HEAL Committee Meeting

STANDING COMMITTEE ON HEALTH

COMITÉ PERMANENT DE LA SANTÉ

EVIDENCE

[Recorded by Electronic Apparatus]

Tuesday, October 23, 2001

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[English]

The Chair (Ms. Bonnie Brown (Oakville, Lib.)): Good morning, ladies and gentlemen. I'd like to call the meeting to order. We have a very distinguished panel of witnesses this morning. I want to make sure they all get sufficient time to speak, and that members of the committee have sufficient time to ask them questions.

We'll begin with the representative from the Canadian Medical Association, Dr. Henry Haddad.

[Translation]

Dr. Henry Haddad (President, Canadian Medical Association): Bonjour. Good morning.

Madam Chair and members of the committee, my name is Henry Haddad. I am the President of the Canadian Medical Association and a practising gastro-enterologist at the University of Sherbrooke. For those of you who may be unfamiliar with the Eastern Townships, this is one of the prettiest spots in Canada. We are very close to nature. In fact I consider myself to be a country doctor.

As President of the Canadian Medical Association, I am here today representing our members, the more than 50,000 physicians from across Canada. Our members include residents, medical students, general practitioners and specialists.

The Association has a two-fold mission, namely to provide leadership for physicians and to promote the highest standards of health and health care for Canadians.

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I am accompanied today be the following members of the CMA: Dr. Bereza, a physician-ethicist from McGill University in Montreal and Chair of our Committee on Ethics, and John Williams, our Director of International Health and Ethics.

I want to thank the committee for providing our coalition of health care provider organizations with the opportunity to comment on the draft legislation on Assisted Human Reproduction.

The organizations appearing before you today all share a similar perspective on the proposed legislation, as do the Canadian College of Medical Geneticists, the Canadian Council on Health Services Accreditation and the National Council on Ethics in Human Research, whose representatives are present today.

Our goal as a coalition is to ensure that government legislation regulating on Assisted Human Reproduction adequately protects and promotes: first, the health and safety of Canadians in the use of human reproductive materials for assisted reproduction, other medical procedures and medical research; secondly, the appropriate treatment of human reproductive materials outside the body in recognition of their potential to form human life; and thirdly, the dignity and rights of all persons, in particular children and women, in relation to uses of human reproductive materials and the treatment they receive.

Turning specifically to the brief submitted by the Canadian Medical Association, we strongly support the objectives of the proposed legislation as laid out in the Preamble.

However, like others who have appeared before this committee, we do not believe that criminalizing the medical and scientific activities named in the bill is an appropriate way to achieve those objectives. We consider that the objectives could be as well achieved by less drastic means than criminalization and, moreover, that criminalization would create major obstacles to legitimate medical and scientific progress in the treatment of infertility.

The CMA is not opposed in principle to the idea of prohibiting certain activities, although we have not at this time taken a position on whether any of the specific activities listed in clause 3 of the draft legislation should be prohibited. Our issue is not with the prohibitions as such but rather with the means by which prohibitions, whatever they are, should be given effect.

We propose that the determination of permissible activities, whether temporarily or long-term, should be made by a regulatory agency on the basis of up-to-date scientific information, public input and ethical review.

Criminal legislation is very difficult to change and is therefore appropriate for activities whose status is unlikely to change over time, such as murder and theft, rather than medical and scientific activities that are constantly developing.

The latter are better left to a representative regulatory body to determine if and when changes in health and safety considerations and public attitudes and values might justify allowing certain formerly prohibited activities to take place under specific conditions.

Criminal penalties could apply where controlled activities are performed without authority of a license from the regulatory agency or in defiance of the licensing conditions established by the agency.

Because the draft legislation has little say about an oversight and regulatory regime, we recommend that the bill not be introduced in Parliament until it incorporates specific provisions for a regulatory agency.

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Such an agency should incorporate and utilize existing bodies and institutions as appropriate. Secondly, it should acknowledge, respect and build upon the important role that various health providers and their professional colleges and associations play with respect to these matters and thirdly, they should be sufficiently accountable to Canadians and involve Canadians as appropriate in ongoing policy decision-making and oversight regarding these matters.

The agency should be give appropriate responsibilities and accountability for coordinating the activities of organizations that are already working in the area of assisted reproduction, many of which are present here today, and for carrying out functions that these organizations cannot perform.

Thank you, Madam Chair and members of the committee. We will be pleased to respond to your questions on our presentation.

[English]

The Chair: Thank you, Dr. Haddad.

We will now have, from the College of Family Physicians of Canada, Dr. Richard MacLachlan, who is the chair of their committee on ethics.

Dr. Richard MacLachlan (Chair, Committee on Ethics, College of Family Physicians of Canada): Good morning. Bonjour.

Madam Chair, members of the committee, I am head of the Department of Family Medicine at Dalhousie University. I've chaired the ethics committee for the past seven years for the College of Family Physicians of Canada.

I'm delighted to have the opportunity, on behalf of my colleagues, to dialogue with you today on the important topic of assisted human reproduction. You should have a copy of the CFPC brief in front of you.

I am here representing the family doctors of Canada. Most Canadians have a family doctor. We're the point of first contact in the health care system for persons with reproductive concerns, and we continue to be involved with our patients as the fertility concerns are addressed. I feel we know what our patients and your constituents are thinking, and want, with respect to assisted human reproduction.

I would also like to laud government for the objectives as spelled out in the preamble of this draft legislation. Clearly government has listened to the discussion since Bill C-47 and incorporated much of the solicited wisdom into the objectives.

I would also like to commend the government on the recognition of the need for a comprehensive regulatory regime, with some reference to the involvement of existing professional organizations. This represents major progress since Bill C-47.

The College of Family Physicians of Canada has three principal concerns about this draft legislation. There is a dearth of information in the proposed legislation about the specifics of the proposed comprehensive regulatory regime, and in particular its relationship to the extensive activities of existing organizations involved in reproductive technique training, accreditation, licensure, research, and quality improvement.

It is unclear from the proposed legislation what the relationship of this proposed regulatory regime would be to government. At the many meetings we've had with Health Canada since the demise of Bill C-47, the unanimous opinion I've heard given to government is that the regulatory regime must be at arm's length from government. This was certainly the position our coalition of health organizations presented to Health Canada when we met with them in March 2000.

The College of Family Physicians can support the prohibition of certain practices. Our significant concern is over the means of prohibition, namely the use of the Criminal Code. We feel, as do others before you today, that the Criminal Code should only be used as a last resort, and only in cases of deliberate contravention of stated professional standards. The Criminal Code should not be used to prohibit specific practices. This again was the position our coalition of health organizations presented to Health Canada in March 2000.

In making briefs and presentations, it's easy to lose sight of why these complex issues of legislation and regulation really matter. The fact is, they matter because of the people they affect. It's hard to imagine draft legislation that could be of a more personal nature to patients and their families than the one now being considered.

There are perhaps 60 of us in the room today. The literature and my own experience as a practising family physician would suggest that at least six of us present today are in a relationship that has, or has been having, reproductive concerns.

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When you consider that there are 20,000 family doctors in Canada, each with perhaps 1,500 patients, in a given year we would see perhaps 30 million Canadians who seek our services for counselling, health promotion, diagnosis, treatment, and referral to specialists. Using the one-in-ten rule, which seems to be the standard in terms of the risk of infertility, it means that as family doctors we would see in excess of 100 couples each year with some sort of fertility concern.

These couples presenting with seeming infertility represent a very special challenge to us. They often come feeling that they're failures; there's something they've done in the past. They present with great emotional turmoil, tension in their relationship, and a lack of hope. Our role is to listen to them, guide them, and support them through the labyrinth of decision-making that will be before them.

These people—our patients, your constituents—are not concerned about the potential of cloning of hybrid species. They're concerned about having biological children, and availing themselves of services to support them in that quest that are appropriately regulated and supported by evidence.

That is why the legislation crafted to address reproductive technology must respond as adeptly to the concerns of today's patients as it does to the concerns of tomorrow's scientific advances. Both priorities are legitimate. Both priorities demand our care and attention.

The draft legislation, to me, fixates on the latter and appears to dismiss the former. That is a profound disservice to the thousands of people who are now, or will soon become, actively engaged as patients of the reproductive technology system.

So much has been achieved in the area of assisted human reproduction in the past 20 years. It has been done through a partnership of patients, governments, health providers, medical and professional associations, medical schools, and licensing authorities. These same partners need to be involved in any new regulatory regime.

It is important that your committee not lose sight of the patient and family unit, as you dwell on the more scientific fiction aspects of proposed prohibited practices. This is what's lacking in the draft bill.

The College of Family Physicians of Canada looks forward to continued active involvement as government refines its thinking on this important part of clinical practice in our patients' lives.

Thank you, Madam Chair.

The Chair: Thank you, Dr. MacLachlan.

We'll proceed to the representative of the Canadian Nurses Association, Dr. Janet Storch, who is the ethics scholar in residence.

Dr. Janet Storch (Ethics Scholar in Residence, Canadian Nurses Association): Thank you very much.

The Canadian Nurses Association is a national voice of Canada's nurses. We represent 100,000 registered nurses through 11 provincial and territorial associations and 27 affiliate and associate groups.

