Proceedings of the Standing Senate Committee on
Social Affairs, Science and Technology
Issue 15 - Evidence
OTTAWA, Tuesday, January 31, 2007
The Standing Senate Committee on Social Affairs, Science and Technology met this day at 4:05 p.m. to review the proposed regulations under section 8 of the Assisted Human Reproduction Act, deposited with the clerk of the Senate on October 27, 2006.
Senator Art Eggleton (Chairman) in the chair.
[Translation]
The Chairman: Welcome to the Standing Senate Committee on Social Affairs, Science and Technology. The committee is reviewing the proposed regulations under section 8 of the Assisted Human Reproduction Act. We will hear officials from Health Canada and Ms. Françoise Baylis, Professor at the Departments of Bioethics and Philosophy, Dalhousie University.
[English]
We will begin with our two witnesses from Health Canada, Ms. Hélène Quesnel and Ms. Francine Manseau.
Hélène Quesnel, Director General, Policy Development Directorate, Health Policy Branch, Health Canada: I apologize for the delay in getting our documents to you. We thought we had sent them a few weeks ago, but it appears that you just received them today. Please accept our sincere apologies, so much for modern technology.
Thank you for the invitation to appear before this committee to discuss with you proposed regulations related to section 8 of the Assisted Human Reproduction Act related to informed consent. I would also like to take this opportunity to provide you with a brief overview of the process Health Canada is following to implement this act.
Last summer, we at Health Canada developed a plan to allow Assisted Human Reproduction Canada, the agency established by the act, to begin its licensing and enforcement activities. I will address our strategy to achieve this goal.
The Assisted Human Reproduction Act received Royal Assent in March 2004. Since then our department has continued to work toward the full implementation of the act, which consists of developing the regulatory system and establishing the agency.
I will give you a brief overview of the activities that the Assisted Human Reproduction Implementation Office has undertaken. We have drafted proposed regulations to address section 8, which is before the committee today. The draft regulations were pre-published in the Canada Gazette in September 2005 for comments from stakeholders. The act also requires that the minister table these regulations with both Houses of Parliament, which was done on October 27 last.
The proposed regulations were then referred to both committees, and we appeared before the House of Commons Standing Committee on Health at the beginning of December.
[Translation]
We have also held workshops and consultations with the interested parties to examine issues such as licensing, counseling, health reporting information and clinical and laboratory practices, among others. We are focusing our consultations in order to solicit policy advice on various clinical and laboratory activities that are being done in the clinics, because complex issues are at stake requiring a detailed and in-depth knowledge of procedures before regulations can be developed.
We also need to understand the views of the parties affected by these activities, including the parents and the children born of these technologies as well as the donors. The reports of these workshops are posted on Health Canada's website for stakeholder interest. Finally, we are looking at alternate mechanisms to seek additional information and expertise, including web based consultations in order to speed up the process of drafting regulations. For example, we expect to post a consultation document on counseling on our website to solicit stakeholder input.
[English]
On December 21, 2006, the government announced the appointment of Dr. Elinor Wilson as President of Assisted Human Reproduction Canada and Dr. John Hamm as Chairperson of the board of directors, as well as the appointment of eight members. The board is expected to have its first meeting in March of this year.
We have secured temporary offices in Vancouver and have done extensive work to develop the necessary governance and accountability structures, business plans, processes and management tools. We continue to work toward the set-up of the agency, so that when appointed, its staff can become operational as soon as possible. This will include development of the personal health information registry.
I note an important activity to support the agency has been the development of a memorandum of understanding with the inspectorate of Health Canada, to provide compliance and enforcement with in-house staff. Twenty-three inspectors were designated under the Department of Health Act and started outreach activities as of the last fall, to encourage compliance by improving awareness of the act, providing information regarding the provisions of the act, and educating the stakeholders about the act and their obligations to it.
I would now like to speak to Health Canada's approach to the regulatory development process. In this particular field, there are few established Canadian standards and procedural guidelines. Following a rigorous planning exercise last year, we developed a new approach that focuses on a set of priorities that deliver key regulations within shorter time frames. We will concentrate on a core set of regulations governing licensing of in vitro fertilization activities with people using their own gametes. This would enable the agency to become operational and start its activities sooner.
[Translation]
In vitro fertilization (IVF) accounts for the majority of licensed activities for the clinics. We held a three city consultation that started in Montreal on November 24 and ended in Vancouver on December 8, where we discussed documents related to ten activities controlled under the act related to in vitro fertilization. We took the opportunity to also discuss the license and framework and health reporting information with the sector to be regulated. These discussions assisted us in better understanding the issues and concerns in developing the regulations. Barring unforeseen circumstances, these regulations should be in place within the next 18 to 24 months.
[English]
I want to assure this committee that, while our goal is to get the regulations in place to allow the agency to begin its licensing activities sooner, by focusing on IVF regulations, we continue to work on the other regulations necessary to implement the act. It is our sincere belief that this approach will produce the expected results.
As you know, proposed section 8 regulations deal with consent issues as they relate to the use of human reproductive material and in vitro embryos.
Ms. Manseau will now go through the deck and deal more specifically with the regulations and some of the feedback we have received.
Francine Manseau, Acting Director, Assisted Human Reproduction Implementation Office, Policy Development Directorate, Health Policy Branch, Health Canada: I have remarks that we have prepared and I think you have a copy but I may need to change the presentation since I understand you did not receive the material before today.
I will go through the deck with you, flip through the pages and stop at the important issues. Please ask questions at any time.
Section 8 is the only statutory prohibition that is not yet in force in the Assisted Human Reproduction Act. All the other prohibitions are in force. This one is not since it is requires regulations to be enforced. We did give priority to drafting those regulations so that all of the prohibited activities could be enforced as soon as possible.
On page 4 of the presentation, we state that the only statutory prohibition that requires development of regulations is section 8. Section 8 requires that human reproductive material and in vitro embryos be used only with the donor's written consent. Violation of section 8 carries the consequence of criminal penalties.
The first point on the next page describes exactly what the act prohibits in section 8. It prohibits making use of human reproductive material to create an embryo without the written consent of the donor, removing human reproductive material posthumously to create an embryo without written consent. Within the context of section 8 the proposed regulations outline who must provide consent, for what use consent is needed, the information required for consent to be valid and the conditions for withdrawal of consent.
The proposed regulations in section 8 do not address the issue of storage or destruction. These were not seen as uses for the purpose of section 8, but they will be dealt with in other sections of the legislation, in the regulations.
