STANDING COMMITTEE ON HEALTH

COMITÉ PERMANENT DE LA SANTÉ

EVIDENCE

[Recorded by Electronic Apparatus]

Tuesday, November 27, 2001

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[English]

The Chair (Ms. Bonnie Brown (Oakville, Lib.)): This meeting is called to order.

Our guest, Dr. Lippman, is going to introduce herself.

Professor Abby Lippman (Department of Epidemiology and Biostatistics, McGill University, Canadian Women's Health Network): Thanks very much.

[Translation]

Good morning. Thank you.

[English]

I am delighted to be here. I must admit that coming in on the bus this morning I was saying, this is either the best of times to come here or the worst of times to come here. That was before the videoconferencing issues and the bells started ringing. Since I was spending most of my time on the bus reading the headlines in the newspapers this morning, I guess this is a timely session. I will just warn you now of what will not be coming later. Most of my comments are not going to be about cloning and embryonic stem cells, although I will say some things about them that may be different from what you've heard, I hope.

So basically I'm here today wearing two hats. I will try to let you know when I take one off and put the other on. I am representing the Canadian Women's Health Network. I am co-chair of the board. I'm also going to be representing myself, and I'll tell you why I'm taking that privilege.

I also warn you that if I do speak in French as well as in English, I speak both with the same New York accent.

Some hon. members: Oh, oh!

Prof. Abby Lippman: As I have referred to myself, I am an audible minority in this country.

The Canadian Women's Health Network, for those of you who are not aware of it, is a national network comprising individuals, organizations, and institutions, all of whom are concerned with women's health. It's a clearing-house for women's health information. We are now, and have been for the last four and a half years, a partner in the national centres of excellence for women's health policy research consortium. The program is funded out of Health Canada. We sit on the steering committee of the centres of excellence program.

The Canadian Women's Health Network is also the women's health affiliate for the Canadian Health Network. I'm not going to start with all the acronyms, because even I can't remember them.

We've also been very involved in other health issues through two working groups. One is on women and health reform, and I believe some of you may have met people from that group. The other is a working group on women and health protection.

It's a voluntary group. Anybody who'd like to may join. If you agree with our principles, you are welcome to become a member. I never waste time soliciting membership.

Right now the CWHN has not formally approved any statement on the draft bill. However, there are parts of the draft bill that are concordant with various positions we have taken in other areas. In that context is how I have been delegated to speak for the women's network.

I've also been asked to speak for them, not only because I'm co-chair of the board right now, but also because I was a member of the federal Advisory Committee on New Reproductive and Genetic Technologies. I resigned in June 2000.

I have also been trained in genetics. I'm now in the Department of Epidemiology. I have been doing my own research and writing on issues having to do with genetic and reproductive technologies since perhaps some of you were born. I think my grey hair shows for the difficulties of dealing with some of these issues. They're painful ones. Whether you're for them or against them, they are not easy. Most of my research has been involved doing qualitative work with women who have been faced with some of the decisions you have to make about using these technologies. So my own opinions have been informed by what I have learned from them.

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To further bore you, the other context I bring to this in terms of some of the consent issues is that I'm on the ethics review board at the Faculty of Medicine at McGill, which is my home base. I was with the ethics committee of the Society of Obstetricians and Gynaecologists of Canada when they drafted some of their positions on elements in the bill, particularly the one on surrogacy. I signed off on that piece for the SOGC.

So that's who I am.

The Chair: Thank you very much, Dr. Lippman. Make sure you get a good seat.

Prof. Abby Lippman: It was very nice being with you today. It was very simple responding to your questions.

The Chair: Good morning, Dr. Dalziel.

Dr. Maureen Dalziel (Chief Executive Officer, Human Fertilisation and Embryology Authority (London, United Kingdom)): Good morning.

The Chair: I'm Bonnie Brown, the chair of the Standing Committee on Health, and we're very grateful that you have agreed to spend some time with us this morning. I believe you will have a statement to make to us, after which we will ask you questions. Is that agreeable to you?

Dr. Maureen Dalziel: That's agreeable to me, yes.

The Chair: Well, then Dr. Dalziel, you have the floor.

Dr. Maureen Dalziel: Thank you. I'm very pleased to give evidence this afternoon, London time.

The Human Fertilisation and Embryology Authority in the U.K. got its start on August 1, 1991, with the following responsibilities: to license and regulate clinics carrying out IVF; the use of donated gametes, including donor insemination, gamete and embryo storage, and human embryo research; to maintain a code of practice giving guidance on the proper conduct of licensed activities; to maintain a register of licensed treatments given and of the children born as a result; to give advice and information to licensed clinics, to perspective patients, and to the public; to keep the field under review; and to give advice when asked to the United Kingdom Secretary of State for Health.

I thought it would be useful to take some time explaining these responsibilities. By far the greater proportion of our regulatory function is exercised through the issue, maintaining, and review of licences—all licences for research, licensed services, and activities that a centre is permitted to provide or in which they may engage.

Before the granting of the licence, the facilities at the centre will have been inspected by one of our inspectorial teams, and the centre staff will have been inspected with regard to their CVs and standard of competence in the techniques they are proposing to use. Treatment licences are usually granted for a period of three years, although a shorter licence may be issued and additional conditions imposed if a centre is found to be in breach of the code of practice.

Whilst the act set out in broad terms the practices for which licences are required and for which they may be issued, it does not get into the level of individual techniques and the assessment of the individual competences required on the part of those practising them. That is left to the HFEA.

All applications for a licence are considered by a committee made up of members of the authority. Sometimes committees are confronted with difficult decisions that require the input of expert peer reviewers. The authority revises and updates its review board in order to ensure that it is equipped to assess technically complex applications by drawing on expertise in the relevant field.

So whilst the licence committee may take as its starting point the code of practice on the authority's current policy, its discretion to award, vary, impose conditions on, or revoke a licence must be unconstrained within the terms of the 1990 act. It has been known for decisions to be challenged through an appeal procedure that is built into the systems. These appeals are heard first of all by the full authority, minus the members of the licence committee, although both the applicant and the licence committee are entitled to representation in front of the authority.

If the outcome is unsatisfactory, there remains the option for the applicant to appeal to the High Court on a point of law. This procedure ensures that any licensing decision made within the authority cannot be arbitrary, inconsistent, or unfair.

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The code of practice is one of the main statutory functions. We publish and maintain a code of practice for those working in assisted reproduction that gives guidance on those activities that may be performed on pursuance of a licence. Whilst the court expresses and interprets the mandatory provisions of the act, its main function is to translate the requirements of the legislation, especially with regard to what is suitable or proper, into a set of realistic and achievable standards, the purpose of which is to ensure that clinics provide the best possible service to patients.

Therefore, its aims are compliance with the law and assurance of a universal quality of service. It does not represent a minimum standard. Its aim is to promote the best practice possible.

What the HFEA has tried to do is develop and refine its structure, systems, and processes to support good decision-making in ART in order to ensure that whatever the outcome of decisions, they are well founded and well made. What neither the code nor the HFEA in general intend to do is usurp the decision-making role of clinicians and patients.

Another important aspect is the register the authority uses to collect detailed information on all IVF and donor insemination treatments. Its main purpose is to be able to report certain details concerning the circumstances of their birth to children once they reach the age of 18 or when they intend to marry. For example, the register will enable the authority to inform patients born through the use of donated gametes whether they are genetically related to the person they intend to marry.

That data can also be used to monitor the performance in clinics, enabling the authority to direct its attention to areas of performance that fall outside the normal range. This has, on many occasions, provided a useful dialogue between clinics and inspection teams.

As you know, the practice of IVF and related treatments has grown extensively with the rapid and extensive expansion of the techniques and technologies. The HFEA is concerned to ensure that any proposed new technique has been fully considered in terms of safety and efficacy before it agrees to license it for clinical application.

Recent examples of new techniques that are being considered include pre-implantation genetic diagnosis, intracytoplasmic sperm injection, and egg freezing. Before the technique will be considered by the HFEA, evidence will be sought from expert groups, and external expert advice will help the authority establish whether the applicant has demonstrated that the technique is safe, its reliability has been demonstrated, adequate pre-clinical research has been conducted, the applicant has the appropriate skills, patient selection criteria have been established, and the appropriate information and consent procedures are in place.

This has been one of the most difficult areas the HFEA has had to tackle in the past ten years. There is always the push of technology combined with the pull of the imperative to provide new and effective treatments that go against the intense pressure the authority has found to allow progress at a rapid pace. The authority is seen within the United Kingdom to take a cautious approach, working to establish mechanisms that ensure thorough evaluation of each new application.