We are pleased to respond to the draft of the proposals for legislation governing assisted human reproduction, and to appear before you as part of this coalition of health providers.

This is not the first time we have appeared before this committee to discuss assisted human reproduction. Our views have not changed since we told this committee almost five years ago, in relation to Bill C-47, that while we are very pleased that this government has moved forward in setting a legislative and regulatory framework for reproductive technologies, we are concerned that the curative approach overrides preventive health strategies.

Nurses working in research and in patient care related to human reproduction face ethical issues on a daily basis. Our approach to these issues is framed by a code of ethics that emphasizes maximizing well-being, whether in situations of normal health, illness, injury, or in the process of dying; respect for the autonomy of clients; the dignity and self-respect of all human beings; respect for privacy; principles of equity and fairness; accountability for professional behaviour; and practice environments that encourage safe, competent, and ethical care.

We have handed out the full text of the code of ethics that guides our work, and we urge you to consider using it to frame your deliberations.

The draft legislation before us causes us some concern. There's concern about the transparency of the regulation making, and concerns about the blending of clinical practice and research. Each deserves focused attention, in our view.

Research ethics review is a complex and critical process. There are guidelines for all research involving human participants, which require consistent ethical practices regarding consents, balancing of risks and benefits, etc.

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Our recommendations are the following. CNA recommends that the assisted human reproduction framework recognize the distinctiveness of research and of clinical practice in dealing with this matter.

CNA further recommends that assisted human reproduction research guidelines and practices be dealt with through the existing Canadian research ethics guidelines and processes.

A number of other concerns have been well addressed, and they will be better addressed by our coalition colleagues. So I will focus on five concerns where we believe a balance must be struck: promoting wellness and curing illnesses; the psychological impacts of assisted human reproduction as well as the physical; providing sufficient information about risks and benefits for truly informed choice; protecting confidentiality; and balancing the application of new laws and regulations with the use of professional ethical standards already in place.

Relative to wellness and illness, CNA recommends that the Standing Committee on Health review the evidence and seek ways to maximize preventive strategies related to sexual and reproductive health.

In relation to psychological impacts, CNA recommends that the Standing Committee on Health review the strategies related to informing and supporting those at risk of psychological effects from assisted human reproduction.

In regard to informed choice, CNA recommends that the act include a definition of consent that embodies the concept of informed choice.

In regard to confidentiality, we support children having access to information about the health status of donors and their families.

In regard to structures and processes, CNA recommends that the committee carefully balance the creation of legal and regulatory regimes with the existing professional codes of practice and accreditation standards in a way that takes advantage of the flexibility of the latter.

We believe that using laws and regulations to manage the delivery of assisted human reproduction services can be compared to a curative approach. It is useful, but as a last resort.

The best way to assure a reproductively healthy population is through prevention, through the promotion of simple, inexpensive, healthy practices on the part of all Canadians. The best and most flexible way to ensure that people receive safe, effective treatment to assist in human reproduction is through the ethical standards that govern the work of all health professionals.

From where you sit, laws and regulations—and that is what we have before us—may look like the logical approach, but we don't think it will do the job.

Thank you for your time.

The Chair: Thank you, Dr. Storch.

We'll move on to the representative of the Society of Obstetricians and Gynecologists of Canada, Dr. André Lalonde, who is the executive vice-president.

Dr. Lalonde.

[Translation]

Dr. André Lalonde (Executive Vice-President, Society of Obstetricians and Gynaecologists of Canada): Thank you, Madam Chair and members of the committee. I am Dr. André Lalonde. I am an obstetrician and gynecologist as well as Executive Vice-President of the Society of Obstetricians and Gynecologists of Canada. I am also the SOC representative on Health Canada's Working Group on Reproductive and Genetic Technologies.

It is a pleasure for me to address the Standing Committee on Health on the issue of assisted reproductive technologies on behalf of the SOC. The SOC represents over 2,750 obstetricians and gynecologists as well as general practitioners, researchers, nurses, midwives and other health care providers involved in women's reproductive health care.

The SOC's mission is to promote optimal women's health through leadership, collaboration, education, research and advocacy. The Society embraces values and beliefs that lead to improved patient care, including the facilitation of change in the health system.

The SOC has submitted a detailed brief on the draft legislation but will limit its presentation today to three areas: the establishment of a regulatory body; the SOC expertise in the establishment of standards of practice and the development of evidence-based clinical practice guidelines; and finally we will address some social justice issues.

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With regard to the proposed regulatory body, new reproductive technologies are continually arising and evolving. The benefits, ethics and safety of each of these techniques will require ongoing evaluation.

Research and funding are required to follow the long-term health of men and women who choose to use these techniques and the offspring arising from the technologies without compromising confidentiality and right to privacy.

The establishment of a regulatory body is therefore essential to monitor and analyze the evaluation of these techniques, the collection of data and the dissemination of information and to determine future research requirements.

The SOC thus commends the government of Canada for proposing the establishment of a regulatory body to oversee the implementation of the proposed legislation. As recommended by the Working Group on Reproductive and Genetic Technologies in its recent report, the Society also strongly endorses a shared model of governance that would include representatives from government, medical colleges, professional associations, service providers and researchers.

These stakeholders would be in a unique position to collaborate and coordinate their respective efforts to oversee and administer the legislative and regulatory framework with regards to assisted human reproduction while ensuring the coexistence of guidelines and standards of practice established by medical and professional associations.

A shared model of governance would ensure an equilibrium between government guidelines that provide broad direction and requirements, and medical guidelines and standards of practice that provide more specific direction and details to service providers.

Secondly, with regard to the establishment of standards of practice and the development of guidelines, the SOGC has 18 clinical committees working on a number of different issues, including a reproductive endocrinology and infertility committee.

The SOGC clinical committees have developed over the years more than one hundred clinical practice guidelines, policy statements and committee opinions on a diverse range of topics. Organizations such as the SOGC and CFAS have a key role to play in the establishment of standards of practice and the development of guidelines.

Health care providers across the country rely on the evidence-based direction and treatment options provided by these guidelines. These documents are therefore considered “state of the art” guidelines for excellence in patient care.

We recommend that the development of guidelines and standards of practice in the field of assisted reproductive technology remain the responsibility of the SOGC and CFAS, two professional associations who have a well-established reputation in this area of expertise, and that funding be available for their development and distribution.

Lastly, with regard to social justice issues, while today's technologies may well open the door to new possibilities, we emphasize that a great deal more can be done to prevent infertility through education, information sharing and dialogue. One need only look at the statistics to be convinced: at least 20 per cent of female infertility is caused by sexually transmitted diseases, and this may rise in the future due to a known increase in chlamydial disease in our current teen and early 20s population in Canada.

The SOGC will soon launch a national initiative to promote sexual and reproductive well-being. One of the goals of this new program is to provide men and women the tools to adopt safer sex practices, thus preventing the spread of sexually transmitted diseases.

We therefore recommend that funding be available for the implementation of national education initiatives on the prevention and treatment of infertility. Currently, the provision of treatment for infertility is not equitable across the country and women who suffer from infertility in our province have greater access to treatment options than women in other provinces.

In Canadian society, infertile couples suffer medical and psychological consequences if infertility is not treated. Even if the treatment is unsuccessful, it allows the couple to cope better and resolve their infertility issues. Therefore, medical treatment, if desired, should be accessible regardless of geography or economic status.

While we acknowledge that not all infertility treatment options can be publicly funded, the adoption of national standards would at least provide equitable access to all Canadians. Access is currently determined by financial considerations and this requires further discussion by all stakeholders, including women's groups.

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As such, we recommend a wide consultation process that will include the public in order to discuss which health investigations and technologies should be covered by public insurance.

We also recommend the development of an annual report card to monitor the progress of prevention and treatment of infertility.

In closing, I would like to state that the SOGC upholds, above all else, that it is the right of every single Canadian to have universality, equality of access, efficiency, and effectiveness in reproductive health care. Thank you.

[English]

The Chair: Thank you, Dr. Lalonde.

We'll now have the Federation of Medical Licensing Authorities of Canada in the person of Dr. Donald Chadsey, who is the acting registrar and executive director.

Dr. Chadsey.

Dr. Donald Chadsey (Acting Registrar and Executive Director, Federation of Medical Licensing Authorities of Canada): Madam Chair, members and colleagues, thank you very much.

My name is Don Chadsey, and for 18 years I practised as an Alberta specialist in obstetrics and gynecology, with the emphasis on reproductive medicine care of couples. For the past 14 years I have been on the staff of the College of Physicians and Surgeons of Alberta, and am presently its acting registrar. It is in that capacity that I represent the Federation of Medical Licensing Authorities of Canada, known commonly as FMLAC. This is a national organization. It's formed by and represents the ten provincial and two territorial medical licensing authorities in Canada.

I pause a moment to emphasize the distinction between a medical licensing authority, called in most provinces a college, and a medical school, sometimes called a medical college. It was an unfortunate historical error that licensing authorities were labelled colleges.

