HEAL Committee Meeting

STANDING COMMITTEE ON HEALTH

COMITÉ PERMANENT DE LA SANTÉ

EVIDENCE

[Recorded by Electronic Apparatus]

Tuesday, September 18, 2001

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[English]

The Chair (Ms. Bonnie Brown (Oakville, Lib.)): I'd like to call this meeting to order. Good morning, ladies and gentlemen. I hope you all had a nice summer and you are ready to get back to work.

As you know, the formal list of committee members has not yet been tabled in the House. You can probably help speed that along by encouraging your whips to get those lists in. When I found out there would probably be two weeks before that list was finalized, I decided, with the help of the clerk and the researchers, that we should get started, because our time is limited and I didn't want to waste two weeks. I'm sure you didn't either. However, the membership could change after this two weeks. I'm not sure.

One of the other issues was that over the summer the work of the researchers was to review the testimony of last spring, both what the witnesses said and what you said, including the questions you asked. In that review, they uncovered the fact that there were certain inconsistencies, sometimes with regard to definitions, sometimes with regard to....

You're not hearing? It's not working?

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Okay, it's working now, so I'll go back to the part about the researchers. The researchers have reviewed every word of testimony and have uncovered certain inconsistencies in definition and/or intent of the draft legislation. They have, in a way, listed those problems, and that list is within your package for today in the form of questions.

Now, for those people who are new to this process, one has to realize that the researchers are responsible for drafting our report. Therefore, it's very important that they be clear as to the definitions and as to the intent. So I would ask you today to try to work your way through these questions, because it's important for them and it's important for us to have a clear understanding of what this legislation actually says and what it means.

As you'll recall, certain of the witnesses pointed out places where they thought things were fuzzy. Those comments have been incorporated into the list of questions, which begins on page 2 of today's paper. So while you may have certain questions of your own, I would ask you to mainly focus on getting answers to the questions that the researchers have worked so very hard to pick out of the testimony. Thank you very much.

Did you want to make some opening comments, Mr. Shugart?

Mr. Ian Shugart (Assistant Deputy Minister, Health Policy and Communications Branch, Department of Health): Madam Chair, with the advice of the staff, we thought we would provide an overview, which may indeed answer some of the questions you've identified.

The Chair: Do you have a copy of the questions?

Mr. Ian Shugart: Yes. We received that a little earlier.

The Chair: Okay. As you give your overview, if there's an answer to any one of these questions, I'm wondering if you could refer to it.

Mr. Ian Shugart: We can certainly try to do that.

Glenn, are you able to throw some additional comments in?

We thought we would provide a bit of a recap of the structure and the policy intent of the provisions. We'll do our best to insert the answers to some of these, as well.

The Chair: Thank you very much.

Mr. Ian Shugart: Indeed, in keeping with the procedure of taking questions as notice, if you run out of time to deal with some of these questions, we could provide subsequent answers as well, if that's helpful.

The Chair: Yes. A short overview or a short review of the intent of the legislation is fine. We don't want to use up too much time, because I really want to leave here today with the answers to as many of these questions as we can possibly get.

Mr. Ian Shugart: Very good.

The Chair: So not too long a review, please.

Mr. Ian Shugart: Thank you. I'll keep that in mind, Madam Chair.

We're glad to do this again. I would just say that what is helpful to us is to have observed the witnesses and monitored the kinds of issues they are raising. As you know, the process that was followed was an opportunity for the government and the department to get a full range of input before final decisions are taken as to what to propose to Parliament formally. So we're monitoring the process in that sense.

As you know, the legislation is intended to provide a regime that ensures that individuals seeking to build families with the assistance of these technologies can do so in a way that is societally acceptable to the maximum degree possible and provides for safety and health considerations in this time when the science is moving so quickly to provide the appropriate research environment in which to do that.

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[Translation]

The draft bill covers two types of activities: those that are prohibited at all times, and controlled or regulated activities. Prohibited activities are listed in the bill, and the detailed list of controlled activities will be set out in regulations.

One of the important issues is the distinction drawn between controlled activities and prohibitions in the legislative text. As we indicated in the beginning of this process, we are awaiting guidance from the committee as to where to draw the line between the two in the most appropriate fashion.

[English]

Finally, the legislation applies to two different purposes in both these categories of prohibitions and controlled activities: actual assisted human reproduction and the use of human embryos in research.

You have before you a short deck, I believe, which seeks to provide the overview. I will, as indicated, go through that fairly quickly. The scope of the legislation, as you know, covers the collection, the handling, the storage, and manipulation of sperm, eggs, and embryos for purposes of reproduction, and it proposes to regulate research with embryos. Only pre-existing embryos could be utilized, and informed consent of the donors is a prerequisite. I'll touch briefly on those a little later.

The draft legislation does not deal with embryos within the body of a woman, and therefore does not pertain to pregnancy per se. So issues relating to diagnosis procedures—amniocentesis, ultrasound, and so on—are outside the scope of the legislation. It is about ex utero or in vitro embryos.

I know the preamble has received some comment from your witnesses. It is the statement of principles, if you will, or recognition of why this area is important and why legislation is justified. It acknowledges that assisted human reproduction is beneficial within society and is recognized as such within society. In that context, it is intended to promote health and safety to respond to those technologies and also to deal with the dignity of the embryo and indeed of women and children who are most affected by these technologies and procedures.

Free and informed consent is a principle that underlies the legislation. Furthermore, the preamble identifies explicitly the notion that reproduction is a unique and special human function and activity, and it ought not to be commercialized, giving rise, as that would, to health and ethical considerations.

Finally, there is a recognition of the uniqueness, the integrity, the individuality of the human genome, and it therefore seeks to preserve that.

These are principles, which are then reflected in the prohibitions and in the controlled activities. So the preamble is actually quite an important part for both the educative purposes and the symbolic and directive purposes of the legislation.

The prohibitions are covered for you in the following pages. We can touch on any of these you wish, but let me highlight three, because I think they have resulted in issues over the course of the witnesses you've heard from.

First of all, with respect to cloning, it is the intention of this proposed legislation to ban all cloning techniques, reproductive and therapeutic. Reproductive cloning represents the most popularly held notion of what cloning is. It's the manipulation of an embryo to produce an individual with exactly the same genetic makeup or genetic code as another individual. This includes the technique of splitting the embryo.

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You will be familiar with the example of Dolly. That is an example of reproductive cloning. You take the genetic material from an adult cell, a non-sex cell, and you place it in the ovum, the egg, which has had the genetic material removed.

Therapeutic cloning uses the same techniques but the goal is different. The goal of therapeutic cloning is to create embryos for research purposes, for therapeutic purposes, and not to produce an individual with identical genetic makeup. The goal of that type of cloning obviously is to produce cells that can be used for therapeutic purposes that are going to avoid the normal process of rejection based on the immunological processes that occur.

So when we're talking about stem cell research and ultimately therapies derived from stem cell usage, we're referring to therapeutic cloning. The bill speaks to both reproductive and therapeutic.

The prohibition recognizes that it is an affront to human dignity to replicate human beings. As I indicated, the preamble identifies the uniqueness of the human genome of individuals. Cloning calls that uniqueness into question and is therefore, in the view of the government, and I might say the royal commission, beyond what is acceptable.

This does not preclude stem cell research. As you know, under the regulations researchers would be able to proceed with stem cell research.

The second issue to touch on briefly is why the 14-day limit. It was stated by some that this is arbitrary. The rationale for the 14-day limit is that it is, by international scientific consensus, at that point in the development of the embryo that the early indications of a nervous system become apparent.

The Chair: Excuse me, Mr. Shugart. I don't think you have to defend every single line in this deck. I just want you to take us through it just as a quick review.

Mr. Ian Shugart: Okay. The last one I'll touch on is gender selection, but I think the rationale for that has been touched on before.

