GUIDELINES FOR PHYSICIANS IN INTERACTIONS WITH INDUSTRY
The history of health care delivery in Canada has included interaction between physicians and the pharmaceutical and health supply industries; this interaction has extended to research as well as to education. Physicians understand that they have a responsibility to ensure that their participation in such collaborative efforts is in keeping with their primary obligation to their patients and duties to society, and to avoid situations of conflict of interest where possible and appropriately manage these situations when necessary. They understand as well the need for the profession to lead by example by promoting physician-developed guidelines.
The following guidelines have been developed by the CMA to serve as a resource tool for physicians in helping them to determine what type of relationship with industry is appropriate. They are not intended to prohibit or dissuade appropriate interactions of this type, which have the potential to benefit both patients and physicians.
Although directed primarily to individual physicians, including residents, and medical students, the guidelines also apply to relationships between industry and medical organizations.
1. The primary objective of professional interactions between physicians and industry should be the advancement of the health of Canadians.
2. Relationships between physicians and industry are guided by the CMA's
Code of Ethics and by this document.
3. The practising physician's primary obligation is to the patient. Relationships with industry are inappropriate if they negatively affect the fiduciary nature of the patient-physician relationship.
4. Physicians should resolve any conflict of interest between themselves and their patients resulting from interactions with industry in favour of their patients. In particular, they must avoid any self-interest in their prescribing and referral practices.
5. Except for physicians who are employees of industry, in relations with industry the physician should always maintain professional autonomy and independence. All physicians should remain committed to scientific methodology.
6. Those physicians with ties to industry have an obligation to disclose those ties in any situation where they could reasonably be perceived as having the potential to influence their judgment.
7. A prerequisite for physician participation in all research activities is that these activities are ethically defensible, socially responsible and scientifically valid. The physician's primary responsibility is the well-being of the patient.
8. The participation of physicians in industry sponsored research activities must always be preceded by formal approval of the project by an appropriate ethics review body. Such research must be conducted according to the appropriate current standards and procedures.
9. Patient enrolment and participation in research studies must occur only with the full, informed, competent and voluntary consent of the patient or his or her proxy, unless the research ethics board authorizes an exemption to the requirement for consent. In particular, the enrolling physician must inform the potential research subject, or proxy, about the purpose of the study, its source of funding, the nature and relative probability of harms and benefits, and the nature of the physician's participation and must advise prospective subjects that they have the right to decline to participate or to withdraw from the study at any time, without prejudice to their ongoing care.
10. The physician who enrolls a patient in a research study has an obligation to ensure the protection of the patient's privacy, in accordance with the provisions of applicable national or provincial legislation and CMA's Health Information Privacy Code. If this protection cannot be guaranteed, the physician must disclose this as part of the informed consent process.
11. Practising physicians should not participate in clinical trials unless the study will be registered prior to its commencement in a publicly accessible research registry.
12. Because of the potential to influence judgment, remuneration to physicians for participating in research studies should not constitute enticement. It may cover reasonable time and expenses and should be approved by the relevant research ethics board. Research subjects must be informed if their physician will receive a fee for their participation and by whom the fee will be paid.
13. Finder's fees, whereby the sole activity performed by the physician is to submit the names of potential research subjects, should not be paid. Submission of patient information without their consent would be a breach of confidentiality. Physicians who meet with patients, discuss the study and obtain informed consent for submission of patient information may be remunerated for this activity.
14. Incremental costs (additional costs that are directly related to the research study) must not be paid by health care institutions or provincial or other insurance agencies regardless of whether these costs involve diagnostic procedures or patient services. Instead, they must be assumed by the industry sponsor or its agent.
15. When submitting articles to medical journals, physicians must state any relationship they have to companies providing funding for the studies or that make the products that are the subject of the study whether or not the journals require such disclosure. Funding sources for the study should also be disclosed.
16. Physicians should only be included as an author of a published article reporting the results of an industry sponsored trial if they have contributed substantively to the study or the composition of the article.
17. Physicians should not enter into agreements that limit their right to publish or disclose results of the study or report adverse events which occur during the course of the study. Reasonable limitations which do not endanger patient health or safety may be permissible.
Industry-Sponsored Surveillance Studies
18. Physicians should participate only in post-marketing surveillance studies that are scientifically appropriate for drugs or devices relevant to their area of practice and where the study may contribute substantially to knowledge about the drug or device. Studies that are clearly intended for marketing or other purposes should be avoided.
19. Such studies must be reviewed and approved by an appropriate research ethics board. The National Council on Ethics in Human Research is an additional source of advice.
