With the advent of technology allowing for the extension of life, and as a result of the increasing importance of personal autonomy, decisional capacity, and informed consent and the growing awareness of issues related to quality of life and dying, Canadians have become increasingly interested in expressing their wishes regarding their health care and having more input into decisions about their care should they become incapable. Advance care planning (ACP) can help patients to achieve these goals.
The CMA supports development of a strategy for ACP1 in all provinces and territories. ACP leads to better concordance between patients' wishes and treatments provided,2,3 decreased anxiety for families,4 decreased moral distress for health care providers,5 decreased hospitalization rates of nursing home residents3 and fewer unnecessary medical treatments.3,6,7
ACP is at the intersection of the provision of health care, ethical values and legal rights and duties. In particular, it involves the acknowledgement of essential aspects of autonomy, informed consent, and respect of patients' care wishes now and in the future, and their intentions if they become incapable.8,9
The balancing of the need to obtain informed consent for a treatment option in the present with the need to respect health care preferences that were stated in the past has been addressed using various clinical, legal and institutional approaches across Canadian jurisdictions."
Physicians10 can play a significant role in ACP throughout the course of the patient-physician relationship, including in the pediatric setting. At any time, outcomes of the planning process can be documented and/or the patient can appoint a substitute decision-maker in writing. These documents can be identified as advance directives, personal directives or powers of attorney for personal care11 (hereinafter all will be referred to as advance directives). An advance directive does not remove the need for a physician to obtain consent before providing a treatment to a patient, except in an emergency. As stated in the Canadian Medical Protective Association's consent guide: "[U]nder medical emergency situations, treatments should be limited to those necessary to prevent prolonged suffering or to deal with imminent threats to life, limb or health. Even when unable to communicate in medical emergency situations, the known wishes of the patient must be respected."12
While much of the focus of ACP is on making care decisions and nominating proxy decision-makers in case the patient becomes incapable of making decisions in the future, ACP has much more utility. ACP conversations13 can assist patients in determining treatment trajectories and making decisions about the intensity level of interventions in their current care. Providers can have discussions with patients and their families about proposed treatments in the context of the patient's communicated goals and wishes. The process of ACP also helps patients and their families to become familiar with the language and processes used to make cooperative health care decisions.
SCOPE OF POLICY
This policy aims to provide guidance on key considerations pertinent to ACP in a way that is consistent with a physician's ethical, professional and legal obligations. This is a complex subject: physicians should be aware of the legislation in the jurisdiction in which they practise, the standards and expectations specified by their respective regulatory authority, as well as the policies and procedures of the setting(s) in which they practise (e.g., regional health authority, hospital).
1. ACP is a process of (a) respecting patients' wishes through reflection and communication, (b) planning for when the patient cannot make health care decisions and (c) discussion with friends, family and professionals; (d) it may result in a written document.5 It informs the substitute decision-maker and provides information for the clinician to consider in the provision of care within the bounds of the law.
2. Although often associated with the end of life, ACP represents the expression of a patient's wishes for any future health care when the patient is incapable. It expresses the patient's values and beliefs regarding current care decisions and provides information that can inform any decisions that must be made during an emergency when the patient's consent cannot be obtained. For these reasons, ACP should occur throughout a person's lifetime.
3. Respect for patients' dignity and autonomy is a cornerstone of the therapeutic physician-patient relationship. Patients' right to autonomous decision-making has become embedded in ethical frameworks, consent legislation and case law.14 Respect for the wishes of an incapable patient constitutes a preservation of autonomy and promotes trust between the physician and patient.15
4. The way in which the act of obtaining consent is weighed against the patient's stated wishes as outlined during the ACP process varies according to the jurisdiction in which the patient and physician are located.
1. Given the practical, ethical and legal complexities of ACP, physicians, medical learners should be supported in becoming familiar with ACP and comfortable in engaging in the process with their patients. To this end, CMA supports the development of training in ACP and efforts to make it available to all physicians and medical learners.16 For practising physicians and residents, many resources are available, for example:
a. Advance Care Planning in Canada: A National Framework
b. Facilitating Advance Care Planning: An Interprofessional Educational Program
c. Information from the Health Law Institute of Dalhousie University on the regulatory policies and legislation of individual provinces and territories
d. A comprehensive collection of Canadian resources compiled by the Speak Up campaign of the Advance Care Planning in Canada initiative
e. Pallium Canada's Learning Essential Approaches to Palliative Care module on ACP
In the case of medical students, the CMA supports the position of the Canadian Federation of Medical Students that end-of-life training is an essential facet of undergraduate medical education.
2. The issue of the supervision of medical learners practising ACP should be clarified, as considerable ambiguity currently exists.17 Medical learners would benefit from unified national guidelines concerning the nature of their participation in ACP, especially regarding end-of-life care. In the case of medical students, the CMA agrees with the recommendation of the Canadian Federation of Medical Students that supervision be mandatory during conversations about end-of-life care.
3. The CMA calls for more research on the outcomes associated with the provision of ACP training to physicians and medical learners.
4. The CMA recommends that governments and institutions promote information and education on ACP to patients and their substitute decision-makers.
PROFESSIONAL AND LEGAL RESPONSIBILITY
1. While respecting patients' values, all physicians are expected to encourage their patients to engage in ACP with them. ACP is not a one-time event. The nature of the conversation between the physician and the patient and the regularity with which they discuss the subject will depend on the patient's health status. Family physicians and physicians have ongoing care relationships with chronically ill patients are particularly well placed to have regular discussions with their patients about their beliefs, values and wishes. An effective exchange of information between family physicians (and other physicians who work in the community with outpatients) and acute or tertiary care physicians would assist in ensuring patient's wishes are considered.
2. ACP, in particular advance directives, are at the intersection of medicine and the law. Physicians should recognize this and ask patients whether they have an advance directive or have done any ACP.
3. There is wide variation across jurisdictions in terms of the requirements and procedures for ACP; therefore, physicians should inform themselves about any relevant legislation and the scope of the requirement to obtain consent within that jurisdiction when carrying out ACP.
1. The CMA supports institutional processes that recognize and support ACP. Support for ACP includes developing a consistent process for the exchange of information about patients' wishes and advance directives among health care providers, as patients traverse sectors and locations of care. Patients with a written advance directive must be identified and the advance directive integrated fully within the patient's records18 so that it is available across the institution (and ideally the health care system). The CMA advocates for the inclusion of advance care directive functionality as a conformance and usability requirement for electronic medical record vendors.19 Provinces and territories should be encouraged to establish robust organizational processes and resources for patients in all locations of care and strong province- or territory-wide policy, such as in Alberta.20
2. Institutions and other organizations should encourage health care providers to ask patients to bring their advance directive to appointments at the same time they ask them to bring a list of their medications or other medical information.
3. The CMA supports institutional/organizational audits of structures, processes and outcomes related to ACP as an important step in improving the quality and frequency of ACP activities.
ROLE FOR GOVERNMENTS
1. The CMA supports infrastructures enabling ACP, including funding that will support ACP and other end-of-life discussions.
2. The CMA promotes the incorporation of ACP into future federal and provincial/territorial senior strategies and dementia and/or frailty strategies.
3. The CMA supports the development of ACP metrics and their future inclusion in Accreditation Canada standards.
Advance care planning (ACP)
Advance care planning is a term used to describe a process of reflection, communication, conversation and planning by a capable individual with family, friends and professionals about their beliefs, values and wishes for a time when they no longer have the mental capacity to make decisions about their health care. ACP can also involve the naming of a substitute decision-maker.8
The legislated term "advance directive" has different names, definitions and legal authority across the country. For example, in British Columbia an advance directive is a written legal document that provides a mechanism for capable patients to give directions about their future health care once they are no longer capable. 21 As such, in BC an advance directive may, under certain circumstances, be considered "equivalent to consent to treatment and may be acted upon directly by a health care provider without consultation with an SDM [substitute decision-maker]." 8 In Alberta it is called a personal directive. In Ontario, "advance directive" is a generic non-legal term and refers to communications that may be oral, written or in other forms.8
In Quebec, advance care directives are legally binding, as set out in the Act respecting end-of-life care, which recognizes "the primacy of freely and clearly expressed wishes with respect to care. . ."22
Current legislation does not allow for medical assistance in dying to be requested by an advance directive.23 The CMA acknowledges that considerable public, expert and legal debate exists around the issue.
To obtain informed consent, physicians must provide adequate information to the patient or capable decision-maker about the proposed procedure or treatment; the anticipated outcome; the potential risks, benefits and complications; and reasonable available alternatives, including not having the treatment; and they must answer questions posed by the patient. Consent is only informed if there is disclosure of matters that a reasonable person in the same circumstances would want to know.24 Consent must be given voluntarily, must not be obtained through misrepresentation or fraud, must relate to the treatment and must be informed.
Substitute decision-maker (SDM or agent or proxy)
A substitute decision-maker is a capable person who will make health care decisions on behalf of an incapable individual. In all jurisdictions the health care provider must take reasonable steps to become aware of whether or not there is a substitute decision-maker before providing health treatment to an incapable patient. Legally there are implementation differences across the country. For example, in BC a substitute decision-maker is appointed through a representation agreement, in Alberta through a personal directive and in Ontario through a power of attorney for personal care.
Approved by the CMA Board of Directors May 2017
1 Canadian Medical Association. Policy resolution GC14-25 - strategy for advance care planning, palliative and end-of-life care. Ottawa (ON): The Association; 2014. Available: policybase.cma.ca/dbtw-wpd/CMAPolicy/PublicB.htm (accessed 2016 Oct 17)
2 Houben CHM, Spruit MA, Groenen MTJ, et al. Efficacy of advance care planning: a systematic review and meta-analysis. J Am Med Dir Assoc 2014;15:477-89.
3 Martin RS, Hayes B, Gregorevic K, et al. The effects of advance care planning interventions on nursing home residents: a systematic review. J Am Med Dir Assoc 2016;7:284-93.
4 Mack JW, Weeks JC, Wright AA, et al. End-of-life discussions, goal attainment, and distress at the end of life: predictors and outcomes of receipt of care consistent with preferences. J Clin Oncol 2010;28(7):1203-8.
5 Canadian Hospice Palliative Care Association. Advance care planning in Canada: national framework. Ottawa; The Association; 2010.
6 Teo WSK, Raj AG, Tan WS, et al. Economic impact analysis of an end-of-life programme for nursing home residents. Palliat Med 2014;28(5):430-7.
7 Zhang B, Wright AA, Huskamp HA, et al. Health care costs in the last week of life: associations with end-of-life conversations. Arch Intern Med 2009;169(5):480-8.
8 Wahl J, Dykeman MJ, Gray B. Health care consent and advance care planning in Ontario. Toronto (ON): Law Commission of Ontario; 2014.
9 Canadian Medical Association. CMA Code of Ethics (update 2004). Ottawa: The Association; 2004.
10 Physician involvement is not mandatory in the process. However, it is important for physicians to engage with their patients in ACP as this can facilitate change in patients' ACP behaviour and understanding.
11 Wahl JA, Dykeman MJ, Walton T. Health care consent, advance care planning, and goals of care practice tools: the challenge to get it right. Improving the last stages of life. Toronto (ON): Law Commission of Ontario; 2016.
13 Frank C, Puxty J. Facilitating effective end-of-life communication - helping people decide. CJS Journal of CME 2016;6(2). Available: http://canadiangeriatrics.ca/wp-content/uploads/2017/02/Facilitating-Effective-End-of-Life-Communication---Helping-People-Decide.pdf (accessed 2017 April 25).
14 Fleming v Reid (1991) 82 DLR (4th) 298 (CA ON); Cuthbertson v Rasouli, 2013 SCC 53; Malette v Shulman (1990), 72 OR (2d) 417; Starson v Swayze (2003) 1 SCR 722.
15 Harmon SHE. Consent and conflict in medico-legal decision-making at the end of life: a critical issue in the Canadian context. University of New Brunswick Law Journal 2010;60(1):208-29.
16 Canadian Medical Association. Policy resolution GC13-69 - training in advance care planning. Ottawa (ON): The Association; 2013. Available: policybase.cma.ca/dbtw-wpd/CMAPolicy/PublicB.htm (accessed 2016 May 26).
17 Touchie C, De Champlain A, Pugh D, et al. Supervising incoming first-year residents: faculty expectations versus residents' experiences. Med Educ 2014;48(9):921-9.
18 Canadian Medical Association. Policy resolution GC14-19 - advance care plans. Ottawa (ON): The Association; 2014. Available: policybase.cma.ca/dbtw-wpd/CMAPolicy/PublicB.htm (accessed 2016 May 26).
19 Canadian Medical Association. BD14-05-163 Advance care directive functionality. Ottawa (ON): The Association; 2014. Available: policybase.cma.ca/dbtw-wpd/CMAPolicy/PublicB.htm (accessed 2016 May 26).
20 Conversations matter. Edmonton (AB): Alberta Health Services. Available: http://goals.conversationsmatter.ca.s3-website-us-east-1.amazonaws.com/ (accessed 2017 May 19).
21 Health Care (Consent) and Care Facility (Admission) Act, RSBC 1996, c 181, s.3
22 Act respecting end-of-life care, S-32.0001. Government of Quebec. Available : http://legisquebec.gouv.qc.ca/en/ShowDoc/cs/S-32.0001
23 An Act to amend the Criminal Code and to make related amendments to other Acts (medical assistance in dying) S.C. 2016, c.3. Ottawa: Government of Canada; 2016. Available: http://canlii.ca/t/52rs0 (accessed 2016 Oct 17)
24 Riebl v Hughes,  2 SCR 880; Hopp v Lepp,  2 SCR 192.
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.
Clinical photography is a valuable tool for physicians. Smartphones, as well as other devices supporting network connectivity, offer a convenient, efficient method to take and share images. However, due to the private nature of the information contained in clinical photographs there are concerns as to the appropriate storage, dissemination, and documentation of clinical images. Confidentiality of image data must be considered and the dissemination of these images onto servers must respect the privacy and rights of the patient. Importantly, patient information should be considered as any information deriving from a patient, and the concepts outlined therefore apply to any media that can be collected on, or transmitted with, a smart-device.
Clinical photography can aid in documenting form and function, in tracking conditions and wound healing, in planning surgical operations, and in clinical decision-making. Additionally, clinical photographs can provide physicians with a valuable tool for patient communication and education. Due to the convenience of this type of technology it is not appropriate to expect physicians to forego their use in providing their patients with the best care available.
The technology and software required for secure transfer, communication, and storage of clinical media is presently available, but many devices have non-secure storage/dissemination options enabled and lack user-control for permanently deleting digital files. In addition, data uploaded onto server systems commonly cross legal jurisdictions. Many physicians are not comfortable with the practice, citing security, privacy, and confidentiality concerns as well as uncertainty in regards to regional regulations governing this practice.1 Due to concern for patient privacy and confidentiality it is therefore incredibly important to limit the unsecure or undocumented acquisition or dissemination of clinical photographs.
To assess the current state of this topic, Heyns et al. have reviewed the accessibility and completeness of provincial and territorial medical regulatory college guidelines.2 Categories identified as vital and explored in this review included: Consent; Storage; Retention; Audit; Transmission; and Breach. While each regulatory body has addressed limited aspects of the overall issue, the authors found a general lack of available information and call for a unified document outlining pertinent instructions for conducting clinical photography using a smartphone and the electronic transmission of patient information.2
The discussion of this topic will need to be ongoing and it is important that physicians are aware of applicable regulations, both at the federal and provincial levels, and how these regulations may impact the use of personal devices. The best practices supported here aim to provide physicians and healthcare providers with an understanding of the scope and gravity of the current environment, as well as the information needed to ensure patient privacy and confidentiality is assessed and protected while physicians utilize accessible clinical photography to advance patient care. Importantly, this document only focusses on medical use (clinical, academic, and educational) of clinical photography and, while discussing many core concepts of patient privacy and confidentiality of information, should not be perceived as a complete or binding framework. Additionally, it is recommended that physicians understand the core competencies of clinical photography, which are not described here.
The Canadian Medical Association (CMA) suggests that the following recommendations be implemented, as thoroughly as possible, to best align with the CMA policy on the Principles for the Protection of Patient Privacy (CMA Policy PD2018-02). These key recommendations represent a non-exhaustive set of best practices - physicians should seek additional information as needed to gain a thorough understanding and to stay current in this rapidly changing field.
* Informed consent must be obtained, preferably prior, to photography with a mobile device. This applies for each and any such encounter and the purpose made clear (i.e. clinical, research, education, publication, etc.). Patients should also be made aware that they may request a copy of a picture or for a picture to be deleted.
* A patient's consent to use electronic transmission does not relieve a physician of their duty to protect the confidentiality of patient information. Also, a patient's consent cannot override other jurisdictionally mandated security requirements.
* All patient consents (including verbal) should be documented. The acquisition and recording of patient consent for medical photography/dissemination may be held to a high standard of accountability due to the patient privacy and confidentiality issues inherent in the use of this technology. Written and signed consent is encouraged.
* Consent should be considered as necessary for any and all photography involving a patient, whether or not that patient can be directly recognized, due to the possibility of linked information and the potential for breach of privacy. The definition of non-identifiable photos must be carefully considered. Current technologies such as face recognition and pattern matching (e.g. skin markers, physical structure, etc.), especially in combination with identifying information, have the potential to create a privacy breach.
* Unsecure text and email messaging requires explicit patient consent and should not be used unless the current gold standards of security are not accessible. For a patient-initiated unsecure transmission, consent should be clarified and not assumed.
* Transmission of photos and patient information should be encrypted as per current-day gold standards (presently, end-to-end encryption (E2EE)) and use only secure servers that are subject to Canadian laws. Explicit, informed consent is required otherwise due to privacy concerns or standards for servers in other jurisdictions. Generally, free internet-based communication services and public internet access are unsecure technologies and often operate on servers outside of Canadian jurisdiction.
* Efforts should be made to use the most secure transmission method possible. For data security purposes, identifying information should never be included in the image, any frame of a video, the file name, or linked messages.
* The sender should always ensure that each recipient is intended and appropriate and, if possible, receipt of transmission should be confirmed by the recipient.
* Storing images and data on a smart-device should be limited as much as possible for data protection purposes.
* Clinical photos, as well as messages or other patient-related information, should be completely segregated from the device's personal storage. This can be accomplished by using an app that creates a secure, password-protected folder on the device.
* All information stored (on internal memory or cloud) must be strongly encrypted and password protected. The security measures must be more substantial than the general password unlock feature on mobile devices.
* Efforts should be made to dissociate identifying information from images when images are exported from a secure server. Media should not be uploaded to platforms without an option for securely deleting information without consent from the patient, and only if there are no better options. Automatic back-up of photos to unsecure cloud servers should be deactivated. Further, other back-up or syncing options that could lead to unsecure server involvement should be ascertained and the risks mitigated.
4. Cloud storage should be on a Canadian and SOCII certified server. Explicit, informed consent is required otherwise due to privacy concerns for servers in other jurisdictions.
5. AUDIT & RETENTION
* It is important to create an audit trail for the purposes of transparency and medical best practice. Key information includes patient and health information, consent type and details, pertinent information regarding the photography (date, circumstance, photographer), and any other important facts such as access granted/deletion requests.
* Access to the stored information must be by the authorized physician or health care provider and for the intended purpose, as per the consent given. Records should be stored such that it is possible to print/transfer as necessary.
* Original photos should be retained and not overwritten.
* All photos and associated messages may be considered part of the patient's clinical records and should be maintained for at least 10 years or 10 years after the age of majority, whichever is longer. When possible, patient information (including photos and message histories between health professionals) should be retained and amalgamated with a patient's medical record. Provincial regulations regarding retention of clinical records may vary and other regulations may apply to other entities - e.g. 90 years from date of birth applies to records at the federal level.
* It may not be allowable to erase a picture if it is integral to a clinical decision or provincial, federal, or other applicable regulations require their retention.
* Any breach should be taken seriously and should be reviewed. All reasonable efforts must be made to prevent a breach before one occurs. A breach occurs when personal information, communication, or photos of patients are stolen, lost, or mistakenly disclosed. This includes loss or theft of one's mobile device, texting to the wrong number or emailing/messaging to the wrong person(s), or accidentally showing a clinical photo that exists in the phone's personal photo album.
* It should be noted that non-identifying information, when combined with other available information (e.g. a text message with identifiers or another image with identifiers), can lead to highly accurate re-identification.
* At present, apps downloaded to a smart-device for personal use may be capable of collecting and sharing information - the rapidly changing nature of this technology and the inherent privacy concerns requires regular attention. Use of specialized apps designed for health-information sharing that help safeguard patient information in this context is worth careful consideration.
* Having remote wipe (i.e. device reformatting) capabilities is an asset and can help contain a breach. However, inappropriate access may take place before reformatting occurs.
* If a smartphone is strongly encrypted and has no clinical photos stored locally then its loss may not be considered a breach.
* In the event of a breach any patient potentially involved must be notified as soon as possible. The CMPA, the organization/hospital, and the Provincial licensing College should also be contacted immediately. Provincial regulations regarding notification of breach may vary.
Approved by the CMA Board of Directors March 2018
i Heyns M†, Steve A‡, Dumestre DO‡, Fraulin FO‡, Yeung JK‡
† University of Calgary, Canada
‡ Section of Plastic Surgery, Department of Surgery, University of Calgary, Canada
1 Chan N, Charette J, Dumestre DO, Fraulin FO. Should 'smart phones' be used for patient photography? Plast Surg (Oakv). 2016;24(1):32-4.
