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Cannabis for Medical Purposes

https://policybase.cma.ca/en/permalink/policy10045
Last Reviewed
2019-03-03
Date
2010-12-04
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
; 2007. Available: http://policybase.cma.ca/dbtw-wpd/Policypdf/PD08-01.pdf. (accessed 2019 Jan22). 8 R
  1 document  
Policy Type
Policy document
Last Reviewed
2019-03-03
Date
2010-12-04
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The Canadian Medical Association (CMA) has always recognized the unique requirements of those individuals suffering from a terminal illness or chronic disease for which conventional therapies have not been effective and for whom cannabis may provide relief. However, there are a number of concerns, primarily related to the limited evidence to support many of the therapeutic claims made regarding cannabis for medical purposes, and the need to support health practitioners in their practice.1,2,3,4 While the indications for using cannabis to treat some conditions have been well studied, less information is available about many potential medical uses. Physicians who wish to authorize the use of cannabis for patients in their practices should consult relevant CMPA policy5 and guidelines developed by the provincial and territorial medical regulatory authorities to ensure appropriate medico-legal protection. The CMA’s policy Authorizing Marijuana for Medical Purposes6, as well as the CMA’s Guidelines For Physicians In Interactions With Industry7 should also be consulted. The CMA makes the following recommendations: 1. Increase support for the advancement of scientific knowledge about the medical use of cannabis. The CMA encourages the government to support rigorous scientific research into the efficacy for therapeutic claims, safety, dose-response relationships, potential interactions and the most effective routes of delivery, and in various populations. 2. Apply the same regulatory oversight and evidence standards to cannabis as to pharmaceutical products under the Food and Drug Act, designed to protect the public by the assessment for safety and efficacy. 3. Increase support for physicians on the use of cannabis for medical purposes in their practice settings. As such, CMA calls on the government to work with the CMA, The College of Family Physicians of Canada, the Royal College of Physicians and Surgeons, 2 and other relevant stakeholders, to develop unbiased, accredited education options and licensing programs for physicians who authorize the use of cannabis for their patients based on the best available evidence. Background In 2001, Health Canada enacted the Marihuana Medical Access Regulations (MMAR). These were in response to an Ontario Court of Appeal finding that banning cannabis for medicinal purposes violated the Charter of Rights and Freedoms.8 The MMAR, as enacted, was designed to establish a framework to allow legal access to cannabis, then an illegal drug, for the relief of pain, nausea and other symptoms by people suffering from serious illness where conventional treatments had failed. While recognizing the needs of those suffering from terminal illness or chronic disease, CMA raised strong objections to the proposed regulations. There were concerns about the lack of evidence on the risks and benefits associated with the use of cannabis. This made it difficult for physicians to advise their patients appropriately and manage doses or potential side effects. The CMA believes that physicians should not be put in the untenable position of gatekeepers for a proposed medical intervention that has not undergone established regulatory review processes as required for all prescription medicines. Additionally, there were concerns about medico-legal liability, and the Canadian Medical Protective Association (CMPA), encouraged those physicians that were uncomfortable with the regulations to refrain from authorizing cannabis to patients. Various revisions were made to the MMAR, and then these were substituted by the Marihuana for Medical Purposes Regulations (MMPR) in 2013/ 2014 and subsequently by the Access to Cannabis for Medical Purposes Regulations (ACMPR) in 2016 and now as part of the Cannabis Act (Section 14)9. Healthcare practitioners that wish to authorize cannabis for their patients are required to sign a medical document, indicating the daily quantity of dried cannabis, expressed in grams. For the most part, these revisions have been in response to decisions from various court decisions across the country.10,11,12 Courts have consistently sided with patients’ rights to relieve symptoms of terminal disease or certain chronic conditions, despite the limited data on the effectiveness of cannabis. Courts have not addressed the ethical position in which physicians are placed as a result of becoming the gate keeper for access to a medication without adequate evidence. The CMA participated in many Health Canada consultations with stakeholders as well as scientific advisory committees and continued to express the concerns of the physician community. As previously noted, the Federal government has been constrained by the decisions of Canadian courts. 