The regulations are divided in three parts to mirror the three sections of section 8. Human reproductive material can only be used with the written consent of the donor. The posthumous removal of human reproductive material can be performed only with the consent of the donor and the use of an in vitro embryo for whatever purpose must first be given written consent by the donor. The regulations require written evidence that the donor was informed of the allowable uses and the conditions for withdrawing consent prior to providing consent. The regulations require written evidence of consent signed by a donor and attested by a witness, before human reproductive material or human embryos can be used. The withdrawal of consent must be in writing, and the onus is on the donor to ensure that it is received by the appropriate person.
Ms. Manseau: Part 1 on page 8 relates to the consent of the use of human reproductive material including gametes, sperm, or eggs, to create an embryo. It requires written consent and those uses are in conformity with the section of the legislation that states the purposes for which an embryo can be created. They are to create a human being, to improve assisted reproduction procedures and to provide instruction in such procedures.
Section 8 regulations would require the consent from the donor. The donor must specify whether in vitro embryos not used for the reproductive purposes of a third party can be used for other purposes, including research. The donor will have to specify for what purposes his or her material can be used. The allowable purposes are based on paragraph 5(1)(b) of the bill which limits the creation of an embryo to three purposes which I just mentioned to you.
If the human reproductive material is removed posthumously, as permitted in Part 2 of section 8, there are only three allowable uses. It can only be used for the reproductive use of the spouse or partner of that person, or for improving human reproductive procedures, or for providing instruction in such procedures. It is not permitted to be used for third party reproductive use, since there are requirements to be testing the material and there is a quarantine period. It would not be feasible and the embryo is limited only to the spouse or the partner.
Page 9 goes through the information needs provided to the donor prior to the donor making that informed consent. Donors must be informed that there may be in vitro embryos created in excess of their immediate reproductive needs. A donor must specify whether in vitro embryos not used for the reproductive purposes of a third party can be used for other purposes, including research. Here, we must understand those people are giving embryos for third parties. They would not be there at the time at which, perhaps, embryos in excess of the reproductive need of the third party need to be provided to research. We must ensure that that person is informed and agrees that eventually, perhaps, embryos that are in excess of their reproductive need could be used for research, and must provide consent. If the human reproductive material is donated to a third party, consent cannot be withdrawn once the third party acknowledges in writing that he has been designated for its use. For example, with someone donating his sperm for a third party, often the couple might be getting more sperm than is needed for a first child. The couple does not know how many trials they will have to undergo to have a child. If they want to have a second child, they want to bank it so that, basically, the children will be genetically related. Once it has been acknowledged by someone that they have the material to use for third party, you cannot withdraw your consent. However, you can withdraw the consent from other material that could yet be in storage and not yet provided to a third party.
Page 10 deals with the second part of section 8 which relates to the removing of human reproductive material posthumously and requires consent for the following uses. It can only be used for the spouse or partner's reproductive use; to create an embryo for improving assisted human reproductive procedures; to provide instruction in human reproductive procedures. Consent for posthumous removal must also be accompanied by consent for use. That is required in Part 1.
Part 3 relates to using an in vitro embryo for any purpose and requires a written consent for the donors own reproductive use, third party reproductive use, to improve assisted human reproductive procedures, provide instruction in these procedures and/or for specific research projects.
Part 3 also defines a donor of an in vitro embryo as an individual or couple for whose reproductive use an in vitro embryo was created, regardless of the source of the human reproductive material. Only the couple or the individual for whom an in vitro embryo was created can consent to the use of the in vitro embryo for those purposes. If the in vitro embryo is not used for the purpose for which it was intended it may be donated for another purpose, provided the donor and the gamete provider are not the same — that is, if it was a third party — has consented to its use for that purpose. The regulations allow for consent to be withdrawn at different times, depending on the purpose for which consent was provided.
The regulations provide transitional stages for human reproductive material and in vitro embryos collected or created prior to the coming into force of section 8. That was to recognize that human reproductive materials such as sperm that has already been collected and has been donated for a third party. For that sperm, they would have to have consent that someone can use it for their third party reproductive use. However, perhaps the information provided was not exactly what is required under this section but that material can still be used. That is why we have a transitional period. Any material that will be provided by an individual for their own reproductive use is usually provided at the time, so those regulations will apply to them. It is to take into consideration the material that has been donated in the past, where they would need to have consent to allow for the reproductive use of a third party.
Generally, with the exception of own reproductive use, the human reproductive material or in vitro embryo can still be used provided there is at least a dated and a signed written consent of the donor to the use of the material or the in vitro embryo for that purpose.
The final page goes through the consultation that we undertook to develop those regulations. There was a public consultation document. We also published a proposed regulation in the Canada Gazette Part 1. Overall, we had the support for the regulation. However, there were comments. Some of them were outside sometimes, stating that we needed to have counselling, which is provided for but they will be dealt with in other regulations in the legislation.
If you have any questions, I am ready to accept them now.
The Chairman: Yes, we do. Thank you very much, both of you. We now have about 20 or 25 minutes for questions.
Senator Trenholme Counsell: I wish to thank our guests. I do not know about my colleagues, but I am feeling overwhelmed by this presentation. I find it strange that all of this has been happening for about two or three years and now we are being given a few minutes to review this soberly and seriously, as senators are supposed to do. It is very challenging to follow it all and to be sure that we are representing the citizens of Canada well. We will do our best, but I do not know whether we can finish it in the time allocated. It must not be glossed over.
First, why has it taken this long? What has happened in the interim with regard to the bill? Under what regulations or authority have things been happening? I need to have this background first, before going into what is in front of us today. In 2004, the bill was brought in and we are close now to three years.
What has happened in the whole sphere of human reproduction technology? It was outside the subject matter of the bill. The activities in Canada have not been subject to that bill; they have been without regulations.
Ms. Quesnel: The prohibitions of the act are currently in effect. The last provision of the act that required regulations is section 8, which is in front of you now. I will apologize again for the delay. We did send a package on October 27 to the clerk of this committee with the regulations.
Senator Trenholme Counsell: With all of this?
Ms. Quesnel: Not with the deck, I am afraid, but on October 27, there was a letter with the proposed regulations as well as the regulatory impact analysis statement. I understand it is a lot of information; I accept that.
In terms of what has taken so long, which is the essence of your request — that is, why are we here today and not two years ago — we have gone through the Canada Gazette Part 1 to consult with stakeholders on consent regulations, these last set of regulations in 2005. A number of events have intervened with our coming forward to this committee, for example an election that has a tendency to disrupt the normal business of presentations and such. We needed to have the endorsement to go forward with tabling to this committee the final regulations that we propose to go to the Canada Gazette Part 2 and we obtained that endorsement in October last year and proceeded as quickly as possible. I do not mean that within the department we have stopped our policy development. We have been consulting with Canadians on other aspects of regulations such as counselling, on patient needs and on the licensed activities. We have consulted with doctors who have been telling us about their current activities. We have been in consultation with the laboratories about their responsibilities and accountabilities within the act. We are proceeding with our development work. Unfortunately, we have not appeared before this committee until today.
