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SOCI - Standing Committee

Social Affairs, Science and Technology


Proceedings of the Standing Senate Committee on
Social Affairs, Science and Technology

Issue 1 - Evidence - Meeting of February 18, 2004

OTTAWA, Wednesday, February 18, 2004

The Standing Senate Committee on Social Affairs, Science and Technology, to which was referred Bill C-6, respecting assisted human reproduction and related research, met this day at 3:33 p.m. to give consideration to the bill.

Senator Michael Kirby (Chairman) in the Chair.


The Chairman: Honourable senators, we are here to begin our first session on what we all know as Bill C-13, but which is now Bill C-6, an act respecting assisted human reproduction and related research.

As you know, colleagues, from the agenda before you, we have three sessions today. The reason that there are video screens on behind you is that a couple of the witnesses on our second panel are participating by videoconference and they wanted the opportunity to listen to the minister and his officials. Therefore, they are plugged in at this time so that they can hear us. When the time comes for the second panel, we will be able to hear them.

Our first witnesses are the new Minister of Health and officials from the department.

First, minister, may I congratulate you. Those of us who have spent many months and years on the health care file should really offer you condolences. Nevertheless, congratulations on your appointment.

Minister Pettigrew has with him Assistant Deputy Minister, Health Policy and Communications, Ian Shugart, who is no stranger to this committee, and Glenn Rivard, General Counsel, Legal Services, who will have to put up with the fact that I always make anti-lawyer jokes when we have a lawyer before us.

We are delighted that you are here.

Senators, the minister will begin with a statement, followed by some questions. He will then leave and Mr. Shugart and Mr. Rivard will continue to answer questions. They are happy to stay here as long as is required for us to get an understanding of the bill. Mr. Shugart will use a deck of overheads that is in the binder everyone received.

Minister, please proceed with your opening statement.

Hon. Pierre Pettigrew, Minister of Health, Minister of Intergovernmental Affairs and Minister responsible for Official Languages: I am pleased to be here today. To demonstrate the importance I give to being with you today, I have delayed the Domestic Affairs cabinet committee by an hour. We normally begin our deliberations at 3:30. I am the chairman of that very important cabinet committee and I delayed the meeting in order to spend some time with you on this very important piece of proposed legislation that you now are considering in the Senate.


Thank you for the opportunity to talk to you about Bill C-6, respecting Assisted Human Reproductive Technologies and Related Research, better known as the Assisted Human Reproduction Act. This bill is the outcome of an important, urgent process — important because what is at stake is the health and safety of women and children and the well-being of all Canadians, and urgent because Canadians have already been waiting too long for this legislation.

This bill is the combination of a number of years of study and effort. It has not been easy. It is an important bill that deals with complex ethical, medical and scientific issues, and approaches them from a comprehensive perspective. It is important, first and foremost, because we cannot allow the status quo to continue any longer.

For example, as things stand today, nothing in Canadian law prohibits the cloning of a human being. Nothing in Canadian law prevents that. So without further delay, the time has come to be bold and take action in this area. We need to determine once and for all which activities Canadians find acceptable, and which they are totally opposed to and consider deserving of criminal penalties.

Despite scientific and technical breakthroughs, Canada still has no legislative framework to safeguard the health and safety of Canadians who use assisted human reproduction, or the health and safety of their offspring.

This long-awaited bill has three main goals: to protect Canadians using assisted human reproduction to help them build a family, so that their health and safety are not compromised; to prohibit unacceptable practices such as human cloning; and to ensure that research related to assisted human reproduction, which may help find treatments for infertility and serious deceases, takes place within a regulated environment. This bill also provides for the creation of the Assisted Human Reproduction Agency of Canada, which will have a number of important tasks.

The agency will be responsible for licensing regulated activities, and for monitoring and enforcing the act and its regulations. The agency will also be responsible for providing reliable information on assisted human reproduction to Canadians.

Assisted human reproduction has become a very important issue in the lives of many Canadians. It is sad that one in eight Canadian couples faces the challenge of infertility, and that almost a thousand children are born in Canada every year through assisted reproduction. These couples want some assurance that the services offered by fertility clinics are safe, appropriate and healthy options for building families.

Without legislation to prohibit or regulate activities related to assisted human reproduction, we cannot ensure the health and safety of Canadians. This has implications not only for infertile Canadians and for those born from reproductive technologies, but also for our society as a whole. Recognizing this, Canadians have clearly said they want national leadership in this area.

For example, a number of Canadian experts on health, ethics and health law, the Society of Obstetricians and Gynaecologists of Canada, health charities and the Fédération du Québec pour le planning des naissances have recently issued press releases expressing their support for the bill.

Surveys also showed that Canadians support the government's approach.

For example, a survey by Léger Marketing in 2003 showed that 84 per cent of Canadians were opposed to human cloning. It is now time for the government to show leadership and legislate in this area, otherwise, without this bill, children born through the use of donor gametes would have no assurance of being able to obtain medical or genetic information about the donor; the thousands of women who use assisted reproduction would not have a reliable source of information on the health impact of assisted reproduction techniques being offered to them; research on in vitro embryos would remain unregulated; and experiments leading to human cloning would be legal.


As stated in the Speech from the Throne on February 2, our government is committed to strengthening our social foundations, building a 21st century economy and ensuring Canada's place in the world. This bill is a good illustration of these commitments. This bill was developed in a manner that reconciles respect for our society's values with the challenges posed by rapid scientific developments in the area of assisted reproduction while enabling Canadians to build a family with complete peace of mind.

Strengthening our social foundations and protecting the health and safety of Canadians in the area of assisted reproduction are major government goals, and Bill C-6 will help attain them. These goals go hand in hand with the effort to equip our society to adequately face the new challenges of the 21st century. The bill reconciles the ethical issues raised by the application of these technologies with health protection goals for Canadians. It promotes the development and application of advanced technologies in the area of research on infertility treatments and treatments for serious diseases, while monitoring this research. It provides the necessary conditions for our professionals working in this area to develop their knowledge and techniques, which will subsequently benefit Canadians who use this knowledge to build their families.

For too long, we have lagged behind other industrialized countries that have a legislative framework for dealing with assisted human reproduction techniques and related research. This bill will bring us into line with these industrialized countries. Canada will adopt a comprehensive approach comparable to the ones taken in the United Kingdom, Australia and France for almost 10 years.

For example, the Human Fertilisation and Embryology Act was adopted in the United Kingdom in 1990. That is 14 years ago. It prohibits activities such as reproductive cloning and created a Human Fertilization and Embryology Authority that licenses, inspects and monitors assisted reproduction clinics. A similar process was also developed in the state of Victoria, in Australia. The Infertility Treatment Act of 1995 established an agency responsible for implementing the act and its regulations. More recently, in 2002, Australia passed two bills at the federal level that prohibit human cloning for either reproductive or therapeutic purposes and govern the use of human embryos. In 1994, France passed three bills on bioethics that established regulations for assisted reproduction. These were revised in 1999.

Because of the type of issues involved, a unique, innovative process of consultation, discussion and debate had to be developed to produce the proposal that is before you today. We consider this to be an important process and a good reflection of how our government is trying to make our democratic institutions work.

As many of you know, the origins of this bill go back to the final report of the Royal Commission on New Reproductive Technologies released over 10 years ago. The report sparked enormous discussion and led to attempts to develop a legislative framework that would be responsive to the many complex, delicate issues raised by the application of these technologies. Since the Royal Commission on New Reproductive Technologies was established in 1989, numerous fora and various groups of individuals representing all walks of life in Canadian society have been consulted. The government has been open and innovative in involving members of Parliament in developing various legislative proposals from the very beginning. Individual senators have also been interested in the issue and have had numerous discussions and made contributions on the subject.

In May 2001, the House of Commons Standing Committee on Health was mandated to review a draft bill on assisted human reproduction. The issues raised by reproductive technologies are complex, and the government wanted them to be the subject of frank, open discussion between MPs and Canadians. The House committee also heard from numerous witnesses representing a wide range of viewpoints. The committee was also asked to express its views on the various options for the possible creation of a regulatory agency that would be responsible for implementing the legislation.


The bill that is before you now is the response to the recommendations of the House of Commons Standing Committee on Health. It includes the changes that emerged from the committee's recommendations and thus reflects a consensus on complex, difficult issues.

The innovative side of this bill does not stop there, because it provides for a mandatory parliamentary review within three years after the establishment of the agency. The appropriateness of every provision of the act can be assessed at that time.

The same act also requires that draft regulations be tabled before the two Houses of Parliament for review prior to being enacted. This is consistent with the government's goals as set out in the February 2 Speech from the Throne.

As well, there has been constructive dialogue on the bill with the provincial and territorial governments, ensuring that their areas of jurisdiction were respected. This legislation is proposed in a spirit of cooperation. It contains a number of provisions that will enable both levels of government to exercise their responsibilities in this area.

The provinces and territories will continue to be major participants in the ongoing dialogue on the act through their representation on the agency's board of directors. The government has undertaken to quickly consult the provinces and territories on the development of the regulatory framework for the act.

In short, the process followed for this bill is innovative and clearly shows how the government intends to proceed from now on in developing legislation focused on Canadians, placing our democratic institutions at the heart of legislative development and implementation.

Honourable senators, it will be a pleasure to stay here a little longer with you, and my officials can remain even after I have to go.


Senator LeBreton: I can certainly attest to your comments that this is long overdue. I was in the Prime Minister's Office 15 years ago when we established the Royal Commission on New Reproductive Technologies, which reported in 1993.

I have many questions and comments on this, but I would like to question you about the assisted human reproduction agency of Canada, which you spoke about on page 3 of your remarks and again at the end of them.

Can you expand a little on the structure of this agency? How large will the group be? What will be its makeup? How will it interact with the medical and professional communities and the provinces and territories? Where will it be located? What kind of mandate will it have?

Mr. Pettigrew: Well, it is an agency that will have 13 directors, and perhaps I can turn to Mr. Rivard on that.

Senator LeBreton: That is fine.

Mr. Glenn Rivard, General Counsel, Legal Services, Health Canada: I would be glad to answer that. The agency reports to the Minister of Health. It has 13 directors, including a chairperson and a president, and is essentially responsible for the operational aspects of the proposed legislation — that is, for licensing activities, inspection of IVF clinics and other licensed establishments and for enforcement of the regulations established under the proposed legislation.

Senator LeBreton: What type of people are you looking at to fill these positions? Are they medical professionals? Will all of the different interest groups have access to this body, or will it be a tightly controlled, smaller group, primarily responsible for the implementation of the act?

Mr. Pettigrew: No, I think it will be a wide range of people representing different groups interested in the sector. Some of them, of course, could be doctors, but not necessarily.

Senator LeBreton: Will it be located here in Ottawa?

Mr. Pettigrew: Yes.

Senator LeBreton: How will it interact with the provinces? This is such a complex area, it is not as if you can just establish an agency and then include everyone, because look at how long it has taken to get to this point. How will we get this agency up and running so that it can address the urgent needs, especially in the scientific community?

Mr. Pettigrew: One of the directors will be appointed by the provinces precisely to remind the agency of its responsibility for cooperation with the provinces. The provincial presence will be built into the directorate.

Senator LeBreton: I am worried about the scientific community. There has been a lot of concern about this proposed legislation from the scientific community. I am trying to get a fix on the mandate and responsibility of this agency. How will they address the concerns and get this thing up and running quickly? That is really my question.

Mr. Pettigrew: Perhaps Mr. Shugart could contribute, and Mr. Rivard.

Mr. Ian Shugart, Assistant Deputy Minister, Health Policy and Communications Branch, Health Canada: One of the provisions in the bill that the committee may want to explore in greater detail concerns the equivalency agreements that are allowed for in the bill, which is one of the vehicles for collaboration with the provinces.

The scope of the bill is carefully constructed so as not to interfere with the provinces' competence with respect to regulating and governing the practice of medicine, for example. We have already had discussions with provinces in working with them to shape the content of the regulations that would flow from the act. You have raised an important question. The construction of the regulations themselves will be an important vehicle for working with the provinces and ensuring that they are comfortable and, as I mentioned, the equivalency agreements are something that we could explore at greater length as well — that is, a vehicle for the application of this law as far as the regulations are concerned. In the event that a particular province was to pass its own law, the equivalency agreements would respect that law and this law would withdraw in that particular jurisdiction.

It is an important issue and one that is provided for in the bill.

Senator Roche: I speak as one who is in support of the anti-cloning aspects of the bill. I do not want you to think from my comments that I am opposed to this whole bill. As a matter of fact, my basic problem is that you have put me in a difficult position — that is, the government that you are representing, minister, at this moment — because this bill has within it, of course, provisions on embryonic stem cell research, which is highly controversial and, in the view of many leading ethicists in the world, unethical. I do have some concerns with your statement.

You say that the bill reconciles the ethical issues. I do not think it does that at all. You praise the actions taken in the United Kingdom. Actually, the actions taken in the United Kingdom, sir, resulted in the killing of the 40,000 embryos.

I really do not think that is the kind of research and technological development that can be cited in a favourable manner.

You say that the government has been open, but I do not think it has been open at all. It has been asked repeatedly in the House of Commons and in the Senate to split the bill. If it had been, the cloning aspects that virtually everyone is in favour of would have passed almost immediately, and the questions concerning the research and the regulatory aspects thereof could have been given far more and deeper attention.

My first question does deal with the fact that the bill was not split. You say that this bill is proposed in the spirit of cooperation. I do not think there was cooperation, sir, with great respect. I feel that the government, which was very concerned about the elements in the House of Commons that were opposing the bill, delayed the bill for a considerable length of time precisely because there was no consensus — in fact a very serious split — and no cooperation.

I would like to ask you, first, if you would consider splitting the bill. I am sure your answer will be no, but I will give you the chance.

Mr. Pettigrew: Give me the opportunity to answer it first.

Senator Roche: I will give you the opportunity to say no, but because I will only have two or three questions, I will just couple that with the question that I think is far more relevant at this time. Would you accept an amendment that would ban embryonic stem cell research? I do not have the time here, and probably not even the ability to go into the technicalities involved, but I understand that adult stem cell research is far more productive and promising than embryonic stem cell research.

I ask you: Will you accept an amendment that would ban embryonic stem cell research, and the rest of the bill would go through? I think you would then have consensus and cooperation, the kind that you are looking for, sir, and the kind that I would certainly support.

Mr. Pettigrew: I understand and respect your point of view but I am confident that the present proposed legislation reflects the values of Canadians quite sincerely. That proposed legislation would place significant restraints on research using the human embryo, where none currently exist. The proposed legislation will prohibit the creation of embryos for any purpose other than reproduction. It is important to recognize that the primary purpose of the bill is to provide health and safety protection for women who make use of the reproductive services and the children born from these technologies. We need to adopt the proposed legislation to address this important need.

As for splitting the bill, it is our view that the reproduction and research issues cannot be separated if we are committed to prohibiting the creation of embryos for research purposes, or committed to prohibiting the commercialization of human reproductive capacity. It is an important bill that addresses complex ethical, medical and scientific issues in a comprehensive manner, and suggestions to split the bill along one line or another undermine the achievement of these objectives.

The House of Commons Standing Committee on Health concluded that the scope of the bill was appropriate and did not recommend that it be split. It has not addressed the ethical questions from all points of view. When you say we have not taken into consideration the ethical questions, I beg to differ. The ethical element has been at the heart of many of these discussions and clearly ethics is at the heart of the bill.

Ethics is a complex issue. These are very complex and delicate matters.

Senator Roche: Embryonic stem cell research ban? An amendment?

Mr. Pettigrew: As I said, there is a balance in this bill at this time that I think is appropriate. My view is that it would be preferable to adopt the bill as is.

Senator Roche: Would you accept an amendment that bans embryonic stem cell research?

Mr. Pettigrew: I think we would not.

Senator Roche: You would accept it?

Mr. Pettigrew: No, I said that I do not think we would accept it.

Senator Roche: You would not accept the amendment.

You said this bill reflects the values of Canadians or your perception of the values of Canadians. That is arguable. I do not suppose, however, that we can argue it here.

There are eminent authorities in the country who state that the bill is deeply flawed and presents a quandary for many people, certainly for myself. You put me in the position of having to accept this bill on the grounds that if we do not vote for it — and there are many good things in this bill that I want to have — then there will not be any bill, and the opportunity will be lost to attend to all the questions that surround reproductive technology. I do not particularly want to associate my name with the loss of good things in reproductive technology.

We are faced with this bill or nothing. I resent that. I speak for many people. The government could have paid more attention, in its desire for consensus and cooperation, to respecting the views of those who hold that embryonic stem cell research is morally wrong.

However, I will give you — or at least give myself — an out on this. We are in the public policy formation process here. That is very serious business. Perhaps I could bring myself to support the bill if I could see the regulations before the third reading vote in the Senate. Will you undertake to publish the regulations prior to the vote on third reading in the Senate?

Mr. Shugart: Perhaps I can give a technical answer to that. The department and others in the government do not have the authority to develop the regulations until the bill has been passed.

Senator Roche: We have had this kind of situation before, a draft of the regulations.

Mr. Shugart: Draft regulations have not been developed, senator.

Senator Roche: Minister, it compounds my anger and rejection of this bill when I am now told, regarding something so important that we have been working through for three or four years — God knows how long it has been in the House of Commons and now they want to rush it for reasons that have to do with a subject not at this table at the moment — that you do not have draft regulations for me to look at. I think that is absolutely wrong.

Mr. Shugart: As you know, the bill does provide, more so than in the vast majority of other legislation, for regulations to be tabled in both Houses of Parliament. This bill is actually at the leading edge of legislation that puts forward regulations precisely for parliamentary scrutiny.

Senator Roche: Why not put the draft regulations on the table and let us have a look at them?

The Chairman: In fairness to the witnesses, Senator Roche, they have made it clear that the regulations are not ready at this point, which is not uncommon. I have never seen the regulations given at the same time.

Mr. Rivard: That is the case, but the bill, through proposed section 66, requires that before any regulations can be adopted, they must come before both Houses of Parliament for review and comment. Should the minister of the day not adopt a recommendation of either House after it examines those draft regulations, the bill requires that the minister provide a written explanation. That is a level of oversight of regulations that does not exist in most other legislation. It is quite outside it.

