HEAL Committee Meeting

STANDING COMMITTEE ON HEALTH

COMITÉ PERMANENT DE LA SANTÉ

EVIDENCE

[Recorded by Electronic Apparatus]

Thursday, May 31, 2001

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[English]

The Chair (Ms. Bonnie Brown (Oakville, Lib.)): I call this meeting to order.

Good morning, ladies and gentlemen. It's my pleasure to introduce to you the panellists who are going to assist us with some of the more thorny questions that we as politicians will face on this file.

I will announce that Dr. Michael Burgess has been unable to come because his flight was cancelled and there wasn't another one that would get him here on time.

So we have Françoise Baylis from the department of bioethics at Dalhousie University; we have Laura Shanner, the associate professor of population health from the University of Alberta, and Dr. Margaret Somerville, the director of the Centre for Medicine, Ethics and Law at McGill University.

I think we could begin with presentations and we'll follow that up with questions. Perhaps I can ask Ms. Baylis to begin.

[Translation]

Ms. Françoise Baylis (Associate Professor, Department of Bioethics, Dalhousie Medical School, Dalhousie University): Good day. First, I would like to thank the committee members for inviting me to make this presentation. I am pleased and honoured.

Secondly, let me specify that I am addressing you today as an independent researcher and not as a representative of any of the national committees on which I sit. My field of expertise is in the philosophy of bioethics, and my research is focussed on embryo research, and currently, more specifically, stem cells, new reproduction techniques, cloning and genetic therapy. I am interested in the concepts of identity and justice.

Now, without further ado, let me make my presentation, which will be in English.

[English]

My presentation today is in two parts. First, I will outline features of the draft legislation that in my view are to be commended. Second, I will identify aspects of the draft legislation that in my view need to be corrected. My comments in the latter category are illustrative and not comprehensive.

At the outset, it's important to highlight aspects of the proposed legislation that are to be applauded. Too often in our eagerness to provide a critical commentary on a draft proposal we neglect to mention that which is positive and should be retained. The risk in so doing is that positive features of the original proposal may be subsequently revised for the worse. At least that's been my limited experience in the realm of policy-making. And so, learning from my past mistakes, I am particularly mindful of the need to first tell you what I like about the draft legislation. My strong recommendation is that these features of the proposal not be amended.

First, the preamble to the draft legislation is exceptionally good. It names a number of important considerations and entrenches core values in the legislation. This will undoubtedly assist lawmakers in interpreting and implementing the legislation and developing coherent regulations.

Particularly noteworthy: one, recognition of the need to attend to the best interests of children born of assisted reproductive technologies; two, recognition of the disproportionate impact of assisted reproductive technologies on women; three, the commitment to respect autonomy and in particular to promote free and informed choice; and four, an awareness of the problems of commercialization and commodification.

The second positive feature I'd like to stress has to do with the list of prohibited activities. The following procedures are prohibited in the legislation: human cloning by blastomere separation and somatic cell nuclear transfer; germ-line gene transfer; maintaining an embryo ex utero beyond 14 days; creating an embryo for research purposes; creating embryos from an embryo or fetus; transplantation of animal sperm, ovum, or embryo into a human; transplantation of human reproductive material into an animal to create a human; and sex selection. As well, offering or paying for any of these prohibited activities is itself prohibited, as is the brokering or paying for surrogacy and purchasing and bartering of gametes and embryos.

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Some will come before you and argue that these prohibitions will hinder research and innovation. Hopefully they're right, because it's imperative that we slow research and innovation in these very areas. I stand firmly with those who maintain that just because we can doesn't mean we should. Unless and until we are confident that we should proceed with the novel and ethically controversial activities identified, it is imperative that they be prohibited. A moratorium is simply not an effective alternative, presuming the goal is to ensure that these activities are not undertaken before critical evaluation can be conducted on the merits of highly questionable practices that threaten core concepts such as identity and justice.

No doubt others will tell you of dire consequences associated with legislating these prohibitions and oft-alleged consequences that talented Canadian researchers and health care providers will leave Canada if their practice is constrained.

First, I doubt the accuracy of this claim. In my view it is mostly scaremongering. Canada is a wonderful place to live and work, and many scientists and health care providers are eagerly looking to the federal government for guidance.

Might some people emigrate? Possibly. And this brings me to my second point. The possible departure of talented Canadians is not a sufficient reason to modify the proposed prohibitions.

Imagine—and this is what philosophers often ask people to do—that a talented group of physicists at one time had told Canadians parliamentarians that they needed to be able to develop the atomic bomb or they would leave Canada. Also, imagine that Canadians believed atomic warfare to be morally wrong and that the government had chose to limit such research. Would the threat of losing these talented physicists have constituted a sufficient sound moral argument against a national policy that was consistent with the will of the people?

Not to put too fine a point on this, consider the current situation with health care and the loss of talented physicians to the United States. This in itself is insufficient reason to introduce a two-tiered health care system and destroy the current system, which Canadians are so proud of.

Now let me move to the features of the draft legislation that I believe need to be revised. The first area has to do with the issue of consent. The preamble to the draft legislation includes the following statement, that the Parliament of Canada:

wishes to promote the principle of free and informed consent as a fundamental condition of the use of human reproductive technologies;

But some questions remain, and perhaps most important amongst these is whose consent is required for embryo research, one of the more controversial practices?

Subclause 6(3) of the draft legislation provides that donors of an in vitro embryo or any part of one must consent, in writing, to its use “for the purpose of research or the prevention, diagnosis or treatment of disease, injury or disability”, which is what appears in subclause 8(2).

This suggests that a licensable, controlled activity pursuant to subclause 8(2) can proceed with the consent of the embryo donor. This is potentially problematic, however, in those areas where gamete donors have been used. The gamete donors may have donated genetic material expressly for reproductive purposes, not for research purposes. How are their wishes to be respected?

Further, this interpretation of the legislation is inconsistent with the accompanying overview document, which portrays the gamete providers as the decision-makers. I quote from that document, page 8:

For example, donors would have to consent in writing to the use of their gametes to assist human reproduction. Their consent would be required for the use of their embryos for purposes both of research and of reproduction.

A critical question then that needs to be addressed in your review of the legislation is, whose consent is required for embryo research, the gamete donors or/and the embryo donors? Your answer to this question must be clearly and consistently reflected in the revised legislation and the supporting documentation.

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My second area of concern with the legislation has to do with the clauses on animal-human hybrids and chimeras. The draft legislation on cross-species research prohibits the transplantation of animal sperm, ovum, embryo, or fetus into a human being, in paragraph 3(1)(f). It also prohibits the creation of a human being using human reproductive material that is or was transplanted into an animal, in paragraph 3(1)(g).

The creation of chimeras, however, is not prohibited. Chimeras could be created for research or other purposes under authority of a licence, as specified in subclause 9(1). As well, a licence could be granted to combine part of the human genome with part of an animal genome, according to subclause 9(2). Significantly and problematically, not all categories of genetic mixing are clearly captured and delineated in these areas of the draft legislation. At the very least, clear definitions of inter-specific hybrids, nuclear cytoplasmic hybrids, and inter-specific chimeras are needed.

In the documents that you will receive after this, I actually explain all of these terms for you, and I can come back to that in the question period. It's a wonderfully complicated topic you have.

Basically those three activities, I would argue, need to be prohibited. I would say, however, that the insertion of a non-human gene into a human or vice versa would not be captured by the three proposed prohibitions that I put before you and could legitimately be classified as a controlled activity.

My third point in terms of the problems with the draft legislation is the excessive reliance on regulations. As regards the controlled activities, in my view too much is left to the regulations. While I well understand the need for flexibility in this fast-paced area—hence the general preference for regulations over legislation—there are some issues in the area of assisted human reproduction better dealt with in legislation than regulations. Three brief examples are provided.

The first is the disclosure requirements for valid, informed consent. In the draft legislation, the disclosure requirements for consent are to be specified in the regulations according to paragraph 40(1)(c). In my view, given the importance of free and informed consent as outlined in the preamble to this very piece of legislation, given the need for national uniform standards of disclosure, and given the option afforded to provinces to not be subject to clauses 8 to 40 of the draft legislation, there would appear to be no good argument against—at minimum—codifying the currently well-accepted common law in this area.

A second example where too much is left to the regulations has to do with the grandfathered activities. Clause 43 provides that a person without a licence carrying out controlled activities may continue to do so “until such time as may be fixed by the regulations”. Instead of having an indefinite period, a limit should be set in this legislation. For example, it should be specified in legislation that a licence should be obtained within a year of the regulations coming into force. Otherwise, it's within the realm of possibility that those to whom this clause refers could successfully lobby to have permanent grandfathering. This possibility should clearly be precluded by legislation.

The third example has to do with the national regulatory body. As currently worded, it is possible to read—and indeed some have read—the draft legislation as not creating any kind of national regulatory body. Yet this was clearly contemplated by the drafters. The overview document states that a regulatory body either within Health Canada or external to it—i.e., at arm's length—would be responsible for overseeing the implementation of the proposed legislation. That's on page 9. The creation of a national regulatory body should be entrenched in legislation.

This brings me to my final point with regard to the aspects of the draft legislation that I believe are problematic. That has to do with the regulatory body. From my understanding, in addition to providing general feedback on the proposed legislation, this committee has specifically been tasked by the Minister of Health to provide recommendations on the proposed national regulatory body. Of particular interest is the committee's view on whether this regulatory body should be within or external to Health Canada.

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I cannot address this specific issue directly as I do not have a clear enough understanding of the ramifications of the choice. There may be increased accountability with a committee internal to Health Canada, but possibly also increased conflict of interest. In any case, I'm sure there are multiple factors to consider.

I can assist you, however, in your appointed task by helping you to appreciate some—not all, because I'd take up everybody's time—of the problems with the current research ethics review system that underline the need for national oversight.

In Canada all research involving humans, human remains, cadavers, tissues, biological fluids, embryos, or fetuses must be reviewed by a research ethics board, and at the present time there is no national oversight. There are significant problems with the current review system, and since 1990 there have been different calls for national committees to review reproductive and/or genetic technologies and research.

I have provided you with an appendix that shows you the breadth of those calls in Canada since 1990. The most recent call has come from the United States, dated May 18 of this year. It is a pressing problem internationally. I've also provided you in the appendix with examples from around the world, where we see consistently a call for national oversight in research in this area.

The problems with research ethics review in Canada are manifold, and they include the following: one, the complete absence of a national education and certification program for REB members to ensure that they're adequately trained for the job; two, the absence of a national accreditation program for REBs, perhaps with special competence areas; three, the failure of REBs to comply with the tri-council policy statements, which are the guidelines governing research involving humans; four, the inability of REBs, which rely on volunteers and are typically understaffed and underfunded, to monitor the research they approve; five, the lack of uniformity across the country as regards what constitutes ethically acceptable and unacceptable research; and six, the lack of legislation, regulations, and guidelines governing privately funded research.

In addition to these problems, which are specific to the ethics review generally, are those that are specific to research on novel genetically based technologies. I'll highlight only two additional problems—first, the lack of expertise at the REB level because of the highly specialized nature of this research; and secondly, the significant potential for conflict of interest, as anybody who would have the talent to review it is likely associated with the team doing it.