Senator Trenholme Counsell: Have you encountered any major scientific objections that have not been addressed in these regulations? I do not mean religious objections. That background information would be useful.
Ms. Manseau: Do you mean on the regulations?
Senator Trenholme Counsell: Yes.
Ms. Manseau: Some of the comments we received were about clarity to ensure that the person donating material was also providing consent for the future use of that in vitro embryo, and that research would specify the consent for future use.
As the legislation was going through Parliament, an amendment was brought forward that donor consent be in conformity with the stem cell guidelines developed by the Canadian Institute of Health Research. In the area of withdrawal of consent, we have modified the amendment to ensure that we were acknowledging the withdrawal of consent as specified in the stem cell guideline. There is a different point at which somebody can withdraw their consent as to the use of an in vitro embryo for research, and the last point would be at the time where the stem cell has been isolated from the in vitro embryos. There were comments like that, but not to object.
Senator Trenholme Counsell: Regarding the withdrawal of consent, I am concerned that it must be in writing and that the onus is on the donor to ensure that it is received by the appropriate person. How would the donor go about that if, for example, the material has been sent to a research laboratory?
I pictured myself in that situation and wondered how I could take on the responsibility of transmitting my withdrawal of consent to X number of people or laboratories. I find that worrisome.
I am going to ask a question about literacy and consent here. It worries me. I know how difficult it is to obtain consent about something with the teeth or birth control pills, and this is far more complicated.
Has this been well thought out, that the onus is on the donor with respect to the withdrawal? We may want to think about it. I find it quite complex.
Ms. Manseau: If you take the example of someone giving an in vitro embryo for research, we are asking that the consent be for a specific research project. It means that the person donating the in vitro embryo would know at that point for what specific project they are willing to give the in vitro embryo. It is not that they would not know where to send it. I think the reason is that they are the only ones who can provide the consent. A clinic has in vitro embryos in storage but it cannot make the decision. We need to go back to the individual who provides that consent. That individual is the only one who can say yes or no and change his or her mind.
Senator Pépin: It is important that they understand all the information that we give to them before.
[Translation]
It is not necessarily included, but it is a regulation that is being taken in isolation, if you want, from the rest of the legislation. However, the legislation requires that the persons do receive counseling. When the regulations are developed, all persons will be required to receive counseling before being allowed to give consent.
[English]
Ms. Quesnel: They will not have the opportunity to refuse counselling, in other words.
[Translation]
Ms. Manseau: No, it is also mandatory under the law to receive counseling.
[English]
Senator Trenholme Counsell: The others on the committee may want to think about the fact that the individual must deal with transmitting the withdrawal to the appropriate persons.
The consent for posthumous removal must be accompanied by a consent for use in Part 1. That means it goes back to the original person or persons at that time.
Is it only then that consent for posthumous use can be given?
Ms. Manseau: If you consent to have your material taken from you after your death.
Senator Trenholme Counsell: Is it the same as transplants?
Ms. Manseau: Yes, but in this case you might be creating an embryo. Therefore, if you agree to have that, you also have to sign a consent where we can use your material to create an embryo.
Senator Trenholme Counsell: Is that done at the same time?
Ms. Manseau: It could be done at the same time, yes.
Ms. Quesnel: The framework would be done at the same time. Anyone deciding or wishing to do that would need to be counselled about what will happen and what are the potential uses for their reproductive material, and they need to provide consent, so at that time, we expect the counselling would at least result in an informed consent.
Senator Trenholme Counsell: That would need to be simultaneously with the original consent. If we are going to allow that, it should be part of the package of what happens at that time.
On page 13, with respect to research, it says,
Generally, with the exception of your own reproductive use, the human reproductive material or in vitro can still be used provided there is at least a dated and signed written consent of the donor for the use for that purpose.
Is this for in vitro embryos from the transitional period?
Ms. Manseau: Yes, but as I said, consent to use an in vitro embryo for research would have to consent to a specific research project.
I think what was envisaged was where you already have collected human reproductive material such as sperm, that could have been collected or provided for third party reproductive use. Often, you can keep the sperm for a certain time when it is frozen. With these regulations, we did not want to not enable couples to use that sperm as long as there was a written consent from the individual that he consented to have his material used by the third party.
Perhaps the information provided to that person that will be required with section 8 might not be exactly what would be required, but there was a decision that as long as the person accepted that he would give it to a third party and there was a written consent to that effect that it should be allowed to be used.
Senator Trenholme Counsell: The level of literacy here is crucial. I have a little medical background — not like Dr. Keon's — but I find this extremely difficult to comprehend. We have already been here for 30 minutes, so imagine the amount of time that is usually between a physician, a researcher, a patient or a donor. I do not know whether this is ever done, but it seems to me that something should be stated here clearly with respect to the responsibility of the person who is providing the information and getting the consent. This is serious, and I do not know how that can be incorporated into regulations.
Ms. Manseau: I reiterate that counselling would also be provided. I agree there is a need to ensure that people understand what is going on and I think there would be opportunities for that information to be provided.
Ms. Quesnel: In our consultations with both parents and clinicians, we heard that the sharing of in-depth information and having an informed discussion on both sides is the key to ensuring the health and safety of the parents and the offspring. All parties recognized the importance of that issue.
Senator Callbeck: How much participation did you get from stakeholders during the public consultations? Did you hear from many people?
Ms. Manseau: Fifty-six people presented written comments.
Senator Callbeck: You say that the stakeholders have expressed support for section 8 regulations. Then you go on to say that, the proposed regulations have been modified to reflect stakeholders' comments and concerns. How have the regulations been changed?
Ms. Manseau: The main changes ensure conformity with the stem cell guidelines. They ensure that the original gamete donor donating for third-party reproductive use, would at the time consent those in vitro embryos that might be in excess of the couple's reproductive needs being used for research. An example is a man donating his sperm to create an embryo for a third party.
The second change is the timing for the withdrawal of consent. We modified the timing to ensure that it reflected the stem cell guidelines. The stem cell guidelines say that donors of in vitro embryos can withdraw their consent until the time that the stem cell has been isolated from the in vitro embryos. That was added to the proposed regulations.
The other change was the transitional aspect, where we had gametes collected prior to the regulations coming into force, especially for the third party. In those cases, they can be used as long as there is a dated, written consent from the donor.