Most recently, as you may be aware, are the debates that were in front of our House in January, when new research regulations were added to the act to allow some of the more innovative, rapidly changing aspects of repro-genetics. In January this year, additional legal purposes for embryo research included increasing knowledge about the development of embryos, increasing knowledge about serious disease, or enabling any such knowledge to be applied in developing treatments for serious disease.

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We have, as a result of these new regulations, enhanced our existing licensing system for research. Applicants will be required to justify why embryonic stem cells are to be used rather than adult or animal stem cells. They will be required to provide detailed information on what will happen to stem cells throughout the project, keeping them within the licensed project, and six monthly progress reports will have to be submitted to the HFEA.

The monitoring of this will be detailed and sensitive; however, it is an expansion of part of the role that has been going on for over ten years within the HFEA. You will be aware that in the past week a judgment has been made that the definition of the embryo within the HFE Act does not cover embryos created by cell nuclear replacement. You'll also be aware that at the moment the House is looking at emergency legislation to stop human reproductive cloning within the United Kingdom in order to plug the gap that has emerged as quickly as possible.

That is the statement I would like to make at this time. Thank you.

The Chair: Thank you, Dr. Dalziel.

I'm going to introduce the lead critic for the opposition in our government, Preston Manning. Mr. Manning will have some questions for you.

Mr. Preston Manning (Calgary Southwest, Canadian Alliance): Good morning, Dr. Dalziel. It's morning here, afternoon there. Thank you for spending this time with us.

My first question is about how the authority is held accountable to Parliament. We're in the process here of trying to set up external authority, and we want to have some independence from the government and the department. On the other hand, we want to be accountable to Parliament and to the public.

Could you tell us exactly how the authority is held accountable for its decisions and actions?

Dr. Maureen Dalziel: The authority is accountable to the Secretary of State through the Department of Health, which is accountable to Parliament. The authority has statutory functions, so it is given a range of responsibilities on behalf of Parliament, which I went through in my statement.

The authority meets in private. Its discussions are not held in public, but it has a web site that keeps members of the public up to date on what is happening at the end of each authority meeting.

The authority meets in private once every four weeks, apart from in December and August, which are the two months of holidays. Licence committees are held completely in private. It's only now, as a result of suggestions from the Department of Health, that we are beginning to consider how we make our judgments much more accessible to the public.

So it's through the usual system of sponsoring department through the House of Commons that we are accountable.

Mr. Preston Manning: What about regulations? Do any of your regulations require concurrence from Parliament, or can Parliament come back on a regulation if it feels it's not consistent with the act or intent of Parliament?

Dr. Maureen Dalziel: The act has been very carefully crafted in the United Kingdom. There are, therefore, some logistical difficulties in implementing the act on a day-to-day basis. One example is confidentiality. Confidentiality has in a way been seen as one of the most important aspects of the HFEA, which has meant that to change that provision of confidentiality, it requires primary legislation, which the United Kingdom government at this time has not been willing to look at.

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If there are some issues that can be amended by secondary legislation, the House will look more favourably upon that. The worry about changing primary legislation is that it opens up the whole tenet of the act.

At the moment, you will be aware, there's a bill going through on human cloning, as an emergency bill. It's a very small bill and has only to do with that aspect, and no other aspect of the act.

Apart from the act and the regulations behind it, there can be conditions imposed, which can mean the interpretation is slightly different than perhaps can be read from the act initially. An example would be that if we wanted to make sure the research regulations were interpreted in a specific way, we could add specific conditions in secondary regulations to the act.

Am I making myself clear?

Mr. Preston Manning: Yes. Thank you.

You made some reference to how you've been handling embryonic stem cells. But could you give us a bit of the history and the high and low points—say, over the last ten years—in the regulation of therapeutic cloning for the purposes of producing embryonic stem cells?

We understand that initially there were restrictions against it; then they were changed. Now there's some controversy over what can and cannot be allowed. Can you give us a history of your regulations for therapeutic cloning, particularly for the purpose of reproduction of embryonic stem cells?

Dr. Maureen Dalziel: The act was very specifically crafted at a time before therapeutic cloning was considered to be an issue. It was particularly seen as an act that protected infertility treatment and infertility research. However, as a result of the confidence the Houses of Parliament, including the House of Lords, have had in the HFEA's application of the act, and as a result of the advances in genetics that are now well seen throughout the world with the genomic projects, it has become apparent that stem cells from adults and animal tissue on their own do not have the potential that stem cells have from embryos—animal embryos being the model that started the debate.

The belief at this time is that embryonic stem cells would be more able to produce the kinds of cells that would be required for therapy in future.

As a result of debate that has probably taken place over the past four years, the chief medical officer pulled together our particular advisory committee to consider this issue. The result of his report was debated by the House. As a result of that, it was agreed to extend the remit of the HFEA act, so that as well as looking at research into infertility treatment, research in embryos could be approved for the following purposes: increasing knowledge about the development of embryos; increasing knowledge about serious disease; or enabling any such knowledge to be applied in developing treatments for serious disease.

You will know that the House of Lords, earlier this year, set themselves up an advisory committee to consider this. The HFEA has agreed, as a result, not to go forward with research that would involve cell nuclear replacement at this time, until the House of Lords' committee has reported.

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A number of days ago, the ProLife Alliance challenged the definition of “specified” in the act and got agreement from the court that an embryo that was not fertilized could not be designated an embryo. As a result of that, the human cloning bill is going through the House of Parliament and Lords at the moment. That leaves a gap for cell nuclear replacement, which has no regulation within the U.K., unless the court of appeal overturns the decision in the lower court. At the moment, the Department of Health is discussing with lawyers how we might handle this gap, which I think at this stage they are confident the court of appeal will overturn.

[Inaudible—Editor]...are seen very much as a therapeutic benefit, the Medical Research Council working with the Medicines Control Agency and with the Human Fertilisation and Embryology Authority to work through a process that ensures the spirit of the regulation is as Parliament would wish it to be seen.

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

I wonder if we could continue on a practical note. You talked about the therapeutic uses of stem cells, and I'm wondering, as the United Kingdom has had more freedom for its scientists to pursue that line of research, have you heard of any very positive results they are getting in the treatment of some of these diseases?

Dr. Maureen Dalziel: I think if you're a scientist or a doctor, the way of describing it is that where the scientists are at the moment is at the stage of developing the methods. It's not, at this stage, about having the therapy ready. If you think about the genomic project, some say it started with the finding of DNA. It took 50 years to get the genome project you and I have heard about in the past 18 months.

My guess is that where we are with stem cells is at the stage of trying to extract the cells from embryos rather than actually designing the therapies that will make a difference tomorrow—to Parkinson's disease, or heart disease. The hope is we will develop a method of extracting cells that could be replicated, once the methods are more sophisticated, to allow the development of therapies.

Anyone who has anything to do with medical research will know it takes about eight years for a drug to get a licence in the United Kingdom and in Europe. I don't know what it is in Canada and the States, but I can't imagine it's any less.

So early research on the methods would need to happen. Once the methods are much more confident and robust scientifically, the extraction of cells should be more routine. When the extraction of cells becomes more routine, it should be possible for the cells to then become like replacement cells, either for the brain, heart, or muscle. I see that the whole process will probably take 10 to 15 years.

Where we are at the moment is developing the method for growing the cells. I think that's something quite hard for people to understand, but if you think about social science rather than biological science—in any kind of research endeavour—there is always a methodological endeavour as well as a results or outcome endeavour. A methodological endeavour is usually ahead of the outcome endeavour or results. The way I see it, we're at a very early stage. The initial applications have all been trying to grow cells from embryos that have been surplus to requirements. At this time in the United Kingdom I'm not aware of any cell lines being grown from them.

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The Chair: Thank you. I have a series of questions that really require a more quantitative response. They concern licensing. I'm wondering, for example, how many licences are active and out there in your country. I'm wondering how many inspectors you have to inspect those licensed places. I'm wondering if the licences apply to a facility—that is, a clinic with a name, maybe even incorporated—or whether the licences are given to the lead researcher. In other words, are they attached to a person, place, or a project with a team listed?

Dr. Maureen Dalziel: There are 118 treatment centres licensed at the moment. In the 11 years the HFEA has been working, over 175 clinics or centres have been licensed.

The process is that there is a person responsible for handling and safeguarding the process overall within the centre. There will also be a nominal licence fee, which is our fall-back position in case anything happens to the person we call “the person responsible”.

There are routine licences issued for IVF, donor insemination, and the storage of embryo and gametes. There are then specific licences that have grown by 180-fold for issues I will label micro-manipulation. Among the things we would be talking about are pre-implantation genetic diagnosis, ICSI, aneuploidy. This has come out of the growth of genetics.