A national oversight committee is recommended in the belief that it will: one, assure the Canadian public that the research undertaken is of the highest scientific quality and is ethically defensible, consistent with the values and mores of Canadians; two, provide a greater degree of accountability than currently exists with self-regulation; three, ensure a national standard for this research that will apply to both private and public sector research, which, I will tell you, is significant, because most of the research is happening in the private domain; and four, ensure greater access to appropriate expertise.

As I've said before, for these and other reasons countries around the world are advocating for national oversight. I stress this because I know a number of you are concerned about the division of powers between the provinces and the federal government, and I'd be happy to talk about that as well.

My closing point is that there is a problem with the draft legislation that concerns the opt-out clause for the provinces. Subclause 41(1) creates a provincial opt-out clause for clauses 8 to 40, provided the minister agrees that there are in force laws of the province equivalent to clauses 8 to 11, clauses 18 to 21, and clauses 23 to 32. There are two discrete and very, very serious problems with this.

First, if a province establishes equivalence with respect to the regulation of controlled activities, they become exempt from the penalty sections for the prohibited activities. How can this be?

Second, the potential for provincial opting out seriously undermines the potential for establishing national standards in this area, which is why I took the extra time to tell you what a horrific problem there is with research ethics in this country. This is precisely what is needed, and I would close by saying that it's precisely what Canadians are asking you for.

In closing, I thank you for your attention. I hope some of my comments have been helpful.

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The Chair: Thank you, Ms. Baylis. We look forward to rereading your paper and getting some of those terms straight in our minds.

Could we move on now to Ms. Shanner.

Dr. Laura Shanner (Associate Professor, John Dossetor Health Ethics Centre and Department of Public Health Sciences, Faculty of Medicine, University of Alberta): Thank you very much for having us here today. My testimony will be available to you afterwards, as well as an article that Jeff Nisker and I just had published, on May 29, in the Canadian Medical Association Journal. I believe Jeff was here a few days ago. We've summarized several issues in a very quick capsule form that I hope will be helpful. So that's what that's for.

My background is in philosophy and premedical sciences. I'm currently an associate professor of health ethics at the University of Alberta. I've studied reproductive and genetic technologies for about 13 years now in Australia, the United States, and a little bit in Britain as well as here in Canada.

I'd like to start by echoing Françoise's comment that there is much to be appreciated in this draft legislation. I'm going to ask you to add a few more things to it, as she has as well.

I'd like to emphasize that legislation in this area is very long overdue. Reproductive technologies like in vitro fertilization started over 20 years ago. At present in Canada, as largely is the case in the United States, these technologies are largely unregulated and almost completely uncontrolled.

I am in frequent contact almost daily with members of several infertility support groups across Canada. I have to tell you I remain appalled at the number of cases and problems that come across my desk on a weekly basis. There are widespread problems in clinical settings with informed consent, both about the ways in which the treatment will affect patients, the outcomes and risks, and also with psychological and social counselling to deal with very difficult and profound decisions about families and family relationships. This is especially a problem when donor gametes are used. The offspring from donated sperm or eggs are not able to find out who their genetic parents are, and I'll come back to this theme in a moment.

In Canada, almost all donated sperm has been quarantined because the vast majority of clinics didn't get around to doing the follow-up hepatitis test that would protect people who received the sperm donation from contracting a serious illness. As a result, almost all donated sperm in Canada is imported from a single American company, and we have no additional regulations to make sure that the imported sperm is any safer than Canadian sperm. It is the clinicians who are supposed to ensure the imported sperm is safe, and they're the ones who failed to ensure the safety of our supply.

Right now we have bidding wars going on for the sale of eggs and sperm. It used to be about $40 per sperm sample. The going rate in Ontario is now about $70. The price for eggs has jumped from about $2,500 to about $5,000 in most Ontario clinics. These kinds of lapses are not ethically acceptable, and that's why the legislation is necessary.

I'd like to go back to some basics. There are many different ways of talking about ethics, and sometimes we get lost in the details. These are complicated technologies. There's a lot of terminology. Let's go back to some basics and keep it simple, in a way.

I'd like to hit three main points. First, procreation is one of the most profound and therefore most complicated of all human experiences. Second, by definition, reproducing involves bringing new people into the world, and their interests must be paramount in a reproductive consideration. Third, reproduction is not quite the same for men and women, so we need to be aware of gender difference and gender equality in any reproductive conversation.

On the first point, birth and death are the only two universal human experiences. You start intervening in either the beginning of life or the end of life and you touch the absolutely most profound of any possible human undertaking. That's what we're doing.

Reproductive and genetic technologies are important to us physically, psychologically, socially, economically, spiritually, and culturally—just about every possible way. It will never be easy to understand these technologies even if you get the terminology. It will never be easy to regulate these technologies. We will not be done simply by passing one piece of legislation.

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It is for this reason that the royal commission and every subsequent significant Canadian inquiry has recommended we establish a free-standing, quasi-governmental advisory board to keep a finger on this pulse. It's that difficult and that complicated.

This is necessary because, first, reproductive technologies are incredibly fast-moving, and you need experts in just about every area of human expertise to make sense out of them. It cannot be done in a part-time, half-baked, half-attentive kind of way, but must be a full-time, dedicated job by a rather large group of people with a wide variety of expertise.

Secondly, reproduction is a highly personal activity, and a lot of people have concerns about the role of government in regulating reproductive choices. For this reason, any regulation needs to be a very public process and it needs to have very broad representation.

Thirdly, as Françoise mentioned, there are concerns about the federal and provincial roles in the delivery of health care, and it's not clear that it's appropriate for the federal government to claim primary jurisdiction on issues that cross federal and provincial boundaries.

In the outline I give several recommendations for what needs to be included in the structure of such an agency. I'd like to call attention to just a few.

One is a commitment to long-term funding, and I'm thinking 10 to 20 years minimum. It would need the authority and resources to collect information and publish outcomes, data, and informed-consent material for clinicians and patients. It would need to keep a registry for donors. It would need to do research review, as Françoise outlined, and there would need to be people who monitor the legislation and regulations at both federal and provincial levels, making recommended changes as necessary, working with all levels of government.

Most importantly, in this agency we need broad representation, not just the scientists who develop the techniques or the clinicians who provide the techniques, not just experts like us, who make our living talking about these techniques. The core people who need to be working with these technologies are the patients, the families, and the offspring who are most directly affected and who can tell us where the problems really lie.

The second point is that the entire purpose of reproductive and genetic technology is to bring healthy children into the world. We're not interested in making embryos just for the sake of making embryos; we're hoping to have babies as the result of infertility treatment. We don't do genetic tests in pregnancy just to run a test because it's fun; we do it because we're trying to ensure the health and well-being of the child before that child is born.

Because we are bringing somebody else into the world without their knowledge or consent, choosing to procreate is one of the weightiest decisions we can make. There are times, reproducing in the old-fashioned, fun way, that when people are interested in sexual activity, sometimes procreative activity follows, and we might say that reproduction was unintended. But reproductive and genetic technologies never just happen. People go out of their way to make babies.

This carries intense responsibility. We owe great responsibility to those offspring in a long-term framework, because it's not just getting born that matters, and it's not just children of reproductive and genetic technologies; these babies grow up to be adults just like the rest of us. They want to get married and need to know if, by accident, they're partnered with a relative from the same sperm donor. They need to know their own health histories. They need to know whether these sperm or egg donors had a history of cardiovascular disease or cancer. And they can't get that information. These offspring need to develop their own social and familial identity, and like the adult children of adoption, we're hearing from great numbers of RGT offspring from donor conceptions that they feel a missing chapter in their lives. They deserve to have that filled.

We need to remember that privacy for the donors and the adults involved is not the same thing as secrecy about a person's origin. Those very reasonable interests need to be balanced.

We also need to consider the challenge that if we move to open donation records, we wouldn't have donors. Experience indicates that's not true. The Sperm Bank of California has had open sperm donations only since 1982 and they have plenty of donors.

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The other point is that some men who gave sperm 20 or 30 years ago are now coming forward to say that they wish they knew whether they had offspring in the world and whether those children are doing well. It's not the case that donation necessarily has to be a secret matter to the donor.

Moving to the prohibited list of activities, the list is appropriate, and I think they should be prohibited for the following reasons regarding the well-being of offspring: first, the health risks. When you manipulate the genetic code or significantly manipulate the embryo or try to raise human offspring in non-human environments, the risks for the resulting offspring are profound, primarily in a physical sense. There is no justification to cause a child to be born into these circumstances without massive, overwhelmingly plausible benefit for the child of having this done rather than having it not done. I don't see any plausible argument to that effect. It is appropriate that these be banned.

There are also psychosocial risks. The concept of the designer baby—of having the child you wish to have either by choosing the sex of your child, by genetic alteration, or perhaps by cloning to create a child identical to another child or another adult—makes an expectation that the child will be just like some idealized image. Well, we know that this is devastating to the psychosocial development of a child. There is no excuse to allow this kind of behaviour that we know is profoundly hurtful and has no plausible benefits.

Finally, commercial surrogacy arrangements literally involve the exchange of cash for the handing over of the child. This is selling a human being, which is abhorrent and cannot be allowed.

There are some comments in the paper, and I'll be happy to discuss these later. Some people suggest that it is not possible to outlaw certain kinds of embryo research or fetal intervention while still allowing embryo research generally or allowing abortion. I think it is possible to draw lines so that some procedures are allowable and others are not.

I won't go into detail here, but I would point out that if we try to grant a broad status of person to embryos or fetuses, you're going to open up so many cans of worms, in a policy context that most people don't think about, that I don't think you'll get out of it. If fetuses or embryos are persons under the law for medical purposes, they should be persons under the law to be dependants under the tax code, to be citizens under immigration and citizenship law, and to be counted in the census. And I don't know how you're going to count embryos and fetuses, the vast majority of which at the embryonic stage we don't even know are there and the vast majority of which do not survive beyond the first six weeks of conception.

The second concern is multiculturalism and respect for the variety of cultural and religious beliefs. The belief that meaningful personhood begins at conception is contrary to the teachings of Judaism and Islam, and it is not appropriate under charter protections of religious freedom to establish one religious framework above others in an area where the science cannot provide conclusive answers.

The third point, again, is obvious. Reproduction is enormously more demanding physically, emotionally, and socially for women than for men. Women carry pregnancies, and men do not; and acquiring ova requires invasive procedures to women's bodies in a way that acquiring sperm does not. We need to ensure that women are protected under the charter non-discrimination section. Women must not be forced to bear undue burdens either for reproductive control or for the pursuit of embryo research, and women must receive a fair share of benefits relative to the burdens shouldered in contributing to embryo research. Any time we do research involving embryos, fetuses, or reproductive processes, we need to think of it as a women's health issue because women's health may be affected by hormones or invasive procedures long after a pregnancy or infertility treatment has ended.

We need to consider the range of women's health interests, which may range anywhere from increasing the likelihood of pregnancy, avoiding injury or poor health for their children, avoiding intervention in the pregnancy, avoiding pregnancy altogether, and perhaps terminating pregnancies that are problematic for them in some way.

