what happens to that embryo is the responsibility of the couple for whom that embryo was created. We're saying that we don't need to go back in this case to the anonymous gamete donor to get his authorization to maybe allow use of that embryo for research purposes.

The rationale behind this is that there was never any intention for the person who donated the sperm to have a role in the life of the future child. So once the sperm has been used to create an embryo, that embryo now belongs to the couple for whom it was created.

You could have instances where an embryo was created in that fashion and the husband died, say. When the embryo was created, usually it would go through the consent process and it would be very clear what would happen to the embryo if one of them died. So if the husband and wife decided they didn't want her to be impregnated by those embryos, and let's say the anonymous donor said, “Look, I'm not sure I want them to be destroyed, and I'd rather have them used by my wife”, then...

So you could get instances where it would be very difficult to try to decide what is going to happen to those. We're saying that somebody who's provided their gametes anonymously for that... I mean, they would be told at the time of donation that they could withdraw their donation if they wanted to—for instance, if they changed their mind and didn't want their sperm to be used any more. However, if an embryo has been created they cannot ask for the destruction of that embryo.

The Chair: So the clinic doesn't come into this at any point. It was one of our witnesses who suggested that. Okay.

Please proceed.

Ms. Francine Manseau: I will move on to item C(4). The issue there was the reimbursement of expenses for sperm or ovum donation or creation of an embryo, or a surrogate mother opens the possibility that such actions could be allowed under licence. You want to have an explanation of some instances where expenses might be permitted under licence, and why.

I think the regulations would be drafted in such a way as to maybe allow some form of expenses. It was highly criticized when we had Bill C-47, I guess, when we said there shouldn't be any buying and selling of sperm, not even reimbursement of expenses.

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People were saying, well, we might get to a point where nobody will be donating sperm, and we should allow some form of payment of expenses. So we said we could allow some. However, I think the intent is that expenses that would be allowed would not be of a magnitude that could be sufficient enough to have an incentive for people to donate, but costs and expenses could be detailed legislatively. But certainly the intent is not to make it a financial inducement for somebody to be giving a gamete.

The Chair: Okay.

We've finished one section, ladies and gentlemen. I think we'll have questions on that section. It doesn't mean everybody has to ask one, but before we move on I'd like to give you the opportunity.

Mr. Manning, please.

Mr. Preston Manning (Calgary Southwest, Canadian Alliance): I'd like to raise the question of urgency. As you well know, it's been ten years since the royal commission. It's been five years since the last legislative attempt. We just defeated a motion to speed things up, so urgency is on my mind.

Of these activities to be regulated, are there some, in the opinion of the department, of high or immediate urgency either because there are people out there doing it now and there's no supervision or because they impose greater health risks? In your list of regulated activities, can you say anything about whether there are some in your judgment that simply have to be attended to because of their importance? Can you say something about the priorities in that sense?

Ms. Rhonda Ferderber: I'll certainly try to address it. We haven't listed or prioritized with respect to the list I'm going to be sharing with you, so when you see the list, don't think of it as necessarily a prioritized list, if you would. Certainly on any given day that list shifts in our minds, given what science presents us with and how things do evolve with respect to the activities. At the moment, we have not had any significant sense of a need to prioritize; rather, we're just continuing to work away on what we call that initial phase of regulatory development.

As you might be aware, the development of regulations in Canada, through our processes, is quite involved. It does involve a fair amount of public consultation and scrutiny wherein the experts, the provinces, the territories, researchers in this case, and the scientists need to and can be involved. That's going to be very important for us in the final phases of the regulatory development procedures.

During the work we're doing now, and will continue to do, we're certainly doing that kind of issue definition, if I may call it that, with this need in mind—that is, which ones might get ready first. The information collection we've undertaken has involved speaking with a lot of stakeholders. Our most recent round of consultations asked them just that question: What would be some of the areas you would want regulations to be developed on, and can you give us a sense of the priority of where you would start?

I would say that the concerns depended on the constituency with which you were speaking. If it was the infertility community, they were certainly concerned about ensuring access to quality information. From their point of view, then, it was ensuring that there was the right consent forms and asking for the right information to be developed as soon as possible.

If you were talking with persons born of assisted human reproduction, they were very concerned about a high degree of openness being there so that they might get the necessary information about their genetic parent.

Provinces and territories have expressed general concerns about overlapping pieces of legislation. They would want to be involved in the development of regulations in areas where they see their areas of jurisdiction if not overlapping, then, as we say, bumping up against each other.

So a very large and wide range of stakeholders have been assisting us to this point. We continue to work with them in trying to move the process along. The formal process of regulatory development is not anticipated to begin in true form until the legislation is finalized, obviously. Once that happens, and through the groundwork we've undertaken, we hope we can move quite quickly and have regulations put into place quite quickly. It will require cooperation and collaboration by everyone so that we can indeed move quickly.

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Mr. Preston Manning: I have a second question. Presumably, control and regulation can range all the way from actually still prohibiting the activity by denying the application for a licence all the way through very restricted permission, subject to a whole bunch of conditions, all the way over to virtually “Go ahead and do what you like”. I wonder if the bill, in your judgment, doesn't make that clear.

I think when people see the term “controlled activity”, they almost automatically assume that means they're going to permit it, when really that's not the case. I mean, a regulatory body could consistently deny applications for licences for that type of activity.

I wonder if in your judgment—and this may be more in Glenn's department—the fact that control can range all the way from prohibitions and moratoriums to almost unlimited permission ought to be spelled out more clearly in the statute.

Mr. Glenn Rivard (Counsel, Legal Services, Department of Justice Canada): Actually, that point is addressed in clause 40, which sets out the authority to regulate. Paragraph 40(1)(a) indicates that you can designate classes of controlled activities that can be authorized and classes of controlled activities that may not be authorized. So it is possible to actually go so far as to indicate that you will not license a particular activity if it raises concerns—for instance, there is a health risk inherently associated with a particular practice, so it won't be authorized.

Mr. Preston Manning: So the regulatory body could itself bring forward prohibitions under that clause?

Mr. Glenn Rivard: It could indicate that it will not authorize a particular type of procedure, that's correct.

Mr. Preston Manning: Thank you.

The Chair: Mr. Merrifield.

Mr. Rob Merrifield: Getting back to some of the prohibitions, some are sort of foggy. In Canada today is there any stem cell research on embryos being worked on at all, to your knowledge?

Ms. Rhonda Ferderber: To our knowledge there's very little. I know that CIHR is busy discussing that very matter with a lot of scientists, etc. As you might be aware, they are putting together a set of guidelines around federal funding for research involving stem cells generally. Obviously the key issue for us is embryonic stem cells.

