HEAL Committee Report

            On 3 May 2001, after tabling Proposals for Legislation Governing Draft Legislation on Assisted Human Reproduction, Allan Rock, the Minister of Health, asked the Standing Committee on Health to provide recommendations on the draft legislation and in particular, to advise on options for a possible regulatory body that would govern the implementation of the legislation, monitor developments, and recommend future changes. The Minister emphasized to the Committee that the draft legislation covers two things: assisted human reproduction and related research.

            Committee members welcomed the challenge of involvement at this formative stage of draft legislation. We saw an opportunity for open, participatory, and thoughtful work on a subject of wide public concern. After listening to the many committed and articulate witnesses involved in areas of assisted human reproduction, we remain convinced that the proposed legislation is fundamental to shaping our future society.

            As a Committee, we see our review of the draft legislation as the beginning of a period of increased parliamentary scrutiny. Through our work, we realized the complexity of the issues and the breadth of the legislation. We know that there is a need for more concrete data collection and information dissemination. We feel that the Minister of Health must also address outstanding concerns about economic implications, federal, provincial and territorial coordination, enforcement details and other particulars relevant to the legislation and its regulations. In our report, we have chosen to address issues of key concern to us and to our many witnesses. We urge the Minister to move quickly to address our recommendations and to introduce comprehensive legislation into Parliament on a priority basis.

The Committee recommends that:

RECOMMENDATION 1:

The Minister of Health introduce legislation on assisted human reproduction and related research as a priority.

            On hearing the multiple ethical, social, legal, scientific, medical, and other perspectives on this complex issue, we understood the urgent need to establish clear boundaries around efforts to assist human reproduction and to conduct related research. We became more conscious of the tension arising from the potentially conflicting interests between facilitating reproduction and supporting research. Witnesses told us about the many benefits arising from procedures and practices and the potential for more good to come from ongoing research. They also pointed to the possibilities for harm to individuals and society if current directions were left unchecked by legislation and regulation.

            But, most important, the witnesses reminded us that assisted human reproduction is first and foremost about enabling people to have children. We have kept this idea central to our thinking in this report.

            Previous consultations on reproductive technologies produced frameworks of guiding principles that were ethical or social in nature. The Health Committee also has adopted a framework to guide its assessment of the proposals for legislation on assisted human reproduction and related research. This framework can be used to ensure a consistent approach and to achieve desirable outcomes.

            We have established three priorities to be used in appraising the individual components of the draft legislation. These flow from the Committee’s view that the primary goal of assisted human reproduction is to build families. Thus, our review focused on the potential effect of the draft legislation for:

(i) Children resulting from the assisted human
     reproduction procedures

    The legislation must protect the physical and emotional
     health as well as the essential dignity of the children who are
     the intended and desired result of the procedures.

(ii) Adults participating in the assisted reproduction
     procedures

      The legislation must protect the adults undergoing the
      procedures from potential negative physical, social, and
      emotional effects.

(iii) Researchers and physicians who conduct
       research leading to and emanating from these
       procedures

      The legislation must oversee the experimental aspects
      of the assisted human reproduction procedures while
      allowing selected procedures that might alleviate
      human suffering.

            Overall, our thinking is directed by the feeling that children conceived through assisted human reproduction warrant even greater consideration than the adults seeking to build families or the physicians or researchers seeking new knowledge.

            In our framework, children who are physically, emotionally, and spiritually healthy are the anticipated and desired endpoint of the activities and procedures. Of the participating adults, while both men and women can experience adverse emotional and financial consequences, women are subjected to the most invasive, and potentially harmful, physical processes. The researchers and physicians seeking new knowledge and applications from the activities, procedures and processes are to proceed only if the general well-being of the directly affected children and adults is paramount.

            But we also heard that the major goal of the legislation is to protect the vulnerable from adverse health effects and from exploitation connected to assisted human reproduction. In addition, we were told that where there is a conflict between the ethically unacceptable and the scientifically possible, the ethical view must prevail. To accomplish this, witnesses suggested that we reflect on several considerations in assessing the legislation. We also feel that if these over-arching considerations are applied to these proposals, it will ensure greater consistency in the final legislation:

(i)   Respect for human individuality, dignity and
      integrity;

(ii)  Precautionary approach to protect and promote
      health;

(iii) Non-commodification and
      non-commercialization;

(iv) Informed choice; and

(v)  Accountability and transparency.

(i)   Respect for Human Individuality, Dignity and
       Integrity

            Assisted human reproduction is technologically oriented and physically intrusive. With its calculated and deliberate use of human reproductive material and production of human embryos, it impinges on society’s sense of the uniqueness, worthiness, and wholeness associated with being human. It raises concerns about the measure of respect and protection that should be afforded to the people who participate, the children produced, and the reproductive materials and embryos containing the potential to mature into full personhood. The Committee agrees that the association of human reproductive material with the genetic, biochemical, and cellular composition of the human species gives it a particular status. It also concurs that there must be a measure of respect and protection for the embryo that is based on its potential for personhood.

(ii) Precautionary Approach to Protect and Promote
     Human Health

            The draft legislation is based largely on the premise that the health and safety of adults, particularly women, undergoing the procedures and children resulting from them must be protected. The Committee feels that a precautionary approach is needed when any activity raises threats of harm to human health. Even where some cause and effect relationships are not fully established scientifically and uncertainty exists, the Committee feels that the burden of proof should be shifted to those who create the risks. We agree with the witnesses who called for greater attention to prevention of infertility and those who argued that, where evidence of the intended benefits is lacking, procedures, treatments or medications should be provided only as part of carefully controlled research, not as standard medical practice. We would like to see more researchers and medical practitioners provide extensive analysis of alternatives to the potentially harmful activities currently associated with assisted human reproduction.