The Chairman: I do not know what other place it exists, quite frankly.

Senator Fairbairn: Minister, in your comments, you made reference to the discussions that have already taken place with the provinces and the territories.

Could you elaborate a little for us on the question of equivalency agreements that are foreseen in this, where the provinces and territories could, according to their own practices, have their own legislation that would be presumably somewhat different from the federal but, nonetheless, within its meaning?

Could you take us through that in terms of the following: Would they be part of the federal registry even if there were differences, or would they have an equivalent type of registry within their jurisdiction? Would it be possible within those agreements for a province to negotiate a stricter or a tighter version of controls in some of the areas? How would these work? You have worked a great deal, I know, in the past with federal-provincial agreements. It seems to me this may be one of your great challenges. Have your discussions already smoothed the way for this particular part of the proposed legislation?

Mr. Pettigrew: As you know, I am also the Minister of Intergovernmental Affairs, as well as health and official languages.

Senator Fairbairn: I know.

Mr. Pettigrew: That is a pertinent question because assisted human reproduction is a shared jurisdiction. The bill includes a number of mechanisms permitting collaboration between both levels of government, and it varies a great deal according to the speed and to the subject that we are discussing.

Indeed, some provinces can have higher standards than the bill or than other jurisdictions could have between themselves. Perhaps I can let Mr. Shugart elaborate on the several mechanisms that we are developing.

Senator Fairbairn: Higher but not lesser?

Mr. Pettigrew: Yes.

Mr. Shugart: That is correct. First, I should make it clear that with respect to the prohibitions in the bill, for example, a prohibition against human cloning, the provincial law would not address that aspect. If those prohibitions are passed into law, they are the law of the land. Because they and the entire bill rest on the criminal law power, those prohibitions would stand everywhere.

However, as we will discuss for you in greater detail, if you like, part of the bill that deals with the controlled activities, for example, those things that are permitted under a licence and governed by the regulations, could be the subject of an equivalent provincial law. No provinces have legislated in the kinds of areas that this bill addresses to this point, but if they chose to do so, the equivalency provision of the bill would come into effect, if, in the opinion of the minister, the content of the provincial legislation is equivalent to that of the federal legislation. That is a matter of policy and of the content of the provincial legislation.

The federal government — the cabinet — would have to be persuaded that the content is indeed equivalent, at least in the sense of meeting the minimum requirements of the federal legislation. If that were the case, the federal law would not apply in that particular jurisdiction. Rather, the provincial law would apply in its place.

Senator Fairbairn: Could you give us an example of what a province might wish to do that would be different from the federal jurisdiction?

Mr. Shugart: Mr. Rivard, could I ask you to answer that?

Senator Fairbairn: We would like to have an idea of how this will work.

The Chairman: I want to make one other observation. This clause is identical to the clause in the federal Privacy Act, which says that the federal Privacy Act pertains unless there is a provincial privacy act. I think the phrase in that act is ``deemed to be essentially similar,'' in which case the federal act does not apply. This mechanism has been used elsewhere.

Mr. Rivard: It is difficult to be more precise in the absence of a province coming forward with a different regime. As Mr. Shugart has indicated, no province has yet sought to legislate in this area.

It is important to note that the provision does not require that it be identical in all aspects to the federal regime but that it provide an equivalent level of protection for the people who are supposed to be protected by it, particularly women undergoing these procedures. Beyond that, it requires that a province decide that it would like to regulate in this area, develop a proposal and discuss it with the federal government. Both levels of government would then have to agree that there is an equivalent level of protection, at which point the federal government could withdraw the application of the controlled activities provisions of the act in that province.

Mr. Shugart: One could imagine a province, speaking hypothetically, wishing to license IVF clinics for itself and to be engaged in the inspection of those facilities, which is one example of the kind of regulatory oversight that is envisaged in the bill.

If the requirements for safety procedures and the training of personnel, et cetera, provided that level of protection — achieved that equivalency — that could be the basis for agreement in that particular respect.

Senator Fairbairn: Is any thought given to federal funding being required in the event that a province does wish to set up an equivalency system?

Mr. Pettigrew: No.

Senator Fairbairn: All right.

Mr. Pettigrew: If you do not mind, I will leave my staff with you and they will continue, because I have another meeting.

The Chairman: I understand.

Mr. Pettigrew: I have already delayed it by one hour and any longer would be neglecting my duties.

The Chairman: I appreciate that, minister. Thank you for appearing before the committee.

I wish to tell Mr. Shugart that perhaps we will deal with the next three questioners and then you might want to highlight the overheads we have not yet touched on and that would be helpful.

Senator Callbeck: I will continue with the question of equivalency agreements. It says that they can assume responsibility for licensing, controlled activities, maintaining a register and for inspection.

Could that agreement be in one area only or does it have to cover all areas?

Mr. Rivard: It could be in one area. I think you would have to make an operational decision such that it is functional to cover only one area. For example, if a province wanted to regulate IVF clinics only, you could have an equivalency agreement with respect to IVF clinics only.

Mr. Shugart: The remainder of the provisions would be provided by the federal legislation, senator. They could be adapted to different jurisdictions and equivalency agreements, in principle, would then not have to be the same everywhere.

Senator Callbeck: In other words, they could decide that they want an agreement on licensing and, as long as the federal government, or the cabinet, agreed to it, then that agreement would take priority within the province.

Mr. Shugart: Yes.

Senator Callbeck: Concerning the regulations, you mentioned that there has been discussion with the provinces. What is the progress? How much input will the provinces have into these regulations?

Mr. Shugart: That discussion has been initiated. In fact, prior to talking about how regulations would be developed, there had been policy discussions about the bill in principle and how it was constructed, going back quite some time. The provinces have been particularly interested in the regulations because their sensitivity on jurisdictional grounds would take form in that area.

Perhaps I could introduce my other two colleagues who have joined us at the table: Ms. Caroline Weber and Ms. Francine Manseau, who have been closely involved with the proposed legislation in the same area. Perhaps you could elaborate on those discussions.

Ms. Caroline Weber, Director General, Policy Planning and Priorities Directorate, Health Policy and Communications Branch, Health Canada: First, we have not been heavily involved because we have not begun the consultation process with the provinces. I would worry about the presumption of doing something like that before the bill has received Royal Assent.

We have had some bilateral discussions with provinces in terms of a consultation process that we might be pursued in the process of developing the regulations. By and large, we have not met with everyone yet, but a couple of the major ones are very interested in being engaged in the development of the regulations. We are thinking about setting up a working group for the provinces and territories to participate with us, or Web sites where we can keep them apprised at all times of what we are learning through the consultation process. It has not advanced in terms of the substantive matter but we are talking about the approach that we may take. It is intended to be extremely inclusive because it does have an impact on an area of shared jurisdiction.

Senator Callbeck: Did you say that to date you have only met with two provinces?

Ms. Weber: No. Prior to tabling the bill, we certainly had conversations with all the provinces, but more recently, while the bill has been under review in the House and now before the Senate, we pursued conversations with Quebec and Ontario. There may have been a brief exchange with Alberta but we have not pursued lengthier conversations about the next steps and how we will proceed.

Mr. Shugart: A commitment has been made to all provinces to engage with them in detail and, again, jurisdictions will take advantage of this offer differently to the extent that they want to engage with us on the regulations as we develop them, if we get to that stage.

Senator Callbeck: Have all provinces been supportive of this proposed legislation?

Mr. Shugart: All provinces have been careful about the jurisdictional sensitivities. I would need to be careful about speaking for them because most have not declared themselves definitively as being in support or not in support. However, we are satisfied, senator, that we are on strong jurisdictional grounds. We have reviewed those arguments with those provinces that have wanted to talk about that. We believe that it will be in the area of regulations that any lingering concerns about jurisdictional appropriateness will be resolved.

Senator Robertson: I do not quite understand the regulation development process or why the provinces have not been more involved, but it is probably because of a jurisdictional issue. Happiness is desired, regardless of the jurisdiction, on many issues.

Let me move to another issue. The Infertility Association of Canada opposes this bill because it will severely limit, if not take away, the rights of infertile people to choose the treatment options that are best for them, as well as potentially endanger the health of infertile people. Would you to respond to that concern?

My next question relates to ReproMed, the largest Canadian donor facility in Canada. They tell us that 71 per cent of sperm donors have stated that they will not continue to participate in the program without appropriate reimbursement. Without an amendment, the bill will eliminate the donor screening and collection services to Canadians.

How has the government made provision for the express concerns of people like the clinical director representing ReproMed? Let us try those two questions first.

Ms. Weber: I do not wish to speak for the infertility association, but my understanding of some of the principles on which their opposition is based concern primarily the issue of commercialization. The bill prohibits commercialization of the human reproductive capacity — the principle that we should not be paying people money for sperm or egg donation, that we should not be allowing payment for surrogacy, is a cornerstone of the bill.

This will potentially have an impact on the supply of surrogacy services available and on gametes, what we refer to as human reproductive material, available, either sperm or eggs. It is from those concerns about the reduction of supply that their opposition to the bill primarily comes. There may be a greater variety of issues there, though.

As far as endangering their health is concerned, I do not understand on what that is based. The further claim from ReproMed is that this will eliminate some of the procedures that we know are essential, but they are actually part of the bill in terms of ensuring that the supply of these materials is safe. That is actually a false claim.

If ReproMed is saying that 71 per cent of sperm donors will not participate, that may be true. I do not remember seeing those survey results, but we know from other jurisdictions that have moved from commercialized to altruistic systems of donation that they have seen a decline in supply at the start, but they have been able to recruit different kinds of donors over time. This is true in France, New Zealand and the United Kingdom, to some extent. We are in the process of studying these systems to try to determine what we can do proactively to reduce any negative effect on supply we might see in the passing of this bill.

The Chairman: You said that what you call ``commercialization'' is a cornerstone of the bill; that is clear from reading it. That does not tell us why it is a cornerstone of the bill.

I look around my colleagues at this table who voted against the last attempt to restrict abortions in this country. We did so on the grounds that women had the right to make decisions with respect to the womb and that that decision ought to be made by the individual and by her alone. Therefore, it seems that these restrictions fly directly in the face of what motivated the Senate to kill the last attempt at restricting abortions.

I understand that it is a cornerstone of the bill. That is easy to say. However, that does not defend the policy.

Ms. Weber: Fair enough. I actually do not agree that this bill is in any way restricting a woman's decision on what to do with her body. We have not outlawed surrogacy here. We are saying that commercial surrogacy would be prohibited. The premise is that an exchange of payment for these kinds of services may actually prey on the most vulnerable.

The Chairman: This is the Big Brother approach; we will look after people who are unable to look after themselves; is that correct?

Ms. Weber: No, I do not think this is a Big Brother approach.

The Chairman: When you tell me that you are protecting those who are most vulnerable in society, there are overtones of a Big Brother approach.

Ms. Weber: That is it one part of the argument. It goes further than that, certainly. There is also the matter of the children who are created through these processes. We are also prohibiting the payment for sperm and eggs, for example, so that children are not born feeling that the person who donated the material did it for beer money for the weekend, perhaps, or because of some lucrative proposition; rather, that these children were created because of someone else's sincere wish to contribute to their creation and make them possible for their social parents.

Mr. Shugart: There is a close parallel to the basis upon which our system of blood or organ donation rests, that we express as a society our solidarity with others by donating from our own bodies. In the case of surrogacy, this sentiment relates to donating with our bodies. The extension of that principle to assisted reproduction means that the donation of gametes and the human sacrifice that is involved in carrying a child for another is done on a purely voluntary basis. That principle is well established in other aspects of health.

This was one of the earliest issues addressed by the royal commission. While on none of these issues that concern ethical positions and the expression of Canadian values would we at any point suggest that opinion is unanimous, certainly the drafters of the bill and members of the House of Commons had the careful, considered opinion of the royal commission on which to fall back on that particular issue.

The Chairman: I cannot resist the comment, but the House of Commons also passed the abortion bill back in 1993.


Senator Plamondon: In my view, supporting the bill creates a dilemma. In voting for the bill, I vote against cloning, but at the same time I vote for research on embryos. I do not like having to vote on both those issues at the same time. In his presentation, Minister Pettigrew indicated that 84 per cent of Canadians believe human cloning should be prohibited.

However, the survey document did not indicate whether Canadians were asked if they approved of research on embryos. Had they been asked, what would they have said about such research?

I would have preferred to see two bills, because one of the issues it deals with is under federal jurisdiction. It would have been easier to rally everyone with two bills. Canadians seem opposed to human cloning, and the surveys attest to that. This issue could therefore have been dealt with quite easily.

But when it comes to research on embryos, we have to harmonize our approach with the provinces. We are concerned because there is no regulatory framework. It was indicated that Australia had two bills on this. Did Australia's two bills separate the two issues? I do not know. I am uncomfortable about this; if I vote for the bill in the Senate, I will be told that I voted for research on embryos. So I will have to explain to everyone I meet why I voted on research on embryos without knowing more about the issue. If I vote against the bill, I will be told that I voted for human cloning. That is what we see in the newspapers these days. Any vote in the Senate against the bill is seen as a vote in favour of human cloning. Arguments are being raised to force my hand, and I do not like that approach.

Mr. Shugart: My colleague Francine Manseau will answer the question, especially with regard to the international parallel mentioned by the senator.

Ms. Francine Manseau, Manager, Policy Development Group, Policy Planning and Priorities Directorate, Health Policy and Communications Branch, Health Canada: Regarding research on embryos, the bill will neither facilitate nor encourage research on embryos. This research is going on right now.

The bill is trying to create a framework for this research and ensure that it be carried out according to important rules and criteria. We must be clear about this; this legislation will not authorize research overnight. The research is already going on. Fertility clinics that were producing in vitro embryos had to do research in order to come up with applications that are safe for the women being treated. The bill neither facilitates nor encourages; on the contrary, it wants to create a regulatory framework for this field. Without this bill, such research will go on. It is already going on.

We want to begin to regulate both publicly funded research and privalety funded research. At this time, no one is regulating this field. With regard to the legislation you mentioned in the Australian states, some legislation was prepared; you might say that it was similar to some aspects of the legislation that aims to regulate these practices in Canada. The national legislation in Australia focused on research using embryos and practices such as cloning; this was regulated at the national level.

Legislation was enacted for various states, which are more or less the equivalent of Canadian provinces, but not every state. They almost all have some kind of legislation to regulate these practices.

Senator Plamondon: I do not understand the logic behind this. You state that without regulation and without a bill, human cloning research can be carried on right now. This is what is written. We decided to ban human cloning. And as research is still being done on embryos, we want to create a framework for it. How can you decide to ban the one and to regulate the other? Decisions were made in this bill. As they are proposed to me, they require a change in my thinking.

Ms. Manseau: The part of the bill which regulates procedures forbids every kind of activity, except for some which will be allowed to the extent that a person is authorized to carry them out and committed to following the rules. In fact, the decision to ban cloning has already been made. But in order to carry out any kind of research on embryos, a person will have to get authorization and follow the regulations. But the legislation defines certain kinds of research or activity involving embryos which will be forbidden; one of these is cloning.

Senator Plamondon: This does not address my concern.

Senator Morin: Senator Plamondon wants to know why research on embryos is allowed in in vitro fertilization clinics. As she is asking why it is not banned, she is suggesting that in vitro clinics would be closed down.

Senator Plamondon: This is not what I mean. You are reading something into what I have just said. With regard to human cloning, you have decided to ban human cloning for the purposes you have mentioned.

Ms. Manseau: For any purposes.

Senator Plamondon: You are deciding to allow research on embryos, which is somewhat similar to cloning, because you need an embryo. I am not a physician, but as far as I am concerned, this is the beginning of an embryo, this is life at its beginning. You have decided to regulate this practice and not to prohibit it. How far will you go to get embryos? I do not know that. Please give me an answer.

Ms. Manseau: The technique and practice of in vitro fertilization, because this practice is allowed — and it is allowed in Canada — is such that the procedures do not make guinea pigs of women. Research had to be done to ensure, when taking a sperm and an ovum for in vitro fertilization outside the body of a woman, that these procedures were tested to ensure the health and safety of women receiving this treatment and of the children resulting from it. It has always been necessary to do research. If no form of research is allowed, then in vitro fertilization will not be allowed.

Senator Plamondon: My question was not about in vitro fertilization, it was about the other type of research on stem cells and embryos, but nevermind.


Senator Cook: Honourable senators, thank you very much. I thank you in advance for your patience in attempting to understand me.

We seem to have moved from substance, that is, the bill, to the process, whereby we engage the provinces, and indeed everyone, in the application of this bill.

I want to stay with regulations for the time being, and I have a number of questions in front of me. I will present them and then I invite your comments.

Individuals have voiced concerns over the number of items left to regulations. Can you offer me examples of other legislation with similar regulatory provisions, and can you indicate to me how these will be developed? What do you see as a priority for those regulations? Also, has Health Canada developed any draft proposals for regulations on such matters as informed consent, counselling or maintenance of records? How about more technical and scientific regulations?

Given that regulations on semen safety already exist, has Health Canada begun to adapt them to cover the safety issues related to ova and embryos? Last but not least, as this evolves over time and there is a need for change, who has oversight, and who signs off on regulations, should they need to be changed and adapted?

Mr. Shugart: Honourable senators, I will take the last question and my colleague, Mr. Rivard, will take the others.

The bill provides quite explicitly, in clause 20, I believe, for the Minister of Health to retain policy responsibility for this area, which, for practical purposes, means that when regulations need to be changed in keeping with new developments in science, or new knowledge, or changing circumstances, it is the responsibility of the government, not of the agency, to put forward the regulations. Therefore the policy oversight remains with the government. This was an important point of debate in designing the bill, and we confronted this issue in the Commons as well.

The bill does set out a number of categories in which regulations will need to be developed, and perhaps Mr. Rivard could elaborate on that.

