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.
Authorizing Cannabis for Medical Purposes
The legalization of cannabis for recreational purposes came into effect with the Cannabis Act in October 2018, and patients continue to have access to cannabis for therapeutic purposes. The Cannabis Regulations have replaced the Access to Cannabis for Medical Purposes Regulations. Patients can obtain cannabis for medical purposes when a physician or nurse practitioner provides a “medical document” , authorizing its use, and determining the daily dried cannabis dose in grams.
With the authorization, patients have the choice whether to (a) buy directly from a federally licensed producer; (b) register with Health Canada to produce a limited amount for personal consumption; (c) designate someone to produce it for them; or (d) buy cannabis at provincial or territorial authorized retail outlets or online sales platforms, if above the legal age limit.
While acknowledging the unique requirements of patients suffering from a terminal illness or chronic disease for which conventional therapies have not been effective and for whom cannabis may provide relief, physicians remain concerned about the serious lack of clinical research, guidance and regulatory oversight for cannabis as a medical treatment. There is insufficient clinical information on safety and efficacy for most therapeutic claims. There is little information around therapeutic and toxic dosages and knowledge on interactions with medications. Besides the need for appropriate research, health practitioners would benefit from unbiased, accredited educational modules and decision support tools based on the best available evidence.
The Canadian Medical Association has consistently expressed concern with the role of gatekeeper that physicians have been asked to take as a result of court decisions. Physicians should not feel obligated to authorize cannabis for medical purposes.
Physicians who choose to authorize cannabis for their patients must comply with their provincial or territorial regulatory College's relevant guideline or policy. They should also be familiar with regulations and guidance, particularly:
Health Canada’s Information for Health Care Practitioners – Medical Use of Cannabis (monograph, summary and daily dose fact sheet),
the Canadian Medical Protective Association’s guidance;
the College of Family Physicians of Canada’s preliminary guidance Authorizing Dried Cannabis for Chronic Pain or Anxiety; and
the Simplified guideline for prescribing medical cannabinoids in primary care, published in the Canadian Family Physician.
The CMA recommends that physicians should:
Ensure that there is no conflict of interest, such as direct or indirect economic interest in a licensed cannabis producer or be involved in dispensing cannabis;
Treat the authorization as an insured service, similar to a prescription, and not charge patients or the licensed producer for this service;
Until such time as there is compelling evidence of its efficacy and safety for specific indications, consider authorizing cannabis only after conventional therapies are proven ineffective in treating patients’ conditions;
Have the necessary clinical knowledge to authorize cannabis for medical purposes;
Only authorize in the context of an established patient-physician relationship;
Assess the patient’s medical history, conduct a physical examination and assess for the risk of addiction and diversion, using available clinical support tools and tests;
Engage in a consent discussion with patients which includes information about the known benefits and adverse health effects of cannabis in its various forms (e.g., edibles), including the risk of impairment to activities such as driving and work;
Advise the patient regarding harm reduction strategies and the prevention of accidental exposure for children and other people;
Document all consent discussions in patients' medical records;
Reassess the patient on a regular basis for its effectiveness to address the medical condition for which cannabis was authorized, as well as for addiction and diversion, to support maintenance, adjustment or discontinuation of treatment; and
Record the authorization of cannabis for medical purposes similar to when prescribing a controlled medication.
The Cannabis Regulations provide some consistency with many established provincial and territorial prescription monitoring programs for controlled substances. Licensed producers of cannabis for medical purposes are required to provide information to provincial and territorial medical licensing bodies upon request, including healthcare practitioner information, daily quantity of dried cannabis supported, period of use, date of document and basic patient information. The Minister of Health can also report physicians to their College should there be reasonable grounds that there has been a contravention of the Narcotic Control Regulations or the Cannabis Regulations.
Approved by CMA Board February 2015
Latest update approved by CMA Board in February 2020
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.
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
CMA CODE OF ETHICS AND PROFESSIONALISM
A compassionate physician recognizes suffering and vulnerability, seeks to understand the unique circumstances
of each patient and to alleviate the patient’s suffering, and accompanies the suffering and vulnerable patient.
An honest physician is forthright, respects the truth, and does their best to seek, preserve, and communicate
that truth sensitively and respectfully.
A humble physician acknowledges and is cautious not to overstep the limits of their knowledge and skills or the
limits of medicine, seeks advice and support from colleagues in challenging circumstances, and recognizes the
patient’s knowledge of their own circumstances.
