t the NCEHR Council Meeting on November 27, 1996, Bill C-47 was discussed at length and Council unanimously passed a motion endorsing the concerns raised by several other professional organizations.

NCEHR supports the objects of Bill C-47, namely:

1. to protect the health and safety of Canadians in the use of human reproductive materials for assisted reproduction, other medical procedures and medical research;
2. to ensure the appropriate treatment of human reproduc-tive materials outside the body in recognition of their potential to form human life and;
3. to protect the dignity of all persons, in particular children and women, in relation to uses of human reproductive materials.

In the view of NCEHR, Bill C-47 would criminalize certain practices as part of a proposed regulatory structure. The rationale for creating such a structure, given the preponderance of existing regulatory structures, is entirely unclear:

• At the present time the creation and ongoing evaluation of national standards for training and certifying physicians in reproductive technologies deemed acceptable is carried out by organizations such as the Royal College of Physicians and Surgeons of Canada and the College of Family Physicians of Canada.
• The licencing and monitoring of individual physicians is currently the responsibility of the Provincial and Territorial Medical Licencing Authorities, all of which have public representation; other health professionals are overseen by similar organizations.
• Guidelines for medical procedures are normally developed by medical specialty societies such as the Society of Obstetricians and Gynæcologists of Canada and the Canadian Fertility and Andrology Society.
• The accreditation of facilities where reproductive technologies are utilized is conducted by the Canadian Council on Health Services Accreditation.
• Finally, NCEHR has within its mandate the task of assisting Research Ethics Boards in interpreting and implementing guidelines for the ethical aspect of research involving human subjects. To ensure that these guidelines are current, the three funding councils (MRC, NSERC and SSHRC) have undertaken a complex initiative, namely the updating of the 1987 Guidelines for Research Involving Human Subjects into a Tri-Council Code of Conduct.

With these regulatory bodies seemingly covering the spectrum of care delivery and research, NCEHR does not see the need for an additional regulatory body.

Of equal concern to NCEHR was that the proposed Bill would seemingly set a dangerous precedent by trying to deal with ethical problems of society through legislation and criminalization. This would seem to be far from choosing the least restrictive alternative and would potentially destroy confidence in existing regulatory bodies.

NCEHR feels that it is vital that there be extensive public discussion and education regarding the issues related to human reproductive and genetic technology and that this discussion needs to specifically include non-medical providers. The goal would be the development of a comprehensive policy and regulatory structure, building upon the strengths of existing regulatory bodies.

In summary, NCEHR welcomes the initiative to secure the safety of the Canadian public on issues relating to reproductive and genetic technologies. A comprehensive policy and regulatory structure will be a major step forward in achieving and ensuring that research in these areas is conducted in a manner compatible with current guidelines and the proposed Code of Conduct. Bill C-47, as tabled, is unlikely to achieve the agreed upon objectives and NCEHR would join with other professional organizations in expressing our grave concerns about this Bill.

These views were submitted to the Chair of the Sub-Committee of the Standing Committee on Health in January 1997. The National Council on Ethics in Human Research was then invited to appear at a Round Table before the Sub-Committee on Bill C-47, the Human Reproductive and Genetic Technologies Act of the Standing Committee on Health, on March 20, 1997. The presentation of NCEHR, which appears hereunder, was presented by Dr. Richard MacLachlan, a member of NCEHR Council since 1990.

"Thank you, Madam Chair:

I am Richard MacLachlan and I am very pleased to be able to speak to you on behalf on the National Council on Bioethics in Human Research; I have been a member of NCEHR since 1990, virtually since its inception. I am a practising family physician in Halifax and am currently the Head of the Department of Family Medicine at Dalhousie University. In the past I have been the Vice-president of Medical Services of a large teaching hospital in Atlantic Canada as well as the head of a research program in developmental disabilities at Queens University. I am currently Chair of the Committee on Ethics of the College of Family Physicians of Canada and am a member of the Canadian Medical Association’s Committee on Ethics. I am also a parent.

The National Council on Ethics in Human Research (NCBHR) was established in 1989 by Health Canada, the Medical Research Council of Canada, and the Royal College of Physicians and Surgeons of Canada. Recently the mandate of NCEHR has been broadened by the addition of the Natural Sciences and Engineering Research Council and the Social Sciences and Humanities Research Council as sponsors. Among the terms of reference is the following:

"Work with the ethics committees or divisions of the various Research Councils, Royal College of Physicians and Surgeons of Canada and Health Canada to ensure that human research ethics guidelines or pronouncements meet the needs of research involving human subjects in Canada."