One of the most important functions of medical licensing authorities is to set standards and to ensure that physicians meet them. It results in a generally high quality of medical care in Canada. The federation's focus in this matter is very narrow, and it is that narrow focus that I bring to your attention today. I particularly wish to address the areas of the draft legislation concerning accreditation and regulation of individuals and facilities providing clinical and research services utilizing reproductive and genetic technologies.

Earlier input by my colleague representing the Canadian Medical Association suggested a shared model to oversee reproductive and genetic technologies, involving representation from government, service providers, medical and professional associations, patient associations, and other stakeholders. That group, it was proposed, would work collaboratively, coordinating their respective strengths. In doing that, roles and responsibilities must be developed—that would be very important—and then accepted by all. Funding sources for start-up and operation of the accreditation agency will be important as well. The question I hope to address is what part medical licensing authorities can play in regulation of our GPs. I suggest the following, two main areas, and then a group of others.

First, the licensing authorities can provide recognition and licensure of physicians suitably qualified to provide clinical and research services in these technologies. This is what we do on a daily basis. We determine whether or not a given applicant for licensure is appropriately qualified. On an ongoing basis, we ensure that this person maintains competency and provides a good quality of care. We are supported by our provincial and territorial legislations in doing this.

Usually licensure is based on the applicant's successful completion of Canadian training programs and certification examinations, such as those established by the Royal College of Physicians and Surgeons of Canada or by the College of Family Physicians of Canada. From time to time appropriate international medical graduates, on presentation of evidence of their training, can be licensed in certain cases.

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Our second main role would be in the area of standard setting, and this again is something we do regularly. We develop and circulate to our members and the public policies concerning professional activities and appropriate behaviour.

We could contribute well, I believe, through experience in these areas, to the development of national standards for the reproductive and genetic technologies facilities, and participate in the development of accreditation processes. We do, in most provinces, regularly engage in the inspection of practice locations, the assessment of the individual physicians working there, and from time to time must require change through retraining and upgrading, when that's found to be necessary.

A group of other activities in which we could contribute includes maintenance of registries. That is something we do with respect to our membership. It could be possible for us to contribute in developing registries related to the activities of these facilities. The development of policies concerning ethics is again something that is done by both the Canadian Medical Association and individual licensing authorities, among others. The Alberta college has currently a functioning research ethics board, which reviews proposals, and so could contribute to the processes to be developed for the national agency proposed in the legislation.

I believe there would be mutual benefit between the national agency, in whichever form it is finally established, and the individual medical licensing authorities. More than that, there would be benefits to all parties among the licensing authorities from their involvement in this.

There is currently a very active process of accreditation and regulation of a large number of facilities, especially in the larger provinces—Quebec, Ontario, Alberta, Manitoba, British Columbia. Alberta, for example, has extensive quality assurance programs in relation to laboratory medicine and diagnostic imaging, including ultrasound, and as I mentioned earlier, it has its research ethics board.

In summary, then, Madam Chair, I do believe that the medical licensing authorities of Canada stand ready to participate in the development and operation of any regulatory agency for reproductive and genetic technologies in Canada.

I thank you most sincerely for this opportunity.

The Chair: Thank you, Dr. Chadsey.

I'd like to welcome the president of the Canadian Fertility and Andrology Society, Dr. Jacquetta Trasler, and speaking on behalf of that society will be Dr. Arthur Leader, who is the chair of the government relations committee.

Dr. Leader.

Dr. Arthur Leader (Chair, Government Relations Committee, Canadian Fertility and Andrology Society): Thank you very much, Madam Chair and members of the committee.

I am a reproductive endocrinologist and infertility specialist in Ottawa, and have been in this field for over 20 years. I'm here today representing over 500 physicians, scientists, health professionals, and patients, those who actually use the reproductive services we're discussing today.

The society has a threefold mission: to promote education and research in reproductive medicine and science; to provide accreditation, expertise, and processes for measuring the outcome of therapy; and to respond to social needs with regard to human reproduction. As noted, Dr. Jacquetta Trasler, our president and a clinician scientist from Montreal, accompanies me today.

I want to thank the committee for giving the CFAS the opportunity to return to comment on the draft legislation. We share the perspectives outlined today by the previous speakers. As with our colleagues, we strongly support the intent of the proposed legislation, but are concerned about certain flaws in the document under consideration. A detailed discussion of our concerns is in our brief, which I trust you have.

We believe these flaws will deprive Canadians of the best care and limit our ability to participate in those research opportunities that will be so important to the future health of Canadian women, men, and children.

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CFAS wishes to emphasize that we deplore and oppose any effort to clone a human being; we oppose ectogenesis, as well as research on embryos after 14 days; we oppose the transfer of embryos between animals and humans; we oppose the use of embryos without the consent of the donor; and we oppose commercial surrogacy.

The other listed prohibitions would prevent both legitimate and important medical-scientific research and the best available care to Canadians who suffer from infertility, diabetes, Parkinson's disease, and spinal cord injury, to name a few. Where necessary, clearly specified activities should be controlled acts.

We have substantial concerns about the following elements.

In paragraph 3(1)(b), we wonder what is the purpose of prohibiting potentially life-saving or life-promoting technologies in advance of their development.

Respecting paragraph 3(1)(d), almost all research to advance infertility or care has required that a technique be validated in the laboratory. To do this we need to create embryos to confirm that fertilization and embryonic development are normal. The CFAS does not support a ban on the creation of embryos in research, but rather believes that this research should be carefully regulated under the oversight of a national regulatory authority.

We believe paragraph 3(1)(e) should be deleted, as it's included in our redefined paragraph 3(1)(a).

Paragraph 3(1)(g) we feel is premature in that it prohibits technologies that could protect the reproductive future of young cancer survivors and women with autoimmune diseases or severe blood disorders.

Paragraph 3(1)(h) should be rewritten to state that there is a controlled act that allows sex determination for the diagnosis of sex-linked chromosome disorders, but not for the selection of a preferred sex for other reasons.

Subclause 9(2) is particularly disturbing to us, because it would effectively stop or impede all Canadian research or studies into the function of the human genome, important to our understanding of human disease and its treatment. As written, this controlled act would require a licence for each research project that uses transgenic mice engineered to carry a human gene—a common procedure that's used to understand the genetic origins of illness and is part of approved genetic research across Canada. The negative impact, both on research and on industrial research, would be huge.

We are surprised and disappointed that this draft bill provides no description of a regulatory framework. As said previously, stakeholders have worked for over a year in partnership with Health Canada to develop a regulatory framework for assisted human conception, the shared model. This consensus is nowhere reflected in this bill.

The CFAS believes accreditation should serve as the basis for licensing facilities that provide these services. Under development for ten years, today this is a practical option. An accreditation program for IVF and donor-sperm clinics has the unanimous approval of all the clinics in Canada today and the CCHSA, and we are planning to start the three-year cycle of accreditation of every Canadian clinic in early 2002. The CFAS agrees that accreditation by the CCHSA and ourselves and the SOGC is a better option than inspection alone.

Over the past three years the CFAS has voluntarily established and managed a program for the collection and analysis of comprehensive nation-wide data on the outcomes of IVF. We have done this because we believe this data is vital to our patients and to the clinics. We have released live-birth data for 1999 and pregnancy data for the year 2000. Currently all clinics participate in this registry. We believe ownership of the information in the registry should be shared with providers, patients, and the public, and the regulatory authority and not Health Canada should maintain such a registry.

Within the draft bill there are several scientifically incorrect or incomplete definitions. In her testimony to this committee, Dr. Patricia Baird raised similar concerns. As these definitions are central to the legislation, the CFAS recommends they be revisited and revised. In our brief we have provided some suggestions and would be willing to further assist the committee if requested.

We hope these comments will be useful to the committee as it works toward recommending a draft bill that respects the real needs of the infertile and encourages an ethical and scientific basis in their care.

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As you consider this bill, we ask that you walk with the women and men who are our patients and those who do the cutting-edge research in university and industrial laboratories across Canada.

Thank you, Madam Chair and members of the committee. We welcome your questions on our presentation and our brief.

The Chair: Thank you, Dr. Leader.

We'll now proceed to questions by members of the committee, and we'll begin with Mr. Manning.

Mr. Preston Manning (Calgary Southwest, Canadian Alliance): Madam Chair, I'd like to thank all our distinguished guests.

I know you've been limited in your time. I'm sure each of you could talk for an hour on your specialties, and we would really like to hear that and certainly will study your briefs with interest.

I have two questions. Maybe the first is for Dr. Haddad and the second for the entire panel.

The first question is on jurisdiction. You referred to your concerns about the heavy emphasis on the criminalization of the prohibited activities in this bill. I think you all realize where that came from. It came from the old argument about whether this is a federal or provincial responsibility.

When the minister told his officials he wanted to legislate in this area, they said “Mr. Minister, you've got a bit of a problem, because this is human health, and a lot of that is in the provincial jurisdiction”. He no doubt said to them “Well, how can you beef up the federal jurisdiction?” The standard argument from the lawyers is to criminalize everything you want to prohibit, because the criminal power is a federal power. So the basis for federal legislation in this area in essence depends to a large extent on criminalization.

My question to you is, really, where should we ideally draw the line between the regulation of the safety aspects of research related to assisted human reproduction, which obviously is a federal responsibility, and the practice of assisted human reproduction services and research, which does tend to get more into the provincial area? Can you give us any guidance on where we could draw a line that would ensure this legislation doesn't end up in the courts, down the road, in a federal-provincial dispute?