A physician who acts with integrity demonstrates consistency in their intentions and actions and acts in a
truthful manner in accordance with professional expectations, even in the face of adversity.
A prudent physician uses clinical and moral reasoning and judgement, considers all relevant knowledge
and circumstances, and makes decisions carefully, in good conscience, and with due regard for principles of
exemplary medical care.
The CMA Code of Ethics and Professionalism articulates the ethical and professional commitments and responsibilities of the
medical profession. The Code provides standards of ethical practice to guide physicians in fulfilling their obligation to provide
the highest standard of care and to foster patient and public trust in physicians and the profession. The Code is founded on
and affirms the core values and commitments of the profession and outlines responsibilities related to contemporary medical
In this Code, ethical practice is understood as a process of active inquiry, reflection, and decision-making concerning what
a physician’s actions should be and the reasons for these actions. The Code informs ethical decision-making, especially in
situations where existing guidelines are insufficient or where values and principles are in tension. The Code is not exhaustive;
it is intended to provide standards of ethical practice that can be interpreted and applied in particular situations. The Code and
other CMA policies constitute guidelines that provide a common ethical framework for physicians in Canada.
In this Code, medical ethics concerns the virtues, values, and principles that should guide the medical profession, while
professionalism is the embodiment or enactment of responsibilities arising from those norms through standards,
competencies, and behaviours. Together, the virtues and commitments outlined in the Code are fundamental to the ethical
practice of medicine.
Physicians should aspire to uphold the virtues and commitments in the Code, and they are expected to enact the professional
responsibilities outlined in it.
Physicians should be aware of the legal and regulatory requirements that govern medical practice in their jurisdictions.
Trust is the cornerstone of the patient–physician relationship and of medical professionalism. Trust is therefore
central to providing the highest standard of care and to the ethical practice of medicine. Physicians enhance
trustworthiness in the profession by striving to uphold the following interdependent virtues:
A. VIRTUES EXEMPLIFIED BY THE ETHICAL PHYSICIAN
B. FUNDAMENTAL COMMITMENTS OF THE MEDICAL PROFESSION
Consider first the well-being of the patient; always act to benefit the patient 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 has occurred.
Recognize the balance of potential benefits and harms associated with any medical act; act to bring about
a positive balance of benefits over harms.
Commitment to the well-being of the patient
Promote the well-being of communities and populations by striving to improve health outcomes and
access to care, reduce health inequities and disparities in care, and promote social accountability.
Commitment to justice
Practise medicine competently, safely, and with integrity; avoid any influence that could undermine
your professional integrity.
Develop and advance your professional knowledge, skills, and competencies through lifelong learning.
Commitment to professional integrity and competence
Always treat the patient with dignity and respect the equal and intrinsic worth of all persons.
Always respect the autonomy of the patient.
Never exploit the patient for personal advantage.
Never participate in or support practices that violate basic human rights.
Commitment to respect for persons
Contribute to the development and innovation in medicine through clinical practice, research, teaching,
mentorship, leadership, quality improvement, administration, or advocacy on behalf of the profession or
Participate in establishing and maintaining professional standards and engage in processes that support
the institutions involved in the regulation of the profession.
Cultivate collaborative and respectful relationships with physicians and learners in all areas of medicine
and with other colleagues and partners in health care.
Commitment to professional excellence
Value personal health and wellness and strive to model self-care; take steps to optimize meaningful
co-existence of professional and personal life.
Value and promote a training and practice culture that supports and responds effectively to colleagues in
need and empowers them to seek help to improve their physical, mental, and social well-being.
Recognize and act on the understanding that physician health and wellness needs to be addressed at
individual and systemic levels, in a model of shared responsibility.
Commitment to self-care and peer support
Value and foster individual and collective inquiry and reflection to further medical science and to
facilitate ethical decision-making.
Foster curiosity and exploration to further your personal and professional development and insight; be
open to new knowledge, technologies, ways of practising, and learning from others.
Commitment to inquiry and reflection
C. PROFESSIONAL RESPONSIBILITIES
The patient–physician relationship is at the heart of the practice of medicine. It is a relationship of trust that recognizes the
inherent vulnerability of the patient even as the patient is an active participant in their own care. The physician owes a duty of
loyalty to protect and further the patient’s best interests and goals of care by using the physician’s expertise, knowledge, and
prudent clinical judgment.