Mr. Rivard: You raised a number of points. I will address the first one, with regard to whether there is other legislation in which there is a similar reliance on regulatory powers. The one that comes to my mind most obviously is the Food and Drugs Act, another piece of legislation of the Department of Health, which has been in existence for 50 years. The statute sets out the fundamental legal principles, and then, through quite a large series of regulations, addresses how drugs and medical devices are to be approved, clinical trials are to be run and that sort of thing. That is one example that I can think of off the top of my head.

In terms of the process, the normal process for development of regulations is that after the bill has been adopted the department consults with stakeholders, including the provinces, interest groups, et cetera. It then develops a draft of the regulations that is published in the Canada Gazette. In the following three months, interested persons can comment on the draft. The government takes those comments into account before the final set of regulations is adopted. There is a whole set of requirements for the consultation process.

This proposed legislation pioneers an additional requirement, to which I referred earlier, that when the government develops draft regulations under this bill, clause 66 requires that those be tabled with both Houses of Parliament, and both Houses have an opportunity to examine them and issue a report. If they make recommendations, the minister must either accept them or explain in writing to Parliament why he or she has chosen not to.

There is a level of oversight in the drafting of regulations under this bill that is almost unique with respect to federal legislation.

Finally, you asked about priorities for the preparation of the regulations. The first priority would be with respect to the clause 8 provisions, requiring consent for the use of gametes, embryos, et cetera. After that, it is likely that there will be a series of consultations on regulations, including on the issues of informed consent, the provision of information to people who participate in these procedures, counselling, the development of the records, the development of the health and safety standards for various procedures like in vitro fertilization, and how licences and inspection should be handled under the proposed legislation.

Mr. Shugart: Honourable senators, I commend to your consideration clause 65 of the bill, which provides a long list of areas in which regulations would be required. These deal very substantially, as Mr. Rivard has indicated, with health and safety considerations. I would mention, for example, subclause (g), which has to do with the number of children that can be created from the gametes of any one donor, or subclause (o), which has to do with the kind of health information that is required so that the medical history of donors is collected in the registry and made available to the offspring of these technologies.

Senator Cook: I understand that process, but the time will come when there will be a need for change within the regulations, and as I understand regulation, it can only be subject to the piece of legislation that it supports. What oversight is there when change comes to a regulation? Will it come back to committee for study, or will it be the purview of the department?

Mr. Shugart: The government has the responsibility to initiate that change, so that for any given regulations, the process as Mr. Rivard has just described it would begin. They are then to be deposited before both Houses of Parliament as prescribed in clause 66. They go through the same regulatory process — publication in the Canada Gazette and so on, and the same parliamentary oversight that is prescribed in clause 66 — but the government does retain the responsibility for adapting those regulations over time and proposing new regulations.

If the bill becomes law, it is subject to a parliamentary review three years from the date of coming into effect of the agency.

Senator Cook: At which time, amendments could conceivably be made?

Mr. Shugart: To the law itself, that is correct.

Senator Keon: I want to go back to surrogacy and the prohibitions on reimbursement. The proposed legislation is quite clear that a surrogate mother cannot be reimbursed for the act of surrogacy. However, subclause 12(3) says she can be reimbursed for loss of wages if her own health or the health of the fetus is threatened. This is a very complex issue. I do not know how you will cover it in the regulations. For example, could a radiology technician become a surrogate mother? She would clearly be putting the fetus at risk if she continued to work.

There must be large numbers of young women who would not be eligible for surrogacy. Indeed, it would seem that this is a pretty loose arrangement, that the decision could be taken to become a surrogate mother and, following that, reimbursement could be gained simply by making a case that this pregnancy poses a threat to the mother or the fetus. How will the regulations deal with the level of reimbursement?

If, for example, a young woman who is making a very large salary decides to become a surrogate mother because of emotional attachment to somebody or that kind of thing, can she be reimbursed up to the loss of her $500,000 per year, or must she accept some lesser salary during the pregnancy?

Mr. Rivard: Perhaps I can answer that by looking at the two examples that you gave. One was the woman who is a radiology technician. There is no limitation in the bill as to who can become a surrogate mother, and therefore any woman could become a surrogate mother if she chose to, regardless of her occupation. In order to receive compensation for lost income, it would require a doctor to issue a certificate indicating that it was necessary that she no longer participate in the workforce for reasons of either her health or that of the fetus. The bill, however, is quite explicit in stating that all she can be compensated for is the lost income. You have to establish what her salary was, and she could receive reimbursement at that level. The objective here is to prevent any financial gain, if you will, from being a surrogate. On the other hand, it was felt that, given that the overall objective of the bill is to promote health and safety, we did not want surrogate women to feel they had to continue in employment if their doctor indicated to them that there was a health reason why they should take time off work. It was out of consideration for the health of the woman or the developing child that this provision was put in.

To answer your second example of the surrogate mother who is enjoying a large salary, there is no limit as to the amount of compensation as long as it is established that she is being compensated to the level of her income and, as a result, is not gaining financially. That also depends on the capacity of the commissioning couple to compensate her for her loss of income. I do not think we would say that could never happen, but that level of income is not typically the income profile of a surrogate mother.

Senator Keon: It seemed to me that the bill as originally drafted was much cleaner, because it did not have this provision in there. This got put in along the way as some kind of amendment.

The Chairman: Senator Keon, to what clause do you refer?

Senator Keon: Sorry, clause 12, item 3. My own feeling is the bill would be a lot better with this taken back out.

It can be difficult to deal with this issue. It is difficult to deal with this issue in the workplace right now, leaving out the surrogacy question.

Mr. Shugart: Senator, your point is certainly noted. It is one of the features of the process of developing the regulations that Mr. Rivard referred to earlier and that does provide for more intensive study and consultation on how that issue would be handled.

It is a reflection of the rather delicate balance between the principle, on the one hand, of not commercializing the issue, and therefore providing an opportunity for enhancing one's economic circumstance from surrogacy, but at the same time, not causing injury to the surrogate financially. We acknowledge that there will be complexities in giving practical life to these provisions in the regulations.

Senator Keon: Are you confident you can cover this in the regulations?

Mr. Shugart: Yes. I am not an expert in regulations, and it is an issue on which we will have to draw on expertise and consult in order to get that right.

Senator Trenholme Counsell: We are obviously going through this with a fine-tooth comb. I share Senator Callbeck's concerns about provincial consultation, but I gather that enforcement will be federal. We are not depending on the provinces for enforcement because it is a federal law.

I am trying to go through it very carefully. Clause 5(b) refers to ``create an in vitro embryo for any purpose other than creating a human being'' — it is the ``or'' that I wonder about — ``or improving or providing instruction in assisted reproduction procedures.'' How loose or how tight is that ``or''? To what extent can embryos be created for this kind of instruction? I sensed, as I read it, that it is perhaps a little open.

Mr. Shugart: The intent, senator, is to allow a very narrow range of activity that relates to improving the safety of the procedures themselves. Ms. Manseau or Ms. Weber might want to elaborate on that. That is clearly the reason for that qualification, and we would assert that it is a very narrow qualification.

Ms. Weber: In the first instance, the intent here is to prohibit the creation of in vitro human embryos for any purposes other than reproductive purposes. We know that in fertility clinics, occasionally embryos are created and used for the purposes of instruction, and perhaps for what might not be called ``classical'' research in the sense of a designed project. There are improvements in method that people are working on along the way, and they are creating embryos for that purpose, but it would be very much in the process of improving and delivering treatment. We added that mostly to ensure that we did not hamper the delivery of treatment in any way. These exceptions would have to be outlined and developed more specifically.

Ms. Manseau: An important point is that in order to be able to manipulate human reproductive material to create an embryo, you would require a licence and would have to follow regulations, and that will be a means of closely ensuring that the objective for which the embryo is created follows those rules.

Senator Trenholme Counsell: Yes, I understand that. It seems to me that perhaps, with respect, rather than being an ``or,'' it might have been a separate item. It seems to almost be put in there as an afterthought. It does require clarification and regulation. I just found it strange that it was lumped in there.

Mr. Rivard: Perhaps I can answer. The provision sets out a general prohibition, and the ``or'' is an exception to that general prohibition.

That is why it is drafted in that fashion. What is important to note about the exception is that that activity can only be undertaken by a licensed clinic, or whatever, and subject to the regulations. It is not as if it is unsupervised or open- ended.

Senator Trenholme Counsell: Would that become clearer when one reads about the licensing and so on?

Mr. Rivard: Correct.

Senator Trenholme Counsell: I am trying to read a little of the scientific background. The next one is (c). Does it mean that once you have created an embryo it is sacrosanct and you cannot take a part of it and create another one?

Mr. Shugart: That is right. The principle is based on the fact that it would be hypothetically possible to create a human being from that which itself had never been a human being. In other words, there would be no connection to a parent of any kind. You could conceivably create a whole string of human beings who had not been derived from or come from a human being in the first place.

It would seem apparent that that is quite contrary to the idea of the dignity of each individual human being.

Senator Trenholme Counsell: There really is no mention in here of embryonic cell research, is there? Is it mentioned in the bill?

Ms. Weber: No. The important distinction that we would like to make is the difference between the use of the in vitro human embryo and stem cell research.

Senator Trenholme Counsell: I meant stem cell research, yes, pardon me.

Ms. Weber: Stem cell research is not in here because once stem cells have been derived from a human embryo, it is outside of the scope of the bill. Once people are using stem cells they are no longer falling under the purview of this proposed legislation.

Senator Trenholme Counsell: Is it true that in no place in this bill are stem cells mentioned?

Ms. Weber: Actually there are the CIHR guidelines, and therefore the words ``stem cells'' by reference.

Senator Trenholme Counsell: No, do the words appear in this bill? I think we might be asked that.

Ms. Manseau: Stem cells come from more than embryos. An embryo is a source from which you can get stem cells, but you can also get them from adults.

Senator Trenholme Counsell: Of course.

Ms. Manseau: Basically the scope of the proposed legislation is the use of a human embryo, and it could be used as a source to extract stem cells, as it is used also to do research on infertility, miscarriages and so on. However, it is just about the use of the embryo. Once the stem cells have been isolated, then that would no longer fall under the proposed legislation. That is why it refers to making use of an in vitro embryo ``for any purpose.'' That could be research or for reproduction.

Senator Trenholme Counsell: In what clause would I find mention of that?

Ms. Manseau: The use of the embryo, the regulation, is under 10(2).

The Chairman: It is at clause 40, correct?

Ms. Manseau: Yes, but in clause 10(2) you have the controlled activity, where it states that: ``No person shall, except in accordance with the regulation and a licence, alter, manipulate, treat or make any use of an in vitro embryo.''

Senator Roche: My point has been picked up now. I just wanted to have clarification that the bill does in fact permit the use of embryos for stem cell research. That is the point of contention in the bill. Right?

Ms. Manseau: Yes.

Mr. Shugart: Yes.

The Chairman: Mr. Shugart, you have covered all the main items of the bill so there is no sense in going through your deck. Is there in the deck of overheads any major issue you think we have missed? While you are thinking about that, I believe Senator Roche has a question.

Senator Roche: Back to regulations. Mr. Shugart, I understand what you said earlier, when the minister was here, that you cannot anticipate passage of the bill before the production of the regulations, but do you take my point, and perhaps on behalf of some others too, that if we could see the direction of the thinking of the department in the drafting of the regulations, it would ease our concern? I would like to say that I am confident that you will do the best you can and this will not get out of hand, but then you did use the example of the United Kingdom, where 40,000 embryos were killed for stem cell research, which is very distressing. Thus, it leads legitimately to a question here in Canada: Will the regulations in Canada be sufficiently strong that we will not have that kind of situation? That is why I would like to see the direction of your thinking.

I put it to you that for some of us, how we will vote on this bill is a question of conscience. I need to be reassured — not that I have any suspicions beforehand — that the regulations will be sufficiently strong. Is that not a fair question, Mr. Chair?

The Chairman: Yes, that is a fair question.

Mr. Shugart: I do, indeed, take your point. One of the reasons I pointed out proposed section 65 was to illustrate the areas that are covered by the regulations. That is only a partial answer. I am told with respect to the situation in the U.K. that you referred to that the destruction of the embryos was actually because of the expiry of the consent that had been given regarding their disposition. I and my colleagues would be more than happy to review what we have in the way of background information and so on that could be made available to the committee in this area. However, it is also important to point out that on the face of it, the bill does deal with the issues that you have raised. It does not attempt to conceal the fact that research on embryos, surplus embryos, can be engaged in. It is subject to licences.

Senator Roche: I know that.

Mr. Shugart: There will certainly be provision for an ethics review. I know that you will be hearing from Dr. Bernstein, who can speak in greater detail about the principles and procedures of ethics reviews, so that indeed there are provisions that govern even that activity, which we understand very well is the subject of differing views.

Again, I would restate that there is no representation here that this bill covers all of these views with any degree of unanimity. There clearly is a range of views here and the bill does not answer all of them perfectly.

I do not know if, with respect to the development of regulations, we could add anything at this stage, but we would be prepared to provide further background.

Senator Roche: I must point out that the minister did say that this reflects a consensus. I challenged him on that and I think that you are now indicating that, yes; there are a variety of views.

Finally, I heard you say a moment ago that you would review the background material at an early stage. Do I take it that your review of the background material might lead to the production of some sort of paper or something that we could read? Can you make your review of the background material available to us before the third reading vote in the Senate?

Mr. Shugart: I meant for the purposes of sharing with the committee what we can.

I will ask Ms. Weber to elaborate on that. I want to be clear that, when the minister referred to ``consensus,'' I do not believe he was asserting that there is unanimity on these issues.

Senator Roche: That gets into the definition of ``consensus.''

The Chairman: I cannot resist making the observation that both Senator LeBreton and I have been in rooms where cabinets were debating things, and the Prime Minister would always call the consensus. The consensus was precisely what the Prime Minister defined it to be.

Mr. Shugart: There has been consensus on a number of features of the bill, certainly, consensus — again, not everyone would agree — that legislation is needed in this field; consensus, certainly, coming out of the royal commission that both prohibitions and a regulated environment should be dealt with; consensus in the House of Commons committee that, while there, too, there were different opinions, in the end, the bill should be held together. The minister was explicit in acknowledging a range of views on these issues. However, on the issue that the senator raised, Ms. Weber will elaborate.

Ms. Weber: We do not have draft regulations. We do not have drafting instructions.

Senator Roche: You have made that clear.

Ms. Weber: However, we have been working on background papers for our priority areas, and consent is the one we are talking about going out with. I do not know if it gets to the issues that you are interested in, which, I think, speak more to licensing, perhaps, and even inspection. We are not that far along, honestly. However, we have one general background paper about the bill, and we have been working on another background paper on consent.

Senator Roche: Can you make that available to the committee?

Ms. Weber: I would be willing to commit to that.

Senator Roche: Before the third reading vote?

Ms. Weber: Yes.

Mr. Shugart: We will give you what we have.

Senator Roche: Thank you.

Senator Robertson: You have obviously now been discussing this bill for a number of years with the various associations and medical and research communities, but I would be terribly surprised if the minister had not wanted, along the way, to hear public opinion on embryonic stem cell research. I should like you to share the results of the general public opinion polls that you have been doing in this regard. Where do they stand? Someone must have been doing them.

Mr. Shugart: Yes, and some of it has not been requested by us but is in the public domain. Ms. Weber may speak to that. I do not think we have anything recent.

Ms. Weber: It is in your briefing binder, but to summarize, in general, Canadians are supportive of the use of embryos to derive stem cells for purposes of therapeutic benefits. Although I do not know if they fully understand the term, they might even support therapeutic cloning.

They have been surveyed on many other issues over a longer period of time. I am thinking about polling results from around 2001 that were more on the issues of surrogacy, for example, and again, we get different kinds of results, depending on what we are asking.

Ms. Manseau: In your briefing binders, at tab 5, we tried to summarize for you all the polling that has been done, to our knowledge, starting in 1999.

Senator Robertson: Thank you. I have not gotten to that yet.

Ms. Manseau: It is tab 5.

Senator Robertson: It is hard to get through all the material.

Ms. Manseau: Yes, but we tried to provide you with a summary of most of what we know.

Senator Robertson: That is most interesting.

Senator Milne: I have concerns when it comes to health reporting information, clauses 14 to 19. Although it depends on the regulations and you do not have them yet, I should like to know what you foresee particularly when it comes to limiting the number of offspring from a donor and facilitating donor-offspring contact and offspring-offspring contact, with mutual consent. I can see an Oedipus situation arising here quite easily if you have donors who have multiple offspring.

Mr. Shugart: The fundamental purpose of the health reporting information is the provision of background information to the clinics in providing information and counselling to couples undergoing these techniques, ensuring that informed consent is obtained from individuals, ensuring that there is the appropriate follow-through from first to last; indeed, in ensuring that, with a particular medical history, some donors' gametes might not be accepted, for example, because of the risks that would be flagged as a result of that history.

With respect to the issue of donor identification and so on, it is important to note that there is an issue surrounding the identification of donors to the offspring of these techniques — again, one of those thorny issues in terms of balance. The registry comes into play in that the identification of donors is contained within the health information that is reported, but it is not made available to the offspring without the consent of the donors. You can see how the registry would be a vehicle for facilitating that because the information is contained therein but is protected under a privacy regime.

If the donor subsequently was willing to be identified, again, the registry makes that possible but does not require it.

When Senator Kirby asked if there were any particular areas that we would want to draw your attention to, the health information reporting and the registry are very important parts of the bill for those reasons.

Senator Milne: You speak of mutual consent, but the problem is that quite often there is not even mutual knowledge.

Mr. Shugart: Yes, absolutely.

Senator Milne: These children are raised in ignorance of their genetic origins.

Mr. Shugart: Yes.

Ms. Weber: The intention is to have a central repository for all this information so that when individuals decide, perhaps, to marry, and they are aware that they both have —

Senator Milne: That is the question; they have to be aware.

Ms. Weber: They have to be aware. That is an issue in this field, in that some of the couples using the services are not comfortable yet with revealing that information. There is a trend toward more openness and, certainly, a general desire of some involved in this — probably the children, especially — to have more openness, and I think that is moving along.

However, at this point we do not have that information stored in such a way that we could put all of it together and even know, if someone came and asked, ``Am I related to him?''

