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Policies that advocate for the medical profession and Canadians


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Academic writing and editing among practicing physicians and physicians-in-training

https://policybase.cma.ca/en/permalink/policy11627
Date
2015-08-26
Topics
Physician practice/ compensation/ forms
Ethics and medical professionalism
Health systems, system funding and performance
Resolution
GC15-47
The Canadian Medical Association will promote the development of resources to foster academic writing and editing among practicing physicians and physicians-in-training.
Policy Type
Policy resolution
Date
2015-08-26
Topics
Physician practice/ compensation/ forms
Ethics and medical professionalism
Health systems, system funding and performance
Resolution
GC15-47
The Canadian Medical Association will promote the development of resources to foster academic writing and editing among practicing physicians and physicians-in-training.
Text
The Canadian Medical Association will promote the development of resources to foster academic writing and editing among practicing physicians and physicians-in-training.
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Accredited standards for the management of life-limiting chronic disease

https://policybase.cma.ca/en/permalink/policy11636
Date
2015-08-26
Topics
Population health/ health equity/ public health
Ethics and medical professionalism
Resolution
GC15-38
The Canadian Medical Association supports the development and application of accredited standards for the integration of a palliative care approach into the management of life-limiting chronic disease.
Policy Type
Policy resolution
Date
2015-08-26
Topics
Population health/ health equity/ public health
Ethics and medical professionalism
Resolution
GC15-38
The Canadian Medical Association supports the development and application of accredited standards for the integration of a palliative care approach into the management of life-limiting chronic disease.
Text
The Canadian Medical Association supports the development and application of accredited standards for the integration of a palliative care approach into the management of life-limiting chronic disease.
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Advance care planning

https://policybase.cma.ca/en/permalink/policy13694
Date
2017-05-27
Topics
Ethics and medical professionalism
Population health/ health equity/ public health
  1 document  
Policy Type
Policy document
Date
2017-05-27
Replaces
Advance care planning (2015)
Topics
Ethics and medical professionalism
Population health/ health equity/ public health
Text
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). GENERAL PRINCIPLES 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. EDUCATION 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. INSTITUTIONS 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. GLOSSARY 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 Advance directive 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. Informed consent 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. 12www.med.uottawa.ca/sim/data/Images/CMPA_Consent_guide_e.pdf 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, [1980] 2 SCR 880; Hopp v Lepp, [1980] 2 SCR 192.
Documents
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Allocation of health care resources

https://policybase.cma.ca/en/permalink/policy389
Last Reviewed
2014-03-01
Date
2000-08-16
Topics
Health systems, system funding and performance
Ethics and medical professionalism
Resolution
GC00-186
That the Canadian Medical Association work with its divisions and affiliates to determine and proclaim the values that should influence health care priority setting and allocation of health care resources in Canada.
Policy Type
Policy resolution
Last Reviewed
2014-03-01
Date
2000-08-16
Topics
Health systems, system funding and performance
Ethics and medical professionalism
Resolution
GC00-186
That the Canadian Medical Association work with its divisions and affiliates to determine and proclaim the values that should influence health care priority setting and allocation of health care resources in Canada.
Text
That the Canadian Medical Association work with its divisions and affiliates to determine and proclaim the values that should influence health care priority setting and allocation of health care resources in Canada.
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Assisted death as defined by the Supreme Court of Canada is distinct from the practice of palliative care

https://policybase.cma.ca/en/permalink/policy11611
Date
2015-08-26
Topics
Ethics and medical professionalism
Resolution
GC15-35
The Canadian Medical Association recognizes that the practice of assisted death as defined by the Supreme Court of Canada is distinct from the practice of palliative care.
Policy Type
Policy resolution
Date
2015-08-26
Topics
Ethics and medical professionalism
Resolution
GC15-35
The Canadian Medical Association recognizes that the practice of assisted death as defined by the Supreme Court of Canada is distinct from the practice of palliative care.
Text
The Canadian Medical Association recognizes that the practice of assisted death as defined by the Supreme Court of Canada is distinct from the practice of palliative care.
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Charter of Shared Values: A vision for intra-professionalism for physicians