2 Unpublished - Heyns M, Steve A, Dumestre DO, Fraulin FO, Yeung J. Canadian Guidelines on Smartphone Clinical Photography.
Inherent in all health care professional Codes of Ethics is the duty to provide care to patients and to relieve suffering whenever possible. However, this duty does not exist in a vacuum, and depends on the provision of goods and services referred to as reciprocal obligations, which must be provided by governments, health care institutions and other relevant bodies and agencies. The obligation of government and society to physicians can be seen as comparable to the obligations of physicians to their patients.
The recent experience of Canadian physicians during the SARS epidemic in Toronto has heightened the sensitivities of the medical profession to several issues that arose during the course of dealing with that illness. Many of the lessons learned (and the unanswered questions that arose) also apply to the looming threat of an avian flu (or other) pandemic. Canadian physicians may be in a relatively unique position to consider these issues given their experience and insight.
The intent of this working paper is to highlight the ethical issues of greatest concern to practicing Canadian physicians which must be considered during a pandemic. In order to address these issues before they arise, the CMA presents this paper for consideration by individual physicians, physician organizations, governments, policy makers and interested bodies and stakeholders. Although many of the principles and concepts could readily be applied to other health care workers, the focus of this paper will be on physicians.
Policies regarding physicians in training, including medical students and residents, should be clarified in advance by the relevant bodies involved in their oversight and training. Issues of concern would include the responsibilities of trainees to provide care during a pandemic and the potential effect of such an outbreak on their education and training.
A. Physician obligations during a pandemic
The professional obligations of physicians are well spelled out in the CMA Code of Ethics and other documents and publications and are not the main focus of this paper. However, they will be reviewed and discussed as follows.
Several important principles of medical ethics will be of particular relevance in considering this issue. Physicians have an obligation to be beneficent to their patients and to consider what is in the patient's best interest. According to the first paragraph of the CMA Code of Ethics (2004), "Consider first the well-being of the patient".
Traditionally, physicians have also respected the principle of altruism, whereby they set aside concern for their own health and well-being in order to serve their patients. While this has often manifested itself primarily as long hours away from home and family, and a benign neglect of personal health issues, at times more drastic sacrifices have been required. During previous pandemics, many physicians have served selflessly in the public interest, often at great risk to their own well-being.
The principle of justice requires physicians to consider what is owed to whom and why, including what resources are needed, and how these resources would best be employed during a pandemic. These resources might include physician services but could also include access to vaccines and medications, as well as access to equipment such as ventilators or to a bed in the intensive care unit. According to paragraph 43 of the CMA Code of Ethics, physicians have an obligation to "Recognize the responsibility of physicians to promote equitable access to health care resources".
In addition, physicians can reasonably be expected to participate in the process of planning for a pandemic or other medical disaster. According to paragraph 42 of the CMA Code of Ethics, physicians should "Recognize the profession's responsibility to society in matters relating to public health, health education, environmental protection, legislation affecting the health and well-being of the community and the need for testimony at judicial proceedings". This responsibility could reasonably be seen to apply both to individual physicians as well as the various bodies and organizations that represent them.
Physicians also have an ethical obligation to recognize their limitations and the extent of the services they are able to provide. During a pandemic, physicians may be asked to assume roles or responsibilities with which they are not comfortable, nor prepared. Paragraph 15 of the CMA Code of Ethics reminds physicians to "Recognize your limitations and, when indicated, recommend or seek additional opinions or services".
However, physicians have moral rights as well as obligations. The concept of personal autonomy allows physicians some discretion in determining where, how and when they will practice medicine. They also have an obligation to safeguard their own health. As stated in paragraph 10 of the CMA Code of Ethics, physicians should "Promote and maintain your own health and well-being".
The SARS epidemic has served to reopen the ethical debate. Health care practitioners have been forced to reconsider their obligations during a pandemic, including whether they must provide care to all those in need regardless of the level of personal risk. As well, they have been re-examining the obligation of governments and others to provide reciprocal services to physicians, and the relationship between these obligations.
B. Reciprocal obligations towards physicians
While there has been much debate historically (and especially more recently) about the ethical obligations of physicians towards their patients and society in general, the consideration of reciprocal obligations towards physicians is a relatively recent phenomenon.
During the SARS epidemic, a large number of Canadian physicians unselfishly volunteered to assist their colleagues in trying to bring the epidemic under control. They did so, in many cases, in spite of significant personal risk, and with very little information about the nature of the illness, particularly early in the course of the outbreak. Retrospective analysis has cast significant doubt and concern on the amount of support and assistance provided to physicians during the crisis. Communication and infrastructure support was poor at best. Equipment was often lacking and not always up to standard when it was available. Psychological support and counselling was not readily available at the point of care, nor was financial compensation for those who missed work due to illness or quarantine. Although the Ontario government did provide retrospective compensation for many physicians whose practices were affected by the outbreak, the issue was addressed late, and not at all in some cases.
It is clear that Canadian physicians have learned greatly from this experience. The likelihood of individuals again volunteering "blindly" has been reduced to the point where it may never happen again. There are expectations that certain conditions and obligations will be met in order to optimize patient care and outcomes and to protect health care workers and their families.
Because physicians and other health care providers will be expected to put themselves directly in harm's way, and to bear a disproportionate burden of the personal hardships associated with a pandemic, the argument has been made that society has a reciprocal obligation to support and compensate these individuals.
According to the University of Toronto Joint Centre for Bioethics report We stand on guard for thee, "(The substantive value of) reciprocity requires that society support those who face a disproportionate burden in protecting the public good, and take steps to minimize burdens as much as possible. Measures to protect the public good are likely to impose a disproportionate burden on health care workers, patients and their families."
Therefore, in order to provide adequate care for patients, the reciprocal obligation to physicians requires providing some or all of the following:
Prior to a pandemic
- Physicians and the organizations that represent them should be more involved in planning and decision making at the local, national and international levels. In turn, physicians and the organizations that represent them have an obligation to participate as well.
- Physicians should be made aware of a clear plan for resource utilization, including:
- how physicians will be relieved of duties after a certain time;
- clearly defined roles and expectations, especially for those practicing outside of their area of expertise;
- vaccination/treatment plans - will physicians (and their families) have preferential access based on the need to keep caregivers healthy and on the job;
- triage plans, including how the triage model might be altered and plans to inform the public of such.
- Physicians should have access to the best equipment needed and should be able to undergo extra training in its use if required.
- Politicians and leaders should provide reassurances that satisfy physicians that they will not be "conscripted" by legislation.
During a pandemic
- Physicians should have access to up-to-date, real time information.
- Physicians should be kept informed about developments in Canada and globally.
- Communication channels should be opened with other countries (e.g. Canada should participate in WHO initiatives to identify the threats before they arrive on our doorstep).
- Resources should be provided for backup and relief of physicians and health care workers.
- Arrangements should be made for timely provision of necessary equipment in an ongoing fashion.
- Physicians should be compensated for lost clinical earnings and to cover expenses such as lost wages, lost group earnings, overhead, medical care, medications, rehabilitative therapy and other relevant expenses in case of quarantine, clinic cancellations or illness (recognizing that determining exactly when or where an infection was acquired may be difficult).
- Families should receive financial compensation in the case of a physician family member who dies as a result of providing care during a pandemic.
- In the event that physicians may be called upon in a pandemic to practice outside of their area of expertise or outside their jurisdiction, they should to contact their professional liability protection provider for information on their eligibility for protection in these circumstances.
- Interprovincial or national licensing programs should be developed to provide physicians with back-up and relief and ensure experts can move from place to place in a timely fashion without undue burden.
- Psychological and emotional counselling and support should be provided in a timely fashion for physicians, their staff and family members.
- Accommodation (i.e. a place to stay) should be provided for physicians who have to travel to another locale to provide care; or who don't want to go home and put their family at risk, when this is applicable, i.e. the epidemiology of the infectious disease causing the pandemic indicates substantially greater risk of acquiring infection in the health care setting than in the community.
- Billing and compensation arrangements should ensure physicians are properly compensated for the services they are providing, including those who may not have an active billing number in the province where the services are being provided.
After a pandemic
- Physicians should receive assistance in restarting their practice (replacing staff, restocking overhead, communicating with patients, and any other costs related to restarting the practice).
- Physicians should receive ongoing psychological support and counselling as required.
C. How are physician obligations and reciprocal obligations related?
Beyond a simple statement of the various obligations, it is clear that there must be some link between these different obligations. This is particularly important since there is now some time to plan for the next pandemic and to ensure that reciprocal obligations can be met prior to its onset. Physicians have always provided care in emergency situations without questioning what they are owed. According to paragraph 18 of the CMA Code of Ethics, physicians should "Provide whatever appropriate assistance you can to any person with an urgent need for medical care".
However, in situations where obligations can be anticipated and met in advance, it is reasonable to expect that they will be addressed. Whereas a physician who encounters an emergency situation at the site of a car crash will act without concern for personal gain or motivation, a physician caring for the same patient in an emergency department will rightly expect the availability of proper equipment and personnel.
In order to ensure proper patient care and physician safety, and to ensure physicians are able to meet their professional obligations and standards, the reciprocal obligations outlined above should be addressed by the appropriate body or organization.
If patient and physician well-being is not optimized by clarifying the obligations of physicians and society prior to the next pandemic, in spite of available time and resources necessary to do so, there are many who would call into question the ethical duty of physicians to provide care. However, the CMA believes that, in the very best and most honourable traditions of the medical profession, its members will provide care and compassion to those in need. We call on governments and society to assist us in optimizing this care for all Canadians.
What is it?
The CMA Charter of Shared Values aims to identify shared values and commitments to each other and to the profession to which physicians and learners can commit to promote trust and respect within the profession and for each other, and identify opportunities for engagement and leadership to promote civility and confront incivility within the profession.
Why does it matter?
The Charter is intended to further strengthen professional responsibilities in support of a unified and aligned profession. We achieve the highest degree of both individual and collective success when we work together, commit together and believe together; when we share a clearly articulated set of common values, virtues and principles; and when we subscribe to the same explicit and implicit understandings.
Commitments to Each Other:
Our most important shared values
As a physician, I will strive to be respectful; I will recognize that everyone has inherent worth, is worthy of dignity, and has the right to be valued and respected, and to be treated ethically; I will respect others and their personal and professional dignity; and I will aim to promote and model respect through collaborative training and practice.
As a physician, I will strive to act with integrity; I will act in an honest and truthful manner, with consistency of intentions and actions; and I will act with moral concern to promote and model effective leadership and to achieve a good outcome for patients.
As a physician, I will strive to cultivate reciprocal relationships; I will be kind with my physician colleagues, and expect them to respond similarly; I will share and exchange my knowledge and experience with them; and I will be generous with them in spirit and in time.
As a physician, I will strive to be civil; I will respect myself and others, regardless of their role, even those with whom I may not agree; I will enter into communication with my physician colleagues with an attitude of active and open listening, whether it be in person, in writing, or virtually; and I will accept personal accountability.
Commitments to the Profession
1. Commitment to promoting a culture of respect and collegiality
As a physician, I will strive to build a culture based on mutual respect and collegiality where physicians treat each other as people in a shared endeavor, and promote civility. I will strive to:
Cultivate respectful, open, and transparent dialogue and relationships
Take responsibility for promoting civility and confronting incivility within the profession
Recognize the relative value among family medicine and specialties and across the educational spectrum, and of the profession’s shared contributions within health systems
Model healthy and supportive training and practice environments
2. Commitment to promoting a culture of self-care and support
As a physician, I will strive to build a culture of self-care and support where physicians are empowered to ask for help and are supported to care for their own physical, mental, and social well-being. I will strive to:
Value physician health and wellness and promote a professional culture that recognizes, supports, and responds effectively to your needs and colleagues in-need
Cultivate an environment of physical and psychological safety, conducive to challenging the status quo, as well as encouraging help-seeking behaviours, without fear of negative reprisal
Recognize that both individual and system-level barriers contribute to health and wellness-related issues and advocate for cultural and systemic change to remove barriers
3. Commitment to promoting a culture of leadership and mentorship
As a physician, I will strive to foster a culture of leadership and mentorship across the career life cycle. I will strive to:
Encourage and enable opportunities and participation in leadership roles across all levels of training, practice, and health system delivery
Promote and enable formal and informal mentorship opportunities and leadership training across all levels of training and practice
Value the exchange of knowledge and experience and encourage reflective relationships (bi-directional) across all levels of training and practice
4. Commitment to promoting a culture of inquiry and reflection
As a physician, I will strive to foster a culture of inquiry and reflection that values and enables reflective practice, individually and collectively. I will strive to:
Value and enable collective inquiry and self-reflection to effect meaningful change
Foster curiosity and exploration to identify strengths and capabilities of teams and health systems to generate new possibilities for action
Cultivate strong connections and relationships between, and meaningful interactions with, colleagues
5. Commitment to promoting a culture of quality
As a physician, I will strive to foster a culture of quality and quality improvement. I will strive to:
Foster intra- and inter-professional collaborations and promote collaborative models of care
Provide high quality patient care and have a view to continuous improvement at the practice and system level, and commit to developing and applying the skills and techniques of quality improvement
Understand that quality improvement is a critical and life-long part of education and practice; participate in maintaining professional standards in myself and my colleagues
Engage patients, families, and caregivers in the process of improvement
6. Commitment to valuing a culture of diversity
As a physician, I will strive to foster a community of practitioners that reflects the diversity of the communities they serve. I will strive to:
Promote diversity within the profession to be receptive and responsive to the evolving (physical, emotional, cultural, socioeconomic) needs of our patient populations
Foster a training and practice environment where diverse and unique perspectives, across generations, cultures and abilities, are heard and appreciated
Foster diversity in leadership across the full spectrum of leadership roles within the profession and health systems
Value the importance of these perspectives within the medical profession, even when they may not be my own patients, families, and caregivers in the process of improvement
These Guidelines constitute an implementation tool of seven recommendations and are informed by Guidelines for CMA’s Activities and Relationships with Other Parties (aka CMA’s Corporate Relationships Policy) and CMA’s Advertising and Sponsorship Policy.
These Guidelines apply to the Canadian Medical Association (and not to its subsidiaries). As these are Guidelines, exceptions may be necessary from time to time wherein staff may use their discretion and judgment.
Endorsement is an umbrella term encompassing “policy endorsement”, “sponsorship1” and “branding”.
Policy endorsement includes:
(a) CMA considering upon request, non-pecuniary public approval, which may include the use of
CMA’s name and/or logo, of an organization’s written policy, on an issue that aligns with CMA policy, where there is no immediate expectation of return; or,
(b) CMA adopting the policy of another organization as our policy; or
(c) CMA asking another organization to publicly support our policy.
(a) Criteria: For policy endorsement requests from another organization to endorse their policy2 the following criteria shall be applied:
i) we have a policy on the subject-matter and
ii) we are actively working on advancing that policy position and
iii) the organization has a follow-up action plan associated with its request.
(b) Approval: Where policy exists, approval requires a policy staff member (with portfolio responsibility) and the VP of Medical Professionalism, or the policy staff member (with portfolio responsibility) and the Chief Policy Advisor. Where no policy exists, approval of the Board of Directors is required.
(c) Annual confirmation: Where CMA adopts the policy of another organization3, CMA staff shall confirm annually, or more frequently if circumstances dictate, that the policy has not been altered by the other organization.
(d) Requests: Pursuit of personal endorsement requests are not appropriate. Wherever possible, requests should come from an organization and not an individual.
(a) Where CMA adopts the policy of another organization, the adopted policy shall become CMA policy, and will include a notation on the document as being an adopted policy of [organization].
(b) All adopted policies will be housed in an accessible searchable database.
(c) All requests by organizations for CMA to endorse their policy will be tracked in a central location, along with any response.
1 Sponsorship means, to consider upon request, pecuniary public approval, which may include the use of CMA’s name and/or logo, of an organization’s event (eg., conference), on an issue that is supported by CMA policy or that promotes CMA brand awareness, where there is an immediate expectation of return.
2 That is, part (a) of the definition in Section 2.
3 That is, part (b) of the definition in Section 2.
Racism is a structural determinant of health and drives health and social inequities. The recent incidents of anti-Black violence, racism and discrimination in the US and Canada also shed light on the structural inequities and racism that exist within the medical profession and the health system.
The profession of medicine is grounded in respect for all people. This commitment recognizes that everyone has equal and inherent worth, the right to be valued and respected, and the right to be treated with dignity.
It’s critical that our medical culture – and society more broadly – upholds these values. But today, we’re reminded that there’s much more to do as a profession, and as a global community, to get us there.
Earlier this year, we launched our first-ever policy on equity and diversity in medicine Opens in a new window to help break down the many broad and systemic barriers that remain, to reduce discrimination and bias within our profession, and to create physically and psychologically safe environments for ourselves, our colleagues and our patients.
Alongside this policy comes a commitment to holding ourselves accountable to recognizing and challenging behaviours, practices and conditions that hinder equity and diversity, including racism.
Instances of racism, intolerance, exclusion, violence and discrimination have no place in medicine, and no place in our society. The Canadian Medical Association condemns racism in all its forms. Today, we stand alongside all those who have been affected by these appalling and inexcusable actions and beliefs.
Dr. Sandy Buchman
President, Canadian Medical Association
What do we mean by "personal information"?
Throughout this policy, we discuss "personal information," and it is important from the outset to set out what we mean by this term. "Personal information" is information that reveals a distinctive trait about yourself and helps others identify you. Some personal information such as your business address may be found in the public domain by accessing publications like telephone or professional directories. The focus of this policy is personal information collected, used and disclosed by the CMA that is NOT in the public domain.
What types of personal information does the CMA collect and use?
Primarily, the CMA collects and uses personal information about its members. CMA also has personal information about individuals who purchase CMA products and services, attend CMA sponsored events and seminars and submit manuscripts to CMA publications. The CMA assigns a personal identifier called a "CMA ID" to each member or purchaser of a CMA product or service so that you can use this number when contacting the CMA, ordering CMA products and publications or registering for the cma.ca Web site.
The CMA collects personal information directly from individuals or receives it from one of its provincial or territorial medical associations ("PTMAs") or subsidiaries, the CMA group of subsidiary companies, including our primary financial services company, MD Physician Services Inc.
-If you are a CMA member, you might have provided on an application form or will provide to the CMA or a PTMA or a CMA subsidiary, personal information like your home address, date of birth and gender. If you are both a client of one or more of CMA's financial subsidiaries and a CMA member, the fact of your client status, but not detailed financial information, will be known to CMA. A circumscribed and limited number of CMA employees, all of whom receive enhanced privacy training and sign specific undertakings, will have access to more detailed MD PS information such as frequency of meetings about your MD client status (but still not specific financial transactional details) in order to perform statistical analysis.
- If you have attended an event organized through CMA's Meetings and Travel Department, you might have provided us with credit card data as well as information about certain travel preferences and food sensitivities.
- If you have purchased a CMA product (e.g., classified advertising) or attended a CMA seminar (e.g., Physician Manager Institute), you provided us with personal contact information such as your name and address. We might also have collected credit card information if you chose to pay for the product or service by this method.
- If you have submitted a manuscript for publication in a CMA journal, you provided us with contact information, financial disclosure and competing interests data and the manuscript itself.
Why does the CMA collect and use personal information?
The CMA will collect and use only the personal information necessary to achieve the following purposes or one consistent with them:
1. to determine an individual's eligibility for membership in the CMA or to serve as a potential contributor to a CMA publication
2. to determine an individual's eligibility to benefit from the services of one of CMA's subsidiaries or its preferred third-party suppliers
3. to provide and to communicate information about CMA member benefits and services (e.g., the delivery of publications and travel reservations, financial services, advocacy, etc.)
4. to develop and to market products and services tailored to the interests of CMA members and the purchasers of CMA products and services
5. to update contact information in the CMA database
6. to assist the CMA PTMAs and CMA's subsidiaries with the maintenance of their membership and client contact information
7. to provide individuals with the opportunity to benefit from supporting the Canadian Medical Foundation which provides CMA members and others with valuable educational programs and services
8. to conduct surveys and research studies of the physician population in order to analyze for statistical and research purposes such issues as the demographics of physician human resources
9.to engage members and physicians in CMA's policy development process
10.to broadcast urgent health alerts of national significance
When and to whom does the CMA disclose personal information?
The CMA does not sell personal information. The CMA will only disclose your personal information to an organization for a purpose outlined in this policy, unless we obtain your consent for a new purpose. For example, one purpose identified above is maintaining up-to-date membership and client contact information. The CMA and its subsidiariesshare a core data field for the purposes of updating addresses and confirming membership status.
In addition to a core data field for the purposes of updating addresses and confirming membership status, CMA shares with its wholly owned subsidiary, MDPS, information about a member's participation in CMA activities and products such as Physician Manager Institute events. MDPS, as the most highly rated provider of CMA products and services, is seeking to have a better understanding and appreciation of physicians' relationship and interaction with CMA. Knowledge of an individual's participation in CMA events and activities provides this complete or "integrated" picture. If a CMA member objects, a note will be entered in the database.