So we're very much in collaboration with them on the development of those research guidelines. It's going to be very helpful for the researchers to have those. Our indications are that they've been hanging back, knowing that this legislation was coming forward, and that the federal funding for such research was going to have guidelines associated with it, and very soon. I certainly know the CIHR is hoping to have those made available this fall and to clarify the field of activity that way.

Mr. Rob Merrifield: So what you're saying is, you're not really sure. You said to your knowledge, “very little”, which means there's some.

Ms. Rhonda Ferderber: It could mean some. I hate to be so definitive to say no, but we haven't any indication.

The Chair: Just as a follow-up to that, is it not a bit presumptive of them to be issuing guidelines when our bill isn't ready?

Ms. Rhonda Ferderber: They've asked us about this, Madam Chair. This work had obviously been begun in terms of activities and responsibilities they have around any federal funding of research using human subjects. In existence there's already the tri-council policy statement. So there are these issues before them as a federal funding agency that they wanted to pursue. They are discussing the issue with the minister with respect to timing for the release of those guidelines.

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At the moment, however, I think it's well understood that they're guidelines only. They're guidelines subject to change and certainly dependent on whatever the ambit and scope of this legislation would require.

Mr. Preston Manning: Madam Chair, I'd like to comment on that.

I've been around to a fair number of these labs, and they would say they're not being presumptive; they'd say they've been waiting for years and years for these regulations. They have not come from where they should have come. That's why they have to go ahead on their own. It is I think connected to this urgency question.

The Chair: I think whoever is taking the minutes has heard your point twice now about how slow everything is, Mr. Manning. We'd have to be pretty thick not to hear it.

Mr. Merrifield, continue, please.

Mr. Rob Merrifield: Actually, I could help him on that.

Voices: Oh, oh!

Mr. Rob Merrifield: You know, we make light of it, but it is a serious matter. It is something we really need to consider.

There's another question I have when we're talking about the expenses and reimbursement for sperm donation or eggs or embryos. It just throws all kinds of flags up for me. You start out thinking it's only rational, only common sense, to sit there and think that somebody who perhaps can do something should be reimbursed somewhat, but is it not a slippery slope when you don't have it much more locked down as to what you really intend? I mean, expenses could mean such a wide range.

Ms. Rhonda Ferderber: Certainly I won't disagree with that comment. Maybe it's one of those urgent areas for regulations development. We're certainly looking at it from the point of view of establishing reasonable limits on whatever expenses so that any reimbursement of any amount is not going to be sufficient enough to be an inducement, and there's no financial profit gained from this activity.

A reasonable expense could be something like parking costs related to coming to give the donation. The donation isn't a one-time thing in the case of a sperm donor. It does involve a commitment of time and effort. So that could be an example of what we would suggest might be a reasonable expense, with a limit set on that as defined in the regulations.

We want to make sure that we are very observant of our key priority and key principle of non-commercialization of the area. We're very conscious of that.

Mr. Rob Merrifield: It's just that reasonable to you, reasonable to me, and reasonable to the donor could be three different things.

Ms. Rhonda Ferderber: Yes.

The Chair: Mr. Lunney.

Mr. James Lunney (Nanaimo—Alberni, Canadian Alliance): Thank you, Madam Chair.

I'd like to pick up on Mr. Merrifield's question on the dollars for gametes and surrogacy. We had witnesses here at our last meeting, yesterday, discussing the surrogacy issue. Interestingly enough, on the question of expenses, Ms. Levitan, the lawyer who was speaking in favour of surrogacy, said that their suggestion was a cap of about $5,000 a month for expenses. Over a ten-month period it would be about $50,000.

The question that I think has to be asked is, are we encouraging creation of a career of child production for women? Might she continue this way at $50,000 a year, with a couple of months' rest in between, until she's ready to retire her body from production? Unless we are very careful in defining these things, I think the intention is clear from those already advancing the industry that this is the way they're thinking.

Do you have any comment on that? That's the first question.

Mr. Rhonda Ferderber: I'm certainly aware of that thinking. I also feel very strongly that we're going to need to be extremely prudent as we establish those reasonable limits.

In the case of surrogacy, if I may, when we think of what kinds of expenses might be there for a surrogate mother, we're talking about costs perhaps incurred by her as she seeks to make her decision. If she's seeking some counselling advice or some legal advice, one would want to see that made available to that person so that the best-informed decision is made for her, and for what she is going to eventually deliver, a child.

So it's that kind of thinking that has us suggesting that if you are going to move in the direction of the provision of reasonable expenses for someone offering to donate sperm, for instance, then a surrogate mother from an altruistic surrogacy base could perhaps also be in receipt of expenses in that kind of limited fashion. There might be expenses a surrogate mother would incur if her provincial health care plan didn't cover them. We'd have to see what those might be.

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I was apprised yesterday of the thinking around the $2,500 a month, that's not been at all where we're at.

Mr. James Lunney: Perhaps that will need to be nailed down a little more as we proceed.

The other comment that came out in the same direction was that perhaps this type of surrogacy would be cutting into, or perhaps even taking over, the market for adoption. Parents would be going this way rather than choosing to adopt a child already looking for parents. They would be looking to produce one with somebody else's help that would have at least some of their gametes there.

There are serious implications here, and perhaps you would like to comment on that. Is that something Health Canada has considered?

Ms. Rhonda Ferderber: We've certainly been looking at the experience of adoption. Of course, that exists right now for everyone. The option of whether we have a surrogate mother or go the adoption route has existed for a long time for parents. At this stage the incidence of surrogacy in Canada is I believe quite low in comparison with, say, the U.S.A., where we're aware that it's quite high.

These are decisions being taken by very responsible individuals. I'm not really able to speak for what decisions individuals will make. But I don't think the inducement factor of reasonable limits on certain expenses is going to create a problem in terms of whether or not there is adoption pursuit. There are issues around why people choose surrogacy over adoption that are probably less related to expenses and more related to their other personal views and concerns.

Mr. James Lunney: I have just one last question.

The Chair: Quickly.

Mr. James Lunney: My question goes back to a comment made earlier about the import and export of embryos and gametes. I just wonder why we feel this language should even be necessary. That we would have to import or export gametes or embryos certainly sounds like commodification.

Could you comment on that?

Ms. Rhonda Ferderber: Glenn, I would invite you to respond.

Mr. Glenn Rivard: Currently, for example, sperm is imported from the United States for reproductive purposes. The reality is that it may be the case that gametes or embryos will cross the border. What this does is it gives some authority to control that and to assure that, say, imported sperm meets the same health and safety standards that would be applied to sperm collected in Canada.

Mr. James Lunney: Could somebody speculate as to why we would need or want to import sperm? Is there some indication that we have a lack in Canada?