3 The current state of evidence regarding harms of cannabis use is also limited but points to some serious concerns. Ongoing research has shown that regular cannabis use during brain development (up to approximately 25 years old) is linked to an increased risk of mental health disorders including depression, anxiety, and schizophrenia, especially if there is a personal or family history of mental illness. Long term use has also been associated with issues of attention, impulse control and emotional regulation. Smoking of cannabis also has pulmonary consequences such as chronic bronchitis. It is also linked to poorer pregnancy outcomes. Physicians are also concerned with dependence, which occurs in up to 10% of regular users. From a public and personal safety standpoint, cannabis can impact judgement and increases the risk of accidents (e.g. motor vehicle incidents). For many individuals, cannabis use is not without adverse consequences.3,13,14 Pharmaceutically prepared alternative options, often administered orally, are also available and regulated in Canada.15 These drugs mimic the action of delta-9-tetra-hydrocannabional (THC) and other cannabinoids and have undergone clinical trials to demonstrate safety and effectiveness and have been approved for use through the Food and Drug Act. Of note is that in this format, the toxic by-products of smoked marijuana are avoided.16 However, the need for more research is evident. Approved by the CMA Board in December 2010. Last reviewed and approved by the CMA Board in March 2019. References 1 Allan GM, Ramji J, Perry D, et al. Simplified guideline for prescribing medical cannabinoids in primary care. Canadian Family Physician, 2018;64(2):111-120. Available: http://www.cfp.ca/content/cfp/64/2/111.full.pdf (accessed 2019 Jan 8). 2 College of Family Physicians of Canada (CFPC). Authorizing Dried Cannabis for Chronic Pain or Anxiety: Preliminary Guidance. Mississauga: CFPC; 2014. Available: https://www.cfpc.ca/uploadedFiles/Resources/_PDFs/Authorizing%20Dried%20Cannabis%20for%20Chronic%20Pain%20or%20Anxiety.pdf (accessed 2019 Jan 8). 3 The National Academies of Sciences, Engineering and Medicine. The health effects of cannabis and cannabinoids: the current state of evidence and recommendations for research. Washington, DC: National Academies Press; 2017. 4 Whiting PF, Wolff RF, Deshpande S, et al. Cannabinoids for medical use: a systematic review and meta-analysis. JAMA 2015;313(24):2456-73. 5 Canadian Medical Protective Association (CMPA). Medical marijuana: considerations for Canadian doctors. Ottawa: CMPA; 2018. Available: https://www.cmpa-acpm.ca/en/advice-publications/browse-articles/2014/medical-marijuana-new-regulations-new-college-guidance-for-canadian-doctors (accessed 2019 Jan 8). 6 Canadian Medical Association (CMA). Authorizing marijuana for medical purposes. Ottawa: CMA; 2014. Available: https://policybase.cma.ca/en/permalink/policy11514 http://policybase.cma.ca/dbtw-wpd/Policypdf/PD15-04.pdf (accessed 2019 Jan 8). 7 Canadian Medical Association. (CMA) Guidelines for Physicians In Interactions With Industry. Ottawa: CMA; 2007. Available: http://policybase.cma.ca/dbtw-wpd/Policypdf/PD08-01.pdf. (accessed 2019 Jan22). 4 8 R. v. Parker, 2000 CanLII 5762 (ON CA). Available: http://canlii.ca/t/1fb95 (accessed 2019 Jan 8). 9 Cannabis Act. Access to Cannabis for Medical Purposes. Section 14. 2018. Available: https://laws-lois.justice.gc.ca/eng/regulations/SOR-2018-144/page-28.html#h-81 (accessed 2019 Jan 8). 10 Hitzig v. Canada, 2003 CanLII 3451 (ON SC). Available: http://canlii.ca/t/1c9jd (accessed 2019 Jan 8). 11 Allard v. Canada, [2016] 3 FCR 303, 2016 FC 236 (CanLII), Available: http://canlii.ca/t/gngc5 (accessed 2019 Jan 8). 12 R. v. Smith, 2014 ONCJ 133 (CanLII). Available: http://canlii.ca/t/g68gk (accessed 2019 Jan 8). 13 Volkow ND, Baler RD, Compton WM, Weiss SRB. Adverse health effects of marijuana use. N Engl J Med. 2014;370(23):2219–2227. 14 World Health Organization. The health and social effects of nonmedical cannabis use. Geneva: World Health Organization; 2016. Available: https://www.who.int/substance_abuse/publications/msbcannabis.pdf (accessed 2019 Jan 8). 15 Ware MA. Is there a role for marijuana in medical practice? Can Fam Physician 2006;52(12):1531-1533. Available: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1952544/pdf/0530022a.pdf (accessed 2019 Jan 8). 16 Engels FK, de Jong FA, Mathijssen RHJ, et.al. Medicinal cannabis in oncology. Eur J Cancer. 2007;43(18):2638-2644. Available: https://www.clinicalkey.com/service/content/pdf/watermarked/1-s2.0-S0959804907007368.pdf?locale=en_US (accessed 2019 Jan 8).
