Like all scientific and medical procedures, assisted human reproduction has the potential for both benefit and harm. It is in the interests of individual Canadians and Canadian society in general that these practices be regulated so as to maximize their benefits and minimize their harms. To help achieve this goal, the Canadian Medical Association (CMA) has developed this policy on regulating these practices. It replaces previous CMA policy on assisted reproduction.
The objectives of any Canadian regulatory regime for assisted reproduction should include the following:
(a) to protect the health and safety of Canadians in the use of human reproductive materials for assisted reproduction, other medical procedures and medical research;
(b) to ensure the appropriate treatment of human reproductive materials outside the body in recognition of their potential to form human life; and
(c) to protect the dignity of all persons, in particular children and women, in relation to uses of human reproductive materials.
When a Canadian regulatory regime for assisted reproduction is developed, it should incorporate the following principles:
For the regulation of assisted reproduction, existing organizations such as medical licensing authorities, accreditation bodies and specialist societies should be involved to the greatest extent possible.
If the legislation establishing the regulatory regime is to include prohibitions as well as regulation, the prohibition of specific medical and scientific acts must be justified on explicit scientific and/or ethical grounds.
If criminal sanctions are to be invoked, they should apply only in cases of deliberate contravention of the directives of the regulatory agency and not to specific medical and scientific acts.
Whatever regulatory agency is created should include significant membership of scientists and clinicians working in the area of assisted reproduction.
Elements of a Regulatory Regime
The regulation of assisted reproduction in Canada should include the following elements:
Legislation to create a national regulatory body with appropriate responsibilities and accountability for coordinating the activities of organizations that are working in the area of assisted reproduction and for carrying out functions that other organizations cannot perform.
The development and monitoring of national standards for research related to human subjects including genetics and reproduction. The regulatory body would work closely with the Canadian Institutes of Health Research, other federal and provincial research granting councils, the National Council on Ethics in Human Research and other such organizations.
The development and monitoring of national standards for training and certifying physicians in those reproductive technologies deemed acceptable. As is the case for all post-graduate medical training in Canada, this is appropriately done through bodies such as the Royal College of Physicians and Surgeons of Canada and the College of Family Physicians of Canada.
The licensing and monitoring of individual physicians. This task is the responsibility of the provincial and territorial medical licensing authorities which could regulate physician behaviour in respect to the reproductive technologies, just as they do for other areas of medical practice.
The development of guidelines for medical procedures. This should be done by medical specialty societies such as the Society of Obstetricians and Gynaecologists of Canada (SOGC) and the Canadian Fertility and Andrology Society (CFAS).
The accreditation of facilities where assisted reproduction is practised. There is already in Canada a well functioning accreditation system, run by the Canadian Council on Health Services Accreditation, which may be suitable for assisted reproduction facitilies.
Whatever regulatory body is established to deal with assisted reproduction should utilize, not duplicate, the work of these organizations. In order to maximize the effectiveness of these organizations, the regulatory body could provide them with additional resources and delegated powers.
The CMA is opposed to the criminalization of scientific and medical procedures. Criminalization represents an unjustified intrusion of government into the patient-physician relationship. Previous attempts to criminalize medical procedures (for example, abortion) were ultimately self-defeating. If the federal government wishes to use its criminal law power to regulate assisted reproduction, criminal sanctions should apply only in cases of deliberate contravention of the directives of the regulatory agency and not to specific medical and scientific acts.
Health and safety in the workplace continue to be areas of concern to the CMA. The CMA recommends that educational programs on the risks of drug-related impairment to health and safety in the workplace be directed toward labour, management and the public in general. Occupations for which impairment resulting from drug use may constitute a serious hazard should be identified and designated as such. The association recommends that supervisors be trained to refer a worker in a safety-sensitive job for a health assessment if the supervisor has reasonable grounds to suspect impairment of the worker. Workers holding safety-sensitive jobs should be educated to report any departure from their usual state of health as well as any drugs (prescribed or otherwise) being taken to the occupational health physician or, in the absence of such, to the physician of the worker's choice. The CMA is opposed to routine pre-employment drug testing. It recommends that random drug testing among employees be restricted to safety-sensitive positions and undertaken only when measures of performance and effective peer or supervisory observation are unavailable. Drug testing should always be conducted in such a way as to protect confidentiality and should be undertaken with the subject's informed consent (except when otherwise required by law).