Mr. Glenn Rivard: I don't know all that's behind it, but there is insufficient donation of sperm in Canada to meet the demand. I suspect there's greater reimbursement in the United States. It's also the case that sperm is already regulated under the Food and Drugs Act. In the last year or so some of the clinics have had difficulty meeting the safety standards imposed by Health Canada. Those are imposed to ensure that sperm does not become a means for transmitting disease. These things have contributed to a lack of sperm, at least in relation to the demand for it.

The Chair: Thank you.

Mr. Dromisky.

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

I'd like to go back a little bit to the whole area of surveillance and control of the research being done in this whole area. I could understand, when there's a research project being supported by federal grants and funds and probably other resources, that there would be controls imposed upon the type of research taking place. However, let's take a look at the private sector.

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Is there anything at the present time to give us some indication of the kind of research being done in this area in the private sector, in private labs? As well, in the private sector, within this area of assisted human reproduction, do they have any kind of controls or guidelines where they have to report to someone of authority about the type of research they're doing in this area?

Ms. Rhonda Ferderber: I'll start and then invite my colleague to add any comments.

Expressly with respect to research in the private sector, we have in Canada, obviously, research ethics boards that operate. They can operate out of universities, etc. But insofar as federal funding of that research, they have strict guidelines to be met through the tri-council policy statement that exists and that is trying to be developed further to meet the growing demands of today and the nature of the research. That is why the Canadian institutes of health research are pursuing their guidelines at this time.

So the private sector in Canada, in terms of research, is expected to be guided by these guidelines, but they're not going to be as bound by them as any set of researchers who would have received federal funds.

Mr. Stan Dromisky: Yes, I understand that, but do they have to report to anyone?

Ms. Rhonda Ferderber: Not really.

Mr. Stan Dromisky: Not really. They can go ahead secretly with their research.

Ms. Rhonda Ferderber: Yes.

Mr. Stan Dromisky: Okay.

Thank you.

The Chair: Madame Picard.

[Translation]

Ms. Pauline Picard (Drummond, BQ): I would like to come back to the issue of surplus embryos.

There will be informed consent by donors for these surplus embryos to be used for research purposes, if I understood correctly. I also understood that there will regulations governing this type of research. An authorization will be required.

Will there be an oversight committee or a committee on bioethics to supervise this type of research? What type of focus will it have? Will this type of research have a particular focus? Will it be mainly to treat infertility, for example, or—and you may find this question a little convoluted—will we be getting around the problem and developing techniques that will result in the creation of children? I would like to know how you think the use of surplus embryos for research purposes will be handled.

Ms. Francine Manseau: That is a good question. Research on surplus embryos will be a controlled activity. There will be regulations on it. For example, in England, they set out the reasons justifying research using embryos. For example, they may be trying to understand better the reasons for infertility, and what happens when the embryo is created, when it attaches itself to a woman's uterus, and so on. So the idea is to decide what type of research could be done.

We expect to have the same type of regulations in Canada. That means that individuals wishing to have authorization to do this type of work will have to explain what they intend to do with these embryos, and this will have to correspond to some of the reasons for which we are prepared to authorize research using embryos. One of the conditions could also be that the research proposal be approved by an ethics committee even before the request of authorization is reviewed. We will also have to make sure the people whose gametes were used to create the embryo have given their consent, and so on.

Ms. Pauline Picard: Thank you, I have one other question.

Ms. Ferderber, I would like to come back to the question Mr. Manning asked you earlier. I did not really agree with your answer.

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With respect to the prohibited procedures mentioned in the draft bill, you seem to say that there was some controversy about this, with some people being in favour, and others against. Consultations we have had since the Baird Commission have shown 85 per cent of people are opposed to the prohibited procedures mentioned in the draft bill. Health Canada is also opposed to these procedures, as are the officials who wrote the draft legislation. The government and the minister are opposed to these procedures as well. UNESCO and the Council of Europe have taken a stand on this as well. Even President Bush did so quite recently.

We may not get the bill until two years from now. Do you not think that we have a dangerous legal vacuum at the moment?

Ms. Rhonda Ferderber: I would like to start by saying that I did not intend to say that there was a controversy or that some people do not necessarily agree with everything I say. I would like to mention that during our consultations, there was a certain consensus about this list of prohibited procedures. When we held our consultations about controlled activities and regulations, we got different views about the most important issues and what we could do to determine them.

This is the type of discussion we held with the stakeholders involved. There is not that much controversy, but everything depends on their interests, their issues and their place within the stakeholder community. Researchers have their views and others do as well.

I certainly agree that the regulations must be drafted as quickly as possible, but this must be done in consultation with the appropriate experts.

Ms. Pauline Picard: Thank you very much.

[English]

The Chair: Thank you, Madame Picard.

Ms. Wasylycia-Leis.

Ms. Judy Wasylycia-Leis (Winnipeg North Centre, NDP): I have a couple of questions as well on the issue of expenses.

What is now the law and/or the practice with respect to expenses for such other life-giving donations as blood or organs? Is there a legal precedent now, through law? Is this draft bill consistent with that? And how do we generally handle the shortages for life-giving donations?

Mr. Glenn Rivard: These are matters regulated by provincial law. They all adopt a similar approach, that there is no payment for these sorts of things. If you donate blood, for example, there is no payment for that.

There is authority under provincial law to reimburse an expectant mother who is intending to give up her child for adoption for the expenses directly associated with that pregnancy. To the extent that this is a valid comparison with the surrogacy arrangement, that's the one exception, if you will.

Ms. Judy Wasylycia-Leis: Is it a valid comparison to talk about expenses for donations of blood and organs and expenses for donations of sperm or eggs, or surrogacy? I don't know; I'm asking; I'm searching.

Ms. Rhonda Ferderber: I guess I'd observe that insofar as our traditions have been, or what we in our society have been proceeding with, it's on the basis of donation—meaning just that. We're trying to keep that in mind and be consistent with that established practice. But it's a point worthy of further consideration.

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Ms. Judy Wasylycia-Leis: I guess we're trying to figure out, given what we heard from witnesses yesterday and from other witnesses, whether or not it wouldn't make sense to not have in any legislation this section on allowing for expenses. Because it can be interpreted widely, and could be the slippery slope that leads to commercialization.

One witness we had yesterday, Phyllis Creighton, was very strong about this. She just felt that the minute you allow for expenses—actually, it's called a “weasel” word—it lets in the back door something to which you said no at the front door. Is there some legitimacy to that argument? And why is it here?

Ms. Rhonda Ferderber: I guess I would just repeat what I was saying earlier around what it is our hope to do by way of legitimacy in terms of the regulations—that is, for expenses to be very precise; not to be too weaselly about it in the regulations; and to establish those limits and sets of activities for which expenses could be paid. Then we're going to have to expect, obviously, that enforcement requirements will be played out, and avoid the issue of people thinking that it is an inducement. That is going to be a factor for us.

The Chair: Thank you, Ms. Wasylycia-Leis.

Before we leave this item I have one question.

