HEAL Committee Report
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LIST OF RECOMMENDATIONS
The Minister of Health introduce legislation on assisted human reproduction and related research as a priority.
The Preamble be replaced by a Statutory Declaration enacted in the body of the legislation.
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
(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.
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
(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.
The prohibited activities currently set out in the draft legislation be retained and enacted as prohibited activities in the new legislation, subject to the additional modifications reflected in the following recommendations.
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.
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.
An additional prohibition be included that bans the creation and use of all animal/human hybrids for the purpose of reproduction.
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.
Clauses 4(4) that excepts legal, medical, and psychological services and 10(d) that allows reimbursement of expenses to a surrogate mother be eliminated.
An exception be created for physicians and other health care professionals who provide services necessary for the care of the pregnant woman.
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.
Clause 10(a) that permits reimbursement of a donor for expenses incurred in the course of donating any sperm or ovum be eliminated.
Research using embryos be a controlled activity requiring a licence. Even if all other regulatory criteria are met, no licence may be issued unless the applicant clearly demonstrates that no other category of biological material could be used for the purposes of the proposed research.
Regulated standards be developed in relation to the following matters:
(a) The maximum number of eggs that may be harvested and
(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
(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.
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 be modified to provide a maximum one-year expiry date for the licensing exemption.
Provisions similar to section 42.1 of the federal Tobacco Act be included in the new Act to require that all proposed regulations be laid before the House of Commons for approval or modification within 30 sitting days. Provision should also be made requiring the proposed regulations to be referred specifically to the House of Commons Standing Committee on Health.
(a) Consent to the release of identifying information be mandatory
before accepting an individual as a sperm, egg, or embryo
(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 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.
Enforcement agreements not be allowed to be entered into with a non-governmental organization.
Both equivalency and enforcement agreements be subject to the following safeguards:
(a) The Minister must be accountable to Parliament for all
equivalency and enforcement agreements;
(b) The public must be actively consulted on the draft agreements
before they are finalized;
(c) The draft agreements, together with a summary of the
comments made by the public, must be tabled in the House of
Commons before they are finalized to give elected
representatives the opportunity to make recommendations in
relation to them;
(d) The text of all finalized agreements must be included in the
public information registry established under the Act;
(e) All agreements be subject to termination or revocation upon
reasonable notice being given by either party;
(f) The Minister must be empowered to intervene under a savings
clause that would enable him or her to take any action deemed
necessary for the administration and enforcement of the Act;
(g) All agreements be subject to a maximum five-year sunset
clause, with the possibility of renewal for further maximum
five-year periods in appropriate cases; and
(h) As a condition precedent to the signing of an agreement, the
other government must agree to comply with the same
reporting requirements that apply at the federal level. The other
government must also agree to transmit the related data to the
regulatory body for inclusion in the federal personal health
information registry and the public information registry.
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.
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
(d) the assessment of the regulatory bodys effectiveness.
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
(c) ensuring compliance with the Act through inspection and
(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
(g) providing complete information to enable Canadians to make
The principles enshrined in the Statutory Declaration be explicitly set out in the regulatory bodys 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.
wisdom, judgment, and
(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
ability to comprehend the multiple dimensions of assisted
human reproduction and related research;
(c) Board members not represent or have any ties with
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 Boards 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 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.
The licensing hearings be held in public.
The Board be authorized to hold public hearings on specific issues of concern.
All of the Boards activities be reported in the public information registry unless specifically excluded in the legislation.
The federal government, under separate appropriations voted by Parliament, adequately fund the regulatory body.
The regulatory body not be subject to the federal governments cost recovery policy.
The new Act require a parliamentary review of the legislation within three years of its proclamation date.
The Minister of Health bring focus and resources to a sexual and reproductive health program with a particular emphasis on data collection, research, information dissemination, and policy development related to prevention of infertility.
The program include horizontal coordination with relevant federal departments such as Human Resources Development Canada on issues related to delayed childbearing and occupational health; Environment Canada on environmental threats to reproductive health; Canadian Institutes for Health Research on research into risk factors for and prevention of infertility.
The program continue the ongoing collaboration with provincial and territorial counterparts.
The Patent Act be amended to prohibit patenting of humans as well as any human materials.
The legislation include a clause to provide that the Act is binding on her Majesty in right of Canada or of a province or territory.
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
(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.