If you are both a CMA member and a client of a CMA subsidiary company, when you inform us of an address change, with your permission, this information will be changed for both organizations.
The CMA might also disclose personal information to third parties or to organizations or companies that are not CMA-affiliated companies or Divisions if these organizations have contracted or partnered with the CMA to help us provide products and services or do research. For example, the CMA might out-source the mailing list function for one of its publications or work with the Canadian Post-MD Education Registry to study physician resource planning.
We may, in certain instances, contract with a third party service provider located in other countries such as the United States. Your information may be processed and stored in the United States and the United States governments, courts or law enforcement or regulatory agencies may be able to obtain disclosure of your information under a lawful order made in that country. If you would like more information about the jurisdictions in which we our service providers may operate please contact us as noted in the What if you have a question... section of this policy.
Within the CMA itself, your personal information in the form of interactions with the CMA will be shared amongst CMA departments. This will enable CMA to have a better understanding of your interests and activities such that CMA might tailor its product and service offerings to your interests. For example, if a member has completed a number of Physician Manager Institute courses, we might send him or her information about our Physician Leadership Credential Program. If a member objects to a particular disclosure of an activity, for instance a particular CME course, a note will be entered into the database
What if you object to CMA's collection, use or disclosure of personal information?
The CMA seeks to respect and honour your privacy and communication preferences. For instance, if you indicate to the CMA that you do not wish to receive certain publications, participate in surveys or receive information about new or specific benefits and services such as communications from CMA's subsidiaries, your preference will be noted and you will no longer receive correspondence from us on these issues. Please contact the CMA Member Service Centre at 888-855-2555 to make such a request.
You may also at any time, subject to restrictions required by law, object to the CMA's collection, use or disclosure of personal information. You need only provide the CMA with reasonable notice in writing of your intention and the details of your objection. For instance, if you do not wish to have contact and demographic information shared with the Canadian Medical Foundation, we will respect your choice.
Please note, however, that your objection to the disclosure of other information might mean that the CMA is unable to continue to provide you with some products or services. For example, if you object to the sharing of your CMA membership status with CMA's financial subsidiaries, then you will not be eligible to benefit from their products or services. MD Physician Services has to confirm your CMA membership status in order to offer you financial services.
It is your responsibility to contact the CMA in order to determine how an objection to the collection, use and disclosure of personal information might affect the services supplied.
How accurate is the personal information held by the CMA?
The CMA makes every reasonable effort to ensure the accuracy and currency of your personal information so that we might fulfill the purposes for which it was first collected. Your personal information is subject to change so please advise us accordingly of such changes so that we might better meet your needs.
How do you access the personal information held by the CMA?
You may send a written request to the attention of the Chief Privacy Officer at 1867 Alta Vista Drive, Ottawa, Ontario, K1G 5W8or to email@example.com to obtain the personal information held about you by the CMA. Within a reasonable time frame, the CMA will then advise you in writing whether it has such personal information and the nature of this information unless there is the rare occurrence that the release of such information is legally prohibited. If the CMA cannot release the personal information, we will provide you with the reasons for denying access.
You may challenge the accuracy and completeness of the personal information that is maintained by the CMA. The CMA will amend personal information when an individual successfully demonstrates inaccuracy or incompleteness.
How secure is your personal information?
The CMA makes every reasonable effort to protect your personal information by implementing security safeguards against loss or theft, as well as unauthorized access, disclosure, copying, use or modification. The CMA uses physical, organizational and technological measures as methods of protection. For instance, only a limited number of staff have access to such sensitive information as credit card numbers. Moreover, the CMA will ensure that employees are aware of the importance of maintaining the confidentiality of personal information.
How long does the CMA retain personal information?
The CMA keeps personal information as long as it is needed to fulfill the purposes identified above. When personal information is no longer required to fulfill the identified purposes, it will be safely and securely destroyed. Moreover, the CMA will retain personal information that is the subject of an access request for as long as is necessary to allow an individual to exhaust any legal remedy that is provided for in applicable federal or provincial/territorial privacy legislation.
While genetic testing is typically provided in a clinical setting through the referral of a health care professional (HCP) or a regulated research project, a number of private companies now offer genetic testing services directly to consumers over the Internet. Direct-to-consumer (DTC) genetic testing is distinguished from clinical genetic testing ordered by a HCP in several ways:
1. DTC genetic tests are not regulated in Canada. The clinical validity and reliability of these tests varies widely, but DTC genetic testing companies make them available to consumers without distinguishing between those that may be useful to the management of one's health, those that have some limited health value, and those that are meant purely for recreational use.
2. Many of the tests advertised and sold via the Internet have not undergone clinical evaluation.
3. Marketing materials for these tests often imply that they have health value, but the terms of reference of some of the companies that offer them state that the tests are to be used for recreational purposes and many vendors do not guarantee the validity or reliability of their results.
4. Resale of personal health information and/or DNA samples is often an important part of the business model of companies that offer DTC genetic testing, raising concerns about patient privacy and insufficient or unclear disclosure of privacy terms.
5. Unlike genetic tests ordered and administered by HCPs, DTC genetic tests are ordered directly by the consumer, who most often has not consulted with a HCP as part of a clinical assessment, and the testing may not be clinically indicated. Some companies only agree to do testing if it has been ordered by a physician, but they will provide a phone conversation with one of their physicians (not based in Canada) if a consumer does not have access to a physician. When the testing is ordered by a physician, it will sometimes be ordered by the patient's personal physician. In such cases, this does not truly represent DTC genetic testing.
6. Without appropriate pre- and post-testing counselling by a HCP, consumers are left to interpret and act upon their results on their own. They might suffer psychological consequences if they overestimate their disease risk as a result of DTC.
7. As access to DTC genetic testing increases, Canadian HCPs (specifically primary care physicians) are faced with the challenge of appropriately counselling patients when they receive their test results. However, few physicians feel they have the necessary
training and knowledge in genomics to provide adequate care in this area. Furthermore, these tests may have no clinical indication, produce uncertain results with ambiguous clinical applicability and have tenuous legal status, but they can potentially influence a patient's sense of well-being.
1. The CMA is concerned with understanding, raising awareness of, and mitigating potential patient and societal harms that may arise from DTC genetic testing.
2. The CMA emphasizes the importance of the principle of protection of patient privacy and supports the right of Canadians to understand how their health information is being used by third parties, including insurance and DTC genetic testing companies.
3. The CMA believes that patients have the right to be fully informed about what a DTC genetic test can and cannot say about their health and that the scientific evidence on which a test is based should be clearly stated and easy to understand.
4. The CMA recommends regulation of both DTC genetic tests and the marketing of these tests through the development of a national framework that would include a combination of government and industry regulation with input from medical experts.
5. The CMA believes that unnecessary genetic testing should be avoided to ensure more appropriate use of health care resources. Even if a consumer pays directly for testing, any test result, even an incidental finding from a DTC genetic testing laboratory without clinical certification, may trigger a cascade of clinical investigations and lead to further unnecessary testing and inappropriate use of resources.
6. The CMA supports educational initiatives on DTC genetic testing for physicians practising in all specialties so that they can respond to patient queries about these tests and, when necessary, their results.
PROTECTION OF PRIVACY
* Privacy and confidentiality of patients' personal health information must be maintained.
* Before a patient submits a sample to a DTC genetic testing company, the company should obtain express informed consent from the patient concerning the way in which their data will be collected and used, who will have access to the data and the interpreted results, what safeguards are in place to protect it, and how it will be disposed of in the event of a company/laboratory closure.
* Patients have the right to a clear understanding of who owns the sample and the generated data, in particular whether their data will be sold or shared with third parties. If resale of personal health information and/or DNA samples is an important part of the business model of DTC-GC companies, this should be stated explicitly in terms understandable by the consumer.
* DTC-GC companies that solicit Canadian consumers should be subject to the Personal Information Protection and Electronic Documents Act (PIPEDA).
* The CMA encourages physicians to become familiar with privacy legislation affecting the use of DTC genetic tests by insurance companies and employers.
ROLE OF PHYSICIAN
* Physicians should generally avoid using DTC genetic tests unless they have been clinically and empirically validated.
* Physicians who are presented with a patient's DTC genetic test results should take the following actions:
o They should explain to their patient the limits of the specific test the patient used. If a physician does not know this information he/she should discuss with the patient the fact that DTC genetic test results are not necessarily obtained from an accredited laboratory or interpreted in a standardized way; therefore, the validity and clinical utility of the results may be highly variable for certain tests.
o They should disclose their level of comfort in providing an accurate interpretation of the results.
o They should assess whether the test results are clinically significant in the context of that patient's symptoms, signs, medical history and family history before deciding whether it is appropriate to formally consult a specialty provider such as a medical geneticist.
o If a physician wishes to use the results of a test in their clinical assessment, they should ensure that the laboratory performing the test guarantees analytical reliability and validity.
* Physicians should adhere to the following principles related to medically indicated genetic testing:
o Physicians should generally avoid recommending and/or ordering DTC genetic tests if they do not have a clear understanding of the validity and limitations of the tests they select.
o Physicians should follow best practice guidelines and make use of clinically valid tests, accredited laboratories and specialist referral(s), when appropriate.
o Physicians must obtain informed consent from the patient before ordering any genetic test, assist the patient in interpreting the results, support the individual with respect to psychological and biological implications of the results, and refer the patient to appropriate resources.
o Many genetic tests require pre- and post-test counselling, particularly (but not limited to) tests involving children, tests establishing carrier status or tests considered to be predictive. If a provider decides to order such testing, they also accept the responsibility for facilitating access to pre- and post-test counselling.
ROLE OF GOVERNMENT
* The CMA calls on the government to enact regulations based on Bill S-201 (An Act to prohibit and prevent genetic discrimination) that establish clear boundaries for the marketing, distribution, accreditation and third-party use of DTC genetic tests.
* The CMA believes that it is the government's responsibility to ensure that Canadians are only offered reliable, accurate and medically relevant genetic testing services.
* The CMA encourages the development of national standards for the reliability and validity of DTC genetic tests by relevant federal government agencies, in conjunction with interested stakeholders (e.g., geneticists and laboratory scientists, genetic counsellors, physicians, private and public laboratories, industry, and patient groups).
* The CMA encourages the government to enact standards that can keep pace with the rapid development of technological innovation in genetic testing and genetics more generally.
* The CMA encourages the government to enact standards that hold companies accountable for being transparent about their uses of data/DNA and the potential resale of such material.
* The CMA encourages the government to enact standards that mandate that the type of testing (e.g., single-nucleotide polymorphism [SNP] analysis, targeted mutation testing, sequencing) be clearly labelled and that a clear explanation be provided of the type of information that can (or cannot) be obtained from such testing.
* Genetic testing and the interpretation of the results of such testing are highly technical and complex processes. For this reason, the CMA believes that clinical testing laboratories that are used by DTC genetic testing companies must be accredited if the companies are to claim that their testing is valid.
* The CMA believes that scientific evidence describing the validity and utility of a DTC genetic test should be clearly stated in language that is easy to understand. This information should include a clear statement of what a test can or cannot diagnose or infer, and statements about the validity of a specific test should be supported with references. A company that does not guarantee the reliability or validity of its test should not be allowed to make any (implicit or explicit) claims about the potential medical utility of its test and/or its potential to improve health.
EDUCATION AND PUBLIC ENGAGEMENT
* The CMA supports public education initiatives to increase patient awareness of the potential implications and limitations of DTC genetic testing for health purposes.
The CMA supports increased genetics training for physicians to help them to further appreciate the complex issues involved and keep pace with the rapid changes in molecular genetics. Such training would support physicians to counsel patients who seek follow-up for their DTC genetic test results.
Approved by the CMA Board of Directors May 2017
See also Background to CMA Policy on Direct-to-Consumer Genetic Testing
BACKGROUND TO CMA POLICY
DIRECT-TO-CONSUMER GENETIC TESTING
See also CMA Policy PD17-05 Direct-to-Consumer Genetic Testing
Some direct-to-consumer (DTC) genetic tests, such as "compatibility testing" for online dating, are purely recreational. Other tests, however, are marketed both as being for recreational use and as producing results that are useful to the management of one's health. This document concerns this second category of tests. The characteristics of these tests differ widely, and some of the companies that offer them clearly state that they do not guarantee the validity and reliability of their tests. As of January 2016, 246 companies offered some form of DNA test online.1 Many DTC genetic tests have started to penetrate the Canadian market, especially after the U.S. Food and Drug Administration issued a warning letter instructing some companies in the U.S. to cease providing unreliable health information that could potentially lead consumers to make misinformed decisions about their health, which caused some of these companies to seek out alternative markets.2
The increasing availability of DTC genetic tests in Canada presents several challenges, as the predictive value of most of the DTC genetic tests currently on the market is very low. Moreover, there is no standard model for the delivery and interpretation of the results of these tests. Greater regulatory guidance and protection is needed to ensure that individuals who choose to submit samples to DTC genetic testing companies are not adversely affected by information that is not necessarily predictive or even accurate.
Survey research indicates that the general public is overwhelmingly interested in genetic testing technologies.3 Researchers predict that an increasing number of individuals will use DTC genetic testing as testing technologies continue to become more affordable and efficient.3 Since genetic issues tend to cross medical specialties, it often falls on primary care physicians to understand the role of genetics in clinical care.4 In fact, genetic testing companies often direct patients to discuss their results with their primary care physician.5 Patients not only seek out their primary care providers to discuss their genetic test results and obtain appropriate follow-up but also expect them to be able to answer questions about personal genome test results.6 Despite these expectations, health professionals' awareness and knowledge of DTC genetic tests remains low.7
Although DTC genetic tests are marketed under similar names, the genetic tests available in Canada have very different characteristics. Three types of tests are offered: (1) single-nucleotide polymorphism (SNPs) analysis, which assesses an individual's risk for common multifactorial diseases (e.g., diabetes, myocardial infarction), (2) targeted mutation analysis and (3) sequencing. Some are ordered directly by the consumer while others are pre-ordered by the consumer and the order is co-signed by a physician (the patient's physician or a physician who has never met the patient and whose services are provided by the company). SNP testing assesses for a number of genetic variants that are common in the general population and that have been identified in association studies to modify (increase or decrease) the risk of a given disease.
Some DTC genetic testing companies explicitly state in their terms of service that they do not guarantee the accuracy or reliability of the test. This is due in part to deficiencies in the science underlying the tests and their interpretation. For example, the interpretation of SNPs analysis for common multifactorial diseases can only be as good as the science behind it. The scientific community has a long way to go before it will have identified all of the significant genetic risk factors and protective factors for these diseases. Because of this, a given consumer could receive greatly divergent risk interpretations.3 In the case of targeted mutation analysis and sequencing, the specific panels offered by DTC genetic testing companies may not include all of the clinically relevant genes and mutations. This could result in a consumer receiving harmful false reassurance. Test results may include information on genetic changes that are only weakly associated with disease, leading to undue anxiety. As such, the clinical and health value of DTC genetic testing continues to be debated despite consumer uptake of, and enthusiasm for, DTC genetic testing offered online.
Currently, most DTC genetic testing services exist in regulatory limbo, benefiting from laws that tend to lag behind technological innovation. Questions about access to the information yielded by these tests have emerged as a particular concern. For some companies, an important part of the business model is to sell consumers' DNA along with the clinical information that the consumers provide via their interactive websites. Most Canadians are unaware of this: they pay for a test and do not expect that their data will later be sold.
ISSUES ARISING IN CLINICAL CONTEXTS
Studies have shown that physicians see a number of benefits with DTC genetic testing, but they also have concerns. The benefits physicians have identified include convenience, promotion of preventive medicine and the provision of personalized services.5 They are concerned about the reliability of test results, the provision of adequate information/counselling, patient anxiety if the results are misunderstood, inappropriateness of advertising, discrimination with respect to employment and insurance, the possible spread of beliefs such as genetic determinism, and the inappropriate disclosure of patients' genetic information.5
The following sections will address primary concerns identified by research and in practice.
1. Patient privacy
Privacy is one of the top concerns of the general public about genetic testing.8 According to a 2010 report commissioned by the Office of the Privacy Commissioner of Canada, approximately 60% of patients indicated that privacy and discrimination fears would influence their decision to undergo genetic testing.9 The average Canadian consumer is not adequately informed that an important part of the business model of many DTC genetic testing companies is to build and sell their database of phenotypic information and DNA accumulated from their clients to third parties, such as biobanks or pharmaceutical companies.
1.1 Informed consent
The increasing quantity, complexity and diversity of DTC genetic testing services pose challenges for informed consent because both specific and generic models do not meet ethical standards when applied to this type of service.10 Many companies bind their consumers to contracts that are activated once the website is viewed, a practice that challenges the adequacy of consent, as it is common for people to view a website without reading or even seeing its terms of reference.1 Consumers who present to genetic clinics tend not to question the validity of the results they have received from DTC genetic testing,11 which can be interpreted as an indication that consumers give their consent without reading or understanding the disclaimers made by the companies.11 Physicians are concerned that this lack of informed consent could compromise the confidentiality of personal health information, encourage requests for unnecessary medical tests and potentially cause distress to patients.
The insurance industry is of particular concern in the context of privacy and DTC genetic tests. A study of patients' perceptions of DTC genetic tests found that participants were concerned that genetic results could affect their health insurance premiums or lead to denial of coverage.12 Private insurance is fundamentally rooted in the practice of discriminating between clients on the basis of risk. While insurers have generally been entitled to request genetic information in the form of family history, to access medical files and to conduct medical tests,13 consumers have expressed the view that the rules governing access to genetic information should be stricter than for access to other forms of personal information.3
While there are studies that report cases of genetic discrimination, it is often unclear whether such treatment is perceived or actual.14. Thus, the consequences of genetic testing remain uncertain. Of particular concern is the potential for discrimination on the basis of results that may not be accurate and/or reliable. Although there is presently no evidence of widespread use of genetic testing by insurance companies,14experts agree that in the next 10 years public acceptance of the use of information from genetic testing will increase and it will become possible to more accurately interpret data from genetic tests (K. Boycott, J. Davies and K. Morin, CIHR Café Scientifique, unpublished remarks), threatening to alter the currently limited role that genetic testing plays in insurance company decision-making. Before policy-makers tackle the potential issues related to the use of DTC genetic testing, it is imperative that they start at ground level and explore options to regulate insurance companies' access to such tests.
2. Patient response
2.1 Interpretation of results and changes in behaviour
Proponents of DTC genetic testing point to the potential for patients to make positive changes to their health as a result of learning about their genetic susceptibility to certain diseases. Findings of studies in this area, however, are inconsistent to date. While some studies have reported that there are some behaviour changes, it is important to keep in mind that early adopters of these services are likely to also be among those most motivated to make health-related changes.15 Recent evidence suggests the opposite response: the general population has a tendency to decrease healthy practices upon learning about a lower health risk, and they do not increase healthy practices when they learn that they have an increased health risk.15 Indeed, patients may make poorer health decisions if they are under the impression that they are not at risk for developing a certain disease; for example, they may avoid routine screening for breast or prostate cancer, or they may not follow exercise and diet advice. 16
These variations in behaviour can be largely attributed to the fact that there is an overarching risk that patients will misinterpret the data they receive from the testing companies. The problem with susceptibility tests in the context of DTC genetic testing is not only that the test results may cause psychological or physical harm but also that there is a possibility that patients will over-interpret their disease risk.10 Without expert guidance, the patient may not be able to evaluate their test results accurately enough to make informed health decisions.14 There is very little evidence to suggest that receipt of a DTC genetic test result produces sustained behavioural change.17 In fact, studies on psychological theories related to motivation do not consider disease risk information a useful tool for motivating patients to change their behaviour.15 Therefore, while receipt of DTC genetic test results may encourage patients to see their family physician and possibly undergo further consultation, the health care resources invested in interpreting results with limited clinical validity may not produce sustained behavioural changes, good or bad.
3. Resource allocation
One of the stated goals of personalized medicine is to save health care systems money by facilitating the use of fewer but more effective treatments.18 However, greater demand for genetic testing, whether public or private, could produce the opposite effect: consumption of health care resources may increase as patients consult with their regular physician about results they obtained through a DTC company.16 Furthermore, physicians who are presented with DTC genetic test results by their patients have a legal and ethical obligation to do their due diligence and carry out a complete, clinically valid investigation, which may ultimately negate the cost savings that personalized medicine is expected to produce.16
Patients who participate in DTC genetic testing are likely to drive up the utilization of health care providers, as they seek out their primary care provider to discuss their results and they obtain follow-up care from a genetic counsellor.19,5 At least one study has suggested that there is an expectation that physicians will help patients to interpret their DTC genetic test results, and DTC genetic testing companies frequently direct patients to discuss their results with their physicians before acting upon their testing information.5 Consequently, the responsibility falls on primary care providers to discuss this technology with their patients.5
Primary care providers, however, believe that genetic specialists are the most appropriate providers of counselling for DTC genetic tests.14 While they acknowledge the benefits of DTC genetic tests, including the potential for test results to encourage patients to be more involved in their care and take responsibility for their health, they also agree that test results may encourage patients to seek unnecessary and potentially expensive follow-up tests.14 As a result, additional health care resources may be required to cope with the increased demand for medical follow-up.20
4. Physician education
Although DTC genetic testing companies have been around since the early 2000s, levels of awareness among health care professionals vary, and knowledge and understanding of the services generally remain low.21 Research suggests that few physicians feel they have the necessary training and knowledge in genomics to provide adequate care in this area.17 A perceived lack of clinical utility appears to be a barrier to learning more about DTC genetic testing.6 Increased genetics training and awareness may allow physicians to better appreciate the complex issues involved and help them to better counsel patients who seek follow-up for their DTC genetic test results.