You alluded to the fact that in an earlier bill the whole idea of compensation was not there. As Mrs. Wasylycia-Leis has so well pointed out, it is our tradition in Canada not to have compensation for donations, even in life-threatening circumstances. Being childless is not life-threatening.

You can probably tell from the questions that most of us were heavily impressed by what we heard yesterday. So I want you to tell me what it is about those... Who was objecting to no compensation when it was no compensation in Bill C-47, and what made you change your mind in drafting this?

Ms. Rhonda Ferderber: I'll go to my colleague, who was here at the time of Bill C-47. Before I do, I would just add that, as you know, we of course work very closely with Ms. Creighton, and we are very interested in what she brings to the debate and the dialogue. It is certainly something we are closely reflecting on.

The Chair: May I clarify that it was not so much Ms. Creighton who made the big impact as the other side of the argument.

Ms. Rhonda Ferderber: Okay. I appreciate the clarification.

Ms. Francine Manseau: At the time of Bill C-47 I would say the discussion was much more focused on sperm donation. The critics came from the medical profession and from patients who certainly feared the thought that there would not be any donors. That certainly came through very clearly.

Sperm donation has been around for years and years, easily forty or fifty years. It's been an entrenched practice to provide payments for that. I think trying to move that system will take a period of adaptation, even by doing more counselling and having men realize what is going on.

Certainly at the time the critics were very vocal, saying, well, basically there won't be any. That certainly came from the medical profession a lot. Their patients were saying, well, we don't want that to happen, because then our chances of having a child will be completely... But I think this was said without any testing to show whether or not that would be the case. Some countries were able to move from a payment system to a non-payment system with some success, and we are aware of it.

So I think there will be a period when we'll need to change completely the way the system has been working. Maybe time would permit us to do that. Maybe at some point we won't have to be paying expenses—maybe.

So I think the pressure was coming from there. A lot of countries also are saying they are not paying for sperm donation. I think England is an example. There would be others. They do reimburse expenses but it's very low. Very often it's an amount that is capped. It's very low.

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The Chair: I find it difficult to imagine the expenses associated with sperm donation, unless it's bus fare. From what we heard yesterday, it's very easy to create expenses.

Ms. Francine Manseau: I think sperm donation, if you want to compare it with blood donation, is different in the sense that most of the time blood clinics will come to your workplace, or very close to it. In sperm donation I gather the commitment is that you go almost every week, or maybe even more than that. You need to be tested. You need the right blood, first of all, and then for your donation, I gather you have to go for a certain amount of time every week, maybe for a month or so, and maybe twice a week.

So I think the demands on you when you do donate semen could be different, but that doesn't necessarily mean you need to be paid because you're doing it. I'm just saying they are different.

Take egg donation, for instance, and just the drugs that have to be taken while the woman is hyperstimulated. Unless you have some kind of prescription plan that would cover that—and a lot of people in Canada don't have that—there could be expenses incurred by an egg donor that would have to be looked at. If the person doesn't have a drug plan, then I don't know what they'd do.

The Chair: I find it interesting that we are trying to make sure that babies do not become commodities, but we're talking about payment for supposedly altruistic donations. We're talking about importing and exporting. The word “trade” is used in the bill. So it seems to me we haven't yet decided. We're talking out of both sides of our mouths here.

That's just a little editorial comment from the chair. Pardon me. Let's move on to the next section.

Mr. Rob Merrifield: Well said, Madam Chair. It's only Canadian dollars, but...

Ms. Rhonda Ferderber: The next question involves administration. You have several questions under that particular item. The first one looks at just the issues of licensing—how licensing responds to the clinical trials, just who gets a licence, etc.

You were explicitly asking us whether we have any indication of the number of clinical trials under way or the number of owners and operators of facilities. As to the clinical trials question, we have no specific indication of the numbers that might be out there. However, with respect to the number of facilities, our indications from the work we've been doing with the Canadian Fertility and Andrology Society are that there are 20 to 25 actual IVF centres in Canada and probably about 100 other types of facilities that would store, for instance, gametes or embryos.

But even as we speak, we're undertaking a profile exercise just to get a better sense of the extent of the assisted human reproductive sector, if I can use that term. We certainly are going to be investigating, with the Canadian Fertility and Andrology Society and others, the nature of that sector. It's our intention to share this information back with you.

There are some questions you posed earlier, and arising from those questions we are undertaking to look at this sector. We had done some work, but it needs to be updated now, so this is a good time to pursue that.

In one of your questions here you ask “In the case of a clinical trial involving several researchers, to whom is the licence issued?” For us, if that's the scenario, this is something that would be stipulated in the regulations. It could be stipulated as to whether one licence were to be granted—for example, maybe to the lead researcher—or whether there would be multiple licences for everyone involved. There could also be a requirement for a particular person or persons who would be responsible, if you like, for that compliance with the act and all that is required of that licence.

Your next question involves proposals for licensing directly, involvement of the minister, and what kind of support. We took that question to mean you were speaking to what kind of authority might be established, etc. Certainly that's one of our major questions in terms of just what kind of regulatory body or regulatory entity would be created.

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Again, depending on which way we go, if it's external to the department body or internal, we certainly do see this task around licensing as one that'll have to be quite well licensed to support it. So the answer there is that certainly within the context of whatever the regulatory body, it would be a function lodged there, and hopefully properly resourced.

Glenn, do you want to proceed with the next couple of questions?

Mr. Glenn Rivard: The next question pertains to clause 15. In particular, why is subclause 15(3), which deals with the privacy aspect, in here instead of in the subsequent clauses that deal with privacy in general? The short answer is that the subclause addresses an issue raised by the procedure set out in subclause 15(1), so it's simpler and clearer, we believe, to deal with it all in clause 15.

Just to expand on that a bit, clause 15 deals with the process for licensing and the hearing and consideration of the application for the licence. It makes it clear that the minister has authority to take into account a wide range of information that might pertain to that application, and from a wide range of people.

In the interests of open government, subclause 15(2) makes it express that this information as a general rule should be made available to the applicants and to the general public, but we recognize that some of that information may be personal and should be protected for privacy. At the same time, there may be a competing need to make it available at least to the applicant so the applicant understands the considerations that the minister is taking into account.

Subclause 15(3) basically allows the minister to balance those competing interests and determine whether that personal information should be released to the applicant if it is necessary to support the application.

Again, then, it just seems clearer to put that authority, and to balance those concerns, right in the clause, because it really goes to the process set out in the first subclause.

The next question, D(3), deals with clause 16. This creates an extraordinary or emergency power for the minister to act quickly to prevent the occurrence of dangers to human health or the environment, etc. Under this the minister can authorize an inspector to enter premises and to assume the management of the clinic or whatever.