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Joint statement on preventing and resolving ethical conflicts involving health care providers and persons receiving care

https://policybase.cma.ca/en/permalink/policy202
Last Reviewed
2019-03-03
Date
1998-12-05
Topics
Ethics and medical professionalism
  1 document  
Policy Type
Policy document
Last Reviewed
2019-03-03
Date
1998-12-05
Topics
Ethics and medical professionalism
Text
JOINT STATEMENT ON PREVENTING AND RESOLVING ETHICAL CONFLICTS INVOLVING HEALTH CARE PROVIDERS AND PERSONS RECEIVING CARE This joint statement was developed cooperatively and approved by the Boards of Directors of the Canadian Healthcare Association, the Canadian Medical Association, the Canadian Nurses Association and the Catholic Health Association of Canada. Preamble The needs, values and preferences of the person receiving care should be the primary consideration in the provision of quality health care. Ideally, health care decisions will reflect agreement between the person receiving care and all others involved in his or her care. However, uncertainty and diverse viewpoints sometimes can give rise to disagreement about the goals of care or the means of achieving those goals. Limited health care resources and the constraints of existing organizational policies may also make it difficult to satisfy the person’s needs, values and preferences. The issues addressed in this statement are both complex and controversial. They are ethical issues in that they involve value preferences and arise where people of good will are uncertain of or disagree about the right thing to do when someone's life, health or well-being is threatened by disease or illness. Because everyone’s needs, values and preferences are different, and because disagreements can arise from many sources, policies for preventing and resolving conflicts should be flexible enough to accommodate a wide range of situations. Disagreements about health care decisions can arise between or among any of the following: the person receiving care, proxies,<1> family members, care providers and administrators of health care authorities, facilities or agencies. This joint statement deals primarily with conflicts between the person receiving care, or his or her proxy, and care providers. It offers guidance for the development of policies for preventing and resolving ethical conflicts about the appropriateness of initiating, continuing, withholding or withdrawing care or treatment. It outlines the basic principles to be taken into account in the development of such policies as well as the steps that should be followed in resolving conflicts. The sponsors of this statement encourage health care authorities, facilities and agencies to develop policies to deal with these and other types of conflict, for example, those that sometimes arise among care providers. I. Principles of the therapeutic relationship<2> Good therapeutic relationships are centered on the needs and informed choices of the person receiving care. Such relationships are based on respect and mutual giving and receiving. Observance of the following principles will promote good therapeutic relationships and help to prevent conflicts about the goals and means of care. 1. The needs, values and preferences of the person receiving care should be the primary consideration in the provision of quality health care. 2. A good therapeutic relationship is founded on mutual trust and respect between providers and recipients of care. When care providers lose this sense of mutuality, they become mere experts and the human quality in the relationship is lost. When persons receiving care lose this sense of mutuality, they experience a perceived or real loss of control and increased vulnerability. Because persons receiving care are often weakened by their illness and may feel powerless in the health care environment, the primary responsibility for creating a trusting and respectful relationship rests with the care providers. 3. Sensitivity to and understanding of the personal needs and preferences of persons receiving care, their family members and significant others is the cornerstone of a good therapeutic relationship. These needs and preferences are diverse and can be influenced by a range of factors including cultural, religious and socioeconomic backgrounds. 4. Open communication, within the confines of privacy and confidentiality, is also required. All those involved in decision-making should be encouraged to express their points of view, and these views should be respectfully considered. Care providers should ensure that they understand the needs, values and preferences of the person receiving care. To avoid misunderstanding or confusion, they should make their communications direct, clear and consistent. They should verify that the person receiving care understands the information being conveyed: silence should not be assumed to indicate agreement. The person receiving care should be provided with the necessary support, time and opportunity to participate fully in discussions regarding care. 5. The competent person<3> must be involved in decisions regarding his or her care. 6. The primary goal of care is to provide benefit to the person receiving care. The competent person has the right to determine what constitutes benefit in the given situation, whether with respect to physical, psychological, spiritual, social or other considerations. 