https://policybase.cma.ca/en/permalink/policy13858
Date
2017-12-09
Topics
Ethics and medical professionalism
  2 documents  
Policy Type
Policy document
Date
2017-12-09
Replaces
CMA Charter for Physicians (Update 1999)
Topics
Ethics and medical professionalism
Text
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 RESPECT 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. INTEGRITY 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. RECIPROCITY 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. CIVILITY 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.ca/medicalprofessionalism
Documents
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CMA’s formal submission to the Federal External Panel on assisted dying

https://policybase.cma.ca/en/permalink/policy11750
Last Reviewed
2019-03-03
Date
2015-10-19
Topics
Ethics and medical professionalism
  1 document  
Policy Type
Parliamentary submission
Last Reviewed
2019-03-03
Date
2015-10-19
Topics
Ethics and medical professionalism
Text
Dear Members of the Federal External Panel: On behalf of the Canadian Medical Association (CMA), I appreciate the opportunity to provide input toward the Federal External Panel's national consultation to support the federal government's legislative response following the Supreme Court of Canada's ruling in Carter v. Canada. As the national professional association representing Canada's physicians, the CMA has played an important role in leading the public dialogue on end-of-life care, including assisted dying. In 2014, the CMA led a national consultation on end-of-life care which included a series of public and member town hall consultations across the country. This national dialogue focused on three main issues: advance care planning, palliative care, and physician-assisted dying. As highlighted in the summary report (enclosed as Appendix 1), the Canadian public emphasized the need for strict protocols and safeguards if the law on physician-assisted dying were to change. This initial consultation provided valuable insights to inform the concurrent CMA's in-depth and comprehensive consultation with its membership as well as medical and health stakeholders as an intervener before the Supreme Court and following the Carter decision. This consultation included engagement of the CMA's Ethics Committee, policy debates as part of the CMA's Annual Meetings in 2014 and 2015, in-person member forums across the country, and an online dialogue. The consultation was critical to the development of the CMA's Principles-based Recommendations for a Canadian Approach to Assisted Dying (enclosed as Appendix 2). These recommendations, guided by a set of ten foundational principles, address patient eligibility for access to and assessment for assisted dying, procedural safeguards for eligibility criteria, the roles and responsibilities of the attending and consulting physicians, and the issue of conscientious objection. Taken together, these recommendations form the CMA's position on the forthcoming legislative and regulatory framework to govern assisted dying in Canada. In addition to our recommendations, we would like to highlight key points that are of particular relevance to physicians: NATIONAL, PAN-CANADIAN LEGISLATIVE AND REGULATORY FRAMEWORK The CMA strongly recommends the establishment of national and coordinated legislative and regulatory processes and systems in response to the Carter decision. The CMA is deeply concerned that in the absence of federal action to support the establishment of national guidelines for assisted dying, a patchwork of differing and potentially conflicting approaches could emerge across jurisdictions. Legislative action at the federal level is needed to provide further clarity for physicians and their patients and support the promulgation of a coordinated and consistent approach across all jurisdictions in Canada. The CMA has been working with the medical regulatory colleges at the national level to mitigate this risk through the development of the CMA's Principles-based Recommendations for a Canadian Approach to Assisted Dying which has encouraged similar efforts by the regulatory colleges. In addition to these initiatives, federal action is required. CONSCIENTIOUS OBJECTION As the Federal External Panel is aware, the Carter decision emphasizes that any regulatory or legislative response must seek to reconcile the Charter rights of patients (wanting to access assisted dying) and physicians (who choose not to participate in assisted dying on grounds of conscientious objection). The notion of conscientious objection is not monolithic. While some conceptions of conscience encompass referral, others view referral as being connected to, or as akin to participating in, a morally objectionable act. It is the CMA's position that an effective reconciliation is one that respects, and takes account of, differences in conscience, while facilitating access on the principle of equity. To this end, the CMA's membership strongly endorses the recommendation on conscientious objection as set out in section 5.2 of the CMA's enclosed Principles-based Recommendations for a Canadian Approach to Assisted Dying. ADDITIONAL SUPPORTS The CMA recognizes, and supports addressing, the need to develop education materials for physicians. To this end, the CMA is actively developing education modules for physicians following an environmental scan of existing courses and discussions with other jurisdictions (e.g., the Royal Dutch Medical Association). The CMA has the support of the Royal College of Physicians and Surgeons of Canada, the College of Family Physicians of Canada, and the Canadian Medical Protective Association to lead this initiative. Finally, as previously stated, the CMA strongly encourages the federal government to make the report of the Federal External Panel publicly available once final. The CMA urges the members of the Federal External Panel to support this recommendation to the federal government. Thank you once again for the opportunity to provide input. The CMA looks forward to our meeting with the Federal External Panel on October 20, 2015. Sincerely, Cindy Forbes, MD, CCFP, FCFP President Jeff Blackmer MD, MHSc, FRCPC Vice-President, Medical Professionalism Enclosed: Appendix 1 - Summary Report: End-of-Life Care A National Dialogue (please see pdf for link to document) Appendix 2 - CMA's Principles-based Recommendations for a Canadian Approach to Assisted Dying Principles-based Recommendations for a Canadian Approach to Assisted Dying On Feb. 6, 2015, the Supreme Court of Canada