Commercial surrogacy—I'm at page 8 now. There are a number of aspects to that. The basic principle is that while expenses...and this will require articulation in the regulations, enumeration in a fair bit of detail, I would imagine, as to what those expenses might be. One will have to become fairly specific in the end. The principle is that inducement ought to be avoided, and therefore commercialization and commercial surrogacy would be prohibited. Similarly with the sale and the purchase of embryos, the reproductive material, including sperm and eggs.

At page 10 we touch on consent, and that is enumerated. The rationale for this is that these are not trivial activities, and consent is considered one of the pillars of the legislation. It obviously pertains to the controlled activities alone. This relates to both the collection and storage of this material. It also holds true for the purposes, whether an embryo is being used for research or is being donated for reproductive purposes.

Consent can be amended at any time. Obviously one of the areas that will have to be spelled out in regulation, given the importance of consent, is the databases and the ability to track individuals so that they can come back and amend consent, and the health and safety information of donors and so on can be tracked.

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Clause 8 gets into the controlled activities. These relate to the safety provisions and so on of IVF donor insemination. Members may recall the regulations that were promulgated under the Food and Drugs Act recently relating to the safety of sperm. That is another example of the kinds of regulations that will be dealt with under this regime. So those are under the broad category of health and safety regulations.

The controlled activities would also deal with the research uses and the medical uses of embryos. These are the purposes, the activities, that researchers would obtain a licence for under the regulatory authority of the Minister of Health, and it relates to how peer review and the ethical review of research protocols and that kind of thing would be applied. We can get into that on your direction.

As I already indicated, clause 10, which would also be under the controlled activities, would deal with the nature of expenses, given that commercial surrogacy is not acceptable but reimbursement of expenses is.

In terms of the kinds of research, we would plan on following more or less the model that has been established and where we have some experience in the U.K., where the legislation would permit the granting of licences, the regulations, or, if you prefer, the legislation could talk about the kinds of research that would be acceptable.

Finally, at page 13—and some of my colleagues will be able to get into this in more detail—controlled activities related to chimeras and transgenic organisms are outlined. This is one area where the line between the prohibition and the regulation is important, and there's been some comment from witnesses, and we will be listening closely to see if we have this right. There will be debate about this area.

We have been advised generally by people expert in the scientific activity in this field not to be too hasty to close off areas of significant scientific promise, where it's felt that the right approach to chimeras and transgenics is quite important. But we're well aware that this is going to be an area where we have to provide some detail, where we'll perhaps be directed somewhat differently by the committee.

That is an overview, Madam Chair. We've not gone into everything. I'd invite Glenn and Lise and Rhonda, whom you'll remember, to add anything at this point, and then we'll be directed by specific questions.

The Chair: Glenn, in reviewing the questions we have today, do you have any immediate answers to any of them?

Mr. Glenn Rivard (Counsel, Legal Services, Department of Justice): I can certainly take you through them, starting with the first one, on which there are really two comments.

Just to get something off the table, there is no repetition of definitions between clauses 2 and 9. There is the term “genome” defined in clause 2 and the definition of “human genome” in clause 9. The definition of “genome” applies to the individual cell, and that term is used under clause 3 as part of the prohibition on germ line alteration. So a definition at the cellular level is the appropriate definition for that prohibition.

The authority to regulate under subclause 9(2) has to do with the species and the mixing of genes between species, and therefore the definition of “human genome” is at the species level. So we required a specific definition that was more appropriate to that regulatory authority.

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As to why they are in two different sections, there's no particular magic to that. The definitions in subclause 9(3) were placed there because they relate only to the provisions of clause 9. But they could be placed into subclause 9(2), if that's felt to be clearer. As I said, there's no particular magic to that.

I'll just continue, unless there are any questions.

Under the act the definition of “donor” for an embryo would be defined in the regulations. That is because the circumstances around the dealings of a particular embryo can vary. Therefore we need to take that into consideration. The simplest way to do that is through the regulations.

For example, if you have a couple who are the gamete donors of an in vitro embryo, and then one of the two should die, and if you have a consent requirement in the statute that requires the consent of both, then you're basically stuck. You don't have any capacity to deal with this embryo. So the regulations have to provide flexibility and allow for that sort of situation.

Another very typical scenario would be where you have an anonymous sperm donor. The woman may be the gamete donor and her partner is not a biological parent. If a decision has to be made as to what to do with the embryo, it would appear that you don't want to bind yourself in a situation where you have to require the sperm donor to consent, because the intention was that he would always be anonymous and that he not be involved in further decision-making around the embryo.

The reality is there are simply quite a number of fact situations that differ with respect to embryos and that require some flexibility as to who you want involved in decision-making around the embryo.

As for the term “zygote”, it is simply a term used for the earliest stage of the development of the embryo. In this legislation there is no provision that deals differently with that earliest stage of the embryo than with any other stage of the in vitro embryo. So in the context of this legislation, it would be a redundant term and it's simply not necessary. Every provision we have that pertains to an in vitro embryo includes the zygote.

On the definition of “genome”, this is the term used in paragraph 3(1)(b), which prohibits germ line alteration. The concern in the scientific community historically has always been around the alteration of the DNA within the nucleus of the cell, which does contain by far most of the genetic information of the individual. So that term was defined in order to really address what was seen as the most significant problem.

In the last short while, a new technique has been developed called mitochondrial transfer. This involves DNA that occurs outside of the nucleus. We're reviewing that.

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I guess we really have two options. One is we could leave the definition as is, because under subclause 8(1) we clearly have the authority to regulate mitochondrial transfer, and even to go so far as to prohibit that process if it's a concern. Alternatively, we could consider amending the definition to include all DNA. As I said, that issue is under review. But if nothing is done, I'm quite confident we still have the capacity under the legislation to address that problem.

On human reproductive material, in the earlier in-house drafts of the legislation the provisions included a list of everything that you see down on the piece of paper before you. So they would address sperm, ovum, other human cells, human genes, in vitro embryos, or any part of these. That would be your standard phrase in those clauses.

There was concern that in fact the intent of those clauses got lost because as you read them along you had to go through this long list of things that were covered by the provision. So we invented a term of art for the purpose of the drafting of the legislation to make each of the provisions simpler to understand. We called that “human reproductive material”, and we included the list of all of these things. It really is a case of which is clearer to the reader. Is it clearer to list all of these elements in each of the provisions, or is it simpler to use this term of art and define it in the regulations as including all of these elements?

I guess we're open to comments on that. There may be a different term, but this is the best we've been able to come up with so far. I guess the logic behind it is simply that these are all elements that in the context of their use contribute to or are part of the process of reproduction.

I see some questions raised here around the use of singulars and plurals. In the interpretation of legislation the use of the singular includes the plural. That's well accepted in law and simply makes it much easier to read the legislation, instead of having to include the references to the plurals all the time.

On the definition of “in vitro embryo”, we can certainly consider the alternative language. I'm not sure it improves on anything. Certainly, just off the top of my head, I could see a concern around the use of the word “maintained” if somebody were to argue that they didn't really do anything to actively maintain this embryo. It seems unlikely, but we like to be as inclusive as possible and use the broadest language that's appropriate.

On “created”, I think the drawback is it's not entirely applicable in the sense that our concern around the in vitro embryo is not just at the moment of creation, but that full 14-day period. So “exist” seems a bit more appropriate, but certainly alternative language can be considered.

With respect to the language of “chimera”, the specific concern that we seek to address is the inter-species chimeras, and that's why it's been defined that way. As for intraspecies, those sorts of activities would be regulated under subclause 8(1). They don't raise the same types of primarily ethical concerns. There may be concerns around them, but it's not the same problem.

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The other difficulty, of course, is that the other provisions talk about embryos, and that's defined as a human organism. When you start talking about chimeras, you immediately run into a definitional problem: is it or is it not a human organism? So whether you stick with the regulation of this activity or create a prohibition, you need something very specific for interspecies chimeras.