The question particularly addressed what sorts of dangers are envisaged to be dealt with. I should make it clear that, again, this is seen as fairly extraordinary. In the normal course of events, the normal inspection and the conditions one attaches to a licence should be sufficient to regulate. So this is seen as a power that would be unusual to be invoked, but nonetheless one that needs to be there.

We can think of just a few examples where the minister had reason to believe, for example, that a laboratory was going to create embryos for research purposes, contrary to the prohibition; or where swift action had to be taken to prevent a possible attempt to clone a human being; or even—just a little more on the mundane side—simply where there were reasons to believe that untested or improperly tested semen was going to be used to create embryos that in turn would then be implanted and become a vehicle for the transmission of disease.

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It may be necessary in some instances to go this far to assume the control of the clinic to determine if that's the case or to actually prevent that from occurring. Again, this is seen as an unusual set of circumstances, but it was felt desirable to have the authority there.

The Chair: Okay. We're on item D(4) now.

Ms. Rhonda Ferderber: You're asking whether Health Canada has any evidence as to how we might work with NGOs in standards development, etc. Quite recently, actually, we had a working group made up of a number of representatives external to government. They came from medical associations. We had a consumer group from the Infertility Awareness Association, we had the Canadian Council on Health Services Accreditation, and the Canadian Standards Association as part of this working group.

That working group was asked to work with us to develop a set of potential regulatory frameworks, or models, if you like, for assisted human reproduction. We certainly found the discussions on all sides and the learning from that kind of an approach to be extremely helpful to all the stakeholders present, including us. So we certainly have worked on in the past, and would see us continuing with, this particular clause in the bill as giving us a very good opportunity to work with the experts and the stakeholders involved.

By the way, that report from the external working group has already been made available to you. It's perhaps more in line with your interest in understanding better what the regulatory body might look like, but it does give evidence as to how working with non-governmental associations and organizations can work to give us a very useful piece of work.

As to whether or not the procession is more rapid, or indeed requiring of less change, certainly that might be the case. It probably would be a less-involved manner than some of the formal processes we have, as I described earlier. However, certainly our approach to regulations development and standards is one that's very pragmatic right now. We're not looking to invent anything, or to reinvent anything. Rather, if standards are already in place with professional associations, we believe these could be referenced in terms of the regulations as long as we can satisfy the requirements of the Governor in Council that these standards or guidelines meet the objectives of the legislation.

We've been mentioning the regulations on semen. Well, that logic would dictate that this is a set of regulations, obviously, that could come under the guise of this legislation and not remain in the Food and Drugs Act.

So certainly the oversight and preparation of any of these types of standards or regulations is necessarily better informed, I think, and better as a result, through the use of that kind of expertise outside our own walls.

The Chair: Okay. We've had section E covered by our witnesses. Are there any questions on it?

Mr. Manning.

Mr. Preston Manning: I wonder if you could tell us a little bit about a story I would like to relate concerning sperm importation that may have relevance for future regulation. This story came to mind when my colleague raised a question on the importing of sperm.

I visited one fertility clinic, and the story they told—I'm not sure I got it 100% straight, which is why I'm asking you—is that Health Canada had regulations on the handling of sperm, one of the first regulations for human reproductive material, with regard to fertilization clinics. Those regulations were not being followed very rigorously, and somebody blew the whistle on that. I think it was someone in Hamilton or someone connected with McMaster. I can't remember the facility.

This brought into question the safety and health of the sperm in fertility clinics. It's sort of like the tainted blood scam in that this might be passing on infectious diseases.

Health Canada then came back with some very rigorous criteria that sperm had to meet, but this particular clinic said the expenses and so on that they would have had to incur to meet those criteria made it easier for them to import sperm from other countries, including the United States, that met the criteria.

• 1650

That story disturbed me. In this particular clinic, it created a great deal of skepticism about Health Canada's capacity to regulate. They said they had a chance to regulate human reproductive material, and it was a big mess. As a result, it's easier for them to meet the criteria by importing sperm.

I may not have gotten that story straight, but I'm just wondering, is there a story about the sperm regulation, and are there lessons out of that experience, whatever it was, that are instructive for us now in trying to regulate human reproductive materials much more broadly?

Ms. Rhonda Ferderber: I'll jump in here. Glenn may have other points to add, because he did mention this very issue of the fact that we have recently updated, if you like, and revised the regulations on—

Mr. Preston Manning: A little more dispassionately than this group that was explaining this to me.

Ms. Rhonda Ferderber: He did indeed.

It was a very major exercise. Of course, it had quite a definitive impact on clinics insofar as much of their semen was put into quarantine for quite a long time, pending the new regulations and their availability. So this did cause a fair amount of consternation on several levels. Certainly the story you tell, where I can't confirm all parts of it... We certainly have had to look again at what kinds of health and safety regulations we need to make sure are explicitly and very clearly spelled out.

We've also had to beef up around issues of inspection and enforcement in this area. That, I guess, is one of the very key learning areas we take from this. Our colleagues at Health Canada who are responsible in this area are very quick to offer us... We do speak with them frequently as part of the work we do around just what kinds of learning and what we take from that as we undertake to develop our own approaches. So there has been a fair amount of learning from this whole exercise.

Glenn, anything further?

Mr. Glenn Rivard: I guess I would just add—

The Chair: More passion, Glenn.

Voices: Oh, oh!

Mr. Glenn Rivard: I would add just two points. First, whether it's blood or organs or semen or whatever, there is always a cost associated with establishing and enforcing health standards. If you want to protect the health and safety of the individuals involved, those costs can't really be avoided.

Second, the semen regulations—and Rhonda has indicated the same with respect to the regulations under this proposed legislation—are developed or will be developed in conjunction with the specialists and the medical profession. Semen regulations are not invented out of the blue. There were extensive consultations with the professions involved. They helped to set the standard that met the prevailing scientific standard for safety of the semen used for this purpose.

Mr. Preston Manning: My second question really gets into this area of cost. As you well know, the history of regulation in other fields—the one I'm most familiar with is energy—is that when you get regulating something, there's a cost to it, quite a huge cost. In the public utility field at one time, the cost of regulating electricity prices, the regulatory burden, was getting up to 5%, 10%, and 15% of the cost of the energy, so this is not insignificant.

In the regulation and administration we're talking about here, how do you envision that cost to be borne? Normally the cost can be borne by either the applicant or the user. Often the applicant bearing it passes it on to the user. I could see that being done in the case of fertility clinics.

Do you envision the cost being borne by the applicant, the user, or the taxpayer? Has some thought been given to the size of the cost and who would carry it?

Ms. Rhonda Ferderber: I think that certainly is going to start to emerge in this exercise where we're profiling the sector. We're just getting down to doing that. That is one of the areas we want to explore, Mr. Manning, although we may not get at all aspects of this particular question.