So the answer is there would be a mixture. There are also separate licences for research, some of which will take place in treatment centres. But once again, a person will be responsible for the research licence.

The number of inspectors we have within the HFEA is as follows. We have five inspector-coordinators to cover the whole of the United Kingdom. One of them has the responsibility for research, the other four principally for treatment. Within the four, a number will have a particular responsibility, mainly around the areas of micro-manipulation. Attached to the authority will be, at this time, up to forty inspectors; that is, clinicians, scientists, and counsellors. We will visit the treatment centre every year, but we will carry out a fuller inspection once every three years—and a fuller inspection if the licence committee, which has five members, has put specific conditions on the licence.

So the answer is, it will depend. Although there is a regular system for what I would see to be the more routine aspects of licensing IVF and donor insemination, there is more intensive scrutiny for ICSI, PGD, aneuploidy, and specific requests such as HLA typing.

Does that begin to answer your question?

The Chair: That's terrific. Thank you very much.

I also wondered whether, either in the legislation or in the regulations that accompany it, Parliament has made any statements that would revolve around the protection of, say, potential mothers, such as the number of times fertility drugs can be repeated on any one person. Then there's protection of the embryo, with the number of ova that can be fertilized in the petri dish, and also the number of times one man can donate sperm. Are there any regulations that restrict those things, or are those the things you leave to the medical practitioners?

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Dr. Maureen Dalziel: There are no regulations around those issues. It's advice we can give and may give in the code of practice. For instance, the code of practice at the moment says we do not expect any more than three embryos to be put back into one woman at any time. In recent months, the authority has decreed that it should be two embryos.

The vehicle we would use to specify these issues would be the code of practice. We feel that allows us to change in line with emerging evidence from research and emerging evidence with clinical practice. It allows us to take on board views expressed by either the Royal Colleges of Midwives, Nursing, and Obstetricians and Gynaecologists, or the Association of Clinical Embryologists.

The Chair: But that code of practice is attached to your authority, isn't it?

Dr. Maureen Dalziel: Yes, it's part of the authority. Ideally a code of practice would be issued every year, outlining not standards but actually what we would expect to see in clinics for treatment and research. I don't have a copy of it with me, but I'd be very happy to send you an update of our latest code of practice, if that would be helpful.

The Chair: It would be very helpful.

Can you remove a licence if your inspector finds someone breaching the code of practice?

Dr. Maureen Dalziel: Removing licences is never simple, because it is a legal process. We have at the moment an example of a clinic in which we find breaches to the code of practice and the act. There is a process of revocation going on at the moment in which evidence is put before a licence committee, which is made up of five members of the authority. The evidence is coming from two sources: from our inspectors but also from the person responsible. They're allowed to put their side of the story too.

In determining whether a licence will be reviewed, there's actually a lot of legal due process that one has to go through. Just assuming that a breach of the code of practice or a breach of the act means that a licence will be revoked is premature. What I would say to you is that there is a process that allows that act to be considered, and to be considered properly.

The Chair: Thank you.

We didn't have all of our committee here when we began, Dr. Dalziel, because they had to go and vote. Mr. Manning and I were holding the fort. But they have returned now, so I'm going to ask if any of them have questions of you.

We'll have Mr. Merrifield next.

Mr. Rob Merrifield (Yellowhead, Canadian Alliance): Thank you.

With regard to your human fertility authority, you have to recognize the different perspectives. You have the public and the science and faith communities. How are they reflected? Are you comfortable that they're reflected in the makeup of your committee?

Dr. Maureen Dalziel: We have a very large committee. There is the chairman and 20 members. The membership is made up of clinicians, scientists, ethicists, and lay people. They are proportional to ensure that the number of clinicians and scientists cannot dominate the committee. Although the United Kingdom is now moving to much more open public participation and we are endeavouring to engage with our patient representative groups much more in an informal way, the committee's constitution itself makes sure there is a voice from all those groups within it.

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Mr. Rob Merrifield: Just to follow up on that with regard to the committee, it's been going on for some time now, and I'm sure it's evolving somewhat. But if you were to go back to its origin, or perhaps reflect on how it's working now, could you tell me its two greatest strengths and its two greatest weaknesses and how you might change it if you could?

Dr. Maureen Dalziel: Its greatest strength has been to reassure the population in the United Kingdom that science in this sensitive area is being regulated in a considered way and that the ethical framework in which these decisions are made tries to be as fair and as timely as possible.

Its second greatest strength is that it has built up a very good working relationship with the clinicians and scientists within the field, so that the authority is not caught unawares by the advance of science.

Its weakness is probably that it was set up in a time when there was a particular view that IVF would be a very small activity. It would only be something that a small number of people would actually need to make use of. At no time was the advance of genetics foreseen when the committee was put together in such a way. Therefore its infrastructure—I've described the number of inspectors and inspector coordinators—is fairly light. I think now we would be saying that in order to reassure the public, particularly with the opportunity there is for research, that would need to be strengthened.

Mr. Rob Merrifield: Thank you. I have just one further question.

Can you highlight for us the annual budget or costs and perhaps the growth of the costs over the last number of years, and maybe explain some of the sources of revenue?

Dr. Maureen Dalziel: Yes. I have explained this. The HFEA has been a very efficient organization. Its budget for the past ten years has been £1.5 million, which if you multiply it by three is probably equivalent to a small amount of Canadian dollars per annum actually. It's become clear that in order to run the research inspection process in a rigorous and sensitive way, that budget will need to increase considerably.

The source of the funding has really been the treatment clinics. The source of the funding in the future will continue to be treatment clinics, but also will be research organizations, which in the U.K. are primarily in the universities. We are presently in discussions with the Department of Health and the Department of Trade and Industry to decide how best this should be funded to ensure that the fees we collect are fair for what we do on behalf of the United Kingdom.

The Chair: Anyone else?

Mr. Ménard.

[Translation]

Mr. Réal Ménard (Hochelaga—Maisonneuve, BQ): I would have liked you to wait for us before starting the meeting, Madam Chair. There was a vote in the House. It will be difficult for us to ask questions when we haven't heard the opening statement. We stayed in the House to vote, we did our job as parliamentarians.

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[English]

The Chair: I'm sorry, Mr. Ménard.

Mr. Dromisky has a question.

Mr. Stan Dromisky (Thunder Bay—Atikokan, Lib.): You probably dealt with this earlier, when we were in the House voting. However, in light of the most recent developments in stem cell research that have occurred in the United States, there's been a reaction in your country, especially in the House of Commons. Can you brief us as to what is the latest?

Dr. Maureen Dalziel: A bill is going through Parliament at the moment. In fact, it was heard in the House of Lords yesterday and is due to be heard in the House of Commons on Thursday. This is a very small bill that will ensure that human cloning cannot take place in the U.K. It's been rushed through as an emergency bill because a number of days ago, the ProLife Alliance managed to get agreement in the High Court that the definition of an embryo did not include the definition of an embryo as determined by cloning.

This does mean, however, that unless the court of appeal overturns this decision, there will be a gap, and cell nuclear replacement will actually be able to take place—that's therapeutic cloning, not human reproduction cloning. The Department of Health is discussing how to plug that gap, though I believe they think the court of appeal will overturn the original ruling.

At the same time, there is a House of Lords committee considering the new research regulations in cell nuclear replacement. It is due to report at the end of January next year, and the HFEA has agreed not to license any cell nuclear replacements until then, although we are continuing with our research regulations as specified under the act.

Is that helpful?

Mr. Stan Dromisky: Could you give us a little more information regarding therapeutic research, the stem cell research?

Dr. Maureen Dalziel: The United Kingdom is well placed because of the research regulations to license research where it considers it's appropriate. The conditions are as follows: increasing knowledge about the development of embryos; increasing knowledge about serious disease; or enabling any such knowledge to be applied in developing treatments for serious disease.

I have explained that at this time the science is at a very early stage of development. It's really at the stage of developing the methods for extracting the cells, not actually turning the cells into therapies as yet.

I tried to describe it as a parallel to DNA being found 50 years ago on the genomic project and taking 50 years to come to some fruition. I'm not saying that will be the case in therapy development, but I was trying to point out that for a drug to be licensed for normal use in the United Kingdom or Europe, it can take eight years of clinical trials, which I'm sure you are aware of. It would strike me that it would be something similar with therapy.

So where we are at the moment, in the United Kingdom, is that no stem cells have been produced. A number of researchers under the previous research regulations have tried to extract embryonic stem cells and have not succeeded in the United Kingdom. The Medical Research Council is very anxious to foster the development of this science in the United Kingdom and is acting with the Department of Trade and Industry to encourage the development of an infrastructure for scientists to conduct this research. Although we have two new applicants with the HFEA at this time, we have yet to issue the licences.