Dr. Henry Haddad: Well, not being a lawyer...

Mr. Preston Manning: That helps you.

Voices: Oh, oh!

Dr. Henry Haddad: Yes, it could.

I want to come at this from perhaps a roundabout way, and try to have the committee realize why it is important for us to distinguish between criminalizing an activity and prohibiting it, if you will permit me.

Research is there to serve the needs of patients. I think that's the bottom line. That's the most important thing we have to live with, and we know that today's research is tomorrow's medicine. This means bringing onstream new treatments and new cures. The object, of course, is to improve the quality of life of our citizens and to enhance human dignity.

Another reason for research is to take existing treatment... I'm a gastroenterologist and have seen what's happened with peptic ulcer disease, where we took existing treatments, did research on them, and now have revolutionized the treatment of peptic ulcer disease. People don't get operated on any more for peptic ulcer disease.

So we're making treatments safer and more effective, and this is very important. Everybody benefits from research, and I think you have had at this committee a number of patient representatives who have expressed their support for research.

What we feel, with all respect, is that criminalization is really an extreme option that in a society such as ours should really be used as a very last resort. We believe the prohibitions can be achieved by other means that are less invasive and just as effective and probably would respect the federal jurisdiction. Criminal prohibition to us is really a blunt instrument that would hinder—I think you've heard my colleagues speak along the same lines—legitimate scientific and medical progress in the treatment of infertility, which none of us around this table would want to see happen.

To achieve prohibitions, I believe that what we recommended to the committee—that is, the creation of a regulatory body that is independent and accountable—would achieve what you were mentioning and also ensure greater flexibility, and an ability to respond rapidly. Scientific evidence is emerging very rapidly, and public opinion is changing rapidly. With what we're proposing, a regulatory body, we could add to prohibitions, strengthen existing prohibitions, and take off prohibitions.

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We saw what happened with Bill C-47, when we had a blanket prohibition on cloning. Things have changed since them. Dr. Leader and Dr. Lalonde have talked about that.

I think if we do criminalize, if we do put things under the Criminal Code, then bringing about changes in ethical and scientific issues, which we have seen is very difficult to do, would take a long time, a lot of effort, and would delay the whole process.

There are things that can be criminal offences—for example, if you're doing your work without a licence, which I think my colleagues have talked about, or if you're going beyond what your licence was accredited for. These, in our view, can be criminal acts and can very well fall under federal jurisdiction.

For a gastroenterologist, this could be a very simplistic way of looking at the law. If I'm making a mistake, please correct me.

I don't know if any of my colleagues have something to add.

Mr. Preston Manning: Maybe I can go on to my second question, because it really follows from what I think your answer is, that the way to solve this jurisdictional thing is to create a regulatory body and make sure it has the right jurisdiction, but don't get the federal jurisdiction just by relying on the Criminal Code. I think many of us here agree with that.

Secondly, I can say we very much agree with your principal recommendation that what this committee has to get onto pretty quickly is the form and shape of this regulatory body. The bill is very loose on that.

The minister, to be fair, said he made it loose so the committee could come up with its best recommendations. We want to fill in that blank.

My second question, really to all of you, is what is your best recommendation on the shape and form of the regulatory body? You can go to one end where you go to a quasi-judicial, court-type regulator, which has the independence. The difficulty with too much independence is it's very hard to hold accountable. At the other end, you can have an agency that's under the minister and under the department, and the minister can be questioned on every detail of it in the House and elsewhere. It has more accountability, perhaps, but it is not at arm's length from the government, nor perhaps from other influences.

My question is, can you give us any general guidelines on the shape and form of the regulatory body that you feel would best achieve independence and accountability?

Dr. André Lalonde: If I may answer this, we have examples internationally. In the U.K., as you know, the HFEA is an independent body; it's at arm's length. It has to report both publicly and through Parliament through the Minister of Health. This way there could be questions on what that body is doing. That body would be composed of representatives from government, providers, and patients, and it would use the existing organizations in Canada for quality assurance, for inspection, etc. So I think it has to be at arm's length from the Department of Health.

With all due respect, we think the Department of Health, having that kind of body attached to it, would be very difficult to move and to adopt new techniques or new demands by Canadians. We think the Department of Health would be very cumbersome and very slow in bringing about new changes or discussing new things. It would be tied down for political and all kinds of other reasons. We're very anxious about viewing an agency that would be tied directly with the Department of Health.

So it would be quasi-judicial, if you like. It would be a corporation that would be that formed, and it would report to Parliament through the Minister of Health.

Mr. Preston Manning: Anyone else?

Dr. Richard MacLachlan: When we met with Health Canada in March 2000 we were asked this very question. The points we put forward at that time, as to why it should be outside of Health Canada, were that it would be more responsive, more transparent, held to a higher standard, and more resilient to government change. Those were the reasons our coalition put forward to Health Canada in March of 2000.

Mr. Preston Manning: Okay.

The Chair: Thank you, Mr. Manning.

Ms. Sgro.

• 1155

Ms. Judy Sgro (York West, Lib.): Thank you, Madam Chair.

Going back to this issue of enforcement and criminalization, in the short time I've been here I've always had concerns with regulatory bodies and the ability to really enforce certain things. That is why, in dealing with this very difficult issue, and being frightened to death with it initially when we started looking at it, the issue of enforcement...

[Editor's Note: Technical Difficulty]

So I felt much better knowing we were talking about going to criminalization.

There's a part of me that knows maybe that isn't the best way to go, but I worry about having teeth and having the ability to actually enforce certain things. I guess we're looking to make sure we do the best job we can on this very difficult piece of legislation.

What kind of enforcement would you see a regulatory body doing that would actually have some teeth in it?

Dr. André Lalonde: I think one of the things a regulatory body would do would be to give a licence to a clinic. If you lose your licence, these physicians, these scientists, cannot work. I think that's a pretty serious move, and it certainly protects the public. You would have to meet certain standards, just as we do now. Why is our hospital system good in Canada? Because we have accreditation. No hospital wants to be seen in the press, in the public, as losing their accreditation. This has served Canada very well until now.

I think even if you had it in the Criminal Code it would not be any faster or slower, because somebody could say they're on appeal, and that clinic could function for another nine years before all the appeals and all the courts have ruled on it. So I think regulation of a licence that has to be renewed every year or two, a regular inspection, would provide a long margin of safety.

Second, the colleges of the provinces are giving you the licence to practice. When you're suspended, it's a very serious issue for any physician or any health professional. I think you have both protections.

Ms. Judy Sgro: But a lot of things will happen before it ever reaches that point. I'm not sure on this particular aspect, but with many things, there are many violations sometimes for many years before action happens. I'm not suggesting it might be in this case; I'm referring to other areas.

Dr. Henry Haddad: If I could just add to what Dr. Lalonde said, in the Canadian Medical Association's brief there is our policy on AHR, which was accepted by the board of directors. It's divided into three: the objectives, the principles, and the elements.

If you look at the elements, what we're proposing, and our colleagues are in agreement with this, is to create this national regulatory body, but they would develop and monitor national standards for research related to human subjects, including genetics and reproduction; develop and monitor national standards for training and certifying physicians; license and monitor individual physicians, as Dr. Lalonde mentioned; develop guidelines for medical procedures; and accredit facilities for AHR. What we're proposing for the regulatory regime is very comprehensive.

The Chair: Would Dr. Chadsey like to comment?

Dr. Donald Chadsey: Madam Chair, thank you.

As a regulator, I understand all too well the doubts that reside with the public as to our effectiveness and our good will in how we function. I understand Ms. Sgro's concerns.

I'm not sure on that point there is a great difference necessarily between regulation with prohibition on the one hand, and with criminalization on the other. Things may happen, or not, for a period of time before they're discovered and dealt with effectively under either system.

As regulatory agencies, the colleges provincially deal all the time with expressions of doubt and concern from the public, who think they're wasting their time bringing any concerns or complaints before the colleges because they believe they will simply be swept under the carpet, that we exist merely to protect bad physicians.

On the other hand, those physicians, whom we deal with effectively in a variety of ways, including punishments of one sort or another, would see it the other way around.

It's a very narrow margin, I suggest, between too much regulation or too little regulation, effective regulation and ineffective regulation. We can only make our case publicly by demonstrating through effective regulation that we do have our hats on the right way and that we are prepared to take tough decisions when they're necessary.

• 1200

The Chair: Dr. MacLachlan and then Dr. Storch.

Dr. Richard MacLachlan: I think other responses that might be even faster, if you think of accreditation every three years, etc., are within your institutional framework.

I come to this having been one of those hospital administrator types, as a vice-president, medical, of a large teaching hospital for five years, but also having been head of a hospital department of 250 members. As head of the department I was responsible for the quality of care in that department. As a vice-president, medical, I was responsible for the overall care. I think we're quite aware of our responsibility to ensure patient care from both of those roles, from hospital administration and from within the medical staff organization.

If you had concerns that things were not up to a standard of care, probably your fastest response in terms of being able to do something today that would stop a practice today would be through your hospital bylaws or your institutional bylaws.