In the context of the patient–physician relationship:
1. Accept the patient without discrimination (such as on the basis of age, disability, gender identity or expression, genetic
characteristics, language, marital and family status, medical condition, national or ethnic origin, political affiliation, race,
religion, sex, sexual orientation, or socioeconomic status). This does not abrogate the right of the physician to refuse to
accept a patient for legitimate reasons.
2. Having accepted professional responsibility for the patient, continue to provide services until these services are no longer
required or wanted, or until another suitable physician has assumed responsibility for the patient, or until after the
patient has been given reasonable notice that you intend to terminate the relationship.
3. Act according to your conscience and respect differences of conscience among your colleagues; however, meet your
duty of non-abandonment to the patient by always acknowledging and responding to the patient’s medical concerns and
requests whatever your moral commitments may be.
4. Inform the patient when your moral commitments may influence your recommendation concerning provision of, or
practice of any medical procedure or intervention as it pertains to the patient’s needs or requests.
5. Communicate information accurately and honestly with the patient in a manner that the patient understands and can
apply, and confirm the patient’s understanding.
6. Recommend evidence-informed treatment options; recognize that inappropriate use or overuse of treatments or
resources can lead to ineffective, and at times harmful, patient care and seek to avoid or mitigate this.
7. Limit treatment of yourself, your immediate family, or anyone with whom you have a similarly close relationship to
minor or emergency interventions and only when another physician is not readily available; there should be no fee for
8. Provide whatever appropriate assistance you can to any person who needs emergency medical care.
9. Ensure that any research to which you contribute is evaluated both scientifically and ethically and is approved by a
research ethics board that adheres to current standards of practice. When involved in research, obtain the informed
consent of the research participant and advise prospective participants that they have the right to decline to participate
or withdraw from the study at any time, without negatively affecting their ongoing care.
10. Never participate in or condone the practice of torture or any form of cruel, inhuman, or degrading procedure.
Physicians and patients
11. Empower the patient to make informed decisions regarding their health by communicating with and helping the patient
(or, where appropriate, their substitute decision-maker) navigate reasonable therapeutic options to determine the best
course of action consistent with their goals of care; communicate with and help the patient assess material risks and
benefits before consenting to any treatment or intervention.
12. Respect the decisions of the competent patient to accept or reject any recommended assessment, treatment, or plan of
13. Recognize the need to balance the developing competency of minors and the role of families and caregivers in medical
decision-making for minors, while respecting a mature minor’s right to consent to treatment and manage their personal
14. Accommodate a patient with cognitive impairments to participate, as much as possible, in decisions that affect them;
in such cases, acknowledge and support the positive roles of families and caregivers in medical decision-making and
collaborate with them, where authorized by the patient’s substitute decision-maker, in discerning and making decisions
about the patient’s goals of care and best interests.
15. Respect the values and intentions of a patient deemed incompetent as they were expressed previously through advance
care planning discussions when competent, or via a substitute decision-maker.
16. When the specific intentions of an incompetent patient are unknown and in the absence of a formal mechanism for
making treatment decisions, act consistently with the patient’s discernable values and goals of care or, if these are
unknown, act in the patient’s best interests.
17. Respect the patient’s reasonable request for a second opinion from a recognized medical expert.
Physicians and the practice of medicine
Patient privacy and the duty of confidentiality
18. Fulfill your duty of confidentiality to the patient by keeping identifiable patient information confidential; collecting,
using, and disclosing only as much health information as necessary to benefit the patient; and sharing information only
to benefit the patient and within the patient’s circle of care. Exceptions include situations where the informed consent of
the patient has been obtained for disclosure or as provided for by law.
19. Provide the patient or a third party with a copy of their medical record upon the patient’s request, unless there is a
compelling reason to believe that information contained in the record will result in substantial harm to the patient or
20. Recognize and manage privacy requirements within training and practice environments and quality improvement
initiatives, in the context of secondary uses of data for health system management, and when using new technologies in
21. Avoid health care discussions, including in personal, public, or virtual conversations, that could reasonably be seen as
revealing confidential or identifying information or as being disrespectful to patients, their families, or caregivers.
Medical decision-making is ideally a deliberative process that engages the patient in shared decision-making and is informed
by the patient’s experience and values and the physician’s clinical judgment. This deliberation involves discussion with the
patient and, with consent, others central to the patient’s care (families, caregivers, other health professionals) to support
In the process of shared decision-making:
22. Recognize that conflicts of interest may arise as a result of competing roles (such as financial, clinical, research,
organizational, administrative, or leadership).
23. Enter into associations, contracts, and agreements that maintain your professional integrity, consistent with evidenceinformed
decision-making, and safeguard the interests of the patient or public.