In the proposed regulations, we are saying that if you donate your material to a third party for their reproductive use, you have to understand that the third party will then make decisions about those in vitro embryos. If there are embryos in surplus of their own reproductive use, then they could perhaps decide to give an embryo to another couple for their reproductive use. I am not saying it happens often, but with regulations, we have to foresee all the possibilities. Nobody knows.
That third-party couple could decide to give the embryo to somebody else, they could decide to give it to research, or they could destroy it. The person donating for the third party is told about those matters and has to give consent if he or she wants those in vitro embryos to be used for research. The donor has already consented to third-party reproductive use, so that does not change if the couple decides to give that in vitro embryo to another third party.
We made a modification. Let us say that a couple is using donated sperm because the husband has a fertility problem, and the woman is using her own eggs. Before we said we needed the consent of both the individuals for each one of them to be using the in vitro embryo. We are now saying that the woman should be recognized as having a right that is different because it is her own reproductive material. The sperm came from a third party, not from her husband and she should be able to decide, as an individual, if she wants to use this in vitro embryo.
I do not know if this is clear. This field is complicated. You have to think of all those possibilities, and that is why it takes time. Much thinking needs to be done on the intent of the policy.
Senator Callbeck: I was reading about a challenge in Quebec over several sections in the act. How does this affect the regulations in Quebec?
Ms. Manseau: The law has passed and there is a responsibility for the Minister of Health to develop the regulation and put this law into action. We are proceeding.
Senator Keon: Thank you both very much. I must admit that I have tried to follow this field since Patricia Baird became commissioner and I was at the Medical Research Council of Canada. That was about 12 years ago.
The issue is so complex that I suspect there will be confusion as the situation unfolds. I commend you for the way you have been able to hone down on the regulations in section 8. I think you have done quite a good job.
How many changes did you have to make after your public consultations? How many changes did you have to make to provide us with the document that we have before us?
Ms. Manseau: As I mentioned, there were just a few changes. I mentioned three or four of the changes that needed to be made from the proposed regulations as they were pre-published in Part 1 of the Canada Gazette.
Senator Keon: I was aware along the road that there was some unhappiness with the board. I have had some correspondence. Has that been cleared up? When you did your consultation process, were people generally happy with the constitution of the board?
Ms. Quesnel: The membership of the board had not been announced when we were doing our consultation. From an official's point of view, I can tell you that we are really looking forward to working with this board. We have had initial meetings with the chair of the board and the president. We certainly are pleased that we have a board and we look forward to working with the board.
Senator Keon: You are satisfied the board is representative of the field?
Ms. Quesnel: That would probably be better answered by someone else. It is a Governor-in-Council appointment.
The Chairman: Our next guest is a member of the board.
Ms. Quesnel: From the point of view of the Governor-in-Council appointment process, we are satisfied that we have done our part in terms of advising the appointments, and the decisions were taken by the Governor-in-Council.
Senator Keon: I think the process has been pretty carefully thought through for the elective process. However, are you satisfied that all these checks and balances that you have in place will kick in for the fresh embryo situation, as well as the slow and steady elective process?
Ms. Manseau: Once the overall scheme and all the regulations are developed, there are many checks needed to be gone through. The legislation requires that the agency, before it provides a licence for someone to use an in vitro embryo for research, has to be satisfied that there is a need to use that in vitro embryo for the purpose of that research.
In cases of research on embryonic stem cell lines, the board will need to see the written consent of the in vitro embryo donors before a decision is made about a licence. Regulations might specify other conditions that should be attached, such as going before a research ethics board. These regulations are being developed and counselling will be provided to the donors. Much information will be available and many requirements will have to be fulfilled before a licence can be provided to an individual to use an in vitro embryo for research.
Ms. Quesnel: The regulations are not yet in place in respect of that so we are envisaging only how it would work.
Ms. Manseau: The first two — ensuring the use an in vitro embryo and the signed consent form in front of the agency — are in section 40 of the legislation.
Ms. Quesnel: The rest would be covered by the regulations.
[Translation]
Senator Pépin: The program is only just beginning, but as far as consent for storage is concerned, are you sure that the information that we have given is well understood? A person who gives his or her consent can, at one point, withdraw that consent. However, at some point it is no longer possible to do so. Is that well understood? After reading all of this, even though we are working on it, I am sometimes confused. Does the person who does not have any previous experience and who wants to take part in the program — whether to have children or to give material for research — understand what storage means? Do we have any way to assess the person's degree of understanding when he or she gives consent? That is very important. Later on, it says that people can withdraw consent, but under certain conditions. Even I do not fully understand the situation.
Ms. Quesnel: In addition to being a work in progress, it is an area that is somewhat difficult. It is very complex. The regulation attempts to establish, for all parties concerned, the requirements and responsibilities. The donor's responsibility, the parents' responsibility, the clinicians' responsibility and that of laboratory people. The regulatory framework will establish as far as it is possible and as clearly as possible the roles and responsibilities of each and every party. Will every individual involved in this situation understand as clearly as it is possible? We have understood from our consultations that the people are happy with what is being proposed.
Senator Pépin: The people are happy with that?
Ms. Quesnel: Human nature being what it is, not everybody accept the data in the same way. Not all individuals can deal with all these data in the same way, depending on their personal situation and their capacity to take up information. The regulatory framework that we are proposing will ensure that the integrity of the person is well respected.
Ms. Manseau: In section 14 of the act, it says that before accepting a donation from someone or having a procedure, the person must have received counseling and must be informed in writing about everything that is required by the act and about what will happen to the material or the in vitro embryo. The legislation will ensure that the minimum information required be given and that everyone has this same information.
Senator Pépin: I always think about legal actions, you understand?
Ms. Manseau: Yes, but the act is clear enough and I believe that one of the principles in Part 2 is the importance of having informed consent. That is one of the basic principles in the act as well as in the regulation being developed. These are the basic principles that give us guidance in our work.
Senator Champagne: My question is twofold and the two aspects are both linked and completely opposite. We are talking about the subject matter being complex, about the constantly changing situation of science, opinion and ethics issues. On the one hand, you are telling us that there are no major problems, that the regulations should be in place within 18 to 24 months. We have already been talking about this for several years. When will we have regulations on which everyone will be able to base their decisions? On the other hand, I understand that for storage and the possible or likely destruction of embryos, this will be done at a later date. Perhaps some determination should be made in that area as well.
So on the one hand I am thinking that this is giving you too much time and leeway, and on the other hand, I do not envy you and I would like to be reassured that you are continuing to work as rapidly as possible.