The Chair: Dr. Storch.

Dr. Janet Storch: This is also in response to your query. I just wanted to add that in addition to the licensing, accreditation, professional codes, and all the other possibilities that are out there, if there were accreditation of the facility and also accreditation of the research ethics board that was reviewing the research or however that would play out, remember that a key part of accreditation is peer review and an educational focus. The educational focus itself allows for continuous quality improvement, because when people are working with peers, they want to meet standards. It's not that you have to meet standards. It's that there is a desire to work with that and to be up to date on some of the latest approaches. So to me it becomes a far better tool because it has a buy-in that is on that educational mode and continuing to improve. I think it certainly exceeds what can happen under criminal law.

The Chair: Mr. Merrifield.

Mr. Rob Merrifield (Yellowhead, Canadian Alliance): Thank you very much for your presentations.

I'm intrigued by the piece of legislation we have in that it's so very weak when it comes to laying out exactly what you've all recommended for a regulatory body. Dr. Haddad suggested in his presentation to us that it had to be accountable. Can you give me—and I'll address this question to everyone—your best advice as to how this can be accountable? It's easy to put a regulatory body at arm's length from government. Yet it's responsive to the public. That to me is something we need to examine in order to try to get the very best model we can. Have you thought about it? I'm sure you have. Can you give me your advice there?

Dr. Henry Haddad: We would see it accountable, of course, to Canadians. Furthermore we would see that it would present to Parliament but through the Minister of Health. We find that to be a very acceptable model.

Dr. André Lalonde: On accountability, it's to make it transparent. I would argue that it's much more transparent with that body or with the British body than if you had it buried in some ministry of 5,000 people and the information was all filtered out through one person. You would have that body publishing every year the success rates and the new technologies that are being investigated.

Don't forget that because of its collaboration with all the other structures, the college of accreditation of Canada would ask how many institutions had been accredited. The colleges would report how many people are licensed in Canada. So you'd have about seven or eight different reports, and that body would have to issue a public statement. I think that's where accountability is the most transparent.

Dr. Arthur Leader: I think the other thing you want is something that recognizes that we live in a federal-provincial confederation and that there are provincial responsibilities. If you have an agency within Health Canada, then the provincial governments, to my understanding, would be loath to participate because being independent authorities, they wouldn't like to subjugate themselves to the federal authority.

• 1205

One of the reasons for having something that's shared is that it's not just shared with the Government of Canada but also with the provincial and territorial governments. It involves the providers and the accreditation.

CSA is working with Health Canada to develop standards for all organ and tissue transplantation, including reproductive tissue. So CSA would devise standards, and Health Canada would refer to them in regulations.

You have the provincial governments, which also need to have a voice. One of the concerns when you have the equivalency is that on the control acts you could, theoretically, have 10 or 12 different ways of doing something. If they signed on to equivalency, each of the provinces could interpret it differently and you'd get a hodgepodge. So you need some place where the various authorities can meet, discuss, and come to a conclusion that gives you a unified approach.

In response to the previous discussion, I would argue that prohibitions per se have not prevented things from going wrong and that the method that has been discussed in terms of enforcement and regulation is far more effective when you bring the various groups together. But within Health Canada you can't do that. It has to be outside, and the sharing has to be among all of the parties that have a responsibility and a duty in this area.

Mr. Rob Merrifield: Just to follow up on that, I would agree with your accountability. You're saying to leave it outside of Health Canada but to report through the minister. It's such a sticky issue in the sense that you have provincial and federal jurisdictions on this regulatory body, so you have to have buy-in from both sides.

I'm narrowing my question. I understand that procedure would take place, but who would be the best individuals and how would they be placed on a regulatory body in order to get that kind of buy-in and then to be accountable to the people of Canada through the minister? We're going to have to wrestle with this.

Dr. Arthur Leader: The “who” is something you're going to have to discuss. It should report both to the federal Parliament and to the provincial legislatures, because under the control sections, however they're defined, they will have responsibility for equivalency enforcement. So it has to be a collaborative approach between all of the parties.

How it actually is structured, what the board of directors does, and so on and so forth is something I don't think we can comment on at this point.

Mr. Rob Merrifield: So you would suggest that the individuals sitting on the committee could be politicians, members at large, and ethicists.

Dr. André Lalonde: We looked at some of these things briefly when we were working with the working group. The federal and provincial bodies would nominate, let's say, a third; a third would come from the providers; and a third would come from the public, just as we do in a lot of our major institutions. There are representative groups, including women's associations and the Infertility Awareness Association of Canada. They represent consumers. These people would be asked to submit names, and then the board would be selected. With regard to the size of the board and the exact functioning, I think all of us here would be willing to work on that, but so far we've not been asked to do that.

The Chair: We're not that far along, Dr. Lalonde.

Dr. MacLachlan wanted to comment.

Dr. Richard MacLachlan: A further point in terms of accountability, which again we talked about with Health Canada in March 2000, is the fact that in virtually all of our organizations we do have lay representation on our governing structures. In my organization, the College of Family Physicians of Canada, we have patients sitting on our governing board. As well as having patient groups represented, our licensing authorities do have lay representation. So it's not totally a self-serving profession. Our profession is governed in a manner that includes lay representation. That's a further check and balance.

Mr. Preston Manning: Madam Chair, could I take 30 seconds to make a suggestion?

The Chair: No, I'm sorry, it's not your turn. It's Madame Thibeault's turn.

• 1210

[Translation]

Ms. Yolande Thibeault (Saint-Lambert, Lib.): Thank you very much, Madam Chair.

With your permission, I'd like to focus on a different subject for a moment.

Dr. Lalonde, you concluded your presentation by referring to our health care system and to the great principles of universality, equality of access and so forth. These are issues near and dear to me. You talked about the adoption of national standards which would result in equal access for all Canadians. In fact, we all know full well that these new technologies are not accessible to everyone, and I think it's important for us to take a closer look at that.

How do you think the provinces would react if the bill contained a reference to this equality of access? Wouldn't they react immediately by saying that we are overstepping their jurisdiction?

Dr. André Lalonde: I believe your role should be to demonstrate that technologies and treatments, or prevention investigations are based on solid clinical proof. The provinces would then be more inclined to have these treatments and investigations.

Right now, a New Brunswick patient with a fertility problem does not receive the same treatment as an Ontario or Quebec resident.

Either we have a national health care system or we do not. A working group could be set up under the auspices of the new agency to try and identify common denominators. Whether it be in the field of heart transplantation or immunology, the provinces are trying to balance out their systems. While differences do exist, these are not major, such as the ones in the field of infertility. I think we could exercise a considerable amount of influence with a view to ensuring that certain basic treatments are available to all women, regardless of where they live in Canada.

Isolation is also a problem. Obviously, a woman who lives in northern Quebec or in Ontario will not have the same access to treatments as a woman who lives in Ottawa or Hull. These are just a few points that we need to consider. We want to make a contribution to this field.

Ms. Yolande Thibeault: I totally agree, Doctor Lalonde, and I thank you for pointing this out in your presentation. This is not an issue that we have examined at length until now.

My question is for any witness who cares to answer. It concerns privacy. Based on the proposed legislation, where assisted reproduction is concerned, the donor must identify himself so that any eventual offspring can have access to information about his genetic makeup. That's good.

Do you not think that the offspring of assisted reproduction also has the right, like any adopted child would, to know who his or her father is? I wouldn't want us to create a class of children who, upon reaching adulthood, would be treated differently because of the fact they are offsprings of these technologies.

[English]

The Chair: Dr. Leader.

Dr. Arthur Leader: I've read through the transcripts that this is a dilemma and a concern this committee has shared on a number of occasions. I think it's a very legitimate and important one. I've been doing assisted human reproduction care for 20 years, and when I started, the donors were not only anonymous but there was very little information available.

• 1215

What's evolved now is that the donors are no longer providing samples fresh; in fact, the samples are frozen and in quarantine, for safety reasons, for up to six months. This means you have the full genetic history of the donor and you have time to collect it. In addition, many clinics require that chromosome analysis be done as well as a full family history. So that information is currently available to all couples or women who choose to use donor sperm in particular.

In addition, many of the sperm banks, and there are a few now in operation, provide the information on the donor such as a picture of the donor as a baby, the picture of the donor as an adult, and sometimes videotaped interviews with the donor. It's really up to the couple who are undergoing the treatment, or the woman, because often it's a woman without a male partner who is doing this, to choose which donor they wish to use.

The experience from my colleagues in Scandinavia and in New Zealand, where they have required that all donors not only have complete genetic and medical information but in fact their identity be known, is that there are couples who don't want to do that and they go elsewhere. So the Swedish women go to Denmark, if they want to use a donor whose identity is not known. There is a choice element here.

The dilemma is—and I don't know the solution—that the couple or the woman who's making the choice may want an anonymous donor and the child who's born may want to know the identity of the donor. The problem is—and again, like Dr. Haddad, I'm not a lawyer—the fetus is not a person and certainly the sperm is not a person. So the child who is yet to be created and the child who is yet to be born can't speak on its behalf.

What you do, as I've done over 20 years, is counsel patients, and tell them. I've seen an evolution from people saying they are going to keep this a secret to saying they're going to tell the child. If they're going to tell the child they want to get complete information.