(iii) Non-commodification and Non-commercialization

            It is contrary to our thinking to treat human beings or human material as commodities that can be regarded in terms of their economic value rather than their intrinsic worth. In particular, we feel that children can never be objects to be acquired or exchanged. Women and men need to know that their bodies and their reproductive material are not for sale or barter. The Committee does not support any elements of trading, exchanging, buying or selling of human reproductive materials. We are aware that, in recent years, commodification, and in many respects, commercialization, have occurred in the field of assisted human reproduction. We want to ensure that the legislation will prevent the commodification of children, women’s bodies, human reproductive material, and reproduction.

(iv) Informed Choice

            The Committee agrees that informed choice can lead to either informed refusal or informed consent. We want individuals participating in assisted human reproduction to be able to choose freely on the basis of full information of risks as well as benefits pertaining to medical, legal, ethical, social, or psychological implications. For the resulting children, they must be able to rely on the involved adults. For participating adults, this can mean having full understanding of short-term as well as long-term ramifications including the consequences for others who may be involved. We want to ensure that consent is given freely for all aspects of assisted human reproduction such as treatment, donation, and research. We also want continual assessment of the consent that is given and an acknowledgement that, for most activities, consent may be withdrawn at any time.

            (v) Accountability and Transparency

            The Committee feels strongly that a high measure of accountability entails an obligation on the part of individuals and organizations to answer for their actions. Thus, individual adults who undertake to produce children through assisted human reproduction have a responsibility to ensure that the future well-being of those children is considered carefully. But, we feel particularly that those in positions of power such as governments and professional organizations have a responsibility to ensure that their actions in this area are always transparent and focused on the overall good of society.

            The preamble may set out the intent, purpose and spirit of the legislation. It may also set out the guiding principles that underpin the legislation, as well as the aspirations that motivated the legislators. The preamble, however, is primarily an interpretive tool intended to assist in explaining the legislation’s purpose and object. As such, it is considered to carry less weight.

            Because the legislation before us deals with such fundamental values as human dignity and integrity, the Committee believes that the guiding principles enunciated in the preamble must be given greater legal significance and effect. They must form an integral part of the enactment by being enshrined in a statutory declaration set out in the body of the legislation.

The Committee recommends that:

RECOMMENDATION 2:

The Preamble be replaced by a Statutory Declaration enacted in the body of the legislation.

            After careful consideration of the current Preamble and applying our framework, the Committee recommends that:

RECOMMENDATION 3:

The Statutory Declaration set forth the following guiding principles:

It is hereby recognized and declared that:

(a)     assisted human reproduction and related
          research must be governed by principles and
          practices that respect human individuality,
          dignity, and integrity;

(b)     the health and well-being of the children born
          from assisted human reproduction must be
          given priority in decisions regarding assisted
          human reproduction;

(c)     while all participating persons are affected by
          assisted human reproduction, women more
          than men are directly and significantly affected
          by the application of the technologies;

(d)      the integrity of the human genome must be
           protected;

(e)      the principle of free and informed choice as a
           fundamental condition of the use of assisted
           human reproduction must be promoted and
           applied;

(f)       human reproductive technologies provide
           benefits to individuals, families, and society in
           general;

(g)      those benefits can be most effectively secured
           by taking appropriate measures for the
           protection and promotion of human health,
           safety, dignity, and rights in the use of such
           technologies;

(h)      persons with disabilities can lead full and
           satisfying lives and enrich the lives of those
           around them; and

(i)        the commodification of the reproductive
           capacities of women and men, and the
           exploitation of children, women and men for
           commercial ends must not be allowed.

            In addition to the Statutory Declaration, it would be desirable if a Purpose Clause were enacted to clearly identify the following objectives of the legislation. The Committee recommends that:

RECOMMENDATION 4:

The Statutory Declaration be supplemented by a Purpose Clause within the body of the legislation, which would state as follows:

The purpose of this legislation is to provide a national legislative framework for assisted human reproduction and the conduct of research using human reproductive material. It is to ensure in particular that:

(a)      the interests of the children born from assisted
           human reproduction procedures are protected
           and given paramount consideration;

(b)      the interests of the adults participating in
           assisted human reproduction procedures be
           protected and their participation is based on
           informed choice; and

(c)      the interests of researchers and physicians are
           supported to the extent that they do not
           compromise the interests of the children and
           adults.

            Under the legislative proposals, the activities and procedures related to assisted human reproduction and related research are classified under two broad categories:

(i)  Prohibited activities that are specifically banned in the legislation
      itself; and

(ii) Controlled activities that may be carried out only under a licence
      issued in accordance with the regulations.

            If the regulations specify that no licences may be issued for a particular controlled activity, that activity becomes, for all intents and purposes a prohibited activity. The prohibition in this case, however, stems from the regulations rather than the statute.

            Both prohibited activities and controlled activities are based on the federal criminal law power. One of the main differences between the two categories is that a prohibited activity could be changed or repealed only through a legislative amendment passed by Parliament. A controlled activity (including any regulatory prohibition that was created through the non-licensing of a particular activity) could in turn be changed or repealed by the usual process for amending the regulations, through public consultation.

            Some witnesses recommended the elimination of the prohibited activities category altogether. Citing the benefits of regulatory flexibility, they felt that all activities should come under the controlled activity category, including the more reprehensible activities like reproductive cloning for which licences, arguably, would never be allowed under the regulations.

            Although prohibitions could be indirectly implemented under the controlled activities categories by simply making licences unavailable in their case, the Committee believes that a licence-related prohibition of this sort would not carry the same weight or degree of social censure as the statutory prohibition. This is reflected in the penalty clauses in the legislative proposals which prescribe maximum penalties for offences involving a prohibited activity that are roughly twice as severe as those prescribed for controlled activity violations.