As to the logic behind this, the fundamental concern is that you don't wish to have a live organism that is of uncertain genetic mix, if you will; that is, you're not sure if this is of the human species or not. So certainly one reaction to that would be to prohibit that activity entirely. There are, however, lines of research, as I understand it, particularly in the cancer area, in which what are technically chimeras are created for a very short period of time to study the interaction of this alien cell in the animal embryo. For that reason, the approach of regulation was used.

That would be an issue as to whether we want to leave open the door for that limited sort of research. Certainly there's a well understood ethical limitation as to how long such an organism continues to exist and that it's never a live birth or anything of that nature. So that would be reflected in your regulatory limits.

The Chair: Mr. Shugart, you've now concluded that first section on definitions. I thank you for those clarifications. The researchers have indicated that they understand now why it was set up the way it was.

I must ask my colleagues if they have any questions on this section or if they prefer to proceed to the prohibited activity section.

Mr. Manning.

Mr. Preston Manning (Calgary Southwest, Canadian Alliance): Maybe just one general question that pertains to definitions.

I wonder—and this may be your department, Glenn—if you could tell us what is currently the legal status of human reproductive material held by a clinic or by a lab. In law, is this material considered property that is owned by either the donors or the lab or the clinic? When you have the adjective “human” attached to it, is it not property, but something human that is held in custody rather than owned? I don't know if I'm making myself clear, but I'm really getting to what is the generic legal status of these human reproductive materials now, and is there a need to clarify that for the future?

Mr. Glenn Rivard: I think it's fair to say that you will not find one source, one statute or whatever, that ascribes particular status to this material. If you look at the case law in which this has become an issue, you will find some differences in approaches. That really depends on how far afield you look, as well.

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I think it is probably most accurate to say that this is considered sui generis, in the legal phrase, which essentially means that it has a status that is really unique unto itself. The concerns of the law have been not so much to classify this material, but rather to establish the rights that individuals have around the treatment of that material. So the case law and statutes will create a requirement for consent to its use, which in effect means, for example, on the part of the donor, a kind of a right to control or to share control, depending on the circumstances vis-à-vis this material.

So it's not described as property. It's not classified by the case law or the statutes. Rather, the focus has been to determine who really has control, under what circumstances, over this material, and that will depend on the particular material and the particular circumstances.

Mr. Preston Manning: Should we actually be trying, in the definitional section or somewhere, to actually specify the legal status of human reproductive material, at least for the purposes of this statute? Is that something that requires clarification and ought to be in the statute, or do you think that's something that should be left?

Mr. Glenn Rivard: I think the primary purpose of the definitions is to provide clarity to the actual provisions in the statute. That really has to be your guiding light. When you have a provision that uses a particular term, do you understand clearly what is meant by that?

The approach in this draft legislation has really been very consistent with that line of thought that we want to focus on: the question of who has control, and under what circumstances. And obviously a key element of that is the question of consent to use. I think the benefit of that is that you've tailored yourself to meeting the needs of the provisions of the statute, whereas if you take a status approach—if you define this all as property, for example—you could have unintended consequences that you haven't really foreseen, because as soon as you label it as that, then in effect all of the law of property comes to apply, and you'd have to ask yourself how that works through in every individual circumstance. For example, if gametes are a person's property, then in effect if you limit the right to sell your gametes, are you expropriating without compensation? You get into concepts that just really don't have any appropriate place in this area.

To sum up the answer, I think this approach meets the needs of the legislation for clarity and avoids the importation of concepts that really could have unintended consequences.

Mr. Preston Manning: Thank you.

The Chair: Thank you.

Mr. Lunney.

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

On the question of chimera and the prohibition in the draft legislation, except under licence, the introduction of animal and human products together, I've yet to hear any rationale for why we'd want to go there. You've taken a stab at that with cancer research, and maybe we need to hear a witness on this or something. I wonder. You very clearly stated that there are ethical concerns about how long you let such a thing exist. My concern is once you go in that direction, there's always somebody who wants to take it a little further to see what you come up with. Why would we want to go there in the first place?

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Mr. Glenn Rivard: Well, I think it's a very legitimate question. It really comes down to a case of whether or not we really want to close down a line of research that, as has been explained to us, is certainly useful, particularly in the area of cancer research.

Perhaps researchers in the area could speak more clearly to that.

Mr. James Lunney: Is there somebody else here who would like to take a stab at that?

Mr. Ian Shugart: I think the fundamental policy question that pervades the whole field is where one draws the line. I think you're right to explore, with independent expert witnesses, the uses and so on. It is anticipated—indeed, it is already the practice—that in the review of research protocols, ethical considerations are brought to bear. That would continue as part of the normal process of research. Societal values and principles are employed by research ethics boards as they evaluate whether a particular protocol is pushing the limits and so on.

One of the areas of application certainly is in the fundamental area of developmental biology. What are the mechanisms, for example, that at the cellular level, changes in the makeup of the cell and so on, contribute to the progress of cancer? In the area of new drug testing, as a precursor, or prior step, if you like, to testing a technology whose effect on humans is unknown, it's being able to observe that kind of interaction at the cellular and genetic level. As medicines, technologies, and therapies increasingly move away from being based on chemical interactions to using genetic mechanisms, science will come to rely more and more on understanding what happens at that level.

So in terms of a research protocol, the basic principle, as Glenn has indicated, would be that the viability of an organism is not only not being sought but indeed would be precluded. So you're restricting the examination of and the research into what happens to understanding that cellular, or subcellular, level, and not in any way pursuing viability of that organism.

But you've touched on a key issue of principle. We can't claim to have the right answer definitively. I think you're right to explore the future implications, perhaps on both sides of that issue, the dangers as well as the benefits, with witnesses from outside the department.

The Chair: Mr. Lunney, the researchers have taken note of this and probably we'll get such experts in so that we can further this discussion.

Mr. James Lunney: Excellent. Thank you.

The Chair: Is there somebody on this side?

Madame Picard, and then we'll proceed to the area of prohibited activities.

[Translation]

Ms. Pauline Picard (Drummond, BQ): Madam Chair, I would first like to make sure that the witnesses who are before us will be able to send us their written responses to the questions prepared by our researchers. This is important and will help us in carrying out our study.

[English]

The Chair: Madame Picard, we're getting a great deal of static on this line from the English translators. I wonder if you would start again, because I didn't hear you at all.

[Translation]

Ms. Pauline Picard: Madam Chair, because we are running out of time, our witnesses cannot answer the questions prepared by the researchers or elaborate further on those questions. I would like to make sure that we will be receiving their answers. The members of the committee collectively request that the Health Department witnesses provide replies to the researchers' questions.

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[English]

The Chair: Madame Picard would like to have a written response.

[Translation]

Mr. Ian Shugart: Madam Chair, after having examined those questions, if we can provide answers, we will be happy to send them to you in written form. There will also be a transcript of the answers we provide here.

Ms. Pauline Picard: I hope you will be able to answer all of the questions, because we have not been able to go through all of the briefing notes we were given. You did not have time to answer all of the questions.

Mr. Ian Shugart: We will re-examine the questions to see if we can provide more detailed replies.

Ms. Pauline Picard: That's fine.

Madam Chair, if I understood correctly, the department that is involved in this study has redone its homework this summer and will be proposing another draft bill, because it seems that there are some big changes on some fronts.

First, before I ask my questions, I want to say that I am very disappointed by this draft bill.

[English]

The Chair: Excuse me, Madame Picard, once again we have so much static that I can't hear the English. They're going to call a technician to try to get this cleared up.

In the meantime, maybe we could just go a little more slowly. If we speak quickly it's just lost altogether.

Madame Picard, was your latest intervention to get written answers to all these questions?

[Translation]

Ms. Pauline Picard: Yes, but I was asking for information. That was not my question.

[English]

The Chair: Okay. Go ahead with your real question.

[Translation]

Ms. Pauline Picard: I was saying that I was disappointed. These questions have been studied since 1989. There was the Baird Commission, and the government bill. I even tabled a bill. Many witnesses have appeared before the committee. The government is tabling a draft bill that is so complex that we cannot make head nor tail of it. Today, the department is telling us that it redid its homework this summer and is proposing new definitions.