The Chair: Thank you.

Mrs. Wasylycia-Leis is next.

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

This is just to pursue the nature of the bill before your Parliament currently. Would that bill, if passed, in fact prohibit the kind of development coming from Massachusetts that was reported yesterday?

Dr. Maureen Dalziel: No, it wouldn't. It's human reproduction cloning. What was reported in the United States was what I would call therapeutic cloning.

Ms. Judy Wasylycia-Leis: What is the current public policy in the U.K. in terms of the creation of embryos for research purposes?

Dr. Maureen Dalziel: Where we are at the moment is that the HFEA Act was extended on January 31 this year to specify additional legal purposes for embryo research. As I said, it's about increasing the knowledge about the development of embryos, increasing the knowledge about serious disease, and enabling any such knowledge to be applied in developing treatments for serious disease.

We have had two applications to the authority, which are going through the process at the moment, but no licences have been issued at this time. There are licences already. There were three projects under the previous regulations for research that were issued. No stem cells or stem cell lines have been developed as a result of those licences.

Ms. Judy Wasylycia-Leis: Thank you.

To what extent is research in this broad area regulated in the public sector? In other words—you mentioned most of the research is being done in universities—what proportion is being done by life science companies and pharmaceutical companies and falls beyond the purview of government regulation and oversight?

Dr. Maureen Dalziel: [Inaudible—Editor]...licences for research in the United Kingdom would include licences for research in private sector companies as well as the public sector. The research that has taken place in the United Kingdom to date has been in the public sector and in the universities. But increasingly our universities—I can't speak for Canadian universities—have been becoming more entrepreneurial, getting partnerships and developing companies alongside universities in order to help the injection of cash into research. I do know that a number of private companies have expressed an interest in supporting research in this area, but they're waiting to see in the United Kingdom whether we will license easily or whether the licensing process will be complicated.

Ms. Judy Wasylycia-Leis: Thank you.

Just on that, how are you handling the patenting process and the development of genetically manipulated human cells? I know it's an important issue globally, but I'm wondering if you have a public policy in the U.K. to deal with requests for the patenting of life forms or for any developments in this area.

Dr. Maureen Dalziel: The HFEA has not had any, but I do know that discussions are taking place on a whole variety of these issues in the Department of Health and the Department of Trade and Industry. I don't know where those discussions are going at this time, but it's one of a number of issues people are beginning to get their heads together on.

Ms. Judy Wasylycia-Leis: This is one other area that may have already been discussed, Madam Chair, but I'd like to ask about the whole question of public financing of services provided in terms of in vitro fertilization, artificial insemination, and any other reproductive technologies. What is covered now through public health insurance, what is left for the individual to pay, and how does your system work that way?

Dr. Maureen Dalziel: The way the system works is that in some parts of the country National Health will pay for IVF treatments, but usually on no more than three occasions for one person or one couple.

• 1210

However, just to give you a feel, 75% of the business takes place in the private sector, and only 25% takes place in the public sector. The National Institute for Clinical Excellence is currently looking at the evidence about infertility and will be considering whether it should be available in the public sector. I think it's more likely to be available in the public sector if it can be demonstrated that it would be cost-effective to do so. At the moment, it has not been demonstrated to that effect.

There is obviously a lobby from patients who are infertile and would welcome the National Health Service providing infertility treatment as part of its normal service, but at the moment it is really something the majority of people do have to pay for.

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

I'll now turn to Mr. Lunney.

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

In the U.K., is there regulation on the sale of gametes? For instance, we had some very generous financial incentives for women to participate in donating ova and so on. How do you handle that in the U.K.?

Dr. Maureen Dalziel: [Inaudible—Editor]...go on, so we say that no more than £10 will be paid for that.

Mr. James Lunney: Excellent.

The next question is on commercial surrogacy. Where considerations are given, in terms of income loss or so-called reasonable expenses, how is that handled in the U.K.?

Dr. Maureen Dalziel: That's not something we actually get involved in. It's outside our remit. That really is because it's in between a number of laws, family law and children's law.... I can't honestly say what the most up-to-date thing is. I can't really give you advice or say what would be helpful to Canadian law except just to say that surrogacy is not something that is really—how shall I put it—welcomed in the United Kingdom. I think that is the best way of putting it, actually.

Mr. James Lunney: So you would say it's discouraged, in essence?

Dr. Maureen Dalziel: Yes.

Mr. James Lunney: Excellent.

Oh, there's just one other thing, and that is on donations. Do you allow anonymous donations, privacy for so-called donors, or is there more interest in making sure the children produced by technology have access to information on their parentage?

Dr. Maureen Dalziel: That is a very pertinent question, because it's a question that is becoming more and more common. In the past, donations were private. What we would keep on the register were descriptions if the donors wished to pass on descriptions of themselves to children.

However, there are two things. There is the human rights legislation and a belief among an increasing number of organizations, ones that support donors and the parents of children who have come from the donated gametes, that there should be a much greater understanding of what a child's genetic origins are and who their father or mother is. In the near future the Department of Health will be going out over a six-month period to consult the public on what sort of information should be made available.

The Liberty Alliance, which very much looks after the freedom to find out who you are for groups of children, is at the moment taking a number of cases to our courts, asking for information about the donor to be made available, one, because there are medical conditions it would be useful for the donor to know about; two, because it would be useful for the child to know their genetic origins and who their father or mother is; and three, very much as a kind of challenge against the law, actually. That's going on at the moment within the United Kingdom.

• 1215

My own personal view is that there will be an expectation eventually that more information should be made available to children as more and more become aware that they were born as a result of donated gametes. I think the research certainly suggests that there are good reasons to think that courts will eventually think it's a good idea. That's my only intelligence to date on that matter.

Mr. James Lunney: Thank you very much.

The Chair: Mr. Manning.

Mr. Preston Manning: I have just one short question. How does the authority relate to local health authorities and other components of the system, such as the Human Genetics Commission? As you know, Canada is a federal system, which is different from yours, and we have a lot of our institutions in other areas than just the federal area. I wonder how your authority relates to local health authorities and to other bodies like the Human Genetics Commission.

Dr. Maureen Dalziel: The authority usually covers England, Wales, Scotland, and Northern Ireland, so it's a U.K.-wide body. Its sponsoring department is the Department of Health, which is the same sponsoring department as that for the NHS, and therefore the NHS and the authority share the same secretary of state.

We, as you can see, regulate treatment services in NHS trusts and in private clinics. We would only relate to regional offices or health authorities if there were a specific issue that was of wider interest than just the individual treatment or research centre we were licensing. I'm trying to think of an example. One example might be if we found HIV or some infectious disease in a particular clinic. It may very well be that in this case we would talk to not only the trust but the health authority.

Until fairly recently it would be true to say that the authority almost acted specifically in this area without recourse to any other organization. But the chairman of the authority, Ruth Deech, sits on the Human Genetics Commission as a member, and I attend all meetings of the Human Genetics Commission and we conduct joint consultations, the most recent example of that being into genetic diagnosis.

In the field of genetics and science, we probably have more strategic relationships and operational relationships. With regard to the health service, the more likely organizations we link into are other regulatory bodies like the Commission for Health Improvement and the new regulatory body, the new national care founders commission, which is regulating practice in the private sector, rather than the health authority, which is responsible for overseeing the health needs of a population.

The Chair: Seeing no further questions, Dr. Dalziel, I want to thank you profusely for your time and for all the knowledge you have brought to the table for us this morning.

• 1220

We are still struggling with draft legislation and hope to report to the minister soon, and then we expect a real bill to be introduced in Parliament. It will probably come back to us again, so we will not be finished when we're finished, if you know what I mean.

So thank you very much. We appreciate this, and hopefully some of us might be able to meet you on trips to the U.K., or you perhaps will meet us on a trip to Canada. Thank you for your time.

Ladies and gentlemen, I think we'll recess for about two minutes in case you want coffee or anything, and then we'll call Dr. Lippman back to the table.

• 1221

• 1226

The Chair: Can we come back to order, ladies and gentlemen?

Dr. Lippman was sufficiently interested to come at 11 a.m. in order to hear from Dr. Dalziel in Britain and get the latest word on what was happening over there. Dr. Dalziel was not ready, so Dr. Lippman came to the table and went through what she called the easy part of her presentation, which was introducing herself.

Believe me, she has a list of credentials that are tremendously impressive, with knowledge from a variety of angles on this field—one being her scientific credentials. She has also served on Canadian bodies developing public policy in this area. It's really what I consider to be a wealth of experience.