            We believe that there is considerable justification for retaining the prohibited activities category. An outright statutory ban signals more clearly that certain activities are either unsafe or socially unacceptable. The use of the statutory ban also signals that these activities are of such concern to Canadians that their status as a prohibited activity may not be altered except with the approval of Parliament.

The Committee recommends that:

            Using our framework, we remain firmly convinced that the prohibited activities listed in the draft legislation warrant statutory status. In terms of activities that are to be banned due to health and safety considerations the Committee is satisfied that a three-year legislative review, as recommended in a later section, is sufficient means by which to re-evaluate their prohibited status.

(i) Cloning for Reproductive and "Therapeutic"
     Purposes

            The Committee feels strongly that the potential adverse effects, whether physical, psychological or social, for the resulting children are sufficient reason to prohibit reproductive cloning. In addition, "therapeutic cloning" should be banned as it is unsafe and commodifies the embryo.

(ii) Germ-line Genetic Alteration

            The Committee heard that germ-line genetic alteration is both unsafe and impractical at this time as well as having unknown consequences for subsequent generations. The Committee acknowledges that the intention of germ-line genetic alteration is to affect patterns of genetically based diseases. However, it agrees with the draft legislation that this should also be banned by statute.

(iii) Maintenance of an Embryo Outside a Woman’s
       Body

            The Committee sees serious social harm in eliminating the role of women in reproduction. The role of a woman in carrying and giving birth to a child is indispensable. Moreover, such a process could cause serious harm to any resulting child. The Committee agrees that it should be prohibited.

(iv) Creation of Embryos Solely for Research
       Purposes

            The Committee agrees that embryo creation should be prohibited when the sole purpose of creating the embryo is to provide material for research. However, the prohibition as stated in the draft legislation does not accurately reflect its intent. The Committee is concerned that the current wording would also prohibit research that aims to improve gamete storage and maturation procedures.

Therefore the Committee recommends that:

RECOMMENDATION 6:

Clause 3(1)(d) be reworded to reflect more accurately its intention to prohibit the creation of embryos on which research is to be carried out.

            (v) Embryo Creation from an Embryo or Fetus

            The goal of this prohibition is to protect against the creation of children whose genetic parents never lived as individuals. The Committee finds that the wording of this prohibition is very awkward and unclear as to what activity is to be banned.

The Committee recommends that:

RECOMMENDATION 7:

The prohibition in clause 3(1)(e) simply state that gametes cannot be removed from embryos or fetuses for the purpose of creating an embryo.

            The Committee concurs that such activities not only have the potential to produce harm for participating adults but they also violate human dignity. In addition, they clearly are not needed to produce a healthy child.

To be fully consistent, the Committee recommends that:

RECOMMENDATION 8:

An additional prohibition be included that bans the creation and use of all animal/human hybrids for the purpose of reproduction.

            On the grounds of human safety and of human dignity, such an activity constitutes a concern for children and for women. The Committee agrees with the draft legislation in prohibiting it.

            (viii) Sex Selection Except for Health Reasons

            The Committee is in agreement with the concept in the draft legislation that sex selection should be a prohibited practice. We are concerned, however, that the stated prohibition does not include sex selection through genetic pre-implantation diagnosis of embryos. It only addresses such procedures as gamete manipulation and modification of fertilization techniques that would increase the probability of obtaining an embryo of one sex or the other.

Therefore the Committee recommends that:

RECOMMENDATION 9:

Clause 3(1)(h) specifically prohibit all sex selection with the noted exception of disorders linked to the sex chromosomes as defined in the regulations.

            The overall well-being of children is compromised by deliberately producing children through assisted human reproduction, who may be uncertain about their origins. Commercial surrogacy treats children as objects and treats the reproductive capacity of women as an economic activity. Non-commercial (altruistic) surrogacy arrangements can also be socially harmful for the resulting child and place the health of women at risk.

            The Committee agrees with the prohibition on surrogacy for commercial gain and also feels that surrogacy for non-commercial reasons should be discouraged but not criminalized.

            There should be a prohibition against any form of consideration, incentive or compensation, financial or otherwise, being offered or provided to any party involved, directly or indirectly, in any surrogacy arrangement. This must include those parties who provide professional medical, legal, and psychological services.

            Therefore, to minimize the commodification of the surrogate mother and resulting child, the Committee recommends that:

RECOMMENDATION 10:

Clauses 4(4) that excepts legal, medical, and psychological services and 10(d) that allows reimbursement of expenses to a surrogate mother be eliminated.

            However, in order to protect the health of the surrogate mother and of any resulting child in any surrogacy arrangement, we further recommend that:

RECOMMENDATION 11:

An exception be created for physicians and other health care professionals who provide services necessary for the care of the pregnant woman.

            If non-commercial surrogacy is to occur, the well-being of the resulting child and the fully informed choice of the participating surrogate mother should be ensured through several mechanisms. Counselling for all parties must be provided with respect to non-commercial surrogacy. Physicians donating services to facilitate non-commercial surrogacy must take responsibility to ensure that all parties have access to social as well as medical counselling. Individuals who aspire to add a child to their family through surrogacy must be subject to the same scrutiny as individuals who seek to adopt a child.

Thus, the Committee recommends that:

RECOMMENDATION 12:

The provinces and territories be encouraged to provide mandatory counselling to the commissioning couple, surrogate mother and partner through existing publicly funded services available for adoption and to amend relevant family law to recognize the birth mother as the legal mother.