One thing that the legislation does not really address that I think would be a good addition is the comment about ensuring the effectiveness of genetic tests before they're licensed for use in Canada. It's one thing to say you need a licence to perform the test or run the tests in a laboratory; it's something else entirely to say that some tests have such a lousy accuracy rate that it's not good to put someone through it, as we won't get good information.

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We need clear guidance, first, about the safety and efficacy of the test. Second, we need to continue the dialogue led by the advisory committee about which genetic conditions are serious enough to warrant testing on a widespread scale. Will we allow tests for baldness, obesity, or homosexuality if genetic links are found for those traits?

One important point is that motherhood is not parallel to fatherhood. There's only one biological father—the genetic father.

Motherhood has those genetic components—the person who provided the ovum—and also a gestational component—the woman who's pregnant. For all of human history until 20 years ago, these two mothers were always, undoubtedly, the same person. That's not true any more. Who's the real mother? If you take Mary's ovum and put it in Susan's body, whose name goes on the birth certificate? Right now, it depends. If Mary is an egg donor and Susan is an infertility patient, then Susan gets to be the mother. If Mary is the infertility patient, and Susan is hired as a contract surrogate mother, then Mary gets to be the mother.

Quebec is the only province to have settled this thorny question. They've decided, I believe rightly, that the woman who gives birth to the child should be listed legally as the child's mother, regardless of any genetic relationship or pre-existing contract or agreements.

I think we need to go farther, however, and talk about identifying the gestational mother and the genetic mother as well as the genetic father on the birth certificate, keeping these records in perpetuity just as with other birth certificates, and creating a new framework roughly equivalent to adoption to handle the custody and social parenting arrangements.

It may be possible to issue a new certificate with the names of the social parents listed, as we do in adoptions. When we issue that new certificate, that could be the legal endpoint of any claims that the child might have against their biological parents in matters such as child support.

Not to identify the genetic and gestational parents creates a gap for the child and also misunderstands the nature of pregnancy and motherhood. This is bad for offspring, and it's bad for women.

Recognizing the additional burdens for women in reproduction does not in any way undermine the importance of men's interests. I find that men are very often taken lightly in a reproductive context. Their interests need to be protected as well, so that they are not exploited for access to sperm, so that their interests in the meanings of fatherhood and the role of being a biological father are clear to them, and so that we support families including donors who participate in reproductive arrangements across all of the family members—fathers, mothers, and offspring—in all of our various relationships.

To conclude, so far, especially in Canada, reproductive technologies have largely been driven by the people who develop the technologies and who therefore have a financial stake in them. The patients who use the technologies and sometimes are hurt by them, and the offspring who result from the technologies and are profoundly affected by them, frankly have very little to say. They're not listened to; they don't have appropriate support; they don't get appropriate information; and they're screaming, in many cases, for assistance.

It is our responsibility to be helpful in the very difficult context of genetic disease or infertility. Canada's federal government, through the health policy division in Health Canada, has supported truly excellent ethical and policy investigations into RGTs. Unfortunately, we failed so far to really accomplish much of substance that filters down to the patients and families.

Assisted procreation and the lives of the patient's families and offspring are too important to be left languishing in an unsupported, free-for-all environment. It's time to embody an RGT regulatory agency, as the royal commission emphasized, and to make sure that patients and their offspring are protected. I urge you to revise the legislation appropriately and move this forward as quickly as possible.

Thank you very much for your time, and I'll be happy to discuss this as we go along.

The Chair: Thank you, Ms. Shanner.

Time is starting to slip away. I'd like to move immediately to Dr. Somerville, please.

Dr. Margaret Somerville (Acting Director, McGill Centre for Medicine, Ethics and Law): Thank you, Madam Chairman, and thank you for the opportunity to address the committee.

I'd just like to make a few introductory remarks, then some general comments, and then some particular ones.

I think it's appropriate to emphasize that the powers opened up by advances in genetics and reproductive technologies are unprecedented. Sometimes we forget this, but we're the first generation of humans to have these powers. We hold life in the palm of our collective human hands in a way that no other humans have ever held it.

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With great power comes great responsibility. We've always recognized the importance to individuals and society of respect for life, and in the past that meant we knew we must not kill each other.

But now, what these new technologies mean is that we must respect life in two new additional ways because of the interventions that we can now make. What we can do here is change the mode of transmission of human life from sexual reproduction to asexual replication. So it changes in both respects. It's not sexual, and its not reproduction. That, of course, is cloning.

We can change the essence of human life itself, the human germ cell line or the collective human genome. We can understand the enormity of that latter power to change the essence of human life itself when we recognize that, for instance, those of us sitting around this table today, so the scientists tell us, are the outcome of, plus or minus, 800 million years of evolution.

We can change what has resulted from 800 million years now in fractions of a second, what the scientists call nanoseconds. Moreover, as my colleagues have already indicated, some of our most important values as individuals and as a society relate to how we view the transmission of human life from one generation to another, how we view birth, and how we view our genetic relationships to other humans. These values will be affected by how we choose both to use and not to use these new genetic and reproductive technologies.

My final introductory remark is that these choices affect all of humankind, present and future, and not just Canadians. As Canadians, and particularly with this draft bill on the agenda, we have an extraordinary, and I believe unprecedented, opportunity to provide international leadership in making, what I would put in inverted commas, the “right choices”.

So to turn to the legislation, how does the draft bill measure up? As with Dr. Baylis, I think there are some good things about it—and I want to go to those first—and some things that I'd like to see changed.

First of all, I think you can put the use of these technologies on a spectrum, and indeed you can find in the literature and the research people who fall all the way along that spectrum. At one end there are people who see these technologies in total as, in a colloquial phrase, the devil's own work, and they believe none of them should be used.

At the other extreme, there are people like my colleague at the University of Texas, Professor John Robertson, who are complete libertarians on this and say that nobody has the right to interfere with any reproductive choices, including cloning. Professor Robertson would approve that, as indeed would some of the scientists with whom I've debated at Princeton.

So where does this legislation fall on this spectrum from total freedom to total prohibition? I think the bill takes a relatively restrained and cautious approach, for which I compliment its drafters. I think a broad range of Canadians would agree with many but not all of the positions taken in the draft bill, and we wouldn't all agree with what we agree about or disagree about. There would be some variation in there.

Turning to the strengths of the bill, the first strength is that in prohibiting certain activities, it—and again I'd put this word in brackets—“arguably” recognizes that some uses of reprogenetics, such as human reproductive cloning, are inherently wrong.

I can't say it definitely recognizes that because it doesn't say so. That is an approach in ethics that is called principle-based or deontological ethics that says some things are inherently wrong and we must not do them. The issue, in a secular, pluralistic, multicultural democratic society, which is what we have in Canada, is how can we reach agreement on what is inherently wrong when we don't have our old access to either an absolute moral authority such as religion or what we believe God told us, or to an absolute monarch, which is another way we did it in the past?

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One of the issues around why that's such an important question for you is that if, for instance, as is true of the report of the president's commission in the United States on cloning, you just simply say that we don't want to do human reproductive cloning now because, for instance, as Dr. Shanner pointed out to you, it's too risky, then that is a situational ethics approach. That says the goods don't outweigh the harms, so we shouldn't do it for that reason. But that means, when we get to a point where we would say the goods do outweigh the harms, we'd say, well, there's nothing inherently wrong in doing it. I would urge you to say that it is inherently wrong to do human reproductive cloning.

The second thing I really like about the bill, too, is that in prohibiting commercialization of the transmission of human life or its gestation, which is really what you've done in the bill, it upholds respect for that transmission and for its gestation.

The third thing I really like about it is that in my reading of it, particularly in the way in which the drafting is constructed, it has chosen as its basic presumption for the use of this new reprogenetic technology “No, unless”. In other words, no, you may not do it unless...whatever the unless might be. Of course we won't all agree on what those unlesses are. But what that does is adopt what is called, in the environmental policy area at the moment, a precautionary principle. It also effects the burden of proof. It means the burden of proof is on those who want to do it.

So those are my compliments. I think they are very important factors, and I think it's wonderful that Canada is probably going to adopt those. I certainly hope it does.

What's the major weakness of the draft bill? It has a lot of little weaknesses. Many of them have been pointed out to you, particularly the regulatory body and the role of regulations versus the use of legislation, which is not irrelevant to the points I've made. For instance, if something is inherently wrong, it should be stated in legislation, not in regulations. So there's a link between form as no mere formality, as we lawyers know; it matters how you say it.

But in my view, the major weakness of the bill is this: It does not recognize risks and harms of reprogenetic technologies to what I call collectively metaphysical realities, to important fundamental norms, values, principles, beliefs, what I've called the human spirit, in the book I've just published. I hasten to say that by “human spirit” I don't mean it in a religious sense. You can believe in the human spirit and be totally secular, but it is not antithetical to being religious and believing in it.

So with that in mind, and with great respect to the drafters and to this committee, I thought I would see if I could draft two additional statements that I would put in the preamble to try to correct that weakness. I also agree with Dr. Baylis that what is written in the preamble at present is to be lauded. It's very good. But I would put—and I would put first, not somewhere down the preamble—the following:

Whereas the Parliament of Canada recognizes that developments in assisted human reproductive technologies raise new responsibilities to ensure respect for the transmission of human life and for the integrity of the human genome;

And whereas the Parliament of Canada recognizes that the use of assisted reproductive technologies affects individuals, in particular, children born through their use, society, in particular, important societal values, and the common good;

I would add those to the preamble.

I also query—and there are arguments for and against it—whether we should add “and the common good of humankind” or “and the common good of Canadians and of humankind”. We might get into trouble doing that, but we can talk about that later.

That would be my major suggestion for alteration. Of course, we know as matters of rules of statutory interpretation, if in the future this act is to be interpreted and there's ambiguity in it, then the interpretation will be through those “whereas” conditions in the preamble. So it's extremely important that we state that we do have those values.

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I agree with Dr. Shanner that the two great events in every human life are birth and death. We have new challenges in relation to both of them because of—

Mr. Réal Ménard (Hochelaga—Maisonneuve, BQ): And love, don't forget love.

Dr. Margaret Somerville: Love? Well, it's kind of related to both—eros and thanatos are very closely connected.

We have to understand that humans have always found meaning in life through wrapping in symbolic and values fabric those two great events of every human life. Our new science affects the fabric and the wrapping and the symbols and the values we find in those situations, so we have to accommodate it, but certainly not in a way that does physical harm, which everyone is worried about.

One reason committees like this tend to focus excessively on physical harm—not that it isn't important, because it is extremely important—but we focus on it, because we can be reasonably sure everyone will agree that we shouldn't impose serious risks on other humans, particularly on children who had no choice in the matter. We tend to pull away from metaphysical risks and harms, because we know we're often into a minefield of disagreement about those principles. I would urge you to have the virtue that is going to become increasingly important in both ethics and politics—namely, the courage to face these issues.

So I'll go very quickly through my notes about some of the particular clauses, and I will give a copy of them to someone if you will need them afterwards. I would point out a small but possibly important thing. Under the definitions in clause 2, to the definition of “surrogate mother” I suggest you add that the child is derived in whole or part from the genes of a donor, because the surrogate mother's genes could be involved. She's not a donor. I don't think this is what you meant.