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We are all too keenly aware that any regulatory body is going to take a set of funds. Those funds at this point are anybody's guess, pending the actual form and function that regulatory body would have to have to operate appropriately. We do take guidance in terms of what we already know by way of our enforcement exercises in other parts of the department to start to try to establish that kind of cost.

In a broad sense, then, there's that body of costs that the department—and the government, I guess you would say—is going to have to get its head around in terms of just what kind of a regulatory authority we need to build and therefore finance and resource.

As to just who pays the costs, still considering that kind of exercise, there are concerns. These were certainly expressed to us as we talked with people, around them all being borne by the clients, if you like, by those who would seek the services in order to try to have a child. Obviously, that's not what would make for that effective a way of operating, so we do have concerns right now around that issue of just how the expenses will be shared, if you like.

The Chair: Okay.

Ms. Wasylycia-Leis.

Ms. Judy Wasylycia-Leis: Does the bill in this aspect deal with the question of fertility clinics finding ways to encourage overproduction of embryos? I know there's the prohibition part of the bill. This is the part that deals with regulating and licensing of clinics.

Again, I'm wondering about a front-door prohibition and a back-door encouragement.

Ms. Rhonda Ferderber: I think the bill does...

Glenn, is it in clause 8?

Mr. Glenn Rivard: Certainly under subclause 8(1) you have the authority to regulate the whole process of creation of embryos and implantation, etc. Therefore, that would go to establishing what would be the acceptable limits as to the numbers of embryos, the condition under which they would be produced, and that type of thing.

Ms. Judy Wasylycia-Leis: One other question. Anywhere in the bill does it mention a mechanism for ensuring that fertility clinics actually provide all the information women need to know in terms of dangers to their health and well-being? Some of the concerns we've heard are about the fact that there is some evidence suggesting a causal relationship between receiving fertility drugs in order to produce embryos and a higher incidence of cancer, and women not getting the full information they need before they make this decision.

So I'm wondering if the bill does this or if the regulations deal with it. How is this dealt with in this full package?

Mr. Glenn Rivard: Clause 6 establishes the need for consent for the use of any human reproductive material, including ova retrieval, etc. Consent is a legal term that requires that all relevant information be provided to the individual and that they be allowed to assess it in circumstances that are free of any duress or pressure, and then they provide their consent.

I think it is foreseen that the regulations would then underwrite that basic legal requirement by spelling out more precisely what we would see as the information that should be addressed by the clinic to the individual so that the clinics have a clear understanding of what's expected of them.

Ms. Judy Wasylycia-Leis: It still sounds a little vague, though, in terms of requiring clinics to actually spell out in detail the possible effects of going down this path and to point to the research that might exist in the field, however conclusive it may or may not be.

• 1700

Ms. Rhonda Ferderber: Perhaps I can add one aspect to the information. Current thinking right now around the functions of the regulatory body do involve this aspect of the requirement to provide public information around all aspects, be they the treatments or the research being undertaken. So we do see that responsibility as being very important to clients who come forward and at least have a point of entrance, if you like, one spot to go to, to seek out information and to be able to trust that this is coming to them from perhaps what will be the more neutral sources, as opposed to, say, a doctor or a clinic that might not be able to stay as current on everything as we hope would the regulatory body in the performance of this function. So this is certainly one of the areas that could address some of the concerns you're speaking to.

We're hoping also that over the course of time, as this regulatory body or entity is in place, this kind of information that currently doesn't really exist in that aggregate level, or as available readily, etc., will start to address that. We hope there will be a higher knowledge and awareness base on which people can operate and make their decisions.

The Chair: Thank you, Ms. Judy Wasylycia-Leis.

To follow up once again on your thinking, it reads as if they can make use of these donations with the person's consent, but it suggests—to me, anyway—that the consent could be elicited from the person after they've made the donation. Should we not be requiring consent for use prior to the donation? It isn't clear in the bill.

Ms. Francine Manseau: At the time of donation.

The Chair: No, “at the time of” is too loose. It should be, for all the possible uses the donation might be put to at that clinic or university, etc., prior to the person donating so that they know the range of activities. Once you've already gone through the act of donating, you might sign anything just to get out of there. I think you should think it all over ahead of time. There probably should be a time delay as well.

Ms. Rhonda Ferderber: These are good thoughts. Again, I took note of a comment more or less to that effect last Tuesday on the timing issue. So in terms of the regulations, and this process, obviously, informing our own, it's very helpful.

Again, I think you're talking more in the regulations development than specifics in the bill. I would just need a clarification there from you, if I could.

The Chair: Two meetings ago, when Mr. Shugart was here, I suggested that most of us are pretty leery about leaving things to the regulations when we know they can be changed two weeks later by the bureaucracy and the minister without our input.

I would think—and my colleagues can shake their heads if I'm off base—that the tendency among parliamentarians today is to get precision more in the bill and less in the regulations. We know it's desirable from the public official point of view to have more flexibility, but I think on this particular topic, there are ethical concerns on the one hand that I think are pan-Canadian—I hate to use that phrase—and at the same time there is a body of lobbyists, many of whom have a vested monetary interest, who indeed might be synonymous with the experts. Some of the experts will have a monetary interest even if they're researchers who are trying to get funds from the CIHR.

So when we have the potential of the general public's idea of what's right and wrong, and the people whose expertise you're tapping into to help you with the regulations, or with standards-setting, and those people, many of whom have a monetary interest, it's in the public's interest, we think, that as much as possible be defined in the bill.

Preston Manning is going to take—

Mr. Preston Manning: No, no.

The Chair: He might agree with me in general, but he's going to point out where I'm off base.

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Mr. Preston Manning: Well, no, I think a lot of us agree with that. The counterbalance we run into from the scientific community, however—and this is where we are going to have to balance—is that they say the science in this field is changing so fast—

The Chair: Yes, I understand that.

Mr. Preston Manning: —six months down the road the bill you did will be out of whack legislatively, and of course it takes so long to change the bill. I guess what we're trying to get is—

The Chair: The balance.

Mr. Preston Manning: —the legislative function that really does spell things out that should not be changed and yet somehow the flexibility to keep up with science.

The Chair: Yes. Seeing as that is sort of my point, perhaps I can just come back to my other point.

Mr. Lunney, you are next.

The standards development, or standards-setting, which I imagine will be sort of ongoing as the science changes, with NGOs involved, concerns me. I would like to add to the point I just made—“Which experts?”—because certainly we are hearing a conflict between people who are providing services and getting money for it. I think the same thing will be true of the scientific community when they come to tell us how important it is that they move forward. So there is that side of the argument compared with the religious and ethical side of the argument, which is saying be very careful, go slowly. Then there's our own general concern about the integrity of the human genome being sort of the bottom line. So I worry about who you're recruiting into this process.

Suppose you had a committee with seven scientists and one ethicist. That, to me, would be out of whack. So this question D(4), standard development by non-governmental organizations, to me is rife with... Well, I'm fearful about it.