            The Committee feels strongly that the commodification and commercialization of human gametes and human embryos can have far-reaching social and emotional effects for any resulting families. But, in addition, such activities are contrary to Canadian practice whereby human organs and tissues are not sold or purchased. The purchase, barter or exchange of human gametes and embryos is contrary to human dignity. The Committee agrees with the prohibition on the sale and purchase of gametes and embryos. We are also opposed to any reimbursement of a donor for any expenses incurred in the course of donating any sperm, ovum or embryo. The Committee further recommends that:

RECOMMENDATION 13:

Clause 10(a) that permits reimbursement of a donor for expenses incurred in the course of donating any sperm or ovum be eliminated.

            Without full and informed consent for any controlled activity, participating adults could face unknown long-term harm. Consent must be freely given and be based on full understanding of the implications of providing one’s personal reproductive material for use by others. The Committee strongly supports this prohibition on the use of reproductive materials and embryos without consent.

            In the draft legislation, controlled activities may be carried out only under a licence issued in accordance with the regulations. We look forward to the opportunity to review any proposed regulations when they are laid before the House of Commons. We have already recommended changes against reimbursement of expenses for donations and surrogate mothers. We also want to place some specific limits on embryo research.

            The Committee wants to emphasize that the gains to be made in new scientific knowledge and medical applications should proceed only if any benefit for society does no harm to the resulting children and participating adults. We particularly want to stress that, while science has tremendous potential for good, its applications can have the capability for negative effects on the diversity of the human population. We do not want to support any public policy, scientific research or medical practices that seek to use knowledge of hereditary or genetic characteristics to change the intrinsic characteristics of the human population. As stated earlier, the activities permitted by this legislation must recognize the importance of preserving and protecting human individuality and the integrity of the human genome.

(i) Embryo Research: The Current Situation

            The Committee heard that embryo research currently could include: research on embryos that already exist as a result of in vitro fertilization (IVF); research that creates embryos as a result of research; and the creation of embryos specifically for research purposes. Generally, research on existing embryos is used to study areas such as fertilization, drug interactions and development. Other research such as perfecting storage techniques for ova could involve the creation of embryos. More recently, stem cell research using embryos as a source has been seen as having potential for the treatment of several ailments and injuries.

            We are concerned that there is a lack of clarity about what is currently taking place in Canada in relation to research that uses existing embryos or research that creates embryos. Rationales for research on embryos up to 14 days include efforts to improve infertility treatments such as IVF, increased knowledge of genetic diseases, and improved conception. This type of research work was noted at the time of the Royal Commission on New Reproductive Technologies. Currently, research in the private sector is not required to report to any authority and is able to operate outside of the Canadian Institutes for Health Research guidelines for embryo research. The Committee would like this situation to be corrected.

(ii) Embryo Research: Our Process

            In our deliberations over these issues, we applied the framework laid out in the introduction. We had to decide whether disallowing all types of research involving embryos, or restricting it in some way, would adversely affect the health and well-being of the children born of assisted human reproduction, or of the women seeking the technologies. Similarly the Committee had to consider how the condition of the embryos intended for but not used in IVF procedures fit within our other considerations.

            On the issue of precautionary measures to protect and promote health, we heard about the potential health advantages that accrue from embryo research. On non-commodification, we heard that there is a potential for commodification and commercialization of women in producing the necessary eggs and embryos that can be traded and exchanged as a source of reproductive material. On informed choice, we were told that women who produced the eggs were seldom fully informed about the need to give consent for additional embryos to be used for research. Some witnesses expressed concerns that the embryo has no part in any consent process. On respect for human individuality, dignity and integrity, we were told that any research on embryos must value their status as having potential for full human personhood. On accountability, we heard that any activity in this area must be transparent and open to public scrutiny.

(iii) Embryo Research: Our Views

            We agree with the draft legislation that embryo research should be a controlled activity. It should, however, be strictly regulated and limited to using only embryos created but not used for IVF subject to the consent of their donors.

            We recognize that the research and medical communities have a responsibility to properly validate fertility techniques. This research does in some instances require the use of existing embryos and can result in the creation of an embryo in other instances. Such research may be necessary to ensure the health of any resulting children as well as the health of the women being treated.

            We heard that while embryonic stem cell research presents some possibilities, other sources such as umbilical cord blood and adult source stem cells are more available, more easily obtainable, and less ethically contentious. Some witnesses argued that research on stem cells using sources other than embryos might be sufficient to attain the stem cell potential. Others pointed out that, although use of adult stem cells is the preference for most researchers, the use of embryonic stem cells at this time might provide the information needed to properly manipulate adult stem cells.

            The Committee was struck by testimony that, in the past year, there have been tremendous gains in adult stem research in humans. We also heard that, after many years of embryo stem cell research with animal models, the results have not provided the expected advances. Therefore, we want to encourage research funding in the area of adult stem cells.

            We are concerned that embryonic stem cell research commodifies the embryo. It involves research that uses embryos to obtain further research material. We believe that licences for the conduct of all research on embryos should be issued only after a clear demonstration that non-embryonic sources would not achieve the sought after research outcomes.

Therefore, the Committee recommends that:

SECTION 7: THE REGULATIONS

            Clause 40 of the draft legislation sets out the matters for which regulations could be made under the legislation. Notably, regulations could be made designating classes of controlled activities for which licences could be issued or withheld. Regulations could also be made to determine the conduct of any class of controlled activity, as well as the terms and conditions under which licences might be issued. These provisions are key because they authorize the development of standards that will regulate the manner in which controlled activities must be carried out.

(i) Regulations in Relation to Selected Matters

            Evidence presented to the Committee suggests that the health of women involved in assisted human reproduction is not always paramount. Ovaries may be over-stimulated through excessive fertility drug therapy. Eggs may be harvested from women too immature to appreciate the full implications of their involvement. Too many in vitro embryos may be produced and too many of them may be transferred into the womb.