Senator Morin: He is your brother.

Senator Milne: DNA testing for everyone.

Mr. Shugart: Close colleague, in any event.

The risk, though, of consanguinity is reduced in the regulatory provision for a limit on the number of children that can be produced from the gametes of any one donor.

Senator Milne: What sort of limit do you envisage, if you can give just a ballpark figure?

Mr. Shugart: That would be based on expert opinion that would be garnered during the process of developing regulations, senator. I would not hazard a guess.

Ms. Weber: Honestly, we do not know because that is an area where we need the experts to tell us at what point, when you have a certain number of offspring, you need to start worrying about something happening as well as how many times the same commissioning couple is using those same gametes.

Senator Milne: They say that everyone in Canada has four degrees of separation, so tread gently.

Senator Callbeck: I want to go back to these agreements with the provinces. You said that it is possible for a province to negotiate a stricter agreement and it could be in one specific area only. Therefore, could a province negotiate an agreement in which they would not allow embryonic stem cell research?

Mr. Rivard: I would think that they could conceivably do that.

Ms. Weber: No pun intended.

Mr. Shugart: We were not the first to use it at this table this afternoon, senator. Hypothetically, yes, they could do that.

Senator Trenholme Counsell: When I listened to your answer about the provinces the first time, I thought that this was the minimum and that they could add to it. I thought that you said this was the foundation and they could add to it. That was what I thought I heard you say. I did not think they could take away but they could add more, such as licensing requirements and so on.

Ms. Manseau: More restrictions.

Senator Trenholme Counsell: Yes, I thought you told us that.

Mr. Rivard: Research is a special case. Obviously, if you are talking about a service such as in vitro fertilization you have to protect people's health and safety. Embryo research is quite a different matter because you do not have the same health and safety concerns as when a person is undergoing a reproductive procedure. All I can say really is this: The proposed legislation, in a regulated regime, simply allows for this research to proceed in certain circumstances. If a province wants to restrict it, then a person in that province is able to comply with the provincial law without breaching the federal law. There is no conflict of law. The real issue then becomes, does the province have the constitutional authority? The provinces do not receive any authority from this bill; we just withdraw the application of our law. They still have to answer the fundamental question: Do they have the constitutional authority to regulate this kind of research?

Senator Trenholme Counsell: The Minister of Health already —

Senator Robertson: I understand that banning will be permitted in the provinces.

Mr. Rivard: I cannot answer the question of whether a province has the constitutional authority to prohibit a certain line of research. That would have to be determined within the province. I am simply saying that that kind of prohibition does not create a conflict under federal law.

The Chairman: That is the classic definitive answer one always receives from a Department of Justice lawyer.

Mr. Shugart: Senator, this bill would also not change that jurisdictional reality in any way. In other words, whatever the constitutionalists would ultimately conclude about the jurisdiction of a province to ban embryonic research — and I think Mr. Rivard is being humble in that respect — this bill would not change that jurisdictional reality in one way or the other.

The Chairman: Mr. Shugart, I wish to thank you and your colleagues for coming here this afternoon. It is my understanding that some of your colleagues are staying in case we need to call on them to clarify points that other witnesses may make.

Ms. Weber: Yes.

Ms. Manseau: Yes.

Mr. Shugart: Mr. Chairman, we are at the disposal of the committee any time that we can be useful.

The Chairman: I welcome our next panel of witnesses. With us at the table are Dr. Alan Bernstein and Dr. Barbara Beckett, from the Canadian Institutes of Health Research. We will also hear from Dr. Timothy Caulfield, at the Health Law Institute in Edmonton; and Professor Maria Knoppers, at the University of Montreal.

Dr. Bernstein and Professor Knoppers heard all of the testimony and the questions that were put to the minister and his officials. If there are any particular issues — and it seems to me there are a number related to research — that you would like to elaborate on, on the basis of the questions that are obviously of concern to members of this committee, you may want to include, ad lib, part of that in your opening statement so we get the facts on the table. Thank you very much for coming. Dr. Bernstein, over to you.

Dr. Alan Bernstein, President, Canadian Institutes of Health Research: We are pleased to be before the committee to discuss the Assisted Human Reproduction Act, Bill C-6. As you know, CIHR and Canada's health research community welcome legislation, and fully support the intent, content and spirit of the provisions of this proposed legislation.


We look forward to the passage of the bill for the much needed guidance and framework it will provide for Canadians and for Canadian researchers. I believe that the bill will establish a consistent national approach to research in both the private and public domains.


It will ensure that research is conducted in accordance with a coherent regulatory framework that respects the ethical, social and cultural values of Canadians. This bill truly provides a balanced approach and sets the right tone and direction for human stem cell research conducted here in Canada.

CIHR funding support for stem cell research has, to date, been in the areas of animal and human adult stem cells. The committee might like to know that, for over 40 years, Canada has been one of the leading countries in the world in stem cell research. Most recently, in the past six years, Canadian researchers such as Derek van der Kooy, Sam Weiss, John Dick, Keith Humphries, Andras Nagy, Janet Rossant and Freda Miller have carried out truly pioneering, groundbreaking research on stem cells in the retina, brain, blood, mouse embryos and adult skin.

As you know, stem cell research holds tremendous promise for new therapies for treatment of serious diseases, including Alzheimer's disease, Parkinson's disease, diabetes, kidney failure and heart disease, and for spinal cord injury.

Recognizing the many sensitive issues surrounding embryonic stem cell research, and the work that Parliament has been doing through Bill C-6, CIHR committed in April 2002 not to fund any new embryonic stem cell research for one year. In fact, it has now been almost two years since CIHR funded any new research involving human embryonic stem cells.

As you are aware, CIHR developed guidelines for stem cell research. They provide an ethical standard that publicly supported research must meet. The guidelines complement the goals of the proposed legislation and are, in fact, referred to in Bill C-6.

In line with those guidelines, CIHR recently established a stem cell oversight committee. Its membership was announced this past November. The committee comprises 12 outstanding individuals from across Canada and three other countries, representing a variety of fields, including ethics, law and biology.

Our mandate from Parliament requires us to ensure that publicly funded research meets the highest standard of ethical conduct. That is why CIHR originally introduced guidelines and moved forward with establishing the stem cell oversight committee. That committee's mandate is to review stem cell research applications that deal with human pluripotent stem cells and other human stem cell research for their conformity with CIHR's guidelines.

The stem cell oversight committee met for the first time last month, and during that meeting they reviewed and provided comments on 18 research applications, all of them dealing with human pluripotent stem cells. The applications reviewed came both from CIHR and other funding organizations, from the voluntary sector and from industry. I anticipate that committee will meet again in the summer of 2004.

In conclusion, I would encourage this committee to pass Bill C-6 so that Canadians and researchers alike not only have ethical guidelines, but also the legislative parameters and framework within which to work.

It is critical that the void that currently exists be addressed, and I commend members of the House and the Senate for the deep consideration and attention that they are giving to such an important issue. I will be pleased to answer any questions you may have.

Mr. Timothy Caulfield, Canada Research Chair, Health Law Institute: Thank you for this opportunity to speak to you today. I congratulate the government and senators for taking on this tremendously challenging area.

I think it is fair to say that there is a degree of consensus, that most people in Canada — most people who have looked at this issue — believe that Canadian society will benefit from a clear and appropriate regulatory framework in this area.

This bill is not perfect. Your challenge will be to decide how perfect it needs to be before it can move forward. In the brief time that I have, I would like to focus on what I continue to believe to be the most problematic component of the bill.

Many of my colleagues who are in the room — Mr. Shugart, Ms. Weber and Mr. Rivard — have heard me speak of this before. Specifically, I am talking about the continued use of legislative prohibitions, which I think are very problematic, particularly in the area of research. To do this, as I have done in the past, I will focus on what has been called therapeutic cloning, research cloning, or somatic cell nuclear transfer — a ban that I believe is tremendously hard to justify, and has not been appropriately justified by the government to date.

I recognize that I am recommending a dramatic change, and I appreciate that you may feel there are important political issues to consider that may not allow significant changes at this juncture. However, I would hope that the Senate would at least consider the possibility of making recommendations that may influence future action.

Why do I think criminal prohibitions are so problematic in this area? First of all, it is a truism that they are not flexible enough to respond to the changing nature of science in this area. We have seen this from recent events around the world.

I think that a regulatory framework needs to be able to respond quickly to both new advances and new social concerns as they emerge. Indeed, a 1982 Government of Canada report called ``Criminal Law in Canadian Society'' noted the inherent difficulty in amending criminal legislation. It stated:

The practice of a century in Canada has shown that...once an act has been made criminal, it is difficult to remove or lessen criminal penalties, even in response to changes in public attitudes, perceived inconsistencies in application, or emerging experience demonstrating that the use of criminal law might be excessive...

The second reason that I think criminal prohibitions are problematic is that they simply do not reflect the complexity and diversity of views associated with many of these technologies, and with research cloning in particular. I have done my best to become aware of all the survey research, all the qualitative research that has been done in Canada and around the world.

The Canadian government has claimed that the public wants the ban, or there is a degree of consensus about the bans in the bill; but every study that I am aware of that has been done in Canada has shown that, in fact, the public favours research cloning or somatic cell nuclear transfer — at least there is a degree of support for it. All the survey research shows between 60 and 75 per cent support for the creation of cloned human embryos for collecting stem cells.

One could argue that people do not understand what therapeutic cloning is; but even focus group work, such as that done by Grace Reid in Calgary, found almost complete support for research cloning. Even President Bush's conservative bioethics committee suggested it was premature to ban all forms of cloning, as we would need time to seek moral consensus.

The third reason, I think, is we need to reflect on the fact that criminal law is the government's biggest regulatory hammer. Criminal law should be an instrument of last resort. Again, this is a point made in the government's report, and is one that has been reiterated by the Supreme Court of Canada, which has stated that criminal bans should be an instrument of last resort, reserved for conduct which is culpable, seriously harmful and generally conceived of as deserving punishment.

I do not believe that research cloning meets many of these criteria. Indeed, the Senate committee may want to consider the fact that an absolute prohibition on therapeutic cloning may infringe section 2(b) of the Charter, the freedom of expression provision, particularly since it leaves no subtlety for balancing under section 1. Other regulatory tools could be used to achieve the government's goal in this regard. I also believe the remaining government explanations for the ban, and I will not go through them now, are not sufficient to justify it.

It should be remembered that the public has drawn a distinction between reproductive and therapeutic cloning. A study done by Ipsos Reid in 2001 found that only 33 per cent supported a complete ban on all forms of cloning; the others believed that reproductive cloning should be regulated. Given the moral ambiguity, is it really appropriate to use criminal law in this context?

Much of this story is about the moral status of the embryo, which is obviously a legitimate point of view, and the diversity of views needs to be respected. I think it is a truism that there is no consensus on the moral status and there never will be. Religions differ on this and we need to embrace, as we have in other Canadian contexts, the pluralistic nature of our society.

I would like to quote James Childress, the well-known bioethicist from the United States who was critiquing a proposed ban in the United States. He stated that an ethical public policy in our pluralistic society has to respect diverse fundamental beliefs, and yet it must not be held hostage to any single view of embryonic life.

How can the Senate committee move this forward? First, ideally — and I know that this is a dramatic move — I think we should do as they have in the U.K., California, New Jersey and many other jurisdictions around the world, that is, make research cloning a regulated, not prohibited, activity. This would simply require moving research cloning from prohibited activities to the agency. As an interim step, the Senate could recommend that therapeutic cloning remain prohibited but be under the purview of the agency.

At a minimum, I ask the Senate to reflect on the appropriateness of criminal prohibitions in this context and to take this opportunity to comment on the use of criminal prohibitions and the need for clearer justifications. At a minimum, I hope that this will inform future amendments to this important proposed legislation.

Ms. Bartha Maria Knoppers, Professor and Canada Research Chair in Law and Medicine, University of Montreal: Thirty years ago, research that I did on artificial insemination showed that it was an uncontrolled and unprohibited environment. Twenty years ago, when I finished my doctoral thesis, only guidelines were available in Canada. Ten years ago, when we published the royal commission report, certain recommendations were made for inclusion of research activities in the Criminal Code.

Today, I would like to say yes to certain research activities being in the Criminal Code, following from my colleague's comments on the effectiveness and the importance of the Criminal Code, but also on its limits. First, research should not take place without donor consent. Second, maintaining embryos outside of the body, i.e., in vitro, should not go over 14 days. I would say no to reproductive cloning, no to commercial surrogacy and no to the creation of hybrids.

However, I have two substantive recommendations to make, like my colleague, Tim Caulfield, but with a few preliminary points.

Leaving aside research activities for the moment, we must be conscious of the fact that we are placing a large part of ordinary medical treatment of infertile couples, Canadian citizens, under the ``taint'' criminal activities.

Also, we are approving a bill that only exacerbates the inequity of access of infertile couples across Canada, depending on their income, to the treatment of infertility. I beg to remind you that neither abortion nor sterilization are so limited.

Third, the requirement of obligatory counselling is, I think, an infringement of the privacy and autonomy of Canadians, and also might not withstand constitutional challenge.

Finally — and I made this plea before of the House of Commons committee — when referring to human dignity in a text, human rights lawyers would beg to remind us that human dignity is a source of human rights and should not be located among environment, safety, health and so on.

What are the two substantive changes that I think the Senate should seriously reflect upon? First, I totally agree with my colleague Tim Caulfield concerning his contention that therapeutic cloning should be, at a maximum, a controlled activity. You will also find the figures he cited in the preparatory materials that Dr. Ron Worton will give you tomorrow. These are public figures. These are Canadians speaking democratically, and Canadians are able to distinguish between reproductive cloning with the aim of creating an identical human being and creating embryos under very strictly controlled circumstances for therapeutic purposes.

At the time the CIHR guidelines were written, due to all the wonderful publications from our great researchers across Canada, we thought that plasticity would allow us to move forward with therapies based on stem cells from adults. That has proven not to be the case and Dr. Worton will speak to you on that tomorrow.

Also, if you ask adult stem cell researchers where their therapies will be in five years, they will tell you that before they even use them in a safe way they need to go back to the embryo to understand differentiation. At what point does a cell decide to be skin, hair and so on? Therefore, in any event, we will have to go back to the embryo before these therapies will be safe.

Finally, on this first recommendation, to leave therapeutic cloning as a controlled activity, I am very involved in international tracking. As Professor Caulfield mentioned, California, New Jersey, Shanghai, Israel, the United Kingdom, Belgium — and who knows who else next month — have decided to review this on a case-by-case basis under very controlled circumstances with scientific and ethical review, and I think that is the right route for therapeutic cloning in Canada.

My second substantive recommendation is on a subject that no one has brought up and that has been given none of the attention that therapeutic cloning has. Paragraph 5(1)(f) of Bill C-6 says you cannot alter the genome of a cell of a human being or in vitro embryo such that the alteration is capable of being transmitted to descendants. This is what they call germ line alteration or germ line therapy.

Do we really want to prohibit this in the Criminal Code? There have been discussions since 1990 on whether we seriously want to have a universal criminal prohibition.

If we are really honest, are we not already, with prenatal diagnosis, and now with pre-implantation diagnosis, preventing the transmission of deleterious genes to next generations? Are we not already doing indirectly what this bill would have us prohibit directly forever? I know there is a three-year review but, as Professor Caulfield says, in France they had a three-year review after the bioethics bill and seven years later they still have not been able to adopt any changes.

In closing, I agree with Minister Pettigrew that we cannot let the status quo continue. However, we should legislate against misuse, not against technologies that we do not yet understand and which one day we may need for the benefit of the health of future generations.

The Chairman: Thank you, Professor Knoppers. Before turning to Senator Morin and then Senator Keon, I would like to ask you and Professor Caulfield if you can help the members of the committee with a practical dilemma that we face. The reality is that any amendment to this bill would send it back to the House of Commons and therefore, in all likelihood, it would kill the bill and force it back to square one in a future Parliament. On the other hand, there are a number of elements of this bill that a number of us find distasteful. We might disagree substantially on which elements each of us finds distasteful, but those elements clearly exist.

You both commented on the criminalization of some of these activities, and that is one of the elements. In all my years in Ottawa, I have never seen such a paternalistic bill as this. It is in many ways offensive and the earlier responses of officials reinforced that this paternalistic view is deeply entrenched in the bureaucracy.

The question is, do we take the bill, and in trying to make it better, thereby kill it, or do we recognize that, however flawed we may view it to be, it begins to give some legal, regulatory and legislative framework to an area of research and science that is otherwise completely unregulated? That is the practical dilemma that each of us around the table will ultimately have to wrestle with within ourselves. I wonder if the two of you could give us your advice as to what you would do, faced with that dilemma. Professor Caulfield?

Mr. Caulfield: I was hoping that you would start with Professor Knoppers so I could reflect further.

The Chairman: I could see you were struggling, and I did not want to give you time to get off the hook.

Mr. Caulfield: I can honestly say that this is a dilemma I have struggled with for the last eight months. When do you support a law that is really flawed because the whole package is needed? That is why I chickened out and gave you three ways forward. One is to amend the bill.

My optimistic vision is that the law goes forward and the agency becomes an informed decision-making body. To some degree, that is what has happened with HFEA in the U.K. When I have my optimistic hat on, I feel that we so desperately need a regulatory framework that we should go for it even with these flaws, with the hope that commentary from your committee and other committees, and with the agency up and running and becoming an informed decision- maker, it will allow informed amendments to occur.

However, as you are probably more aware than I, given the lack of momentum around some of these changes, when I have my pessimistic hat on, I think it might be better to let it die and then try to resurrect it, but I am afraid that will never happen. Without a regulatory framework, as Dr. Bernstein pointed out, Canadian scientists are left with a degree of uncertainty that makes them very skittish.

How is that for skating around the issue?

The Chairman: Having given the classic lawyer ``on the one hand and on the other hand'' answer, I take it that, without saying it, you lean towards saying it is better to have a slightly or somewhat flawed regulatory framework than to have nothing at all?

Mr. Caulfield: I would lean that way. I do not want to put words in my colleague's mouth, but I think my colleague leans the other way, so we balance each other nicely.