Currently they can get that information. They can go to any of the sperm banks and they have full medical history, genetic history back to grandparents. Under the new standards a sample of blood from the donor will be required, because we're moving into a genetic era where in fact you may want to know the exact genetic makeup of the donor.

That has evolved over time. But in the end, whether a donor should be known, for example it's George Brown or whoever, or whether the donor should be anonymous is really up to the couple. They can make that choice now. There are donors who say at the age of 18, when the child is at the age of majority, whatever that is, I will let myself be known to that offspring. But it's up to the woman to choose that donor and it's up to us to counsel them as to the importance of making that choice. And we try to. But in the end it's a woman's choice as to who she selects as the donor. But that information is available.

[Translation]

Ms. Yolande Thibault: Don't you think the rights of the child should take precedence in all instances? If a mother doesn't want her son or daughter to know who the parents are, does she really have the right to keep this information from her unborn child who may one day want to know?

[English]

Dr. Arthur Leader: I think it should be part of the process of informed consent and informed choice so that women are made aware of this as being an important consideration. But in the end I don't think you can oblige anybody to do that. I think what you can do is counsel them on the importance of this.

What the various donor groups have done, to their credit, is that the women who have had donor children who have sought to know the identity of the sperm donor—and it gets more complex when you talk about egg donors and then embryo donors—is that they have educated both the profession and the public that this is a question they must ask. I think it's a reasonable question, but it's not something you can legislate, because if not, people will go to another jurisdiction. They've done that in Sweden and in New Zealand. They've gone to another jurisdiction where it's not mandated.

So the right of choice still has to be there. And you can alter that choice by education.

Ms. Yolande Thibeault: Thank you very much, Doctor. You haven't convinced me, but thank you very much.

Dr. Arthur Leader: My pleasure.

The Chair: Madame Picard.

[Translation]

Ms. Pauline Picard (Drummond, BQ): Thank you, Madam Chair.

Let me start by saying, Dr. Haddad, that I agree with your observation about the Sherbrooke area being one of the prettiest parts of the country. Part of my riding is located in the Eastern Townships and I know for a fact that it's a lovely area indeed.

• 1220

You stated in your presentation that criminalizing certain activities would be obstacle to legitimate medical and scientific advances in the treatment of infertility. As I see it, human cloning for reproductive purposes would be more of a Band-Aid solution than an actual treatment for infertility. Could you elaborate further on your definition of infertility treatment?

Dr. Henry Haddad: I will leave that to my colleagues who are more familiar than I am with infertility issues.

It's important that we look at one thing very closely here. I would ask Dr. Bereza... On the subject of criminalizing certain activities, it's important for the committee to understand the effect that criminalizing certain activities would have on the doctor-patient relationship, which forms the true basis of the healing act and which has been a critical component since the time of Hippocrates.

With your permission, I would ask Dr. Bereza, a long-standing colleague who chairs our ethics committee, to talk to you more about the importance of the doctor-patient relationship in this area.

Ms. Pauline Picard: Fine.

[English]

Dr. Eugene Bereza (President, Biomedical Ethics Unit, Faculty of Medicine, McGill University): Thank you, Madam Chair.

[Translation]

I'll try to answer your question if I can. As Dr. Haddad pointed out, when we talk about the possibility of criminalizing certain activities,

[English]

I think we have to remember or keep in mind the primary importance of what the effect of criminalization would have on the actual doctor-patient relationship. In this case, if it's a woman or a couple who comes to speak to the physician about a potential form of treatment or a direction to go forward, we consider the doctor-patient relationship as a sacred building block. You have to have that trusting relationship so that you can actually help your patients.

My assumption would be that if we do fall back on the traditional ethic of the doctor-patient relationship, it's far more beneficial and therapeutic and helpful to the woman or the couple for the physician to be able to discuss a variety of options without labouring under the sword of Damocles that this is potentially or already a criminal act, especially when the things we're talking about are in a process of evolution and aren't fixed.

I would be giving you a very different answer if we were talking about a fixed entity that we all as a society agreed on. But my understanding—and I'm not an expert in obstetrics or gynaecology—is that we're looking at acts that are currently still moving. We give them single names. We say, well, this is cloning, whereas my understanding is cloning does not describe one kind of thing but several things. So what is it we're actually talking about when we say cloning should be outlawed? Are we talking about all of them or a subset of them?

We need to be very careful that we're specific, and we have to be very careful that, when we say something is criminal because we all agree, what are those criteria ethically that make it so?

Now, I was looking through some of the literature, and we use terms such as it would be “self-evident” that this would not be any good, or it would be bad. I'll be really honest with you; as an individual, some of those strike me at first perusal as being self-evidently... At the very least, I should be cautious about them.

My point, however, is that self-evident moral conclusions at a time like this, when the science is not fixed, when the moral and value structure isn't fixed, would be premature. We've seen things where we think we have a self-evident response, but in a multi-ethnic, pluri-ethnic society, it's not so apparent after careful consideration.

So when I tie that together with the context—the umbrella under which I would be entering a relationship with my patient and saying, these are potentially criminal things that we're going to be discussing—that's very different from me saying, let's talk about how I can help you. And then if I'm doing things that the licensing bodies are saying are out of reach, because all Canadians have had an input in that and have a quick way of turning over what cloning meant yesterday compared to next week, I think it's a far more efficient system.

• 1225

[Translation]

I don't know whether I've answered your question directly.

Ms. Pauline Picard: Yes, you have, because this brings me to my second question.

As you noted, the draft legislation addresses the issue of human cloning for both reproductive and therapeutic purposes, as well as other assisted reproduction technologies. It's all rather complicated.

Is the scope of this bill really too broad, as you seem to be implying? Everything seems to be thrown in the mix. As you said, this might discourage some couples from seeking treatment or from using these new technologies. Where do we fit in in all of this? We're not quite certain. Do the prohibitions apply to cloning for reproductive purposes? As you said, it's all rather complicated. Would you care to comment?

[English]

The Chair: I'm sorry, I'm not understanding your question. That was more of a statement. What is the question?

[Translation]

Ms. Pauline Picard: The draft legislation addresses the issue of cloning for both reproductive and therapeutic purposes, as well as other assisted reproduction technologies.

Is the scope of the bill overly broad? Wouldn't it be preferable to have one bill about cloning for reproductive purposes, and another bill that would ban cloning for therapeutic purposes?

[English]

The Chair: Dr. Leader.

Dr. Arthur Leader: I would agree with what you're suggesting, that it be quite closely limited. As we've said, we oppose the cloning of another human being. I can't see anybody in my lifetime wanting to do anything different. I think if you made it that specific, that would deal with the issue, and then you could allow latitude on the other aspects of manipulating cells. After all, therapeutic cloning is not for reproductive purposes, it will not benefit the reproductive capability of a person. As you've heard from the Parkinson's group and the diabetics and the spinal cord injury people, it will offer them the opportunity for therapy that is currently not available.

And that field, to expand on what my colleague was saying, is growing. We've talked about stem cells and embryonic stems cells. There are now indications that you can take the egg and use that as a basis for cloning, without getting into the area of embryos at all. So there are new developments occurring even as we're considering the bill at hand. There ought to be, in our opinion, a flexibility that allows you to take advantage of these developments, but in a framework that doesn't allow people to do things that are wrong.

When people, even Canadians, looked to cloning—the group that was in the press in Quebec—they didn't come to a Canadian clinic, because they knew we wouldn't do it. They went to an American or an Italian group, because they know that by our standards, as practitioners, this is something we oppose and would not do. To some extent, you have to trust the underlying ethics that we have, and then you have to guarantee that it's maintained.

The Chair: Dr. Castonguay.

[Translation]

Mr. Jeannot Castonguay (Madawaska—Restigouche, Lib.): Thank you, Madam Chair. Thank you to all of the witnesses for their presentations. It may make our lives more complicated, but it's our job.

As I understand it, the idea would be to place all of these activities under the direction of a regulatory agency which would operate according to a broad-based code of ethics. Given the rapidly evolving nature of this field, this would leave the door open to the possibility of fine-tuning along the way. Despite all of this, do you still feel that certain activities should be prohibited?

• 1230

I understood that cloning for reproductive purposes was one of the banned activities. Do you see any other problems with the bill?

[English]

Dr. Arthur Leader: I think in my opening statement I did indicate that we oppose ectogenesis, which means growing embryos outside the womb. We oppose research on embryos beyond 14 days. We oppose the transfer of embryos between animals and humans. We oppose the use of embryos without the consent of the donor and of a research ethics body. And we oppose commercial surrogacy. That's very clear.

[Translation]

Dr. Henry Haddad: Just so that you are clear on the CMA's position, we haven't really looked at certain areas. Certainly we don't oppose a ban on certain procedures. What Dr. Leader has just said seems perfectly reasonable to me.

At the national level, our association has focused on the process of regulating assisted reproduction. The CMA has devoted all of its energies to this undertaking. First, we wanted to ensure that we got the structure right and then we could attend to other matters. However, Dr. Leader's list of prohibitions seems entirely reasonable to me, and I think I could support it.