            The Committee is particularly concerned about the excess number of embryos that may be produced and stored, allegedly for reproductive purposes. We appreciate that, until egg-storage techniques are perfected, an excess number of embryos may have to be produced. However, we expect this practice to cease once the storage technology has been validated. At that time, it will be possible to limit the number of embryos produced to those actually used for implantation.

In keeping with our framework to protect children and participating adults, the Committee feels that it is essential that specific requirements and restrictions be prescribed in the regulations to guard against abuses and exploitation.

The Committee recommends that:

RECOMMENDATION 15:

Regulated standards be developed in relation to the following matters:

(a)   The maximum number of eggs that may be
        harvested and fertilized;

(b)   The maximum number of embryos that may be
        produced, stored, and transferred for in vitro
        fertilization procedures, although a prohibition
        on the production and storage of excess
        embryos should be prescribed once egg-storage
        techniques have been perfected and validated;

(c)   The maximum number of times a patient should
        be offered a given procedure;

(d)   The counselling that must be provided to donors
        and recipients of treatment;

(e)   The maximum number of children that may be
        produced from a single gamete donor;

(f)    Eligibility requirements for donors and
        recipients; and

(g)   The known pre-existing heritable genetic
        diseases or conditions in relation to which
        pre-implantation genetic diagnosis would be
        allowed.

(ii) The Exemption in Clause 40(1)(m)

            Several witnesses questioned the propriety of allowing regulations to be developed under clause 40(1)(m) of the draft legislation. This clause allows regulations to be made that would essentially exempt a class or classes of controlled activity from the application of the legislation or regulations.

            The Committee joins the witnesses in believing that subordinate legislation, namely the regulations, should not be able to override the provisions of the statute. If there is a need to create exemptions, these should be enacted through legislative amendments subject to full parliamentary scrutiny.

The Committee recommends that:

RECOMMENDATION 16:

Clause 40(1)(m), which allows regulations to be made to exempt a class or classes of controlled activities from the application of the legislation or regulations, be eliminated.

            Clause 43 would exempt from the licensing requirements any person engaged in a controlled activity commenced before the cut-off date (the date on which the controlled activity clauses come into force) until such time as was prescribed by the regulations.

            The Committee notes that this vaguely worded clause is capable of at least two different interpretations. The first is that, on the cut-off date, the requisite regulations would not be ready. Consequently, any pre-existing activities carried out lawfully could not be licensed on the cut-off date. They would thus become controlled activities carried out unlawfully, unless they were exempted under the regulations.

            The second interpretation is that the requisite regulations would be in place on the cut-off date, thus allowing licences to be issued immediately for that particular activity. However, a given party or parties would be exempt under the regulations from complying with the licensing requirements, possibly because they needed more time to adjust to the regulated standards.

            Whichever interpretation applies, we find this clause to be objectionable. It is too open-ended and could lead to abuses. It could also lead to a flurry of activities being undertaken just before the cut-off date in order to defer compliance with the regulated standards for as long as possible.

            The Committee appreciates that a transitional period might be needed to develop the requisite regulations or to enable some parties to make the necessary adjustments in order to comply with the regulated standards. The exemption, however, should be of a reasonably short duration. We recommend a maximum period of one year. One year should be sufficient for the relevant action to be taken.

The Committee recommends that:

RECOMMENDATION 17:

Clause 43 be modified to provide a maximum one-year expiry date for the licensing exemption.

            The Committee is also concerned about the broad and largely unfettered regulation-making power of the Governor in Council. We believe that some form of direct parliamentary oversight is needed, along the lines of section 42.1 of the federal Tobacco Act. (see Appendix A)

            The Tobacco Act section requires that regulations proposed under that Act be laid before the House of Commons for possible study by the appropriate House committee — presumed to be the Health Committee. If the House concurs with the committee’s report, the Governor in Council is limited to making regulations in the form that was concurred in, including any changes that were recommended. Conversely, if the House disagrees with the committee’s report, the Governor in Council may proceed to promulgate the regulations, as originally proposed.

            Given that assisted human reproduction and related research is such a highly sensitive and controversial area, we strongly feel that a parliamentary safeguard of this nature is necessary. Elected representatives should have the opportunity to shape essential regulations to ensure that they reflect the best interest of Canadians.

The Committee recommends that:

            The collection and maintenance of registries aim to facilitate surveillance in the area of assisted human reproduction. In the draft legislation, health reporting information is defined as information respecting the:

(a) identity, personal characteristics, genetic information
      and medical history of:

(i)   donors of human reproductive material
       including sperm, eggs and embryos;

(ii)  persons who have undergone assisted
       reproduction procedures including infertility
       drugs, assisted insemination, and in vitro
       fertilization;

                    (iii)  persons who were conceived by means of such
                            procedures;

            (b) custody of donated human reproductive materials and
                  any uses that are made of them.

            The Committee heard that the information collected through the personal health information registry proposed in clause 21(2) of the draft legislation is intended to serve several purposes:

(i)   Assessment of short and long-term health
      outcomes for the children resulting from the
      procedures;

(ii)  Assessment of health effects for the
       women who undergo the procedures;

(iii) Ongoing information on assisted human
       reproduction services, drugs and
       procedures including the outcomes and
       success rates;

(iv) Access by genetic offspring from sperm,
      egg or embryo donation to non-identifying
      donor information;

(v)  Provision of research data for
      understanding the physical and emotional
      outcomes on persons involved with or
      resulting from assisted human reproduction
      processes.

            We agree with the establishment of the proposed personal health information registry in clause 21(2), but would like to see it given more prominence at the beginning of the section currently called Privacy and Information. We want this information to be collected on a national basis. We feel that this registry can be a positive contribution to our desire to ensure respect for human individuality, dignity and integrity, precautionary measures to protect and promote health, non-commodification, informed choice and accountability and transparency.