7. Informed decision-making requires that the person receiving care or his or her proxy be given all information and support necessary for assessing the available options for care, including the potential benefits and risks of the proposed course of action and of the alternatives, including palliative care. 8. The competent person has the right to refuse, or withdraw consent to, any care or treatment, including life-saving or life-sustaining treatment. 9. Although parents or guardians are normally the primary decision-makers for their minor children, children should be involved in the decision-making process to the extent that their capacity allows, in accordance with provincial or territorial legislation. 10. When the person receiving care is incompetent, that is, lacking in adequate decision-making capacity with respect to care and treatment, every effort must be made to ensure that health care decisions are consistent with his or her known preferences. These preferences may be found in an advance directive or may have been communicated orally. In jurisdictions where the issue of decision-making concerning care and medical treatment for incompetent persons is specifically addressed in law, the requirements of that legislation should be met. 11. When an incompetent person’s preferences are not known and there is no family member or proxy to represent the person, decisions must be based on an attempt to ascertain the person's best interests, taking into account: (a) the person's diagnosis, prognosis and treatment options, (b) the person's known needs and values, (c) information received from those who are significant in the person's life and who could help in determining his or her best interests, and (d) aspects of the person's culture, religion or spirituality that could influence care and treatment decisions. 12. When conflicts arise despite efforts to prevent them, they should be resolved as informally as possible, moving to more formal procedures only when informal measures have been unsuccessful. 13. In cases of disagreement or conflict, the opinions of all those directly involved should be given respectful consideration. 14. Disagreements among health care providers about the goals of care and treatment or the means of achieving those goals should be clarified and resolved by the members of the health care team so as not to compromise their relationship with the person receiving care. Disagreements between health care providers and administrators with regard to the allocation of resources should be resolved within the facility or agency and not be debated in the presence of the person receiving care. Health care authorities, facilities and agencies should develop conflict resolution policies for dealing with such issues and monitor their use. 15. When the needs, values and preferences of the person receiving care cannot be met, he or she should be clearly and frankly informed of the reasons for this, including any factors related to resource limitations. 16. Health care providers should not be expected or required to participate in procedures that are contrary to their professional judgement<4> or personal moral values or that are contrary to the values or mission of their facility or agency.<5> Health care providers should declare in advance their inability to participate in procedures that are contrary to their professional or moral values. Health care providers should not be subject to discrimination or reprisal for acting on their beliefs. The exercise of this provision should never put the person receiving care at risk of harm or abandonment. 17. Health care providers have a responsibility to advocate together with those for whom they are caring in order that these persons will have access to appropriate treatment. II. Guidelines for the resolution of ethical conflicts Health care organizations should have a conflict resolution process in place to address problems that arise despite efforts to prevent them. There may be need for variations in the process to accommodate the needs of different settings (e.g., emergency departments, intensive care units, palliative care services, home or community care, etc.). The conflict resolution policy of a health care authority, facility or agency should incorporate the following elements, the sequence of which may vary depending on the situation. The policy should designate the person responsible for implementing each element. That person should work closely with the person receiving care or his or her proxy. Anyone involved in the conflict may initiate the resolution process. 1. Clarify the need for an immediate decision versus the consequences of delaying a decision. If, in an emergency situation, there is insufficient time to fully implement the process, it should be implemented as soon as possible. 2. Gather together those directly involved in the conflict; in addition to the person receiving care and/or his or her proxy, this might include various health care providers, family members, administrators, etc. 3. If necessary, choose a person not party to the conflict to facilitate discussions. It is imperative that this person be acceptable to all those involved and have the skills to facilitate open discussion and decision-making. 