ROYAL COMMISSION FINAL REPORT
Prepared by Nancy Miller Chenier
Political and Social Affairs Division
22 April 1994
TABLE OF CONTENTS
ONE: REPRODUCTIVE TECHNOLOGIES AND CANADIAN SOCIETY
TWO: CONDITIONS, TECHNOLOGIES, AND PRACTICES
A. Prevalence, Risk Factors and Prevention
B. Methods of Assisted Human Reproduction
C. Prenatal Diagnosis Techniques and
D. Research Involving Human Zygotes,
Embryos and Fetal Tissue
PART THREE: RECOMMENDATIONS
PART FOUR: ANNEX, GLOSSARY AND APPENDICES
ROYAL COMMISSION FINAL REPORT
In November 1993,
the Royal Commission on New Reproductive Technologies released its final
report, Proceed with Care. It was the culmination of an inquiry,
initiated in October 1989, into "current and potential medical and
scientific developments related to new reproductive technologies"
to consider their "social, ethical, health, research, legal and economic
implications." Comprising 1,275 pages in two volumes and containing
293 recommendations, the report is divided into four parts.
PART ONE: REPRODUCTIVE TECHNOLOGIES AND CANADIAN
The ethical framework
of the Commissioners' deliberations gave priority to families and communities,
to building relationships and preventing conflict. The eight principles
used to assess the application of a technology were: individual autonomy,
equality, respect for human life and dignity, protection of the vulnerable,
non-commercialization of reproduction, appropriate use of resources, accountability,
and achieving balance between individual and collective interests.
national surveys, more than 15,000 Canadians participated in personal
interviews, focus groups, phone interviews, or questionnaires. The results
revealed serious concerns about the technologies, including their potential
threat to health, the ethical dilemmas they create, and their adverse
impact on particular groups such as women, children, families, and the
insisted that all evidence about the technologies must be carefully evaluated
and all decisions about their use must be based on a comprehensive assessment
of their safety, effectiveness and cost, as well as their ethical, legal,
and social implications. Where evidence of their intended benefits was
lacking, procedures, treatments or medications should be provided only
as part of carefully controlled research, not as standard medical practice.
recommended that two actions be taken immediately by Parliament. These
were: changing the Criminal Code to prohibit certain practices
related to the use of reproductive technologies, and establishing a new
regulatory body, the National Reproductive Technologies Commission.
PART TWO: CONDITIONS, TECHNOLOGIES, AND PRACTICES
A. Prevalence, Risk
Factors and Prevention of Infertility
the sociological and psychological dimensions of infertility, the report
addresses infertility principally as a medical condition with physiological
defined as the absence of pregnancy for couples who had been married or
cohabiting for at least a full year or two full years and who had not
used contraception during that period. With this definition, random sampling
showed that after one year 8.5% (or about 300,000 couples) of the Canadian
population, and after two years 7% (or about 250,000 couples) were infertile.
The impact of various
risk factors on fertility was investigated in cases of failure to carry
a pregnancy to term and to give birth to a healthy child as well as in
cases of inability to conceive. Risk factors examined included: sexually
transmitted diseases (accounting for an estimated 20% of infertility cases),
smoking, delaying childbearing, harmful agents in the workplace and the
environment, alcohol use, eating disorders, excessive exercise, stress,
and medical intervention. The Commissioners recommended immediate establishment
of a country-wide program of sexual health education for young people,
training of health care professionals, and funding for programs and research.
B. Methods of Assisted
the most common method of treating infertility, are synthesized hormones
developed to regulate the reproductive system. The two most common drugs
used to induce ovulation - clomiphene and human menopausal gonadotropin
(hMG) - were not fully evaluated before their introduction; when used,
both have side effects, ranging from mild to life-threatening.
An observed increase
in multiple births in Canada was attributed to use of fertility drugs
and prompted questions about their health risks for pregnant women, developing
fetuses, and children, as well as about the costs of health care and other
societal implications. The recommendations on fertility drugs included
calls for well-designed clinical trials, changes in the drug approval
system, the development of guidelines for practitioners prescribing the
drugs, and enhanced monitoring and reporting.
In assisted insemination
(AI), the oldest known technique for treating infertility, sperm from
the husband or from a donor is introduced into the woman's body to fertilize
the egg. In 1991, about 3,400 women used services at the 24 assisted insemination
programs across Canada but no data were available on the AI offered by
family practitioners and obstetricians. Estimates suggest that between
1,500 and 6,000 children are born through donor insemination each year.
Questions on assisted insemination focused on its effectiveness and risks,
the advantages and disadvantages of disclosure, commercialization, access
to treatment, and the safety of collected semen.
fertilization (IVF), the most publicized infertility treatment, was carried
out on several thousand women in 1991 but resulted in fewer than 400 infants.