24. Avoid, minimize, or manage and always disclose conflicts of interest that arise, or are perceived to arise, as a result of
any professional relationships or transactions in practice, education, and research; avoid using your role as a physician to
promote services (except your own) or products to the patient or public for commercial gain outside of your treatment role.
25. Take reasonable steps to ensure that the patient understands the nature and extent of your responsibility to a third party
when acting on behalf of a third party.
26. Discuss professional fees for non-insured services with the patient and consider their ability to pay in determining fees.
27. When conducting research, inform potential research participants about anything that may give rise to a conflict of
interest, especially the source of funding and any compensation or benefits.
28. Be aware of and promote health and wellness services, and other resources, available to you and colleagues in need.
29. Seek help from colleagues and appropriate medical care from qualified professionals for personal and professional
problems that might adversely affect your health and your services to patients.
30. Cultivate training and practice environments that provide physical and psychological safety and encourage help-seeking
31. Treat your colleagues with dignity and as persons worthy of respect. Colleagues include all learners, health care partners,
and members of the health care team.
32. Engage in respectful communications in all media.
33. Take responsibility for promoting civility, and confronting incivility, within and beyond the profession. Avoid impugning
the reputation of colleagues for personal motives; however, report to the appropriate authority any unprofessional
conduct by colleagues.
34. Assume responsibility for your personal actions and behaviours and espouse behaviours that contribute to a positive
training and practice culture.
35. Promote and enable formal and informal mentorship and leadership opportunities across all levels of training, practice,
and health system delivery.
36. Support interdisciplinary team-based practices; foster team collaboration and a shared accountability for patient care.
Physicians and self
Physicians and colleagues
Managing and minimizing conflicts of interest
38. Recognize that social determinants of health, the environment, and other fundamental considerations that extend
beyond medical practice and health systems are important factors that affect the health of the patient and of
39. Support the profession’s responsibility to act in matters relating to public and population health, health education,
environmental determinants of health, legislation affecting public and population health, and judicial testimony.
40. Support the profession’s responsibility to promote equitable access to health care resources and to promote resource
41. Provide opinions consistent with the current and widely accepted views of the profession when interpreting scientific
knowledge to the public; clearly indicate when you present an opinion that is contrary to the accepted views of the
42. Contribute, where appropriate, to the development of a more cohesive and integrated health system through interprofessional
collaboration and, when possible, collaborative models of care.
43. Commit to collaborative and respectful relationships with Indigenous patients and communities through efforts
to understand and implement the recommendations relevant to health care made in the report of the Truth and
Reconciliation Commission of Canada.
44. Contribute, individually and in collaboration with others, to improving health care services and delivery to address
systemic issues that affect the health of the patient and of populations, with particular attention to disadvantaged,
vulnerable, or underserved communities.
Approved by the CMA Board of Directors Dec 2018
37. Commit to ensuring the quality of medical services offered to patients and society through the establishment and
maintenance of professional standards.
Physicians and society
The CMA’s stance on intervention and judicial advocacy is to bring an evidence-based perspective to assist in relation to the decision-making of issues at hand.
CMA’s strategic plan and guiding principles opens the possibility that there may be circumstances when legal advocacy, and in particular judicial advocacy, may be leveraged strategically and proactively as a further tool in CMA’s advocacy toolbox to bring a non-partisan, evidence-based perspective to the courtroom that would further the organization’s vision for “a vibrant professional and a healthy population”.
Purpose and Scope of Policy
Given CMA 2020, and informed by knowledge of past experiences, the purpose of this policy is to provide guidelines to assist with decision making as to whether CMA should use legal action, as part of its advocacy toolbox, to move CMA’s work forward on a cause or issue.
Cases Deemed Appropriate for CMA Judicial Advocacy – General Principles
1. Stage and Venue of Proceedings
a) Generally, CMA will only engage in a proposed case at an appellate level or in the highest forum in which a matter is likely to be finally decided.
b) Exceptionally, the CMA may engage in a proposed case at a lower court or a court of first instance where:
i) circumstances justify engagement, such as an invitation from the court or where physicians’ expertise is necessary to create a trial record that supports the CMA’s policy position(s) or provides added relevant information that is not otherwise being provided or would highlight a critical issue that requires attention or would attract the attention of relevant parties.
c) Exceptionally, CMA may leverage international fora (e.g., United Nations treaty bodies) where involvement could help advance a specific cause or issue being championed by the CMA.