You have a ban on creation of human cloning. I strongly agree with that. I wonder, though, whether this means you can split a spare embryo for research or therapeutic purposes. I couldn't decide under the bill whether that would have been allowed or not, because it is possible to make multiple embryos out of a single human embryo and those embryos are clones of the original embryo.

The bill proposes to prohibit altering the genome of a cell or embryo if the alteration is capable of being transmitted to descendants. Colloquially, that is alteration of the human germ cell line. I agree, but I query the reason for that ban. Is it because it's currently not a safe thing to do? Or do you believe it's inherently wrong to alter the human germ cell line?

There's a very big debate going on now about that and there's a very big difference, for instance, between many of the European views on this and many of the views on it expressed in the United States. The Europeans on the whole are tending to view the human germ cell line as what they call the common heritage of humankind that must be held on trust for future generations. It becomes a question, of course, of what holding on trust means. Does it mean that, as was always true in the past, we must never intentionally alter it, which we didn't because we couldn't? Or does it mean we must now choose not to alter it?

Or would it be acceptable to, say, change the gene for Huntington's chorea, or cystic fibrosis, so that the embryo's descendants would never have this disease? Would that be acceptable? That's why I raise with you the issue of whether you had said that all of the prohibited activities were inherently wrong—meaning you could never do them under any condition whatsoever—or whether you would like to consider whether some of them are inherently wrong, while others might not be under certain conditions.

You've also put a 14-day limit on the use of embryos for the purposes of research. This 14-day limit has a long history, and it has no clear basis in my view; there's no raison d'être for it. The reasons given for a 14-day limit are that it's when the primitive steak appears; it's when the primitive nerve cells start; it's when twinning is no longer possible, so you have a unique individual; and it's when implantation is no longer possible. But when you have so many disparate reasons, difficulty in justifying that cut-off is indicated. You might still want to use it, but at least recognize that there is no clear reason for using it.

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Paragraph 3(1)(d) states that you shall not “create an in vitro embryo solely for the purposes of research”. I would ask you to compare that provision with “You should not create embryos for any purposes other than reproduction”, which is a more extensive prohibition. I was pleased in this respect to see that we had not followed the United Kingdom's lead in that. It is now allowing the creation of embryos simply for research purposes.

It also occurred to me, if you cannot do it solely for the purpose of research, does that mean you can make some extra embryos when there's a faint chance that you might want to use them for IVF? What if you're not making the embryos for a research use? For instance, it's been suggested that in the future we'll have human embryo manufacturing plants producing these therapeutic products we can use for the benefit of others—which at that point would not be research use—so would it be prohibited? I think we mean to do so.

I also point out to you that not everyone thinks that the use of so-called spare embryos, that is those left over after in vitro fertilization procedures, should be used for research. There's been a recent development in California where they have set up the Snowflake Embryo Adoption Program, called Operation Snowflake. These embryos are like tiny, frozen snowflakes in liquid nitrogen at -273°C, I think it is.

Those are some of my points on embryo research. The other thing very much on the horizon I'd point out to you is the possibility of alternatives to using human embryos for research—umbilical cord blood, bone marrow, or fat cells, for instance. In ethics, one of the things we look at is on using the least destructive alternative, so if there are other alternatives, that would be an argument against using embryos, even if you thought, if that was the only thing you could do, that it might be justified.

I would also point out to you that science doesn't always create additional ethical problems. Sometimes it solves ethical problems. So in the future if we can use sources other than embryos, we will solve the ethical problem of having to use human embryos. I think we also need to consider whether, seeing as how these paths are so new, we should take the time—at least some minimum amount of time—to see what else we can do, other than using human embryos, even if we personally don't think it's a morally wrong thing to do, simply out of respect for the views of those people who do believe this is not morally acceptable.

I've already mentioned the non-commercialization. I applaud that. The creation and transmission of human life is hors de commerce. It's an important message in societal value. In this respect we contrast with the United States, because they are very much into commercialization.

I would ask you, though, how extensive is this prohibition on commercialization? It says it prohibits payment for anything prohibited by this section. Also, surrogate motherhood is prohibited, except, it seemed to me, if a lawyer, a physician, or a psychologist is involved. So I'm not sure if you really want to create a new trade for lawyers, physicians, and psychologists. I would again query the interpretation of that clause.

There are some other points here I won't go into, because obviously there's not a huge amount of time. With respect to the removal of gametes after death, it would not be allowed without the written, informed consent of the donor. That's fine as far as the donor is concerned, but is it fair to intentionally create a child when you know its parent is already dead? That is a very different kind of intervention than when this isn't known, or when the parent might simply die later on.

Again, I have the same problem as Dr. Baylis with the consent of the donor of an embryo for use in research. I was surprised it said “donor” and not “donors”, and then I saw that the donor would be defined in the regulations. The same problem arises with destruction of human reproductive material at the request of the donor. Some of the cases that have already been in the courts have involved the use of embryos when the two donors of the embryos, who had been married, were getting divorced. So those are some of the things we need to consider as well.

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I will turn to controlled activities. In clause 16, the minister may take into account the need to “reduce or mitigate any danger to human health or the environment or any harm to human dignity or human rights”. I would suggest to you that orders of priority are not neutral. I'm not very keen on the term “human dignity”, which I'll explain in a moment. I would suggest that order of priorities be changed.

With respect to human dignity, there's a big argument, again in ethics, about what that means. Are we dignified simply because we're human, which is an intrinsic concept of human dignity? As one person put it, it is because we're human beings, not human doings. Or do we only have human dignity because somebody else sees us as dignified and treats us as such, which is an extrinsic idea of human dignity? Depending on which of those theories you use, you will have a very different interpretation of what human dignity requires in order to respect it.

As to not knowing the identity of the donor, I would pick up on Dr. Shanner's point. Certainly it's fine for the donor, but don't forget the donor is the person who has control over the situation. They do not have to donate if they don't want to. The question here must be, what is in the best interests of the child? Is it fair to the child? Mainly the research seems to be showing that anonymity of their origins is intensely painful for a lot of those children.

In clause 26 I have a point that might seem petty, but again I think there's a symbolic message here. It says an inspector can seize “any thing” in one of these licensed facilities. What I wanted to know was, would “thing” be an embryo or gamete? It wasn't clear from—

A voice: Possibly a patient.

Dr. Margaret Somerville: It could be a patient, too.

To turn briefly to another issue, there was an article by Minister Allan Rock in the Globe and Mail on May 16, 2001, in which he said the act would limit the number of embryos that may be implanted.

I looked through the draft bill and I couldn't find that. I looked through the regulatory powers and I wasn't sure there was a regulatory power that would allow such a prohibition, because it is a matter of clinical judgment and usually physician-patient decision-making. However, that's an issue with important societal ramifications.

First, multiple pregnancies are much more dangerous for both mothers and children. As a secondary consideration, very premature newborn babies have a very high rate of fatality and disability, and they cost enormous amounts of money—not that we shouldn't spend it, but if we can avoid spending it that is better.

Secondly, what's called selective reduction of multiple pregnancies, which means leaving the woman pregnant but killing off some of the fetuses, is ethically of great concern. That is done in these multiple pregnancies that are resulting from the use of reproductive technologies.

Thirdly, in the future we might not need to create embryos for transfer until we need them to transfer to the uterus. When we can successfully preserve ova as well as we can sperm, we won't have any spare embryos.

To summarize my suggestions of what I would like to see happen here, I would place equal and primary emphasis on respect for the transmission of human life and for the integrity of the human genome; for protection of important societal values around those realities; for the safety and well-being of children born as a result of reproductive technology; and for the safety of people, especially women, using that technology to treat infertility.

Those principles will not solve all dilemmas. For instance, they don't tell us any rules about who will have access to the technology and some other very controversial questions, such as whether children need two parents. But I think they would go a long way to setting a value base on which we can then address some of these more difficult and contentious issues.

I think we must recognize more clearly that not only physical harms or risks presented by reprogenetics matter, but also risks and harms to important non-physical or metaphysical realities, such as norms, values, the nature of human relationships, human rights, and human ethics.

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Third, I agree with the basic presumption “no, unless”. We will not all agree on what constitutes acceptable conditions that fulfil the “unless”, but the burden of proof of justification is, as it should be, on those wanting to use these technologies.

Fourth, the use of embryos for research is probably the most contentious issue in the way in which it's dealt with in this legislation. I would suggest that if it's allowed, it must be the only reasonable alternative, the least number of embryos used, etc.

Those are my suggestions. On the whole I think the legislation is very much on the right track and I thank you for listening to my comments.

The Chair: Thank you very much, Dr. Somerville.

Thanks to all of you for the work you have put into your presentations. We really appreciate it.

We'll now proceed to questions, beginning with Mr. Manning.

Mr. Preston Manning (Calgary Southwest, Canadian Alliance): I, too, would like to thank each and every one of you for your presentations. I think I'm probably accurate in saying on behalf of all of us that of all the aspects of this bill—the scientific aspects, the clinical aspects, the legal aspects—it's probably the moral and ethical aspects that are going to be the most difficult both to decide upon and to communicate to the public, whose support we hope to have for this legislation. So your testimony is absolutely critical.

I think, Madam Chairman, we probably all feel we'll have to spend more time on this. It's hard to know how to start. But let me get to a couple of questions.

As you know from this bill there are really two functions it will perform, prohibitions and regulations in relation to two subjects, assisted human reproduction procedures and related research. Many of the procedures involve the use of embryos, and the department's own definition of related research hinges around the use of embryos.

So my first question to you is, what should be the moral status of the embryo as captured by this legislation, and how do we establish and define that moral status in law?

Dr. Laura Shanner: I'll jump in. I think you've asked one of the hardest possible questions.

Mr. Preston Manning: That's what the opposition is paid to do.

Dr. Laura Shanner: And good on you, sir.

I think what we have seen legally as well as philosophically is, again, there is such a range. We might talk about embryos from conception as persons. Some people go back before that, and talk about the status of eggs and sperm as more important than body cells or other materials, and somehow related to us as persons.

At the other extreme, some religions, such as the more liberal branches of Judaism, teach that birth is where personhood really needs to be understood metaphysically. And there is everything in between. Most people are really not quite clear what they believe as to when life becomes really meaningful and important. A lot of it really depends on how you envision your relationship to the embryo or fetus, whether you want to have a pregnancy or a child, whether you are afraid of having a pregnancy or a child, whether you perceive yourself as connected, you define yourself in relationships and define yourself socially, or whether you define yourself as an isolated, liberalist, free person who's not connected to others, including maybe not connected to embryos or fetuses. So we're all over the place.

In picking a definition for the purposes of law it seems to me that it's going to have to be open. It's going to have to be broad and inclusive rather than restrictive. I think what this turns out to mean is that the hard lines, the real protections, come in when people are living in a body that is not residing in someone else's, which would be birth, and which is the status quo.

Moving back before that, as I mentioned, creates all kinds of legal problems in terms of counting embryos and fetuses, in terms of protecting them without violating the civil rights of the person in whose body they happen to reside, in terms of justifying such a status or behaviour in a multicultural context.

So I think Margaret's on the right track here, and Françoise has echoed this as well. I think all of us agree that it's simply not acceptable to talk about embryos or fetuses as if they're just stuff. They're not.