20. The physician still has an obligation to report adverse events to the appropriate body or authority while participating in such a study.
Continuing Medical Education / Continuing Professional Development (CME/CPD)
21. This section of the Guidelines is understood to address primarily medical education initiatives designed for practicing physicians. However, the same principles will also apply for educational events (such as noon-hour rounds and journal clubs) which are held as part of medical or residency training.
22. The primary purpose of CME/CPD activities is to address the educational needs of physicians and other health care providers in order to improve the health care of patients. Activities that are primarily promotional in nature, such as satellite symposia, should be identified as such to faculty and attendees and should not be considered as CME/CPD.
23. The ultimate decision on the organization, content and choice of CME/CPD activities for physicians shall be made by the physician-organizers.
24. CME/CPD organizers and individual physician presenters are responsible for ensuring the scientific validity, objectivity and completeness of CME/CPD activities. Organizers and individual presenters must disclose to the participants at their CME/CPD events any financial affiliations with manufacturers of products mentioned at the event or with manufacturers of competing products. There should be a procedure available to manage conflicts once they are disclosed.
25. The ultimate decision on funding arrangements for CME/CPD activities is the responsibility of the physician-organizers. Although the CME/CPD publicity and written materials may acknowledge the financial or other aid received, they must not identify the products of the company(ies) that fund the activities.
26. All funds from a commercial source should be in the form of an unrestricted educational grant payable to the institution or organization sponsoring the CME/CPD activity.
27. Industry representatives should not be members of CME content planning committees. They may be involved in providing logistical support.
28. Generic names should be used in addition to trade names in the course of CME/CPD activities.
29. Physicians should not engage in peer selling. Peer selling occurs when a pharmaceutical or medical device manufacturer or service provider engages a physician to conduct a seminar or similar event that focuses on its own products and is designed to enhance the sale of those products. This also applies to third party contracting on behalf of industry. This form of participation would reasonably be seen as being in contravention of the CMA's Code of Ethics, which prohibits endorsement of a specific product.
30. If specific products or services are mentioned, there should be a balanced presentation of the prevailing body of scientific information on the product or service and of reasonable, alternative treatment options. If unapproved uses of a product or service are discussed, presenters must inform the audience of this fact.
31. Negotiations for promotional displays at CME/CPD functions should not be influenced by industry sponsorship of the activity. Promotional displays should not be in the same room as the educational activity.
32. Travel and accommodation arrangements, social events and venues for industry sponsored CME/CPD activities should be in keeping with the arrangements that would normally be made without industry sponsorship. For example, the industry sponsor should not pay for travel or lodging costs or for other personal expenses of physicians attending a CME/CPD event. Subsidies for hospitality should not be accepted outside of modest meals or social events that are held as part of a conference or meeting. Hospitality and other arrangements should not be subsidized by sponsors for personal guests of attendees or faculty, including spouses or family members.
33. Faculty at CME/CPD events may accept reasonable honoraria and reimbursement for travel, lodging and meal expenses. All attendees at an event cannot be designated faculty. Faculty indicates a presenter who prepares and presents a substantive educational session in an area where they are a recognized expert or authority.
Electronic Continuing Professional Development (eCPD)
34. The same general principles which apply to "live, in person" CPD events, as outlined above, also apply to eCPD (or any other written curriculum-based CPD) modules. The term "eCPD" generally refers to accredited on-line or internet-based CPD content or modules. However, the following principles can also apply to any type of written curriculum based CPD.
35. Authors of eCPD modules are ultimately responsible for ensuring the content and validity of these modules and should ensure that they are both designed and delivered at arms'-length of any industry sponsors.
36. Authors of eCPD modules should be physicians with a special expertise in the relevant clinical area and must declare any relationships with the sponsors of the module or any competing companies.
37. There should be no direct links to an industry or product website on any web page which contains eCPD material.
38. Information related to any activity carried out by the eCPD participant should only be collected, used, displayed or disseminated with the express informed consent of that participant.
39. The methodologies of studies cited in the eCPD module should be available to participants to allow them to evaluate the quality of the evidence discussed. Simply presenting abstracts that preclude the participant from evaluating the quality of evidence should be avoided. When the methods of cited studies are not available in the abstracts, they should be described in the body of the eCPD module.