Ms. Quesnel: As far as section 8, the central element of this discussion, is concerned, we hope that the regulations will be in place by this spring. When I said 18 to 24 months, I was talking about the framework for all other regulations.
Senator Champagne: Great! Good news!
Ms. Quesnel: We are pushing for March-April, but it should be very soon because this is the last prohibition under the act and we would really like for everything to be in place before going forward with the rest. I should have been clearer on this.
Senator Champagne: I thought I had heard rather clearly, but the important thing is that this be settled as soon as possible. Thank you for giving us hope.
[English]
Senator Fairbairn: I will go back to the issue raised by Senator Trenholme Counsell, which is interesting for all of us, although it is difficult to understand the dimensions of it.
In one part of your presentation, Ms. Manseau, you said that the regulations require that donors provide a written consent attested by a witness. Considering the state of mind individuals are likely to be in when having to make this decision, are they permitted to have a third party accompany them to help with questions?
Ms. Manseau: Before a donation is accepted, the person has to undergo counselling and provide detailed written information about what will happen to their material. That provides a suitable time to ask questions.
The witness must confirm the signature on the consent form. With the section 8 regulation, they wanted to respect the reproductive autonomy of the individual. Only the individual can consent to use this material for reproduction.
The law intends that there will be counselling and that information should be provided. We are trying to ensure that will happen as much as possible and that it will happen in the same way in all the clinics across Canada.
Ms. Quesnel: Are you asking whether there is a prohibition for a third person being in the room as a support?
Senator Fairbairn: Yes.
Ms. Quesnel: No, there is no prohibition. The person donating needs to consent and there must be a witness, which is fair. Certainly, in this case, that is what the regulation requires. In our consultations, we heard of situations where people do look not only for informed consent, but for moral support.
Senator Fairbairn: Exactly.
Ms. Quesnel: Especially when couples are using their own material. In that situation, they often have someone to help them through that difficult experience.
Senator Fairbairn: Or if at the last minute, they change their mind.
Ms. Quesnel: Yes, there seems to be quite a network.
Senator Fairbairn: That is important to know.
Ms. Quesnel: I would not guarantee that there is in all cases, but there seems to be an awareness of the need for a strong network.
Ms. Manseau: There are many support groups.
Senator Fairbairn: I cannot think of a more fundamental situation.
Senator Cook: Are the clinics licensed? Who licenses them? What are their terms of reference? When these regulations come into effect, what impact will they have on the existing clinics?
I am looking at process rather than the how. What are the ethical standards and who developed those standards? Now we are going to regulate existing working clinics; that is what I am trying to unravel in my head.
Ms. Quesnel: That is an excellent question; thank you for raising it.
I understand there are about 25 in vitro clinics, primarily in Toronto, Montreal and Vancouver, although we met individuals from across the country. These clinics are not licensed under this act because there is no regulatory framework under which to license them. However, they are operating right now. Many of them were in operation before the act came into force.
Senator Cook: By what standard were they created? Who has oversight for this ethical situation? That is what I am trying to get at. What will the impact be when this goes into effect?
Ms. Manseau: As you said, the act is in place. We are working to develop regulations to enable the licensing. Once we have all the regulations developed, the clinic will have to go to the agency and get a license and they will have to follow the regulations.
There are a lot of areas where we need to develop regulations. If you look at the legislation, in clause 65 it goes from A to Z — Z.1, Z.2 — all of those need to have regulations and we are working on all of them. It is a difficult area because it has never been regulated and there are not that many national guidelines or standards that we can use. We have to create many things that do not exist. We are working with people in the field and trying to progress as quickly as possible. They are not licensed yet, but they will eventually be licensed.
Considering the regulations, we know that most of the clinics have some type of consent form. We are trying to ensure some uniformity and to ensure that the same information will be provided to everyone. Once those regulations are in force, it will be the responsibility of the agency to ensure that clinics are informed. Through consultations, we have made it clear to the clinics that they must develop consent forms that meet the requirements of the regulations.
Senator Cook: Will it be compulsory for the clinics to be licensed?
Ms. Manseau: Yes, anyone manipulating human reproductive materials, or gametes, to create an embryo will require a license; and anyone who uses an in vitro embryo for whatever purpose will require a license.
Senator Cook: Now I can think about all the other bits and pieces; I was trying to get the process in my head because the clinics are in operation.
Under what ambient are they are operating. Is it from an ethical point of view, from the medical profession, from where did they come into being?
Ms. Manseau: Clinics just started. A doctor opened a clinic and started to offer his services. We have had a voluntary accreditation process since early 2000. It was started in collaboration with the Canadian Fertility and Andrology Society and the Canadian Council on Health Services Accreditation. There is some form of accreditation or governance. It is voluntary but many clinics participate in it. Eventually, however, they will need to be licensed by the agency, based on the regulations they are developing.
Senator Cook: Do you see any adverse impact on the existing operations of those clinics by virtue of these regulations?
Ms. Manseau: With the section 8 regulations?
Senator Cook: Yes.
Ms. Manseau: No, we do not anticipate an adverse impact.
Senator Cochrane: I do not envy your job, I must say. Section 8 is very soul-searching.
What effect do you think these new regulations will have?
Ms. Manseau: The regulations will ensure uniformity and the provide assurances that the minimum information is provided. There will also be written consent. Presently, you could have instances where there is semen in the freezer and the husband dies. The woman goes in and she says, ``He told me he wanted me to use his material.'' That will be clear now because it needs to be in writing.
It is so that everyone is clear on what is compulsory and what is needed. One of the most important principles is to respect the reproductive autonomy so there will have to be written consent. That written consent will ensure uniformity, and everyone will receive the same information required to make an informed decision.
Senator Cochrane: On the issue of the right to withdraw, how does this work in practice for research participants? Do they also retain the right to withdraw?
Ms. Manseau: Yes.
Senator Cochrane: How does this work? Are there any special considerations in these circumstances? People do change their mind.
Ms. Manseau: The legislation acknowledges that and provides different points at which you can withdraw your consent. Let us say that you have donated your in vitro embryos for research. Depending on what it is, there are three points at which you can withdraw your consent.
One would be at the point where the in vitro embryos are taken out of the freezer. At that point, if you change your mind, the embryos will have to be destroyed because they cannot be used for another purpose. We tried to put that point as far away as possible so that people can have a chance to change their mind. At that point, if they change their mind, that is fine but they will not be able to be used for reproduction.
The point that is the latest would be the point where you are isolating stem cells from the in vitro embryos. Until that time, someone could change his or her mind. Again, you also consent to a specific research project. That is required.