The idea of drug testing among workers has developed from society's concern over the relation between drug use and impairment, with resultant risks to the worker, fellow workers and the public.
Education: Since prevention is the principal and ultimate objective the association recommends that educational programs on the risks of impairment to health and safety in the workplace be directed toward labour, management and the public in general.
Illicit drugs are not the only ones that may cause impairment. Certain prescription drugs and even some over-the-counter medications may affect a person's ability to carry out professional functions safely; such effects may vary considerably from one person to another.
Alcohol is by far the most common impairing drug implicated in accidents; in addition, the scientific literature contains a growing body of information on impairment and dangers resulting from the use and misuse of various therapeutic medications. Far less is documented or known about the role of illicit drugs in work-related accidents.
Safety-sensitive occupations: In most workplaces there are occupations for which impairment may constitute a serious hazard. Such occupations should be identified and designated as such. Workers who hold such safety-sensitive jobs must accept the fact that other workers and the public need to be protected from the hazards of impairment, whether from physical or psychologic ill health or from the use of drugs (over-the-counter, prescription or illicit).
Performance assessment of safety-sensitive occupations: The CMA recommends that supervisors be trained to refer a worker in a safety-sensitive job for a health assessment if the supervisor has reasonable grounds (e.g., unsatisfactory performance or observed unusual behaviour) to suspect impairment of the worker. The examining physician may recommend that some tests (including tests for the presence of certain drugs) be carried out under pre-agreed protocols. Workers holding safety-sensitive jobs must be educated to report any departure from their usual state of health as well as any drugs (prescribed or otherwise) they may be taking to the occupational health physician or, in the absence of such, to the physician of the worker's choice.
Testing: Any discussion of drug testing must take the following into account:
If a quantitative test is to be used to determine impairment a limit must be established beyond which a person is deemed to be impaired. However, since the threshold of impairment varies from one person to another this variation should be taken into account when a worker is being assessed.
The tests must be valid and reliable. They must be performed only in laboratories accredited for drug testing.
The tests must provide results rapidly enough to be useful in deciding whether the person should continue to work.
If different testing procedures are available and the differences between the validity and reliability are not significant the least intrusive alternative should be chosen.
The test should be conducted in such a way as to ensure confidentiality and should be undertaken with the subject's informed consent (except when otherwise required by law).
Pre-employment testing: The CMA opposes routine pre-employment drug testing for the following reasons:
Routine pre-employment drug screening may not objectively identify those people who constitute a risk to society.
The mass, low-cost screening tests may not be reliable or valid.
The circumstances may not justify possible human rights violations.
Random testing: The CMA believes that random drug testing among employees has a limited role, if any, in the workplace. Such testing should be restricted to employees in safety-sensitive positions and undertaken only when measures of performance and effective peer or supervisory observation are unavailable.
Role of occupational health services: Occupational health physicians must not be involved in a policing or disciplinary role with respect to employee testing.
CMA recommends that employers provide a safe environment for all workers. With the help of experts such as those from national and provincial agencies dedicated to dealing with substance abuse occupational health departments should develop lists of drugs known to cause short-term or long-term impairment, including alcohol. These lists should be posted prominently in the workplace, and workers should be advised that in the event of obvious impairment those involved in safety-sensitive occupations will be asked to undergo medical assessment. If testing for drugs is indicated refusal to submit to testing may result in a presumption of noncompliance with the health requirements of the job.
Alcohol impairment should not be tolerated, and legislation should be considered that would set a legal blood alcohol level for safety-sensitive occupations. Breathalyzers or other detection methods could be used if alcohol impairment is suspected in a person holding safety-sensitive occupation. As stated previously, refusal to submit to testing may result in a presumption of noncompliance with the health requirements of the job.
These measures should be discussed with labour and management. Labour should be expected to recognize drug-related impairment as a serious health and safety issue, and management should demonstrate its concern by ensuring access to treatment, prevention and educational programs such as employee assistance programs.