4.1 Topics that physicians want to learn about
Most physicians are concerned about the privacy implications of DTC genetic testing, specifically health insurance and employment discrimination, which may affect their patients who present with a DTC genetic test.5 Therefore, important discussion points to include in a physician education program would be information on the risks of insurance and employment discrimination, legislation currently in place to protect against genetic discrimination, and guidelines for managing risk.6 Given the ease with which patients can access DTC genetic testing, it is essential to provide health professionals with appropriate education on the potential benefits and risks of DTC genetic testing and help them develop an approach to interpreting the results of such testing, so that they can protect their patients from harm and arrange follow-up appropriately.19
5. Legislative landscape in Canada
Before May 2017, Canada did not have a law to specifically protect against genetic discrimination. Existing human rights and privacy law could only be ambiguously and tenuously applied to DTC genetic testing issues, including genetic discrimination and information collection, use and disclosure.14 The laws that regulate medical devices, such as the Food and Drugs Act, did not clearly apply in the context of DTC genetic tests either,2 because consumers are not purchasing genetic testing kits but rather they are purchasing testing services, which fall outside the scope of that legislation.22 As a result, there was limited evidence to form the regulations necessary to ensure the validity and utility of these tests.
Fortunately, on May 4, 2017, Bill S-201 (hereinafter termed S-201), An Act to prohibit and prevent genetic discrimination,23 received Royal Assent and will soon become law. S-201 provides a basis for the creation of regulations concerning the validity and utility of DTC genetic tests. The bill prohibits the requirement that an individual submit to genetic testing or disclose the results of genetic tests in order to receive goods or services or in order to enter into or continue a contract or agreement, and it prohibits submission to genetic testing or disclosure of test results from being used as the basis of any specific conditions in a contract or agreement. S-201 amends the Canada Labour Code to protect employees from being required to undergo or disclose the results of genetic testing and amends the Canadian Human Rights Act to prohibit discrimination on the grounds of genetic characteristics.21 Legislation at a provincial level, however, may still be required. Private Member's Bill 127, An Act to amend the Human Rights Code with respect to genetic characteristics,24 was presented to the Legislative Assembly of the Province of Ontario in 2013 but did not move past the first reading.
Federal and provincial privacy legislation (such as the federal Personal Information Protection and Electronic Documents Act, or PIPEDA) also plays a role in protecting against genetic discrimination by requiring an individual to consent to the collection, use or disclosure of personal information.25 Currently, the Office of the Privacy Commissioner of Canada does not support amending the Privacy Act or PIPEDA, on the grounds that these laws sufficiently apply to genetic information.23 While this legislative framework might provide some protection against genetic discrimination, there is a lack of clarity as to whether it strikes the appropriate balance between consumers' rights to privacy and the interests of insurers. Furthermore, the courts have yet to provide an opinion regarding the constitutionality of S-201 or to assist in the interpretation of privacy legislation in the context of DTC testing, because of the novelty of the service.
It is uncertain if and how Bill S-201 will inform future regulations placed upon employers and insurers. Significant gaps in the legislative framework remain; in particular, privacy protection in Canada has yet to counterbalance the lack of consumer protection in Canadian insurance laws.22 While existing legislation may offer some protection, the absence of legal precedents creates uncertainty and leaves consumers to engage in DTC testing services at their own risk.
See also CMA Policy PD17-05 Direct-to-Consumer Genetic Testing
1 Phillips AM. Only a click away - DTC genetics for ancestry, health, love ... and more: a view of the business and regulatory landscape. Appl Transl Genom 2016;8:16-22.
2 US Food and Drug Administration. Warning letter. Silver Spring (MD): The Administration; 22 Nov 2013. Available: www.fda.gov/iceci/enforcementactions/warningletters/2013/ucm376296.htm (accessed 2017 May 19).
3 Caulfield T. Direct-to-consumer testing: if consumers are not anxious, why are policy makers? Hum Genet 2011;130:23-5.
4 Delaney SK, Christman MF. Direct-to-consumer genetic testing: perspectives on its value in healthcare. Clin Pharmacol Ther 2016; 99(2):146-8.
5 Powell KP, Cogswell WA, Christianson CA, et al. Primary care physicians' awareness, experience and opinions of direct-to-consumer genetic testing. J Genet Couns 2012;21(1):113-26.
6 Powell KP, Christianson CA, Cogswell WA, et al. Educational needs of primary care physicians regarding direct-to-consumer genetic testing. J Genet Couns 2012;21(3):469-78.
7 Jackson L, Goldsmith L, Skirton H. Guidance for patients considering direct-to-consumer genetic testing and health professionals involved in their care: development of a practical decision tool. Fam Pract 2014;31(3): 341-8.
8 Caulfield T, McGuire AL. Direct-to-consumer genetic testing: perception, problems, and policy responses. Annu Rev Med 2012; 63:23-33.
9 Office of the Privacy Commissioner of Canada. Analysis of privacy policies and practices of direct-to-consumer genetic testing companies: private sector databanks and privacy protection norms. Ottawa: The Office; March 2010. p. 6.
10 Bunnik EM, Janssens AC, Schermer MH. Informed consent in direct-to-consumer personal genome testing: the outline of a model between specific and generic consent. Bioethics 2014;28(7):343-51.
11 Brett GR, Metcalfe SA, Amor DJ, et al. An exploration of genetic health professionals' experience with direct-to-consumer genetic testing in their clinical practice. Eur J Hum Genet 2012;20(8):825-30.
12 Wasson K, Sanders TN, Hogan NS, Cherny S, Helzlsouer KJ. Primary care patients' views and decisions about, experience of and reactions to direct-to-consumer genetic testing: a longitudinal study. J Community Genet. 2013;4:495-505
13 Lemmens T, Pullman D, Rodal R. Revisiting genetic discrimination issues in 2010: policy options for Canada [PowerPoint presentation]. Ottawa: Genome Canada; 15 June 2010. Available: www.genomecanada.ca/sites/default/files/pdf/en/gps_speakers_presentation/trudo-lemmens-daryl-pullman.pdf
14 Zinatelli F. Industry Code: Genetic testing information for insurance underwriting [Internet]. Toronto, ON: CLHIA; 2017 Jan 11. Available from https://www.clhia.ca/domino/html/clhia/CLHIA_LP4W_LND_Webstation.nsf/page/E79687482615DFA485257D5D00682400/$file/Industry%20Code%20Genetic%20Testing%20-%20Updated.pdf
15 Adams SD, Evans JP, Aylsworth AS. Direct-to-consumer genomic testing offers little clinical utility but appears to cause minimal harm. N C Med J 2013;74(6): 494-8.
16 Ram S, Russell B, Gubb M, et al. General practitioner attitudes to direct-to-consumer genetic testing in New Zealand. N Z Med J 2012;125(1364):14-26.
17 Caulfield T. Obesity genes, personalized medicine and public health policy. Curr Obes Rep 2015;4(3):319-23.
18 Caulfield T, Zarzeczny A. Defining 'medical necessity' in an age of personalised medicine: a view from Canada. Bioessays 2014;36(9):813-7.
19 Bloss CS, Schork NJ, Topol EJ. Direct-to-consumer pharmacogenomic testing is associated with increased physician utilisation. J Med Genet 2014;51(2):83-9.
20 Daly AK. Direct-to-consumer pharmacogenomic testing assessed in a US-based study. J R Coll Physicans Edinb 2014;44:212-3.
21 Jackson L, Goldsmith L, Skirton H. Guidance for patients considering direct-to-consumer genetic testing and health professionals involved in their care: development of a practical decision tool. Fam Pract 2014;31(3):341-8.
22 Mykitiuk R. Caveat emptor: direct-to-consumer supply and advertising of genetic testing. Clin Invest Med 2004;27(1):23-32.
23Parliament of Canada. Legislative summary of Bill S-201: An Act to prohibit and prevent genetic discrimination. Ottawa: Parliament of Canada; 2016
24 Parliament of Canada. Bill 127: An Act to amend the Human Rights Code with respect to genetic characteristics, 2nd Sess, 40th Leg, Ontario, 2013.
25 Personal Information Protection and Electronic Document Act (PIPEDA), S.C. 2000, C.5, para 5(3).
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.
The objective of this policy is to provide guidance to physicians and institutions by identifying a set of guiding principles and commitments to promote equity and diversity in medicine (as defined in the Guiding Principles section). We address equity and diversity in medicine to improve circumstances and opportunities for all physicians and learners as part of our efforts to create a more collaborative and respectful culture and practice of medicine. To achieve this, we must redress inequities, bias, and discrimination in learning and practice environments.
Individual protection from bias and discrimination is a fundamental right of all Canadians. By embracing the principles of equity and diversity, we can systematically address root causes and reduce structural barriers faced by those who want to enter the medical profession and those practicing medicine. In so doing, we improve their opportunities for advancement, health, and livelihood.
The principles of equity and diversity are grounded in the fundamental commitment of the medical profession to respect for persons. This commitment recognizes that everyone has equal and inherent worth, has the right to be valued and respected, and to be treated with dignity. When we address equity and diversity, we are opening the conversation to include the voices and knowledge of those who have historically been under-represented and/or marginalized. It is a process of empowerment—where a person can engage with and take action on issues they define as important. Empowerment involves a meaningful shift in experience that fosters belonging in the profession and draws on community supports.
As part of equity and diversity frameworks, inclusion is often articulated to refer to strategies used to increase an individual’s ability to contribute fully and effectively to organisational structures and processes. Inclusion strategies are specific organisational practices or programs focused on encouraging the involvement and participation of individuals from diverse backgrounds to integrate and value their perspectives in decision-making processes. Robust processes for inclusion are a vehicle to achieving equity and diversity. Thus, in this policy, the process of inclusion is understood to be positioned at the nexus of the overarching principles of equity and diversity.
Equity and diversity initiatives can be carefully structured to complement and strengthen merit-based approaches. Enhanced support and appropriate methods of evaluation that increase equity of opportunity (for example, equity in training, hiring processes, and in access to resources) provide all physicians and learners with a fair opportunity to cultivate and demonstrate their unique capabilities and strengths, and to realize their full potential.
Promoting equity and diversity fosters a just professional and learning culture that cultivates the diverse perspectives within it, reflects the communities physicians serve, and promotes professional excellence and social accountability as means to better serve patients. An increasingly diverse medical population provides opportunities for underserviced populations to receive better access to medical services and bolsters the management of clinical cases through the contribution of different points of view. Evidence indicates that when demonstrably more equity and diversity in medicine is achieved, physicians experience greater career satisfaction, health and wellness, and a sense of solidarity with the profession while patients experience improved care and a more responsive and adaptable health care system. Evidence further indicates that realizing the full potential of human capital is an essential driver of innovation and health system development.
This policy is consistent with the CMA Code of Ethics and Professionalism and the CMA Charter of Shared Values and strives to be in the spirit of the recommendations relevant to health made in the report of the Truth and Reconciliation Commission of Canada. The policy is informed by a body of evidence described in the accompanying Background document that includes a Glossary of terms.
A clear set of principles and commitments to improving equity and diversity demonstrates that we hold ourselves accountable to recognizing and challenging behaviours, practices, and conditions that hinder equity and diversity and to promoting behaviours, practices, and conditions that will achieve these goals.
Achieving equity in medicine
Equity refers to the treatment of people that recognizes and is inclusive of their differences by ensuring that every individual is provided with what they need to thrive, which may differ from the needs of others. It is a state in which all members of society have similar chances to become socially active, politically influential, and economically productive through the absence of avoidable or remediable differences among groups of people (defined socially, economically, demographically, or geographically). Equity in the medical profession is achieved when every person has the opportunity to realize their full potential to create and sustain a career without being unfairly impeded by discrimination or any other characteristic-related bias or barrier. To achieve this, physicians must 1) recognize that structural inequities that privilege some at the expense of others exist in training and practice environments and 2) commit to reducing these by putting in place measures that make recruitment, retention, and advancement opportunities more accessible, desirable, and achievable. To that end, physicians must apply evidence-based strategies and support applied research into the processes that lead to inequities in training and practice environments.
Fostering diversity in medicine
Diversity refers to observable and non-observable characteristics which are constructed—and sometimes chosen—by individuals, groups, and societies to identify themselves (e.g., age, culture, religion, indigeneity, ethnicity, language, gender, sexuality, health, ability, socio-economic and family status, geography). The barriers to diversity in medicine are broad and systemic. Individuals and groups with particular characteristics can be excluded from participation based on biases or barriers. Even when they are included, they are often not able to use the full range of their skills and competencies. As with improving equity, the benefits of a more diverse medical profession include improved health outcomes, system-level adaptation, and physician health and wellness. To achieve these benefits, the medical profession must become increasingly diverse by striving to create, foster, and retain physicians and learners who reflect the diversity of the communities they serve and it must be responsive to the evolving (physical, emotional, cultural, and socioeconomic) needs of patients.
Promoting a just professional and learning culture
Physicians value learning and understand that it reflects, and is informed by, the professional culture of medicine. A just professional and learning culture is one of shared respect, shared knowledge, shared opportunity, and the experience of learning together. An environment that is physically and psychologically safe by reducing bias, discrimination, and harassment is critical to creating and sustaining such a culture. To achieve this, the profession must strive to integrate cultural safety by fostering and adopting practices of cultural competence and cultural humility. Physicians and leaders across all levels of training, practice, and health settings, and through formal and informal mentorships, must also promote and foster environments where diverse perspectives are solicited, heard, and appreciated. In this way, diverse individuals are both represented in the professional culture of medicine and actively involved in decision-making processes in all aspects of the profession.
Fostering solidarity within the profession
Solidarity means standing alongside others by recognizing our commonality, shared vulnerabilities and goals, and interdependence. It is enacted through collective action and aims. To show solidarity within the profession means making a personal commitment to recognizing others as our equals, cultivating respectful, open, and transparent dialogue and relationships, and role modelling this behaviour. Solidarity enables each of us to support our colleagues in meeting their individual and collective responsibilities and accountabilities to their patients and to their colleagues. Being accountable to these goals and to each other means taking action to ensure the principles that guide the medical profession are followed, responding justly and decisively when they are not, and continually searching for ways to improve the profession through practice-based learning and experience.
Promoting professional excellence and social accountability
Engaged and informed research and action on equity and diversity is critical to promoting professional excellence and social accountability in medicine as means to better serve patients. Professional excellence is a fundamental commitment of the profession to contribute to the development of and innovation in medicine and society through clinical practice, research, teaching, mentorship, leadership, quality improvement, administration, and/or advocacy on behalf of the profession or the public. Social accountability is a pillar of the commitment to professional excellence by focusing those efforts on fostering competence to address the evolving health needs of the patients and communities physicians are mandated to serve. For care to be socially accountable, and to achieve professional excellence, physicians must provide leadership through advocacy and through action: advocacy about the benefits of addressing equity and diversity to achieve equitable health outcomes; and actions to be responsive to patient, community, and population health needs through high-quality evidence-based patient care.
To accomplish equity and diversity in medicine, organizational and institutional changes will be required across many facets of operation and culture including leadership, education, data gathering/analysis, and continuous improvement through feedback and evaluation of policies and programs. To achieve this, the CMA seeks to provide direction on broad action areas that require further specific actions and development measures in specific recruitment, training, and practice contexts. The CMA recommends:
All medical organizations, institutions, and physician leaders:
A. Take a leadership role in achieving greater equity and diversity by co-creating policies and processes that apply to them, and the individuals therein, in an accountable and transparent manner. This includes:
1. Identifying and reducing structural inequities, barriers, and biases that exist in training and practice environments to create fair opportunities for all physicians and learners; and providing the appropriate platforms, resources, and training necessary to do so to effect change collaboratively.
2. Practicing and promoting cultural safety, cultural competence, and cultural humility.
3. Providing training on implicit bias, allyship, cultural safety, cultural competence, and cultural humility, structural competence, and the value of diversity in improving health outcomes.
4. Ensuring a process is in place to review all workforce and educational policies, procedures, and practices toward considering their impact on equity and diversity. Areas of consideration include (but are not limited to) recruitment, promotion, pay, leave of absence, parental leave, resources and support, and working/learning conditions and accommodations.
5. Ensuring safe, appropriate, and effective avenues exist for those who may have experienced discrimination, harassment, or abuse in training and practice environments to report these events outside of their supervisory/promotional chain. Those experiencing these events should also be able to seek counselling without the fear of negative consequences.
6. Working towards creating and appropriately funding equity and diversity Chairs, Committees, or Offices with a mandate to investigate and address issues in equity and diversity.
7. Promoting and enabling formal and informal mentorship and sponsorship opportunities for historically under-represented groups.
B. Encourage the collection and use of data related to equity and diversity through research and funding, and, specifically, review their data practices to ensure:
1. Historically under-represented groups are meaningfully engaged through the co-development of data practices.
2. Data regarding the representation of under-represented groups is being systematically and appropriately collected and analyzed.
3. Information collected is used to review and inform internal policy and practice with the aim of reducing or eliminating system-level drivers of inequity.
4. Findings relating to these data are made accessible.
C. Support equity and diversity in recruitment, hiring, selection, appointment, and promotion practices by:
1. Requesting and participating in training to better understand approaches and strategies to promote equity and diversity, including implicit bias and allyship training that highlights the roles and responsibilities of all members of the community with emphasis on self-awareness, cultural safety, and sensitivity to intersectionalities.
2. Studying organizational environments and frameworks and identifying and addressing hiring procedures, especially for leadership and executive positions, that perpetuate institutional inequities and power structures that privilege or disadvantage people.
3. Adopting explicit criteria to recruit inclusive leaders and to promote qualified candidates from historically under-represented groups in selection processes.
Additional recommendations for institutions providing medical education and training:
1. Establishing programs that espouse cultural safety, cultural competence, and cultural humility.
2. Encouraging all instructors develop competencies including non-discriminatory and non-stereotyping communication, awareness of intersectionality, and cultural safety.
3. Providing training programs, at the undergraduate level onwards, that include awareness and education around stereotypes (gender and otherwise), intersectionalities, and the value of diversity in improving health outcomes.
4. Providing diversity mentorship programs that aim to support diverse candidates through education and training to graduation.
5. Promoting and funding student-led programs that create safe and positive spaces for students and principles of equity and diversity.
6. Ensuring recruitment strategies and admission frameworks in medical schools incorporate more holistic strategies that recognize barriers faced by certain populations to enable a more diverse pool of candidates to apply and be fairly evaluated.
7. Developing learning communities (such as undergraduate pipelines described in the background document) to promote careers in medicine as a viable option for individuals from historically under-represented communities.
Approved by the CMA Board of Directors December 2019
This paper discusses the current state of the professional relationship between physicians and the health care system. A review of the concept of medical professionalism, and the tensions that can arise between the care of individual patients and a consideration of the broader needs of society, provides some basic groundwork. Our understanding of what it means to be a physician has evolved significantly over the years, and the medical profession is now being challenged to clarify the role it is willing to play in order to achieve transformation of our health care system.
We have arrived at this point due to a convergence of several factors. Regionalization of health care has led to a change in the leadership roles played by practising physicians and to the opportunities they have for meaningful input into system change. Physicians are now also less likely to be involved in hospital-based care, which has resulted in a loss of collegiality and interactions with peers. Changing models of physician engagement status and changing physician demographics have also presented new and unique issues and challenges over the past few years.
The Canadian Medical Association (CMA) suggests that its physician members and other stakeholders employ a "AAA" lens to examine the challenges and opportunities currently facing Canadian physicians as they attempt to engage with the health care system: Autonomy, Advocacy and Accountability. These important concepts are all underpinned by strong physician leadership. Leadership skills are fundamentally necessary to allow physicians to be able to participate actively in conversations aimed at meaningful system transformation.
KEY CMA RECOMMENDATIONS ARE AS FOLLOWS:
Physicians should be provided with the leadership tools they need, and the support required, to enable them to participate individually and collectively in discussions on the transformation of Canada's health care system.
Physicians need to be provided with meaningful opportunities for input at all levels of decision-making, with committed and reliable partners, and must be included as valued collaborators in the decision-making process.
Physicians have to recognize and acknowledge their individual and collective obligations (as one member of the health care team and as members of a profession) and accountabilities to their patients, to their colleagues and to the health care system and society.
Physicians must be able to freely advocate when necessary on behalf of their patients in a way that respects the views of others and is likely to bring about meaningful change that will benefit their patients and the health care system.
Physicians should participate on a regular and ongoing basis in well-designed and validated quality improvement initiatives that are educational in nature and will provide them with the feedback and skills they need to optimize patient care and outcomes.
Patient care should be team based and interdisciplinary with smooth transition from one care setting to the next and funding and other models need to be in place to allow physicians and other health care providers to practise within the full scope of their professional activities.
The concept of medical professionalism, at its core, has always been defined by the nature and primacy of the individual doctor-patient relationship, and the fiduciary obligation of physicians within this relationship. The central obligation of the physician is succinctly stated in the first tenet of the CMA Code of Ethics:
Consider first the well-being of the patient.1
Since the latter half of the 20th century, however, there has been a growing emphasis on the need for physicians to also consider the collective needs of society, in addition to those of their individual patients. As stated in the CMA Code of Ethics:
Consider the well-being of society in matters affecting health.