Dr. Françoise Baylis: I'm not sure I agree.

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Dr. Laura Shanner: Okay, maybe you don't agree.

This is debatable. But I think we can say that respect is important, but does respect mean all or nothing? No.

Mr. Preston Manning: Yes, that's what we want to get at.

Are there other comments here?

Dr. Françoise Baylis: I'd like to offer a couple of comments. With respect, I don't agree with Dr. Shanner on this point, and I think that's just reflective of what you would find if you consulted a variety of Canadians. That's why I would also say to you, while I support a number of comments that have been made, and I'm sure you will continue to hear that it is important in terms of issues of process to consult Canadians, on the question of moral status, I can tell you what the consultation will reveal. Multiple committees and commissions have done that. So I don't think that's the key place to put your energy in terms of consultation. Those views are well known. They're well documented.

I would like to offer you the following as background. In philosophy, we would refer to this as an essentially contested concept. There is no answer to it because it is not a matter of fact, and there are no more facts to put on the table that will resolve the question, though there are more facts about human development. What is absolutely key, and I encourage you, is to be very clear and careful with your use of language in the legislation. There is debate where the language is sloppy, and that leads you into very deep problems.

The first thing to recognize in the legislation and in all of your conversations is that embryos are human beings. That is an uncontested biological fact. They are a member of the human species. What is contested is their moral status. The language we use there is technical and that's where we talk about persons.

I think what becomes very clear is that when you're talking about embryos, you don't need to have a debate about whether or not they're human or human beings. The answer's yes. That's a biological claim. The term “person”, however, is not a biological term. It is not a term about which there are facts. It's a moral term. It's a value-laden term about which people will disagree, and they will then point to facts to try to tell you that their definition is the right one. But the term itself is not a factual term.

The second thing I'd like to suggest to you, and I'm sure it could be available to you through the research staff, is the national bioethics advisory commission document, which is probably one of the more recent documents where they have really surveyed this question about the moral status. They will summarize for you that you will find everything along this spectrum, from complete claims about moral status from the moment of conception to no claims of moral status until sometime after birth, which would in fact even allow infanticide. So if you want, the range of argument is there.

What I think is important to think about is that for historical reasons, Warnock in 1984 put forward the proposal that you would have up until 14 days to do the research. As Dr. Somerville mentioned, it has been picked up by people as a way of not just dismissing embryonic material and saying it's of no value, but saying it has special status but the status is not equivalent to full moral status.

The last point I would encourage you to think about very carefully—because language here will tie you in knots—is the use of the term “respect”. That term is actually very difficult and very complicated, because it's not well understood. It becomes a mom-and-apple-pie statement. We can respect everything, but what does it mean when you actually have to act on it and you have to entrench it for it to have some meaning?

The problem with the term respect is that as it has been used in this debate, it is largely about the issue of protectability. So when people are saying to you, you should respect the embryo, they're making a claim about its right to protection. What happens, however, is that other people are using the term respect in the context of accountability. What they do then is set up a series of regulations to say, we will respect the embryo because we will do only these sorts of things to it. We won't do anything that would be disrespectful of it. But it's actually holding ourselves accountable and saying nothing about the moral status of the developing embryo. So one of the things I think you need to think about is how you use that language of respect.

The last thing I would point you to look at—and I don't have an answer to this, but if you find it out please get back in touch with me—is that around the world, we have seen a consensus emerging around 14 days. As Dr. Somerville has explained, it could have been something else. It could have been 21 days, and I could have given you a biological argument for that. It could have been 42 days. I could have given you a biological argument for that.

What's interesting to me is that the most recent document to come out in terms of issues of guidelines in this whole general area came out from NIH on stem cell research in the past year. It's the first time a recent national document did not use 14 days, and I don't know why they didn't.

What they chose to do was name a developmental stage; they referred to the development of the mesoderm. The mesoderm actually develops just slightly after the primitive streak, because what happens is the embryo opens up. I know the biology is complicated, but imagine I have a round cell here. Actually, the cells move apart. It opens up, and the other cells go down below that and begin to spread out and establish the mesoderm.

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The interesting thing about them choosing to do that is it becomes observable, and so in some sense it's an attempt to remove some of the arbitrariness about 14 days, though strictly speaking it doesn't, because you've still decided that for some reason you will attribute some weight to this biological phenomenon.

But it would be interesting to find out from NIH why they did not follow what is this emerging consensus of 14 days and what the purpose was of picking the mesoderm. I don't know, but somebody must have come to them in this kind of context and presented them with an argument that was persuasive for them to pick that, so I would suggest you look into that.

The Chair: Would you like to comment, Dr. Somerville?

Dr. Margaret Somerville: Yes, although I don't have much to add. I agree with Dr. Baylis on this. What you have again is a spectrum from....

For instance, I was debating with a scientist from Princeton on what we could do to human embryos. There was a glass of water in front of him, like this, and he said, “If somebody gives me 1,000 human embryos, I'm happy to throw them in the glass and drink them, and I'd like Margaret Somerville to know that's what I think the moral status of human embryos are.”

Now, that's an extreme example, but it is true that...and particularly scientists who want to do work in this area, although not all of them by any means. I don't know of Canadians who have said anything like that. But there are those who do not see the human embryo.... Actually, he also happened to blow his nose, and he said, “This tissue has cells on it from the inside of my nose. I think they have the same moral status as a human embryo.” So they see the cells just as any other human cells.

At the other extreme, you have the people who see this—as indeed is absolutely true—as the human embryo being the earliest form of human life. It is human life scientifically, biologically. So the question is, can we justify saying that...? Again, if you take your “no, unless” presumption, you'd have to ask, “Can we justify not giving the human embryo the same moral status as the rest of us?”, rather than saying that it doesn't have it and anybody who wants to say that it should have it has to prove it. Can we justify not giving it the same moral status?

That's where we differ, because some people say that as long as it's treated with respect.... Again, I agree with Dr. Baylis that there are these two forms of respect, what you do and how you view the moral status, but they are linked, because what you view as the moral status of this embryo will determine what you feel entitled to do to it.

If you are a utilitarian or a consequentialist or a situational ethicist, which is what my colleague Dr. Shanner is—

Dr. Laura Shanner: No, I'm not.

Dr. Margaret Somerville: Well, more than the other two of us, I think.

Dr. Laura Shanner: But I'm not.

Dr. Margaret Somerville: In fact, if you look at, for instance, President Clinton and Mr. Tony Blair, when they were both justifying reducing the restrictions on embryo research, in former President Clinton's case for the U.S. and Mr. Blair for the U.K., the first thing they came out with was a litany of all the wonderful things this research could do. It will be maybe a cure for Alzheimer's, for cancer, for multiple sclerosis, for severed spinal cords, etc., all of which is justifiable.

Looking at that ethically, what are they doing? They're saying that these goods justify any harms or wrongs we're doing in using these embryos, and you couldn't do that to one of us.

Let's say I could take you, Madam Chairwoman, and say “Well, we could save 10 other lives by using your heart, your eyes, your lungs, your skin, whatever else”. We can't justify doing that to you. Why? Because you're a person. You are entitled to full moral respect, so we have to ask, is it different? Mainly we want to make it different because we can see that we could do extraordinary scientific research, reduce suffering, and find cures for horrible diseases.

Is it worth the values that we will infringe upon in doing that? That's the question.

Dr. Françoise Baylis: Perhaps I can add something in terms of basic science that I think might be helpful to the committee.

The Chair: Go ahead.

Dr. Françoise Baylis: As a non-scientist, it's sometimes easier for me to explain science, but I think there's one thing that the committee ought to be aware of, as I think it plays into this question, which I think is very difficult. It does have to do with the research that is being alluded to at the end here, which is largely the stem cell research and the potential for developing therapies from these special cells.

One of the things that I think you need to think about, because the legislation once entrenched is not as easy to change as regulations, is what is it that the science is doing and is likely to be doing?

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Let me explain to you three concepts that I think are very key. When you have egg and sperm together, you make an embryo. We, the scientists of the day, believe that, in the human model—and we're extrapolating this from animal models—up until the eight-cell stage, after going from one to two to four to eight, those cells are totipotent. That means, in the abstract, if you could disaggregate the embryo, take it out of its zona pellucida, which is the sack in which those cells sit, create artificial zona spore, and put eight cells into it, we would get eight identical beings.

What happens, though, in human development is that we go on from being an eight-cell being, and we continue to divide. We then go beyond being totipotent cells to being pluripotent cells. The pluripotent cells are the cells that the scientists want to use, and what becomes important is that they're taking the cells that are part of what would be referred to scientifically as the embryo proper—not the cells that are on the outside that will become the placenta, but the cells that would become the embryo.

What's important about those cells is that they no longer have the potential to become any and every cell of the human body. They've started to differentiate. They've started to become narrower.

So I'm the cell. I now know I'm going to be part of the brain. I don't know if I'm going to be dopamine, but I'm part of the brain. What they want to do is to be able to take those cells, learn from them, and—this is the key thing, and this is what I'd like you to appreciate—what they want to learn is this: how do I push the cell in that direction? Because it goes from being totipotent to being pluripotent to being multipotent to being multiple possibilities but still differentiated, etc.

What's key in terms of the issue of the moral status and the issue of cells and what their status is—trust me—is that if they learn, and they are learning, to push it in that direction, they're also learning how to push it in this direction. Right? You're not learning one without the other.

So the real potential from the science point of view, which is what is really phenomenal and striking, is what if it's true that every cell in our body is another human being in potentia? If what's special and precious about the embryo is its potential, then isn't every cell as precious as every other cell?

Notice that this is different from cloning, because you're not manipulating to take embryonic material out of one cell and putting it into the other cell. All you're doing in theory, in the abstract, is providing it with the correct environment. So it's not in the correct environment. These cells that are on the outside of my body can't become humans. They're in the wrong environment.

What's missing from this conversation, and most conversations, is that we focus on the genetics, and we forget that there are epigenetic requirements. There are environmental requirements. We don't understand that, and a lot of the stuff that a lot of us have said today fails to appreciate the complexity of reproduction in that regard.

What becomes important here is the most recent scientific developments, which actually have to do with the adult stem cells. The reason they're now finding that if they take fat cells, they can make blood cells is the environment. Part of the environment is part of what's telling them what they're going to be. So depending on how you want to think of that historically and acontextually, it is very complicated.

I would just urge you to always be mindful of how complex this is. That's just a really specific example of what it is we don't know about our own development.

The Chair: Dr. Somerville is going to jump out of her skin if I don't let her talk.

Dr. Margaret Somerville: Yes, I'd just like to put a spin on that. All of that is true, but what we're talking about here in terms of the ethics of the intervention on a human embryo is that taking those stem cells from that 100- to 200-cell human embryo necessarily kills it.

Dr. Françoise Baylis: Absolutely.

Dr. Margaret Somerville: There is no way you can do that without killing that embryo, so it is a human scientific intervention with a purpose of creating, let's say, a very likely therapy, but with an intention of killing the embryo. It's not necessarily a desire but a definite outcome.

So the morality or the ethics of that act does not centre around “Do I have a cell in my skin that could become another me, heaven forbid?”, but “What are the ethics of what I'm doing in intentionally inhibiting the normal development of that embryo in that way for that purpose, and is that ethically acceptable?” That's what we have to decide.