40. If the content of eCPD modules is changed, re-accreditation is required.
41. Physicians may be approached by industry representatives and asked to become members of advisory or consultation boards, or to serve as individual advisors or consultants. Physicians should be mindful of the potential for this relationship to influence their clinical decision making. While there is a legitimate role for physicians to play in these capacities, the following principles should be observed:
A. The exact deliverables of the arrangement should be clearly set out and put in writing in the form of a contractual agreement. The purpose of the arrangement should be exclusively for the physician to impart specialized medical knowledge that could not otherwise be acquired by the hiring company, and should not include any promotional or educational activities on the part of the company itself.
B. Remuneration of the physician should be reasonable and take into account the extent and complexity of the physician's involvement.
C. Whenever possible, meetings should be held in the geographic locale of
the physician or as part of a meeting which he/she would normally attend. When these arrangements are not feasible, basic travel and accommodation expenses may be reimbursed to the physician advisor or consultant. Meetings should not be held outside of Canada, with the exception of international boards.
Clinical Evaluation Packages (Samples)
42. The distribution of samples should not involve any form of material gain for the physician or for the practice with which he or she is associated.
43. Physicians who accept samples or other health care products are responsible for recording the type and amount of medication or product dispensed. They are also responsible for ensuring their age-related quality and security and their proper disposal.
44. Practising physicians should not accept personal gifts of any significant monetary or other value from industry. Physicians should be aware that acceptance of gifts of any value has been shown to have the potential to influence clinical decision making.
45. These guidelines apply to relationships between physicians and all commercial organizations, including but not limited to manufacturers of medical devices, nutritional products and health care products as well as service suppliers.
46. Physicians should not dispense pharmaceuticals or other products unless they can demonstrate that these cannot be provided by an appropriate other party, and then only on a cost-recovery basis.
47. Physicians should not invest in industries or related undertakings if this might inappropriately affect the manner of their practice or their prescribing behaviour.
48. Practising physicians affiliated with pharmaceutical companies should not allow their affiliation to influence their medical practice inappropriately.
49. Practising physicians should not accept a fee or equivalent consideration from pharmaceutical manufacturers or distributors in exchange for seeing them in a promotional or similar capacity.
50. Practising physicians may accept patient teaching aids appropriate to their area of practice provided these aids carry at most the logo of the donor company and do not refer to specific therapeutic agents, services or other products.
Medical Students and Residents
51. The principles in these guidelines apply to physicians-in training as well as to practising physicians.
52. Medical curricula should deal explicitly with the guidelines by including educational sessions on conflict of interest and physician-industry interactions.
Medical professionalism (Update 2005)
The environment in which medicine is practised in Canada is undergoing rapid and profound change. There are now continued opportunities for the medical profession to provide leadership for our patients, our communities and our colleagues through strengthened professionalism. The Canadian Medical Association (CMA) is strongly committed to medical professionalism and has developed this policy both to inform physicians and others about its meaning and value and to promote its preservation and enhancement. This document outlines the major features of medical professionalism, the opportunities which exist in this area and the challenges which lie before us.
Why Medical Professionalism?
The medical profession is characterized by a strong commitment to the well-being of patients, high standards of ethical conduct, mastery of an ever-expanding body of knowledge and skills, and a high level of clinical independence. As individuals, physicians' personal values may vary, but as members of the medical profession they are expected to share and uphold those values that characterize the practice of medicine and the care of patients.
Medical professionalism includes both the relationship between a physician and a patient and a social contract between physicians and society. Society grants the profession privileges, including exclusive or primary responsibility for the provision of certain services and a high degree of self-regulation. In return, the profession agrees to use these privileges primarily for the benefit of others and only secondarily for its own benefit. Three major features of medical professionalism - the ethic of care, clinical independence and self-regulation - benefit physicians, their patients and society:
Ethic of care: This is characterized by the values of compassion, beneficence, nonmaleficence, respect for persons and justice (CMA's Code of Ethics). Society benefits from the ethic of care whereby, in the provision of medical services, physicians put the interests of others ahead of their own. Dedication and commitment to the well-being of others is clearly in the interests of patients, who are the primary beneficiaries.
Clinical independence: Medicine is a highly complex art and science. Through lengthy training and experience, physicians become medical experts and healers. Whereas patients have the right to decide to a large extent which medical interventions they will undergo, they expect their physicians to be free to make clinically appropriate recommendations. Although physicians recognize that they are accountable to patients, funding agencies and their peers for their recommendations, unreasonable restraints on clinical autonomy imposed by governments and administrators, whether public or private, are not in the best interests of patients, not least because they can damage the trust that is an essential component of the patient-physician relationship. Conversely, physicians are not morally obliged to provide inappropriate medical services when requested by patients despite their respect for patient autonomy.