This shift in thinking has happened for at least two reasons. First, there have been tremendous advances in medical science that now enable physicians to do much more to extend the length and quality of life of their patients, but these advances inevitably come at a cost which is ultimately borne by society as a whole. Second, since World War II, Canadian governments have been increasingly involved in the financing of health care through taxation revenues. As a result, there have been growing calls for physicians to be prudent in their use of health care resources, and to be increasingly accountable in the way these resources are employed.
The 2002 American Board of Internal Medicine (ABIM) Foundation Charter on Medical Professionalism calls for physician commitment to a just distribution of finite resources: "While meeting the needs of individual patients, physicians are required to provide health care that is based on the wise and cost-effective management of limited clinical resources."2 This has also been described as civic professionalism.
Lesser et al have put forward a systems view of professionalism that radiates out from the patient-physician relationship to broader interactions with members of the health care team, the training environment and to the external environment, dealing with payers and regulators and also addressing the socio-economic determinants of health.3 Understandably, given that the resources available for health care are finite, tensions will arise between the care of individual patients and the collective needs of society, and these tensions can at times be very difficult to resolve for individual medical practitioners.
As stated in the CMA policy Medical Professionalism (Update 2005):
Medical professionalism includes both the relationship between a physician and a patient and a social contract between physicians and society. Society grants the profession privileges, including exclusive or primary responsibility for the provision of certain services and a high degree of self-regulation. In return, the profession agrees to use these privileges primarily for the benefit of others and only secondarily for its own benefit. 4
Over time the delivery, management and governance of health care have become more complex, and as a result the health care sector now accounts for roughly one in 10 jobs in Canada. There are more than two dozen regulated health professions across Canada, as well as numerous professional managers employed in various capacities, many of whom have had little or no exposure to the everyday realities of the practice of clinical medicine. Notwithstanding the acknowledgement of the very real and important need for inter-professional collaboration and teamwork, inevitably this creates competition for influence in the health care system.
The CMA 2005 update of its policy on medical professionalism acknowledges the need for change.
While maintaining responsibility for care of the patient as a whole, physicians must be able to interact constructively with other health care providers within an interdisciplinary team setting. The relationship of physicians with their colleagues must be strengthened and reinforced. Patient care benefits when all health care practitioners work together towards a common goal, in an atmosphere of support and collegiality.
Now, physicians are being challenged to clarify exactly what it is that they are prepared to do in order to advance the much-needed transformation of our health care system, and how they will partner with patients, other care providers and the system in order to achieve this common goal. This provides a significant opportunity for physicians to continue their leadership role in the health care transformation initiative in the interests of their patients, while at the same time redefining their relationship with the system (understood in this context as health care administrators, governments and their representatives, health districts, health care facilities and similar organizations) in order to ensure that they have a meaningful and valued seat at the decision-making table, now and in the future.
The common refrain among health administrators, health ministry officials and health policy analysts for the past decade and longer has been that physicians are "not part of the health care system", that they are independent contractors and not employees, and that they are too often part of the problem and not the solution.
Over this period of time, several developments have resulted in a diminished role of physicians in clinical governance in Canada and have, to varying degrees, transformed the professional and collegial relationship between physicians and their health regions, health care facilities and communities to one that is increasingly governed by legislative fiat or regulation.
Beginning with New Brunswick in 1992, all jurisdictions except Ontario, the Yukon Territory and Nunavut have adopted a regional governance model. This change has eliminated all hospital and community services boards within a geographic region and replaced them with a single regional board. Clinical governance is now administered through a regional medical advisory committee (MAC). Some provinces such as Saskatchewan recognize the role of the district (regional) medical staff association. This has had a profound impact in reducing the number of physicians engaged in the clinical governance of health care institutions.
Another by-product of regionalization is that in virtually all jurisdictions, physicians no longer sit on governing boards. While physicians continue to serve as department heads and section chiefs within regions and/or individual hospital facilities, the level of support and financial compensation to do so varies greatly, particularly outside major regions and institutions, and there has been a lack of physician interest in such positions in some places.
In addition to a diminished presence in clinical governance, physicians are less likely to be actively involved in hospitals than they were previously. Anecdotally, many physicians, particularly in larger urban communities, describe having been "pushed out" of the hospital setting, and of feeling increasingly marginalized from the decision-making process in these institutions. Another result of the diminished engagement with hospitals has been the loss of the professional collegiality that used to be fostered through interaction in the medical staff lounge or through informal corridor consultations.
In the community setting, there have been some positive developments in terms of physician leadership and clinical governance. Ontario and Alberta have implemented new primary care funding and delivery models that promote physician leadership of multidisciplinary teams, and at least two-thirds of the family physicians in each of these jurisdictions have signed on. British Columbia has established Divisions of Family Practice, an initiative of the General Practice Services Committee (a joint committee of the BC Ministry of Health and the BC Medical Association), in which groups of family physicians organize at the local and regional levels and work in partnership with the Health Authority and the Ministry of Health to address common health care goals.
Looking ahead, regionalization is also likely to affect physicians in community-based practice. There is a clear trend across Canada to require all physicians within a region to have an appointment with the health region if they want to access public resources such as laboratory and radiology services. In the future this may also result in actions such as mandated quality improvement activities which may be of variable effectiveness and will not necessarily be aligned with the learning needs of physicians.
Physician engagement status
Traditionally physicians have interfaced with hospitals through a privileges model. This model, which has generally worked well, aims to provide the physician with the freedom to reasonably advocate for the interests of the patient.5 In this model, legislation and regulations also require that there are minimum procedures in place for renewing, restricting, and terminating privileges, and that procedures are set out to ensure that this takes place within a fair and structured framework. The hospital's MAC generally reviews physician privileges applications and recommends appointment and reappointment. The MAC thus plays an integral role in ensuring the safety of care within the region or hospital.5
There has been increasing attention recently on engaging in other types of physician-hospital relationships, including employment or contractual arrangements. This type of arrangement can vary from an employment contract, similar to that used by other professional staff such as nurses and therapists, to a services agreement whereby the physician provides medical services to the hospital as an independent contractor.5 However, there are concerns, expressed by the Canadian Medical Protective Association (CMPA) and others, that many of the procedural frameworks and safeguards found in hospital bylaws pertaining to the privileges model may not necessarily extend to other arrangements, and that physicians entering into these contractual agreements may, in some cases, find their appointment at the hospital or facility terminated without recourse. Under such arrangements the procedural fairness and the right of appeal available under the privilege model may not be available to physicians.
One relatively new approach is the appointment model, which aims to combine many of the protections associated with the privileges model with the advantages of predictability and specificity of the employment model. It generally applies the processes used to grant or renew privileges to the resolution of physician performance-related issues.5
It has been argued that changes in appointment status and relationship models can have a detrimental impact on the relationship between practitioners and health care facilities.6 While this has been reported specifically within the context of Diagnostic Imaging, the same may hold true for other specialties as well.
It should also be noted that the issues raised in this paper are applicable to all members of the profession, regardless of their current or future practice arrangements or locations.
Changing physician demographics and practice patterns
It is well recognized that physician demographics and practice patterns have changed significantly over the past several years. Much has been written about the potential impact of these changes on medicine, and their impact on patient care, on waiting lists and on the ability of patients to access clinical services.7 It is also acknowledged that "lifestyle factors," that is to say the attempt by many physicians to achieve a healthier work-life balance, may play a role in determining the type and nature of clinical practice chosen by new medical graduates, the hours they will work and the number of patients they will see.
All of these changes mean that clinical practices may have smaller numbers of patients and may be open shorter hours than in the past. Physicians are being increasingly challenged to outline their understanding of their commitment to ensuring that all patients have timely access to high quality health care within the Canadian public system, while balancing this with their ability to make personal choices that are in their best interests.
Put another way, how can we assist physicians in adjusting their clinical practices, at least to some extent, based on the needs of the population?
While there are clearly challenges and barriers to physician participation in meaningful transformation of the health care system, there are also opportunities for engagement and dialogue, particularly when the doctors of Canada show themselves to be willing and committed partners in the process. Health care transformation cannot be deferred just because it involves difficult decisions and changes to the status quo. Regardless of how we have reached the current situation, relationships between physicians and other parties must evolve to meet future needs. Physicians need to be assisted in their efforts in this regard, both by local health boards and facilities, and by organizations such as the CMA and its provincial and territorial counterparts.
Physicians, individually and collectively, need to demonstrate what they are willing to do to assist in the process and what they are willing to contribute as we move forward, and they need to commit to having the medical profession be an important part of the solution to the challenges currently facing the Canadian system.
We examine some of these challenges through the "AAA" lens of Autonomy, Advocacy and Accountability, which are underpinned by the concept of Physician Leadership.
To a large extent, physicians continue to enjoy a significant degree of what is commonly termed clinical or professional autonomy, meaning that they are able to make decisions for their individual patients based on the specific facts of the clinical encounter. In order to ensure that this autonomy is maintained, physicians need to continue to embrace the concept of clinical standards and minimization of inter-practice variations, where appropriate, while also recognizing the absolute need to allow for individual differences in care based on the requirements of specific patients. Professional autonomy plays a vital role in clinical decision-making, and it is at the heart of the physician-patient relationship. Patients need to feel that physicians are making decisions that are in the best interest of the patient, and that physicians are not unduly limited by external or system constraints. As part of this decision-making, physicians may also need to consider carefully the appropriate balance between individual patient needs and the broader societal good.
In recent years, governments have sometimes made use of the "legislative hammer" to force physicians to conform to the needs of the health system, thus undermining physicians' individual or personal autonomy. Historically, physicians have organized themselves to provide 24-hour coverage of the emergency room and other critical hospital services. This has proven increasingly challenging in recent years, particularly in the case of small hospitals that serve sparsely populated areas where there are few physicians.
Physicians need to continue to make sure that they do not confuse personal with professional autonomy and that they continue to ensure that health care is truly patient-centred. Physicians have rights but also obligations in this regard and they need to make sure that they continue to use a collaborative approach to leadership and decision-making. This includes an ongoing commitment to the concept of professionally-led regulation and meaningful physician engagement and participation in this system.
While physicians will continue to value and protect their clinical and professional autonomy, and rightly so as it is also in the best interests of their patients, they may need to consider which aspects of personal and individual autonomy they may be willing to concede for the greater good.
For example, physicians may need to work together and collaboratively with administrators and with the system to ensure that call coverage is arranged and maintained so that it need not be legislatively mandated, or imposed by regions or institutions. They may need to consider changing the way they practice in order to serve a larger patient population so that patients in need of a primary care physician do not go wanting, and so that the overall patient care load is more evenly balanced amongst colleagues. New primary care models established in Ontario and Alberta over the past decade that provide greater out-of-hours coverage are one example of such an initiative.
By working collaboratively, both individually and collectively, physicians are finding creative ways to balance their very important personal autonomy with the needs of the system and of their patients. These efforts provide a solid foundation upon which to build as the profession demonstrates its willingness to substantively engage with others to transform the system.
To paraphrase from the discussion at the CMA's General Council meeting in August 2011: Physicians need to carefully examine their individual and collective consciences and show governments and other partners that we are willing to play our part in system reform and that we are credible partners in the process.
All parties in the discussion, not only physicians, must be able to agree upon an appropriate understanding of professional autonomy if the health care system is to meet the current and future needs of Canadians.
Physician advocacy has been defined as follows:
Action by a physician to promote those social, economic, educational and political changes that ameliorate the suffering and threats to human health and well-being that he or she identifies through his or her professional work and expertise.8
This can consist of advocacy for a single patient to assist them in accessing needed funding for medications, or lobbying the government for changes at a system level. How and when individual physicians choose to undertake advocacy initiatives depends entirely on that individual practitioner, but physicians as a collective have long recognized their obligation to advocate on behalf of their individual patients, on behalf of groups of patients, and at a societal level for changes such as fairer distribution of resources and adequate pandemic planning.
Traditionally, physicians have served as advocates for their patients in a number of arenas; however, various factors such as provincial/territorial legislation, regulatory authorities, and hospital contracts have combined to make them more reluctant to take on this important role and as a result overall patient care may suffer and the patient-physician relationship may be threatened. Increasingly, hospital bylaws urge or require physicians to consult with their institution or health region before going public with any advocacy statements, and in at least one health region physicians are required to sign a confidentiality agreement. Because of this, many physicians fear reprisal when they decide to act as an advocate.
The ability to undertake advocacy initiatives is a fundamental concept and principle for Canadian physicians. Indeed, the CMA Code of Ethics encourages physicians to advocate on behalf of the profession and the public. Patients need to feel that their concerns are heard, and physicians need to feel safe from retribution in bringing those concerns forward.
A well-functioning and respectful advocacy environment is essential to health care planning. Health care is about making choices every day. Governments struggling to balance budgets should be aware that the public can accept that hard choices must and will get made - but they are less likely to be supportive if physicians and their patients do not feel that their opinions are sought and considered as part of the process.
Frontline health care providers, many of whom work in relative isolation in an office or community setting, also need to feel that they have a voice. The CMA supports the need for a forum where primary care physicians can speak with one voice (and make sure that this voice is heard and respected) in a community setting.
In addition to advocating for issues related directly to patient care, physicians, as community leaders, may also be called upon to advocate for other issues of societal importance, such as protection of the environment or social determinants of health. These advocacy undertakings can also be of great importance.
There can be a fine line between advocacy that is appropriate and is likely to affect important and meaningful change, and advocacy that others will perceive as being obstructive or counterproductive in nature. To further complicate matters, what might be seen as appropriate advocacy in one circumstance might not be in a different setting. Physicians should be clear on whose behalf they are speaking and whether they have been authorized to do so. If they have any questions about the possible medicolegal implications of their advocacy activities, they may also wish to contact their professional liability protection provider (e.g., CMPA) for advice in these instances.
Depending on the facts of the individual circumstances, physicians may need to consider other factors as well when deciding if, when and how to undertake advocacy activities. They should also be aware that their representative medical organizations, such as national specialty societies, provincial and territorial medical associations and the CMA, may be able to assist them with their initiatives in certain situations.
Physicians should not feel alone when advocating for their patients, particularly when this is done in a reasonable manner and in a way that is likely to effect meaningful and important change.
Physician accountability can be seen to occur at three levels: accountability to the patients they serve, to society and the health care system and to colleagues and peers.
Accountability to patients
The physician-patient relationship is a unique one. Based on, optimally, absolute trust and openness, this relationship allows for a free exchange of information from patient to physician and back again. Physicians often see patients at their most vulnerable, when they are struggling with illness and disease. While other health care providers make essential contributions to patient care, none maintain the unique fiduciary relationships that are at the heart of the physician's role and which are recognized by law.
Physicians are accountable to their individual patients in a number of important ways. They provide clinical services to their patients and optimize their availability so that patients can be seen and their needs addressed in a timely fashion. They follow up on test results. They facilitate consultations with other physicians and care providers and follow up on the results of these consultations when needed. They ensure that patients have access to after hours and emergency care when they are not personally available.
Physicians can also fulfill their obligation to be accountable to patients in other ways. They can participate in accreditation undertakings to ensure that their practices meet accepted standards. They can ensure, through lifelong learning and maintenance of competency activities, that they are making clinical decisions based on the best available evidence. They can undertake reviews of their prescribing profiles to ensure that they are consistent with best current standards. All of these activities can also be used to maximize consistencies within and between practices and minimize inter-practice variability where appropriate.
Accountability to society and the health care system
Physician accountability at this level is understandably more complex. In general, society and the health care system in Canada provide physicians with financial compensation, with a significant degree of clinical autonomy as reflected by professionally-led regulation, and with a high level of trust. In some cases, physicians are also provided with a facility in which to practice and with access to necessary resources such as MRIs and operating rooms.
In return, physicians agree to make their own individual interests secondary in order to focus on those of their patients, and they agree to provide necessary medical services. Accountability then can be examined based on the extent that these necessary services are provided (i.e. patients have reasonable access to these services) and also the level of quality of those services. Clearly, neither access nor quality can be considered in isolation of the system as a whole, but for the purposes of this paper the focus will be on the role of the physician.
The issue of level and comprehensiveness of service provision has been considered to some extent above under the concept of physician autonomy. Physicians as individuals and as a collective need to ensure that patients have access to timely medical care and follow up. They also need to make sure that the transition from one type of care to another (for example, from the hospital to the community setting) is as seamless as possible, within the current limitations of the system.
Collectively and individually, physicians also have an obligation to make sure that the quality of the care they provide is of the highest standard possible. They should strive for a "just culture of safety", which encourages learning from adverse events and close calls to strengthen the system, and where appropriate, supports and educates health care providers and patients to help prevent similar events in the future.9
Thousands of articles and hundreds of books have been published on the subjects of quality assurance and quality improvement. From a physician perspective, we want to be able to have access to processes and resources that will provide us with timely feedback on the level of quality of our clinical care in a way that will help us optimize patient outcomes and will be seen as educational in nature rather than punitive. As a self-regulated profession, medicine already has strong accountability mechanisms in place to ensure the appropriate standards of care are maintained.
To ensure that physicians are able to meet their obligation to be accountable to the health care system for high quality care, the CMA has developed a series of recommendations for Continuous Quality Improvement (CQI) activities (see box below).
Physicians need to take ownership of the quality agenda. New medical graduates are entering practice having come from training systems where they have access to constant feedback on their performance, only to find themselves in a situation where feedback is non-existent or of insufficient quality to assist them in caring for their patients. While regulators and health care facilities have a legitimate interest in measuring and improving physician performance, ultimately physicians themselves must take responsibility for ensuring that they are providing their patients with the highest possible standard of care, and that mechanisms are in place to ensure that this is in fact the case.
Accountability to colleagues
Physicians are also accountable to their physician peers and to other health care providers. While much of this accountability is captured by the concept of "collegiality," or the cooperative relationship of colleagues, there are other aspects as well.
Anecdotal evidence suggests strongly that many physician leaders find themselves marginalized by their peers. They describe being seen as having "gone over to the other side" when they decide to curtail or forego their clinical practices in order to participate in administrative and leadership activities. Physicians should instead value, encourage and support their peers who are dedicating their time to important undertakings such as these. As well, physicians should actively engage with their administrative colleagues when they have concerns or suggestions for improvement. Collaboration is absolutely vital to the delivery of safe and quality care.
Physicians also need to make sure that they do everything they can to contribute to a "safe" environment where advocacy and CQI activities can be undertaken. This can mean encouraging physician colleagues to participate in these initiatives, as well as serving as a role model to peers by participating voluntarily in CQI undertakings.
Physicians are also accountable to ensure that transition of care from one physician to another occurs in as seamless a manner as possible. This includes participating in initiatives to improve the quality and timeliness of both consultation requests and results, as well as ensuring professional and collegial communications with other physicians and with all team members.
Finally, physicians need to support each other in matters of individual health and well-being. This can include support and care for colleagues suffering from physical or psychological illness, as well as assisting with accommodation and coverage for duty hours and professional responsibilities for physicians who are no longer able to meet the demands of full-time practice for whatever reason.
"You will not find a high performing health system anywhere in the world that does not have strong physician leadership."
Dan Florizone, Deputy Minister of Saskatchewan Health
As we can see from the discussion above, having strong physician leaders is absolutely critical to ensuring that the relationship between physicians and the health care system is one of mutual benefit. Physicians as a collective have an obligation to make sure that they support both the training required to produce strong physician leaders, as well as providing support for their colleagues who elect to undertake this increasingly important role.
Physicians are well-positioned to assume leadership positions within the health care system. They have a unique expertise and experience with both the individual care of patients, as well as with the system as a whole. As a profession, they have committed to placing the needs of their patients above those of their own, and this enhances the credibility of physicians at the leadership level as long as they stay committed to this important value. Leadership is not just about enhancing the working life of physicians, but is about helping to ensure the highest possible standard of patient care within an efficient and well-functioning system.
As part of their leadership activities, physicians need to ensure that they are consistently engaged with high quality and reliable partners, who will deliver on their promises and commitments, and that their input is carefully considered and used in the decision-making process. These partners can include those at the highest level of government, and must also include others such as medical regulators and senior managers. Without ensuring that they are speaking with the right people, physicians cannot optimize their leadership initiatives.
Physician leadership activities must be properly supported and encouraged. Many physicians feel increasingly marginalized when important meetings or training opportunities are scheduled when they are engaged in direct patient care activities. Non-clinician administrators have time set aside for these activities and are paid to participate, but physicians must either miss these discussions in order to attend to the needs of their patients, or cancel clinics or operating room times. This means that patient care is negatively impacted, and it presents a (sometimes significant) financial disincentive for physicians to participate. Some jurisdictions have recognized this as a concern and are ensuring that physicians are compensated for their participation.
Patients want their physicians to be more involved in policy-making decisions and this must be enabled through the use of proper funding mechanisms, reflective learning activities, continuing professional development credits for administrative training and participation, assisting in the appropriate selection of spokespersons including guidelines on how to select them, and guidelines for spokespersons on how to provide meaningful representation of the profession's views.