Senator Hubley: Thank you for your presentation. My question arises from page 8 of your presentation with regard to the uses for human reproductive material to create an embryo. In bullet points 4 and 5 say ``. . . improving assisted human reproductive procedures; to provide instruction in assisted human reproductive procedures.''
Will there be very specific identification of how that material will be used? Would there be any possibility of inadvertently creating a human being other than between the donor and the recipient? Would there be any possibility of using that material to create a human being that was not thought of beforehand?
Ms. Manseau: There would be some problems. In order to use the material to create an embryo, you must have the consent of the donor. The consent should clearly indicate for what purpose it is being donated and it should be used for that purpose only.
Senator Hubley: Under the last two bullet points there would be no mistake about how that material could be used? There would not be an unfortunate occurrence?
Ms. Manseau: It says that you cannot use material to create an embryo unless you have the consent of the donor, and it must clearly specify the purpose.
Ms. Quesnel: Are you suggesting that there could be a mistake such as using the wrong sperm?
Senator Hubley: No. I am just wondering how far those two divisions could be taken. Could they be taken to create a human being?
Ms. Manseau: There is a criminal prohibition against using human reproductive material to create an embryo without the written consent of the donor for that specific use.
Senator Hubley: You are obviously comfortable with that.
The Chairman: I wish to thank both of our witnesses. We will see a lot more of you. We have only dealt with the regulations pursuant to section 8 and there is much more work to do. I have been told that this section is one of the easier in the group, so we will see what the rest are like when we get to them.
Our next presenter is Ms. Françoise Baylis, professor and Canada Research Chair in Bioethics and Philosophy at Dalhousie University. Ms. Baylis is also the founder of the Novel Tech Ethics research team. Professor Baylis has an outstanding research and publication record that spans a wide range of topics including novel technologies, assisted human reproduction, stem cell research, research involving humans, women's health, and feminist ethics. Her work is widely regarded as original and thought provoking. She is currently principal investigator on two Canadian Institutes of Health Research grants in neuroethics, one entitled ``States of Mind: Emerging Issues in Neuroethics,'' and the other ``Therapeutic Hopes and Ethical Concerns: Clinical Research in the Neurosciences.''
In addition to her academic research, Professor Baylis contributes to national policy making via government research contracts, national committee work and public education. This work focuses largely on issues of justice in the community.
Ms. Baylis is currently a member of the board of directors of the Canadian Centre for Ethics in Sports as well as the board of directors of the agency we are here talking about, Assisted Human Reproduction Canada.
[Translation]
Françoise Baylis, Professor, Departments of Bioethics and Philosophy, Dalhousie University: Mr. Chairman, it is a great pleasure for me to have been invited here to address the committee. I would like to briefly explain the document that you have in front of you. Then I will do my presentation in English and I will make sure that it is very brief in order to give you enough time to ask questions.
I gave you a rather lengthy document, but the first page is the summary of what I have to say, together with some specific recommendations.
In pages 2 and 3, I tried to group together the recommendations in order to help you understand the themes that concern me. I am trying to offer some reasoning in support of the recommendations. And finally, for those who are really interested, I give some more details on the same three points.
[English]
I gather from some of your comments that you are already onside with the view that it is important to get the regulations in place. That is the only way that the objectives of the act can be met in terms of promoting the health and safety of women and of children who are born of these technologies. I am supportive of anything that will help to move that process along.
Many of you have commented that the regulations for section 8 are complicated. They are, but that is because the issue at hand is complicated. A tremendous amount of innovative work has been done. I can assure you of that as I have a sense of other regulations around the world. There are aspects of these regulations that are exactly right. It would have taken time to figure those out because they are not to be found elsewhere. Those who worked on this are to be commended for that work.
I am left with three issues that are still of concern to me, and I have grouped them thematically. I still have some concerns around the issue of the timing of consent, specifically with respect to the research use of embryos. I still have some concerns about the timing of withdrawal, and I have concerns about the issue of fresh embryos for research purposes.
On page 1 of my brief are the recommendations I would make. I would like to take you through pages 2 and 3 where you will find my attempt to offer up a summary defence of the view.
It is important that the legislation specifically incorporate reference to the 2001 CIHR guidelines. In Appendix B, you will find important excerpts of that legislation. In the CIHR guidelines there is a requirement for a reiterated consent. I think the reason for that is to be respectful of the right to withdraw. It is in recognition of the fact that one could participate in infertility treatment today, have frozen embryos and perhaps not donate those to research for another 10 years or so. In that context, it becomes important they have an opportunity to provide additional consent. Why? Because things could have happened in the intervening time which would have them change their opinion.
One of the things done with the regulations in an attempt to address this issue was, as you have already heard, this requirement that the consent be to a specific research project. This would not be something that might happen 10 years from now.
One of the things that I try to articulate clearly in this commentary is that a project can be many things. It can be a plan, a strategy, a scheme, a proposal or an undertaking.
If you look at it in that context, I think that one of the things that we see in terms of what is current practice right now in IVF clinics is that some consent forms say you donate them to research, that is it. I have all of the consent forms that people were willing to provide in the context of empirical research I have done. Other consent forms will say you are donating it specifically to research on pre-implantation genetic diagnosis. There is one that says specifically you were donating it to stem cell research.
There is already a difference in terms of specificity. One could think it was not generally a donation to research but that it was a specific donation to stem cell research. Alternatively, one could say that is not what we meant by a specific research project. Then I would respond by saying: ``Oh, you wanted me to say it was for haematopoietic stem cell research at the University of McMaster under the tutelage of Dr. X?'' That might be more specific, but perhaps what you really meant for me to say is that it was this researcher, this research project number, funded on this day, ending on this day, et cetera.
My concern is that we do not know how to understand or interpret this consent. Therefore, it is possible that this description of a specific research project could legitimately be understood as a very long project. For example, I have funded research that is five years in duration. If I obtained consent today, five years down the road it might still be for that specific research project. I recommend a tighter time frame. The phrase I have used is that it should be ``proximate to the anticipated research use'' in order to get away from this long gap within which people could have changed their minds.
The point I am making, if you are committed to getting high quality consent, the closer it is to the activity and the more precise information you will be able to give, the better the quality of that consent.
My second point concerns the timing for the withdrawal. Throughout the regulations there are statements that basically say you can withdraw, which is important. We have to protect the right to withdraw in order to understand the consent was meaningful in the first place because it always includes the possibility of saying ``no.''
In this attempt to do something, which is very important, is a way of trying to balance competing needs and interests. The competing needs and interests of the donor of reproductive material and the recipient of reproductive material have different needs and interests. For example, the couple that has finished their reproductive project and the researcher who wants to receive that project have different needs and interests.