Ms. Knoppers: I would not want to see a flawed bill adopted as representing how Canadians look at these technologies. It is true that we have been at this for over a decade in terms of debate, and maybe that is the way in this country that lawmaking or regulation goes forward. You said it was completely unregulated, and I do not agree. I do not think it is unregulated. We have laws in all the provinces that safeguard the children born by these methods. We have professional guidelines, as you will see from the Canadian Medical Association and andrology and fertility societies and so on. We have the CIHR guidelines, which if they are truly guidelines should be subject to constant revision and review. My ideal would be for this flawed bill to die, but I am, however, as I said in my opening statement, in favour of putting in the Criminal Code, very simply, one article concerning certain prohibited activities that I think all Canadians could agree on, and then creating an interprovincial agency for safety and other issues.

Senator Morin: Dr. Knoppers, it is interesting that when you appeared before the House committee, you said, ``I know that it is time to act. I am not against the bill.'' Your preliminary statements all pointed towards you being opposed to certain elements, but you said that it is time to act and that you were not against the bill. I agree with what you said before the House, not what you are saying now. It is unfortunate that Senator Roche did not hear your preliminary remarks.

As you probably have heard, Professor Knoppers, some people are opposed to all research on embryos. They are vehemently opposed to embryonic stem cell research. They feel strongly about this. They believe we are going too far. Obviously you think we are not going far enough.

I understand the therapeutic cloning. I have a list of countries that have legislation. It is interesting to see that South Korea, where this was done, has no legislation at all. The immense majority of countries who have passed legislation recently do ban both reproductive and therapeutic cloning. The U.K. is in a special situation, because they are 10 years ahead of us. They passed an act in 1990, and for those who feel it is not possible to amend such an act, they did amend it and introduced a change in the law to permit therapeutic cloning.

For me, research is important, but most important in this bill, by far, is the protection of children born out of these procedures and the protection of women who use these services. Believe me, and we will be hearing more about this, there is an extremely serious void in this country. It is not true to say that provinces are regulating this. These clinics are freestanding. They are not within hospitals. There is no oversight. Unlike other countries, we have no results on what these clinics are doing. I think it is urgent to act on this. I am extremely disturbed by those who feel that we can go another 10 years without this. One purpose, therapeutic cloning, which just started a week ago, was very limited in scope. It was with the mother's nucleus, a gender issue.

We realize that in three years, this bill will be reviewed completely by Parliament. It may well be that we should start working now on the issue of therapeutic cloning, but not say that we will kill the bill and have a legal void. I am actually surprised at all these prohibitions. I am not sure whether you feel that with certain prohibitions, like the production of hybrids, chimeras and so forth, introducing embryos into animals and so forth, we would not legislate for another 10 years. I think this is an extremely important issue, and for one specific point, which is not a great scientific need for the present, which is the matter of cloning.

I feel very strongly about this. We are not alone. We are not the only country. Only the U.K., as a country, has acted on this, and as I said, they had a 10-year advance on everybody, and we may well do it in three years. I think to throw the bill away right now is irresponsible.

Ms. Knoppers: I do not change my mind by saying that I am not against the bill. I am not against legislating in Canada. I am not against the prohibitions found in article 5, including hybrids and so on, except for the one on therapeutic cloning. No, I am not basing my position today only on the potential that this research technique may have.

There are many other elements in what I was told should be a five-minute presentation that, in the bill, represent overreach in terms of not having a registry, which we should have for all activities on health — outcomes and what is safe and what is not; how many children are born with what condition, whether they are created through infertility treatments or others. We should have better registries on the births of all children, the reasons for malformations or the reasons for multiple births, and so on.

We are singling out particular individuals and couples who have medical conditions for a type of intrusion into their private lives, with potential donors calling in and children trying to find parents, and so on. Couples will probably never tell their children how they were conceived simply because of this possibility of mutual consent and so on in the future. There are so many other aspects of this bill.

Nevertheless, I would argue in favour of certain criminal prohibitions, and I certainly argue in favour of an interprovincial agency for the protection of the health of children and women involved in any kind of hazardous activities. I certainly am not arguing against that. Maybe it is because I am in law and I know how people see the criminal law, feel about the criminal law and are scared of the criminal law that I think we should put all of it together in one package, when we really could split it into two distinct activities.

Dr. Bernstein: It is rare that I disagree with my colleagues who are on the screen behind me, and I do that with some trepidation.

The Chairman: Remember they are behind you.

Dr. Bernstein: You will realize that I have thought long and hard about this and have followed the pace of this bill through Parliament since the CIHR's guidelines were first brought down more than two years ago. I share Senator Morin's concerns. I am only commenting, again, on the research aspects of this bill.

I believe it is better to have a bill that perhaps is less than perfect, although it is pretty close to perfect from a research perspective. It raises the general issue of whether one should build into law a rapidly changing area of science. It is very important for Parliament and the Senate to revisit the bill in three or four years. Who knows what the world will look like at that time? It is also important though to have a framework in place as soon as possible for research in both the public and private sectors. That trumps the issues raised by my colleagues.

Mr. Caulfield: First, Dr. Bernstein, I do not think that we actually do disagree. The point that Senator Morin made actually very much rings true with me, and it is why I have struggled with my position so greatly over eight months. Indeed, I agree with him that we are 10 years behind HEFA, and that is why I am hopeful that if this bill goes through, the agency will act not unlike HEFA and become this learned engine of change that will also be a focal point for public engagement, which is also important.

Senator Morin, it is important to note that this issue of therapeutic cloning is perhaps not as narrow as you suggest. For me also, the broader question is how we in Canada make science policy, how we in Canada will make policy in areas where there is a great degree of moral ambiguity. For me, therapeutic cloning — I agree with you — is a narrow issue, although its benefit is becoming not just the Korean experience, but other basic research is showing its benefit may be real.

For me it is a symbolic issue that demonstrates the difficulty of making laws in morally ambiguous areas. It is not so much, for me, this one issue but how can we move forward on all fronts? I just use it as an example, but you can tell the same story for many of the other prohibitions. This, as pointed out by Senator Kirby, is why I fall on the side of letting the law go forward.

We have also forgotten the core. The core is about reproductive technologies, not necessarily about stem cell research and therapeutic cloning.

Senator Keon: I will not repeat what Senator Morin said about the protection of women and children because there is universal agreement about that. I do not know anyone who disagrees with that aspect of the proposed legislation and the need for us to get on with that.

As for the outcomes in the other areas that you were talking about, some of your colleagues feel strongly that if the prohibitions continue you will fall very far behind your colleagues in Britain and in some other areas.

Therefore the conundrum here is, from the point of view of the scientist, if the proposed legislation does go through without amendment, how far does it set you back? The flip side is if the bill dies, what freedom does this give you to continue, considering the guidelines of CIHR and the influence that CIHR and the university ethics committees will bring into your labs? If this bill dies, what freedom will you have to uncover the scientific knowledge that is necessary to come up with intelligent regulation?

Dr. Bernstein: That is a two-part question, Senator Keon. In terms of the first part, remember that the bill allows Canadian researchers, under certain conditions, to go forward with human embryonic stem cell research. What it does not allow is reproductive or therapeutic cloning. It certainly allows that research to go forward. We have had that one paper from Korea. We do not know yet really where this line of investigation will go and what the ultimate promise will be of those kinds of cells for potentially curing human diseases of the kinds I mentioned in my introductory comments.

I am comfortable with the balance the bill has struck and that is in our guidelines. There is one point that has not yet been made, and I would like to make it here, and Mr. Caulfield alluded to it in his mention of HFEA, the Human Fertilization and Embryology Authority in the United Kingdom. It is very important that we not lose the trust and confidence of the Canadian people as we go forward. If we lose that in this area of science, there will be a backlash and we will move backward, not forward. To err at the moment on the side of being conservative is not a mistake. I believe it is wise.

That is probably true, and, Professor Caulfield, I will generalize like you, in any area of science. That would be my first comment.

The second comment about if this bill were to die — and again, I want to stress that it is very important it go forward — is that CIHR's guidelines are in place. They relate only to stem cell research. They do not relate at all to the issues that both you and Senator Morin have been stressing — about artificial human reproduction itself, in vitro fertilization and the need of women and children in this country and couples in this country for a legislative framework. Our guidelines only refer to research, in the first instance, in the public sector. Obviously we have no purview within the private sector.

Senator Keon: May I ask Dr. Bernstein to expand on that a little? In America the private sector is a problem. In other words, they can move outside the NIH granting system and do fundamentally what they like in their private labs, but we really do not have that situation in Canada, do we?

Dr. Bernstein: At the moment we have no legislation. All we have are the CIHR's guidelines. Our guidelines have what we call a ``reach through provision.'' If a private company wanted to fund research in a university or hospital in this country, CIHR's guidelines would apply. However, if a private company set up their own lab and wanted to do this sort of research, including reproduction cloning, there is no law, nor do CIHR's guidelines apply. There would be nothing stopping them.

Senator Keon: In all objectivity, that is not anywhere on the radar screen right now in Canada, is it, compared to America?

Dr. Bernstein: I am not sure quite what you are getting at. Certainly there are stem cell companies that are being discussed, that want to set up in Canada, in part because of the legislative framework that is being contemplated, so that they know they are working within the law. That would be an important boon to Canada, not a reason to bring down this law. It provides a clear framework for the private sector, which is not true in the United States, as you pointed out.

Senator Keon: Would you both deal with the two sides of the issue that I gave you?

Ms. Knoppers: I am a social scientist, not a scientist. As to offshore companies and the possibility that failure to enact this law will lead to a sort of haven for procreative tourism or adventures or commercialization in Canada, I do not have such a mistrust and fear of the Canadian environment as being conducive to a wild-west heyday of activities that we would have prohibited in its absence.

I have every confidence in our current regulatory system, which goes well beyond the CIHR guidelines — which are limited to stem cells — our Tri-Council Ethics guidelines, our guidelines from the different professional associations, the different laws governing medical practice or research in the different provinces, the health information acts, and so on. We are not in a legal void.

We may be with respect to those certain activities that I mentioned under article 5, with which I am in agreement. Because I live in Quebec, people keep asking me about the Raelians. Even the courageous lawyer who went after the Raelians in Florida did so under youth protection legislation, saying that this child would be born into a situation where there would be a danger to his or her health and well-being.

I would like to emphasize, as a law professor, that there is not a legal void in Canada. We do, however, need precision and oversight, and I think we have other instruments in Canada for that.

Senator Keon: Mr. Caulfield, will you address the scientific issue of the freedom you have, with or without this law, to ferret out the information that would make intelligent regulation possible.

Mr. Caulfield: Let us look at the situation where there would be no law. In other words, are you asking the following question: If there is no law here, would this allow our researchers to have more freedom than in other jurisdictions?

Senator Keon: Right.

Mr. Caulfield: I am aware, and I am sure Dr. Bernstein is also aware, of Canadian researchers who would like to do therapeutic cloning, particularly here at the University of Alberta, where they are doing a lot of diabetes research and are interested in exploring the use of therapeutic cloning in the hopes of creating pancreatic eyelets to help cure diabetes. That would be a long way away, but the interest is there. We have to recognize that if this law passes, that avenue of research will shut down.

Having said that, my experience — and I bet Dr. Bernstein will back this up — is that if you speak to most stem cell researchers in Canada, what they want now is a degree of certainty and comfort. Rightly or not, the law does give them that.

Ms. Knoppers also made an important point: The area is not completely unregulated. There are professional codes, et cetera, that are relevant here, but the law would give the community a little more certainty.

I do want to raise one practical issue that touches on what you raised. With respect to therapeutic cloning, one of the uses in the near future, perhaps, of therapeutic or research cloning is the creation of disease models, for example, a cell line with a disease model. If you wanted to study someone who had a certain kind of cancer, or Alzheimer's, you could create a cell line that had that person's Alzheimer's or cancer, which would be a very valuable research tool. That is a possibility in the near future. That cell line would certainly be patented in the United States. There is nothing prohibiting it from being patented in Canada.

Could Canadian researchers use that model, those cells, to do research in Canada? Could those cells be patented in Canada?

Again, in response to Senator Morin, we need to be very clear, in a democratic society, about why we want criminal prohibitions and be prepared to face these kinds of inevitabilities.

Senator Roche: When I came in, I heard Ms. Knoppers saying that it was better to let the bill die. Senator Morin reminded me that I had missed her opening comment. I would like the committee, as well as Ms. Knoppers, to know that I am very sensitive to the argument that Senator Morin has introduced, namely, that it is urgent to get on with this. However, I am apprehensive about this, and Dr. Morin referred to the U.K., where 40,000 embryos were killed, as being the leading country in this area. That is 40,000 human beings. I am not prepared to go along with the United Kingdom as the arbiter in this situation.

I would like to begin my questioning, first, of Ms. Knoppers, but I would also like to ask Dr. Bernstein to reply to my question.

Ms. Knoppers, could you elaborate on your statement that it is better to let the bill die? We all recognize the consequences of the bill dying. We do not want to have therapeutic cloning in this country. However, if we let the bill die, would that shake up the government to bring in a bill immediately on therapeutic cloning, which I am confident would pass quickly and give us more time to study the effects of embryonic stem cell research?

I think, Ms. Knoppers, you were present for the earlier part of this meeting when the officials were here. They do not even have regulations on this. Yet we are being asked to pass a bill that has a positive aspect in preventing therapeutic cloning, but from my point of view, a negative aspect in allowing for stem cell research on embryos.

I would have to say to you, Mr. Chairman — and this is my final comment before I go to Ms. Knoppers — that in my six years in the Senate, I consider this to be possibly the most difficult decision I have had to make. I do not consider myself to be one person who will decide the law, although we had a vote the other day that was 32 to 31.

The Chairman: May I remind you that when the abortion bill was killed, it was killed on a tie vote.

Senator Roche: Therefore, it could be, honourable senators, that every vote is important. I take my responsibility seriously, Mr. Chairman.

The Chairman: Absolutely.

Senator Roche: I am not saying I am right. I am not certain I am right, but I am agonizing about this. I do not want to make any extended comment on that aspect.

I would like to ask Ms. Knoppers if she will, considering her considerable reputation in this country, which I respect, elaborate on her statement that it is better to let the bill die. I will then hear from Dr. Bernstein.

Ms. Knoppers: Senator Roche, I apologize for speaking in English but we are on one line with my colleague, Mr. Caulfield. I was responding to a question by Senator Kirby, which he introduced by sharing his point of view that this was a very paternalistic approach to a difficult question. I want this flawed bill to die. I am not against criminal legislation for certain research activities or commercial surrogacy. I am all for a statutory approach to creating an interprovincial agency to protect the health and welfare of couples and children involved in reproductive technologies. Like my colleague, Mr. Caulfield, I am against using a criminal weapon — the area of law that is so heavy with symbolic overtones. Criminal law is supposed to be confined to morally reprehensible activities. I am sorry, but people seeking infertility treatment are not engaging in a morally reprehensible activity. I would like to distinguish between a need for a regulatory agency for health and welfare and the protection of children, and criminal activities that all Canadians can agree on, such as reproductive human cloning and others that should be prohibited. We can respect the privacy and autonomy of couples that are, nevertheless, subject to provincial legislation and professional guidelines; have a regulatory agency for safety and protection; and have Criminal Code provisions to deal with values that all Canadians share.

Dr. Bernstein: The first comment I would make, Senator Roche, is that I do not envy senators in having to face this difficult decision — it is so important.

Senator Roche: These decisions go with the territory.

Dr. Bernstein: It is a tough one. I will comment only on the research aspects of the bill. CIHR's working group developed guidelines on stem cell research. They met three years ago to try to strike a balance, in a legislative void, between the ethical issues around human embryonic stem cell research, given the source of these cells, and the potential of those cells to cure serious diseases.

Senator Roche: Doctor, there is the potential of adult stem cells to cure serious diseases, and there is the potential of embryonic stem cells to cure serious diseases. Why are we insisting on embryonic stem cells when the research that I have seen shows that adult stem cells do the job?

Dr. Bernstein: This is an active area of research. About two years ago there was a claim about plasticity, or the ability of adult stem cells to give rise to many different kinds of cell types in the body. Without getting into the technical aspects, there are now reinterpretations of data in that area that would question the validity of those conclusions. Most people today working with even adult stem cells would agree that we need to understand that first, embryonic stem cells hold much more promise than adult stem cells of giving rise to all the cell types that we would like to eventually generate. After all, an embryo makes a human being at the end of the day.

Second, this goes back to a point that Ms. Knoppers made. If we are to be able to manipulate these cells to do what we want, we need to understand the biological process of development or differentiation. Again, that is where human embryonic stem cells come in. I will not say in front of this committee what will be the best source of cells five years from now; I think that would be foolish. At the end of the day, it may be adult cells under certain conditions. However, I can certainly say that as of today, embryonic stem cells hold the greatest promise.

Senator Roche: Perhaps, Mr. Chairman, I should ask my fellow Edmontonian, Mr. Caulfield. I do not want to exclude him from this question. Mr. Caulfield, is it your view that it is better not to let the bill die but to proceed? Could you elaborate for a moment on your view?

Mr. Caulfield: Briefly, you are right. I fall on that side of the debate by a very slim margin, for many of the reasons that Senator Morin pointed out, including that the central goals of the bill are the protection of children and of women. If we were to lose that framework, I would worry that we would not get it up and running again in the near future.

However, I will take this opportunity to ask senators to please consider my third option: to ask for clarification of the use of criminal prohibitions in this context, their appropriateness, and the need for appropriate justifications. If we were to ask Canadians whether therapeutic cloning should be banned, I am not so sure that is the answer we would hear. All the evidence we have indicates that Canadians support therapeutic cloning.

Senator Roche: My question is for Dr. Bernstein. I do not think that Canadians do support therapeutic cloning. That is the one issue we could get through pretty quickly, but I will leave that for the moment.

Dr. Bernstein, you said, when responding to the question about letting the bill die, that we had good guidelines in place. That is the issue for me, because we do not have guidelines in place. I have been trying all afternoon to get the government to move their guidelines into the form of regulations, or at least advance papers. What do you have to say on that issue to alleviate the deep concern of senators about voting on third reading for Bill C-6 without the knowledge of what those guidelines will be?