2. CMA’s Role in Proceedings
With some rare exceptions , , the CMA will only assume the role of intervener in a proposed case. The CMA will intervene where the CMA may bring a non-partisan, evidence-based analysis to an issue and where there are compelling reasons for doing so, considering the evaluation criteria contained in the Reference Guide in Appendix 1 of this policy.
3. Relevance to Existing CMA Policy
a) The CMA may engage in a proposed case where engagement would constitute a significant contribution to the consideration of the issue or issues involved and only when the position sought to be advanced is:
i. supported by and consistent with previously adopted policy of CMA; or
ii. a matter of compelling public or professional interest which the Board of Directors then adopts as CMA policy following appropriate consultation.
b) Where there is CMA policy that is clear, relevant to the proposed case and a matter of record, the policy should be cited and explained (e.g., in factum or affidavit).
c) If the CMA’s proposed stance in a case proceeding supports a position which the CMA has not previously adopted as policy, the CMA Board of Directors must adopt the position as policy before authorizing the activity.
4. Issue of National, Special and/or Unifying Significance to Profession
a) The CMA will generally only engage in a proposed case of special and unifying significance to the medical profession.
b) The CMA will not engage in a proposed case where the matter is only of local or regional concern or of a private nature with no public interest or compelling professional or public policy component.
5. Potential Case Outcome(s) and Effect(s)
Prior to engagement, the CMA must consider the potential impact(s) (both favourable and unfavourable) of the legal precedent that may set by the proposed case on members of the medical profession and patients.
6. Collaboration with Provincial/Territorial Associations, Affiliates and other Organizations
a) In the spirit of community building and collaborating with those who share our vision, the CMA welcomes opportunities to collaborate with provincial or territorial associations, affiliates and other organizations provided that these Guidelines are followed and that the other organizations
i. share positions on the issues at stake in the case that are consistent with CMA policy.
ii. can follow through on tasks, deadlines and communication needs related to collaboration.
b) While not mandatory, CMA would expect mutual assistance in funds and in kind when it collaborates with another organization (in relation to a judicial proceeding) or is asked to intervene.
7. Reputational Risk and Stakeholder Relations Implications
The CMA will consider as a general principle whether involvement in a proposed case:
a) may present the CMA with reputational risk(s) (e.g., inconsistent with mission and values, controversial, too political).
b) may impact relations with other stakeholders, including provincial/territorial medical associations, associates, affiliates and other organizations.
8. Financial and Resource Implications
The CMA will consider as a general principle the financial and resource implications of involvement in a proposed case such as the affordability of the proceeding, or competing demands for limited resources and staff availability. To the extent possible, the CMA will seek pro bono external legal assistance.
Authorization to Engage in Judicial Advocacy
CMA’s Senior Management Team will generally perform a preliminary analysis of the proposal to engage in a proposed case and may use the Reference Guide appended to these guidelines as a decision-making tool (see Appendix 1). The decision to engage in a proposed case must be ultimately authorized by the CMA Board of Directors. Once the Board has authorized the application, CMA staff will follow established internal protocol and procedures in the preparation of the required documentation according to the appended Working Draft Protocol (see Appendix 3). CMA staff will regularly provide the CMA Board with updates of the Court proceeding.
Appendix 1: Reference guide for determining if appropriate for CMA to engage in judicial advocacy on a matter, in accordance with CMA Guidelines on Judicial Advocacy
Degree to which criterion favours proposed judicial advocacy initiative
(please provide reasons for choice)
Somewhat favours Mildly favours Does not favour
Stage and venue of proceedings
Court of highest level?
If yes, mark as “strongly favours”
If yes, mark as “somewhat favours”
If not court of highest level or other appellate court, indicate jurisdiction
Relevance of matter to existing CMA policy
Is matter consistent with previously adopted policy?
Is matter of compelling public interest that may be adopted as policy?
Is matter of compelling professional interest that may be adopted as policy?
Issue of National, Special or Unifying Significance to the Profession
Does matter have impact beyond local/regional level?
Does matter have special or unifying significance for medical profession?
Collaboration or Request for Involvement
Other request for involvement?
Stakeholder relations implications
Appendix 2: Contents of Request for CMA to Intervene
1. Requests for CMA to intervene in court proceedings can arrive from multiple sources (internally – CMA Board, CMA provincial or territorial associations, affiliates, another organization, an individual member, etc.). CMA’s Legal Services Department may also monitor judicial developments and identify cases of special interest to CMA.