Mr. Lunney.

Mr. James Lunney: I'd like to go back to a comment that was mentioned earlier, touching on the issue of consent. When we're dealing with the issue of consent, particularly informed consent, it is my concern that there is a segment of the population that is very vulnerable to exploitation, especially when dollars are associated with gametes.

I notice that you have to be over 18 years of age. I think there is a concern that young people especially, at 18... I think we all remember when we were 16 and thought we knew everything. As you get a little bit older it's quite alarming to realize how much you didn't know.

I think young people could be very vulnerable to exploitation in terms of dollars for gametes, in terms of young women being exploited for the risks associated with accelerating their ovulation to produce supernumerary eggs, and also in terms of surrogacy. Young women could be enticed, because of financial incentives, into a career of child-bearing without really considering the consequences to their future fertility and so on. So the issue of informed consent I think is a very real one, especially for the young.

I don't know if anybody wants to comment on that. I just wanted to state that, since you mentioned consent.

Ms. Rhonda Ferderber: I think we totally agree. It's been one of the very basic principles identified, and considered a pillar of the legislation. As you read through the legislation, you will see suffused throughout this issue of prior written and informed consent.

So we do agree. It's not what we have now, and it is certainly something we need to ensure we get. Some would argue—and you'll see on the top of the list of the regulations I'm going to share with the clerk—that consent is there, but...

The Chair: Thank you.

Mr. Castonguay.

[Translation]

Mr. Jeannot Castonguay: I would like to come back to the point raised by James. Consent may take the form of a one-page document or a 20-page document, and even though the person signs at the bottom, this does not reassure me that there is informed consent.

I want to talk about counselling in particular. How can we ensure that the counselling offered will enable people to see both sides of the issue... Personally, I feel that is how we guarantee informed consent, much more than a 10 or 20-page document that contains all the information.

I worked in an area in which I saw many signed consent forms, and I must tell you that their worth is very relative. My discussion with a client was much more important than what was written on a sheet of paper. How can we be sure that counselling of this type will be provided? I think that is extremely important.

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There are many unknowns in this area. As Mr. Manning was saying, we want to make scientific developments possible, but on the other hand, we have to have one foot on the brake and the other on the gas pedal. How can we make sure we do this?

[English]

Ms. Rhonda Ferderber: If you want to see passion on the basis of the team, Francine is passionate on this issue of counselling and the kinds of efforts that have to be made to beef up this side. I'll turn the floor over to her.

[Translation]

Ms. Francine Manseau: I agree with the comment. We hope to see that the regulations make much greater provision for counselling. At the moment, most clinics do not have full-time counsellors, people with diplomas that demonstrate they have counselling skills. This does not exist, and we want this situation to change.

I agree with you about informed consent. It is essential that someone discuss the issue with the individuals, give them things to read and think about, and meet with them again, before consent can really be established. We must ensure that people ask themselves the questions that must be asked for the long term.

As far as possible, we want to ensure that the regulations provide that this counselling will be given to these individuals. However, I think we may have a problem in Canada, because I do not know whether we have trained enough people to provide the proper counselling.

I certainly do not disagree with what you say. We will be trying to define these matters in the regulations. We were talking about sperm donors. At the moment, the donors receive no information. They may be told what types of tests they have to undergo, but there's no attempt to explain the implications of sperm donation. It is important that this be done, so that when a donor provides his sperm, he realizes that children will be born as a result. So far, we have tried to dissociate completely the two events. All we were interested in was the sperm. The donor was paid and had no say in the matter. For example, he may not necessarily have been given the option of limiting the number of children that could be produced from his sperm. There was no mention of that. We want to ensure in the act and the regulations that before we take someone's sperm, the person has received counselling and understands what he is about to do. When donors are questioned about their medical or genetic history, they must be made aware of the impact of their sperm donation. An individual will be created as a result, and he or she will require this information.

So there is no doubt that we will have to change the way the system works at the moment. I think that the whole issue of counselling is very important, and must be taken into account much more than it is at the moment.

[English]

The Chair: Madame Picard.

[Translation]

Ms. Pauline Picard: Thank you, Madam Chair.

I think we are going to need social workers with special training in this type of counselling, Ms. Manseau. This may become a new profession.

Ms. Francine Manseau: There are some who do this at the moment in Canada. We have been in touch with these people. I am not saying that there has been no such counselling at all, but it is not organized in the same way as it is in England or Australia, where this practice is much more developed than it is here. That may be because it was seen much more as a medical procedure than as one involving a multidisciplinary team. We have been relying mainly on the medical model, perhaps without giving enough importance to other aspects of the issue. However, we hope to change this situation.

Ms. Pauline Picard: My question is about the minister's records, which will contain a host of personal information. The minister himself told us that he would prefer that this be governed by an independent agency, and I agree with him on this. The clause states that the minister may, at his or her discretion, disclose certain information. Am I interpreting this correctly? What information could the minister reveal, and who would have access to it?

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Ms. Rhonda Ferderber: To which clause are you referring?

Ms. Pauline Picard: I am referring to subclauses (2) and (3) of clause 15.

[English]

Mr. Glenn Rivard: It is correct that the minister, in introducing the draft legislation to the committee, specifically asked the committee to address this question of how the legislation should be administered—in particular, should there be an agency that would administer it. However, in preparing the legislation we had to in effect make a choice for the purposes of the draft legislation. The draft legislation leaves all of the authority for administration to the minister himself. That's the normal form.

What that means in reality is that it would be the Department of Health, under this draft legislation, that would administer the act, that would enforce it and review applications for licence. Everything under the act would be handled by the Department of Health on behalf of the minister. So if a decision were made at some point to create an agency that would carry out some or all of these functions, then clearly the legislation would have to be redrafted to allow for that.

[Translation]

Ms. Pauline Picard: Fine. The committee wanted to recommend the creation of an agency. Thank you.

[English]

The Chair: Ms. Wasylycia-Leis.

Ms. Judy Wasylycia-Leis: Going back to the issue of informed consent, I'm still not sure what would be different if we had this legislation and this approach in place today vis-à-vis fertility clinics being required to inform clients of the possible long-term side effects, or ill-health risk.

I'm referencing a couple of studies that I've heard about in terms of fertility clinics now in Ontario, for example. In surveys of those clinics, 60% of women reported that they were not informed of the possible links to ovarian cancer. Another study—I'm just citing now from an article I read recently—found that 70% of reproductive endocrinologists did not believe fertility drugs increased the risk of ovarian cancer, and yet 83% of them reported that they addressed the risk when obtaining patient consent.

I guess the question is, what is in this package, in this bill, that will ensure that this situation is addressed, and what would change if we moved on this tomorrow?