unanimously struck down the law prohibiting assisted dying. The court suspended that decision for 12 months. This has provided an opportunity for the Canadian Medical Association (CMA) to build on its past work and pursue further consultation with provincial and territorial medical associations, medical and non-medical stakeholders, members, legislatures and patients for processes, whether legal, regulatory or guidelines, that respect patients' needs and reflects physicians' perspectives. The goal of this process is twofold: (a) discussion and recommendations on a suite of ethical-legal principles and (b) input on specific issues that are particularly physician-sensitive and are worded ambiguously or not addressed in the Court's decision. The touch points are reasonable accommodation for all perspectives and patient-centeredness. For purposes of clarity, CMA recommends national and coordinated legislative and regulatory processes and systems. There should be no undue delay in the development of these laws and regulations. The principles are not designed to serve as a tool for legislative compliance in a particular jurisdiction or provide a standard of care. Rather, the CMA wishes to provide physicians with guidance and a vision of what physicians might strive for to further their professional and legal obligations in a complex area. The CMA recommends adopting the following principles-based approach to assisted dying in Canada: Foundational principles The following foundational principles underpin CMA's recommended approach to assisted dying. Proposing foundational principles is a starting point for ethical reflection, and their application requires further reflection and interpretation when conflicts arise. 1. Respect for patient autonomy: Competent adults are free to make decisions about their bodily integrity. Specific criteria are warranted given the finality of assisted dying. 2. Equity: To the extent possible, all those who meet the criteria for assisted dying should have access to this intervention. Physicians will work with relevant parties to support increased resources and access to high quality palliative care, and assisted dying. There should be no undue delay to accessing assisted dying, either from a clinical, system or facility perspective. To that end, the CMA calls for the creation of a separate central information, counseling, and referral service. 3. Respect for physician values: Physicians can follow their conscience when deciding whether or not to provide assisted dying without discrimination. This must not result in undue delay for the patient to access these services. No one should be compelled to provide assistance in dying. 4. Consent and capacity: All the requirements for informed consent must clearly be met, including the requirement that the patient be capable of making that decision, with particular attention to the context of potential vulnerabilities and sensitivities in end of life circumstances. Consent is seen as an evolving process requiring physicians to continuously communicate with the patient. 5. Clarity: All Canadians must be clear on the requirements for qualification for assisted dying. There should be no "grey areas" in any legislation or regulations. 6. Dignity: All patients, their family members or significant others should be treated with dignity and respect at all times, including throughout the entire process of care at the end of life. 7. Protection of patients: Laws and regulations, through a carefully designed and monitored system of safeguards, should aim to minimize harm to all patients and should also address issues of vulnerability and potential coercion. 8. Accountability: An oversight body and reporting mechanism should be identified and established in order to ensure that all processes are followed. Physicians participating in assisted dying must ensure that they have appropriate technical competencies as well as the ability to assess decisional capacity, or the ability to consult with a colleague to assess capacity in more complex situations. 9. Solidarity: Patients should be supported and not abandoned by physicians and health care providers, sensitive to issues of culture and background, throughout the dying process regardless of the decisions they make with respect to assisted dying. 10. Mutual respect: There should be mutual respect between the patient making the request and the physician who must decide whether or not to perform assisted dying. A request for assisted dying is only possible in a meaningful physician-patient relationship where both participants recognize the gravity of such a request. Recommendations Based on these principles, the Supreme Court decision in Carter v. Canada (2015)1 and a review of other jurisdictions' experiences, CMA makes the following recommendations for potential statutory and regulatory frameworks with respect to assisted dying. We note that this document is not intended to address all potential issues with respect to assisted dying, and some of these will need to be captured in subsequent regulations. 1. Patient eligibility for access to assisted dying 1.1 The patient must be a competent adult who meets the criteria set out by the Supreme Court of Canada decision in Carter v. Canada (2015. 1.2 Informed decision * The attending physician must disclose to the patient information regarding their health status, diagnosis, prognosis, the certainty of death upon taking the lethal medication, and alternatives, including comfort care, palliative and hospice care, and pain and symptom control. 1.3 Capacity * The attending physician must be satisfied that: - the patient is mentally capable of making an informed decision at the time of the request(s) - the patient is capable of giving consent to assisted dying, paying particular attention to the potential vulnerability of the patient in these circumstances - communications include exploring the priorities, values and fears of the patient, providing information related to the patient's diagnosis and prognosis, treatment options including palliative care and other possible interventions and answering the patient's questions * If either or both the attending physician or the consulting physician determines that the patient is incapable, the patient must be referred for further capacity assessment. * Only patients on their own behalf can make the request while competent. 