Dr. Laura Shanner: I'd just like to make one last comment.

Margaret called attention to the wording of “no, but”, and I'd really like to call attention to the subtle difference between “yes, but” and “no, but”. Whenever you have the word “but” in there, it implies that it could go either way. We might make a change, and at some level something is perhaps permissible. “Yes, but” says “Go ahead, but we might hold you back”, while the other says “Don't go ahead, but we might let you if you convince us”. That difference is crucial, and I agree with Margaret, on principle grounds, that “no, but” is the better choice.

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The presumption has to be that we are not going to stand on the edge of the precipice. We are not going to play casually with human life. We are not going to put the health and well-being of patients, offspring, or the community at risk. Maybe it will be a change in the facts because of science, a change in societal attitudes in the future, or something that's already part of our world that none of us have noticed that will figure it out. If somebody constructs the compelling argument, then we might go forward. Until we hear the convincing argument, the answer has to be no.

I really want to impress upon you that it's so subtle, to be permissive with restriction as opposed to restricted with permission possible, but it makes such a difference both in the attitudes that are conveyed in the practices governed by the regulation as well as in the actual structuring of the regulatory framework itself. I really encourage you to retain the “no, but”. Be very careful. The burden of proof is on the people who want to go forward. There may be good reasons to go forward, but we're going to have to hear them. And we need to be open to them.

The Chair: Thank you.

Mr. Preston Manning: Madam Chair, I know we've run out of time. Could I just take 30 seconds to list my other questions but not take the time to have them answered now?

The Chair: Would you consider making note of Mr. Manning's other questions?

Mr. Preston Manning: We could pass them on to you through the record. I know you can't answer them now, but they are on our minds.

My second one is, what is the most important ethical principle to be applied to the regulation if it's just human reproduction? In particular, how important is it that those principles be grounded in the values of the community, as distinct from being professionally and academically acceptable but maybe not grounded in the community?

My third question is, how should the regulatory body be structured so as to ensure that the ethical side of this issue has standing and is taken into account?

When you create the regulatory body, we know that the science, the commercial aspects, and the health aspects will be brought before it. You've appeared before many regulatory bodies and quasi-judicial committees. How do you guarantee that the ethical dimensions will be part of the decision-making when you're setting up a regulatory body?

I know we could spend an hour on each one.

The Chair: Mr. Manning, we can't take the time to hear the answers to those questions, but it's something to think about.

Perhaps you could get back to us on those. We'd really appreciate it. The clerk will get the precise questions from Mr. Manning, and he will get them to you later.

We'll now move to Mr. Dromisky.

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

Thank you very much for your presentations. They were very enlightening. I wish we could continue for a few more hours, because you're raising so many controversial issues. I don't mean that in a negative way, but rather with regard to the human brain, the mind, being able to grasp the issues.

I've been here long enough to know that with regulations and much of the legislation, my interpretation and that of others of a statement or clause are often different in a crisis, a certain situation, or within specific environments and so forth. This happens all the time.

The whole issue of consent comes into my mind. I'm really concerned about this whole area. I'm not going to ask you a question. I just want a response from the ethical viewpoint as well as the moral viewpoint for situations such as this. If consent is given and the major players know who the biological parents are and so forth and the offspring comes along, what about the biological mother turning around and saying that support must be provided for the offspring if she knows who the donor of the sperm is? What if the biological father who has donated the sperm demands the right to know who the offspring is and the right to have some type of relationship with that offspring? I'm looking at it from an ethical viewpoint as well as a moral viewpoint. Where do we draw the line? Is it right to draw lines? We have rules and regulations regarding these situations at the present time.

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Dr. Laura Shanner: I certainly share your frustration and confusion. My world is full of really big headaches, and I'm sorry for giving you one today.

Human beings are complicated critters, and the law is a very blunt instrument. I don't think you can regulate how the consent goes, how the relationships get structured, and how people interact with each other. What you can regulate is that no clinician will get anywhere near a patient unless we have people with psychological and social counselling skills to provide ongoing support and opportunities for people to think through what they want and need out of these choices and relationships. People won't make the same choices, and we can't force them to. If somebody wants contact with a genetic relative and someone else doesn't, this is human life, and we have people wanting different things. It's not for the law to try to regulate this, especially in advance. It's rather to find compassionate, understanding, and thoughtful interventions to help people navigate very difficult waters.

What we need from the law and the regulations are the social commitment, the financial commitment, and the practical guidelines to make sure that qualified, knowledgeable, and helpful people are there to help everybody else through the hoops. Which hoops any individual or family will encounter can't really be predicted in detail, so we're going to have to set up a framework and an infrastructure that allows responses to human lives as they unfold.

Watch out for the big mistakes. Somebody who comes into a donor clinic demanding to have a relationship with a child might not be suited to be a donor. That can be sorted out. The people who know what they're doing in dealing with these family relationships are very quick to point out dangerous situations and those prone to fail.

Again, the notion of informed consent, which you're raising, is so crucial. This is the second point I'd like to emphasize. Please do not think of informed consent as a one-time deal. The worst thing you can do is hand a sheaf of papers to the patient and say, sign here, sign here, sign here, and it's all in small print, because the vast majority of informed consent documents are nothing more than legal forms that indemnify the clinic and clinicians from any malpractice suits should anything go wrong. That's what informed consent tends to be in practice. In effect and from the perspective of patients, informed consent means, I understand what I'm getting myself into. I understand the science as far as I can understand that, I understand what it means to me, and I really understand what the options are, not just that there are options but what those options mean.

In these areas of reproduction and family relationships, the meanings are so incredibly profound. You can't just sign a form and consent to this. It's an ongoing process. The regulations should not just say that everybody signs a form and you have consent. That's wrong. It has to be, we have a process and an infrastructure and good people around to help other people understand what they're getting into and to choose the options that are really best for them. Once that choice is made, we may need to continue support.

The Chair: Dr. Somerville.

Dr. Margaret Somerville: The first thing is that consent is necessary but not sufficient for acceptability. That's the first thing. Some people think as long as you have consent, that's all you need.

The second thing is that in the problem you raised of the anonymous donor versus the child who wants to know its identity, there is a conflict of interest between whose best interests predominate. There's no best of all worlds. Sometimes we refer to it as a world of competing sorrows. One principle I would apply there ethically would be what I call a preferential option in favour of the most vulnerable person. In other words, you do what is best for the most vulnerable person. Who is that in that situation? It's the child. Therefore, you say, sure, there's a loss to this donor. If they don't want others knowing who the donor is, they're not going to be able to donate. You say, okay, that's the choice you make. And you have to be clear about the basis on which you make that choice.

Dr. Françoise Baylis: I'd like to make a very quick comment. I wrote 100 pages for the Royal Commission on New Reproductive Technologies solely on the topic of informed choice. It's in Volume I of Ethical Aspects. I think it might be very helpful, because what I do there is actually take the issue of informed choice and reproductive technologies generally and break it down into all of its component parts—what would people have to know; what would they have to understand; and what is it that they would be participating in?

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I then take that same set of questions—it's actually a framework—and I put every technology through it, or at least the ones we knew about at that time, ending up with prenatal implantation diagnosis, because at the time that was the cutting-edge science. So I would recommend that to at least your research staff, as it looks at informed choice.

My second point is just to notice the use of my language. I talked about informed choice, not consent. In my very basic lectures for my first-year medical students, one of the things I emphasize to them is that their job as a physician in training, because they're often the people who are asked to approach patients, is not to get a consent. That's part of the problem in contemporary medicine. They're trained go and get a consent, but the problem is, if they don't get a consent, they've failed. Right? They didn't do their job. So one of the things we're trying to teach the next generation of physicians is that their job is to get an informed choice. Sometimes that will be a consent, and sometimes that will be a refusal.

In the context of legislation, you do end up using the language “informed consent” because it has an appropriate legal context. But I would urge you to think about that in other places where it may be important that what you be specifying is that you're looking to ensure that people have made informed choices, because that legitimizes refusals.

The Chair: Thank you very much.

Mr. Merrifield.

Mr. Rob Merrifield (Yellowhead, Canadian Alliance): It's an amazing subject, and as one of you said, we're standing on the precipice.

Sometimes just sitting back and thinking about what we've done or where we've come in the last 10 years, I wonder if we're actually over the precipice and in free fall, if we're starting to see the bottom and we're trying to climb back up.

Dr. Françoise Baylis: And looking for a parachute.

Mr. Rob Merrifield: Yes, that's probably true.

Earlier we talked about the idea of the embryo and the value of the embryo, and the mesoderm. That's a concept I don't...and I wonder what stage that is, 14 days or where it's at.

Dr. Françoise Baylis: It's shortly after, within 24 to 48 hours after, depending on the speed at which that embryo is moving. It's very close to it.

Mr. Rob Merrifield: Okay. But I'd like to go back to the third question that Mr. Manning had asked. We can get into the ethics of this, but let's look at the framework and how we ensure there are actually ethical people in the regulative framework. Can you comment on that?

Dr. Françoise Baylis: I'd like to think all the people would be ethical. I think one of the difficulties with this, and I don't mean to be facetious, is that there's considerable interest in ethics generally in the policy-making context right now. Too often I've seen that turn into what I would describe as “cookbook ethics”, because all of a sudden it's like, well, tell us what the template is, tell us what the framework is, and we'll just push our problem through it.

I don't think that's what you're looking for. I think you're looking for people who are committed to a certain kind of conversation.

I'm hesitating because it's hard to explain. I have all this stuff on overheads. If I had only known, or if you were in Halifax....

There are ways you engage in a process that make it legitimate in and of itself. If I can simplify it, it's that you set up a process where you've agreed on the fundamental commitments, the core values, the principles that you're engaged in, that you're committed to, and then you engage in a process whereby you've agreed to play by the rules of the game. That means you agreed to the rules of the game, but then after the game is played, you don't get to say, I didn't get what I wanted out of it.

That's a really simplified version of what I'm trying to say, but I think there are actually a number of facets to that process. For example, there's a commitment in terms of interpersonal interaction. There's a commitment in terms of making sure you have put your values out on the table, so silence doesn't become an option. There are rules of engagement for a certain kind of conversation. There are people in ethics who have written about this in the context of articles entitled “Don't Stop the Conversation”.

So what becomes really important then is that you have to hear everybody. All of the values get to be considered, and they have to be either adopted or argued against.

If I had the time, and I don't, I would explain it to you in more detail, but it's very rich, much richer than what I think I'm seeing happen in a number of other places where I am doing work with the federal government, where there seems to be a tendency to get a framework together, and then we just push all the problems through the same common framework. I don't think that will ultimately be successful.

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Everything counts on your people. I think somebody said “virtue of courage”. That's what you need.

The Chair: Dr. Somerville.

Dr. Margaret Somerville: I'd just like to add to that. I agree with that entirely. I think one of the things we have to recognize is that one reason we're using these types of ethics committees is that we can't any longer assume, in our kind of society, that we have a basic consensus on the important values. We used to be able to assume that when we thought we all, more or less, belonged to the same traditional religion or whatever it was. That's why it's important to articulate those values or principles or whatever else it is that you need to use.