Self-regulation: Physicians have traditionally been granted this privilege by society. It includes the control of entrance into the profession by establishing educational standards and setting examinations, the licensing of physicians, and the establishment and ongoing review of standards of medical practice. In return for this privilege, physicians are expected to hold each other accountable for their behaviour and for the outcomes they achieve on behalf of their patients. Self-regulation is exercised by many different professional organizations, from medical practice partnerships to the statutory provincial/territorial licensing bodies. It has evolved into a partnership with the public. Self-regulation benefits society by taking the best advantage of the professional expertise needed to appropriately set and maintain standards of training and practice, while providing suitable accountability in matters of professional behaviour. The profession's commitment to the maintenance of those standards is demonstrated by its willingness to participate in outcomes review at many levels, from institutional quality assurance activities to formal prospective peer review, and to actively support their statutory and legislated licensing authorities.
Opportunities in Medical Professionalism
Over the past few years much has been written about the issue of medical professionalism in both the lay and scientific media. The practice of medicine has changed considerably, and with these changes have come challenges but also opportunities. The medical profession continues to be a greatly respected one, and it is still generally seen as being distinct from many others because of the unique nature of the physician-patient relationship. There exists now an opportunity to reinforce the professional values and priorities that have sustained medicine for so long, and to embrace new approaches which will serve it well in the years to come.
Medical professionals must recognize that patients have a wide variety of resources available for their health care needs, from traditional physician services to paramedical practitioners, to complementary medicine and to information obtained from the internet. While maintaining responsibility for care of the patient as a whole, physicians must be able to interact constructively with other health care providers within an interdisciplinary team setting, and must be able to interpret information for patients and direct them to appropriate and accurate resources.
The relationship of physicians with their colleagues must be strengthened and reinforced. Patient care benefits when all health care practitioners work together towards a common goal, in an atmosphere of support and collegiality.
Although there are some challenges to professionalism, as outlined below, the greatest opportunity before us may be to remind physicians of the reasons they chose a career in medicine to begin with - for many, it is a calling rather than a job. In spite of the numerous recent changes in the health care system and the practice of medicine, the primary reason most physicians entered the field remains the same - the sanctity of the fiduciary relationship between physicians and their patients. The renewal of medical professionalism must be led from within the profession itself, and the CMA and its members are in a unique position to take advantage of the many opportunities which exist and to respond to the challenges we face.
Challenges to Medical Professionalism
Medical professionalism is being challenged from within and without. These challenges arise from pressures that may serve to undermine the ethic of care, clinical independence and self-regulation and may result, for individual physicians and the medical profession, in diminished morale and changes in lifestyle and practice patterns. These changes may have a detrimental impact on the health of physicians, and also on the quality of patient care.
Resource restraints: The CMA has identified scarcity of resources, whether human or material, as undermining the ability of physicians to maintain excellence in clinical care, research and teaching. Although much attention has been paid recently to the insufficient number of physicians in Canada, and although recent developments indicate some limited cause for optimism, much work remains to be done. Issues of access to continuing professional development, workforce sustainability, inadequate numbers of training positions for new doctors, the integration of foreign-trained physicians into the workforce and the apparent inability of governments to resolve inadequacies in health care funding continue to frustrate physicians' attempts to achieve their professional goals and care for their patients. These factors all have the potential for contributing to the decline of professional morale.
Bureaucratic challenges: This refers to the introduction of layers of management and policy directives between the physician and the patient. It is a result of changes that have taken place in the organization and delivery of medical care, especially the involvement of governments in all aspects of health care. The traditional one-on-one relationship of physician and patient is now set within a context of government and corporate interests, in which the physician may sometimes assume the status of an employee, that pose considerable challenges to the exercise of the professional values of clinical autonomy and self-regulation. Moreover, while the responsibility for organizing the delivery of scarce resources has been increasingly transferred from physicians to managers, physicians are still ultimately responsible, both morally and legally, for providing quality care. Although the increasing complexity of health care delivery requires recourse to sophisticated management systems, there is a danger that as physicians become increasingly answerable to or constrained by third parties, their ability to fulfill their commitment to their individual patients can be seriously compromised.
Unprofessional conduct: Some physicians do not uphold the values of the profession. A few put their interests or the interests of third parties ahead of the interests of their patients. The profession needs to meet this challenge by demonstrating its ability to uphold its values and its commitment to doing so. Supporting strong and transparent self-regulatory systems will be a key component of this endeavor.