So I will introduce Dr. Lippman to you and ask her to proceed with her opinions on what we're doing.

Prof. Abby Lippman: I just want to clarify that sometimes—and I'll try to make you aware—I'll be speaking on behalf of the Canadian Women's Health Network as well as myself, and other times I'll be speaking only for myself. The CWHN does not have a formal statement that is approved on all of these issues, but we have certain positions we can take, nevertheless.

Thank you for inviting me. As I said at the beginning, I don't know if this is the best of times or the worst of times, looking at the newspapers' front pages and editorial pages the last two days. It's an interesting time to be here, to say the least.

I will try to touch on a number of issues, and if I go rapidly over them—I speak fast as well as move fast—I hope you'll come back with some questions I might be able to answer when I'm finished.

I will start with some general issues first, and then a couple of very specific—

Mr. Réal Ménard: Point of order.

I want to make sure there's a translation of the text because it's difficult.

Prof. Abby Lippman: I don't have it because I only prepared it yesterday.

Mr. Réal Ménard: Oh.

Prof. Abby Lippman: I will be leaving one with the committee.

I apologize. I have a diskette, but it was too late.

[Translation]

I'm sorry.

[English]

The Chair: Try to speak more slowly because otherwise the translators won't be able to keep up with you.

Prof. Abby Lippman: Sorry.

Let me start with some commentaries about the preamble first. I'd like to start with some positive commentaries about the bill itself. Basically, the CWHN is pleased to see there is finally something on the table. We have been asking for one for a very long time, and I will not go back into history to remind you of that.

However, it's important that at the same time you are deliberating this bill, the public, as well as practitioners and researchers, are very well aware that no matter what you may be prohibiting, as soon as you get to prohibit things, it does not mean that everything else is okay to do, that you just need to get a licence and move ahead. It will be very important to make it clear to the public that the absence of a prohibition at the start of this legislation does not mean it won't be prohibited later on, or that it is an acceptable practice.

• 1230

Turning to the preamble, again we are pleased to see that a tone is being set for the legislation that follows. We are delighted to see that the special effects on women of these technologies are recognized. However, there are a couple of elements that we would like to see added.

The first would be recognition of the value of protecting the vulnerable. The second would be a reflection of charter rights commitments to equality, with mention that assisted reproductive technologies must not contribute to discrimination against vulnerable social groups, particularly women and people with disabilities.

We would also like it mentioned that all of this is occurring within the broader reproductive and sexual health context in which these activities are placed. That would at the least enable the educational work that the regulatory body is supposed to do.

There are some specific issues related to women's health, in general, that I'd like to comment on as well. First I'd like to emphasize that the Canadian Women's Health Network supports, as do other women's health advocates, what can be called the precautionary principle. When there is uncertainty about an activity or procedure, the onus should be on those who wish to carry it out to demonstrate in advance its lack of harm. This contrasts with letting it happen until we find something has gone wrong, and then stop doing it. This overarching principle should set a tone for the legislation that comes.

We would also like to emphasize that although this bill is looking at treating and circumventing infertility, the real issue for most people is the prevention of infertility to begin with. There are some very non-technological approaches to preventing infertility, through treatment of STDs and the reduction in the frequency of sexually transmitted diseases. Other things, such as structural changes in how women live their lives, would allow them to have children at earlier ages, which would again preclude the need for facing infertility treatments later on.

The other thing is to realize that if you take the precautionary and preventive approach, some of these treatments proposed for infertility are being done on very healthy women, who happen to have male partners who are not fertile, so we need to protect the health of healthy women.

Parenthetically, it's worth noting—and there was an article in the newspaper recently that reminded me of this—one of the ways in which in vitro fertilization is favoured is by covering the costs of it. It is cheaper for many women to have IVF than to adopt a baby. That is something worth keeping as a contextual feature. Women may be pushed into some of these activities because some other ways they may want to use to form a family are just not available to them.

Switching gears—and as I said, this is going to be a mélange of things—on the matter of informed consent and informed choice, we are firmly committed to the notion that free and informed choice and consent are fundamental to the use of the technologies. The process of getting consent is probably as important as seeing a signature on a piece of paper. I've learned this from serving a couple of years now on an institutional ethics review board.

It's very often a legalistic thing to have a signature on a piece of paper, but you don't know why someone has been consenting. Given the importance, we would like the act to ensure the process and existence of informed choice through regulations, with oversight to guarantee the choices are not coerced.

This would include writing into legislation the requirement that counselling by disinterested individuals—those with no conflict of interest—would be a condition for informed consent by parties considering the use of any activity related to assisted reproduction.

Taking off my CWHN hat and putting on my own hat as a researcher and ethics review board member, I would like to mention that there is also the need for informed consent with respect to the researched scientific use of the health information that's going to be collected, as well as any other material that's collected. I'll be coming back to that.

There is a clause in the bill, I believe it's 21(6)—I don't know the right lingo for referring to these sections—where it might be appropriate to offer individuals the right to refuse re-use of the information they've provided at the time you collect it, if that information is going to be used only for research and not for monitoring and surveillance, which I am fully in support of. I think there has to be monitoring and surveillance. But to the extent there would be no interference with an open-donor system, which CWHN and I support, there has to be a right to refuse participation in all kinds of research, even if it's only demographic data types of things.

• 1235

This brings me to another issue about the disclosure of health information. I must admit that in looking at the bill, I was confused, because my linguistic skills are not too great in either English or in French, but it seems to me the words used in English are not the same as the words used in French and that “biological information”, which is how I translated the French, is not the same as “reproductive health information”—or however it was—in English. This needs to be made consistent. The other thing is, I don't know why it was called health reporting information. Why don't we just call it health information? I didn't know what the reporting was.

This being put aside, it's important that the data be collected, in particular because we do not know about the safety of many of the medications and procedures either used to stimulate oocyte production.... There had been reports of ovarian scarring, ovarian cancer, strokes, later infertility. Particularly if people are going to even consider obtaining eggs and ova from young women who have not had their own families themselves, one does not want to try to help someone else with infertility by creating it in another woman.

So the complete reporting is necessary, and an open system is to be commended; it's the way it should be done.

My next topic is surrogacy. I have to admit that I, personally, don't like the term “surrogacy”, but I'm not sure the other terms that have been used in this context, either “pre-conception arrangements” or “contract pregnancies”, are any better, so I will stick with surrogacy.

The CWHN supports entirely the prohibition of commercial surrogacy. However, we have serious concerns about the distinctions made between commercial and non-commercial arrangements in the draft bill, for the simple reason that the same social harms pertain in both situations. Both situations lead to a commodification of children, to exploitation of the vulnerable, and to health risks—for instance, perhaps, later infertility for the young women.

As a result, all women need the assurance that no coercion will be involved in any and every contract pregnancy. There is without doubt the potential for coercion in both situations. It may be economic vulnerability in the commercial context; it could result from emotional and other kinds of pressures in the non-commercial variety. In fact, there may be even more concerns about free and informed choice in non-commercial arrangements than in the commercial ones.

So in view of these concerns and the sort of arbitrary distinction between commercial and non-commercial, we find the language in the current draft bill too enabling of non-commercial surrogacy. We would therefore strongly encourage a moratorium on non-commercial surrogacy, at least until a regulatory structure is up and running.

On a specific matter—and I don't want to get into a lot of the clauses in the bill—there seems to be some contradiction also between two of the clauses, one of the subclauses in 4 and one of the subclauses in 10. It seems here that you're allowing expenses to be paid for something you have previously prohibited. If you are paying for something in one place you prohibited in another, you may want to get it sorted out.

The other issue is I don't know how one defines “consideration”, but I do think one should talk about expenses, and only expenses such as travel and parking, not the expenses of being pregnant.

Considering the regulatory body, as I said at the start, regulations need to be written now, not one year or many years from now. This is a cri de coeur really—as some of you who may be aware, I was on the federal advisory committee. I was one of the original members of the committee when it was set up several years ago.

I resigned in June 2000 with a public letter saying that my resignation was not because I had lost interest in this issue but because I could no longer sit and be part of a process that was moving so slowly. I had to get out of it because I felt my own integrity was being compromised by all of us working hard—and I would like to give great thanks to the people in Health Canada who have worked on this because they have done heroic, and “heroine-ic”, work in this area. They have just been superb, but the committee was being caught. So with that political statement, I'll stop.