In trying to balance those competing needs and interests, there is a statement that says you can withdraw up until such time as the person who has had this material designated to them acknowledges in writing that it has been designated for their use.
It is my view, that this limit on the right to withdraw is premature. It should be a bit further down that process. I think it needs to be there because both parties need assurances; however, I am suggesting that it should be at the time the designated material was received. This already puts it slightly further down that transition.
Let me provide an example with respect to the use of sperm and what would be very important for a couple, which is to know that if they chose to have a second child or attempt a second pregnancy, there would be this possibility of a genetic link. You would not want to be held hostage to the donor changing his mind and saying, sorry, you have had one child, and I am now withdrawing my sperm.
I ask you to think about it from the perspective of an ova donor rather than the sperm donor. We cannot freeze ova and this example is in the context of a fresh donation. There are some real issues because, for example, if I am the donor and you are starting to cycle me in terms of hormonal treatments, you are doing the same thing for the other woman in the context of being prepared to receive that material.
Let us imagine this scenario: My sister or best friend has asked me to be a donor, and I agree. I sign the proper consent form saying I fully understand what I am about to do and my friend or sister signs other papers saying the ova is designated for her treatment use. I cannot withdraw and by law, she has done what was required, which is, she has generated a piece of paper saying she understands this ova is designated for my use. I then go through superovulation and I hate it. It is horrible, I am sick and bloated. I then go back to my friend or sister and say, sorry, I love you, I wanted to do this but I cannot.
I have changed my mind. Suddenly I think that I do not want my genetic child being both my niece and my daughter. My concern is that there is absolutely no clinician who will force me to do anything. They cannot force me to take the drugs or to come in and have my eggs retrieved. I am not worried, in one sense, that I cannot affect my withdrawal. I can withdraw. I can leave the country or all sorts of things to withdraw. However, what if I create a mechanism where my best friend is no longer my best friend or my sister chooses to say I have violated a contractual relationship? I do not understand all of the possible ramifications, but I do know much of this could be resolved by identifying that the point of withdrawal is the moment it was received. It means that sometimes people will be disappointed. One needs to balance the interests of both parties.
I suggest to you that the same thing is true with respect to frozen embryos. It is in the context where I might have said you can use these frozen embryos, they are still sitting in the IVF clinic, they have not been transferred to the researcher, the research has not started, but the researcher has generated a piece of paper that says I understand there are frozen embryos in your IVF clinic that have been designated for my specific research project. I want to say, if I have changed my mind, the embryos are sitting in the clinic and they have not been received by the researcher, why can I not say no, forget it? You know that shipment that was leaving on Monday? Do not send it.
There is a huge difference between saying this right to withdraw is lost at the moment that the person for whom it has been designated indicates in writing that it has been designated versus indicating in writing that that which was designated has been received. That is an important distinction that moves the right to withdraw along.
The last point concerns the issue of the use of fresh embryos for research. I want to take you back again to the Assisted Human Reproduction Act and the sections that were introduced into legislation. The drafters wanted the consent regulations to be consistent with the 2002 CIHR guidelines.
It is very clear that those guidelines were permissive in relation to the research use of frozen embryos but not fresh embryos. It is true that the guidelines were amended in 2005, and now they explicitly say you can use fresh and frozen embryos. However, that sentence was not there in 2002. What was there in 2002 was the clear statement about the need for a reiterated consent, because of the anticipated delay between the time of donation and the time of use.
They would not have written that if they thought they were fresh embryos because there will not be this huge delay such that you need to ask on a Monday, and then three days later, when you need them in the context of research, you need consent as a result of the long delay during which you might have changed your mind.
Separate from the fact that I think consistency with the act would require a statement, I think a number of arguments have been developed in support of the view that it would be the ethically right thing to do. If you are interested, I summarize some of those arguments on page 5.
It is not in the best medical interests of women in infertility programs to give their fresh embryos away for research. If they have to go through another cycle, they must be superovulated all over again, go through oocytes retrieval again, pay additional costs and there is psychological stress and disruption to their social life. Why are they doing all of this?
If we are trying to protect the goals and objectives of the women who have donated their material or those who are actually involved in an infertility project that is supposed to be for reproductive use, in my view, those embryos do not become spare until they have finished their reproductive project. They do not become spare on every cycle such that you give them away and start a new cycle again. From my point of view, that is an important distinction, and I think is consistent with, if not the letter of the guidelines, certainly their spirit.
I would be happy to entertain questions and will do that in either French or English.
The Chairman: Have you discussed these recommended changes with the department or with the minister's office? You also made the presentation, I believe, to the House of Commons committee.
Ms. Baylis: I did make a presentation to the House of Commons committee in December. The substance of the presentation would have been similar in terms of the kinds of concerns that I have brought forward. I would say that I think the presentation I made to you is clearer and more concise, having had the opportunity to reflect and refine my thoughts. In terms of substantive content, I would have made the same comments and perspectives.
The Chairman: Have you had the opportunity to discuss theses proposed changes with the department or the minister?
Ms. Baylis: I have not had a chance to discuss these items in any detail with any of the members of Health Canada. They are aware of my views in that they have been made public before in formal contexts such as the presentation before the Standing Committee on Health and in media and my written work.
Earlier in the process, while the draft regulations under development, I was amongst those who submitted comments, and there was a conversation back and forth with members of Health Canada and I found them to be open, receptive and supportive of my ideas. We have a collegial and positive relationship.
The Chairman: I wonder why they did not make the changes themselves, or why the House committee did not make these changes. Can you shed any light on that?
Ms. Baylis: On December 12 2006, a representative from the Canadian Fertility and Andrology Society, a representative from the Society of Obstetricians and Gynaecologists of Canada, Mr. Tim Caulfield and myself presented before the Standing Committee on Health. At the end of the day, we were asked, maybe it is not perfect, and would we be prepared to sign off on this as is, recognizing that one would not want to engender further delays. Three out of four people said yes; I was the one who said no. While I was still generally very supportive of the regulations, I was committed to the view that it was important to have those regulations in place. In the abstract, I do not want to be the one delaying anything, but I felt the three points I was making were substantive and important. There was a difference of opinion.
The Chairman: You have developed them more since then.
Ms. Baylis: With that intervening time, I have developed them, and I feel this is a clearer presentation. If I had a chance to make that presentation again, I would do so.
Senator Trenholme Counsell: It was a very stimulating presentation.
Could you briefly go through the transition from the use of only frozen embryos on hand to fresh embryos in the context of Canadian legislation and now regulation? How did that happen? What were the steps?