            We were surprised to learn that Canadians do not yet have ready access to data about assisted human reproduction. Although we were told that medical practitioners have been trying for ten years to develop a voluntary registry, we received neither concrete evidence of a registry nor specific data from a registry. We heard that few sperm banks in Canada keep detailed information about donors and the uses of the donated sperm and we heard nothing about egg or embryo donations.

            The Committee wants more than voluntary efforts by the medical professionals. We want mandatory reporting, collection and analysis of data. We want consistent and clear facts on the: clinics offering all or some procedures related to assisted human reproduction; general practitioners offering drugs and assisted insemination; sperm, egg or embryo banks and donors; recipients of assisted insemination, egg donation or embryo donation; etc. Without this information, we have no conclusive evidence for supporting the further development of assisted human reproduction.

(ii) Open System for Donation

            In particular, the Committee was told that registries with donor information are important to offspring resulting from donor treatment procedures; descendents of offspring; couples who had a child through donation procedure; donors who provided sperm, eggs, or embryos; relatives of the people; and genetic siblings of offspring resulting from procedures.

            We were particularly moved by the arguments for an open donation system that would not treat children as commodities to be negotiated among participating adults such as parents, donors, and physicians. We agree that the children who result from gamete and embryo donation should receive equivalent respect to those who are adopted. Like adoption, we want a donation system that is regulated, non-commercial, and transparent. We aim for a system whereby donation records are securely controlled but accessible to those who need relevant information. We also believe that children who are born from surrogacy arrangements should have access to full information.

            In moving to an open system that eliminates secrecy, the Committee would like to see a strategy that combines legislation and education, focusing particularly on physicians and others who facilitate the process of donation. We want to ensure that before any donation takes place, the prospective donor is fully informed of the implications of assisted human reproduction, especially of having an offspring. We believe that only donors who consent to have identifying information released to offspring should be accepted. We feel that, where there is a conflict between the privacy rights of a donor and the rights of a resulting child to know its heritage, the rights of the child should prevail. We need a system of responsible donation and greater public awareness. We want to end the current system of anonymous donation.

As a Committee, we recommend that:

RECOMMENDATION 19:

(a)   Consent to the release of identifying
        information be mandatory before accepting an
        individual as a sperm, egg, or embryo donor;

(b)   All donor offspring (or legal guardians) have
        access to their regularly updated medical
        histories;

(c)   The number of babies born through the same
        donor be limited;

(d)   The number of donations from the same donor
         be limited;

(e)   Connections between genetic siblings are to be
        facilitated to avoid possibilities of sexual
        relations or marriage; and

(f)    Medical and personal records be maintained;

(g)   Mandatory counselling be provided for
        donors before a choice to donate is made and
        before an offspring establishes a link with a
        donor;

(h)   No legal responsibilities respecting offspring,
        financial or otherwise, should arise out of a
        donation.

            The Committee heard that several provinces (Newfoundland, Nova Scotia, and Quebec) and one territory (Yukon) have already enacted laws that specifically or implicitly exclude donors as the legal parent of a child, thereby eliminating them as a possible source of financial support for the offspring.

To encourage this type of legislation in other provinces and territories, the Committee recommends that:

RECOMMENDATION 20:

The federal Minister of Justice, in collaboration with provincial and territorial counterparts, seek to develop uniform legislation across the country establishing the legal status of donors in relation to offspring.

            Clause 41 of the draft legislation authorizes equivalency agreements to be signed with the provinces and territories. Such agreements may be entered into if a province or territory has enacted laws that are equivalent to selected clauses and corresponding regulations, namely: clauses 8 to 11 (controlled activities), clauses 18 to 21 (health reporting information) and clauses 23 to 32 (inspection and enforcement). Once in place, an equivalency agreement suspends the application of clauses 8 to 40 of the federal legislation. Instead, the "equivalent" measures enacted at the provincial or territorial level apply.

            The Committee heard widespread unease about clause 41. Some witnesses were concerned that the provinces and territories would not be required to establish a public information registry because clause 22 is not among the selected clauses for which equivalent measures would have to be enacted. Others were worried that equivalency agreements would not have to incorporate equivalent penalty provisions to those set out in the federal legislation. Still others were apprehensive that equivalency agreements would undermine the establishment of a strong, national regulatory regime for assisted human reproduction and related research.

            The Committee shares these concerns. Equivalent measures are clearly not identical measures. There is room for interpretation and therefore the potential for different systems to be enacted from one jurisdiction to the next. A patchwork might result. In our opinion, it would be in the best interest of the resulting children, as well as the men and women participating in assisted human reproduction, if a single regulatory regime encompassing one set of standards and one set of penalties, was in effect across the country, with no exceptions.

            We recognize, however, that assisted human reproduction and related research is an area of shared responsibility. The provinces and territories may also want to take action. Equivalency agreements would enable them to do so. Even though the Committee has serious reservations about equivalency agreements, we accept that these agreements may be a necessary tool in the advancement of cooperative federalism.

            In addition to equivalency agreements, it would be possible for the Minister, under clause 33, to sign enforcement agreements with provincial/territorial governments, law enforcement agencies and non-governmental organizations.

            The Committee also has misgivings about this type of agreement. We are particularly concerned that such agreements might be signed with non-governmental organizations. In our opinion, the law enforcement powers of the state should not be delegated to non-governmental bodies.

            Given the specialized nature of the inspections that would have to be carried out, as well as the high degree of technical expertise that would be required, it would be preferable, in our opinion, if a single, specialized inspection body were put in place to inspect and enforce the legislation. A single inspection body would best ensure that the legislation was being applied evenly across the country. We question whether consistency could be ensured if more than one inspection body was involved.

            Both enforcement and equivalency agreements are of concern to us. Although we are not prepared to recommend that they be precluded, we agree with witnesses that a number of safeguards must be put in place to ensure accountability and transparency.