• 1240

In terms of the regulatory body, therefore, we formally recommend that instead of accepting activities in practice now, which seems to be implied by the grandfathering in clause 43, there be binding moratoria on all procedures to be considered by the regulatory body. So if it's not prohibited, there should be a binding moratorium, with attention to at least two of these in particular. If I can't sell the whole package, I would at least like to pull out pre-implantation genetic diagnosis and non-commercial surrogacy as two that really need flagging.

In addition, if I could really have my way, I would encourage the prohibition of any activity until such time as it has been fully evaluated for its safety. Until you know something is safe and effective—and I use the word “effective” because it means in practice, not “efficacy”, which is what the laboratory people tell you, but if an activity is actually going to work in the public, then it should be there.

If you don't want to go as far as prohibiting anything until it can be proven safe, then there should be at least a very short time limit—no more than six, maximum twelve, months, and that's really pushing it—within which those carrying out some activity must have a licence in order to continue it. In other words, you don't give open field on what people are doing now.

When we see the headlines in the newspapers, as we did yesterday and today, my gut feeling is those things hit the headlines to see what the traffic will bear, but what's happening behind the headlines, what we haven't heard yet, is going to come at us like a bolt of lightening, because people don't just do these things overnight. Whatever you haven't heard about you should assume is already being done and will be announced very shortly. I've been saying this for about 20 years, but no one believed me until now; so maybe you will.

Another issue is if no long-term information exists on a practice, it is to be regulated as research and not as a service. In this way you can sort of avoid trying to figure out what to do with a thing when you don't know about it. Regulate it as research. Get it proven safe, effective, and then have it provisionally regulated so it can get conditional licensing, for instance, except under research conditions. This is a sort of tactic you might use.

Further to the regulatory body...and I won't go into the various conditions everyone seems to be agreeing on in terms of independence, transparency, accessibility—I would just like to stop there.

I was very surprised to hear Dr. Dalziel say the HFEA meets in private. I would hope this would not happen in this country, and I would encourage you to see that it does not. Meetings not only need to be open to the public, but transcripts of them need to be made available, web sites need to be established—but not everyone has Internet access. These meetings need to be recorded, as your hearings apparently are as well. These issues are too important to be left for small groups of people to decide on in private. They are of great public interest.

In this sense, the other part, which I'll come to later if I have any time left, in terms of the education and knowledge-building activities of the regulatory body, is that there be funding for just these kinds of things. There are some very interesting models of public consultation that have been developed in England in particular—and I think here of citizens' juries and things known as science colleges, which aren't colleges as we think of them but places where citizens come to make recommendations about policy, sometimes even binding recommendations. These are activities that a regulatory body should be encouraging.

I cannot get away without saying something about cloning. I was really hoping not to have to, but I guess that's impossible.

I hope Canada will join most other countries and immediately establish a ban on cloning, both reproductive and non-reproductive, without waiting for the rest of the bill to be drafted. I speak in a personal context right now. There have been proposals put before this Parliament previously about cloning; the time to act on them is long past.

Human embryos should not be cloned for the specific intention of using them as a resource for medical experimentation or for producing a baby. Human life and its various parts and processes are not mere research tools, nor are they manufactured products or commodities. Moreover, this practice would only encourage further marketing of women's eggs and provide unethical incentives for women to undergo health-threatening hormone treatment and surgery.

Thus it would seem that the definition of cloning in the draft bill needs to be widened in paragraph 3(d) to ban the creation of embryos for non-reproductive matters, and we must limit, not end, the increasing bio-industrialization of life by the scientific committee, of which I am a member, and life science companies. I'm so dismayed to see cloned human embryos already being patented as inventions.

• 1245

I think it was interesting when Dr. Dalziel was talking about the research being done in private companies. It's being done in private companies, and already there are patents that have been taken out in the United States for the use of stem cells. I think one would be very naive to think, if you're going to be developing treatments, that these are going to be benefiting anybody other than the companies that are manufacturing them in the near and perhaps even the long term.

I'm going to relate that to a couple of comments I'm going to make about embryonic stem cell research.

I've left a document with the clerk of the committee that comes from the United States. Unfortunately, it's only in English. But it highlights there, as well as in other places, that the research that has been done on embryonic stem cells up until now has mostly been done in animals, primarily mice.

For 20 years we have had promises that we're going to cure all these models of disease in animals. Not one of those promises has yet been met. It is easier by far to work with mice. It is certainly ethical to work with mice, unless you are a member of PETA, which is another story.

So assuming I can handle the ethics of working with mice, which I can, why should we suddenly believe the promises that are being given to us now? We are being sold a very large bill of goods with promises of things that are not happening.

There have been no scientific papers, according to Stuart Newman, published in the last 20 years that have reported cures, and fewer than half a dozen have indicated any amelioration in the condition of the mouse using mouse embryonic stem cells.

Again, you may remember that with all of these unfulfilled promises, there have been many failures to date using gene “therapy” and fetal tissue transplantation. None of them have yet worked. I think we ought to just take a deep breath.

About ten years ago, I was at an obstetrics meeting and was collecting a lot of paraphernalia. One thing was a picture. It's hanging on my office door, which you cannot possibly see from there. It is an adorable little child holding what looks like a toy—or maybe it's a mouse for a computer—and it says: “Science you can hug”. It was given out by a company that had these books with all the information you want to know about sperm donors. I think that's where this is going, not to cure diseases.

I think embryonic cell selection has been oversold, and I don't think we need to create embryos to make embryonic stem cells right now. We can use the...I don't like the term “extra”, but the embryos that have been created for IVF. If people give signed, informed consent to their use for research, use those. The others have not really worked.

Even the article that was posted on the Internet yesterday.... Realize that is a publication that does not have peer review, other than by its own internal people. It has its own internal ethics committee reviewing these things. And I think we all need to take a deep breath and say, yes, it showed us these are going on, but it has not moved us that much further.

I'll move quickly to sex selection, because I'm sure my time has run out.

The draft bill needs to be extended. It deals now only with sperm cell sorting, but sex selection can be done with pre-implantation genetic diagnosis, which is why I don't want that happening. I think you need to consider whether you want to have the act expanded to include sex selection for the creation or implantation of an embryo chosen strictly on the basis of its sex.

Regarding pre-implantation diagnosis, as I've mentioned, I think this is a dangerous activity right now. It is under debate in the U.K. They did a public opinion poll, and the public seems to be in favour of it there. I didn't see the questions the public was asked, and I would like to know that before I say the public really wants this done.

It's very difficult to distinguish medical from non-medical conditions. What is a medical condition when we're doing pre-implantation diagnosis? If you open the door, is this a proper technology to use for people who are not infertile, but who are requesting IVF specifically to be able to assess the condition of an embryo before implantation? This is already being done. I think you have to be careful there.

• 1250

Finally, as I've said already, I think the consulting and educational roles of a regulatory body are critical. They should be funded and they should really engage the public in an honest, participatory, democratic discussion—not a consultation where people like me go to the table surrounded by everybody from industry and have to fight for their lives most of the time, but real consultations.

The final worry is about financing and management.

We're disappointed there's nothing in the draft bill about how the activities will be covered financially—those that are licensed. I think we need to have a public discussion about what's going to be publicly insured and what will be left, if anything, for individuals to pay for themselves. If the costs of the services are to be borne by the individuals using them, it causes grave concerns because it will lead to unequal access. If you think these things are worth doing, why should they not be available to everybody? I also believe it will lead to further privatization of the health system for reproductive care—something we do not want to see happening at all.

I also have concerns, as do others, about using cost-recovery mechanisms to finance the regime, because I think they will likely only encourage privatization. I believe the CWHN's position would be that there be medicare coverage if an activity has been proven safe and effective; otherwise the activity should be done only within a research protocol that has been approved for its science and its ethics.

I will stop here. I'm sorry for going on probably longer than you wanted me to, but I will answer questions. And with all due respect, as much as I want to beat up on you for taking so much time, as a government, to do this, I recognize these are not easy issues. I've been doing this for 20 years. I thought 20 years ago they were complicated. I realize I was understating what has happened since then. So I know you're agonizing with a lot of hard things, but on the other side, realize there are a lot of women and a lot of children who are going to be harmed if you don't move judiciously and quickly. They need things that are safe, effective, and well regulated. So you have a lot of people in your hands.

Thank you.

The Chair: Thank you very much, Dr. Lippman. You're so wide-ranging, and you have opinions about all the things we're struggling with. We're most grateful.

I have to personally apologize because the clerk and I have to go somewhere to accomplish a budget so that this committee can bring witnesses like yourself to speak to us in future. I'm going to have to ask my vice-chair if he'll take over for the questioning period. But thank you very, very much.

Prof. Abby Lippman: Thank you.