Physician leadership training must take place throughout the continuum of medical education, from the early days of medical school through to continuing professional development activities for those in clinical practice. Physicians with an interest in and aptitude for leadership positions should ideally be identified early on in their careers and encouraged to pursue leadership activities and training through means such as mentorship programs and support from their institutions to attend training courses and meetings where they will be able to enhance and refine their leadership skills.
There has been action on several fronts to support the organized professional development of physicians in leadership roles. Since the 1990s the Royal College of Physicians and Surgeons of Canada (RCPSC) has been implementing its CanMEDs framework of roles and competencies in the postgraduate medical training programs across Canada, and this has also been adopted by the College of Family Physicians of Canada (CFPC). The CanMEDs framework sets out seven core roles for physicians. Two that are most pertinent to the relationship between physicians and the health care system are those of manager and health advocate.10 These roles highlight the importance of physician involvement in leadership and system engagement activities, and are relevant for physicians in training as well as those in practice.
As managers, physicians are integral participants in health care organizations, organizing sustainable practices, making decisions about allocating resources, and contributing to the effectiveness of the health care system.
As health advocates, physicians responsibly use their expertise and influence to advance the health of individual patients, communities and populations.
A number of key enabling competencies have been identified for each role, and the RCPSC has developed a variety of resource materials to support the framework.
For almost 30 years, the CMA has been offering the Physician Manager Institute (PMI) program in order to provide training for physicians pursuing leadership and management positions. PMI is offered in "open enrolment" format in major cities across Canada, and also "in house" through longstanding associations with hospitals and health regions (e.g., Calgary zone of Alberta Health Services [AHS]). In 2010 the CMA and the Canadian Society of Physician Executives introduced the Canadian Certified Physician Executive (CCPE) Program. The CCPE is a peer-assessed credential that can be attained either through an academic route that is based on completion of PMI courses or through a practice-eligibility route based on formal leadership experience.11
The CMA also partners with several provincial and territorial medical associations to provide leadership training. Currently CMA has agreements with the Saskatchewan, Ontario and Quebec medical associations and this will extend to the four Atlantic medical associations and the Alberta Medical Association/AHS in 2012.
In addition, a number of university business schools have developed executive program offerings for health leaders. During the past decade, a number of physicians have taken up CEO positions in Canada's major academic health organizations.
Internationally, it has been recognized that physician leadership is critical to the success of efforts to improve health services.12, 13
Having well trained and qualified physicians in leadership roles is critical in making sure that physicians continue to play a central role in the transformation of the Canadian health care system. The CMA and its membership unreservedly support our physician colleagues who dedicate their time and energies to these leadership activities and the CMA will continue to play an integral part in supporting and training the physician leaders of the future.
CONCLUSION: THE CMA'S VISION OF THE NEW PROFESSIONAL RELATIONSHIP BETWEEN CANADIAN PHYSICIANS AND OUR HEALTH CARE SYSTEM
We have explored the factors that have brought us to this point, as well as the issues that must be examined and addressed to enable us to move forward. It is now time for the physicians of Canada to commit to meaningful participation in the process of transforming our health care system. This can only be achieved through the concerted efforts of all parties, including governments, health authorities, health care facilities, physicians and other health care providers. It will not be easy, and it is not likely that this transformation will take place without commitment and sacrifice on our part.
However, now is the time for physicians to demonstrate to their patients, to their colleagues and to society that they are willing to do their share and play their role in this critically important process, at this critically important time. Doing so will help them to achieve the CMA's vision of the new professional relationship between Canadian physicians and the health care system.
In this vision:
Physicians are provided with the leadership tools they need, and the support required, to enable them to participate individually and collectively in discussions on the transformation of Canada's health care system.
Physicians are provided with meaningful opportunities for input at all levels of decision-making, with committed and reliable partners, and are included as valued collaborators in the decision-making process.
Physicians recognize and acknowledge their individual and collective obligations (as one member of the health care team and as members of a profession) and accountabilities to their patients, to their colleagues and to the health care system and society.
Physicians are able to freely advocate when necessary on behalf of their patients in a way that respects the views of others and is likely to bring about meaningful change that will benefit their patients and the health care system.
Physicians participate on a regular and ongoing basis in well-designed and validated quality improvement initiatives that are educational in nature and will provide them with the feedback and skills they need to optimize patient care and outcomes.
Patient care is team based and interdisciplinary with seamless transition from one care setting to the next and funding and other models are in place to allow physicians and other health care providers to practise within the full scope of their professional activities.
1. Canadian Medical Association. CMA Code of Ethics. http://policybase.cma.ca/PolicyPDF/PD04-06.pdf. Accessed 05/20/11.
2. ABIM Foundation. Medical professionalism in the new millennium: a physician charter. Annals of Internal Medicine 2002; 136(3): 243-6.
3. Lesser C, Lucey C, Egener B, Braddock C, Linas S, Levinson W. A behavioral and systems view of professionalism. JAMA 2010; 304(24): 2732-7.
4. Canadian Medical Association. Medical professionalism 2005 update. http://policybase.cma.ca/dbtw-wpd/Policypdf/PD06-02.pdf. Accessed 06/03/11.
5. Canadian Medical Protective Association. Changing physician : hospital relationships. Managing the medico-legal implications of change. 2011. https://www.cmpa-acpm.ca/cmpapd04/docs/submissions_papers/com_2011_changing_physician-e.cfm. Accessed 02/07/12.
6. Thrall JH. Changing relationship between radiologists and hospitals Part 1: Background and major issues. Radiology 2007; 245: 633-637.
7. Reichenbach L, Brown H. Gender and academic medicine: impact on the health workforce. BMJ. 2004; 329: 792-795.
8. Earnest MA, Wong SL, Federico SG. Perspective: Physician advocacy: what is it and how do we do it? Acad Med 2010 Jan; 85(1): 63-7.
9. Canadian Medical Protective Association. Learning from adverse events: Fostering a just culture of safety in Canadian hospitals and health care institutions. 2009. http://www.cmpa-acpm.ca/cmpapd04/docs/submissions_papers/com_learning_from_adverse_events-e.cfm. Accessed 02/07/12.
10. Royal College of Physicians and Surgeons of Canada. CanMEDS 2005 Framework. http://rcpsc.medical.org/canmeds/bestpractices/framework_e.pdf. Accessed 05/20/11.
11. Canadian Society of Physician Executives and Canadian Medical Association. Canadian Certifies Physician Executive. Candidate Handbook. http://www.cma.ca/multimedia/CMA/Content_Images/Inside_cma/Leadership/CCPE/2012CCPE-Handbook_en.pdf. Accessed 05/20/11.
12. Ham C. Improving the performance of health services: the role of clinical leadership. Lancet 2003; 361: 1978-80.
13. Imison C, Giordano R. Doctors as leaders. BMJ 2009; 338: 979-80.
The current global pandemic caused by the novel coronavirus has presented the international medical community with unprecedented ethical challenges. The most difficult of these has involved making decisions about access to scarce resources when demand outweighs capacity.
In Canada, it is well accepted that everyone should have an equal opportunity to access and receive medical treatment. This is possible when there are sufficient resources. But in contexts of resource scarcity, when there are insufficient resources, difficult decisions have to be made about who receives critical care (e.g., ICU beds, ventilators) by triaging patients. Triage is a process for determining which patients receive treatment and/or which level of care under what circumstances in contexts of resource scarcity. Priority-setting for resource allocation becomes more ethically complex during catastrophic times or in public health emergencies, such as today’s COVID-19 pandemic, when there is a need to manage a potential surge of patients.
Physicians from China to Italy to Spain to the United States have found themselves in the unfathomable position of having to triage their most seriously ill patients and decide which ones should have access to ventilators and which should not, and which allocation criteria should be used to make these decisions. While the Canadian Medical Association hopes that Canadian physicians will not be faced with these agonizing choices, it is our intent, through this framework, to provide them with guidance in case they do and enable them to make ethically justifiable informed decisions in the face of difficult ethical dilemmas. Invoking this framework to ground decisions about who has access to critical care and who does not should only be made as a last resort. As always, physicians should carefully document their clinical and ethical decisions and the reasoning behind them.
Generally, the CMA would spend many months in deliberations and consultations with numerous stakeholders, including patients and the public, before producing a document such as this one. The current situation, unfortunately, did not allow for such a process. We have turned instead to documents, reports and policies produced by our Italian colleagues and ethicists and physicians from Canada and around the world, as well as provincial level documents and frameworks.
The CMA is endorsing and recommending that Canadian physicians use the guidance provided by Emmanuel and colleagues in the New England Journal of Medicine article dated from March 23rd, as outlined below. We believe these recommendations represent the best current approach to this situation, produced using the highest current standard of evidence by a panel of internationally recognized experts. We also recognize that the situation is changing constantly, and these guidelines may need to be updated as required.
The CMA will continue to advocate for access to personal protective equipment, ventilators and ICU equipment and resources. We also encourage physicians to make themselves aware of any relevant provincial or local documents, and to seek advice from their regulatory body or liability protection provider. It should be noted that some provinces and indeed individual health care facilities will have their own protocols or frameworks in place. At the time of its publication, this document was broadly consistent with those protocols that we were given an opportunity to review.
The CMA recognizes that physicians may experience moral distress when making these decisions. We encourage physicians to seek peer support and practice self-care. In addition, the CMA recommends that triage teams or committees be convened where feasible in order to help separate clinical decision making from resource allocation, thereby lessening the moral burden being placed on the individual physician.
The CMA recommends that physicians receive legal protection to ensure that they can continue providing needed care to patients with confidence and support and without fear of civil or criminal liability or professional discipline. In this time of uncertainty, physicians should be reassured that their good faith efforts to provide care during such a crisis will not put them at increased medical-legal risk. Providing such reassurance is needed so that physicians have the confidence to continue to provide care to their patients.
Recommendation 1: In the context of a pandemic, the value of maximizing benefits is most important. This value reflects the importance of responsible stewardship of resources: it is difficult to justify asking health care workers and the public to take risks and make sacrifices if the promise that their efforts will save and lengthen lives is illusory. Priority for limited resources should aim both at saving the most lives and at maximizing improvements in individuals’ post-treatment length of life. Saving more lives and more years of life is a consensus value across expert reports. It is consistent both with utilitarian ethical perspectives that emphasize population outcomes and with nonutilitarian views that emphasize the paramount value of each human life. There are many reasonable ways of balancing saving more lives against saving more years of life; whatever balance between lives and life-years is chosen must be applied consistently.
Limited time and information in a Covid-19 pandemic make it justifiable to give priority to maximizing the number of patients that survive treatment with a reasonable life expectancy and to regard maximizing improvements in length of life as a subordinate aim. The latter becomes relevant only in comparing patients whose likelihood of survival is similar. Limited time and information during an emergency also counsel against incorporating patients’ future quality of life, and quality-adjusted life-years, into benefit maximization. Doing so would require time-consuming collection of information and would present ethical and legal problems. However, encouraging all patients, especially those facing the prospect of intensive care, to document in an advance care directive what future quality of life they would regard as acceptable and when they would refuse ventilators or other life-sustaining interventions can be appropriate.
Operationalizing the value of maximizing benefits means that people who are sick but could recover if treated are given priority over those who are unlikely to recover even if treated and those who are likely to recover without treatment. Because young, severely ill patients will often comprise many of those who are sick but could recover with treatment, this operationalization also has the effect of giving priority to those who are worst off in the sense of being at risk of dying young and not having a full life.
Because maximizing benefits is paramount in a pandemic, we believe that removing a patient from a ventilator or an ICU bed to provide it to others in need is also justifiable and that patients should be made aware of this possibility at admission. Undoubtedly, withdrawing ventilators or ICU support from patients who arrived earlier to save those with better prognosis will be extremely psychologically traumatic for clinicians — and some clinicians might refuse to do so. However, many guidelines agree that the decision to withdraw a scarce resource to save others is not an act of killing and does not require the patient’s consent. We agree with these guidelines that it is the ethical thing to do. Initially allocating beds and ventilators according to the value of maximizing benefits could help reduce the need for withdrawal.
Recommendation 2: Irrespective of Recommendation 1, Critical Covid-19 interventions — testing, PPE, ICU beds, ventilators, therapeutics, and vaccines — should go first to front-line health care workers and others who care for ill patients and who keep critical infrastructure operating, particularly workers who face a high risk of infection and whose training makes them difficult to replace. These workers should be given priority not because they are somehow more worthy, but because of their instrumental value: they are essential to pandemic response. If physicians and nurses and RTs are incapacitated, all patients — not just those with Covid-19 — will suffer greater mortality and years of life lost. Whether health workers who need ventilators will be able to return to work is uncertain but giving them priority for ventilators recognizes their assumption of the high-risk work of saving others. Priority for critical workers must not be abused by prioritizing wealthy or famous persons or the politically powerful above first responders and medical staff — as has already happened for testing. Such abuses will undermine trust in the allocation framework.
Recommendation 3: For patients with similar prognoses, equality should be invoked and operationalized through random allocation, such as a lottery, rather than a first-come, first-served allocation process. First-come, first-served is used for such resources as transplantable kidneys, where scarcity is long-standing, and patients can survive without the scarce resource. Conversely, treatments for coronavirus address urgent need, meaning that a first-come, first-served approach would unfairly benefit patients living nearer to health facilities. And first-come, first-served medication or vaccine distribution would encourage crowding and even violence during a period when social distancing is paramount. Finally, first-come, first-served approaches mean that people who happen to get sick later on, perhaps because of their strict adherence to recommended public health measures, are excluded from treatment, worsening outcomes without improving fairness. In the face of time pressure and limited information, random selection is also preferable to trying to make finer-grained prognostic judgments within a group of roughly similar patients.
Recommendation 4: Prioritization guidelines should differ by intervention and should respond to changing scientific evidence. For instance, younger patients should not be prioritized for Covid-19 vaccines, which prevent disease rather than cure it, or for experimental post- or pre-exposure prophylaxis. Covid-19 outcomes have been significantly worse in older persons and those with chronic conditions. Invoking the value of maximizing saving lives justifies giving older persons priority for vaccines immediately after health care workers and first responders. If the vaccine supply is insufficient for patients in the highest risk categories — those over 60 years of age or with coexisting conditions — then equality supports using random selection, such as a lottery, for vaccine allocation. Invoking instrumental value justifies prioritizing younger patients for vaccines only if epidemiologic modeling shows that this would be the best way to reduce viral spread and the risk to others.
Epidemiologic modeling is even more relevant in setting priorities for coronavirus testing. Federal guidance currently gives priority to health care workers and older patients but reserving some tests for public health surveillance could improve knowledge about Covid-19 transmission and help researchers target other treatments to maximize benefits.
Conversely, ICU beds and ventilators are curative rather than preventive. Patients who need them face life-threatening conditions. Maximizing benefits requires consideration of prognosis — how long the patient is likely to live if treated — which may mean giving priority to younger patients and those with fewer coexisting conditions. This is consistent with the Italian guidelines that potentially assign a higher priority for intensive care access to younger patients with severe illness than to elderly patients. Determining the benefit-maximizing allocation of antivirals and other experimental treatments, which are likely to be most effective in patients who are seriously but not critically ill, will depend on scientific evidence. These treatments may produce the most benefit if preferentially allocated to patients who would fare badly on ventilation.
Recommendation 5: People who participate in research to prove the safety and effectiveness of vaccines and therapeutics should receive some priority for Covid-19 interventions. Their assumption of risk during their participation in research helps future patients, and they should be rewarded for that contribution. These rewards will also encourage other patients to participate in clinical trials. Research participation, however, should serve only as a tiebreaker among patients with similar prognoses.
Recommendation 6: There should be no difference in allocating scarce resources between patients with Covid-19 and those with other medical conditions. If the Covid-19 pandemic leads to absolute scarcity, that scarcity will affect all patients, including those with heart failure, cancer, and other serious and life-threatening conditions requiring prompt medical attention. Fair allocation of resources that prioritizes the value of maximizing benefits applies across all patients who need resources. For example, a doctor with an allergy who goes into anaphylactic shock and needs life-saving intubation and ventilator support should receive priority over Covid-19 patients who are not frontline health care workers.
Approved by the CMA Board of Directors April 2020
The future of medicine
In 1997 the Canadian Medical Association (CMA) embarked on a study of the future of medicine. Two premises guided this activity: (1) the pace of change in the practice of medicine that physicians experienced in the last quarter of the 20th century is bound to increase in the 21st century; and (2) it is essential that the medical profession position itself to influence future developments in medical practice.
In order to prepare the profession to anticipate and meet the challenges of the future, the CMA is engaged in a medium- to long-term (5–20 years) planning exercise. This policy statement summarizes the results of the first part of this exercise: working definitions of health, health care and medicine; a vision for the future of the medical profession; and the implications of this vision for the roles of physicians. This work was conducted by an expert project advisory group, which developed background papers on these topics and prepared this statement for approval by the CMA Board of Directors.
Health: is a state of physical, mental, emotional and spiritual well-being. It is characterized in part by an absence of illness (a subjective experience) and disease (a pathological abnormality) that enables one to pursue major life goals and to function in personal, social and work contexts.
Health care: is any activity that has as its primary objective the improvement, maintenance or support of physical, mental, emotional and spiritual well-being, as characterized by the absence of illness and disease.
Medicine: is the art and science of healing. It is based on a body of knowledge, skills and practices concerned with the health and pathology of individuals and populations. The practice of medicine encompasses those health care activities that are performed by or under the direction of physicians in the service of patients, including health promotion, disease prevention, diagnosis, treatment, rehabilitation, palliation, education and research.
A vision for the future of the medical profession
Medicine will continue to be a healing profession dedicated to serving humanity. Its cornerstone will continue to be the relationship of trust between the patient and the
physician. It will uphold with integrity the values of respect for persons, compassion, beneficence and justice. It will strive for excellence and incorporate progress in its art and science. It will maintain high standards of ethics, clinical practice, education and research in order to serve patients. It will encourage the development of healthy communities and of practices and policies that promote the well-being of the public. It will demonstrate its capacity for societal responsibility through self-regulation and accountability. It will actively participate in decision-making regarding health and health care policy. It will guard against forces and events that may compromise its primary commitment to the well-being of patients.
The roles of physicians in the future1
Although the vision and values of medicine are enduring and will remain stable, the practice environment of physicians will change as the medical profession responds to health system and societal influences. This in turn will have implications for the roles of physicians.
The traditional role of physicians has been medical expert and healer. This has involved diagnosing and treating disease and other forms of illness, comforting those who cannot be cured and preventing illness through patient counselling and public-health measures. While this role will remain at the core of medical practice, the evolving context of health care requires physicians to assume additional roles to support their primary role.
The CMA proposes the following roles as essential to the future practice of medicine (cf. Fig. 1 for their interrelationship). Although no physician will function in all roles simultaneously, they should all have the fundamental competencies to participate in each of these roles.
-Medical expert and healer: Physicians have always been recognized for their role as medical expert and healer; it is the defining nature of their practice and derives from the broad knowledge base of medicine and its application through a combination of art and science. This is the foundation for continued physician leadership in the provision of medical and health care in the future.
-Professional: There must be renewed efforts to reaffirm the principles of the medical profession, including upholding its unique body of knowledge and skills; maintenance of high standards of practice; and commitment to the underlying values of caring, service and compassion. The medical profession of the future must continue to develop standards of care with ongoing opportunities for continued assessment of competency in order to remain a credible, self-regulated discipline worthy of public respect and trust.
-Communicator: Increasing emphasis will be placed upon the ability to gather and communicate medical information in a compassionate and caring fashion, to enter into a partnership with patients when organizing care plans and to provide important information through counselling and the promotion of health. As always, the patient–physician relationship will remain paramount, with its essential features of compassion, confidentiality, honesty and respect.
-Scholar: Scholarship involves the creation of new knowledge (research), its uniform application (clinical practice) and its transfer to others (education). It is this strong association with the science of medicine and physicians’ willingness to embrace the scholarship of their practice that is closely linked to their roles of
medical experts and professionals.
-Collaborator: Health care services will increasingly be provided by interdisciplinary teams throughout the continuum of care from health promotion activities to the management of acute life-threatening disorders to the delivery of palliative care. In the role of collaborator, physicians recognize the essential functions of other health care workers and respect unique provider contributions in patient-centred health care delivery.
-Advocate: As the health sector becomes increasingly complex and interdependent with other sectors of society, it will be essential for physicians to play a greater role as health advocates. This may pertain to advocacy for individual and family health promotion in the practice environment; it may also relate to the promotion of improved health at the broader community level.
-Manager: In order to provide quality care, physicians of the future must be effective resource managers at the individual practice level, at the health care facility level and as part of the wider health care system.
In order to fulfil these roles and participate in communities as integral members of society, physicians need to lead balanced lives.
Physicians may sometimes experience conflicts among these roles. The CMA Code of Ethics specifies the basic principles of professional ethics for dealing with such conflicts.
The CMA has developed this vision for the future of medicine and the future roles of physicians to assist individual physicians and medical organizations to anticipate and prepare for the challenges of the next 20 years. The vision provides the profession with criteria for evaluating proposed changes in how medicine is practised and reaffirms the core values of medicine that must be upheld in whatever system emerges.
The CMA invites other organizations, nonmedical as well as medical, to comment on the contents of this statement and its implications for health and health care. The CMA welcomes opportunities to dialogue with others on how the health care system can be improved for the benefit of future patients and society in general.