Developed originally to treat fallopian tube blockage, this fertilization
of the egg outside the body has come to be used for many other infertility
diagnoses but without proof of its effectiveness in such cases. Once the
eggs are removed from the uterus, they may be used for research or gamete
manipulation to improve fertilization, transfered back to the body followed
by or accompanied by the sperm, donated to a recipient, or fertilized
in a culture medium. Commissioners agreed any use of IVF except for blocked
fallopian tubes should be considered research only and argued that a similar
evidence-based approach should be the model for all health care.
C. Prenatal Diagnosis
Techniques and Genetics
for genetic diseases and anomalies is done through routine screening tests
during pregnancy; examples are: ultrasound, maternal serum alpha-fetoprotein
(MSAFP), amniocentesis, chorionic villus sampling (CVS) and targeted ultrasound
to identify fetal anomalies. Newer technologies, such as DNA analysis
of fetal cells in a pregnant woman's blood, pre-implantation diagnosis,
and magnetic resonance imaging, are under development. A Commission survey
of genetics centres found that approximately 5% of diagnostic tests showed
the fetus to have a serious congenital anomaly or genetic disease; in
such cases about 80% of pregnancies were terminated.
focused on the need for supportive counselling, informed consent, protection
of privacy and confidentiality, and reasonable access to the technologies.
The Commission found evidence of effectiveness and low risk in the standard
applications of all common diagnostic PND technologies. Funding for large
multicentre trials of newly developing technologies was recommended.
testing is currently provided for a few late-onset disorders such as Huntington
disease and adult polycystic kidney disease, where, if either parent has
the disorder, each child has a 50% chance of inheriting the gene. The
Commission argued for the restriction of this testing to genetic centres.
Prenatal testing for genetic predisposition toward multifactorial disorders,
such as certain cancers, cardiovascular disease and mental illness, is
not currently being done in Canada and the Commission recommended against
its introduction. Gene therapy and genetic alteration in the reproductive
context are experimental and as such were seen to require close monitoring
The three distinct
techniques employed in sex selection for non-medical reasons are sperm
treatment followed by assisted insemination, sex-selective zygote transfer,
and prenatal detection of fetal sex to enable sex-selective abortion.
Except where medically indicated (for example, in cases of diseases linked
to the X chromosome), the Commission recommended that the techniques not
be available for use.
D. Research Involving
Human Zygotes, Embryos and Fetal Tissue
It was recommended
that egg and embryo donation and embryo research made possible through
IVF be permitted only under particular conditions. Women who have experienced
menopause at the usual age would not be candidates for donated eggs or
zygotes. Designated donation of human eggs and embryos and payment for
donation would not be permitted. Research involving genetic alteration
of zygotes or embryos would be prohibited.
The serious social
and ethical implications of transplanting fetal tissue obtained from elective
abortions to correct diseases such as Parkinson, Alzheimer and diabetes
were addressed. Other uses of fetal tissue from both spontaneous and elective
abortions include: basic medical research on normal and abnormal fetal
development; viral diagnostics; pathology testing; the development and
testing of new pharmaceutical products; and medical education. It was
recommended that fetal death must be established before tissue is taken
and that any tissue must be used only to increase understanding of human
functioning or disease.
PART THREE: RECOMMENDATIONS
The first category
of federal recommendations called for Criminal Code prohibitions
on selling human eggs, sperm, zygotes, or fetal tissue; advertising for,
paying for, or acting as an intermediary for preconception (surrogacy)
arrangements; using embryos in research related to cloning, creating animal/human
hybrids, fertilizing eggs from female fetuses for implantation; and unwanted
medical treatment or other interference with the physical autonomy of
The second category
focused on the creation of the National Reproductive Technologies Commission
(NRTC) to oversee licensing and to monitor reproductive technologies and
practices. The NRTC would have five areas of regulatory responsibility:
sperm collection, storage and distribution with assisted insemination
services; assisted conception services, including egg retrieval and use;
prenatal diagnosis; human zygote research; and the provision of human
fetal tissue for research or other specified purposes. A sixth area would
be responsible for compilation and evaluation of data on causes of infertility,
promotion of national and international research, and options for preventing
or reducing infertility.
More active roles
were recommended for certain federal departments. Health would initiate
and coordinate campaigns for the prevention of infertility and its Drugs
Directorate would improve its system of drug approval and post-marketing
surveillance. The Medical Research Council would give higher priority
to basic and applied research on sexual and reproductive health concerns.
Human Resources would address issues related to delayed childbearing and
occupational health, while Environment would have a role in controlling
environmental threats to reproductive health.
PART FOUR, ANNEX, GLOSSARY, AND APPENDICES
This part of the
report includes: the dissenting opinions of one Commissioner on six areas
of the report, suggesting greater caution in the application of some technologies;
a glossary of technical terms; and six appendices of general information
on the Commission's work.
The report of the
Royal Commission on New Reproductive Technologies represents a major step
toward regulating the proliferation of scientific and medical applications
in the area. The report is limited, however, in that it fails to challenge
the current organization of the science and medicine underlying the technologies;
thus some doubt arises with respect to the Commission's decisions about
the evaluation of these technologies and the resulting evidence in support
of their use.