The Vice-Chair (Mr. Reg Alcock (Winnipeg South, Lib.)): We design questions by the pound here in this committee.

Mr. Manning, I trust you will have a question.

Mr. Preston Manning: Yes, just a couple.

I want to thank you for your testimony. I find we're very much in agreement, particularly with your statements on cloning and regulation of embryonic stem cells.

I have two quick questions. One is on your reference to the importance of informed choice, consent, and the need to specify the process, not just the documents. We've had a number of witnesses who have provided us with the forms that are used to get consent, but do you have any model in mind of a process for obtaining informed choice and consent that somebody's worked out that could be perhaps even incorporated in a statute?

Prof. Abby Lippman: No, unfortunately, I'm not aware that there are any templates.

I think the critical issue, really...I would be comfortable in trusting those who are doing the counselling beforehand if they were not part of the process themselves. It's one thing if you go into an infertility clinic and the infertility nurse is telling you about it. I think that puts a constraint on it. So I think they have to be people who don't have a conflict of interest doing this. I haven't gone into the exact details of how to set it up. I could create some, but I don't want to take up your time making them up.

Mr. Preston Manning: Yes, okay.

• 1255

Given your reservations about altruistic, or so-called altruistic, surrogacy, why not ban both altruistic and commercial surrogacy?

Prof. Abby Lippman: I'm concerned about the banning of the altruistic surrogacy. I'm thinking of some of the native women's groups. There are situations where giving babies to someone else is part of their behaviour. I would not like to see it done.

I'm speaking only for myself. I've been grappling with this. I go back and forth on feeling I want to completely criminalize the commercial surrogacy. Since I see them as so parallel, the logical conclusion would be to regulate both. I'm concerned that giving a message where we're only regulating commercial is not strong enough.

I've taken what I recognize is a somewhat inconsistent position, given how I feel, in saying I want to have the prohibition on the commercial. I'm willing, because of my concerns about trapping innocent women, to let the non-commercial be heavily regulated. I do not want to call it altruistic. It's why I've changed some of the words so we get rid of this notion of altruism. It would be non-commercial surrogacy under very close regulation.

Mr. Preston Manning: Okay, thank you.

The Vice-Chair (Mr. Reg Alcock): Thank you.

Mrs. Sgro was next, but the next one we'll have is Mr. Ménard.

[Translation]

Mr. Réal Ménard: Thank you. I have two questions.

You said that the preamble of the bill should indicate clearly that we intend to respect the values of the Charter. I would like to give you the example we heard yesterday, from the Lesbian Mothers Association, which wanted it to be mentioned in the preamble that there should be no discrimination on the basis of sexual orientation and against single mothers. We were told that heterosexual women who live alone, who do not have a man in their life, are not entitled to use fertility clinics. So, my first question is this: Do you want that to be included in the preamble?

Secondly, I want to make sure I understood. If a woman is stimulated and that several eggs are produced and she chooses freely and voluntarily to give those excess eggs for research, there would be no difficulty. When you say that embryos should not be used for research, I suppose that would not apply to such a scenario.

Ms. Abby Lippman: Can I answer in English?

Mr. Réal Ménard: Absolutely.

[English]

Prof. Abby Lippman: You were not here when I said I am an audible minority. I speak both languages with the same New York accent.

In terms of the first part of your question, the answer is yes. It's why I refer to the charter. I think there may be other examples besides lesbian women or single mothers who want access to the technologies. I believe they should have them. In terms of the specifics on how it's written, rather than just taking the two cases, I refer to charter liberties that would encompass them.

Does it answer your question?

The second point is I would strongly object to having the creation of embryos strictly for research. If a woman has given her free and informed consent—she has been stimulated to produce eggs for the purpose of her own treatment, there are extra eggs, and she chooses to allow them to be used for research that is ethically and scientifically approved—I would accept it. She should not be stimulated merely to produce eggs that will be used for research, if she's not going to be stimulated first to produce the eggs for her own purpose, because it's too dangerous. I don't think any ethics review board would allow it to happen. You're giving a healthy woman a risk to her own health for material to play with in a lab.

Does that address it?

[Translation]

Mr. Réal Ménard: What you said is very interesting. You have exactly answered my question.

If we go further, if a person is being treated, her primary reason would be to give birth to a child. If she has several eggs and wants to contribute to research, you have no difficulty with that. I suppose your position is based on the ethical value that embryos should first of all serve to give birth to children. This is what Minister Rock had stated in the communiqué that he gave us when we started our debates. So, I have no problem with that.

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However, what would you answer to a scientist telling you that, at the present time, excess embryos are not in sufficient number to meet the needs of research and that the type of research that would be carried out with excess embryos could lead to a significant improvement of human life by allowing us to find cures for heart diseases, Parkinson's disease, Alzheimer's and other degenerative diseases?

[English]

Prof. Abby Lippman: If I understood you correctly, I would say we have not, as far as I am aware of the science. I'm not in the lab daily as a scientist.

We have not pushed hard enough to know what can be done with the cells already there, either from adults or from the fetus. In fact, someone recently was recording that they can get cells from amniotic fluid, when a woman has amniocentesis, and can make the cells behave as if they are stem cells. It's a bit scary.

I don't think we're stopping science in saying we're going to work with the cells we have and not create embryos to get the cells. If things are going slowly, so be it. I am willing to say it's unfortunate. It's not unfair, to me, that we slow things until we can do the science in a rigorous, sound, ethically appropriate way that does not do more harm than good.

The Vice-Chair (Mr. Reg Alcock): Thank you, Mr. Ménard.

Ms. Wasylycia-Leis.

Ms. Judy Wasylycia-Leis: Thank you, Mr. Chairperson.

There's so much to raise as a result of your brief. I'm going to have to focus on a couple of issues that I think we haven't heard much about.

One is the development in this country around pre-implantation and genetic diagnosis. As I understand it, in fact, private clinics exist now to which people can go for precisely the purpose you identified. It is not for medical reasons, but to create designer babies, in effect.

I'd like you to comment more on the pervasiveness of this service for Canadians. Can you indicate whether you think this bill, as it's now drafted, will do anything to shut down or outlaw such operations to prohibit that kind of activity?

You talked about the patent for genetic manipulation of human cells, which as a committee we haven't really grappled with. I think part of the reason is the patent office probably reports to the Ministry of Industry, if I'm correct. We know there are numerous applications before the Canadian Patent Office for patenting the different genetic manipulations of human cells.

What can we do, through this bill or otherwise, to prevent the patenting of life forms and to stop this move toward a commercial genetic civilization? It appears to be happening all around us, and it is aided and abetted by the lack of any legislation in this area.

Prof. Abby Lippman: Thank you. I'm afraid I'm going to give very weak answers to both your questions.

I cannot comment on the extent to which there are private clinics actually doing pre-implantation genetic diagnosis. I don't know. I've heard about them, but I have not done a survey on how much is going on.

I know the technique is used in some of the university centres for specific diseases. It may be being used; it's not clear that it is. It's something that has really not started here.

The U.K. is ahead of everyone in this area. The licensing agency has been happily licensing a lot of the things. I don't think pre-implantation genetic diagnosis has gone very far in this country, at the present time, but it may be offered.

In terms of the patenting, I wish I knew how to answer the question. When I was listening to Dr. Dalziel talk about how they're in close discussions with the Ministry of Industry and Trade in the U.K., a shiver went up and down my spine. I kept thinking about who was going to be there to commercialize the material.

I don't know how to put it into law that these things will not be patented. Certainly, if they're being made here, I'd be less than naive to think they're not going somewhere else. There are going to be border crossings for all the activities. There's going to be access across borders.

I'm concerned that some of the regulations that may be in NAFTA will allow for the opening of private clinics here, that it will come here.

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So there's a whole intersection between what's happening in the trade ministry, what's happening in the economic development, and what's happening in the reproductive technology. I don't think any one bill can really get at it. Certainly I think to this extent you want to have the bill be as close and have as much teeth in it as possible to get at commercialization, where you can get at it.

The other part of this is that this bill is primarily focused on those techniques and those activities that have to do with assisted reproduction. There are a whole vast number of issues dealing with developments in genetics that this bill probably should not incorporate, but it cannot be apart from that.

So how do you interdigitate these two sets of things that are going on? On the one hand, you're going to have the CIHR pushing research and genetics to get this done, insisting that you have partnerships in the private domain, and yet this bill is trying to do the tightening. To the extent you can limit commercialization through the assisted reproductive technologies is about all you can do here. It's a modest goal. It will not solve all the problems. That's why I'm not a member of Parliament, because I don't know how to solve them.

The Vice-Chair (Mr. Reg Alcock): Ms. Wasylycia-Leis.