2. Unless there are exceptional circumstances, the request for CMA to intervene in a court proceeding shall contain the following:
(i) The style or caption of the case, identification of the last court to render a decision in the case and the court in which it is proposed to intervene. A copy of the decision or order appealed from, any accompanying reasons and other relevant documentation must be attached to (or linked from) the proposal;
(ii) The date by which the proposed application for leave to intervene and factum must be filed;
(iii) The issues before the Court and potential outcomes, dissenting views and likelihood of success, including policy implications for CMA depending on the various outcomes;
(iv) The position sought to be advanced on CMA’s behalf and how this position is consistent with existing CMA policy. If there is no existing CMA policy, the request should state why CMA should adopt the policy prior to intervention;
(v) If the request relates to a local or regional matter, an explanation of how the position to be taken is not inconsistent with CMA policy and the broader interests and concerns of CMA;
(vi) Consultations undertaken, if any, on why the matter warrants CMA intervention as a compelling issue of public policy and special interest to the medical profession;
(vii) A list of other organizations that might have an interest in the intervention or co-intervening with CMA;
(viii) Disclosure of any personal or professional interest, in the matter on the part of any individual or organization participating in the decision to seek the Board of Directors’ authorization to intervene; and
(ix) Budget development.
3. Where the request to intervene arises in a case where there is no existing CMA policy on the issue, the party making the request should demonstrate the urgency and importance of adopting the policy position to be advanced.
Appendix 3: Working Draft Protocol and Procedures for Court Intervention Document
CMA staff will prepare the application documents for leave to intervene in concert with expert litigation legal counsel.
Depending on the issues before the Court, the President or Chair or the CMA Board may review the contents of the application documents for leave to intervene and the actual factum prior to filing with the Court. Alternatively, the application documents and factum will be shared as information items with the CMA President and Board after filing. The decision to obtain the President and/or Chair and/or Board approval or not prior to filing lies with the CMA CEO.
CMA staff may also consult with the President and Chair on the choice of individual filing the affidavit (called the “affiant”) on CMA’s behalf. The affiant will in most circumstances be a physician, usually at the elected level, with experience and expertise on the issues before the Court.
All CMA Departments will consult with and co-ordinate with the CMA Legal Department. For example, the content of any Communication Strategy documents (e.g. press releases, media alerts, news articles, etc.) as part of the court proceeding must be consistent with the contents of CMA’s application for leave to intervene documents and factum.
Approved by the CMA Board of Directors Dec 2018
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.
COMPLEMENTARY AND ALTERNATIVE MEDICINE
This statement discusses the Canadian Medical Association's (CMA) position on complementary and alternative medicine (CAM). CAM, widely used in Canada, is increasingly being subject to regulation. The CMA's position is based on the fundamental premise that decisions about health care interventions used in Canada should be based on sound scientific evidence as to their safety, efficacy and effectiveness - the same standard by which physicians and all other elements of the health care system should be assessed. Patients deserve the highest standard of treatment available, and physicians, other health practitioners, manufacturers, regulators and researchers should all work toward this end. All elements of the health care system should "consider first the well-being of the patient."1 The ethical principle of non-maleficence obliges physicians to reduce their patient's risks of harm. Physicians must constantly strive to balance the potential benefits of an intervention against its potential side effects, harms or burdens. To help physicians meet this obligation, patients should inform their physician if the patient uses CAM.
CAM in Canada
CAM has been defined as "a group of diverse medical and health care systems, practices and products that are not presently considered to be part of conventional medicine."i This definition comprises a great many different, otherwise unrelated products, therapies and devices, with varying origins and levels of supporting scientific evidence. For the purpose of this analysis, the CMA divides CAM into four general categories:
* Diagnostic Tests: Provided by CAM practitioners. Unknown are the toxicity levels or the source of test material, e.g., purity. Clinical sensitivity, specificity, and predictive value should be evidence-based.
* Products: Herbal and other remedies are widely available over-the-counter at pharmacies and health food stores. In Canada these are regulated at the federal level under the term Natural Health Products.
* Interventions: Treatments such as spinal manipulation and electromagnetic field therapy may be offered by a variety of providers, regulated or otherwise.
* Practitioners: There are a large variety of practitioners whose fields include chiropractic, naturopathy, traditional Chinese and Ayurvedic medicine, and many others. Many are unregulated or regulated only in some provinces/territories of Canada.