I think it is very difficult for the members of the standing committee to follow what you are saying. I do not know where we are going with this. I have been doing clause-by-clause study with people from the Research Branch, people who know this topic, and we cannot make sense of things. I hope that if you submit another text, we will be able to understand it. In this one, there are such terms... and even in the French translation, we are having to guess at what you mean.

If there are legal challenges, people will be able to interpret the various sections any way they like. I think you still have a great deal of work to do.

Here is my question. The bill forces us to take a stand on the value of human life.

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In your opinion, is the human embryo, biologically speaking, a human being, and what is your definition of what it means to be a human being? From the ethical and legal standpoints, if an embryo had to be destroyed, what value would you attribute to the human embryo? The text of the draft bill tends to objectify the human embryo. That is, in any case, my understanding of clause 29, which deals with forfeiture. The clause states that “the thing seized is forfeited”. What is your definition of “the thing”?

[English]

Mr. Glenn Rivard: Maybe I can answer the last question first. The word “thing” is all-inclusive. Other witnesses have asked whether that would include seizure of an embryo, an in vitro embryo, or a fetus. It may be that this is an area in which we could clarify that language to make it clear to people that this is a possibility that may be necessary to determine whether there's been a breach of the act or the regulations. But it's certainly the intent that, where necessary, an in vitro embryo, say, might have to be examined.

More generally, this seems to be a variation on the question answered earlier—that is, whether there is an advantage to be gained by defining the term “embryo” in particular as a human being, or not a human being, or by defining the term “human being”. I guess the answer would remain the same, that the definitions are best thought of as tools to assist in the understanding of the particular provisions. Therefore, they are defined in the context of clarifying their use in the particular provisions of the act. Trying to fit them within broader categories or accord them particular status will likely import questions and issues that don't really contribute to a better understanding of the substantive provisions of the legislation.

The Chair: Mr. Ménard.

[Translation]

Mr. Réal Ménard (Hochelaga—Maisonneuve, BQ): I would like to ask a brief question, if I may.

I don't know if you remember this, Madam Chair, but when the representatives of the Catholic Organization for Life and Family appeared before the committee, they told us that the information document indicated that surrogate motherhood could be authorized by regulation, for altruistic reasons. I tried to line up their testimony before the committee with the various definitions contained in the bill, and I wonder whether the representatives of the Catholic Organization for Life and Family were not mistaken in their interpretation. Are they right in believing that such a thing would be possible, that under the definitions and the regulatory framework you are proposing, there could be cases where an exception would be authorized by the minister, where surrogate motherhood could be authorized for altruistic reasons?

Ms. Francine Manseau (Senior Policy Analyst, Health Policy and Communications Branch, Special Projects Division, Department of Health): Your question is whether or not this would be regulated by law.

Mr. Réal Ménard: Would this be possible under the terms of the bill?

Ms. Francine Manseau: Yes, this is regulated in the bill.

Mr. Réal Ménard: But it is not contained in the definition.

Ms. Francine Manseau: In the definition of surrogate motherhood?

Mr. Réal Ménard: Well, what is one to think? These people came here to speak to us about surrogate motherhood, about surrogate mothers—

Ms. Francine Manseau: Surrogate mothers, yes.

Mr. Réal Ménard: —who would do this for altruistic reasons. Now, when the Catholics said this to us, we examined the bill and felt that there must surely be a definition of “altruistic reasons”, but it does not appear in the bill. There is no such definition. I have been trying to make sense of this ever since. Why is it not defined, and what were they alluding to?

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Ms. Francine Manseau: What the bill does contain is a definition of what is meant by surrogate mother, or surrogate motherhood. What the bill prohibits is the commercialization of surrogate motherhood: you cannot offer to pay someone to become a surrogate mother. That is what is prohibited.

As for regulations, surrogate mothers are often genetically related to the child, i.e. the sperm used might be provided by the man in the couple that wants to have a child. In other cases, a surrogate mother may carry an embryo created from the gametes of the couple that want to become parents. Such activities will fall under subclause 8(1), which states that anyone wishing to alter, manipulate or treat any human reproductive material for the purpose of creating an embryo shall not do so except under the authority of a licence issued under that clause. Only under the authority conferred by such a licence will the creation of the embryo and the implantation of that embryo into the body of a woman be authorized.

Mr. Réal Ménard: What is meant by altruistic reasons?

Ms. Francine Manseau: The person who does this without receiving payment, not for profit, has altruistic motives.

Mr. Réal Ménard: But isn't this incompatible with the implicit position of the legislative text, which prohibits payment for surrogacy and forbids acting as an intermediary to arrange the services of a surrogate mother? Isn't it possible that what the bill expressly prohibits could be achieved indirectly? That is the concern expressed to us by the representatives of the Catholic Organization.

Ms. Francine Manseau: I did not understand that last comment.

Mr. Réal Ménard: The witnesses told us that the text of the bill, like the Civil Code of Quebec, has set out a clear position by stating that surrogate mothers cannot be paid and that a woman may not bear a child for someone else; but they were concerned. That is substantive law. It is plainly stated in the bill, it is clear. But when it says that the minister may for altruistic reasons authorize another scenario, and no definition is given of what these altruistic reasons might be, does that not indirectly authorize surrogate motherhood? This is the concern the Catholic Organization representatives came here to share with us.

Ms. Francine Manseau: The text of the bill does not prohibit surrogate motherhood as such. What it does prohibit is accepting or offering payment. The law is the same in Quebec: such a contract would not be recognized. But, unless I am mistaken, there is nothing in the Civil Code which would prevent a woman from carrying a child for someone else. At least, that is my impression. What it says is that a contract for such services would not be recognized in law; the Civil Code also states that the mother of the child is the woman who gives birth to it, whether or not it was created using her ovum.

So, something done without thought of payment or profit is altruistic. It says that if a woman wants to carry a child for another couple, that is not prohibited. It is certainly regulated, because it is a process that requires the manipulation, outside the body of a woman, of gametes to create an embryo, and that embryo must then be implanted in a woman's body. There is the whole process surrounding informed consent. There are issues relating to the safety of the person who undergoes such a procedure to give birth to a child, etc. So, all of these activities are regulated by subclause 8(1). They would be considered controlled activities.

Is that clear?

Mr. Réal Ménard: Yes. This is an interesting debate, but I am going to give others a chance to speak. Thank you.

[English]

The Chair: Thank you, Mr. Ménard.

With your permission, ladies and gentlemen, we'll ask the health—

Mrs. Diane Ablonczy (Calgary—Nose Hill, Canadian Alliance): Can I just have one quick question, Madam Chairman?

This is with respect to item number five and it's really a question for Glenn. If we're going to expand the definition of human reproductive material to include a list of things, then it seems to me that anything not included in that list would be excluded.

My question to you is, do any of you see anything that could foreseeably fall under the category of human reproductive material that would not be caught by the list that's presently given and therefore could conceivably be excluded from the ambit of the legislation?

Mr. Glenn Rivard: I guess the answer to that is no.

Again, the origin of this is that for each of these provisions we started off by identifying the specific items we wanted covered by the provision. What we found, of course, was that in section after section we were listing the same items, if you will, the same things. So we then created a general phrase to avoid having to list these things over and over again.

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“Human reproductive material” is just a term of convenience. For each of these particular provisions, we have thought through, if you will, what things need to be protected by that provision. You will see in some instances that there are provisions that don't use this phrase, that are restricted to.... For example, the purchase of gametes. That provision deals just with gametes. We have a separate one that deals with in vitro embryos because we wanted to deal with them slightly differently.

We believe anything you would want addressed by those provisions is accurately included in the provisions by use of this term.

Mrs. Diane Ablonczy: Thank you.

The Chair: Madam Picard, you were trying to say something. I'm sorry, I didn't hear you.

[Translation]

Ms. Pauline Picard: I thought we had until 1 o'clock to ask questions. I am mistaken? We were convened for a meeting from 11 o'clock to 1 o'clock.