The Committee therefore recommends that:

RECOMMENDATION 21:

Enforcement agreements not be allowed to be entered into with a non-governmental organization.

The Committee further recommends that:

            According to the draft legislation, the Minister of Health, aided by his Department, would be responsible for implementing the legislation. Given the many moral, ethical and social questions surrounding human embryo research and infertility treatment, most witnesses felt that an arm’s length agency would be more appropriate. Some witnesses also felt that an outside agency would be better able to provide timely responses in such a rapidly changing technological field.

            While there was broad consensus for the creation of a regulatory body outside the Department, the Committee heard differing views on the regulatory body’s structure and mandate. There was also disagreement on whether the regulatory body should report directly to Parliament or whether it should report to Parliament through the Minister of Health. We endorse the creation of an outside agency to manage and oversee the operation of the Act. Such an agency should be a semi-independent body, directed by a Board that reports directly to the Minister of Health, and with mechanisms that ensure accountability to Parliament.

The Committee recommends that:

RECOMMENDATION 23:

A regulatory body be created outside the Department of Health to manage and oversee the operation of the Act. The regulatory body should be a semi-independent agency, directed by a Board that reports directly to the Minister of Health, and with mechanisms that ensure accountability to Parliament.

            In our opinion, requiring the agency to report to the Minister is more in keeping with the principle of ministerial accountability. The Minister’s involvement is also desirable in terms of intergovernmental relations given that the provinces and territories share constitutional authority to take action in this area.

            In devising a regulatory framework for assisted human reproduction, we were asked to consider a "checks and balances" approach. Under this approach, the Minister would be responsible for establishing general policies and standards relating to the safety and efficacy of reproductive and genetic technologies allowed in Canada. The Minister would also be responsible for auditing and assessing the effectiveness of the inspection and enforcement activities of the regulatory body to ensure compliance with health and safety standards. The Minister, however, would not participate in the day-to-day operations of the agency.

            The Committee supports this approach as it provides a workable compromise between ministerial accountability, on the one hand, and an autonomous, arm’s length agency, on the other.

The Committee recommends that:

RECOMMENDATION 24:

The Minister under the legislation be responsible for:

(a)   reproductive and genetic technology
        policies for the Government of
        Canada;

(b)   the overall direction of the regulatory
        body;

(c)   the negotiation of equivalency
        agreements and enforcement
        agreements; and

(d)   the assessment of the regulatory
        body’s effectiveness.

            The role of the regulatory body, in turn, should consist of monitoring relevant domestic and international developments in order to make recommendations to the Minister about changes required to the legislation, regulations, and policies. It should be responsible for issuing, renewing, amending, suspending or revoking licences to qualified applicants regarding approved treatments and research. It should ensure compliance with the Act, either through its own "in-house" inspection staff or through some other entity deemed acceptable as a substitute under an enforcement agreement.

            In addition, the regulatory body should be responsible for maintaining the personal health information registry, as well as the public information registry. Notably, it should keep track of the children born of assisted human reproduction and, to the extent possible, update the information collected on donors and offspring. In addition, in order to ensure that sound science is applied, the regulatory body should report on the outcomes of the treatments that were provided and the research that was carried out.

            The regulatory body should also assume a strong information and communications role. In this regard, it should engage in ongoing consultations with interested parties. It should also provide the individuals involved in assisted human reproduction with complete information to enable informed choices.

            In addition to its day-to-day operations, the regulatory body should be accountable to Parliament and the public through a combination of mechanisms including the following:

(i)   Annual report to Parliament;

(ii)  Audit by the Office of the Auditor General of Canada;

(iii) Strategic plan every three years for approval by
       Parliament as well as the Minister;

(iv) Public hearings on licensing matters and specific
      issues of concern;

(v)  Reporting of activities in the public information registry;

(vi) Ministerial review of the effectiveness of the regulatory
      body; and

(vii) Scrutiny by the House of Commons and the Standing
       Committee on Health of proposed regulations before
        implementation by the regulatory body.

            In order to ensure that the regulatory body carries out its functions in a manner that is faithful, and gives effect, to the core values of the legislation, the Committee strongly believes that the principles enshrined in the Statutory Declaration should be explicitly set out in the regulatory body’s mandate. The regulatory body should also be required to develop a Code of Ethics based on these principles that would inform Canadians about the way in which it proposes to exercise its powers.

The Committee recommends that:

RECOMMENDATION 25:

The regulatory body be given a statutory base. Its functions should include:

(a)    monitoring Canadian and international developments
         in order to make recommendations to the Minister
         about changes that should be made to the
         legislation, regulations, and policies;

(b)    issuing, amending, renewing, suspending or
         revoking licences for qualified applicants with
         respect to approved treatments and research;

(c)    ensuring compliance with the Act through
         inspection and enforcement;

(d)    maintaining the public information registry, as
         well as the personal health information registry,
         including information on the number of children
         born from assisted human reproduction and
         updates on offspring and donor information;

(e)   reporting to the public on the outcomes of the
        treatments provided and the research carried
        out;

(f)    engaging in regular, ongoing consultations with
        interested parties;

(g)   providing complete information to enable
        Canadians to make informed choices.

The Committee also recommends that:

RECOMMENDATION 26:

The principles enshrined in the Statutory Declaration be explicitly set out in the regulatory body’s mandate and the regulatory body should be required to develop a Code of Ethics based on these principles. The regulatory body must also table an annual report in Parliament and prepare a strategic plan every three years for the approval of the Minister and Parliament.