Many Canadians have used, or are currently using, at least one CAM modality. A variety of reasons has been cited for CAM use, including: tradition; curiosity; distrust of mainstream medicine; and belief in the "holistic" concept of health which CAM practitioners and users believe they provide. For most Canadians the use is complementary (in addition to conventional medicine) rather than alternative (as a replacement). Many patients do not tell their physicians that they are using CAM.
Toward Evidence-Informed Health Care
Use of CAM carries risks, of which its users may be unaware. Indiscriminate use and undiscriminating acceptance of CAM could lead to misinformation, false expectations, and diversion from more appropriate care, as well as adverse health effects, some of them serious.
The CMA recommends that federal, provincial and territorial governments respond to the health care needs of Canadians by ensuring the provision of clinical care that continually incorporates evidence-informed technological advances in information, prevention, and diagnostic and therapeutic services.2 Physicians take seriously their duty to advocate for quality health care and help their patients choose the most beneficial interventions. 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.3 Until CAM interventions are supported by scientifically-valid evidence, physicians should not recommend them. Unless proven beneficial, CAM services should not be publicly funded. To help ensure that Canadians receive the highest-quality health care, the CMA recommends that CAM be subject to rigorous research on its effects, that it be strictly regulated, and that health professionals and the public have access to reliable, accurate, evidence-informed information on CAM products and therapies. Specific recommendations are provided below:
a) Research: Building an Evidence Base
To date, much of the public's information on CAM has been anecdotal, or founded on exaggerated claims of benefit based on few or low-quality studies. The CMA is committed to the principle that, before any new treatment is adopted and applied by the medical profession, it must first be rigorously tested and recognized as evidence-informed.4 Increasingly, good-quality, well-controlled studies are being conducted on CAM products and therapies. The CMA supports this development. Research into promising therapies is always welcome and should be encouraged, provided that it is subject to the same standards for proof and efficacy as those for conventional medical and pharmaceutical treatments. The knowledge thus obtained should be widely disseminated to health professionals and the public.
b) An Appropriate Regulatory Framework
Regulatory frameworks governing CAM, like those governing any health intervention, should enshrine the concept that therapies should have a proven benefit before being represented to Canadians as effective health treatments.
i) Natural Health Products. Natural health products are regulated at the federal level through the Natural Health Products Directorate of Health Canada.
The CMA believes that the principle of fairness must be applied to the regulatory process so that natural health products are treated fairly in comparison with other health products.5 The same regulatory standards should apply to both natural health products and pharmaceutical health products. These standards should be applied to natural health products regardless of whether a health claim is made for the product. This framework must facilitate the entry of products onto the market that are known to be safe and effective, and impede the entry of products that are not known to be safe and effective until they are better understood. It should also ensure high manufacturing standards to assure consumers of the products' safety, quality and purity. The CMA also recommends that a series of standards be developed for each natural health product. These standards should include:
* manufacturing processes that ensure the purity, safety and quality of the product;
* labelling standards that include standards for consumer advice, cautions and claims, and explanations for the safe use of the product to the consumer.6
The CMA recommends that safety and efficacy claims for natural health products be evaluated by an arm's length scientific panel, and claims for the therapeutic value of natural health products should be prohibited when the supportive evidence does not meet the evidentiary standard required of medications regulated by Health Canada.7 Claims of medical benefit should only be permitted when compelling scientific evidence of their safety and efficacy exists.8
The Canadian Medical Association advocates that foods fortified with "natural health" ingredients should be regulated as food products and not as natural health products
The CMA recommends that the regulatory system for natural health products be applied to post-marketing surveillance as well as pre-marketing regulatory review. Health Canada's MedEffect adverse reaction reporting system now collects safety reports on Natural Health Products. Consumers, health professionals and manufacturers are encouraged to report adverse reactions to Health Canada.
ii) CAM Practitioners. Regulation of CAM practitioners is at different stages. The CMA believes that this regulation should: ensure that the services CAM practitioners offer are truly efficacious; establish quality control mechanisms and appropriate standards of practice; and work to develop an evidence-informed body of competence that develops with evolving knowledge.
Just as the CMA believes that natural health products should be treated fairly in comparison with other health products, it recommends that CAM practitioners be held to the same standards as other health professionals. All CAM practitioners should develop Codes of Ethics that insure practitioners consider first the best interests of their patients.