[English]

The Chair: We're doing it in sections. We are right now just doing the section that has to do with the interpretation of terms. The officials will come back in and they will try to answer the questions in part B, called “Prohibited Activities”. When they finish that section, anybody around the table who wants further clarification or who wants to inject a different topic into this list of prohibited activities may do so.

But I was trying to do it in sections so we could get the idea that we were making some progress. We're now on the verge of finishing part A.

[Translation]

Ms. Pauline Picard: Here is a quick question.

[English]

The Chair: One question in part A?

[Translation]

Ms. Pauline Picard: Yes.

[English]

The Chair: Okay.

[Translation]

Ms. Pauline Picard: Ladies and gentlemen of the department, I would like you to tell me why Health Canada did not prepare two separate texts, one on cloning for reproductive purposes and one on cloning for therapeutic purposes, as was done in Great Britain, for instance. I think that that would have been much less complicated than mixing all of this up together in the draft bill we have before us. Further on, mention is made of certain controlled activities regulated by the minister.

Ms. Francine Manseau: I think that on the topic of cloning, the text is clear. Clause 3 of the bill states that no one shall create a clone, and a human clone is defined as an embryo that contains the same DNA as another embryo or foetus.

The bill also contains another clause that forbids the creation of embryos for use in research or for therapeutic applications.

As for therapeutic cloning, it falls under two prohibitions. In therapeutic cloning, an embryo is created not for reproduction, but in order to be used as a source of stem cells. The creation of an embryo to be used strictly for research purposes is prohibited.

Ms. Pauline Picard: Yes, but don't you think it would have been better to discuss these things in two separate texts? In the United States and in Great Britain, there are separate texts. As things stand, you can't make sense of the text. Because of its enormous complexity, I fail to see how it will be possible, at the legal level, in sentencing and laying charges, to enforce the clauses that deal with the prohibition of reproductive cloning and the regulation of therapeutic cloning.

Ms. Francine Manseau: All types of cloning are forbidden.

Ms. Pauline Picard: And yet, cloning-related research is permitted.

Ms. Francine Manseau: No. Stem cells may be derived from an existing embryo donated by a couple for research purposes, but an embryo may not be created containing DNA identical to that of another individual, for any reason whatsoever. That is prohibited. It is stated very clearly in paragraph 3(1)(a).

Mr. Ian Shugart: For research, only existing embryos created for reproductive purposes may be used.

Ms. Francine Manseau: For instance, those embryos could be used for the purpose of deriving stem cells for research applications, with the prior consent of donors. But it is very clear that cloning for whatever purpose is prohibited.

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[English]

The Vice-Chair (Mr. Rob Merrifield (Yellowhead, Canadian Alliance)): Thank you. It's actually very difficult to get the translation. I think half of the committee is probably missing some of the conversation, but I hope it was answered.

I think we'll proceed now to the prohibitions.

Do you have one more question?

Ms. Judy Wasylycia-Leis (Winnipeg North Centre, NDP): I just have a little point of order. If you'll permit me, I have to go to the House for the debate that's happening right now, but I did want to use a moment to ask for clarification. As I understand it, an employee of Health Canada is missing in the terrorist attacks on Tuesday. I understand Christine Egan, who works in Winnipeg, was visiting her brother. On behalf of the committee, I wanted to express the condolences of our committee and ask that these concerns be passed along to family and co-workers.

I want to ask Ian if there's anything else we should know, or if any other employees were affected in this tragic turn of events.

Mr. Ian Shugart: Thank you very much for that. I don't have confirmation of that, or anything comprehensive about employees who were affected. I know of one group that was in Washington at the time of the attack and they were stranded there, including one colleague who is eight months pregnant. But they looked after themselves quite well and made sure they found lodging next to a hospital. I don't have anything further than that at the moment. I appreciate the sentiment and will pass that on.

Thank you very much.

The Vice-Chair (Mr. Rob Merrifield): Thank you. Let's proceed with the prohibitions.

Mr. Glenn Rivard: The first provision really takes us back to cloning. Just to repeat what was said earlier, the prohibition itself is against cloning without any limitation. If you look at the definition of “human clone”, again there is no limitation as to the purpose for the creation of the clone. The simple creation of the clone is prohibited. The prohibition doesn't care why it's being created.

I guess my reaction to the specific suggestion is that for that reason it's not necessary to put that in. Probably the drafters would say it's redundant, but we can certainly look at it. But again, there's nothing in either the actual prohibition or the definition of “clone” that in any way restricts the purpose that is covered. Any creation of a clone is prohibited under the act.

Maybe the second question is better answered by somebody from Health.

Ms. Francine Manseau: I guess the point that was raised here is the fact that prohibiting therapeutic research has far-reaching consequences and implications on prohibiting reproductive cloning. You are asking if we consulted on this issue and how the position was resolved internationally. It is certainly an issue that is being discussed right now by a lot of countries—countries that have been very restrictive, that have not been allowing any form of research on the embryo. An example would be Germany. Even France has not yet...because they haven't developed their regulations.

So it's an issue that has been looked at by a lot of countries. We did look at this issue here also. There were a lot of presentations. I gather that even in the animal domain right now the experiments that are being done are showing that there are some health and safety concerns. Scientists were saying to us that maybe at this point it's better to continue the research on the animals before getting into it and then creating those embryos and using those tissues to transplant into human beings—that there was no need at this point.

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I might also point out that last March the Canadian Institutes of Health Research did a report, a consultation document. In that report they were also recommending that we should not be creating embryos for research purposes for therapeutic cloning. So that's also a recommendation that was supported, if you want, by the Canadian Institutes of Health Research in their document.

To our knowledge, I think the U.K., les Pays-Bas, and Japan have legislation where they do allow that type of research. But the other countries have not yet...France said they would, but there was a lot of controversy and they have kind of stepped back. They haven't yet produced their changes to the legislation. They expect it in 2002, but it looks like they might not be going that route. So it's certainly an issue that a lot of countries are looking at.

[Translation]

Mr. Réal Ménard: There is one thing I would like to understand clearly. No one may obtain a ministerial licence authorizing the creation of embryos exclusively for research, that much is clear. That is included in the list of activities that are prohibited under any circumstances. As for existing embryos, in what context were they created? Are they extra embryos, surplus embryos from fertility clinics? Do a man and a woman agree to donate an existing embryo to a clinic for research purposes?

Ms. Francine Manseau: Yes.

Mr. Réal Ménard: Those are the only circumstances where research may be carried out on existing embryos.

Ms. Francine Manseau: That is correct. The embryos must have been created for reproductive purposes, and the couple must decide that they do not need them and will consent to donate them for research.

Mr. Réal Ménard: So in all cases, fertility clinics are involved. Can you conceive of any circumstances where fertility clinics would not be involved?

Ms. Francine Manseau: In any case, to create an embryo, you will need authorization. This is what the bill says in clause 8. Whoever intends to manipulate or treat any human reproductive material—this could mean gametes—for the purpose of creating an embryo must obtain authorization. Indeed, where will the embryos be? They will be in clinics, if you will, that will have been given the authorization to create embryos and store them. The whole consent procedure, the circumstances under which an embryo may be stored, all of this will be regulated.

Mr. Réal Ménard: For instance, the Canadian Institutes of Health Research, those 13 institutes that were created... We read the document on stem cells in our briefing book. If people wanted to do research on embryos using federal funds or in those Canadian Institutes of Health Research, that would not be possible.

Ms. Francine Manseau: Why not? I don't see what the—

Mr. Réal Ménard: What I mean is that the embryo... An embryo is the product of an ovum and a sperm.

Ms. Francine Manseau: Yes.

Mr. Réal Ménard: You say that fertility clinics will always be involved, because—

Ms. Francine Manseau: For the creation of the embryo.

Mr. Réal Ménard: Its creation.

Ms. Francine Manseau: Yes.