The other thing is that my experience has been—I think it's getting a bit better—that there's been a belief that, as long as you put a lot of good-willed, conversational people together who had a variety of expertise, then that would “work”. And in fact, it's a bit like a random process—fling them all in there and hope they're going to come up with something that is called ethical at the outcome of it.

I've used a metaphor for that. It's the same thing as having a six-year-old boy who says, I want to make a cake, and the mother says, fine; here are eggs, butter, sugar, flour, milk, raisins, whatever else. And he throws them all into the bowl and stirs them with a wooden spoon. He doesn't get a cake; he just gets a mess. But the mother in fact knows that, if she does certain things—she separates the eggs and puts the egg whites in at the end, or she does other things—she'll get not only a cake, but she'll get different kinds of cakes. And that's very true for the ethical process.

There's now a lot of work going on—for instance, how do you actually do the ethical process effectively, and better rather than worse? We have a book that's just come out, called Transdisciplinarity: Recreating Integrated Knowledge, in which we were fortunately given the money to bring in 30 people from around the world, all from different fields, all of whom have had experience of trying to do this process. And we all locked ourselves up in an old Cistercian monastery north of Paris for four days and tried to work at how we actually did what we do. And the range of views of how you actually would go about doing this was astonishing.

Dr. Françoise Baylis: I found my slides. I will leave them with your clerk. I'm doing something for Health Canada, and I happen to have that subset with me, so I'll leave them. I guess they have to be translated?

The Chair: Yes.

As a matter of fact, I should raise the point for my committee members that the presentations that have been coming to us have rarely been translated. So we're now into a backlog at translation.

I'm sorry Mr. Ménard left, because I wanted him to hear this. It's going to be a little slower to get the written texts of some of our witnesses because of this backlog at translation. And my guess is that there are probably translators specific to these kinds of scientific terms that are part of our testimony. So that's another reason it's kind of slow.

We're going to have to wait until mid- to late June, at this point.

Dr. Shanner, quickly, please.

Dr. Laura Shanner: I have a short comment about how to ensure ethics on the committee.

The kinds of questions that many of you are raising now are exactly the right ones. And I would echo the points made. Please do not try to get a framework or a cookbook that you can just follow, because life is too complicated for that. Please don't assume that you can just make a decision and be done, because life is too complicated for that.

What tends to happen in committee meetings is that we get piles of evidence. We get certain interests that are very widely voiced and represented while others are silenced, and what tends to happen is that we get into a rut and groupthink, and we're marching towards solutions. The number one thing we have to do is slow down the march to the solutions and make sure we ask the right questions, because getting a great answer to the wrong question is no help to you whatsoever.

So the role, I think, is not that you get the ethicist with the frameworks or the answers. It may or may not even be someone trained as an ethicist, although people with good background may be very helpful in that way. What we really need are the people who ask the hard questions and ask the left-field questions, really to make sure that we're marching on the right track before we go wherever the track leads us.

And that, I think, is the most important thing to look for among your qualifications—people who are willing to sit back and say, “I don't know; let's think about it.” Even if they have an opinion, are they willing to change that opinion because they're asking hard questions?

That's the number one piece of advice I can give.

The Chair: Thank you.

Ms. Wasylycia-Leis.

Ms. Judy Wasylycia-Leis (Winnipeg North Centre, NDP): Thank you.

I'd just like to pick up where Laura left off. I'm sure, based on what she said, that at the same time she would probably agree that we wouldn't want to slow down the march towards getting this law finally on the books after waiting for so long.

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My questions will be similar to the ones I've asked of other witnesses. First, are we not too late, and how do we get some balance back in this whole field? It seems to me that the voices around ethical issues, all of your voices, are being drowned out. Every day you open a newspaper you're blitzed with the latest new discovery, genetic testing, finding—whatever. The geno-hype is overwhelming, and yet we can't seem to get major focus on the issue of ethics and to balance out the whole scientific explosion going on around us.

My question is, how do we get the balance back into the equation in a general sense? I know, for example, when we raise questions in Parliament around biotechnology and reproductive technologies, or the genome project, we're looked at like we're living in the past, we're old-fashioned; get with it, this is important for human survival.

The more specific question is, with respect to a mechanism for this bill in terms of an ethical research body, what should it be? I thought there was supposed to be something in place, through Bill C-13 and the Canadian Institutes of Health Research, that was to be a framework, a mechanism, for ensuring ethical questions are addressed. Did that happen or not? What should we do here?

Dr. Laura Shanner: I would say that there are a few questions in there. First, have courage. If it really is too late, then I'm jumping off the bridge, but I am confident that it's never too late. We are a way delayed, and we should not delay further. But stepping in now is better than not stepping in at all, because there are future patients and future children whose lives are at stake. So it's never too late.

About the role of the CIHR, the extent to which CIHR will be effective in regulating RGTs needs to be established. Remember that CIHR focuses on research. The practice of reproductive and genetic technology as a clinical undertaking is way outside the bounds of CIHR, so we still need to deal with the laboratories, the clinical settings, the counselling, the informed consent, the donor records. That whole set of issues will not be touched by CIHR.

Again, I would emphasize that I think a lot of the questioning work has gone on and continues to go on within the policy division at Health Canada. We just need to bring it this last step. What has been accomplished so far needs to be brought home. But then we're not done; we need to keep going from there.

Dr. Françoise Baylis: CIHR is one of the granting councils. It grants funds for research. Nearly four years ago now it introduced the Tri-Council Policy Statement for Ethical Conduct in Research Involving Humans. A subsection of that deals with research involving embryos. A subsection of that deals with fetuses.

There are several points to think about. Those guidelines are just that; they are only guidelines. Strictly speaking, they only apply to research that is funded by the council. The councils don't fund the vast majority of the research that is taking place in this country. When those guidelines were published in 1998, if you go and look at the beginning page, the preamble states that it is to be a living document, to be updated in light of scientific advances. But not a single word, never mind a sentence, a paragraph, or a section, has been altered since 1998. At this point, they do not have the expertise to do that.

In fact, a memo—which is on my desk—was just sent out on letterhead from the three councils asking for nominations nationally for what they're calling an inter-council committee. Membership would be in the order of ten people. Some people have questioned that. They've said that maybe they could move it up to twelve. These twelve people are supposed to address all kinds of issues with respect to research in Canada and specifically would have as one of their mandates interpreting the tri-council statement, because there was considerable disagreement about what those words mean, as you might well imagine.

That was why one of my comments was to say that people are in fact not following the tri-council statement, partly because it's voluntary, and guidelines, etc., but partly because people choose to disagree. I do say “choose” to disagree because there are statements I would take to be quite straightforward and clear. For example, there is an article with respect to placebo research and what can and cannot happen in this country. There is no uniformity across the country. There is no uniformity amongst research ethics boards. There is no uniformity amongst what TPP is telling people, what Health Canada is telling people, what researchers are telling each other. It's a mess.

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The problem as it stands, though, is that they do not have a comparable national oversight body. They do not have a mandate to monitor research, even the research that's approved and ongoing. We don't even know how many research ethics boards exist in Canada. We don't know who sits on them. We can't say anything about the quality of the review. I will be at such a meeting tomorrow, and I'm reading my stuff on the plane. That's not to say that what I'm doing is acceptable, it's to tell you what is happening in reality.

The only committee at a national level that could have a role to play here is the National Council on Ethics in Human Research. Its funding is in jeopardy, and it has been told that it will not exist after this year. Therefore, there will now be nothing. At least that organization had a mandate to educate research ethics boards, but its budget is wholly dependent on the goodwill of CIHR, NSERC, SSHRCC, Health Canada, and the Royal College. Its funding is in jeopardy, and so the only thing we have, instead of being strengthened and turned into something that could at least be useful in one area, is being destroyed, after it's existed for 13 years on a shoestring budget.

Let me say this very clearly: the money we spend on the oversight for research involving humans is less than we spend on animals—and that's a fact, that's not hyperbole. A report was submitted by Michael MacDonald on the governance of research involving humans in Canada to the law commission, and it outlines all of this and speaks specifically, again, to the need for national oversight, especially in these highly contentious areas, where everybody could benefit from the research.

The Chair: I'm going to stop you there, because this meeting is assembled to talk about the ethical implications, and you have more knowledge than I expected on the whole administration and making people conform to guidelines. I think we need another meeting on that, and I'd like you to come back and tell us what's gone wrong, what you predict, is it necessary, etc. But there are other people waiting to ask questions about ethics. We are beyond our time, but I think, with the agreement of the committee, I would like to go on, so we can take advantage of our guests' knowledge and make sure that everybody gets to ask at least one question.

So I'm going to move now to Dr. Castonguay.

[Translation]

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

In the draft bill, we are told that creating embryos solely for research purposes would be prohibited. It seems that this is because of the potential human life that might exist in these embryos. I am trying to understand whether there is any difference between a surplus embryo made for in-vitro fertilization and an embryo created for research purposes. Is there really any difference? Is this not some kind of illusion meant to cover up something else?

My other point is that when we are involved in research using embryo stem cells, we know that it is possible to do research with non-embryo stem cells. By facilitating, and even encouraging this research, are we not taking away any interest that there might be in doing some more research on non-embryo stem cells?

Ms. Françoise Baylis: First, from the moral standpoint, you are absolutely right. Whether the embryo was created for this or that purpose makes no difference at all. Any specific moral position is independent from the way the embryo was created.

The difference, and also the reason why some emphasize this within this context, is that embryos created for reproduction are already existing and will be destroyed in any case. They can simply be destroyed without using them for anything positive, or they can be destroyed in another way that at least allows some positive results for developing therapies. We should at least try to put these embryos to some good use. That is the argument that was put forward. I do not defend this, but this is why people are telling us that this has already been done.

Now, you should understand that what is already being done has never been justified. There is a problem in basing an argument on the fact that this has already been done and therefore, we can continue doing it. The currently existing practice, namely the destruction of these embryos rather than the obligation of donating them or doing something else with them, cannot work.

Regarding the second question, the researchers I have spoken to, even those who work with stem cells for adults, prefer, at least for a limited time, to continue research or to allow their colleagues to continue research on embryos. They say that there are some mechanisms that they do not seem to understand in their work.

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A researcher from London, Ontario, told me recently that he thinks that embryonic stem cells will even be found in human blood. The problem is that all these cells cannot be differentiated without knowing the development process. Thus, they want to be able to use embryonic cells to understand the process. Researchers specialized in regenerative medicine, or transplants, know that the future lies in the work done on adult stem cells, because this will eliminate rejection problems. Thus, I think that this research must go on. It is difficult to know, if embryos are used, preferentially, whether this research will go ahead as quickly.

[English]

Dr. Margaret Somerville: Just to respond to the question, it really relates to the addition I suggested for the preamble of this act. When you create an embryo just for research, what you are doing in effect is transmitting human life to another human entity, another human being, for no purpose other than to destroy it, to kill it in the process of the research. So to transmit human life for no purpose other than that I think is extraordinarily damaging to respect for the transmission of human life itself.

You don't have that problem, at least to the same degree, when what you've done is transmitted human life because you think you might need that embryo in order to create a baby for somebody, and it happens you don't need it, and then you say, “What do we do with this, do we let it die”—that is possibly the least ethically difficult thing to do, because embryos do die all the time—“do we donate it to somebody else”—that has problems in it, although some people would say it's like adoption—“or do we use it for research?”

