Policy Design for Human Embryo Research in Canada: 1989–2015

Abstract

In Canada, research involving human embryos is circumscribed by law and research guidelines. This chapter describes the development of these policy instruments over the past 25+ years and analyses this history using a typology of modes of public consultation developed by Eric Montpetit (2003). Over time, the degree to which the views of Canadians on human embryo research have been solicited as part of the policy-making process has diminished significantly. We expect this trend to continue, given the presence of powerful interest groups and policy communities “speaking for” Canadians.

Appendices

Appendices

Appendix 6.1: Royal Commission on New Reproductive Technologies, Proceed with Care

Consultations and communications
Input from Canadians
Public and Private Hearings: more than 550 Canadians took part in and presented briefs to public hearings across the country.
Submissions and Letters of Opinion: 500 written submissions and opinions up to September 1993.
Personal Experiences and Private Sessions: 500 individuals wrote to the Commission about their personal experiences or participated in private sessions held across the country.
Information Meetings: to consult organizations such as public health associations, women’s groups, religious organizations, groups representing people with disabilities, the legal and medical professions, the research community, and the pharmaceutical industry.
Search Conference: three-day session involving 32 experts in fields such as health, law, bioethics, and religion, as well as representatives of people with disabilities.
Public Opinion Research: more than 15,000 surveyed; surveys explored awareness, values, and attitudes.
Toll-Free Telephone Lines: to facilitate participation in the Commission’s consultations for people who might have found it difficult or inconvenient to participate through hearings or submissions; to provide access to information about the Commission and its work; more than 6000 calls received.
Informing Canadians
Research Reports Released: Commission released 14 research studies during its mandate.
Newsletter Published: 50,000 copies of semi-annual newsletter, Update, detailing our research and other activities, were distributed through mailing list and public events.
Distribution and Information: 250,000 pieces of information distributed during the life of the Commission, such as information kits, brochures on the public participation and research programs, newsletters, speeches; information for use by community newspapers, journals, and opinion and editorial page editors; and information distribution also by cable television and satellite networks.
Media Activities: more than 1,000 media interviews were given and more than 7,000 media articles appeared about the Commission and its work.