Dr. Bernstein: I will not comment on the issue of what the guidelines will be. I know you have been concerned about the uncertainty this afternoon. However, on balance, it is important to have a legislative framework for both assisted human reproduction and for stem cell research. Without that, we do not have a way of regulating the clinical and research activities. Our guidelines do not pertain to the private sector. CIHR is not a legislative body. I think the country, certainly the scientific community, is looking for a legislative framework to go forward.

Senator Trenholme Counsell: I may have made a mistake, but I wrote down, Dr. Bernstein, that this law would provide a clear framework for private sector cloning research. Did you say that?

Dr. Bernstein: I said that it was for private stem cell research. If I said cloning, I meant to say stem cell research.

Senator Trenholme Counsell: Okay. You gave the impression that this would not necessarily outlaw or prevent human cloning research done by private companies. Would it not?

Dr. Bernstein: I was referring to CIHR's guidelines, which, obviously, do not pertain to the private sector.

Senator Trenholme Counsell: This proposed legislation would, would it not?

Dr. Bernstein: Yes, absolutely, it would.

The Chairman: Ms. Knoppers, could you expand on one point that you made in your opening statement? You made the observation that the impact, of making reproductive technology less available to lower-income couples, would thereby skew the availability of the technology in favour of upper-income couples. Would you expand on why and how you reached that conclusion?

Ms. Knoppers: First, that is currently the situation, as you know. It is a patchwork of possibilities across the country. Most provinces will cover the actual diagnosis of infertility, but thereafter it is up to the patient to find the financial resources to pay for treatments, if and where available.

That means not all Canadian women and couples can afford to have the treatment that will allow them to have children.

This bill does not speak to the issue of whether infertility treatment is a medically necessary activity under the Canada Health Act. Putting everything else under the federal umbrella, via the Criminal Code, and yet ensuring safety through the regulatory agency, which I am not against, does not speak to the issue of inequitable access.

The Chairman: I absolutely agree with you that the current access is inequitable, but I thought you were implying this would make it more inequitable. What you are really saying is it does not make it more inequitable, but neither does it make it less inequitable; it just does not deal with it.

Ms. Knoppers: It exacerbates the current situation by having everything else — counselling and everything — paid for, but not the actual treatment.

The Chairman: Thank you very much to all three of you for coming. We appreciate you taking the time to be with us. While we switch to our next panel, I will ask my assistant to distribute to you an article that I wrote for The Globe and Mail back in December. I do so because three or four of you today raised the question with me, in light of Svend Robinson's outrageous statement in the House of Commons. The same issue came up back in December, raised by different people from the left — Shirley Douglas, Roy Romanow and others — and The Globe and Mail asked me to write a column in response, which I did. I distribute it to you now so that you understand why their position is unbelievably outrageous.

Senator Roche: Would you consider going in camera for five minutes following the testimony on this subject?

The Chairman: Which subject?

Senator Roche: The Svend Robinson issue.

The Chairman: I would be glad to, at the end.

Our next panel consists of Dr. Calvin Green, the Chair of the Government Relations Committee of the Canadian Fertility and Andrology Society; Beverly Hanck, the Executive Director of the Infertility Awareness Association of Canada; Dr. Eugene Bereza, the Chair of the Committee on Ethics of the Canadian Medical Association; and Dr. Arthur Leader, who is a member of the Society of Obstetricians and Gynaecologists of Canada.

Dr. Calvin Green, Chair, Government Relations Committee, Canadian Fertility and Andrology Society: Honourable senators, first of all, I would like to express my gratitude at being asked to speak in front of the standing committee on this important issue. I am a clinical professor of obstetrics and gynaecology at the University of Calgary. I am also the medical director of the Regional Fertility Program, which is an IVF clinic, and one of the busiest in the country.

I am here today speaking on behalf of the Canadian Fertility and Andrology Society, which I will call the CFAS, with your permission. CFAS is a voluntary association of more than 500 physicians, scientists and allied health professionals. Each year, our members deal with thousands of treatment cycles to assist many of the one in six or one in eight couples in Canada who have difficulty in conceiving.

We do understand the government's desire to legislate the emotionally and technically complex issues surrounding assisted reproduction procedures. CFAS has been involved throughout the long process of creating the present bill and is supportive of the majority of the provisions of Bill C-6. However, we have some serious reservations.

I come here today to ask the members of this chamber of sober second thought to consider the following questions. Does Bill C-6, as it stands, achieve its stated objectives, that is, to protect the health and safety of the people of Canada who turn to assisted reproductive technology to help them build their families? Or do certain provisions in the bill, as it is presently written, run contrary to these objectives and therefore require amendment? The position of CFAS is that there are provisions that do run contrary to these objectives.

Our objections to the bill centre around three major issues, and I will go through them in turn. The first one is that of access, the second of privacy, and the third the prohibition of legitimate medical research.

Regarding access, for Canadians struggling with fertility issues, this bill will limit access to treatment. Clause 7 prohibits donors of gametes from being compensated for their donation, except for expenses for which they have receipts. If this provision is allowed to stand, the present system of egg and sperm donation that has been in place for decades, and has produced thousands of offspring, will be prohibited.

The present system operates under the principle of reasonable donor compensation for time and inconvenience. Reasonable compensation is not the same as commercialization or commoditization. The royal commission agreed with this principle as it applied to the sperm donors and did not regard the stipend that we pay them as either commoditization or commercialization.

If the present system of gamete donation is prohibited and an alternate method will have to be provided somehow, who will set that up? Who will pay for it and who will administer the program? There is no indication in the bill how that will happen.

Even with our present system of limited compensation, we cannot recruit enough gamete donors. In fact, it is estimated that 80 per cent of the donor sperm that Canadian fertility clinics use at the present time comes from the United States. Attempting to implement an altruistic system, however noble a concept that is, will further exacerbate the present shortage of donor gametes. You will hear passionate testimony from witnesses in the days to come in your hearings, and from the patients who have gone through these struggles.

If we are not able to provide donor gametes in Canada, our patients will have to go somewhere else. There is even talk of American clinics setting up just over the border to receive our Canadian patients.

Even more Canadians who require donor eggs and sperm to have children will be forced to travel abroad. We would call that ``reproductive tourism,'' and it limits access to the more wealthy in our society who have the wherewithal to make those journeys.

Alternately, others may decide to use donor sperm from questionable sources. These sources of sperm will not be screened in an appropriate fashion and there is risk of transmission of infectious diseases. That would put women and children at risk.

We therefore urge the Senate to amend the bill to not prohibit modest compensation outright, but rather to regulate the practice to ensure safeguards are built into the system to prevent commercialization. If you do not change the bill to reflect these principles, there are couples that will not become parents, and there are children who will not be born.

Even more problematic with regard to access to medical treatment for Canadians struggling with infertility is the failure of provincial health care plans to fund fertility treatments. Canada is one of the few countries with universal health coverage that abandons its infertile citizens when it comes to fertility treatments. We presently have a two-tier system, consisting of those who can pay and those who cannot.

The royal commission stated in its report: ``A caring society should provide reproductive health services through the health care system.'' We therefore urge the Senate to put forth an amendment to the effect that fertility treatments be designated as medically necessary under the Canada Health Act, and, therefore, funded by provincial health care plans. Surely, as a fair and just society, this is an amendment that everybody can agree on.

The next point I would like to address is that of privacy.

The act, as written in clause 17, requires the assisted human reproduction agency to, and I quote, ``maintain a personal health information registry containing health reporting information about donors of human reproductive material and in vitro embryos, persons who undergo assisted reproductive procedures and persons conceived by means of those procedures.''

The infertile couples from whom I sit across the table every day do not want their private medical records sent to Ottawa. Their anguish would only be compounded by the state's unnecessary intrusion into their reproductive lives. Our patients do not want a state registry, and we have heard some legal opinions today that there may even be challenges through the Charter. We therefore urge that clause 17 be amended to limit federal registration to recipients of egg, sperm and embryos and to remove the requirement for infertile couples seeking fertility treatments, and their children, to register with the government.

I will speak next on prohibition of legitimate research, on which we have already heard quite a lot today. In my position, I talk with couples who are struggling with infertility. I am also a scientist, and I am trying to wear both of those hats. There has been discussion today about somatic cell nuclear transfer, another name for therapeutic cloning, which is prohibited under Bill C-6. This technique, in combination with stem cell science, has the potential to be one of the greatest medical advances of our time, albeit it will not be here any time soon.

It was reported last week in the prestigious journal Science that scientists not only successfully performed this technique but also produced a stem cell line. This is the essential first step in finding cures for diseases that affect our families, such as Parkinson's disease, muscular dystrophy, diabetes and countless others. It is the goal of this type of research to find such cures. Will we tie the hands of our researchers, who have historically taken the leading role in this work, and deny Canadians the benefits of this type of research? Faced with the inability to conduct this research in Canada, more scientists than have already left will leave and go to more progressive places that have different research regulations, such as the United Kingdom.

While CFAS deplores reproductive cloning, we urge the Senate to amend clause 5 to allow for somatic cell nuclear transfer and to move it from a prohibited activity to a controlled activity.

CFAS agrees with the good intentions of Bill C-6. However, as presently drafted, this bill does more harm than good. CFAS wants to partner with the government to improve this proposed legislation to benefit all Canadians, and we have been working with the government since 1995.

Without amendments, this bill runs contrary to Canadian values by further limiting access to fertility treatments, unnecessarily intruding into the private lives of infertile patients and prohibiting legitimate medical research that has potential benefit for all Canadians.

Fertility treatments should be funded under the umbrella of the provincial health care system, so that everyone, irrespective of wealth, can access them.

We strongly urge the Senate to amend the bill to improve the health and welfare of all Canadians so that we can indeed protect the health and safety of the people of Canada who turn to assisted reproductive technologies to help build their families.

Dr. Eugene Bereza, Chair, Committee on Ethics, Canadian Medical Association: I am a physician and clinical ethicist at McGill University Health Centre in Montreal and Chair of the Committee on Ethics of the Canadian Medical Association. I am accompanied today by Dr. Jeff Blackmer, Director of Ethics.

I am here today representing the CMA, but I would like to advocate on behalf of not only doctors, but also patients affected by infertility and those patients who are suffering or will suffer from the myriad diseases for which medical science is searching for a cure.

While there has been considerable debate over the past decade on the moral and ethical issues associated with assisted human reproduction, discussion about this as a health issue has been overlooked. We must remember that this is about the practice of medicine and, above all, the health of Canadians. My remarks today will focus on the inappropriateness of using criminal sanctions to deal with medical and scientific activities. It is important to make clear at the outset that the CMA does not oppose the prohibition of certain medical and scientific activities. Others here today are in a better position to address the specific concerns regarding specific prohibitions in the law. Our issue is the means chosen to give effect to these prohibitions and their potential impact on the ability of a physician to ensure the welfare of his or her patient. That is where we are coming from.

Criminal law, as you heard, is a blunt instrument. As parliamentarians, you know how difficult it can be to change that law. For some activities prohibited under the criminal law, such as murder and theft, change is not an issue. However, the science of medicine evolves constantly, by some estimates doubling every 18 to 24 months.

I chair a research ethics board at the Montreal Neurological Institute, and some scientists there tell me that we have learned more about the human brain in the last four years than in all of previous human history.

Advances in science and medical practice, coupled with the difficulty of anticipating new developments, make it difficult to adjust the law to remove criminal prohibitions in science as society changes.

In the context of prohibiting medical and scientific activities, it is the position of the Canadian Medical Association that the use of the criminal law is inappropriate because it would ultimately not serve the best interests of our patients.

Prohibitions, specifically those listed, could still be secured through much less drastic means than criminalization. The CMA proposes that a determination of permissible activities, temporarily or for the longer term, should be made by the proposed regulatory agency working with up-to-date scientific information while providing for public input and ethical review.

Bill C-6 begins with the statement:

This enactment prohibits assisted reproduction procedures that are considered to be ethically unacceptable.

However, many Canadians, especially those who are infertile, do not consider some of these procedures to be ethically unacceptable and nor do many of the physicians charged with their care. The CMA questions whether criminal prohibitions are appropriate for dealing with activities about which there is considerable ethical disagreement among Canadians.

Legislators in Canada have been justifiably reluctant in the past to use the criminal law to deal with medical and scientific issues such as abortion, withdrawal of life-sustaining treatment and the conduct of medical research. Why is an exception being made for assisted reproduction? What sort of precedent will this set for other controversial bioethical issues, especially in the realm of patient care? What about the chilling effect criminalization will have on research in this important area?

For the Canadian Medical Association, the most important question is: What about the patients? I refer not only to our current patients but also to the future generation of patients with whom we will be dealing. Tomorrow's care is based on today's research, as you well know.

What about patients suffering from conditions for which research is banned but may lead to a cure? Should they be denied the opportunity to benefit from this research?

Just as Bill C-6 unfairly targets patients, we feel the bill's penalties for infractions unfairly target physicians and medical researchers. Jail terms of up to 10 years and fines of half a million dollars will create a climate of fear and excessive caution for physicians and scientists working in this area. The chill created by these penalties will be such that scientists may well avoid any activity potentially covered by this bill, even to the detriment of patient care. That is what we fear.

The CMA recognizes the good faith among parliamentarians in proposing statutory bans to prohibit certain activities; however, we are convinced that, in this case, the potential harm outweighs potential benefits. We believe there is a better way to prohibit these activities, while at the same time facilitating important research and necessary treatments. You can have it both ways.

Instead of institutionalizing criminal prohibitions within the bill, the Canadian Medical Association suggests that the assisted human reproductive agency of Canada manage procedures deemed permissible by moving the procedures listed under the prohibited activities to the controlled activities. We recommend that criminal sanctions apply to breaches of agency directives, such as performing activities prohibited by the agency, and performing controlled activities without a licence. Such an approach would have the dual advantage of being able to prohibit those activities deemed unethical while still providing the flexibility to ensure legitimate medical and scientific progress in the treatment of infertility.

In conclusion, our overriding concern in addressing this bill is the well-being of patients — in this case, patients who are infertile and patients afflicted by conditions for which medical research offers significant promise of treatment. We support government efforts to regulate assisted human reproduction activities, including the prohibition of certain practices, either temporarily, or permanently when necessary. However, we do not believe that criminalization of the medical and scientific activities named in the bill is an appropriate way to achieve these objectives. We believe that we have advanced a workable alternative within the spirit of the bill.

Dr. Arthur Leader, Member, Society of Obstetricians and Gynaecologists of Canada: The Society of Obstetricians and Gynaecologists of Canada appreciates the opportunity to provide comments. We commend the government on Bill C-6 and respectfully ask that the bill be reported by this committee without amendment.

The bill addresses complex and often perplexing medical, scientific, ethical, legal and public policy issues that we have heard about throughout this afternoon and will probably hear more about in the future. We believe that this law is long overdue. Bill C-6 takes the first step towards legislation and regulations that are medically, socially and ethically sound. The SOGC's position on assisted human reproduction is outlined in our briefing note, which should have been pre-circulated to you, and is elaborated further in the joint ethics document of the SOGC/CFAS that has also been distributed to this committee. I will highlight what we consider to be the strengths of Bill C-6 that outweigh the weaknesses that we have heard about.

The principles of the bill are good, in particular, the recognition of assisted human reproduction and the need to promote the welfare of the child as well as the health and safety of the woman. There is a clearly outlined list of prohibitions and controlled activities. The information needs of persons using assisted human reproductive technologies are addressed and viewed as essential. The success rates of ART therapies by centre will be available to the public and will allow women to make informed choices as to where they receive their care. The establishment of the agency with the authority to regulate assisted human conception and related research is another strength. The SOGC believes that any system of regulation must be able to respond with efficiency and effectiveness to the rapid changes that occur in the reproductive/genetic sciences and medicine.

As we work toward a more open system of gamete donation, the bill protects the public identity of sperm, egg and embryo donors. Access of donor offspring to the full medical history of the donor is assured. The bill recognizes the importance of research in the advancement of both patient care and scientific knowledge. The bill recognizes the role that reimbursement of expenses plays in altruistic programs of sperm, egg and embryo donation. Finally, the bill is comparable to oversight initiatives currently in place or underway in the United Kingdom, the European Union, the United States and Australia.

The SOGC also recognizes that this bill has shortcomings, and we have heard about them. First of all, we, like the CMA and CFAS, do not believe that it is correct or appropriate to designate specific medical and scientific procedures as criminal acts. The new agency is not required, but should be obliged, to develop education activities around assisted human reproductive technologies, infertility prevention and other relevant reproductive health issues, especially as we are seeing an increase now in the silent chlamydia infection epidemic.

The bill should recognize that infertility treatments are medically necessary and should be insured services under the Canada Health Act. The SOGC recognizes the importance of the structure and composition of the agency as well as the critical role of regulations in the successful implementation of the wishes of Parliament, and we have heard this from a number of the honourable senators around the table. Under clause 70, this bill will be reviewed by Parliament three years after the agency is established, and we respectfully request that this committee make recommendations on Bill C-6 as presented in our brief.

I will just highlight some of those recommendations that we would value: One, that the structure, function and composition of the agency should include members of the public, including the infertile; two, that individuals from a wide variety of relevant disciplines be on that agency; three, that the agency be independent; four, that there be a transparent decision-making process within the agency; five, that there be a commitment to engage in broad consultations prior to the introduction of regulations; and six, that the agency have a public and professional education function.

We also feel that the agency should incorporate into its regulations the accomplishments of health providers and scientists in the ongoing accreditation process of ART clinics and the surveillance of cells and tissues used for assisted reproduction. We believe there should be a shared model of governance selected by the agency in preference to more traditional models. We feel that the regulations should help ensure that a balance exists between the privacy rights of gamete donors, infertile women, and children born from assisted conception. We ask that the federal government establish a national system of altruistic sperm and egg donation or banking, similar to that which exists for blood and blood products.