4. Identify and agree on the points of agreement and disagreement. While ensuring confidentiality, share among those involved all relevant medical and personal information, interpretations of the relevant facts, institutional or agency policies, professional norms and laws. 5. Establish the roles and responsibilities of each participant in the conflict. 6. Offer the person receiving care, or his or her proxy, access to institutional, agency or community resources for support in the conflict resolution process, e.g., a patient representative, chaplain or other resource person. 7. Determine if the group needs outside advice or consultation, e.g., a second opinion, use of an ethics committee or consultant or other resource. 8. Identify and explore all options and determine a time line for resolving the conflict. Ensure that all participants have the opportunity to express their views; the lack of expressed disagreement does not necessarily mean that decision-making is proceeding with the support or consent of all involved. 9. If, after reasonable effort, agreement or compromise cannot be reached through dialogue, accept the decision of the person with the right or responsibility for making the decision. If it is unclear or disputed who has the right or responsibility to make the decision, seek mediation, arbitration or adjudication. 10. If the person receiving care or his or her proxy is dissatisfied with the decision, and another care provider, facility or agency is prepared to accommodate the person's needs and preferences, provide the opportunity for transfer. 11. If a health care provider cannot support the decision that prevails as a matter of professional judgement or personal morality, allow him or her to withdraw without reprisal from participation in carrying out the decision, after ensuring that the person receiving care is not at risk of harm or abandonment. 12. Once the process is completed; review and evaluate: (a) the process, (b) the decision reached, and (c) implementation of the decision. The conclusions of the evaluation should be recorded and shared for purposes of education and policy development. III. Policy development Health care authorities, facilities and agencies are encouraged to make use of an interdisciplinary committee to develop two conflict resolution policies: one for conflicts among health care providers (including administrators) and the other for conflicts between care providers and persons receiving care. Membership on the committee should include care providers, consumers and administrators, with access to legal and ethics consultation. The committee should also develop a program for policy implementation. The successful implementation of the policy will require an organizational culture that encourages and supports the principles of the therapeutic relationship as outlined in this joint statement. The implementation program should include the education of all those who will be affected by the policy with regard to both the principles of the therapeutic relationship and the details of the conflict resolution policy. It should also include measures to ensure that persons receiving care and their families or proxy decision-makers have access to the policy and its use. The policy should be reviewed regularly and revised when necessary in light of relevant clinical, ethical and legal developments. Because policies and guidelines cannot cover all possible situations, appropriate consultation mechanisms should be available to address specific issues promptly as they arise. Notes 1. The term "proxy" is used broadly in this joint statement to identify those people who are entitled to make a care and treatment decision for an incompetent person (in some provinces or territories, the definition of proxy is provided in legislation). This decision should be based on the decision the person would have made for himself or herself, to the best of the proxy’s (substitute decision maker’s) knowledge; or if this is unknown, the decision should be made in the person’s best interest. 2. The term "therapeutic relationship" is used broadly in this document to include all professional interactions between care providers, individually or as a team, and recipients of care. 3. Competence can be difficult to assess because it is not always a constant state. A person may be competent to make decisions regarding some aspects of life but not others; as well, competence can be intermittent: a person may be lucid and oriented at certain times of the day and not at others. The legal definition and assessment of competence are governed by the provinces or territories. Health care providers should be aware of existing laws relevant to the assessment and documentation of incompetence (e.g., capacity to consent and age-of-consent legislation). 4. Professional judgement will take into account the standard of care that a facility or agency is committed to provide. 