Commercialism: In recent years the market mentality has expanded its influence to many areas formerly outside its domain, including governments, universities and the professions. Health care has become a major industry, one in which physicians play a central role, and commercial interests, whether private or public, may pressure physicians to compromise their responsibilities to their patients, research subjects and society. The potential for physicians and medical associations to become drawn into conflict-of-interest situations is increasing. Commercialism may compromise both the ethic of care and clinical independence by its reinterpretation of medical care as a commodity and the patient-physician relationship as something less than a fiduciary relationship. There is an inherent opportunity for the profession to address the issue of conflict of interest and to re-affirm its primary obligation and dedication to the patients it cares for.
Consumerism: Physicians strongly support the right of patients to make informed decisions about their medical care. However, the CMA's Code of Ethics requires physicians to recommend only those diagnostic and therapeutic procedures that they consider to be beneficial to the patient or to others. There is a proliferation of health information and advertising in the popular media and on the Internet that may be inaccurate or poorly understood. Taken to its extreme, consumerism can be detrimental not just to professionalism but to the well-being of patients and the interests of society.
Industrialization: This refers to the increased division and specialization of labour in the delivery of health care, whereby the delivery of health care may become fragmented. There is increasing pressure within medicine to improve efficiency and optimize cost savings. While these may be important goals in the broader context of health care, we must ensure that they do not impact negatively on the doctor-patient relationship.
Realizing Opportunities and Dealing with Challenges
Individual physicians should protect, enhance and promote professionalism in medicine by reflecting the values of the medical profession in their practice and by contributing to the efforts of organized medicine to maintain and enhance the ethic of care, clinical autonomy and self-regulation. These efforts require action in 3 areas: policy, education and self-regulation.
Policy: All those involved in health care - physicians, patients, other health care providers, administrators, governments and the general public (as taxpayers, potential patients, relatives of patients, etc.) - should be informed about the values of the medical profession and where it stands on issue related to accountability, clinical autonomy and self-regulation. Policies of medical associations should reflect these values and should speak clearly on topics such as conflict of interest. Policies should be reviewed frequently and updated when necessary, in order to take account of the rapidly changing environment in which medicine is practiced. The topic of professionalism should be granted increasing importance in policy discussions. Policies should be developed and updated in related areas, such as conflict of interest and physician-industry interactions.
In order to be consistent and trustworthy, medical associations should adhere to the same high standards of behaviour that they require of individual physicians. The challenges posed by resource restraints, bureaucratization, unprofessional conduct, commercialism and consumerism are no less serious for associations than for individuals and require sound harmonized policies for both. The CMA has an opportunity for leadership in this regard.
Education: However professional values and policies are established, they must be transmitted to current and future members of the profession in order to have any effect.
Like most other aspects of medical education, the values of professionalism are both taught and modeled. Professionalism should be an essential component of the formal medical curriculum at the undergraduate and postgraduate training levels. Moreover, active demonstration of professionalism such as role modeling by physicians, and in the internal culture of the medical schools and hospitals where students receive their training, should be used to advantage and challenged when necessary. Likewise for physicians in practice, formal continuing professional development programs and role modeling by other physicians are important for the maintenance of professionalism.
Physicians need to communicate and test their understanding of their professional role with others involved in patient care at numerous levels. Such initiatives, which would engage patients, other professionals and policy-makers, require further development.
The CMA and other medical organizations have taken leadership roles in assisting patients and health care providers in making informed decisions by creating numerous continuing professional development opportunities and readily available clinical information for physicians, effective patient education materials, self-help books and validated Web sites, including www.cma.ca. These efforts need to continue and be strengthened.
Self-regulation: In order to maintain self-regulation in an environment that is increasingly suspicious of such privileges, the medical profession has to demonstrate that self regulation benefits society in general. This requires, among other things, that the medical profession continue to demonstrate its commitment to the tasks required by self-regulation, including setting and enforcing high standards of behaviour for both individual physicians and medical associations.
Physicians continue to value medical professionalism highly. They believe that it benefits patients greatly and that it should be preserved and enhanced. Professionalism will continue to be based on the relationship of trust between patients and physicians, and the primacy of the physician-patient relationship. It encompasses the values of compassion, beneficence, nonmaleficence, respect for persons and justice. As professionals, physicians will strive to maintain high standards of ethics, clinical practice and education and demonstrate a capacity for social responsibility through self-regulation and accountability (see CMA Policy Statement The Future of Medicine).
The CMA welcomes opportunities to engage in dialogue with others as to how professionalism in health care can be preserved and enhanced for the benefit of patients, physicians and society in general.
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.
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
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