Guidelines for CMA’s Activities and Relationships with Other Parties
As the national voice of medicine in Canada, the CMA provides leadership for physicians, promotes the highest standards of health and health care for Canadians and acts as advocate for all Canadian physicians. In the furtherance of its purpose, the CMA conducts a variety of activities and has a variety of relationships with other parties. The CMA’s activities range from policy development to the delivery of products and services to physicians and the public. Its relationships with other parties range from the purchase of goods and services that support operations to partnerships that further or are consistent with its advocacy strategies.
The CMA actively seeks out relationships with others in recognition of the benefits these bring in the attainment of the CMA’s purposes. Such benefits may include:
- unifying the profession through relations with physician groups, including the divisions and affiliates
- enabling a stronger advocacy voice in association with others
- enhancing the CMA’s credibility with other parties
- providing financial and human resources to support CMA activities
- providing skills and capabilities that CMA may not possess
- providing additional membership services.
Activities or relationships with other parties and products and services produced through the activity or relationship (“activities or relationships”) that undermine the CMA’s reputation of professionalism, independence and quality are to be avoided, not only for their own sake but also because a diminishment of the CMA’s reputation impedes its ability to achieve its purposes.
The following principles have been developed to help guide decisions about the kinds of activities CMA undertakes and about its relations with other parties, with the objective of ensuring the integrity and good reputation of the CMA. A process or processes will be developed to implement the principles, which will include the preparation of subdocuments on applying the principles to specific areas; for example, sponsorship, endorsement and coalitions.
The CMA should rigorously and actively pursue its laudable ends and seek out relationships with others to attain them with the caveat that activities or relationships that would tarnish the integrity or reputation of CMA or the medical profession or that would diminish the trust placed in them should be avoided.
Conformity with CMA’s purpose
The activity or relationship should further or support the CMA’s purposes as elaborated in its objects, vision and mission.
The CMA’s purposes have been explicitly and widely agreed upon.
The CMA holds itself to be, and encourages reliance that it is, an organization that pursues its specified purposes.
Activities and relationships that do not further or support the CMA’s purposes have the potential to thwart these purposes in a number of ways, including inadequate accountability, inappropriate use of resources, unconstrained exercise of merely private judgement or inappropriate self-interest.
2. Medical professionalism and ethics
The activity or relationship should be consistent with medical professionalism and with CMA’s Code of Ethics.
The CMA is an association of physicians.
When the CMA acts, it represents the medical profession.
The CMA’s actions reflect upon the medical profession.
The CMA’s stature and reputation are inextricably linked to the medical profession’s work, the professional stature of its member physicians and the trust Canadians place in their physicians.
Engaging in activities or relationships that are inconsistent with medical professionalism and CMA’s Code of Ethics would erode trust in the CMA.
The activity or relationship should not undermine the CMA’s independence.
To be a credible voice and influence and to be worthy of the trust and confidence of physicians and of the public, the CMA should be, and be seen to be, free of undue influence and in control of the decisions it makes.
Undue influence occurs when one is induced to do or not do something that is contrary to what one would otherwise do if left to act freely. Undue influence deprives one of free agency and destroys free will such that it is rendered more the will of another than of one’s own.
Activities and relationships that may undermine independence include:
activities or relationships that provide revenue or benefit to the CMA such that ongoing dependency on the revenue or benefit impedes independence
activities and relationships that create a product or service that is seen to be associated with the CMA but over which the CMA does not have final control or veto or the capacity to extricate itself
Consistency with policy
The activity or relationship should be consistent with CMA policy.
The CMA develops policy in pursuance of its purposes; these should be referred to when making decisions in connection with activities or relationships.
Conflicting goals and activities
Relationships with parties whose goals or activities directly conflict with the CMA’s objects, mission or vision should be avoided.
This does not preclude discussion with others or participation in events for the purposes of obtaining information, monitoring or lobbying.
The terms and conditions of the activity or relationship should be transparent.
Transparency promotes an openness to scrutiny and serves to enhance accountability and to discourage relationships or activities that could be considered problematic.
The principle is generally applicable except in connection to matters related to competitive advantage, trade secret or a reasonable agreement of confidentiality.
Compliance and accountability
Processes must be in place to ensure that proposed and ongoing activities or relationships are appropriately reviewed for compliance with and clear accountability for these principles.
These include the activities of the secretariat and the corporate subsidiaries.