5. On this matter, cf. Guiding Principle 6 of the Joint Statement on Resuscitative Interventions (Update 1995), developed by the Canadian Healthcare Association, the Canadian Medical Association, the Canadian Nurses Association and the Catholic Health Association of Canada, “There is no obligation to offer a person futile or nonbeneficial treatment. Futile and nonbeneficial treatments are controversial concepts when applied to CPR (cardiopulmonary resuscitation). Policymakers should determine how these concepts should be interpreted in the policy on resuscitation, in light of the facility's mission, the values of the community it serves, and ethical and legal developments. For the purposes of this joint document and in the context of resuscitation,'futile' and 'nonbeneficial' are understood as follows. In some situations a physician can determine that a treatment is 'medically' futile or nonbeneficial because it offers no reasonable hope of recovery or improvement or because the person is permanently unable to experience any benefit. In other cases the utility and benefit of a treatment can only be determined with reference to the person's subjective judgement about his or her overall well-being. As a general rule a person should be involved in determining futility in his or her case. In exceptional circumstances such discussions may not be in the person's best interests. If the person is incompetent the principles for decision making for incompetent people should be applied.” © 1999, Canadian Healthcare Association, Canadian Medical Association, Canadian Nurses Association and Catholic Health Association of Canada. Permission is granted for noncommercial reproduction only. Copies of the joint statement can be obtained by contacting: Membership Services, Canadian Medical Association, PO Box 8650, Ottawa ON K1G 0G8, tel 888 855-2555, fax 613 236-8864 or by visiting the Web site www.cma.ca/inside/policybase (English) or www.cma.ca/inside-f/policybase (French); or Customer Services, Canadian Healthcare Association, 17 York Street, Ottawa ON K1N 0J6, tel 613 241-8005, x253, fax 613 241-9481, or by visiting the Web site www.canadian-healthcare.org; or Publication Sales, Canadian Nurses Association, 50 The Driveway, Ottawa ON K2P 1E2, tel 613 237-2133, fax 613 237-3520, or by visiting the Web site www.cna-nurses.ca; or Publications, Catholic Health Association of Canada, 1247 Kilborn Place, Ottawa ON K1H 6K9, 613 731-7148, fax 613 731-7797, or by visiting the Web site www.net-globe.com/chac/.
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Physician advocates

https://policybase.cma.ca/en/permalink/policy9915
Last Reviewed
2017-03-04
Date
2010-08-25
Topics
Ethics and medical professionalism
Physician practice/ compensation/ forms
Resolution
GC10-98
The Canadian Medical Association opposes any bylaws, codes of conduct or policies that have the potential to limit physicians’ ability to speak out or advocate on behalf of their patients or to comment on issues that affect their ability to provide high quality clinical care.
Policy Type
Policy resolution
Last Reviewed
2017-03-04
Date
2010-08-25
Topics
Ethics and medical professionalism
Physician practice/ compensation/ forms
Resolution
GC10-98
The Canadian Medical Association opposes any bylaws, codes of conduct or policies that have the potential to limit physicians’ ability to speak out or advocate on behalf of their patients or to comment on issues that affect their ability to provide high quality clinical care.
Text
The Canadian Medical Association opposes any bylaws, codes of conduct or policies that have the potential to limit physicians’ ability to speak out or advocate on behalf of their patients or to comment on issues that affect their ability to provide high quality clinical care.
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CMA Response: Health Canada's Medical Marijuana Regulatory Proposal

https://policybase.cma.ca/en/permalink/policy10702
Date
2013-02-28
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
://policybase.cma.ca/dbtw-wpd/Policypdf/PD08-01.pdf 7 Lee J. “Ross Rebagliati to Open medical marijuana franchise
  1 document  
Policy Type
Parliamentary submission
Date
2013-02-28
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The Canadian Medical Association welcomes the opportunity to comment on proposed changes to Health Canada's Marihuana for Medical Purposes Regulations, published in the Canada Gazette, Part I on December 15, 2012. CMA provided comments on the proposed changes when Health Canada first announced them in June 2011. Our position on these changes, and indeed on the entire Medical Marihuana Access Program (MMAP), has been consistent since the program was initiated. We remain deeply concerned that, though the program has made a physician's authorization the key to a patient's access to medical marijuana, physicians and other health professionals have little to no evidence-based information about its use as medical therapy. As our President, Dr. Anna Reid, noted in December, the regulatory proposals are "equivalent to asking doctors to prescribe while blindfolded." Health Canada gives two reasons for its regulatory proposal: first, to address concerns about the safety of home grow-ops; and secondly, to reduce the cost of administering a program that has proven more popular than anticipated. Neither of these reasons is related to improving patient care or advancing our clinical knowledge of marijuana as a medical treatment. CMA understands that many Canadians suffer constant pain from chronic or terminal illnesses and are searching for anything that will provide relief. We know that some patients find that use of marijuana relieves their symptoms and that some health professionals also believe it has therapeutic value. However, we are concerned that these claims remain inadequately supported by scientific research. Controlled studies of medical marijuana have been published recently and some have shown benefits. However, these studies are