1.4 Voluntariness * The attending physician must be satisfied, on reasonable grounds, that all of the following conditions are fulfilled: - The patient's decision to undergo assisted dying has been made freely, without coercion or undue influence from family members, health care providers or others. - The patient has a clear and settled intention to end his/her own life after due consideration. - The patient has requested assisted dying him/herself, thoughtfully and repeatedly, in a free and informed manner. 2. Patient eligibility for assessment for decision-making in assisted dying Stage 1: Requesting assisted dying 1. The patient submits at least two oral requests for assisted dying to the attending physician over a period of time that is proportionate to the patient's expected prognosis (i.e., terminal vs non-terminal illness). CMA supports the view that a standard waiting period is not appropriate for all requests. 2. CMA recommends generally waiting a minimum of 14 days between the first and the second oral requests for assisted dying. 3. The patient then submits a written request for assisted dying to the attending physician. The written request must be completed via a special declaration form that is developed by the government/department of health/regional health authority/health care facility. 4. Ongoing analysis of the patient's condition and ongoing assessment of requests should be conducted for longer waiting periods. Stage 2: Before undertaking assisted dying 5. The attending physician must wait no longer than 48 hours, or as soon as is practicable, after the written request is received. 6. The attending physician must then assess the patient for capacity and voluntariness or refer the patient for a specialized capacity assessment in more complex situations. 7. The attending physician must inform the patient of his/her right to rescind the request at any time. 8. A second, independent, consulting physician must then also assess the patient for capacity and voluntariness. 9. Both physicians must agree that the patient meets eligibility criteria for assisted dying to proceed. 10. The attending physician must fulfill the documentation and reporting requirements. Stage 3: After undertaking assisted dying 11. The attending physician, or a physician delegated by the attending physician, must take care of the patient until the patient's death. 3. Role of the physician 3.1 The attending physician must be trained to provide assisted dying. 3.2 Patient assessment * The attending physician must determine if the patient qualifies for assisted dying under the parameters stated above in Section 1. * The attending physician must ensure that all reasonable treatment options have been considered to treat physical and psychological suffering according to the patient's need, which may include, independently or in combination, palliative care, psychiatric assessment, pain specialists, gerontologists, spiritual care, and/or addiction counseling. 3.3 Consultation requirements * The attending physician must consult a second physician, independent of both the patient and the attending physician, before the patient is considered eligible to undergo assisted dying. * The consulting physician must - Be qualified by specialty or experience to render a diagnosis and prognosis of the patient's illness and to assess their capacity as noted in Stage 2 above. 3.4 Opportunity to rescind request * The attending physician must offer the patient an opportunity to rescind the request at any time; the offer and the patient's response must be documented. 3.5 Documentation requirements * The attending physician must document the following in the patient's medical record: - All oral and written requests by a patient for assisted dying - The attending physician's diagnosis and prognosis, and their determination that the patient is capable, acting voluntarily and has made an informed decision - The consulting physician's diagnosis and prognosis, and verification that the patient is capable, acting voluntarily and has made an informed decision - A report of the outcome and determinations made during counseling - The attending physician's offer to the patient to rescind the request for assisted dying - A note by the attending physician indicating that all requirements have been met and indicating the steps taken to carry out the request 3.6 Oversight body and reporting requirements * There should be a formal oversight body and reporting mechanism that collects data from the attending physician. * Following the provision of assisted dying, the attending physician must submit all of the following items to the oversight body: - Attending physician report - Consulting physician report - Medical record documentation - Patient's written request for assisted dying * The oversight body would review the documentation for compliance * Provincial and territorial jurisdictions should ensure that legislation and/or regulations are in place to support investigations related to assisted dying by existing provincial and territorial systems * Pan-Canadian guidelines should be developed in order to provide clarity on how to classify the cause on the death certificate 4. Responsibilities of the consulting physician * The consulting physician must verify the patient's qualifications including capacity and voluntariness. * The consulting physician must document the patient's diagnosis, prognosis, capacity, volition and the provision of information sufficient for an informed decision. The consulting physician must review the patient's medical records, and should document this review. 5. Moral opposition to assisted dying 5.1 Moral opposition by a health care facility or health authority * Hospitals and health authorities that oppose assisted dying may not prohibit physicians from providing these services in other locations. There should be no discrimination against physicians who decide to provide assisted dying. 5.2 Conscientious objection by a physician * Physicians are not obligated to fulfill requests for assisted dying. There should be no discrimination against a physician who chooses not to participate in assisted dying. In order to reconcile physicians' conscientious objection with a patient's request for access to assisted dying, physicians are expected to provide the patient with complete information on all options available to them, including assisted dying, and advise the patient on how they can access any separate central information, counseling, and referral service. 1 Carter v. Canada (Attorney General), [2015] 1 SCR 331, 2015 SCC 5 (CanLII)
Documents
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Creation of a specific criminal offence to assault health care providers performing their duties