1The section is indebted to the work of the Educating Future Physicians for Ontario (EFPO) project supported by the Associated Medical Services group, the Ontario faculties of medicine and the Ontario Ministry of Health, and the Canadian Medical Education Directions for Specialists 2000 (CanMEDs 2000) project of the Royal College of Physicians and Surgeons of Canada.
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.
GUIDELINES FOR PHYSICIANS IN INTERACTIONS WITH INDUSTRY
The history of health care delivery in Canada has included interaction between physicians and the pharmaceutical and health supply industries; this interaction has extended to research as well as to education. Physicians understand that they have a responsibility to ensure that their participation in such collaborative efforts is in keeping with their primary obligation to their patients and duties to society, and to avoid situations of conflict of interest where possible and appropriately manage these situations when necessary. They understand as well the need for the profession to lead by example by promoting physician-developed guidelines.
The following guidelines have been developed by the CMA to serve as a resource tool for physicians in helping them to determine what type of relationship with industry is appropriate. They are not intended to prohibit or dissuade appropriate interactions of this type, which have the potential to benefit both patients and physicians.
Although directed primarily to individual physicians, including residents, and medical students, the guidelines also apply to relationships between industry and medical organizations.
1. The primary objective of professional interactions between physicians and industry should be the advancement of the health of Canadians.
2. Relationships between physicians and industry are guided by the CMA's
Code of Ethics and by this document.
3. The practising physician's primary obligation is to the patient. Relationships with industry are inappropriate if they negatively affect the fiduciary nature of the patient-physician relationship.
4. Physicians should resolve any conflict of interest between themselves and their patients resulting from interactions with industry in favour of their patients. In particular, they must avoid any self-interest in their prescribing and referral practices.
5. Except for physicians who are employees of industry, in relations with industry the physician should always maintain professional autonomy and independence. All physicians should remain committed to scientific methodology.
6. Those physicians with ties to industry have an obligation to disclose those ties in any situation where they could reasonably be perceived as having the potential to influence their judgment.
7. A prerequisite for physician participation in all research activities is that these activities are ethically defensible, socially responsible and scientifically valid. The physician's primary responsibility is the well-being of the patient.
8. The participation of physicians in industry sponsored research activities must always be preceded by formal approval of the project by an appropriate ethics review body. Such research must be conducted according to the appropriate current standards and procedures.
9. Patient enrolment and participation in research studies must occur only with the full, informed, competent and voluntary consent of the patient or his or her proxy, unless the research ethics board authorizes an exemption to the requirement for consent. In particular, the enrolling physician must inform the potential research subject, or proxy, about the purpose of the study, its source of funding, the nature and relative probability of harms and benefits, and the nature of the physician's participation and must advise prospective subjects that they have the right to decline to participate or to withdraw from the study at any time, without prejudice to their ongoing care.
10. The physician who enrolls a patient in a research study has an obligation to ensure the protection of the patient's privacy, in accordance with the provisions of applicable national or provincial legislation and CMA's Health Information Privacy Code. If this protection cannot be guaranteed, the physician must disclose this as part of the informed consent process.
11. Practising physicians should not participate in clinical trials unless the study will be registered prior to its commencement in a publicly accessible research registry.
12. Because of the potential to influence judgment, remuneration to physicians for participating in research studies should not constitute enticement. It may cover reasonable time and expenses and should be approved by the relevant research ethics board. Research subjects must be informed if their physician will receive a fee for their participation and by whom the fee will be paid.
13. Finder's fees, whereby the sole activity performed by the physician is to submit the names of potential research subjects, should not be paid. Submission of patient information without their consent would be a breach of confidentiality. Physicians who meet with patients, discuss the study and obtain informed consent for submission of patient information may be remunerated for this activity.
14. Incremental costs (additional costs that are directly related to the research study) must not be paid by health care institutions or provincial or other insurance agencies regardless of whether these costs involve diagnostic procedures or patient services. Instead, they must be assumed by the industry sponsor or its agent.
15. When submitting articles to medical journals, physicians must state any relationship they have to companies providing funding for the studies or that make the products that are the subject of the study whether or not the journals require such disclosure. Funding sources for the study should also be disclosed.
16. Physicians should only be included as an author of a published article reporting the results of an industry sponsored trial if they have contributed substantively to the study or the composition of the article.
17. Physicians should not enter into agreements that limit their right to publish or disclose results of the study or report adverse events which occur during the course of the study. Reasonable limitations which do not endanger patient health or safety may be permissible.
Industry-Sponsored Surveillance Studies
18. Physicians should participate only in post-marketing surveillance studies that are scientifically appropriate for drugs or devices relevant to their area of practice and where the study may contribute substantially to knowledge about the drug or device. Studies that are clearly intended for marketing or other purposes should be avoided.
19. Such studies must be reviewed and approved by an appropriate research ethics board. The National Council on Ethics in Human Research is an additional source of advice.
20. The physician still has an obligation to report adverse events to the appropriate body or authority while participating in such a study.
Continuing Medical Education / Continuing Professional Development (CME/CPD)
21. This section of the Guidelines is understood to address primarily medical education initiatives designed for practicing physicians. However, the same principles will also apply for educational events (such as noon-hour rounds and journal clubs) which are held as part of medical or residency training.
22. The primary purpose of CME/CPD activities is to address the educational needs of physicians and other health care providers in order to improve the health care of patients. Activities that are primarily promotional in nature, such as satellite symposia, should be identified as such to faculty and attendees and should not be considered as CME/CPD.
23. The ultimate decision on the organization, content and choice of CME/CPD activities for physicians shall be made by the physician-organizers.
24. CME/CPD organizers and individual physician presenters are responsible for ensuring the scientific validity, objectivity and completeness of CME/CPD activities. Organizers and individual presenters must disclose to the participants at their CME/CPD events any financial affiliations with manufacturers of products mentioned at the event or with manufacturers of competing products. There should be a procedure available to manage conflicts once they are disclosed.
25. The ultimate decision on funding arrangements for CME/CPD activities is the responsibility of the physician-organizers. Although the CME/CPD publicity and written materials may acknowledge the financial or other aid received, they must not identify the products of the company(ies) that fund the activities.
26. All funds from a commercial source should be in the form of an unrestricted educational grant payable to the institution or organization sponsoring the CME/CPD activity.
27. Industry representatives should not be members of CME content planning committees. They may be involved in providing logistical support.
28. Generic names should be used in addition to trade names in the course of CME/CPD activities.
29. Physicians should not engage in peer selling. Peer selling occurs when a pharmaceutical or medical device manufacturer or service provider engages a physician to conduct a seminar or similar event that focuses on its own products and is designed to enhance the sale of those products. This also applies to third party contracting on behalf of industry. This form of participation would reasonably be seen as being in contravention of the CMA's Code of Ethics, which prohibits endorsement of a specific product.
30. If specific products or services are mentioned, there should be a balanced presentation of the prevailing body of scientific information on the product or service and of reasonable, alternative treatment options. If unapproved uses of a product or service are discussed, presenters must inform the audience of this fact.
31. Negotiations for promotional displays at CME/CPD functions should not be influenced by industry sponsorship of the activity. Promotional displays should not be in the same room as the educational activity.
32. Travel and accommodation arrangements, social events and venues for industry sponsored CME/CPD activities should be in keeping with the arrangements that would normally be made without industry sponsorship. For example, the industry sponsor should not pay for travel or lodging costs or for other personal expenses of physicians attending a CME/CPD event. Subsidies for hospitality should not be accepted outside of modest meals or social events that are held as part of a conference or meeting. Hospitality and other arrangements should not be subsidized by sponsors for personal guests of attendees or faculty, including spouses or family members.
33. Faculty at CME/CPD events may accept reasonable honoraria and reimbursement for travel, lodging and meal expenses. All attendees at an event cannot be designated faculty. Faculty indicates a presenter who prepares and presents a substantive educational session in an area where they are a recognized expert or authority.
Electronic Continuing Professional Development (eCPD)
34. The same general principles which apply to "live, in person" CPD events, as outlined above, also apply to eCPD (or any other written curriculum-based CPD) modules. The term "eCPD" generally refers to accredited on-line or internet-based CPD content or modules. However, the following principles can also apply to any type of written curriculum based CPD.
35. Authors of eCPD modules are ultimately responsible for ensuring the content and validity of these modules and should ensure that they are both designed and delivered at arms'-length of any industry sponsors.
36. Authors of eCPD modules should be physicians with a special expertise in the relevant clinical area and must declare any relationships with the sponsors of the module or any competing companies.
37. There should be no direct links to an industry or product website on any web page which contains eCPD material.
38. Information related to any activity carried out by the eCPD participant should only be collected, used, displayed or disseminated with the express informed consent of that participant.
39. The methodologies of studies cited in the eCPD module should be available to participants to allow them to evaluate the quality of the evidence discussed. Simply presenting abstracts that preclude the participant from evaluating the quality of evidence should be avoided. When the methods of cited studies are not available in the abstracts, they should be described in the body of the eCPD module.
40. If the content of eCPD modules is changed, re-accreditation is required.
41. Physicians may be approached by industry representatives and asked to become members of advisory or consultation boards, or to serve as individual advisors or consultants. Physicians should be mindful of the potential for this relationship to influence their clinical decision making. While there is a legitimate role for physicians to play in these capacities, the following principles should be observed:
A. The exact deliverables of the arrangement should be clearly set out and put in writing in the form of a contractual agreement. The purpose of the arrangement should be exclusively for the physician to impart specialized medical knowledge that could not otherwise be acquired by the hiring company, and should not include any promotional or educational activities on the part of the company itself.
B. Remuneration of the physician should be reasonable and take into account the extent and complexity of the physician's involvement.
C. Whenever possible, meetings should be held in the geographic locale of
the physician or as part of a meeting which he/she would normally attend. When these arrangements are not feasible, basic travel and accommodation expenses may be reimbursed to the physician advisor or consultant. Meetings should not be held outside of Canada, with the exception of international boards.
Clinical Evaluation Packages (Samples)
42. The distribution of samples should not involve any form of material gain for the physician or for the practice with which he or she is associated.
43. Physicians who accept samples or other health care products are responsible for recording the type and amount of medication or product dispensed. They are also responsible for ensuring their age-related quality and security and their proper disposal.
44. Practising physicians should not accept personal gifts of any significant monetary or other value from industry. Physicians should be aware that acceptance of gifts of any value has been shown to have the potential to influence clinical decision making.
45. These guidelines apply to relationships between physicians and all commercial organizations, including but not limited to manufacturers of medical devices, nutritional products and health care products as well as service suppliers.
46. Physicians should not dispense pharmaceuticals or other products unless they can demonstrate that these cannot be provided by an appropriate other party, and then only on a cost-recovery basis.
47. Physicians should not invest in industries or related undertakings if this might inappropriately affect the manner of their practice or their prescribing behaviour.
48. Practising physicians affiliated with pharmaceutical companies should not allow their affiliation to influence their medical practice inappropriately.
49. Practising physicians should not accept a fee or equivalent consideration from pharmaceutical manufacturers or distributors in exchange for seeing them in a promotional or similar capacity.
50. Practising physicians may accept patient teaching aids appropriate to their area of practice provided these aids carry at most the logo of the donor company and do not refer to specific therapeutic agents, services or other products.
Medical Students and Residents
51. The principles in these guidelines apply to physicians-in training as well as to practising physicians.
52. Medical curricula should deal explicitly with the guidelines by including educational sessions on conflict of interest and physician-industry interactions.
The legalization of medical assistance in dying (MAiD) raises a host of complex ethical and practical challenges that have implications for both policy and practice. The CMA supports maintaining the balance between three equally legitimate considerations: respecting decisional autonomy for those eligible Canadians who are seeking access, protecting vulnerable persons through careful attention to safeguards, and creating an environment in which practitioners are able to adhere to their moral commitments.
Recognizing the educational, legislative, regulatory and practice changes that will result, the CMA recommends that legislative and regulatory processes be coordinated at the federal and provincial/territorial levels to consistently guide health systems, practitioners and patients. To that end, the CMA calls for rigorous information gathering at all levels and for experience with and research on the impacts of this new practice to be reported as it unfolds. The CMA encourages medical schools to incorporate reflective training opportunities at the undergraduate and postgraduate levels that address all aspects of medical practice that might be affected by this new intervention. Further, CMA recognizes the opportunity that exists for all health systems and practitioners to facilitate effective patient access to information about all end-of-life care options.
The CMA acknowledges the importance of understanding that other acts within the realm of end-of-life care are distinct from the practice of medical assistance in dying. Further, the provision of specific assessments for eligibility to access medical assistance in dying is a distinct service unrelated to consultations for general palliative end-of-life care.
It is important that physicians be aware of this distinction and the relationship between legal, medical and ethical norms with respect to medical assistance in dying. The judicial and legislative branches of government have made changes to Canadian law in this area. Society has placed assistance in dying within the realm of regulated medical practitioners. Physicians' ethical norms and duties, arising from long-standing traditions that entail moral commitments to preserve and protect life, have not changed. The CMA supports the right of all physicians to follow their conscience when deciding whether to provide or otherwise participate in assistance in dying as per the legislation governing medical assistance in dying. The CMA equally supports conscientious participation in and conscientious objection to assistance in dying by physicians.
SCOPE OF POLICY
This policy aims to provide guidance on key considerations in a way that is consistent with a physician's ethical, professional and legal obligations. Physicians should be aware of the federal and provincial laws in the jurisdiction in which they practise, the standards and expectations outlined by their respective regulatory authority, advice from the Canadian Medical Protective Association as well as the policies and procedures of the setting(s) in which they practise (e.g., regional health authority or hospital).
RELEVANT FOUNDATIONAL CONSIDERATIONS
The following considerations underpin the CMA's position on what ought to constitute the basis of any evolving legislation, regulation or guideline on the implementation of medical assistance in dying. These considerations are not ranked according to priority or importance. As with any foundational considerations, they provide a starting point for ethical reflection, and their application requires further thought and interpretation when conflicts arise.
1. Respect for autonomy: The CMA upholds the importance of respect for decisional autonomy by competent patients - such persons are free to make informed choices and autonomous decisions about their bodily integrity, their personal aims and their care that are consistent with their personal values and beliefs. CMA also asserts that persons have inherent dignity regardless of their circumstances. Services ought to be delivered, and processes and treatments ought to be applied, in ways that strive to preserve and enhance dignity. End-of-life care strives to maintain the integrity of personhood even as bodily functions deteriorate in advance of death.
2. Respect for vulnerability: In consideration of the importance of a patient's decision regarding medical assistance in dying, and the permanence of death if medical assistance in dying is chosen by a patient, the CMA believes that careful and non-judgmental exploration with patients of the reasons they are seeking assistance in dying is always warranted. Care in this regard assists physicians to fulfill the duty to ensure that conditions of vulnerability have been identified and addressed satisfactorily. Physicians should maintain diligent attention to identifying undue coercive influences on the patient. Legislation and regulations, through a carefully designed and monitored system of safeguards, should aim to minimize harm to all patients and should also address issues of vulnerability and potential coercion.
3. Respect for freedom of conscience: The CMA believes that physicians must be able to follow their conscience without discrimination when deciding whether or not to provide or participate in assistance in dying. The CMA supports physicians who, for reasons of moral commitments to patients and for any other reasons of conscience, will not participate in decisional guidance about, eligibility assessments for, or provision of medical assistance in dying. To enable physicians to adhere to such moral commitments without causing undue delay for patients pursuing this intervention, health systems will need to implement an easily accessible mechanism to which patients can have direct access. Further, the CMA believes that physicians' general employment or contract opportunities should not be influenced by their decisions to participate in, or not participate in, any or all aspects of medical assistance in dying with patients. The right of patients to seek medical assistance in dying does not compel individual physicians to provide it. Learners should be equally free to follow their conscience without risk to their evaluations and training advancement.
4. Accountability: Physicians providing or otherwise participating in assistance in dying must ensure they have the requisite training and the appropriate competencies, and the ability to assess a patient's decisional capacity or the ability to consult with a colleague to assess capacity in more complex situations. Physicians are expected to use appropriate medical judgment to make a determination of eligibility by (1) assessing the capacity of an adult to consent to the termination of life and (2) determining whether the patient has explored their options (and the putative impacts of any of the options). If the patient wishes to continue seeking medical assistance in dying, physicians are expected to use appropriate medical judgment to determine whether s/he meets the eligibility criteria as per the legislation governing medical assistance in dying. This ought to be a shared decision, and it should be made as part of a deliberative process in the context of the patient-physician relationship. The CMA encourages physicians to participate in accountability processes within their jurisdictions that ensure equitable access to all end-of-life options, including palliative and end-of-life care provided by skilled practitioners, in service of their patients' needs and values. To that end, the CMA believes that a federal oversight body and reporting regime should be established to ensure that all processes are followed.
ADDITIONAL CONSIDERATIONS: PHYSICIAN DUTIES
5. Duty of non-abandonment: Physicians have an obligation to respond to a request for assistance in dying, regardless of how their moral commitment is expressed. Patients should never be abandoned and must always be supported by their physician and other members of their care team. The patient's physician ought to explore the reasons motivating the request and be sensitive to issues of culture and background throughout the dying process, regardless of the decisions the patient makes with respect to assistance in dying. There should be no undue delay in providing access to assistance in dying and all other end-of-life options, either from a clinical, system or facility perspective. For those who choose to provide assistance in dying, the duty of non-abandonment means that physicians have a duty to be available to patients during the act of ending their life. Physicians should be present or immediately available to manage any unexpected complications during the medical procedure, whether the chemical administration is done by the patient or by a regulated practitioner.
6. Duty to support interdisciplinary teams: The CMA advocates that physicians work within, and support other members of, interdisciplinary teams, pay close attention to the impacts of participation and non-participation in medical assistance in dying on their non-physician colleagues, and demonstrate solidarity with their team members as they navigate new legal and ethical territory together.
7. Duty to learners: The CMA recognizes the importance of unique moral considerations within learning environments. Learners are encouraged to reflect on their moral understanding of and views about assistance in dying and to seek a wide range of views and experiences from their patients and from their teachers and colleagues.
ADDRESSING ADHERENCE TO MORAL COMMITMENTS
CMA's position on conscientious participation and conscientious objection aims to harmonize two legitimate considerations: (1) effective patient access to a legally permissible medical service and (2) protection of physicians' freedom of conscience (or moral integrity) in a way that respects differences of conscience.
a. The CMA believes that physicians are not obligated to fulfill a patient's request for assistance in dying but that all physicians are obligated to respond to a patient's request. This means that physicians who choose not to provide or otherwise participate in assistance in dying are:
i. not required to provide it, or to otherwise participate in it, or to refer the patient to a physician or a medical administrator who will provide assistance in dying to the patient; but
ii. are still required to fulfill their duty of non-abandonment by responding to a patient's request for assistance in dying.
There should be no discrimination against a physician who chooses not to provide or otherwise participate in assistance in dying.
b. The CMA believes that physicians are obligated to respond to a patient's request for assistance in dying in a timely fashion. This means that physicians are obligated to, regardless of their beliefs:
i. provide the patient with complete information on all options available, including assistance in dying;
ii. advise the patient on how to access any separate central information, counselling and referral service; and
iii. transfer care of the patient to another physician or another institution, if the patient requests it, for the assessment and treatment of the patient's medical condition and exploration of relevant options. If relevant, such options may include palliative care, mental health care and, if the patient meets the eligibility criteria, provision of assistance in dying. The duty of non-abandonment still applies in all other aspects of the patient's care.
c. Physicians are expected to make available relevant medical records (i.e., diagnosis, pathology, treatment and consults) to the physician accepting care of the patient when authorized by the patient to do so.
d. Physicians are expected to act in good faith. They are expected to never abandon or discriminate against a patient requesting assistance in dying and to not impede or block access to a request for assistance in dying. Physicians should inform their patients of the fact and implications of their conscientious objection. No physician may require a patient to make a commitment not to seek assistance in dying as a condition of acceptance or retention of the patient.
WHAT MEDICAL ASSISTANCE IN DYING (MAID) ENCOMPASSES
1. Medical assistance in dying encompasses the assessment of a patient for eligibility for assistance in dying, deliberation with the patient, accompaniment of the patient through the process of deciding and, if so chosen by the patient, the provision of assistance in dying, which refers to:
a. The administering by a medical practitioner or nurse of a substance to a person, at their request, that causes their death; or
b. The prescribing or providing by a medical practitioner or nurse practitioner of a substance to a person, at their request, so that they may self-administer the substance and in doing so cause their death.
2. The Supreme Court of Canada in Carter used the terms physician-assisted dying and physician-assisted death.
These terms refer to both of the following:
a. Voluntary euthanasia, or physician-administered assistance in dying:
The physician takes the final act that will end the individual's life via, usually, the intravenous administration of a lethal substance, at the request and with the consent of a patient
b. Assisted suicide, or physician-prescribed, self-administered assistance in dying:
An individual performs the final act to end their life by, usually, ingesting a lethal substance prescribed or provided by the physician, at the request and with the consent of the patient.
3. Other commonly used terms are hastened death, physician-administered hastened death and physician-prescribed, patient-administered hastened death.
a. These terms are proposed to make a clear distinction between palliative care and other practices that hasten or bring about death, such as through the legitimate removal of life-sustaining interventions or via the provision or administration of chemicals.