few in number, of short duration and with small samples, and knowledgeable clinicians say that more research is required. In addition, some say that marijuana has become more potent since it became a popular recreational drug in the 1960s, though others disagree,1 and growers say they can develop strains tailored to the needs of individual medical users.2 Though these claims are part of the popular understanding of medical marijuana, there is no scientifically valid evidence that supports them. What Physicians Have Told Us In May 2012, CMA surveyed members of its "e-panel" of physicians to obtain more information about their attitudes and needs regarding medical marijuana. The survey received just over 600 responses out of more than 2,200, for a 27 per cent response rate. Among the findings: * About 70 per cent of respondents had been asked by patients to approve medical marijuana, though only four per cent said they were asked to do so "often." Of those who were asked, one-third reported that they "never" supported such requests, while 18 per cent "usually" did so. * 64 per cent of respondents were concerned that patients who request medical marijuana may actually be using it for recreational purposes; * A large majority of respondents said they would find more information on the appropriate use of marijuana for medicinal purposes, and on its therapeutic benefits and risks, useful or very useful. * About two-thirds agreed or strongly agreed that they would feel more comfortable if: o Physicians wishing to use medical marijuana in their practices were required to undergo special training and licensing; and, o Health Canada offered them protection from liability. * In open-ended questions, some respondents expressed favourable views on marijuana's medical benefits. However, a larger number expressed concern over its harmful effects, such as: psychotic symptoms, especially in younger people; potential for addiction and dependency; and the risks to lung health from smoking it or any other substance. Marijuana is Not Like Other Therapeutic Products Theoretically, marijuana, when used for medicinal purposes, is regulated under the Food and Drugs Act. However, because of its unique legal position, Health Canada has exempted it from the applications of the Act and its regulations, and it has not undergone the scrutiny of benefits and risks required of other therapeutic products approved for use in Canada, be they prescription-only or over-the-counter. According to the Food and Drugs Act (FDA), all drugs requiring a health professional's authorization must be approved for use by Health Canada, based on evidence of effectiveness obtained from controlled clinical trials, which remain the best currently available means of validating knowledge. In addition, Health Canada has a system of post-market surveillance to keep track of problems that arise with prescription drugs in real-world use. Though the CMA has been critical of some aspects of this system,3 we acknowledge that it has added to our body of knowledge on drug safety risks. If marijuana were not an illegal product, it might have been assessed through some form of pre-approval and post-approval surveillance. By exempting marijuana from the FDA's pre-approval and post-approval requirements, Health Canada has lost an opportunity to improve our knowledge of the drug's therapeutic uses. The Views of Canadians A recent online survey conducted by Ipsos-Reid on behalf of the CMA provides insight into the views of Canadians on Health Canada's regulatory proposal.4 The survey found: * 92 per cent of Canadians think it is very or somewhat important that Health Canada not remove itself from its oversight role until guidelines are put in place for physicians; * 90 per cent believe that research on the effectiveness, safety and risks of medical marijuana is needed before Health Canada removes itself from the authorization process; * 85 per cent of Canadians believe medical marijuana should be subject to the same rigorous testing and approval standards as other medicines; * 79 per cent agree that Health Canada has a responsibility to maintain its role in the authorization process.; The Role of the Physician The CMA cannot with certainty predict the consequences of these regulatory changes for the practising physician (and, if the regulations are approved, for the nurse practitioner as well). However, we have several causes for concern: * The gatekeeper role of health professionals: The most significant change, from our point of view, is that Health Canada is removing itself from the approval process, making it a transaction between the patient, the practitioner and the licensed producer. In addition, Section 125 of the regulatory proposal would reduce the content of the authorization form, from its current two-page format to a brief document requiring little more information than is required for a standard medical prescription. We are concerned that these changes will put an even greater onus on physicians than do the current regulations. The CMA agrees with the Federation of Medical Regulatory Authorities that the lack of evidence to support the use of marijuana for medicinal purposes signifies that it is not a medical intervention. In our opinion, putting physicians in the role of gatekeeper for access to marijuana is inappropriate and may be an abdication of responsibility on Health Canada's part.5 