Ms. Baylis: It is relatively straightforward insofar as the legislation. The Assisted Human Reproduction Act, which received Royal Assent in March 2004, does not address the issues. It does not speak to them in one way or the other. It does not draw distinctions between fresh or frozen embryos. In two places is makes reference to the CHIR guidelines and the 2002 guidelines.
In 2002, the CHIR guidelines did not include a statement one way or another. In fact, there was silence. It did not actually say you can or cannot use fresh or frozen embryos, but it did say you must get consent and a reiterated consent because of the anticipated delay. That wording leads most people to conclude that they were talking about frozen embryos. I was a member of the committee that drafted those guidelines, and as a co-author of the guidelines, I can say that was our working assumption.
The guidelines insofar as this issue has been raised were at fault for not having been more specific. There was ambiguity, in other words, in terms of how one could choose to understand the guidelines because there was no specific sentence. There is only section 7.2.2, which clearly says there must be a reiterated consent at the time of anticipated research use because of the long delays between the time the embryo would have been donated and used. In the minds of those authors, we were thinking that they were talking about frozen embryos.
In 2005, CHIR, one of the funding agencies, elected to update its guidelines. It is within its right to do that. It is not a legislative body. In that context, it elected to change the guidelines to alleviate confusion or the possibility for misunderstanding. The way they elected to do that was to say that it would be for both fresh and frozen embryos.
I have written a paper detailing the history of that event, which will be coming out in about two months, and I raise specific concerns or questions about the motivation in making that change.
Senator Trenholme Counsell: I keep hearing what we heard during those hearings in 2004, and it seemed to be that we were talking about the use of frozen embryos in storage. I wonder if all the people who participated so passionately would want to have that debate again in that we are now talking about frozen and fresh embryos. I would not want anyone to take me the wrong way. I am in favour of the use of fresh embryos providing all of these consents are working well and it is very clear and no one is taken advantage of. This concerns all of us. It is a different debate than it was in 2004. The issue is different. They were talking then about frozen material that was on hand.
Ms. Baylis: It is important for you to know that Canada's first two stem cell lines were derived from fresh embryos, and that is an important fact in this story.
I, too, share your concern about the issue of consent. The problem is that with respect to the issue of consent to the use of fresh embryos, people focus on the disclosure requirements, but valid consent includes three parts — one of them has to do with disclosure, one with competence, and the other with voluntariness. The concern I have has more to do with voluntariness, not purposeful but subtle and indirect potential forms of coercion and exploitation. These women and couples are potentially vulnerable. They are involved in an infertility treatment for the purpose of having a child. They are dependent on those clinics and physicians. You cannot shop around. There are not that many of them in this country. It is difficult to say, ``No, I do not want to help you,'' and then expect that this physician might do the same.
It is a complicated scenario, and there are other arenas where we said the most important thing might not be this notion of full and informed consent. If I turn to the legislation, we do not allow pre-conception agreements and I suggest that it is not because I could not find a competent, autonomous woman who would agree to that, but there are constraints. We allow them in a voluntary context but not a paid context. There are contexts in which we will choose to limit practises, not because of issues around whether we can find competent people but because there are other things at play.
Senator Trenholme Counsell: What is the date of those two stem lines in our research stream? Was that before the act?
Ms. Baylis: They were publicly announced within a few days of the CHIR guidelines being updated. They were not in use. They were created.
Senator Keon: In your proposed amendments on page 3 about the use of fresh embryos for research, in both of them, in brackets, you have ``morphological or biological or genetic reasons.'' I would have thought genetic reasons would have been well sorted out before that stage. Were they not?
Ms. Baylis: I am not sure what you mean by ``genetic reasons being sorted out.'' These embryos are created outside the body and at that time, one has the option of doing pre-implantation genetic diagnosis. During that process one might identify that this particular embryo is at risk for this particular genetic disease and it would not be amongst the embryos either transferred to this woman in that cycle or frozen for later reproductive use so if she does not want them transferred fresh she likely does not want them transferred frozen. If they were not suitable for freezing, meaning that they are not perceived to be useful in pursuit of the reproductive project, I would have no objections to those embryos being used in a fresh context because they would otherwise be destroyed.
Senator Keon: I understand.
Senator Pépin: Regarding the board that you will be directing, have you had any women who went through all the process?
[Translation]
Are there patients who have had a child through assisted reproduction? Are there any persons who have already gone through this process?
Ms. Baylis: That is one of the comments that keeps coming back in the media. When we examine the make-up of the committees, we notice a lack of expertise in this area. Presently, we do not know whether this expertise exists or not. Although no one has identified himself or herself has being infertile, it is possible that among the members, someone do have this expertise, even though it is not being made public.
The answer that I usually give the media is this: ``Do you know whether I am infertile or not? Do you know what I have done in my private life? No. So give me the chance to meet my colleagues because I do not know them and at some point, if I realize that this expertise is lacking around the table, I would be the first to insist on this issue.''
We should not consider scientific or academic knowledge only, experience is also of vital importance.
So, to answer your question, I do not know whether this expertise exists, but it is obviously a situation that concerns me. If I realize that there is a weakness on this level, I will certainly be among those who will demand to see this expertise.
I underline that to date, only eight members have been appointed and that some positions must yet be filled. It is still possible to correct this mistake, if indeed it is a mistake.
Senator Pépin: We wish you luck.
Ms. Baylis: Thank you.
[English]
The Chairman: Let me just expand on that. There has been a fair bit of controversy about whether all the interests are represented on this board, whether there is balance to it. Aside from this specific expertise that you just talked about, what would your answer be to that question?
Ms. Baylis: In some respects it would be the same in that I do not know the other members of the board well. I know a few by reputation and I have some sense of what their expertise. Many judgments have been made in the press that I think are unfortunate and I am extrapolating my own experience from that. I was quickly labelled in The Globe and Mail, the day after the announcement, as a social conservative and I was surprised. That is the term that is the politically correct term for, I guess, something that is to the far right. I do not know what it means any more.
I did say that it is a very strange day when somebody who is supportive of a woman's right to choose, supportive of the research use of fresh embryos under certain contexts, gets described as a social conservative. What does it mean to be a liberal — small l, small c? So the reason I am sharing that with you is to say that if I have been miscast, others may have. I have to give everyone the benefit of the doubt.
It is possible, in terms of competence, for ethical decision making, that one can have commitments but around the table be able to do the work they have been mandated to do. One ought not to confuse one's private commitments to the quality of work that can be done around a business table. I will wait and see and judge people based on their work.
The Chairman: We will now go to that phase and go in camera.
The committee continued in camera.