4. Medical aid in dying has a distinct technical and legal meaning within Quebec, described in Bill 52, and is limited to physicians administering the lethal substance at the request of the individual.
WHAT IT DOES NOT ENCOMPASS
1. Palliative care is an integrated approach that aims to relieve suffering and improve the quality of life of those facing life-limiting acute or chronic conditions by means of early identification, assessment and treatment of pain and other symptoms.
2. Continuous palliative sedation therapy1 refers to complete sedation, with the intent of rendering the patient unable to experience the environment, sensation or thoughts, until the patient dies naturally from the underlying illness.
3. Withdrawing or withholding treatment or treatment cessation refers to withdrawing or withholding life-prolonging treatment where it is no longer indicated or desired.
4. Voluntary refusal of hydration and nutrition is the conscious and active choice to refuse and to discontinue food and fluid, orally or parenterally, with the intention of hastening death.
Approved by the CMA Board of Directors May 2017
1 Consensus statement on continuous palliative sedation therapy: www.chpca.net/media/343120/final_cpst_framework.pdf.
Medical professionalism (Update 2005)
The environment in which medicine is practised in Canada is undergoing rapid and profound change. There are now continued opportunities for the medical profession to provide leadership for our patients, our communities and our colleagues through strengthened professionalism. The Canadian Medical Association (CMA) is strongly committed to medical professionalism and has developed this policy both to inform physicians and others about its meaning and value and to promote its preservation and enhancement. This document outlines the major features of medical professionalism, the opportunities which exist in this area and the challenges which lie before us.
Why Medical Professionalism?
The medical profession is characterized by a strong commitment to the well-being of patients, high standards of ethical conduct, mastery of an ever-expanding body of knowledge and skills, and a high level of clinical independence. As individuals, physicians' personal values may vary, but as members of the medical profession they are expected to share and uphold those values that characterize the practice of medicine and the care of patients.
Medical professionalism includes both the relationship between a physician and a patient and a social contract between physicians and society. Society grants the profession privileges, including exclusive or primary responsibility for the provision of certain services and a high degree of self-regulation. In return, the profession agrees to use these privileges primarily for the benefit of others and only secondarily for its own benefit. Three major features of medical professionalism - the ethic of care, clinical independence and self-regulation - benefit physicians, their patients and society:
Ethic of care: This is characterized by the values of compassion, beneficence, nonmaleficence, respect for persons and justice (CMA's Code of Ethics). Society benefits from the ethic of care whereby, in the provision of medical services, physicians put the interests of others ahead of their own. Dedication and commitment to the well-being of others is clearly in the interests of patients, who are the primary beneficiaries.
Clinical independence: Medicine is a highly complex art and science. Through lengthy training and experience, physicians become medical experts and healers. Whereas patients have the right to decide to a large extent which medical interventions they will undergo, they expect their physicians to be free to make clinically appropriate recommendations. Although physicians recognize that they are accountable to patients, funding agencies and their peers for their recommendations, unreasonable restraints on clinical autonomy imposed by governments and administrators, whether public or private, are not in the best interests of patients, not least because they can damage the trust that is an essential component of the patient-physician relationship. Conversely, physicians are not morally obliged to provide inappropriate medical services when requested by patients despite their respect for patient autonomy.
Self-regulation: Physicians have traditionally been granted this privilege by society. It includes the control of entrance into the profession by establishing educational standards and setting examinations, the licensing of physicians, and the establishment and ongoing review of standards of medical practice. In return for this privilege, physicians are expected to hold each other accountable for their behaviour and for the outcomes they achieve on behalf of their patients. Self-regulation is exercised by many different professional organizations, from medical practice partnerships to the statutory provincial/territorial licensing bodies. It has evolved into a partnership with the public. Self-regulation benefits society by taking the best advantage of the professional expertise needed to appropriately set and maintain standards of training and practice, while providing suitable accountability in matters of professional behaviour. The profession's commitment to the maintenance of those standards is demonstrated by its willingness to participate in outcomes review at many levels, from institutional quality assurance activities to formal prospective peer review, and to actively support their statutory and legislated licensing authorities.
Opportunities in Medical Professionalism
Over the past few years much has been written about the issue of medical professionalism in both the lay and scientific media. The practice of medicine has changed considerably, and with these changes have come challenges but also opportunities. The medical profession continues to be a greatly respected one, and it is still generally seen as being distinct from many others because of the unique nature of the physician-patient relationship. There exists now an opportunity to reinforce the professional values and priorities that have sustained medicine for so long, and to embrace new approaches which will serve it well in the years to come.
Medical professionals must recognize that patients have a wide variety of resources available for their health care needs, from traditional physician services to paramedical practitioners, to complementary medicine and to information obtained from the internet. While maintaining responsibility for care of the patient as a whole, physicians must be able to interact constructively with other health care providers within an interdisciplinary team setting, and must be able to interpret information for patients and direct them to appropriate and accurate resources.
The relationship of physicians with their colleagues must be strengthened and reinforced. Patient care benefits when all health care practitioners work together towards a common goal, in an atmosphere of support and collegiality.
Although there are some challenges to professionalism, as outlined below, the greatest opportunity before us may be to remind physicians of the reasons they chose a career in medicine to begin with - for many, it is a calling rather than a job. In spite of the numerous recent changes in the health care system and the practice of medicine, the primary reason most physicians entered the field remains the same - the sanctity of the fiduciary relationship between physicians and their patients. The renewal of medical professionalism must be led from within the profession itself, and the CMA and its members are in a unique position to take advantage of the many opportunities which exist and to respond to the challenges we face.
Challenges to Medical Professionalism
Medical professionalism is being challenged from within and without. These challenges arise from pressures that may serve to undermine the ethic of care, clinical independence and self-regulation and may result, for individual physicians and the medical profession, in diminished morale and changes in lifestyle and practice patterns. These changes may have a detrimental impact on the health of physicians, and also on the quality of patient care.
Resource restraints: The CMA has identified scarcity of resources, whether human or material, as undermining the ability of physicians to maintain excellence in clinical care, research and teaching. Although much attention has been paid recently to the insufficient number of physicians in Canada, and although recent developments indicate some limited cause for optimism, much work remains to be done. Issues of access to continuing professional development, workforce sustainability, inadequate numbers of training positions for new doctors, the integration of foreign-trained physicians into the workforce and the apparent inability of governments to resolve inadequacies in health care funding continue to frustrate physicians' attempts to achieve their professional goals and care for their patients. These factors all have the potential for contributing to the decline of professional morale.
Bureaucratic challenges: This refers to the introduction of layers of management and policy directives between the physician and the patient. It is a result of changes that have taken place in the organization and delivery of medical care, especially the involvement of governments in all aspects of health care. The traditional one-on-one relationship of physician and patient is now set within a context of government and corporate interests, in which the physician may sometimes assume the status of an employee, that pose considerable challenges to the exercise of the professional values of clinical autonomy and self-regulation. Moreover, while the responsibility for organizing the delivery of scarce resources has been increasingly transferred from physicians to managers, physicians are still ultimately responsible, both morally and legally, for providing quality care. Although the increasing complexity of health care delivery requires recourse to sophisticated management systems, there is a danger that as physicians become increasingly answerable to or constrained by third parties, their ability to fulfill their commitment to their individual patients can be seriously compromised.
Unprofessional conduct: Some physicians do not uphold the values of the profession. A few put their interests or the interests of third parties ahead of the interests of their patients. The profession needs to meet this challenge by demonstrating its ability to uphold its values and its commitment to doing so. Supporting strong and transparent self-regulatory systems will be a key component of this endeavor.
Commercialism: In recent years the market mentality has expanded its influence to many areas formerly outside its domain, including governments, universities and the professions. Health care has become a major industry, one in which physicians play a central role, and commercial interests, whether private or public, may pressure physicians to compromise their responsibilities to their patients, research subjects and society. The potential for physicians and medical associations to become drawn into conflict-of-interest situations is increasing. Commercialism may compromise both the ethic of care and clinical independence by its reinterpretation of medical care as a commodity and the patient-physician relationship as something less than a fiduciary relationship. There is an inherent opportunity for the profession to address the issue of conflict of interest and to re-affirm its primary obligation and dedication to the patients it cares for.
Consumerism: Physicians strongly support the right of patients to make informed decisions about their medical care. However, the CMA's Code of Ethics requires physicians to recommend only those diagnostic and therapeutic procedures that they consider to be beneficial to the patient or to others. There is a proliferation of health information and advertising in the popular media and on the Internet that may be inaccurate or poorly understood. Taken to its extreme, consumerism can be detrimental not just to professionalism but to the well-being of patients and the interests of society.
Industrialization: This refers to the increased division and specialization of labour in the delivery of health care, whereby the delivery of health care may become fragmented. There is increasing pressure within medicine to improve efficiency and optimize cost savings. While these may be important goals in the broader context of health care, we must ensure that they do not impact negatively on the doctor-patient relationship.
Realizing Opportunities and Dealing with Challenges
Individual physicians should protect, enhance and promote professionalism in medicine by reflecting the values of the medical profession in their practice and by contributing to the efforts of organized medicine to maintain and enhance the ethic of care, clinical autonomy and self-regulation. These efforts require action in 3 areas: policy, education and self-regulation.
Policy: All those involved in health care - physicians, patients, other health care providers, administrators, governments and the general public (as taxpayers, potential patients, relatives of patients, etc.) - should be informed about the values of the medical profession and where it stands on issue related to accountability, clinical autonomy and self-regulation. Policies of medical associations should reflect these values and should speak clearly on topics such as conflict of interest. Policies should be reviewed frequently and updated when necessary, in order to take account of the rapidly changing environment in which medicine is practiced. The topic of professionalism should be granted increasing importance in policy discussions. Policies should be developed and updated in related areas, such as conflict of interest and physician-industry interactions.
In order to be consistent and trustworthy, medical associations should adhere to the same high standards of behaviour that they require of individual physicians. The challenges posed by resource restraints, bureaucratization, unprofessional conduct, commercialism and consumerism are no less serious for associations than for individuals and require sound harmonized policies for both. The CMA has an opportunity for leadership in this regard.
Education: However professional values and policies are established, they must be transmitted to current and future members of the profession in order to have any effect.
Like most other aspects of medical education, the values of professionalism are both taught and modeled. Professionalism should be an essential component of the formal medical curriculum at the undergraduate and postgraduate training levels. Moreover, active demonstration of professionalism such as role modeling by physicians, and in the internal culture of the medical schools and hospitals where students receive their training, should be used to advantage and challenged when necessary. Likewise for physicians in practice, formal continuing professional development programs and role modeling by other physicians are important for the maintenance of professionalism.
Physicians need to communicate and test their understanding of their professional role with others involved in patient care at numerous levels. Such initiatives, which would engage patients, other professionals and policy-makers, require further development.
The CMA and other medical organizations have taken leadership roles in assisting patients and health care providers in making informed decisions by creating numerous continuing professional development opportunities and readily available clinical information for physicians, effective patient education materials, self-help books and validated Web sites, including www.cma.ca. These efforts need to continue and be strengthened.
Self-regulation: In order to maintain self-regulation in an environment that is increasingly suspicious of such privileges, the medical profession has to demonstrate that self regulation benefits society in general. This requires, among other things, that the medical profession continue to demonstrate its commitment to the tasks required by self-regulation, including setting and enforcing high standards of behaviour for both individual physicians and medical associations.
Physicians continue to value medical professionalism highly. They believe that it benefits patients greatly and that it should be preserved and enhanced. Professionalism will continue to be based on the relationship of trust between patients and physicians, and the primacy of the physician-patient relationship. It encompasses the values of compassion, beneficence, nonmaleficence, respect for persons and justice. As professionals, physicians will strive to maintain high standards of ethics, clinical practice and education and demonstrate a capacity for social responsibility through self-regulation and accountability (see CMA Policy Statement The Future of Medicine).
The CMA welcomes opportunities to engage in dialogue with others as to how professionalism in health care can be preserved and enhanced for the benefit of patients, physicians and society in general.
Organ and Tissue Donation and Transplantation (OTDT) is a rapidly changing area of medical science and practice. Organ and tissue transplantations represent significant lifesaving and life-enhancing interventions that require careful consideration by multiple stakeholders spanning medical disciplines. Technological and pharmacological advancements have made organ and tissue transplantation increasingly viable for treating related medical conditions. Changing social norms have also led to shifting perceptions of the acceptability of organ and tissue donation. Within this context, there is a need for renewed consideration of the ethical issues and principles guiding organ and tissue donation and transplantation in Canada.
The overarching principle that guides OTDT is public trust, which requires that the expressed intent either for or against donation will be honoured and respected within the donation and medical systems, and that the best interests of the potential donor are always of paramount importance; policies and mechanisms that guide OTDT should aim to maintain and foster that public trust. The CMA acknowledges and respects the diverse viewpoints, backgrounds, and religious views of physicians and patients and therefore encourages physicians to confront challenges raised by OTDT in a way that is consistent with both standards of medical ethics and patients’ values and beliefs.
This policy identifies foundational principles to address the challenges surrounding deceased and living donation. In conjunction with applicable laws and regulations in Canada, the Declaration of Istanbul, the World Health Organization (WHO) Guiding Principles on Human Cell, Tissue and Organ Transplantation, and leading clinical practices this policy aims to inform physicians and other interested parties on the guiding principles of OTDT in Canada. This policy is intended to address OTDT in adult populations; the challenges, considerations, legislation, and policy surrounding pediatric and neonatal OTDT are unique and deserve focused attention.
Physicians should be aware of relevant legislation, regulatory requirements, and policies in the jurisdiction in which they practice. Physicians are encouraged to refer to the various Canadian specialty societies that deal directly with OTDT for up-to-date information and policy, as well as innovative techniques and approaches.
The practice of OTDT is of great value to patients and society. The CMA supports the continued development of greater capacity, efficiency, and accessibility in OTDT systems in co-ordination with comprehensive and compassionate end-of-life care for Canadians while acknowledging the importance of justice, informed consent, beneficence, and confidentiality to this practice.
There is a continuous need to improve the efficiency and effectiveness of OTDT in an effort to narrow the gap between demand and supply in what remains a scarce, lifesaving resource. The principle of justice should continue to guide the equitable allocation of organs and tissues in a manner that is externally justifiable, open to public scrutiny, and balances considerations of fairness (e.g., medical need or length of time on the wait-list) with medical utility (e.g., transplantation success). There should be no discrimination based on social status or perceived social worth. Lifestyle or behavioral factors should only be considered when clear evidence indicates that those factors will impact the medical probability of success. OTDT should also not rely on the patient’s ability to pay; such actions are inconsistent with the principles that underlie Canada’s publicly-funded health system. Of note, living donation to a loved one or acquaintance (via a directed donation) is regarded as ethically acceptable if potential donors are informed of all options, including that of donating in a non-directed fashion.
All levels of government should continue to support initiatives to improve the OTDT system, raise public awareness through education and outreach campaigns, and fund ongoing research, such that any Canadian who may wish to donate their tissues or organs are given every reasonable opportunity to do so. Potential donor identification and referral, while legislated in many jurisdictions, is an important area of continued development as failure to identify donors deprives families of the opportunity to donate and deprives patients of potential transplants.
To diminish inequities in the rates of organ donation between jurisdictions, federal and provincial governments should engage in consultations with a view to implementing a coordinated, national strategy on OTDT that provides consistency and clarity on medical and legal standards of informed consent and determination of death, and institutes access to emerging best practices that support physicians, providers, and patients. Efforts should be made to ensure adequate engagement with potential donors from communities that have historically had lower living donor rates to help reduce inequities in access to living donation. Policymakers should also continue to explore and appraise the evidence on policy interventions to improve the rates of organ donation in Canada – for example, see a brief overview of opt-in vs. opt-out donation systems in the background to this policy.
2. INFORMED CONSENT AND VOLUNTARINESS
Organ and tissue donation must always be an autonomous decision, free of undue pressure or coercion. By law, the potential organ donor, or their substitute decision-maker, must provide informed consent. Physicians should direct patients to appropriate resources if that patient has expressed interest to become a donor after their death. If a potential donor has not made an expression of intent for or against donation, substitute decision-makers, families, or loved ones may be approached to provide authorization for donation. It should also be noted that consent indicates a willingness to donate, but that donation itself hinges on factors such as medical suitability and timing.
End-of-life decisions must be guided by an individual's values and religious or philosophical beliefs of what it means to have a meaningful life and death. The autonomy of an individual should always be respected regarding their wish, intent, or registered commitment to become a donor after death. Input from family and loved-ones should always be considered in the context of the potential donor’s wishes or commitments – these situations must be handled on a case-by-case basis with respect for cultural and religious views while maintaining the autonomously expressed wishes of the potential donor. Physicians should make every reasonable effort to be aware and considerate of the cultural and religious views of their patients as they pertain to OTDT. Likewise, Canadian medical schools, relevant subspecialties, and institutions should provide training and continuing professional development opportunities on OTDT, including both medicolegal implications and cultural competency.
To protect the voluntariness of the potential donor’s decision, public appeals to encourage altruistic donation should not seek to compensate potential donors through payment and should not subvert established systems of organ allocation. Any exploitation or coercion of a potential donor must be avoided. However, remuneration from officially sanctioned sources for the purpose of reimbursement of costs associated with living donation (e.g., transfer to another location or lost wages during the procedure), may be considered when no party profits financially from the exchange. The CMA supports proposed amendments to the Criminal Code and the Immigration and Refugee Protection Act that criminalizes or otherwise seeks to prevent the coercive collection and transplantation of organs domestically and internationally (i.e., organ trafficking – see relevant guidelines on trafficking ). The CMA also discourages Canadians from participating in organ tourism as either a recipient or donor; physicians should not take part in transplantation procedures where it is reasonable to suspect that organs have been obtained without the donor’s informed consent or where the donor received payment (from WHO Guiding Principle 7); however, in accordance with physicians’ commitment to the well-being of the patient and the professional responsibilities relating to the patient-physician relationship in the CMA Code of Ethics and Professionalism, physicians have an obligation to treat a post-tranplant patient if requested after the patient has participated in organ tourism; physicians should be aware of any legal or regulatory obligations they may have to report a patient’s organ tourism to national authorities, taking into consideration their duties of privacy and confidentiality to the patient. ,
3. BALANCING BENEFICENCE AND NON-MALEFICENCE
Balancing beneficence and non-maleficence means to: Consider first the well-being of the patient; always act to benefit and promote the good of the patient; provide appropriate care and management across the care continuum; take all reasonable steps to prevent or minimize harm to the patient; disclose to the patient if there is a risk of harm or if harm occurs; recognize the balance of potential benefits and harms associated with any medical act; and act to bring about a positive balance of benefits over harms.
Prospective donors can benefit from the knowledge that they can potentially save lives after their own deaths. However, potential donors must not be harmed by the act of donating. In accordance with the Dead Donor Rule, organ or tissue procurement should never be the cause of death. Moreover, the care of the dying patient must never be compromised by the desire to protect organs for donation or expedite death to allow timely organ retrieval. Physicians determining that a potential donor has died should not be directly involved in tissue or organ removal from the donor or subsequent transplantation procedures, nor should they be responsible for the care of any intended recipients of such tissues and organs (from WHO Guiding Principle 2). Leading clinical criteria, in conjunction with legally prescribed definitions of death and procedures, should inform the determination of death before donation procedures are initiated.
DCD should be practiced in compliance with the regulations of individual transplant centers, relevant legislation, and leading Canadian clinical guidelines including the national recommendations for donation after cardiocirculatory death in Canada and the guidelines for the withdrawal of life-sustaining measures. Patients undergoing medical assistance in dying (MAiD) may also be eligible for organ and tissue donation – see relevant policy guidelines.
Living donors are motivated to act primarily for the benefit of the recipient. The perceived acceptability of living donation varies from person to person; living donation is deemed to be ethically acceptable when the potential benefits outweigh the potential risks of living donation; living donation is not ethically acceptable where there is a material risk of death of the donor; living donors must provide informed consent, meet medical and psychological requirements, and receive appropriate follow-up care. It is not necessary for the potential donor to be biologically or emotionally related to the recipient.
4. CONFIDENTIALITY AND PRIVACY
Current practice protects the privacy of both donor and recipient and does not allow donation teams, organ donation organizations, or transplant teams to inform either party of the other’s identity. The continuation of this practice is encouraged at the present time to protect the privacy of both donors and recipients. In addition, healthcare providers should consider the privacy and confidentiality implications of practices employed throughout the assessment and post-operative periods – patient consent should be obtained for practices involving any loss of privacy or confidentiality (e.g. group education sessions, etc.).
A person’s choice about whether or not they intend to donate organs and tissues after their death is individual and, like other health-related information, should be considered private. The right to privacy regarding personal health information extends beyond the declaration of death.
Whenever possible, potential donor and recipients should be cared for and evaluated by separate medical teams. In the case of non-directed donations, it may be necessary for information to be shared between donor and recipient teams (e.g. recipient’s underlying disease and risk for recurrence); however, such information should be limited to what is necessary for making an informed choice. Conversely, the CMA recognizes that the choice and process of directed donation is one that is deeply personal, which is likely to result in the intersection of both donor and recipient pathways of care. In such cases, the same onus of confidentiality may not apply given the choices of the donor and recipient involved.
Approved by the CMA Board of Directors December 2019