Mr. Réal Ménard: But as for the ones that exist, the reason they exist is that they have already been created.

Ms. Francine Manseau: Yes. They often are to be found in fertility clinics, in containers where they have been frozen, because extra embryos are often created when a couple undergoes fertility treatment. Often, more embryos are created than are needed. The whole process of creating embryos can have quite serious consequences for the woman because of ovarian hyperstimulation. You don't want a woman to have to undergo this cycle of injections and medication any more often than is necessary. So, there is a tendency to choose hyperstimulation in the course of these treatments, to remove more ova than necessary, because during the process of creating an embryo, several will not make it, will not develop sufficiently to reach the point where they can be implanted into the woman's uterus. So, the embryos that are not needed are in fact frozen.

Mr. Réal Ménard: So, there may be hyperstimulation when a couple is undergoing fertility treatment, and this may produce several embryos. A couple may decide to keep one for reproductive purposes and to donate another to research.

Ms. Francine Manseau: Perhaps. The couple may also choose to keep all of them and to keep trying because the woman may have trouble conceiving. Thus, some embryos may be used in successive attempts.

Mr. Réal Ménard: But what I am trying to understand—and I will conclude on this—is whether or not an embryo can be used for research somewhere else than in a fertility clinic, in another setting.

Ms. Francine Manseau: Yes. If, for instance, a couple decides to donate an embryo to a research project that is being carried out in a university located somewhere else, the embryo could be taken there. But the university or the institution doing the research must have obtained the authorization to do so. So there will have to be monitoring to ensure that conditions are—

Mr. Réal Ménard: So your answer is that a couple could very well donate an embryo to a university research centre, which will have to obtain a ministerial authorization to carry out such research.

Ms. Francine Manseau: Yes.

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Mr. Réal Ménard: So embryos may be manipulated elsewhere than in fertility clinics.

Ms. Francine Manseau: Yes, that could happen.

Mr. Réal Ménard: I see.

The Chair: Mr. Castonguay.

Mr. Jeannot Castonguay (Madawaska—Restigouche, Lib.): Thank you, Madam Chair.

Following up on what Mr. Ménard was saying, I understand quite well that currently in fertility clinics a certain number of embryos can be created when that is the wish of the couple involved. Is there a regulation, or any other measure to prevent someone from creating 20 embryos instead of 10 in order to create surplus organisms for research? Are there limits? Is this monitored? Are any measures in place to prevent that from happening? That is one of the dangers I am concerned about with the existing situation. I can see that it might be very tempting for researchers to create more in order to have some left over for research.

Ms. Francine Manseau: When regulations are drawn up, such ethical questions will certainly be considered. I also think that these are questions that should be examined by physicians and their association, because these really are matters that come under the purview of medical ethics and practice. There will be regulations, and people will certainly want to examine these issues. There also has to be informed consent. Individuals must know what is going to happen and what the risks are. A person may also decide to impose certain limits. We will have to examine ethical and health considerations for the people involved, because ovarian hyperstimulation that could lead to the creation of 20 embryos would be risky.

Mr. Jeannot Castonguay: Thank you.

The Chair: Ms. Scherrer.

Ms. Hélène Scherrer (Louis-Hébert, Lib.): I am going to follow up on the same topic. Earlier, in reply to Mr. Ménard's question, you said that embryos would normally or exclusively be created in fertility clinics. However, subsequently, if some research project is appropriate and relevant and embryos are needed, it will obviously be possible to move those embryos, if the couple is in agreement.

There is something I would like to know. Will the couple be asked whether they accept that the embryo be used for a particular type of research, in this or that facility, under the direction of a given researcher? The primary objective of the parents was to have a child or a second child, and they are now being asked to manage the unused product of their efforts by asking them to decide where, when, how by whom and for what purpose those embryos may be used. I think that things are taking a nonsensical turn. The couple's objective was to procreate, and it took them three or four years. Artificial stimulation was employed and this led to the creation of an additional embryo. Will the law decide that the parents or owners of that embryo will forever more have the right to say where, when, how, by whom and to what ends research will be carried out? This makes no sense.

Ms. Francine Manseau: Through this bill, it will be made clear that the embryo belongs to that couple and that it is up to them to decide what they want to do with it. Of course the couple will decide. When they have concluded their efforts to start a family, whether they were successful or not, they will be asked what they want to do with the surplus embryos. They will be asked whether they want to donate them to another couple, have them destroyed or donate them to research. They will certainly be told about the possible types of research that could be done with the embryos, and they will decide at that point whether or not to give their consent. If the couple agrees to donate its embryos to research, that will be the end of it for them. They will not be asked to further consent to giving their embryos to this or that institution, for this or that project.

Ms. Hélène Scherrer: Very well.

Ms. Francine Manseau: The research projects will have to be acceptable. The regulations will define what constitutes an acceptable research project, and if the couple decides to donate its embryos for research purposes, that will be the end of it for them. They will not be asked to donate them to a given institution or a particular physician. On the contrary, they will donate the embryo to research, and that will be the end of the process. We want to ensure that couples are made aware of the fact that when these embryos are created, they are responsible for them. They will have to decide the fate of these embryos if they are not used for reproductive purposes.

Ms. Hélène Scherrer: They could decide to have them destroyed, for instance.

Ms. Francine Manseau: Yes.

[English]

The Chair: Thank you, Madame Scherrer. Madame Picard.

[Translation]

Ms. Pauline Picard: I would like us to take another look at the issue of consent discussed in clause 6.

Ms. Francine Manseau: Yes.

Ms. Pauline Picard: You have been referring to “consent”. I don't find this clause clear and I think more explanations should be provided. Rather than simply referring to consent in writing, perhaps we should talk about informed consent.

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You know, when the woman produces ova that are retrieved, when things go well and she is fertile, she is really very enthusiastic and happy to be pregnant. She could be asked by anyone to give her consent to thank the physician or anyone involved, and she might give it readily because she is pregnant and very happy about it. I think that there should be a definition of the “consent” involved, that there should be further explanation. The persons who are to give their consent have to be able to say that they were well informed.

Ms. Francine Manseau: I think that you are raising a very important point. Consent is really one of the bases of this bill. In the regulations, the details relating to consent will be much more elaborate, because there are different situations that require consent, for instance the case of someone who is donating gametes anonymously, which is different from the consent required when someone is donating his or her own gametes for the creation of an embryo. So, indeed, the principle of informed consent is a very important one. The regulations will set out the minimum information that will have to be provided to a patient before she can agree to undergo a course of treatment.

Mr. Ian Shugart: Also, Ms. Picard, the concept of “informed consent” is well established, not necessarily in this bill, but in law, it is well accepted and used everywhere in the professions and in health care. In this context, the regulations will provide the details. The term itself is well known and accepted in law.

Ms. Pauline Picard: Madam Chair, I am remembering another clause. I don't have the number of that clause, but it is the one that refers to a deceased donor, for instance, or one who could die and who is being asked for his or her consent, or to sign a document. There is nothing precise in all that. A bit further, speaking of the law, it says that it will not be necessary to obtain proof of the authenticity of the signature. There is something worrisome about that. Does anyone have this clause?

Mr. Réal Ménard: It is about concerns people who die and who might donate organs.

Ms. Pauline Picard: Yes, and it says in clause 29 that when you prove... I think it's in the part that discusses seizure, isn't it?

A voice: Clauses 6 and 32.

Ms. Pauline Picard: Clauses 6 and 32. Under the heading “Certificate of analyst”, it says:

—in the absence of evidence to the contrary, is proof of the statements contained in the certificate without proof of the signature or official character of the person appearing to have signed it.

There seems to be a contradiction there.

[English]

Mr. Glenn Rivard: Maybe I can answer that.