            With respect to the composition of the regulatory body, we recognize that there are two distinct regulatory areas suggested in the draft legislation; on the one hand, assisted reproduction treatments and on the other, research involving embryos, eggs, and sperm. We acknowledge that the expertise required to issue a licence respecting assisted human reproduction is quite different from that required to license embryonic research unrelated to the treatment of infertility. Although this could eventually lead to the creation of two distinct bodies to regulate these two materially different fields of assisted human reproduction and research involving human subjects and human tissue, we want no further delays in relation to the enactment of this much-needed legislative framework. We want legislation tabled immediately to establish appropriate boundaries around ongoing activities. In the short term, we believe that our proposed regulatory board can deal with the separate fields.

            After careful consideration of the various options presented to us, the Committee largely supports a regulatory body governed by a Board of about nine members who are chosen for their wisdom, judgment, and ability to comprehend the multiple dimensions of assisted human reproduction and related research. This Board composed of broad thinkers with diverse life experiences should be supported by multiple panels or advisory committees representative of persons drawn from a variety of academic disciplines and community perspectives.

            To maintain the Board arm’s length status, none of its members should be drawn from government or represent any specific interests. In particular, members should not be in any financial conflict of interest. Since women are affected more directly by the reproductive therapies than men, the Committee believes that a majority of the Board should consist of women.

            After consultation with provincial and territorial governments, stakeholders, and the House of Commons Health Committee, Board members should be appointed by the Governor in Council. They should serve for a three year renewable term and the initial appointments must be staggered to ensure rotation and gradual replacement of the knowledge base.

The Committee recommends that:

RECOMMENDATION 27:

(a)   The Board consist of about nine members to be
        appointed by the Governor in Council, after
        consultation with provincial and territorial
        governments, stakeholders, and the House of
        Commons Health Committee;

(b)   Board members be chosen for their wisdom,
        judgment, and ability to comprehend the multiple
        dimensions of assisted human reproduction and
        related research;

(c)   Board members not represent or have any ties
        with specific interests nor have a financial
        conflict of interest;

(d)   There be no government representation on the
        Board;

(e)   Women comprise at least half of the Board’s
        membership;

(f)   Board members serve for staggered terms of
       three years, which could be renewed twice.

            A Secretariat, headed by a Chief Executive Officer and staffed by individuals with expertise in such areas as medical and health policy, regulatory affairs, etc. should be established to assist the Board in achieving its policy and administrative objectives. In addition, the Board should be authorized to create expert panels or advisory committees to advise it and to study special issues and developments. Notably, these panels or advisory committees should be established to provide advice and make recommendations to the Board on the two broad regulated areas, namely, reproductive therapy and research.

The Committee recommends that:

RECOMMENDATION 28:

A Secretariat, headed by a Chief Executive Officer and staffed by individuals with expertise or experience in a variety of relevant fields, be established in the legislation to assist the Board in its policy and administrative objectives.

The Board be authorized to establish expert panels or advisory committees to advise the Board and to study special issues and developments.

The panels include persons with perspectives of those with disabilities, those who are infertile, those who are members of racial minorities, those from the faith communities as well as those with a broad range of expertise, including reproductive medicine, health research, ethics, social sciences, and law.

            One of the Board’s more immediate tasks will be its licensing function. In our opinion, the licensing hearings should be public. Some hearings will obviously be more routine than others, but we believe that it is important to give the public an opportunity to be heard.

            The Committee also believes that the Board should have the authority to hold public hearings on specific issues of concern. By providing a public forum for debate on possibly contentious subjects, the Board will enable Canadians to participate more fully in the formulation of policy. The Board will also benefit from the public debate and will be in a better position to make recommendations to the Minister.

The Committee recommends that:

RECOMMENDATION 29:

The licensing hearings be held in public.

The Board be authorized to hold public hearings on specific issues of concern.

            We feel that the actions of the regulatory body, as well as those of the Minister, should be as transparent as possible. The public information registry proposed in clause 22 of the draft legislation is a step in the right direction in requiring information prescribed by regulations such as licences issued, applied for, and renewed; decisions on licensing and enforcement; aggregated outcomes of procedures performed by licencees, and so on. However, to keep the public more fully informed, we believe that all of the Board’s activities should be reported in the public information registry, except for those explicitly exempted in the legislation.

The Committee recommends that:

RECOMMENDATION 30:

All of the Board’s activities be reported in the public information registry unless specifically excluded in the legislation.

            Finally, many witnesses emphasized the need to provide adequate funding to the regulatory body to enable it to do the job at hand. The Committee agrees. We want the regulatory body to be given a separate, adequate budget to cover its activities. We do not want the process of regulating assisted human reproduction and related research to be influenced by cost-recovery considerations. We believe, therefore, that the regulatory body should not be made subject to the current federal cost-recovery policy.

The Committee recommends that:

            Clause 42 in the proposed legislation calls for a five-year parliamentary review of the legislation. The Committee believes this proposed five-year term is too long.

            Once the legislation is adopted by Parliament, regulations essential to its application will have to be developed. The regulatory body will also have to be set up and be ready to go. It may therefore take months before the legislation can be proclaimed in force. In the meantime, the technology employed in assisted human reproduction and related research may evolve at such a rapid pace that the new legislation will require updating.

            Because of the rapidly changing scientific and technological environment, we feel that a parliamentary review within three years would be more appropriate. The subject matter of this legislation is highly sensitive and controversial. Parliament must carry out an earlier, more timely review to ensure that the legislation is still in tune with the changing times and technologies.

The Committee recommends that:

RECOMMENDATION 36:

The legislation include a clear definition of informed choice. The definition and subsequent regulations should include, but not be limited to, the following components:

(a)   Mandatory independent counselling
        for all assisted human reproduction;

(b)   The provision of such counselling be
         made a condition of any licence;

(c)   Consent be obtained at all stages of all
        processes; and

(d)   Consent may be withdrawn at any
        time, except as regards the retention
        and disclosure of medical records and
        personal identifying information
        where an offspring is involved.