Mr. Glenn Rivard: Perhaps I can answer that. There are several differences. It's currently a requirement, as it were, of civil law that before someone performs a medical procedure on somebody they obtain informed consent, which means they should be informing them of all the associated risks. The method, if you will, of enforcing that requirement is that a person can sue the doctor for negligence if they fail to do that. As well, it's conceivable it could form the basis for a complaint to the licensing society.

With this legislation there are, I think, two important differences. One, a failure to provide the necessary information that would form the basis for a valid consent becomes a criminal offence under this bill. Secondly, and perhaps more practically, under clause 40 there is authority to create regulations addressing the issue of consent. It is under this that we foresee the creation of regulations that would outline, in greater detail and specificity, the type of information that must be provided to individuals who are going to undergo the procedures regulated by the bill. So there would be a clearer indication of what it is expected that these people will be provided with.

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Ms. Rhonda Ferderber: Perhaps I would add just one comment, and that's with respect to the work we're doing with existing clinics and those that have these types of consent forms already developed. We're starting to collect these, and we see a tremendous variety in terms of what kinds of information is given through the context of the consent form and then collected. So we know that through the exercise of getting a piece of legislation, and then regulation, that is cross-Canada, it will go a long way toward filling some of those gaps, or the gaps that exist now.

Hopefully, then, through that process alone we'll get at where some of your concerns lie, and then, in addition, the kinds of public information that might start to be more readily available, etc.

The Chair: Is it possible that this whole idea of informed consent and counselling are tied together? I'm wondering if the fertility clinic itself is the place to get the informed consent.

Even if there's no money changing hands, the people who work there are being paid, and therefore their living is tied to a stream of customers and a set of activities that continue to go on. It seems to me they have a bit of a bias trying to share all of the negative possibilities with a potential donor or surrogate mother, whatever it happens to be. I'm wondering about the idea of counselling and informed consent being in the hands of a different agency.

Ms. Rhonda Ferderber: It's a possibility.

Ms. Francine Manseau: It's a possibility, yes. There are countries who have been doing that for quite a while—for example, Australia and Britain. I think we are in contact to try to understand how it works within their clinics. In terms of the conflict you raise, it may be apparent there; I'm not sure.

I mean, professional counsellors do have a code of ethics in terms of how they go about doing their business.

The Chair: Yes, but is it not also true, if these other countries are sometimes using the medical model, that they might have a registered nurse giving the counselling and the consent as opposed to a person who incorporates the psychological implications?

Ms. Francine Manseau: I think what the regulation does in those countries is specify what qualifies a person to be a counsellor. Then it specifies the type of degree or experience that person needs. Very often, yes, it's not a nurse or a doctor who does that but someone who has the right type of training. I think we would envisage the same thing here, that the person who is entitled to do counselling is a person who meets those qualifications.

The Chair: But if that person is actually employed by the clinic and ends up presenting such a balanced picture to the potential participant that nine out of ten participants, having heard all the negative possibilities, then say no, that particular counsellor would be soon let go by the clinic.

Ms. Francine Manseau: That's a possibility. I'm not—

The Chair: It's just something to think about.

Ms. Francine Manseau: I agree with you, there could be dangers there and so on, but I think we would certainly be careful about defining what is a counsellor to make sure that the people who are doing the counselling are really, truly counsellors, at a minimum.

The Chair: Yes.

Mr. Lunney.

Mr. James Lunney: I would add my affirmation to your comments, having worked in the world where informed consent is necessary, involved in medical care. Other members at the table here might agree with me that many times in medical procedures consent is given lip service by those who are intent on proceeding with the procedures rather than genuine informed consent. That's certainly a big issue in law, too, when it comes to proving negligence.

At any rate, I think your point is well taken.

The Chair: Thank you, ladies and gentlemen.

We've come to the end of a section but we haven't come to the end of the paper. I think each time we work through three or four questions we get two opportunities. One is to clarify issues in our minds and one is to feed to the officials some of the attitudes we're developing as a group so that they have an idea as to what they might or might not get approval for. So I'm hoping it's becoming a two-way street.

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I'd like to thank the officials for coming today and give them notice that we'll probably need them back. In the meantime we'll hear witnesses, so we may actually want to go back in this paper to comment on some of these things.

When you come back we'll proceed from where we have finished, which I think is on page 6 in English. We'll begin with item E.

In the meantime, may I tell my colleagues that we keep getting more assistants. You've seen from your briefing notes the fact that we've had Mr. François Coté from the science and technology division added to our list of researchers. This is another person to whom you can ask questions.

We've also had Monique Hébert added from the legal section. So we now have another scientific person and the addition of a legal person to assist us with these deliberations.

Welcome to the two of you, and thank you for joining us.

Madame Picard.

[Translation]

Ms. Pauline Picard: Madam Chair, I would like to know whether we will be able to have some information about what is done elsewhere, about legislation that has been passed in Great Britain, for example? Is there a comparison between what is being proposed and the procedures in place elsewhere?

[English]

The Chair: Well, we're planning a meeting to interact with somebody in Britain, probably by teleconference.

[Translation]

Ms. Pauline Picard: I see, excellent.

[English]

The Chair: Prior to that meeting I hope we might be able to get some description of what you understand about what's going on in England, and perhaps Australia, so that we can read it and then take advantage of the meeting time to interact via the screen with persons from that place.

In actual fact, I'm working with the researchers and the clerk around the plan for after the tabling of the committee list. We'll have some new members, and some of our regular members won't be back. I want the new committee to agree to the plan. That's why it hasn't been presented yet.

In the meantime, these people are all trying to get something in place. Yesterday we discussed this whole thing about the international scene. They're trying to work it through. But I think we should at least have some preliminary reading on it, so we may ask you to share what you know about that.

Mr. Manning.

Mr. Preston Manning: I guess the last thing we need is more information, but in your profiling of the reproductive sector—and you probably looked at this—one of the sources I found most helpful and hadn't even known existed was each website of the pharmaceutical companies selling fertility drugs. The websites had a more comprehensive list of not just the clinics but even of particular physicians and doctors who were open to that kind of treatment. That might be a source if you haven't looked at it.

The second is more for you, Madam Chair. I was talking to the former Auditor General, and he mentioned that in the course of his work he had looked at every kind of regulatory body under the sun. I wonder if when we get to the section looking at the different regulatory models—this is Monique's field—whether there might be some source of information there from the Auditor General's office, or even the former Auditor General. He had looked at a lot of these—which ones worked, which ones had problems, and what combination might be best. That might be a source of help for us when we get to that section.

The Chair: We'll ask the researchers to write that down as a possibility. Thank you for that.

Seeing no further hands, and seeing the clock is showing 5:30 p.m., I want to thank everybody for their attendance and their participation.

I also want to thank our guests and say that I look forward to seeing them tomorrow morning at 11 o'clock.

This meeting is now adjourned.