Among other things, associations representing CAM practitioners should develop and adhere to conflict of interest guidelines that require their members to:
* Resist any influence or interference that could undermine their professional integrity;9
* Recognize and disclose conflicts of interest that arise in the course of their professional duties and activities, and resolve them in the best interests of patients;10
* Refrain, for the most part, from dispensing the products they prescribe. Engaging in both prescribing and dispensing , whether for financial benefit or not, constitutes a conflict of interest where the provider's own interests conflict with their duty to act in the best interests of the patient.
c) Information and Promotion
Canadians have the right to reliable, accurate information on CAM products and therapies to help ensure that the treatment choices they make are informed. The CMA recommends that governments, manufacturers, health care providers and other stakeholders work together to ensure that Canadians have access to this information. The CMA believes that all natural health products should be labeled so as to include a qualitative list of all ingredients. 11 Information on CAM should be user-friendly and easy to access, and should include:
* Instructions for use;
* Indications that the product or therapy has been convincingly proven to treat;
* Contraindications, side effects and interactions with other medications;
* Should advise the consumer to inform their health care provider during any encounter that they are using this product.12
This information should be provided in such a way as to minimize the impact of vested commercial interests on its content.
In general, brand-specific advertising is a less than optimal way of providing information about any health product or therapy. In view of our limited knowledge of their effectiveness and the risks they may contain risks, the advertising of health claims for natural health products should be severely restricted. The CMA recommends that health claims be promoted only if they have been established with sound scientific evidence. This restriction should apply not only to advertising, but also to all statements made in product or company Web sites and communications to distributors and the public. Advertisements should be pre-cleared to ensure that they contain no deceptive messages. Sanctions against deceptive advertising must be rigidly enforced, with Health Canada devoting adequate resources to monitor and correct misleading claims.
The CMA recommends that product labels include approved health claims, cautions and contraindications, instructions for the safe use of the product, and a recommendation that patients tell physicians that they are using the products. If no health claims are approved for a particular natural health product, the label should include a prominent notice that there is no evidence the product contributes to health or alleviates disease.
The Role of Health Professionals
Whether or not physicians and other health professionals support the use of CAM, it is important that they have access to reliable information on CAM products and therapies, so that they can discuss them with their patients.
Patients should be encouraged to report use of all health products, including natural health products, to health care providers during consultations. The CMA encourages Canadians to become educated about their own health and health care, and to appraise all health information critically.
The CMA will continue to advocate for evidence-informed assessment of all methods of health care in Canada, and for the provision of accurate, timely and reliable health information to Canadian health care providers and patients.
i Working definition used by the National Center for Complementary and Alternative Medicine of the U.S. National Institutes of Health.
1 Canadian Medical Association. CMA code of ethics (update 2004). Ottawa: The Association; 2004.
2 Canadian Medical Association. Policy resolution GC00-196 - Clinical care to incorporate evidence-based technological advances. Ottawa (ON): The Association; 2000. Available: http://policybase.cma.ca/dbtw-wpd/CMAPolicy/PublicB.htm.
3 Canadian Medical Association. CMA code of ethics (update 2004). Ottawa: The Association; 2004. Available: http://policybase.cma.ca/dbtw-wpd/CMAPolicy/PublicB.htm.
4 Canadian Medical Association. CMA statement on emerging therapies [media release]. Ottawa (ON): The Association; 2010. Available: www.facturation.net/advocacy/emerging-therapies.
5 Canadian Medical Association. CMA statement on emerging therapies [media release]. Available: www.facturation.net/advocacy/emerging-therapies.
6 Canadian Medical Association. Brief BR1998-02 - Regulatory framework for natural health products. Ottawa (ON): The Association; 1998.
7 Canadian Medical Association. Policy resolution GC08-86 - Natural health products. Ottawa (ON): The Association; 2008.
8 Canadian Medical Association. Policy resolution GC10-100 - Foods fortified with "natural health" ingredients. Ottawa (ON): The Association; 2010. Available:
9 Canadian Medical Association. CMA code of ethics (update 2004). Ottawa: The Association; 2004. Paragraph 7. Available: http://policybase.cma.ca/dbtw-wpd/CMAPolicy/PublicB.htm.
10 Canadian Medical Association. CMA code of ethics (update 2004). Ottawa: The Association; 2004. Paragraph 11. Available: http://policybase.cma.ca/dbtw-wpd/CMAPolicy/PublicB.htm.
11 Canadian Medical Association. Brief BR1998-02 - Regulatory framework for natural health products. Ottawa: The Association; 1998.
12 Canadian Medical Association. Brief BR1998-02 - Regulatory framework for natural health products. Ottawa: The Association; 1998.
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 firstname.lastname@example.org 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.
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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.
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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).