Ms. Judy Wasylycia-Leis: Your comments are much appreciated. It's not an issue we've heard a lot on in terms of all these hearings. I think it's probably one of the more central issues to be grappled with if we're going to present meaningful legislation on the whole area of reproductive technologies.

My last question is simply on the following issue. You were very clear about moving immediately on prohibitions on cloning, whether it's for research purposes or the creation of life forms or a baby. What do we need to do? How can we convince this government to move quickly on that issue? We've had this before us for so many years. There has been a consensus in Parliament, a consensus in the public. What's the hold-up, and what can we do to break down that wall?

Prof. Abby Lippman: My guess right now is—and I'm only speaking as an ex-Brooklynite—you have a moment of opportunity. I think the public is enough aroused now that if there was to be a bill right now, you'd have the public behind you. I think the public has always been behind you about cloning.

The issue needs to be made really clear about non-reproductive cloning and the emphasis on how this is a commercial activity and not about treating diseases. Even if you did non-reproductive cloning now, it might be my great-grandchildren who might benefit from it—if then. Put a sunset clause in and say we're going to do that, because we need to take a breath. I know it's a bad term right now in terms of the other bill that's here. But you didn't ask me to think about Bill C-36. Why not put in a sunset clause? We're going to prohibit reproductive and non-reproductive cloning now. We will revisit it in three years. But we need to take a deep breath and we're not going to move until then. That's a thought.

The Vice-Chair (Mr. Reg Alcock): Ms. Beaumier.

Ms. Colleen Beaumier (Brampton West—Mississauga, Lib.): I just have a very short question. We have activities in third world countries such as removing kidneys, kidney donations, and selling of kidneys. Do you feel we need to work in an anti-importation piece into the legislation? We know if there is money to be made, it's probably a lot easier to have women produce extra ova for the production of embryos than it is to have them give away kidneys. Are we going to need to consider that in our legislation—to disallow any importation of the embryo?

Prof. Abby Lippman: I think so. In fact I try to understand it a little bit. I don't always understand legalese talk that way. But it seemed to me that one of the things in the bill, as it stands now, does not allow you to buy or sell.... You can't pay money to buy eggs or sperm, but once those eggs or sperm are in a bank, you can then do trade in them to somebody else. So there's a third-party activity that is allowed in this bill.

I would have no problem. In fact, I would encourage there to be. If it's not commercial to the person who is providing it, why should some bank, to which I've given my eggs, suddenly be able to sell them to some place else or import them for something else?

In some of the text I had earlier written, which I was not going to bore you with, one of the concerns I have is the downstream or secondary use of previously accumulated material. I think this is a serious issue that should be tightened harder.

The Vice-Chair (Mr. Reg Alcock): Thank you.

Mr. Lunney, and I believe that's the last person I have on the list.

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Mr. James Lunney: Thank you, Mr. Chairman.

First, you're very clear on the surrogacy issue about not providing incentives. I think that was what we heard come across very clearly. Most of us would agree with that.

Just moving along here, on the embryonic stem cells, you were very clear about the 20 years of promise and the very dismal delivery—I'll use your words, “sold a bill of goods”—and the many failures to date. I certainly appreciate that being advanced, because there has been a lot of hype in this arena.

You did touch briefly on this in response to Mr. Ménard's question. But to put adult stem research in perspective, what's going on in McGill in particular with the skin precursors and so on? Would you comment from your perspective, from where you sit in medical epidemiology, for all these years on whether you see tremendous encouragement in the advances in adult stem cell research and the prospects there?

Prof. Abby Lippman: Yes. Quite honestly, my single-word answer is yes. I don't think anybody would have predicted what they are finding these days. As I said, yes.

I don't think we've given that as much.... It's getting some attention. But why should we not privilege that and push it as fast and as far as we can go, before we say we have to have these embryonic stem cells. I don't think we're going to lose a lot of time. I think if people say that Canada will be a second-rate country because of this, that's foolishness. That's silly. We won't be a second-rate country. We're doing research that's sound and good.

Mr. James Lunney: Would you say in a word then that the promise that has been pushed with embryonic stem cells probably has a greater likelihood of being delivered with adult stem cells?

Prof. Abby Lippman: I'm not a good gambler. I have never bought a lottery ticket in my life. I would say I would want to give it a good try first. My background comes in biology, not even in genetics. And genetics is not biology. Biology is fascinating in terms of what you can learn about what cells can do and how they do it. We've had too much hype.

Several years ago I made up a word that has now become the subject of several theses unfortunately, called “geneticization” I use the word because I think we're trying to see everything that happens in this world as an issue of genetics, whether it's disease, whether it's health, whether it's the food we eat—whatever.

Let's take a deep breath again and say, think how genetics is very small. The DNA plays a very minor part in all of this. It's all the things that the cells are doing. In that sense they could be more dangerous from embryonic stem cells. What I first learned about embryonic stem cells, as a starting graduate student in genetics, was they are the cells that cause something called a teratoma. I don't know if you've ever heard of teratoma, but teratoma are when you grow hair and skin and fingernails in your belly, because these are stem cells that have gone awry and started doing what stem cells do. They are cancer-causing cells. Adult stem cells maybe need a little bit more play in the lab to become a skin cell or a.... But I'd be more comfortable in a certain sense, biologically, trying to work with an adult cell.

Mr. James Lunney: So if we were to pour coals on the adult stem cell research and perhaps have a moratorium on the embryonic stem cell research, it would be interesting to see where that would lead Canada.

Thank you.

The Vice-Chair (Mr. Reg Alcock): Ms. Wasylycia-Leis.

Ms. Judy Wasylycia-Leis: I've two quick questions.

The Vice-Chair (Mr. Reg Alcock): A short one.

Ms. Judy Wasylycia-Leis: I think you are one of the few people who actually suggested that we include in the bill mandatory counselling of a disinterested party. Do you have any recommendations—and you can think about this for later—on where we should put that and how we can make sure it's advanced as a...? I can just hear the arguments that this doesn't belong in legislation. So I'm trying to figure out a way—

Prof. Abby Lippman: Well, I think I would leave that to the regulatory body to figure out. I think it's harder to legislate. How it's done can be done afterwards, but I think it should be done.

Ms. Judy Wasylycia-Leis: But should it be in legislation, do you think, right in the bill?

Prof. Abby Lippman: I can't answer, because I don't know how detailed the bill is going to get, and there would probably be others. I think if you have counselling as part of the informed consent process, and that's in the bill....

Ms. Judy Wasylycia-Leis: But is there enough of an emphasis in the bill? I'm wondering if we should.... It's probably one of the really clear checks we have against this whole issue of women being used as egg-producing machines and going to the extraction of extra eggs for research purposes.

Prof. Abby Lippman: Let me broaden that, and that is in terms of the bill. What I didn't get to say, when I was reading from my notes, was that even in terms of the regulatory body, I don't think there should be anybody appointed to that who has a conflict of interest—in other words, who's going to have any financial gain from being on that regulatory body.

This does not mean you won't pull in the clinicians and the researchers for their input. They have that skill. But I don't think anybody who gets money from this should be part of that. If you do it in the regulatory body, then it can filter down so that anybody involved would have to declare no conflict of interest and have complete disclosure.

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The Vice-Chair (Mr. Reg Alcock): Judy.

Ms. Judy Wasylycia-Leis: I have a final question. On this issue of genetics and pre-implantation genetic diagnosis, should we be clearly calling for prohibitions on the use of eugenic techniques for non-medical purposes? Is that the right phrasing? Does that capture that whole issue around sex selection and use of these new procedures for designing babies according to certain characteristics?

Prof. Abby Lippman: To be consistent with everything I have written for 20 years, I couldn't accept that term, even though I know what you're getting at, for the simple reason that for 20 years I have lost many friends and made many enemies by saying in public, in print, that even the simple use of amniocentesis is a form of eugenic approach to life.

I support doing prenatal testing for various reasons in various circumstances. But since I have referred to that and have been pilloried for calling it a eugenic practice, even though I might support it, I wouldn't go so far as to put that kind of prohibition into the law. It would catch too many things inappropriately. I think the wording would have to be a little bit more nuanced. I would like to say yes, but I can't.

Ms. Judy Wasylycia-Leis: If you have any suggestions on wording, that would be appreciated by the committee.

The Vice-Chair (Mr. Reg Alcock): Go ahead, Professor Lippman.

Prof. Abby Lippman: Thank you, and my apologies to the translators. I know I am a real pain. I thank you for tolerating my speed and my going on.

Thank you all.

The Vice-Chair (Mr. Reg Alcock): And thank you very much.

We are adjourned.