https://policybase.cma.ca/en/permalink/policy11656
Date
2015-08-26
Topics
Ethics and medical professionalism
Resolution
GC15-76
The Canadian Medical Association calls on the federal government to amend the Criminal Code by making it a specific criminal offence to assault health care providers performing their duties.
Policy Type
Policy resolution
Date
2015-08-26
Topics
Ethics and medical professionalism
Resolution
GC15-76
The Canadian Medical Association calls on the federal government to amend the Criminal Code by making it a specific criminal offence to assault health care providers performing their duties.
Text
The Canadian Medical Association calls on the federal government to amend the Criminal Code by making it a specific criminal offence to assault health care providers performing their duties.
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Cultural awareness

https://policybase.cma.ca/en/permalink/policy13704
Date
2017-08-23
Topics
Ethics and medical professionalism
Health care and patient safety
Resolution
GC17-16
The Canadian Medical Association encourages medical licensing bodies to require registrants to have training in cultural awareness.
Policy Type
Policy resolution
Date
2017-08-23
Topics
Ethics and medical professionalism
Health care and patient safety
Resolution
GC17-16
The Canadian Medical Association encourages medical licensing bodies to require registrants to have training in cultural awareness.
Text
The Canadian Medical Association encourages medical licensing bodies to require registrants to have training in cultural awareness.
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Direct-to-consumer genetic testing