We ask that regulations should mandate that counselling be available, and not that counselling be mandatory. We also ask that processes for appeal should be outlined in the regulations in equal detail to the processes currently there surrounding the issuance, amendment, renewal and suspension of licences. Finally, we ask that subclause 40(2) should only apply to research not directly related to the care of infertile Canadians. That section would regulate novel uses of the human embryo, but we are concerned that another review process of quality improvement activities, in addition to local ethics committees, would slow the application of the best research ideas to patient care.

In conclusion, the SOGC is the oldest and one of the largest medical specialty organizations in Canada. Over the past 60 years, the mission of the society has been to promote optimal reproductive health through leadership, collaboration, education, research and advocacy in the practice of obstetrics and gynaecology. The SOGC and government have followed a long and tortuous path to reach this point, but we feel we are just at the beginning of a still longer process to create a safer and better-informed oversight of research and clinical practice in assisted human conception.

We urge this committee to report Bill C-6 without amendment. The SOGC asks that your recommendations on the bill respect the infertile and the medical model of care. Particularly as our national birth rates are declining to record low levels, we must find a balanced approach that protects the children and women while assisting and encouraging those who want a family.

Ms. Beverly Hanck, Executive Director, Infertility Awareness Association of Canada: Honourable senators, I represent IAAC, the Infertility Awareness Association of Canada. That association currently has 22 support groups across Canada. Our objective is to provide support and education to patients so that they can make dignified choices. We do everything possible to empower the patient who needs to surmount the many hurdles associated with infertility. Personally, I have spoken with hundreds of patients, maybe thousands, on our 1-800 support line, and our Web site currently welcomes 6,000 to 7,000 visitors per month.

I would ask you to listen carefully as we share our experience, strength and hope with you. Although it has been stated that this bill is intended to provide safeguards that patients need, we believe that Bill C-6 will result in the closing of many doors for infertility patients and the opening of doors for unregulated services in which the health, well being and safety of all parties will be threatened.

If we are unable to provide a nominal reimbursement to donors to cover the cost of their time and expenses, we will lose gamete donors from our programs. Will this promote and protect human health, safety, dignity and rights in the use of these technologies? We think not. These patients have been seriously under-represented as the members of Parliament were busy struggling with the cloning and stem cell issues, which have absolutely nothing to do with assisted human reproduction.

We want to take this opportunity to document our belief that it is totally unacceptable that assisted human reproduction procedures are incorporated into a bill governing cloning. This argument has been raised many times, only to fall on deaf ears.

Infertility patients need gametes, some need sperm, some need eggs, and they must continue to have an adequate supply of donor sperm and even more eggs than are currently available. In many, if not most, cases, this is essential for their infertility treatment. Elimination of reimbursement to donors will likely all but eliminate supply. Can anyone answer the question: Where will patients acquire sperm and eggs? Has this been addressed? Can the government assure the patients that there will be adequate donor sperm and eggs available to them?

Passing Bill C-6 in its present form will cripple the infertility patients, the very patients who need our help to realize their dreams of having a family.

A recent study, one of the largest studies of its kind, has found that men's sperm counts have fallen by almost a third since 1989. The findings add to the evidence that suggests a growing number of men may have problems fathering children. Researchers in Aberdeen said their findings, based on 16,000 semen samples taken from 7,500 men, do ``cause concern.''

Australia, with its rigid, restrictive laws, now advertises at Canadian universities to entice our young men to holiday in Australia. What is the deal? The young male university students are to top up Australia's sperm supply in exchange for airfare and lodging. Can you tell me that their laws are functional? Whom will we entice? How will we entice? Not with our minus 40 degree temperatures.

I also saw recently an e-mail that came out of CBC that stated that the U.K. is quite upset because they have serious concerns that patients are buying the donor sperm on the Internet. I do not think that is the way to go either.

A lack of donor sperm will result in what have already become known in other countries as fertility tourists — patients travelling for medical holidays. We must assess what we are truly trying to accomplish. Only patients with the financial means will be able to travel outside the country and access this service. Patients may be forced to access donor sperm in jurisdictions where no standards or regulations exist. The Canadian health care system will, in essence, relinquish control of the process of providing patients with tested and safe sperm samples while unwittingly accepting all the medical consequences; that is, babies and mothers who have contracted infectious diseases such as AIDS, hepatitis, syphilis, et cetera, from unsafe sperm samples and medical practices. Can we afford to let this happen? Others will achieve a pregnancy by using semen from men who have not been thoroughly screened. The consequences with respect to transmission of infectious and genetic diseases could potentially be catastrophic.

Has anyone stopped to think that this bill could be perceived as ethnocentric? The government has completely overlooked the vast multicultural society that exists in Canada. With the restrictions Bill C-6 threatens to impose, the few sperm donors of ethnic origin will cease to donate.

As for eggs, there is already a tremendous shortage of donated eggs in Canada and women who need them generally face a long wait for treatment. The idea that there would be an adequate and safe supply of donor sperm and eggs in Canada with no reimbursement being permitted is not evidence based.

Egg sharing may be a way to help some of these couples. A couple is offered free IVF treatment in exchange for donating a few of the eggs the woman produces to another woman who requires egg donation. In this way, both the donor and the recipient have a chance to have babies that neither would otherwise have had, with one lacking eggs and the other lacking the financial means.

As far as the Infertility Awareness Association is concerned, it needs to be clearly understood that in surrogacy, a couple is paying for a professional medical service. They are not paying for a baby. What is more, we believe that commercial surrogacy will not be stopped, no more than abortion was. When abortion was illegal, Canadians continued to seek out the procedure and there were no safeguards or standards to protect them. Bill C-6 invites history to repeat itself. Non-compensated surrogacy will prompt deal making and it likely will become an underground activity. It would be better to develop criteria and parameters designed to fairly treat all parties and to maintain this as a legal activity.

We receive calls from women who suffer from the Mayer-Rokitansky syndrome. Tragically, they are born without a uterus. Will we deny these women the joy of parenthood when a surrogate could provide them with the child they naturally desire? This applies likewise to patients with diabetes, Crohn's disease, lupus and cancer, and to women who have had hysterectomies as a result of medical diseases.

Patients want their privacy and they want to be treated with dignity. We must acknowledge here and now the stamina and perseverance of infertility patients in withstanding this difficult emotional state. It is a testimonial to their bravery, courage and love of family. Patients seeking assisted reproductive technology treatments want at the very least, the privilege of having their privacy protected in the same manner as other patients undergoing medical procedures.

To create a registry is a violation of privacy and our human rights. There is no registry in Canada for any other disease or any other medical procedure. If a couple needs donor sperm therapy or IVF in Canada, Bill C-6 dictates that they and their children will have to be registered with a federal agency. This personal health information registry will contain their identity. How many infertile people will want their names and those of their children on a federal infertility register? Moreover, is this type of registry the best use of our scarce health dollars? Another consideration is whether the registry conflicts with the principles of the recently implemented Personal Protection and Electronics Documents Act.

Please note the following amendments, which are mandatory if we are to meet the needs of the infertility patient. For sperm donors, continue to allow reasonable compensation for providing semen samples. For female egg donation, the procedures are more time consuming and invasive than for sperm donation. Allowing current compensation trends to continue is sensible, bearing in mind that it is estimated that egg donors spend roughly 56 hours in medical settings. For surrogacy, continue to allow reasonable monetary compensation for a woman's time and effort over the course of the pregnancy.

A decade ago, the Baird commission on new reproductive and genetic technologies consulted 40,000 Canadians and concluded that a caring society should provide reproductive health services through a health care system. Notwithstanding this conclusion, there is currently substantially less IVF being performed in Canada per capita in comparison to other developed countries because those countries provide the financial support required to carry out the treatments.

Canada performs a modest 5,000 to 6,000 IVF cycles, compared to France's 47,000 and England's 26,000. Both these countries have populations only twice that of Canada.

Every Canadian wants to continue to enjoy freedom of choice. It is truly a matter of live and let live, whereby individuals can continue to make free and informed choices with dignity.

The Chairman: Dr. Leader made it clear where he stands, and the other three of you heard the discussion we had earlier about where do you fall when you have to make a choice between amending the bill in the way you would like, thereby killing it, or proceeding with an unamended but flawed bill.

Given that choice, Dr. Green, where do you come down?

Dr. Green: I would refer to the title of the report of the royal commission in setting boundaries, but proceed with care. I am not allowed to compromise; I am a physician. You would be asking me to compromise my oath to pursue cures and stamp out disease. I think we should do it right.

The Chairman: I understand.

Dr. Green: I fundamentally support many of the provisions of the bill. If you read my brief, there are other things that I suggested, as did Dr. Leader.

The Chairman: I was just asking because of the dilemma we are in.

Dr. Bereza: I apologize because I will not give you a good answer. I can tell you this much: I do not believe that the Canadian Medical Association sent me here representing Canadian physicians to kill the bill. They did not give me those instructions. That is the case.

Perhaps we are naive, but we also believe strongly that this bill as it stands, because of the arguments I raised, is so seriously flawed that in our judgment, the harms are very considerable, and we look to this body to make a difference. Perhaps it is a naive hope, but that is what we are coming to.

Senator Morin: I will take him up on that question. Is there anyone from the CMA here who can answer? Is he in favour of killing the bill or letting the bill go forward with its flaws? He is representing the CMA, and we should have a clear answer here.

Dr. Bereza: I would like to be clearer than that. I introduced my comments as an apology. Whereas my learned colleagues who preceded me, who are lawyers, managed to skate around the issue, here is one example of where a physician does not claim to be omniscient and all-powerful. I do not know. We have not been able to solve your dilemma for you. I heard you use the word ``dilemma.'' With all due respect, senators, this is your decision to make. It is a legitimate judgment call. I cannot do that.

The Chairman: You have every right to put it that way. I am simply trying to seek advice.

Dr. Bereza: I wish I could. I cannot do that.

The Chairman: I understand. You are in the dilemma that you are here representing a group. You are not representing yourself.

Ms. Hanck: Kill the bill.

Senator LeBreton: That is compelling testimony.

Dr. Green, I have heard those arguments before, as Ms. Hanck has. I have seen those advertisements enticing our students over to Australia. You spoke about reasonable compensation for sperm donors, and you said that 80 per cent of our donor sperm comes from the United States.

How then, would this bill as it presently is, have an impact on the supply from the United States? What procedures are in place right now for the proper screening of donor sperm from the United States?

Dr. Green: There are sperm regulations. There are laws governing the processing, distribution and use of donor sperm in Canada. Although 80 per cent of our supply comes from the U.S., the U.S. companies that provide semen to Canada have to fulfil all those requirements, and Canada has the strictest requirements. Dr. Leader and I, along with Health Canada, were instrumental in setting up those regulations.

The Chairman: You said 80 per cent of your current sperm donations come from the U.S.

Dr. Green: Yes.

The Chairman: Therefore, they would be unaffected by this change in the Canadian law.

Dr. Green: The plan of Health Canada would be the following, and representatives of Health Canada are here and can stand up for themselves if I am not correct: fairly soon, if this bill were to pass, Canadian sperm banks would not be permitted to provide remuneration. The amount is a fairly standard $50 to $75.

Senator LeBreton: What about the 80 per cent coming from the United States? Who pays for that?

Dr. Green: We pay for it when we buy the sperm from the bank in the U.S. Health Canada will close the sperm banks in Canada, basically. They will say, ``You can no longer pay your donors.'' ReproMed is the biggest one in Canada. They have surveyed their clients and 70 per cent say they will no longer participate in the program. We will lose our Canadian source quickly, I would say.

Senator LeBreton: You would still have to pay for sperm from the United States, however.

Dr. Green: Health Canada is saying that in two years, it will no longer permit sperm to come in from the U.S. That would give us two years to establish an altruistic system, I presume.

Senator LeBreton: The other question is for Dr. Bereza. With respect to the issue of criminal sanctions, I think, Dr. Bereza, you gave some solutions in your paper. I am curious as to why, when you talk about the alternative solutions, Health Canada would not have put this entire part of the bill under the agency.

Perhaps someone from Health Canada can answer that for us. Every one of you, including Dr. Leader, who supports the bill, has problems with the criminal sanctions. When Health Canada was developing this piece of proposed legislation, would it not have been better to put any potential criminal prohibition under the agency and not in the bill?

The Chairman: When we are finished with the panel, I will ask Health Canada to respond to that question.

Dr. Bereza: I do not know why Health Canada did not consider it that way. That is precisely our point. The sense of the CMA is that you could have had it both ways, namely, have the prohibitions in place and the criminal sanction element when you breach those prohibitions. You could have had that without all the negative elements that go with criminalizing medicine.

Senator Robertson: I have a supplementary to Senator LeBreton's first question. I used a quotation from Ms. Hanck's report, because you suggest it will severely limit, if not take away, the rights of infertile people to choose treatment options that are best for them, as well as potentially endanger the health of infertile people. Also, 71 per cent of sperm donors have stated that they will not continue to participate in the program without appropriate reimbursement, et cetera.

In terms of both of those issues, I was advised by Health Canada that in Britain, France and elsewhere, I believe, where they had the same prohibitions, the supply was not affected. There are huge differences there in concerns. I should like to have this straight in my head, if I could.

Dr. Leader: In the U.K., HFEA, the Human Fertilization and Embryology Authority, regulates assisted human conception. They have a schedule. They say that sperm donation is a public duty, so they do not compensate. However, they also say that jury duty is a public duty, and they give you the fee that you would get for a day of jury duty. They also have a schedule that says if you live 100 miles away from the centre, there is a travel allowance.

The result is that the amount that people are receiving is equal to what they would have received before the new system was introduced. They have a schedule whereby sperm donors are compensated.

Senator Morin: They are paid 15 pounds.

Dr. Leader: There are travel expenses in addition.

Senator Morin: In London it is 15 pounds.

Dr. Leader: That seems to be adequate.

In the U.K., the agency has recently announced that it will make all gamete donors known, and that lack of anonymity will have a much greater impact. My understanding of the anonymity aspect here is that family law in the provinces does not permit that for sperm donors.

The issue for egg donors is more complex, it has been stated, because the amount of effort women have to make to become an egg donor is greater. In Ottawa, people come with known egg donors, usually a friend or a relative, and the only costs are for the procedure itself. We seem to be able to meet our needs with that kind of system. However, it may not be workable for a larger centre such as Toronto.

In France, they have a national system supported by the French government. If you bring in a willing sperm donor then you can withdraw sperm, not from the person that you bring but from an account, if you like. For every sample that you bring to the bank, you are allowed to withdraw one. That is how they run their system without compensation.

Senator Morin: Could you tell us about systems in Australia, New Zealand and Sweden?

Dr. Leader: In Sweden they have solved the problem by making sperm donors known but not paid. I spoke to the fellow who runs the largest sperm bank in Denmark and over 60 per cent of his patients come from Sweden. Sweden has dealt with this by exporting the problem to Denmark. The issue that was raised in previous discussions, about identity and sharing of information, is why people left Sweden. They did not want a system in which they were identified or the donors were identified. What we have in this case, on balance, is a good compromise between the ideal and the not ideal, in respect of gamete donation.

Senator LeBreton: Dr. Green, you mentioned that provincial plans do not fund fertility treatment. I can only imagine the cost of that treatment. For the benefit of the committee, could you tell us what the cost would be for a couple if it were not covered by a provincial plan? What kind of money are we looking at? Is there an average cost for a couple to meet with success?

Dr. Green: For in vitro fertilization, the base charge is $4,500. It is akin to buying a car, because you can add options. If a couple requires other things such as assisted fertilization or embryo hatching, there would be an additional cost. If the couple has no drug insurance, it could cost $8,000 or $9,000. If they have drug insurance, it could be $2,000 less. That is a rough guess. In our clinic, the chances of becoming pregnant are 50 per cent; 50 per cent of our patients become pregnant with the first embryo transfer and 50 per cent do not. If, in the in vitro fertilization process they produce more embryos than we use in the fresh embryo transfer, they may get additional chances of getting pregnant with the frozen embryos. In our clinic they have a 40 per cent chance of getting pregnant each time we do a frozen embryo transfer.

Senator LeBreton: Is there any private health insurance that couples could buy?

Dr. Green: There is not. Some patients will have insurance that covers fertility drugs. In the Province of Ontario, if both of a woman's tubes are proven by some test to be blocked at some time in history, then the province will fund three cycles of IVF procedures but not the drugs.

Senator LeBreton: That is because of the specific medical condition of blocked tubes.

Dr. Green: Yes.

Senator Morin: I have a few comments before posing a question about the present situation. We are one of the few countries in the world where there are no nationally known outcomes for our fertility clinics. That is a major lack of information. The U.S., which has no system, has that information.

Is it not a fact that one of the reasons we rely so much on the U.S. is that in 1999 there was a major problem concerning Canadian sperm, which was quarantined? We had to rely completely on U.S. sperm at that time.

Dr. Green: That is a good point.

Senator Morin: That is one of the reasons, and you had so many questions that addressed the issue. You gave the figure of 80 per cent, and I am surprised this fact did not arise.

Dr. Green: The sperm regulations were actually passed in 1996. In 1999, a disgruntled employee of a fertility clinic reported to Health Canada that that particular clinic was not following the guidelines. The government put the sperm regulations in place. The guideline document, which I had amended for the Canadian Fertility and Andrology Society, outlined one way to set up a sperm bank in Ottawa.

The government actually adopted that document into law without consultation. It was not appropriate because that was only one way of doing it and, although it reflected much of what we were doing in Calgary, we were not doing exactly what was described in that document. That does not mean that it was unsafe.

Senator Morin: It was still quarantined.

Dr. Green: At that point, the ministry sent out a questionnaire to find out whether we were following all the guidelines in the law. The answer was that no one in the country was.

Senator Morin: That is the explanation. I would like to come back to the matter of paying donors. The system is either commercial or altruistic. You have to choose. It is the same as the issue of killing this bill — it is yes or no.

I still do not know what reasonable compensation is. What does the word ``reasonable'' mean? What is reasonable compensation for a kidney donor? We have people dying in Canada waiting for a renal transplant. I am certain that renal specialists would agree if kidney donors were paid. They would not agree with it on an ethical basis, but on a practical basis because it would increase the number of kidney donors. It is the same for marrow transplants. There is a move afoot to pay for marrow donations but Canadians do not agree with this concept. Children are dying from leukemia because compatible marrow cannot be found for a transplant. I am certain that if you paid reasonable compensation for marrow, donors would be found. It could be the same for blood. I do not see what the difference is, really.