Mr. Jeannot Castonguay: Madam Chair, mention was made of national standards. Obviously, each province has a say in the matter and the committee's concern is that we end up with a dozen or so agencies and with different standards from province to province. We could even see patients deciding to change provinces, based on the standards in place. Are we merely dreaming to think that national standards could be implemented and that the provinces could be pressured into complying with them? We talk about a Canadian law, but the fact of the matter is that variations exist, even among the different colleges that issue licenses to practice medicine in Canada. I'd be interested in hearing your comments.

Dr. André Lalonde: Our association, which has been around for 55 years, publishes clinical practice guidelines for the fields of obstetrics and gynecology that are accepted in all provinces. These are sent to all medical colleges in Canada through the FMLAC. The standards, which have changed very little, serve as the basis for these guidelines.

Recently, working with the CFAS, we published a position paper on ethical considerations in reproductive health which was very well received. Professional medical associations such as those representing gynecologists and pediatricians have an advantage. Each individual province is much too small to develop clinical practice guidelines. Therefore, we look to international associations. Our committees operate jointly and we have representatives in every province. I'm prepared to state that 99 per cent of the clinical practice guidelines that we publish are adopted in all Canadian hospitals.

Therefore, we don't see this battle between federal and provincial jurisdictions because our members come from all regions of the country. I think that's an advantage. The hospital certification service is also Canadian. Therefore, it is to our advantage to use existing structures rather than to try and establish pan-Canadian regulations that will only give rise to debates among the provinces.

[English]

The Chair: Maybe Dr. Chadsey would like to comment on this.

Dr. Donald Chadsey: Thank you, Madam Chair.

I feel confident that the licensing authorities would not be likely to have difficulty in coming to consensus in these areas. It is true that there are differences in what the various licensing authorities do and have done, more particularly in how they do it, but there is general agreement about most important issues, perhaps especially ethical issues. I don't know that it would be likely that one province would say a given behaviour or medical service, cloning for example, is a good thing, whereas the other nine provincial and two territorial authorities would say it's a bad thing. I don't foresee a renegade licensing authority.

• 1235

The Chair: Thank you, Dr. Castonguay.

On a major point like cloning I agree with you, but there are many subtleties here. The number of witnesses we've had shows us a tremendous variation, a real spectrum of ideas based upon different values, and that's going to be more of a problem.

Ms. Wasylycia-Leis.

Ms. Judy Wasylycia-Leis (Winnipeg North Centre, NDP): The discussion that was occurring as I walked in late—and I apologize, Madam Chairperson—I think probably goes to the heart of the issues we're dealing with. It's that whole issue of flexibility and fluidity, given that the science is always changing and that people are not all the same, we bring different values to this whole area of reproductive health. And there is the knowledge that there are so many forces eager to rush in and take advantage of that flexibility in respect of commercialization and commodification.

I think history shows us that often in this kind of situation women's health is not always top of the list. I think the issue we're grappling with, and my question for all of you, anybody who wants to give us some help on this, is how you actually protect women's health and ensure that we aren't pushing women beyond limits, giving false hopes, treating women as walking wombs, all in the interest of science or finding that magic solution. If you could answer that, it would probably help us a great deal through this debate.

The Chair: Dr. Lalonde.

Dr. André Lalonde: I could take a crack at it.

I think it comes down to transparency and public education. We deal every day with heart transplants, kidney transplants—what is more acute than having a heart transplant? Yet the information is out there. The public education is there. There are groups of women who are out there. And if these groups of women have four representatives, let's say 25%, 30%, 40% on this body, they're going to be there so that information is given to the Canadians. I believe that inherently, each Canadian woman has the choice to decide this. What we have to be careful about is that no group convinces so many of the committee that their opinion is the only one that is retained. We want to make sure we provide a framework, we provide the information, we provide the transparency about complications, about pregnancy rates, about alternative treatments, so that an individual woman, with her partner, can make an informed decision. That I think is the basis of medicine in Canada right now.

The Chair: Dr. Storch would like to comment.

Dr. Janet Storch: Thank you for your question, because it certainly is very much along the lines of some of the concerns the Canadian Nurses Association put forward.

In addition to what Dr. Lalonde has said, I think if we look at various levels in the way this might be dealt with—and I'll go back to the idea of the accreditation processes in place and peer review—if you had teams of peers or experts, which may include lay people, just as Canadian health care facility accreditation does, you would have on such a team visiting a centre not just the medical point of view, but other points of view as well. You might have social workers, you might have nurses, you might have any number of people looking very carefully at what is happening in this clinic. Are people getting information in an unbiased way? Do they understand the effects?

I think there was mention before about not having information available to the children who might be conceived out of artificial insemination by donor. Some of what we know is that people don't know very much about that until it's too late, and the way that information is handled and the way the decisions are made are so critical to how people live with this family afterwards.

So we would certainly share your concerns and see a lot of levels where that could be built in, including all the ones I think we've talked about, building more of that idea into professional codes, with specific emphasis in this area; as I said, standards of all kinds around accreditation for research and for clinical practice; and an overseeing body that is widely representative.

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The Chair: Dr. MacLachlan.

Dr. Richard MacLachlan: To expand on that in terms of your concern about us being balkanized with different standards in the 13 different jurisdictions in Canada, a large part of the world we operate in is meeting national standards.

Our training programs for obstetricians, for family doctors, for endocrinologists—there is one standard for these, and all of the schools are accredited every six years. If there are problems with schools, they are accredited more frequently than that, but it's a single national standard. Similarly, when my hospital or my facility is accredited by the Canadian Council on Health Services Accreditation, a single standard is used nationally. It's not a different standard in Nova Scotia than it would be here in Ontario.

Finally, as far as our research standard is concerned, we have one reference point, the tri-council code of conduct on human research that was developed after extensive consultation. It is used as a single reference point by every research ethics board tied in with an institution in the country.

Can we set national standards? We are doing it in those areas already. I hope this may give you some confidence that we can extend it.

The Chair: Thank you, Dr. MacLachlan and Ms. Wasylycia-Leis.

Mrs. Chamberlain, did you want to participate?

Mrs. Brenda Chamberlain (Guelph—Wellington, Lib.): No, Mrs. Beaumier will.

The Chair: Mrs. Beaumier

Ms. Colleen Beaumier (Brampton West—Mississauga, Lib.): Most of my questions have been answered. However, is everyone at this table opposed to the criminalization of any aspect of this reproductive technology? Are you totally opposed to criminalization, or are there some things that could be included?

It's fine to talk about a regulatory board that is set up to monitor these things. However, we as politicians have a responsibility as well to the people of Canada to try to address their issues and issues that frighten them.

The Chair: Dr. Haddad.

Dr. Henry Haddad: We're talking about it not being criminal law, but that doesn't mean there could not be criminal actions taken against a physician or a researcher who's working without a licence, for example, or who is contravening the rules of the licence. This we all agree on.

The Chair: Dr. Lalonde.

Dr. André Lalonde: Under the medical law in Canada, if you do something that is not approved or is not within the process that has been approved by your college, it could lead to administrative or even criminal sanctions. Criminal sanctions are possible if I do a medical act that is not recognized as a medical act in Canada. The medical law is there. We are protected.

People always think when a new thing comes on we have to make a law, we have to have criminal sanctions. The medical law is there. If I practice illegally in Ontario and I do some clinical research or some treatment that is not approved by the college of Ontario, not only could I be sanctioned and lose my licence, but if it's something criminal I could also be charged with a criminal act. So there doesn't need to be another law over and above this.

Ms. Colleen Beaumier: But we don't have a law saying human cloning for the purposes of reproduction is criminal, do we? I don't understand. If it's not written into the Criminal Code, how can someone be criminally charged because he or she has contravened your standards? I'm neither a lawyer nor a physician.

Dr. André Lalonde: Let's go back. There were no heart transplants forty years ago. Heart transplants are done now. I don't think a law was passed in Parliament outlining how a gynecologist would not be able to do a heart transplant, right?

The Chair: No, but I really don't like this example, Dr. Lalonde, because the need for a heart transplant indicates a life-threatening situation. This is one of the things that makes this topic so tricky.

Infertility, for the most part, is not life-threatening. It is someone's wish for a path to pursue, but it's not life-threatening and it can't be compared to a heart transplant, in my view.

Dr. André Lalonde: Well, that would be an interesting philosophical discussion, because I think the definition of health is the emotional, physical, and psychological well-being of a person. Are we now trying to equate a physical danger with a psychological danger, or which one is worse?

I mean, some infertile people—

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The Chair: More simple than a definition of health—and I agree with you, we have to have this holistic definition—is the definition of death. It's a lot clearer. And that's what a person who needs a heart transplant is usually facing, either in the short or near term.

Dr. Haddad.

Dr. Henry Haddad: If my memory serves me right—sometimes it doesn't at my age—we had nearly come to the point in this country of making abortion a criminal offence. Abortion is not a criminal offence, but certain activities related to abortion can lead to criminal sanctions.

If my colleague, Dr. Lalonde, agrees with me, I think that would be the closest I could get to answering the question.

Ms. Colleen Beaumier: That's a can of worms most of us don't really want to open. However, we do know you have standards for that. We do know there are physicians who violate those standards, and we have never seen a physician tried criminally for that.