https://policybase.cma.ca/en/permalink/policy13696
Date
2017-05-27
Topics
Ethics and medical professionalism
  2 documents  
Policy Type
Policy document
Date
2017-05-27
Topics
Ethics and medical professionalism
Text
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. GENERAL PRINCIPLES 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. SYSTEMS INFRASTRUCTURE * 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. 1.2 Insurance 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. May 2017 See also CMA Policy PD17-05 Direct-to-Consumer Genetic Testing REFERENCES 1 Phillips AM. Only a click away - DTC genetics for ancestry, health, love ... and more: a view of the business and regulatory landscape. Appl Transl Genom 2016;8:16-22. 2 US Food and Drug Administration. Warning letter. Silver Spring (MD): The Administration; 22 Nov 2013. Available: www.fda.gov/iceci/enforcementactions/warningletters/2013/ucm376296.htm (accessed 2017 May 19). 3 Caulfield T. Direct-to-consumer testing: if consumers are not anxious, why are policy makers? Hum Genet 2011;130:23-5. 4 Delaney SK, Christman MF. Direct-to-consumer genetic testing: perspectives on its value in healthcare. Clin Pharmacol Ther 2016; 99(2):146-8. 5 Powell KP, Cogswell WA, Christianson CA, et al. Primary care physicians' awareness, experience and opinions of direct-to-consumer genetic testing. J Genet Couns 2012;21(1):113-26. 6 Powell KP, Christianson CA, Cogswell WA, et al. Educational needs of primary care physicians regarding direct-to-consumer genetic testing. J Genet Couns 2012;21(3):469-78. 7 Jackson L, Goldsmith L, Skirton H. Guidance for patients considering direct-to-consumer genetic testing and health professionals involved in their care: development of a practical decision tool. Fam Pract 2014;31(3): 341-8. 8 Caulfield T, McGuire AL. Direct-to-consumer genetic testing: perception, problems, and policy responses. Annu Rev Med 2012; 63:23-33. 9 Office of the Privacy Commissioner of Canada. Analysis of privacy policies and practices of direct-to-consumer genetic testing companies: private sector databanks and privacy protection norms. Ottawa: The Office; March 2010. p. 6. 10 Bunnik EM, Janssens AC, Schermer MH. Informed consent in direct-to-consumer personal genome testing: the outline of a model between specific and generic consent. Bioethics 2014;28(7):343-51. 11 Brett GR, Metcalfe SA, Amor DJ, et al. An exploration of genetic health professionals' experience with direct-to-consumer genetic testing in their clinical practice. Eur J Hum Genet 2012;20(8):825-30. 12 Wasson K, Sanders TN, Hogan NS, Cherny S, Helzlsouer KJ. Primary care patients' views and decisions about, experience of and reactions to direct-to-consumer genetic testing: a longitudinal study. J Community Genet. 2013;4:495-505 13 Lemmens T, Pullman D, Rodal R. Revisiting genetic discrimination issues in 2010: policy options for Canada [PowerPoint presentation]. Ottawa: Genome Canada; 15 June 2010. Available: www.genomecanada.ca/sites/default/files/pdf/en/gps_speakers_presentation/trudo-lemmens-daryl-pullman.pdf 14 Zinatelli F. Industry Code: Genetic testing information for insurance underwriting [Internet]. Toronto, ON: CLHIA; 2017 Jan 11. Available from https://www.clhia.ca/domino/html/clhia/CLHIA_LP4W_LND_Webstation.nsf/page/E79687482615DFA485257D5D00682400/$file/Industry%20Code%20Genetic%20Testing%20-%20Updated.pdf 15 Adams SD, Evans JP, Aylsworth AS. Direct-to-consumer genomic testing offers little clinical utility but appears to cause minimal harm. N C Med J 2013;74(6): 494-8. 16 Ram S, Russell B, Gubb M, et al. General practitioner attitudes to direct-to-consumer genetic testing in New Zealand. N Z Med J 2012;125(1364):14-26. 17 Caulfield T. Obesity genes, personalized medicine and public health policy. Curr Obes Rep 2015;4(3):319-23. 18 Caulfield T, Zarzeczny A. Defining 'medical necessity' in an age of personalised medicine: a view from Canada. Bioessays 2014;36(9):813-7. 19 Bloss CS, Schork NJ, Topol EJ. Direct-to-consumer pharmacogenomic testing is associated with increased physician utilisation. J Med Genet 2014;51(2):83-9. 20 Daly AK. Direct-to-consumer pharmacogenomic testing assessed in a US-based study. J R Coll Physicans Edinb 2014;44:212-3. 21 Jackson L, Goldsmith L, Skirton H. Guidance for patients considering direct-to-consumer genetic testing and health professionals involved in their care: development of a practical decision tool. Fam Pract 2014;31(3):341-8. 22 Mykitiuk R. Caveat emptor: direct-to-consumer supply and advertising of genetic testing. Clin Invest Med 2004;27(1):23-32. 23Parliament of Canada. Legislative summary of Bill S-201: An Act to prohibit and prevent genetic discrimination. Ottawa: Parliament of Canada; 2016 24 Parliament of Canada. Bill 127: An Act to amend the Human Rights Code with respect to genetic characteristics, 2nd Sess, 40th Leg, Ontario, 2013. 25 Personal Information Protection and Electronic Document Act (PIPEDA), S.C. 2000, C.5, para 5(3).
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