Appendix 6.2: Discussion Group on Embryo Research

Summary of recommendations
Recommendation 1
No research on human embryos should be allowed unless it is approved and overseen on an ongoing basis by a National Regulatory Body (NRB). Violations should be subject to criminal sanction.
Recommendation 2
Human embryo research should be allowed only:
1.  after the exhaustion of useful inquiry using animal or other non-human models;
2.  when demonstrably necessary for the improvement of the human condition;
3.  when of the highest scientific quality as determined by rigorous peer review; and
4.  when approved by the NRB.
This recommendation should be incorporated in the appropriate legislation.
Recommendation 3
In keeping with current internationally accepted norms, research involving developing human embryos, ex utero, should not be permitted later than 14 days after conception. This limit should be subject to modification should there be new and compelling ethical or scientific justification to do so. This recommendation should be incorporated into appropriate legislation.
Recommendation 4
Viable human embryos should only be used in research where a compelling case is made that non-viable embryos cannot be successfully employed. This recommendation should be incorporated into appropriate legislation.
Recommendation 5
For acceptable regulation of RHE, a National Regulatory Body must provide a process of oversight of the clinical practice of reproductive technologies, in cooperation with the appropriate provincial licensing bodies and professional organizations.
Recommendation 6
After the woman/couple has arrived at a settled intention not to use their embryos for gestation, they should be given the choice of donating them to another woman/couple for gestation or donating them for research or directing that they be discarded. This recommendation should be incorporated into appropriate legislation.
Recommendation 7
Any use of embryos for purposes other than consented to by the woman/couple should be subject to criminal sanction.
Recommendation 8
Medical procedures related to infertility treatment should be undertaken with the sole objective of the medical well-being of the woman undergoing the procedures and the resulting offspring. Medical management should be directed toward minimizing risk and maximizing the likelihood of a successful pregnancy. Procedures must not be altered in any way that compromises the medical interests of the woman and the offspring, even if doing so would make ova or embryos available for research. This recommendation should be incorporated into appropriate legislation.
Recommendation 9
While approved clinical procedures exist which involve manipulation of the embryos, appropriate mechanism for their approval and monitoring should lie within the clinical domain.
This recommendation should be incorporated into appropriate legislation.
Recommendation 10
Fertilization of human ova for research is prohibited unless the National Regulatory Body considers the research proposal to contain an exceptional circumstance in which anticipated benefits to society or future offspring require that the experiment occur. Such knowledge would have to be unattainable by other means. Violations should be subject to criminal sanction.
Recommendation 11
All research or experimentation on a human embryo (including but not restricted to human cloning, chimeras, production of interspecies embryos and transgenic human embryos) without the explicit approval of the National Regulatory Body should be prohibited. Failure to secure such explicit approval should constitute a criminal offense.
Recommendation 12
In the absence of a National Regulatory Body vested with the powers listed in Recommendation 19, fertilization of human ova for research and research into human cloning, chimeras, production of interspecies embryos and transgenic human embryos should be banned without exception.
Recommendation 13
PGD should only be offered in the context of structured, clinical trials approved and monitored by the National Regulatory Body.
Recommendation 14
Even if proven to be safe and effective, PGD should only be available to diagnose the most serious of genetic conditions as established on a list by a National Regulatory Body, because of its potential social and health impacts.
Recommendation 15
Commercialization of gametes and embryos for research should be prohibited both within Canada and in the context of importation and exportation. Violations of this recommendation should be subject to criminal sanction.
Recommendation 16
Payment for gametes or embryos shall not exceed the out-of-pocket expenses for the donors and the costs of handling, storing, transporting and transferring the gametes and embryos. Violations of this recommendation should be subject to criminal sanction.
Recommendation 17
Reduction in the price of IVF or other medical services should never be exchanged for gametes or embryos for use in research. This recommendation should be incorporated into appropriate legislation.
Recommendation 18
A multi-perspectival National Regulatory Body should be created by Parliament through legislation without delay. This body should have jurisdiction over all aspects of reproductive technology. This legislation should also specify which conduct should be subject to criminal sanctions.
Recommendation 19
The National Body created through Recommendation 18 should include but not be limited to the following powers with specific reference to RHE:
1.  setting of technical standards of investigation, clinical practice, and education within an ethical framework;
2.  ongoing exploration of emerging ethical issues in RHE;
3.  approval of research protocols and monitoring of approved investigation;
4.  accreditation and supervision of facilities and licensing of practitioners and researchers using human gametes or embryos, in cooperation with the appropriate provincial and national organizations;
5.  defining violations and breaches of conduct, and the enforcement of sanctions;
6.  development of a strategy for information management related to such priorities as registries, research outcomes and clinical practice guidelines;
7.  undertaking other functions as detailed in recommendations in this report.
Recommendation 20
The mandate of the NRB should allow for delegation of powers (other than whose falling within criminal jurisdiction), and development of partnerships with the provinces as well as regional and professional bodies.

Appendix 6.3: Assisted Human Reproduction Act

Prohibited activities
Prohibited procedures
5. (1)  No person shall knowingly
(a)  create a human clone by using any technique, or transplant a human clone into a human being or into any non-human life form or artificial device;
(b)  create an in vitro embryo for any purpose other than creating a human being or improving or providing instruction in assisted reproduction procedures;
(c)  for the purpose of creating a human being, create an embryo from a cell or part of a cell taken from an embryo or foetus or transplant an embryo so created into a human being;
(d)  maintain an embryo outside the body of a female person after the fourteenth day of its development following fertilization or creation, excluding any time during which its development has been suspended;
(e)  for the purpose of creating a human being, perform any procedure or provide, prescribe or administer any thing that would ensure or increase the probability that an embryo will be of a particular sex, or that would identify the sex of an in vitro embryo, except to prevent, diagnose or treat a sex-linked disorder or disease;
(f)  alter the genome of a cell of a human being or in vitro embryo such that the alteration is capable of being transmitted to descendants;
(g)  transplant a sperm, ovum, embryo or foetus of a non-human life form into a human being;
(h)  for the purpose of creating a human being, make use of any human reproductive material or an in vitro embryo that is or was transplanted into a non-human life form;
(i)  create a chimera, or transplant a chimera into either a human being or a non-human life form; or
(j)  create a hybrid for the purpose of reproduction, or transplant a hybrid into either a human being or a non-human life form.
Offers
(2)  No person shall offer to do, or advertise the doing of, anything prohibited by this section.
Payment for prohibited act
(3)  No person shall pay or offer to pay consideration to any person for doing anything prohibited by this section.