But I don't want to talk about this one. Let me talk on a different topic, since this is my nickel.

Is my nickel over? Have I spent it?

The Chair: No, no. You're fine.

Ms. Colleen Beaumier: You brought up another interesting aspect. You're saying the psychological damage of being unable to reproduce can be extremely serious. Well, I would think that may indicate a little bit of instability in the person wanting to avail themselves of your services.

Dr. Leader, you're talking about counselling the people who come to see you. How many people do you send away? Or do you ever send any away?

Dr. Arthur Leader: Of course we do. When I sit down with couples I offer them a choice. The first thing I put down as a choice is that they can do nothing. They can accept the situation they're in.

The second thing I suggest to them is they could consider adoption. If you live in Quebec, adoption internationally is the only choice. It's $25,000 to go to China or elsewhere. If you live in the rest of Canada, you can do private adoption for about $8,000 to $10,000. Public adoption is rare, although it fluctuates, depending.

Aside from the fact that they want to have the experience of pregnancy—and women in particular want the experience of carrying a pregnancy—many couples cannot afford the adoption alternative. But those are the first two choices I discuss with a couple.

And then I discuss whether they're going to pursue any investigations. Because if they're not going to pursue treatment, if it's contrary to their beliefs—and many people have beliefs that say they shouldn't pursue treatment—then we don't do any investigations. So there is a choice, but the first two choices are not to treat.

With regard to infertility, I have seen very stable marriages break up over the fact that one partner or the other is sterile. It does have a tremendous impact on families.

I also know that in our multicultural society certain cultures will not allow the use of donor sperm. That's the easier, low-tech solution. Therefore they must go to assisted conception, because in their ethical framework neither adoption nor the use of donor sperm is possible.

So each person has to be looked at, and we do, in terms of what their needs are, what they're prepared to consider. And it's not always treatment.

With regard to the issue of what should be prohibited, I don't see any problem in saying that human cloning or cloning for reproductive purposes should be controlled, or saying it should be banned, but you can make that statement without saying perpetrators will go to jail and pay $500,000 in fines.

There is a framework in place. We have accreditation, medical licensing; Health Canada and the CSA have set up standards to regulate the use of tissues in these situations. They can cite those standards and regulations, which is what they intend to do, so that in fact all of the areas are currently under development, and these will provide a framework for regulating what goes on.

I think the issue is whether we make criminals of those people—and in the bill there are some instances, as we cite—who inadvertently... For example, if you sell a book, any book, that talks about how to have boys versus girls, that's a criminal offence under the proposed legislation.

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Ms. Colleen Beaumier: Okay, but—

The Chair: Your time is up.

I have two more names and I have nine more minutes. So for about four and a half minutes each, we have Mr. Manning and then Ms. Sgro.

Mr. Preston Manning: The first thing is just a suggestion to the Canadian Medical Association, and you can maybe get back on it rather than take the time today.

Dr. Haddad, in your exchange with Mr. Merrifield, when he asked how you get accountability, you said one way would be to have an arm's length agency, but to have it report through the minister in the House.

The problem with that is when you set up that situation and the minister comes to the House and is questioned about some issue, he says, “Look, you set up this agency at arm's length. Don't ask me about it. You built these firewalls, so don't question me.”

I like Dr. Leader's suggestion, and I know we've talked about this before, about getting the shared jurisdiction first and setting the regulatory body on top of that. But when you have one minister reporting to Parliament and one reporting to the legislature in joint jurisdiction areas like agriculture and environment, the federal minister always says “It wasn't me who screwed up, it was those provincial guys”, and in the provincial legislature, that minister gets up and says “It wasn't us, it was the feds”.

I like the idea of arm's length regulation, but perhaps the association and some of your people could come up with a list of how to get accountability and arm's length. I think it has to be something more than just the minister reporting in the House.

My real question is a practical one on costs. When this bill hits Parliament, if we can stick to a schedule, it'll be next spring. For the first time in 10 years, the growth in federal revenues will be starting to go down because we're in a recession. We're going to have a huge bill for this international and national security thing. So the question that will be asked about every bill, but even more so next spring, will be: what's it going to cost?

Several of you mentioned the need for funding to facilitate your organizations doing, for example, some of the regulating, developing some of the regulations, and accreditation. Can you give us any idea what the price tag would be on handling regulation the way you suggest? If that's not possible today, can you at least suggest how those costs should be paid?

Are you assuming they'll all be paid by the taxpayers? If they aren't—and I know Dr. Leader knows where I'm going—the cost of regulation could very well be passed on to the client, customer, or user of fertility clinics, for example, which would jack sky-high the cost of an already costly service.

Dr. Arthur Leader: On the second question, first of all, accreditation is the model, is approved, and is under way. We have set up a process whereby it's self-funded. So accreditation is the basis for licensing facilities. There's a cost there, and it'll work out to about $5,000 per clinic, but it's considered to be something the clinic will absorb.

The registry is currently in operation. It will probably require minimal funding. We're talking in the neighbourhood of probably $30,000 to $50,000. I can talk about the specifics we're involved in. The licensing of health professionals is already funded within the various provinces and territories by the members. So what you're really talking about is an administrative cost.

In terms of the standards for donor sperm, eggs, reproductive tissues, and embryos, there is a contract—and I don't know what the value of it is—between Health Canada and the CSA. There is an intent to regulate and inspect to those standards, encompassing all donated tissues.

So on the incremental cost of what's going on in the pipeline, my guess—and I haven't sat down and figured it out—is it's going to be small as compared to setting everything up yourself from scratch, which would be significant. But it requires the utilization of what's been done and the integration of that.

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The Chair: Thank you, Mr. Manning.

Ms. Sgro, go ahead. I'd appreciate it if if you could leave me one minute at the end. I have about three announcements.

Ms. Judy Sgro: Okay. I'll just ask one simple question, then. Forget the complicated ones.

Providing we are able to get this legislation, after many years, onto the books, how long should it be there before we review it, given the fact that science is just galloping ahead so very quickly? Should it be three years, five years—assuming you think we should be reviewing it once we've brought it in?

Dr. Arthur Leader: It shouldn't be five years. In many regulations, two years seems to be an appropriate statute of limitations.

Ms. Judy Sgro: So it should be two to three years.

Dr. André Lalonde: It changes so rapidly.

Ms. Judy Sgro: Yes, exactly. Thank you.

Madam Chair.

The Chair: Thank you very much.

Thank you to all the presenters. We're very grateful for the work you've done, both the preparatory work for this meeting and the work you're doing behind the scenes with the government as we try to prepare the country for this. Our researchers may review your testimony and come up with questions, so they may wish to contact you and ask for further elaboration. I hope that will be all right.

Thank you very much for your time.

Members of the committee, as promised, the summary of evidence from the first meeting in September to the Thanksgiving break has been prepared and will be given out now.

Second, there seemed to be quite a lot of upset about the surrogacy situation, so I've asked the clerk to pull out the chapters on surrogacy from the royal commission. The royal commission report, as you know, is pretty daunting in that it's about this high. But that particular chapter I've had copied for you, and it will be given out for your reading.

Third, and I don't know if you want to defer this until tomorrow, we have that letter from the ministers asking us to look at the labelling of genetically modified food. I have to write back to them. Do you want to deal with that now or do you want to wait until tomorrow? We could just have a motion that I write a letter back saying we'll be glad to do it when we finish this work.

Ms. Judy Sgro: I move to look at that issue once we've managed to complete this work we're on. Can we get any time limits?

The Chair: That is an acceptable motion.

Are you ready to deal with this?

Some hon. members: Agreed.

The Chair: Okay. There's a motion on the table that we respond positively to the four ministers who requested us to look at the topic of the mandatory labelling of genetically modified food. Ms. Sgro has made a motion that we say yes to the ministers and that I write a letter to that effect.

Are you ready for the question?

Would you like to speak, Mr. Merrifield?

Mr. Rob Merrifield: Yes. You're going to say yes to it after we complete this.

The Chair: Oh, yes, I forgot about that. In the terms of the motion, put “when this work is finished”.

Ms. Judy Wasylycia-Leis: This is the draft bill that we're going to try to do a report on by December. Originally the minister said the real bill would come back to committee early in the new year, so presumably that will take some time as well.

The Chair: We'll probably have time to get started on the genetically modified food. Then we might have to interrupt our work for a clause-by-clause of the bill, if they're as fast as they think they're going to be.

I think the important thing is to let the ministers know what our intention is.

(Motion agreed to—See Minutes of Proceedings)

The Chair: Thank you very much.

There is one more piece of business. I'm sorry about the change in the meeting we all agreed to, which was supposed to be Monday night. I found out late Friday and the clerk has been trying to keep you informed. As quickly as I know anything, he will have it on the e-mail.

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It seems that the minister is now coming at 9 a.m. Thursday. The meeting will be in room 253D. Because that's not our usual meeting place, the unfortunate thing is that if we go for two hours with the minister, we will be following that with two hours here.

I suggest you make your questions fairly succinct, because four hours in a row is going to be pretty hard on everybody. We also have a very big group of people coming at 11 a.m.

This meeting is now adjourned. Thank you.