I understand the plea of infertile people, but in other cases, we are talking about life and death. Other countries, as Dr. Leader said, such as the United Kingdom, France, Australia and New Zealand are moving in that direction. It is a trend. Times are changing and people do not agree with the commercialization of body parts, tissues and so on. It is unfortunate but that is the way of the world. As you know, the House committee and the royal commission have debated this at great length. The ethic of the SOGC is clear: No commercialization. I am not sure whether your society was involved in the ethics part.

There can be either altruism or reasonable compensation; we have to make the choice. That is no different from the other examples that I gave.

I should you like to come to the issue of prohibitions. I was not too clear, Dr. Bereza, what you meant. Would you remove all prohibitions in the bill from the Criminal Code?

Dr. Bereza: Yes, senator.

Senator Morin: This would mean having inspectors under a regulatory process to visit clinics and shut them down, where required, for activities such as putting animal sperm into a human egg, or introducing a human embryo into an animal body, or cloning. These would not then fall under the Criminal Code, but they are morally abhorrent. These things are universally abhorrent to all religions, like murder or incest or rape. These things are morally abhorrent to all Canadians. I am surprised that they would not fall under the Criminal Code.

I should like to move to your statement that assisted human reproduction is no different from any other medical procedure. However, it is completely different and that is why it should be treated differently.

It deals with the creation of human life.

I know there are different views on the status of the embryo, but everybody agrees it is the first step to personhood. For many, a significant minority of Canadians, an embryo is in fact a human being. I think that is why it should be treated differently. To say that it is no different from other medical procedures or medical acts and should be treated by regulation and professional bodies is not correct.

I was not too clear about what both Dr. Green and Dr. Bereza said concerning research — that the research would now be impossible and so forth. Are we strictly talking about therapeutic cloning? Is that the only thing that renders research impossible? The rest of the field is pretty well open. Therapeutic cloning is a very specific procedure. The work of one lab in South Korea has not been reproduced. People have doubts about it.

The Chairman: Can you start to wind up your question please?

Senator Morin: That is my question.

Dr. Green: I think therapeutic cloning and stem cell research is very much in its infancy, but I have no doubt that it will bear fruit with time.

Senator Morin: Yes, but stem cells are authorized in the —

Dr. Green: I qualified that with somatics on nuclear transfer, or therapeutic cloning. I think these things, put together, have tremendous promise. I think you will hear that theme repeatedly from your witnesses during the next hearings. You will hear that from every witness — that therapeutic cloning, combined with stem cell research, has the potential to be one of the biggest medical advances in history.

Senator Morin: I agree, but stem cell research is authorized and therapeutic cloning is not. However, to say that research is impossible, to use your words —

Dr. Green: No, I did not say that research is impossible.

Senator Morin: Therefore your only point is concerning therapeutic cloning.

Dr. Green: I am part of a university environment. I follow everybody's guidelines. I am saying the only thing this bill would interfere with is therapeutic cloning. On the other hand, if this bill does not pass, things will go on. Theoretically, therapeutic cloning could take place.

Senator Morin: Cloning and —

Dr. Green: No, reproduction cloning. I do not know of any reputable scientist — and you even said this in your address to the Senate during second reading in October —

Senator Morin: Well, they are aliens.

Dr. Green: They are not scientists.

Senator Roche: I would like to thank the witnesses for coming. Their testimony has been very illuminating. Mr. Chairman, I think they brought a new dimension to the subject.

The Chairman: I agree.

Senator Roche: I thought the fertility society representatives were in favour of the bill because it would help to foster a solution for infertile couples. I had that mindset coming in here. Now I find that the experts on fertility are opposed to the bill — and that creates another dimension, as I said. I thought coming in here today that it was the research on stem cell production that was the most difficult and so on. Now there is another dimension.

In putting my question, which will be first to Dr. Green, but not excluding others, I want to assure the witnesses that we are not trying to load on to them our responsibility for whether we will accept the bill or not. However, their views are extremely important, and we have experts here who are split.

Dr. Bereza says the bill is seriously flawed, but he is reluctant to recommend killing it. I suppose he feels he does not have the authority to say that. That leads me, Mr. Chairman, to ask you to consider having the Canadian Medical Association give us a definitive view on this bill. I personally would be greatly influenced by that.

The Chairman: I am happy to ask, but I will be stunned if I get a reply.

Senator Roche: Okay. Anyway, Ms. Hanck is very clear on killing the bill, and Dr. Leader says we should let it go without amendment.

It is Dr. Green who poses, for me, the most interesting part of this dilemma. He suggested an amendment, and I took it that if he got that amendment, he might be more or less happy with the bill. However, I am sure that if we send it back to the House of Commons with an amendment, it would never get out of there in the present Parliament, and thus we would, in effect, kill the bill. Perhaps a better bill would come in the next Parliament, so I do not want to be spooked by the idea of killing the bill.

Dr. Green said that the bill, as it now stands, contains more harm than good. Those were his words, and I was greatly influenced by that. That is the prudential judgment that we have to make. This bill has some good things in it and, from my point of view, some bad things. How do you weigh it? From your perspective, that of the Canadian Fertility and Andrology Society, you say that it contains more harm than good.

Therefore I ask you, if we did not make the amendment, what would your position be on the bill as it is now — what would be your thoughts concerning the validity of the bill?

Dr. Green: I think the bill has many fine features and provisions in it. Dr. Leader and I, and others, have been very supportive of Health Canada in putting this bill together over many years. However, the Canadian Fertility and Andrology Society has been consulted. All members, 500 of them, had an opportunity to comment, and the position is: It does more harm than good. It compromises the care of our patients, and our patients tell us they do not want it. Therefore, if you are saying, do I support the bill, and what if it dies, it will die before we give up on our idea for the amendments. We are asking for the amendments.

Senator Roche: I would like to see the bill amended, too. I asked the minister earlier, when he was here, if he would take an amendment to ban stem cell research on embryos, and he said no. Therefore, I do not think the government will take any amendments, and that will send us back to our own decision-making, which I have to leave with us and not transfer to you, as I said earlier.

My final question, Mr. Chairman, is to Ms. Hanck. You said that this bill will close the doors and will cripple infertility patients. As a layman on this subject, from my point of view that is strong language. I respect your use of the word — it would ``cripple'' infertility patients. Interestingly, you also tossed in that it would lead to ethnocentricity, which is another dimension that I had never thought of in connection with the bill. Mr. Chairman, we are getting some interesting testimony tonight. Let me ask Ms. Hanck if she would elaborate on her use of the words ``cripple infertility patients,'' because if it is so, it is a strong reason why we ought to hesitate before letting this bill go forward.

Ms. Hanck: As I said, I speak to hundreds of patients because we have a 1-800 support line. What is consistently clear concerning the demands and needs is that a lot of women who are suffering from various diseases need eggs, and there are very few available. You can get an egg at McGill — waiting time, five years.

Some of these women are 35; they do not have five years. I think we would be in a better position to accept this bill if there were a workable altruistic system in place, but there is not. When you ask Health Canada what they will do, they say, ``Well, we are thinking about it. You have to advertise.''

I have also been told by doctors that the sperm of males over 40 causes more neurological problems in babies. This is another factor, and it is complicated.

Senator Roche: It certainly is.

Dr. Leader: There are a couple of issues. One is that, as we stand now, the position of Canada in terms of regulation in this area is similar to that of Bulgaria, Bangladesh, Ecuador, El Salvador, Korea and Romania. These countries, similar to Canada, have no guidelines or legislation. If the bill fails, it is open season, despite what people might say. Whether or not Canadians are interested in doing this, it is a business proposition for those who undertake these activities. They will find the opportunity in an unregulated environment.

Criminal prohibitions are, unfortunately, necessary. Mr. Rivard and others have explained to me that the federal government does not have power in this area except through the criminal law, which is unfortunate. The provinces, frankly, are uninterested in regulating this. They have had the opportunity in Ontario, with the Independent Facilities Act, for a number of years. I think that criminal sanctions are unfortunate but necessary.

The Chairman: Having watched the angst and political flack that has accompanied this bill, it is easy to understand why the provinces have been prepared to leave it to the federal government.

Senator Roche: Dr. Bereza, you are here tonight as Chair of the Committee on Ethics and you have expressed your view as well as you can, and I sense that you are reluctant to make a definitive statement. Your testimony about the flaw in the bill was very strong. When I raised the idea of the Canadian Medical Association giving a definitive view, the Chairman, and perhaps others, thought that might be difficult to arrange.

The Chairman: Just to be clear, I told their director of government relations that I would like an answer to the question. I also said that I will not be surprised if we do not get one, but we have asked.

Senator Roche: Is it reasonable, Dr. Bereza, for me to ask you to ask that of the authorities in the Canadian Medical Association, for whom I, as a layman in this area, have deep respect? I need their guidance. Are you prepared to seek a definitive view on this bill, as is, from the Canadian Medical Association? Is that a reasonable request for me to make of you, sir?

Dr. Bereza: I think it is a reasonable request and I can only promise to make my best effort to convince the board and others to give that.

Senator Roche: Will you do so with some dispatch?

The Chairman: I said that I would like an answer one way or the other, or a statement that they will not answer. We would like a definitive answer of some form before we finish our hearings.

Senator Roche: That will be in another week.

Senator Keon: Dr. Leader said that he believes that a system of altruistic donors could be set up. We have heard that people are really concerned about the number of embryos that are being created. Apparently, there are drugs now that can enable the harvesting of 30 to 40 eggs from a single woman. The field is so new that there is a potential for the kind of thing that has occurred with blood donations and so forth.

While you people are very knowledgeable about this field, the general population is not. It has not yet hit the radar screen and there have not been the educational programs there could be.

Dr. Green mentioned that this should be a medically necessary act. It is very disturbing that this whole business is occurring outside medicare with no regulation. We hear some horror stories about some of the clinics that are operating.

I come back to Senator Morin's earlier rantings and ravings. We really must do something here. You people from whom we have heard tonight are a microcosm of the deluge of information that is hitting us. You are all very good at what you do, but you all have different opinions.

Dr. Green: With respect, the last time I checked, the blood system was 40 per cent American, and American blood donors get paid. That speaks to our Canadian altruistic system.

Senator Morin: They do not in Quebec.

Dr. Green: Quebec provides its own sperm, too, senator. They do not like to get it from the United States.

Senator Morin: Let me just say, it is the best.

Dr. Green: I was going to say that.

Fertility clinics do not exist in an unregulated environment. For example, this year, we have been accredited by the Canadian Council on Hospital Services Accreditation, just the same as the Ottawa Civic and the Ottawa General. It is the same people doing the same kind of accreditation process.

We will also have an inspection by Health Canada of our donor semen. About eight months ago, we were accredited by the Alberta College of Physicians and Surgeons.

Senator Morin: Why are there no outcomes?

Dr. Green: We do have outcomes. Each year, the Canadian Fertility and Andrology Society issues a press release with aggregate results.

Senator Morin: Aggregate does not mean a thing. What about per clinic? We are one of the few countries that do not have that, and with this law we will.

Dr. Green: At the last general meeting of CFAS in Victoria in November, the directors committed to moving toward clinic-specific data. We move at about the same speed as government.

Dr. Bereza: In partial response to Senator Keon, you said we represent a microcosm of vastly different opinions. I hear it slightly differently. I think that these are legitimate dilemmas, a judgment call on which benefits you want to have and which risks you want to avoid. Having said that, I heard it differently. I did not hear anyone here say that the criminalization aspect is a good idea. I heard consistency there. Everyone said that the criminalization part of this bill is seriously flawed. I heard only one organization say unequivocally that the bill should go forward.

Senator Morin: Which is the largest. The CMA has not committed.

Dr. Bereza: I am just responding to Senator Keon's point that there is wide disparity. It may not be that wide. Only one person has said unequivocally that we should let it go forward as it is.

Senator Keon: I think you are correct. I do not think there is one person who is satisfied with this bill. However, there is also a large body of opinion that we cannot allow this situation to continue.

I have been saying that this bill was badly drafted and should have been split into at least two bills, maybe more. However, there is a large body of opinion that we just cannot put this whole subject matter off any longer. We may have to find a way of correcting it along the road and so forth. We have to make progress.

Senator Callbeck: I have a short question on fertility clinics. Dr. Green, you touched on this a minute ago when you talked about accreditation. I have heard that these clinics do not have any regulations under which to operate and that they are not inspected, and then I heard that Health Canada does inspect some of them. You say that they are accredited, at least in Alberta. What is the situation?

Dr. Green: Let me expand. Every body that handles donor sperm is inspected by Health Canada, usually, I think, every two years. In Alberta, we are inspected every two to three years by the Alberta College of Physicians and Surgeons to make sure we are complying with rules of operating clinics. The third and most important accreditation is something that Dr. Leader and I, the CFAS and SOGC have been working on since 1992, and we have the same accreditation, as have 7 other fertility clinics across the country, and another 13 are committed over the next two years to completing this process. As I mentioned before, that is the same accreditation process that the Ottawa Civic or Ottawa General goes through. It is the same organization. There is no statutory requirement. The clinics are doing this on a voluntary basis. There are lots of people looking over our shoulder.

Senator Léger: I would like to join Senator Roche in saying I am a layperson in this. I am no specialist at all. First, Dr. Bereza, thank you very much for reminding us that it is our dilemma. It is our responsibility. Even if I am a layman, I am a senator. That makes it difficult for me. Also, I have heard many pleas for patience in the name of the patients and so on.

After hearing everything, we have to proceed. Commercialization creeps in easily. I heard estimates that it could cost $9,000, I think, and it is $500,000 if they get caught. I call that commercial.

Then there is the danger for professionals. There is university research. We have the scientific dangers versus the human application, and that is extremely serious.

Now my question: I come from a generation that had 9, 12 or 15 children per family. What has happened? What is the cause of fewer sperm? What is the cause of fewer eggs? What is going on? Why is there so much infertility? I know that is not the subject here, and it is not in this bill, but what has happened? It has happened quickly.

Dr. Leader: I think that probably your generation and previous generations got married much younger. The average age in Canada for the first birth is 30. A decade ago, it was 28, and three decades ago, it was mid 20s. Fertility decreases with age. As well, older women are marrying older men.

The Chairman: To put that in perspective, the single demographic statistic in Canada that has changed most dramatically in the last quarter century is the age at which a woman has her first child. If you think about it over the size of the sample, moving from 22 to 30, which is roughly where it has gone in 25 years, is an unbelievable shift in the nature of society. All of us with kids know that.

Senator Léger: These 15- to 30-year-olds, they must have a lot of eggs and a lot of sperm, must they not?

Dr. Leader: However, they are using birth control. They are getting married later, because thankfully, women are empowered to have a career and they are delaying their families to a time when their reproduction capacity deteriorates. We are exposing ourselves to more toxins, such as cigarette smoke, alcohol, environmental toxins that impact on reproduction. When you put all of that together, you have a reason for decreasing fertility. The economics have been well studied also. People appreciate that having fewer children means that you enjoy a better standard of living. There are many reasons. This is what has happened, and it has been a tremendous shift. Our birth rate is now well below our replacement rate, so that the infertile are asking to have children at a time when we need them to.

The Chairman: I thank all of you for coming. I would request a few things from the officials from Health Canada. Can we have, by next Wednesday, a written response to two questions?

Why did you choose the Criminal Code option? What other options did you consider? Was it the only one, as Dr. Leader said, open to you in the federal jurisdiction? I would like to know what other options were considered and rejected, and why.

Second, with respect to the comment that Ms. Hanck made, that outlawing commercialization will in fact make it very difficult to find an adequate supply of sperm and eggs, and your response in earlier testimony that other countries have so-called altruistic systems, I would like to know the performance evidence, or whatever the correct terminology is, for countries with those kinds of systems.

If we could have that in our hands before next Wednesday, that would be very helpful. Thank you very much.

We are finished except for one thing. I think at 8 o'clock at night, Senator Roche, trying to do an in camera session is difficult. Let me bring our colleagues up to date on the so-called Chaoulli case. The Supreme Court has accepted a number of interveners representing the left, the centre and the right. The applicants are seeking a parallel private system, and they are supported by a number of private clinics, like the Cambie clinic led by Dr. Brian Day, and others. On the extreme left, you have the Canadian Health Coalition, the poverty coalitions and the Canadian Labour Congress, who are arguing against doing anything at all to change the system. In some sense, in the extreme centre are this committee and the Canadian Medical Association, both arguing very passionately for a care guarantee. There are very minor variances but it is essentially the same position. We are saying absolutely nothing in this report that we have not said in the court case. It is essentially chapters 5 and 6 reduced to the length of factum we are allowed. Frankly, you are seeing the demagoguery of the left as represented by the Canadian Health Coalition — when we were doing other things — as represented by Svend Robinson and others, versus the demagoguery of the right. The people in the middle are the Canadian Medical Association, the Canadian Orthopaedic Association and our committee. I believe that the reason the Supreme Court accepted that collection of opinions is that it guaranteed a genuine cross-section of views. I responded in The Globe and Mail when they asked me to. You were happy with that?

Senator Fairbairn: Very well.

The Chairman: We have to understand that, as this case gets closer, the attacks from the left, which frankly are totally and utterly illogical, will continue. I do not believe there is anything we can do about it.

Senator Fairbairn: If anyone has not done so, do read the article. The first piece I read recently was how the Senate and these individual members of the Senate were supporting —

Senator Roche: Point of order, Mr. Chairman. I have great respect for the points that are being made, but I really think this discussion should be in camera.

Senator Fairbairn: This is in public.

The Chairman: I realize that, but after five hours, that is difficult to do.

Senator Roche: I understand that people do not want to have an in camera meeting after five hours of sitting, but we need an in camera meeting to discuss this situation. The comments that I want to make, I want to make in camera.

The Chairman: That is fine. I was trying to bring our colleagues up to date on where the Supreme Court stood on the various questions.

The committee adjourned.

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