Clause 32 is actually a fairly standard section. It follows very closely, for example, the provisions in the Food and Drugs Act. For the purposes of enforcing the legislation, the minister can create inspectors to go into, say, a clinic. They can inspect how it operates and if necessary seize material or written records, whatever. He can also create analysts. Analysts are the scientists who are trained to examine the material that may be an in vitro embryo and draw a conclusion as to whether, for example, it has been manipulated in some way that is not in accordance with the licence. Maybe they've tried to alter the genome of the embryo, contrary to the prohibition in the act, or something like that. What the analyst does then is prepare a report and sign it.

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This provision allows the tabling of that report in a court of law, without having to call evidence that the analyst is in fact an analyst of the Department of Health and trained, etc., to do all of this. It also allows that if the abilities of the analyst are questioned by the other party, by the defendant, then he can be called and his expertise can be established in front of the court. Generally speaking, it facilitates the court process so that you don't have to have these analysts coming to court all the time, and you have to take them through and establish their scientific training, etc. That deals with the Health Canada employee who is trained to be an analyst.

Clause 6 in general deals with other people. These are essentially the people who donate gametes or have control over the in vitro embryo, as the case may be. Subclause 6(1) basically says that you can't use any human reproductive material—that is, gametes or in vitro embryos—for reproduction unless the donor has consented to its use. So it protects the donor and ensures that full consent has been achieved.

Subclause (2) deals with the special case where the donor has died. What it says basically is that you can't retrieve gametes from this deceased person for reproduction unless he consented in writing prior to death for retrieval for the purpose of reproduction. The intent here really is to cover off those situations where you have a couple and the husband dies and the wife then wishes to retrieve his sperm and carry his child. What we are doing here is saying that you can't do that unless he has given specific consent to that prior to death.

There are two very different situations.

The Chair: We have four people waiting to ask questions at this point. I would ask you to restrict your questions to the section we are now in, if we could.

Next on the list is Madame Parrish, then Mr. Mayfield, Mr. Manning, and Mr. Ménard.

Mrs. Carolyn Parrish (Mississauga Centre, Lib.): Thank you very much, Madam Chairman.

I'm fascinated by this idea of informed consent, because the two most traumatic times in a human's life, I believe, are birth and death. I think women who are going through in vitro fertilization are going through a very traumatic time, something that most of us can't understand. So the point at which you get consent in that process is important to me. I've given consent for organ retrieval on my driver's licence or the card I carry. I made that decision in a peaceful and quiet moment; I didn't make that decision while I was lying on a stretcher in a hospital. I think we give respect to people making informed consent on organ donation, but if a woman has gone through in vitro fertilization and is thrilled to death to find out she's about to give birth to a child and a doctor or her clinician asks for consent to use the rest of those fertilized creatures, you may get a yes that you wouldn't get in a calmer moment.

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I'm very concerned that the consent needs to be at the beginning of a process, not when something has happened that's joyous and has altered your way of thinking. That's very important to me.

The other one I notice that you're kind of missing.... In subclause 6(2) you've talked about retrieving sperm from a dead spouse. I imagine the timing would be crucial. But what you haven't talked about is sperm that's already been donated and a couple who is in the process and then the husband dies of a heart attack and the woman continues with the process when he would not have given permission for her to get involved in single parenthood. I know of a case where it happened. The woman didn't tell the clinic that her husband had passed away and she continued with the process and did get pregnant.

That concerns me a lot. I know there are a lot of men who would say this is great, but if they were to die they wouldn't want to leave a child attended by one parent, or a child in a situation where it's a single parent family with economic strains. That hasn't been included in this. I'm wondering if there's any possibility that you could look into that.

Ms. Francine Manseau: If I may, I think the whole issue of consent is not detailed, it is true, in the legislation; it will be in the regulations. The intent is certainly that at a time when material is taken from a patient—that is, eggs or sperm—consent of what happens to those will be dealt with at that time.

If you have a couple that goes into an infertility treatment, and then sperm from the husband is taken to create an embryo—let's say that sperm is taken from a cancer patient even—at that point there will be questions asked as to what happens to your sperm. If you die, do you want your sperm to be used to create an embryo for that person in particular? So unless there is a consent from that person in writing to do so, you would not be able to do so.

Mrs. Carolyn Parrish: Okay. Often we hear on legislation that it's going to be addressed in regulations, and we don't pay as much attention to regulations as we do to legislation as a body. And I'm speaking for all my colleagues. So I would hope that my concern over the timing of consent is fully emblazoned on your memories, so that we don't just say we'll take care of that in regulations, because I don't think that's the place to do it.

The Chair: If I could interject here on this idea of consent, I would remind my colleagues that one of the ethicists who was a witness here, Dr. Françoise Baylis, told us that in her view the consent concept was so integral to the integrity of this bill that she felt it should not be in the regulations. So while Madame Manseau has said it will be in the regulations, I don't think that's written in stone. I think that if we choose, we can recommend to the minister that it not be in the regulations, that the whole section be expanded and be made more specific and also be in the bill. I'm just putting that out to you as a possibility, because certainly I felt that Dr. Baylis was one of the most helpful witnesses we had.

Mr. Rivard.

Mr. Glenn Rivard: It may be that the provisions can be expanded upon, but certainly all of the fundamental circumstances are covered in these provisions. I think that regardless of how it's expanded upon or changed, you will still need a provision very similar to what is in paragraph 40(1)(c), which creates the authority to regulate with respect to consent. The intention there is to create a consent form that would cover off in greater detail the type of information that has to be provided to ensure informed consent and would create separate choices for different outcomes with respect to the embryos.

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I think it is very difficult to foresee all of the circumstances with respect to consent and at the end of the day be satisfied with provisions in the act.

The Chair: No, I can understand that.

Mr. Glenn Rivard: It's not to say these can't be amended, but I think you will always need that extra regulatory flexibility.

The Chair: The thing we worry about as legislators is what you refer to as “regulatory flexibility”. Most MPs are very uncomfortable with too much regulatory flexibility. That's why I'm saying that we may decide as a group that we want some pretty specific things in the legislation itself, even if in the regulations we need things like a form, a description of a form, a list of information that has to be gathered by the person who is supposedly leading the patient on to informed consent.

I think the number of people who want to talk about this is a warning flag to the creators of the legislation and the regulations that this is an area of concern. That's all I'm saying. I'm trying to assure Madame Parrish and others that we have this option open to us to make sure it's in the legislation as well as the regulations, so that the essential principles of informed consent can at least be in the legislation.

Madame Parrish, are you finished?

Mrs. Carolyn Parrish: Yes. Thank you very much. You interpreted my words very well.

The Chair: Thank you.

Mr. Merrifield.

Mr. Rob Merrifield: I just want to get back to the subject prior, which was talking about the embryos in in vitro cases. The suggestion was that in the future there perhaps would be some limitations on those.

I guess it's a grey area, because it's the intent that is sort of subjective in this thing. The intent initially is to reproduce another child from couples wanting another child. But the intent then becomes very fuzzy and foggy when it gets into research. It's so subjective.

I guess my point is, are we creating embryos today that are being frozen with the wrong intent, and is there any way we should be restricting it now? We talk about it in the future, but it's now that I'm even more concerned with. Is there any reasonable number that should come out of an in vitro...? I know there are some in vitro clinics that will only draw three eggs, or two eggs. There are others that are unlimited.

Ms. Francine Manseau: Are you talking of the number of embryos being created, or the number that's being put back into a woman?

Mr. Rob Merrifield: The number that are being created more so.

Ms. Francine Manseau: That there be a limit on the number that would be created.

Mr. Rob Merrifield: Yes.

Ms. Francine Manseau: I would say the intent of the legislation is certainly to protect the health and safety of the people involved. Without getting to the point of dictating exactly, I think you do have to.... Doctors are trained to make decisions, not to put the lives of their patients into risk. Certainly with the authority to regulate, if there are instances where it is said that maybe a woman went through hyper-stimulation and 20 or 25 eggs were retrieved, I guess you could go in and ask some questions. I think it's a protocol of good medical practice, it's not something that....

Mr. Rob Merrifield: I just wanted to flag that. I don't really expect much of an answer.

Ms. Francine Manseau: No.