As stated in our brief to Ms. Hickey on January 29th, 1997, NCEHR supports the objects of Bill C-47. We recognize the legitimate need for government action to ensure public safety in the domain of Human Reproductive and Genetic Technology. We do not feel that this will be achieved through Bill C-47, and in fact public harm will likely ensue.

NCEHR is in total agreement with government that the public needs to be assured that there exists a comprehensive policy and regulatory framework to oversee this rapidly advancing field. However, this comprehensive approach does not seem to be part of the current strategy of government. Bill C-47 would criminalize certain practices, many of which we would all find unacceptable. Nevertheless it precedes confirmation and definition of the comprehensive regulatory security of the Canadian public. It will also put Canadian women and families at a significant disadvantage in accessing current approved medical research.

NCEHR feels that there are a number of issues relating to public safety and access to current accepted and approved medical practices and research:

• There already exist a number of regulatory structures to ensure public safety with respect to the provision of health care, the creation and evaluation of standards of the training of health providers, the licensing and monitoring of health providers in the provinces and territories, the development of new procedures, the accreditation of health facilities and the conduct and evaluation of research involving or affecting human subjects in Canada. The details of these structures are in our brief to your Sub-Committee in January. It is very difficult for us to support the creation of yet another regulatory structure without definition of perceived gaps in the current structures and of how a new structure would add to the comprehensive nature of the process and relate to existing bodies.
• My understanding is that the government officials who appeared before this Sub-Committee last week confirmed our assessment that there is no evidence that researchers in Canada are currently working in any of the very troubling areas such as human cloning or human-animal hybrids. It would thus seem as though we have the time to address these issues in a comprehensive manner without moving piece-meal into criminalizing activities that are not yet a major societal problem.
• Much of the impact of Bill C-47 is likely to be not on practices yet to occur such as those described above but will be on research with direct impact on patient care. This will limit the access of Canadians to current research and innovative therapies. It will also advance a two-tier approach to health care as the affluent will be able to access these therapies in other jurisdictions.
• NCEHR has, almost since its inception, been concerned that all Canadians have equitable access to properly approved research studies. In particular, we have been concerned with the access of "Special Populations" such as children, the elderly and the developmentally challenged to properly conducted research. Bill C-47 will add a new part of the Canadian population to these vulnerable categories – women and families.
• NCEHR supports the concept that research subjects should be compensated for reasonable expenses incurred in participating in research studies. Bill C-47 bans the reimbursement of research participants in certain studies involving reproductive technology. It asks these subjects to underwrite the costs of their altruism as volunteers in approved research studies.
• In closing, it may be helpful to walk your Committee through the current process with respect to a fictitious research proposal in which a researcher proposed to clone human embryos:
• This type of research would occur only in a setting where there is access to human embryos and this would have to be what we call an Academic Health Science Centre (AHSC) – a union of a Faculty of Medicine and a Teaching Hospital(s).
• The researcher would need to be appointed to the AHSC; his/her credentials would have been reviewed by both the credentialling process of the hospital (if a physician or a Ph.D. clinical scientist) and the University.
• This would have in turn triggered a review of the researcher’s credentials granted by the appropriate provincial/ territorial licensing authority and his/her current registration.
• The hospital involved would have had its quality assurance standards and research approval process accredited by the Canadian Council on Health Services Accreditation. The Faculty of Medicine concerned is regularly accredited as well, including its process of managing research protocols.
• The researcher would have had to submit his/her research protocol to an institutional Research Ethics Board (REB); the composition of these boards is outlined in the current Medical Research Council of Canada "Guidelines on Research Involving Human Subjects" including representation from the public. This proposal would be turned down by any AHSC REB in Canada.
• NCEHR has accepted as part of its mandate the overseeing of the function of the REBs reviewing research involving human subjects. NCEHR has visited all 16 Academic Health Science Centres in Canada in the past four years and assessed the process of research ethics review. The results of these reviews are now a matter of public record and certainly did not detect any concerns over the practices that Bill C-47 seems to focus upon.
• This type of research would require extensive funding; no funding agency in Canada would contemplate supporting such a proposal.
• Standards of what is an appropriate approach to research change as well as their significance. To this end, the three Councils that are our sponsors (MRC, NSERC, & SSHRC) have undertaken a thorough review of the current "Guidelines on Research Involving Human Subjects".

In summary, Madam Chair, I strongly laud the efforts of government to ensure public safety in these domains. NCEHR is committed to its role in working with others to ensure the highest possible standard of clinical care and clinical research for Canadians. In our estimation, Bill C-47 is a significant retrograde step as currently proposed.