Such a move could increase physicians' liability risk and put them at odds with their medical regulatory authorities, which have no choice but to continue to advise physicians to exercise extreme caution. The CMA believes, as does the Canadian Medical Protective Association, that a drug's approval under the Food and Drugs Act does not impose a legal obligation on physicians or nurse practitioners to authorize its use if, in their judgment, it is clinically inappropriate. The Ontario Court of Appeal reached a similar decision recently in the case of R. v. Mernagh. * Protection of Physician Privacy. Under the proposed regulations, health information and physician data - such as the patient's name and date of birth, or the provider's licence number - will be collected by licensed producers who may not be subject to the same regulatory and privacy constraints as the health care sector. The draft regulations also indicate that the licensed producer is expected to confirm that the data on the "medical document" is correct and complete - in other words, health providers who authorize medical marijuana use will receive correspondence from the producer. We are very concerned about the risks this would pose to the privacy of patient and health care provider information. We believe Health Canada should conduct a privacy impact assessment of its proposed regulations or, if it has done so, to share the results. * Physicians as Dispensers. Section 124 of the proposed regulations would allow authorized health care practitioners to "sell, provide or administer dried marijuana." This is contrary to Article 46 of the CMA Guidelines for Physicians in Interactions with Industry, which states that "Physicians should not dispense pharmaceuticals or other products unless they can demonstrate that these cannot be provided by an appropriate other party."6 * Other possible consequences. We are also concerned about other potential consequences of the regulatory changes. Will more people go to health professionals requesting an authorization, on the assumption that the new regulations will make it easier to get? Will entrepreneurs seize the opportunity to establish "dispensaries" whose intended clientele are not those in legitimate medical need, as recent news stories have suggested?7 Will medical marijuana advocates put increased pressure on physicians to authorize its use? Meeting the Information Needs of Physicians In one respect, Health Canada has listened to physicians' concerns regarding the lack of evidence about medical marijuana, and acknowledged the need to remedy this problem. Though it is not addressed in the draft regulations, Health Canada has established an Expert Advisory Committee (EAC) to help provide comprehensive information to health professionals. The CMA has attended meetings of this committee in an observer capacity, suggested the names of practising physicians to serve as members, and made a presentation to the committee at its meeting in November 2012. If the EAC follows the CMA's suggestions, it will consider actively supporting the following activities: * Funding of scientific research on the clinical risks and benefits of marijuana; * Knowledge translation activities to convert this research into accessible, user-friendly tools for education and practice; * Development of best practice guidelines in the therapeutic use of marijuana. Though this guideline would of necessity be based on "C" level evidence, it would be an improvement on what now exists; and * Support for a compulsory training and licensing program for physicians wanting to authorize marijuana for medicinal purposes. The CMA believes that the EAC should be given the mandate and resources to undertake these activities. Conclusion Health Canada's stated mission is to help the people of Canada maintain and improve their health. The CMA believes that if Health Canada wants its Medical Marihuana Access Program to serve this mission, it should not withdraw from administering the program, leaving it to health professionals working within a large knowledge gap. Rather, it should support solid research into the use of marijuana as medication and make a commitment to share this knowledge with the health professional community and to support best clinical practices. 1 Bonsor K: "How marijuana works". Accessed at http://science.howstuffworks.com/marijuana5.htm 2 http://medicalmarijuana.ca/learning-center/marijuana-strains 3 CMA Submission to the House of Commons Standing Committee on Health: Post-Market Surveillance of Prescription Drugs (February 28, 2008). Accessed at http://www.cma.ca/multimedia/CMA/Content_Images/Inside_cma/Submissions/2008/brief-drug-en-08.pdf 4 Online survey of 1,000 Canadians the week of Feb. 24, 2013 conducted by Ipsos-Reid. Summary report of the poll can be accessed at www.cma.ca/advocacy/cma-media-centre. 5 Letter to Health Canada from Yves Robert, MD, President of the Federation of Medical Regulatory Authorities of Canada, November 4, 2011. 6 CMA. 2004. Guidelines for Physicians in Interactions with Industry. Guideline can be accessed online: http://policybase.cma.ca/dbtw-wpd/Policypdf/PD08-01.pdf 7 Lee J. "Ross Rebagliati to Open medical marijuana franchise." Vancouver Sun. January 23, 2013. Accessed at http://www.vancouversun.com/health/Ross+Rebagliati+open+medical+marijuana+franchise/7860946/story.html
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