Mr. Rob Merrifield: But there's another one that struck me a little bit, and that's with the therapeutic and reproductive cloning. You're suggesting and the bill is suggesting that both would be banned because the intent doesn't matter, as long as if you're cloning, whether it's for reproductive—another Dolly the sheep—or for therapeutic, which is to draw stem cells, that's not differentiated, and that would be fine. The other place to get a stem cell is from an embryo, not cloned. Is there a distinction between a cloned one and an embryonic one? I mean, they're both embryos, but there's a difference.

Ms. Francine Manseau: They are both embryos.

I think the rationale that's been put forward to create embryos specifically for therapeutic use was that the stem cell that would be derived from an embryo that's been a clone of let's say another human being...the rationale has been that the stem cell would not be rejected by the individual into whom those cells would then be transplanted. That has been some of the rationale for allowing therapeutic cloning.

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I guess people are still saying that not enough research has been done yet using existing embryos and using those stem cells. There hasn't been that much. Some people are saying maybe the rejection would not be the same as when you are transplanting adult cells into another adult, because those cells have developed a kind of immunity, which would not be the case with embryonic stem cells. I think people are saying we haven't yet done enough research even with existing embryos. We should do that before we go ahead and start creating embryos just for the purpose of deriving cells.

The Chair: Thank you, Mr. Merrifield—

Mr. Ian Shugart: Madam Chair, just to be clear, cloning is of course not the only means of creating the embryo. For research purposes, things are proposed to be allowed subject to the licence, but cloning for therapeutic or reproductive purposes is categorically proposed to be disallowed.

Mr. Rob Merrifield: Sure, and I agree with that. My point was why the push, and you explained it: because of the rejection. That's why people are suggesting that perhaps for therapeutic there's a rationale for it. I didn't understand the rationale.

Thank you.

The Chair: Thank you.

Mr. Manning.

Mr. Preston Manning: Just a comment and a question. I'm always concerned about how the laymen reading the legislation will interpret it. I know you can't satisfy the laymen and the lawyers.

There is some confusion when you say people shall not create or participate in the creation of a human clone. The layman thinks you're talking about the creation of the whole person. When you talk to the public, and some of our colleagues, the distinction is between reproductive cloning and therapeutic cloning: in one you're trying to create a whole person and in the other you're trying to create organs. I know that's not the case. This defines a human clone as meaning an embryo. But I'm just conscious that our political colleagues will have trouble explaining that.

This provision, the way it is now, as has been mentioned, bans both reproductive cloning and therapeutic cloning. Could you summarize the reasons for wanting to ban reproductive cloning? There is a difference. Just what are the principal reasons for banning therapeutic cloning as well as reproductive cloning?

The Chair: Do you really want to get into that right now? That could take another hour.

Mr. Preston Manning: No, just 30 seconds. What's the principal reason? I think we all just instinctively know why we're against reproductive cloning. Most of us have grave reservations about therapeutic cloning as well. What's the number one reason, different from reproductive cloning?

Ms. Francine Manseau: I think there's another prohibition in the legislation that says you cannot create an embryo just for the purpose of research. Be it for therapeutic cloning or for other reasons, you cannot do it.

Specifically for therapeutic cloning, I guess what we have heard is that even right now in the animal domain there are still problems and issues in terms of safety of those cells that are derived from those animals that have been cloned for that purpose and to test if the procedure is going well or not. Some researchers are saying we still need to do more research into the animal domain before we go ahead and create embryos, if we're not sure yet if it's going to work. People are also saying there are embryos right now that are not being used for reproductive purposes that are surnuméraire, and we haven't yet done enough research with them to draw the conclusion that we need to create embryos just for the purpose of research.

As I said, the Canadian Institutes of Health Research, the group of scientific people there, who wrote their working group report, also recommended that at this time there should not be the creation of embryos for that purpose.

The Chair: Thank you.

Mr. Lunney.

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Mr. James Lunney: Just a footnote to that. The great research breakthroughs on adult stem cells recently at McGill University and others, where they've been able to take skin cells and grow them in vitro into neurons, muscle cells, and so on, are going to obviate the need to go with therapeutic cloning.

Ms. Francine Manseau: It could be. I guess there are other avenues to....

Mr. James Lunney: It will avoid the issues of viral transmission, mitochondrial DNA from the donor, and so on.

The Chair: Mr. Lunney, you're satisfied with...?

Mr. James Lunney: I just wanted to make that comment. There are tremendous breakthroughs in that particular arena that are very promising that would obviate the need for using.... You'd be able to find the cells in your own body, to grow tissue for your own body.

The Chair: Yes. I think most of us heard that particular one on skin out of Montreal mid-summer. It was very encouraging.

Are there any other questions on part B? I should tell you that these guests are coming back again on Thursday as we proceed to work our way through.

I think one of the advantages of this process has been...I don't know about you, but I have had issues brought back to me, reminders of what we went through in the spring, just by going through the process. So I'm very grateful for the work the researchers have done in the summer, plus the preparation for this meeting with the officials from Health Canada.

Before I close this meeting, are there any more questions on part B? If not, we'll start with part C at the next meeting.

Mr. Ian Shugart: Madam Chair, I wonder if I could add a point. In both Ms. Parrish's questions related to informed consent and tangentially to Mr. Merrifield's question, in dealing with the provisions of a future bill and the regulations, and taking your point very clearly about where that line is drawn, we do need to be careful not to impinge on directions or issues that in fact would relate to the practise of medicine. That's purely a jurisdictional question and doesn't really relate to whether it's in the law itself or in the regulations.

There would be, for example, professional codes of practise and so on that would speak to these issues of the practise of medicine and how informed consent is obtained and so on—well-established, not cast in stone, they evolve, and so on.

One of the things that we have to be careful of is the actual jurisdictional line between the federal authority and provincial authorities related to the practise of medicine.

So that's an issue that you carry in your mind as members of the committee that we will need to be quite strict about when we come to the drafting.

The Chair: If I can respond to that, Mr. Shugart, certain of the letters we're getting from people who have participated in this in vitro fertilization process would suggest to me that some of these codes of conduct that are put in place by the medical brotherhood or sisterhood out in the provinces aren't working too well. Is it not the fact that we are considering the use of the Criminal Code for precisely the reason that that is the jurisdiction of the federal government and that in fact some of these practises might need the oversight of the federal government?

Mr. Ian Shugart: You're absolutely right. That is entirely the rationale for the use of the federal Criminal Code.

I'm simply indicating that judgment will have to be exercised as to when the use of the Criminal Code is justified in taking precedence over something like the practise of medicine.

I don't wish to argue that everything is fine in that regard, but I simply want to identify an area of.... The interface is one that is fairly intricate and will have to be taken into account in the legislation ultimately.

The Chair: Yes, and I think my colleagues and I understand the fact that we have yet to hear from the medical fraternity/sorority, and that they will be trying to defend their right to a lot of their own choices. We have yet to hear from the scientific research community, which will be pushing us to have very few rules in order that they can get as many stem cells from embryos as possible, etc., to further their passion for their research. We understand the pressures that are going to be coming at us, but I think we start from a position that our main goal is the protection of the public and the protection of the integrity of...humanness? There is some kind of term about the genetic code, I think it is.

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Mr. Ian Shugart: The integrity of the human genome.

The Chair: The integrity of the human genome. That's our basic rule. So these people will come and try to push us hither and thither. But we know what our purpose is here.

I want to thank you for coming today.

I want to tell my colleagues that I've had handed to me a motion from Mr. Merrifield, which, being presented today as a notice, will come up at the committee on Thursday. It says: “Moved that the committee recommend the government take immediate action to ban human reproductive cloning in Canada”, the main idea being “immediate action”, which would move it forward ahead of what we are doing.

So I want you to think about that, because we will be voting on this motion and probably debating it a little bit on Thursday. So consider yourself given notice.

Thank you very much. I'm sorry I was late this morning. I'll try to be more prompt the next time.

This meeting is adjourned.