One of the problems with using it for research is what we call commodification, objectification, or reification. What we're doing is we're not treating it any longer as a human entity, a human being at a very early stage of development, we're making it into a thing, into sometimes a product, to be used for the benefit of the rest of us. That raises ethical difficulties that are not present when you haven't deliberately created that situation.

Madam Chairman, may I just add one point on that previous question? I think it's really important.

The Chair: Yes.

Dr. Margaret Somerville: The worst thing that could happen would be that people become cynical about the possibility of using this technology ethically, properly, and consistently with Canadians' values. I don't think Canadians feel that has happened, and I think it's a declaration of ethical and moral bankruptcy to say that the horse is out of the barn and there's nothing we can do.

From one small kind of basis, what we know, for instance, about getting what's called a high ethical tone in a health care institution. Some of the research shows that in a health care institution that employs about a thousand people, it's the five people at the top who set the overall ethical tone. May I suggest to the people here that you're the people at the top in this country, and it's up to you to set the ethical tone for the use of this technology. That's why what you do is so important in terms of values and symbols and not just in terms of practical realities, as important as the practical realities are.

The Chair: Thank you for that piece of encouragement and optimism.

Dr. Lunney.

Mr. Jeannot Castonguay: Could I have a follow-up here?

The Chair: Okay.

Mr. Jeannot Castonguay: Should there be a limit on the number of embryos that one could create for the purpose of reproduction?

Dr. Laura Shanner: Yes. I wanted to comment on that.

Mr. Jeannot Castonguay: Otherwise there's an open door there.

Dr. Laura Shanner: I would not look for a number out of the blue, some arbitrary number. It has to be a very careful balance, first, of the health of women in producing the eggs to make the embryos, causing....

What happens with in vitro fertilization is that several different hormones are given to break the woman's normal hormone cycle and then the ovaries are stimulated to produce lots of eggs. Usually between 10 and 20 are harvested. If more than about 15 or 20 eggs are produced at one time, they tend to be of very low quality and the embryos don't tend to survive as well.

So there are some health limitations in there about how many the upper bound can reasonably be to get healthy embryos. There remain unsettled questions about what it means to stimulate the ovaries to work at 15 or 20 times their normal capacity. If you got your liver to produce 15 times the normal amount of liver enzymes, I suspect there might be long-term problems, and the research into long-term help for infertility patients afterward is minimal. So there are some practice concerns there.

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We need to target the number of embryos returned and the number of embryos created in the first place to the safest practices in retrieving the ova and the best outcomes for the infertility treatment.

Somebody here raised a very good point earlier that it would be so easy just to crank up the production of embryos to make babies for IVF, when in fact what we know is that nobody is going to use that large number of embryos. Of course, there will be so-called leftover embryos and then those might be used in research. It's sort of a backhanded, dishonest way of making new embryos for research. We can't allow that to happen. So there has to be careful coordination between best medical practice and the regulation to try to restrict how many embryos are inappropriately created.

[Translation]

Ms. Françoise Baylis: It is very difficult to give you a figure, because we never know what the quality will be. If the service is not paid by the government, someone has to pay out of their pocket. That person will exert a great deal of pressure, because he or she will find it hard to accept that only five embryos will be created and that these may not be of good-enough quality to be transferred, which would oblige the person to pay another $5,000 for another cycle. This is very complicated and very difficult because the government did not think of subsidizing this therapy.

Let me also mention the fact that science is constantly changing and evolving. We will see practices change. Our capacity for growing mature ova outside of the body is developing, and this will change the practice of in-vitro fertilization. I think that it is even more difficult to give you a figure because of these factors.

[English]

The Chair: Thank you.

Dr. Lunney.

Mr. James Lunney (Nanaimo—Alberni, Canadian Alliance): A whole pile of questions of course comes out of this. Some of those questions have been addressed. I thank all of the witnesses for their very thoughtful contributions. It would be very valuable if we could have them back for another two-hour session, or six hours; it would be helpful, I'm sure.

I want to pick up on something that Dr. Somerville mentioned, that one of the underlying principles of ethics is to consider doing the least harm. With regard to the adult stem cells, we seem to be potentially on the verge of great breakthroughs in the use of adult stem cells, and reactivating adult stem cells to bring them back to a more pluripotent state.

For example, we heard a witness here in the House not long ago, Doctor Hudson from Montreal, talking about a mouse with an infarct and they were able to isolate muscle stem cells, grow in vitro cardiac cells and reintroduce them, and grow active cardiac tissue rather than scar tissue. So the fantastic potential in this type of research seems to me something that we should be pushing headlong and putting as much as we can into, because we don't have the complications of genetic incompatibility and anti-rejection drugs for the rest of your life, which we would have with embryonic stem cells.

Dr. Somerville, do you have anything further to say on that?

Dr. Margaret Somerville: I know Tom Hudson. He's a colleague of mine, and he's doing some fabulous work. I think it's extraordinarily exciting.

One of the concepts I've played around with, and I've actually been heavily criticized for.... In fact, I was called in quite a prestigious scientific journal a “neo-Luddite”. It went on to say that it thought Canada should get itself a bioethicist who came from this planet. This was said because I suggested this concept I called “ethics time”.

I think the example you bring up is a perfect example. Should we say that ethics time requires us to wait a certain period to see if we can do this without the need to use human embryos, and what would that period be?

I mean, when I look at the fact that we've never been able to do this in our lives before...and this is why I brought up that period. It's an extraordinary period, 800 million years, but when we think that the things we're talking about—what should we do with them now—are things we've only been able to do for two, three, or five years, and yet life has evolved over this other period of time, then I think we have to put this concept that sometimes waiting is worth it.

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Actually, one of the other old virtues I've been playing around with is called restraint, and courage, the courage not just to say yes, where it's easy to identify courage when we willingly and rightly and ethically take risks, but the courage to say no, which is very difficult sometimes, especially when you have really sick people in front of you. If you're a physician, you would know—it's a terrible thing to say no, we can't do that.

So ethics time requires courage to sometimes say let's go slowly on this for some ethical reason and see, in a way, if the science can catch up. As I pointed out, sometimes scientific advances solve ethics problems, they don't create them. Yes, I think we have to think about that.

The big issue, though, is how to come to some reasonable consensus as Canadians about when, how long, and where we are going to do that. I think this draft bill is a good start, because at least it puts all the decisions into the same decision-making context and forum. And I think it has a good start on, as we've all said, the basic principles, but I would like to see—and I really would like to emphasize this as my final statement—the values and other principles in that realm expressly in there. They're not at the moment. Those are important and need to be recognized as something that should also be protected.

Dr. Françoise Baylis: I would add to this that I think most people certainly see the advantages of working with adult stem cells in that they're a non-controversial source of stem cells. However, the scientists I talked to made two points when I challenged them on that very question.

One of them was to remind me that the work we keep seeing and reading about is done in animal models and in fact may not be transposable to the human model. The other thing I got reminded of is that although the goal in some areas is to do work with adult stem cells, largely to be able to avoid problems of rejection in the context of transplantation, those benefits may never be achieved without some preliminary work that needs to be done on embryonic stem cells. Now, whether you're persuaded by that argument or not, I think we need to listen to the scientists some more.

But what I would put before the committee in terms of background is that Industry Canada has funded a centre of excellence on stem cell research. That funding has just been received, and you may wish to hear from some of the scientists who are part of that group, which brings together about 50 scientists across the country.

Mr. James Lunney: Thank you.

The Chair: Thank you very much.

I have one question for Doctor Somerville. I can't remember if you actually commented on this, but Doctor Baylis made a very strong point about national oversight and had a very serious concern about the opting-out provision for the provinces on this particular piece of legislation.

Do you have an opinion on that?

Dr. Margaret Somerville: Yes, I totally support Doctor Baylis' comments on that. I think it's extremely important that we deal with this as a national reality. There's enough concern at the moment, and one of the arguments that's brought forward is that if we ban something in Canada we'll just go offshore and do it somewhere else. It would be terrible to see that kind of reality even as a possibility between provinces.

When I'm thinking about the constitutional reality, I would assume that given the issues here that cross provincial boundaries, this is a really classic example of something where it's not going to be possible to adequately regulate or have values as Canadians unless it is nationally done.

The Chair: National law and a national regulatory body.

Dr. Margaret Somerville: I would add that you may get some criticism of using the criminal law in this area, and of course one reason to use it is as an entry into having federal law, but I think it is entirely appropriate to have the criminal law.

The classic raison d'être of the criminal law was to protect human life and safety. This is the 21st century issue of human life and safety and the values that surround it.

The Chair: Thank you very much.

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Dr. Laura Shanner: Just to add a third voice of exuberant agreement, please keep this as a coordinated effort among provinces rather than a fractured free-for-all.

The Chair: No, no, that's a different thing. A coordinated effort among provinces—

Dr. Laura Shanner: I know; it's herding cats.

The Chair: —is not a national authority. I'm asking you if you support a national law attached to the Criminal Code and a national authority.

Dr. Laura Shanner: Yes, I support a national authority with the proviso that the national authority does have limits about how far it can step into provincial responsibilities. The authority to create the agency strikes me as a clear realm for the national level to participate. This agency needs to coordinate between and among federal and provincial levels, but the embodying of it is a national activity.

The Chair: That's not what Dr. Somerville meant, I don't think.

Dr. Laura Shanner: No, but it's another route of entry with or without criminalizing.

Dr. Margaret Somerville: May I just add that in terms of your opt-out clause, I would opt out the opt-out clause, and I would leave it to a charter challenge if there's any concern about whether this is validly within jurisdiction. It would be an extraordinarily interesting charter case. I'd quite like to work on it.

Dr. Françoise Baylis: If I can come back to my point, I did mean exactly what I said. You need uniformity in this area, and it should not fall to the constitutional debate.

Please look at the clauses I talked to. Part of what they can opt out of, which I cannot understand, is the offences to the prohibitions. That just has to be an error.

Dr. Margaret Somerville: It wouldn't be because provinces have no criminal—

Dr. Françoise Baylis: No, but the prohibitions would be federal. They don't get to opt out of the prohibitions. That's just a mistake.

The Chair: Preston wants another word.

Mr. Preston Manning: Madam Chairman, I invite our panellists to make this argument to the Quebec government.

Dr. Françoise Baylis: Avec plaisir.

Mr. Preston Manning: We need your help.

The Chair: Perhaps the provincial governments will be wise enough to say, those people had a headache for a year trying to figure this out, not to mention all the people who preceded us with all these advisory panels, etc., and why would we want to adopt that headache? That's what I'm hoping. Therefore, the national will shall prevail.

Anyway, thank you very much. You've made our job more difficult, but you've also given us encouragement to move forward. If we need you again, I hope you will be kind enough to come back.

Dr. Laura Shanner: Absolutely. I won't speak for my colleagues, but if anyone wants to call or e-mail, those are options for following up.

The Chair: After our researchers have gone over today's testimony, I think they might phone you to clarify some of your remarks.

Thank you very much for your time. It has been most stimulating. I hope we'll see you again.

This meeting is now adjourned.