Prepared for Health Canada by
The Health Law Institute
Faculty of Law
University of Alberta
Edmonton, Alberta
March 2003
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a. Approval of products for sale
b. Labelling and informed choice
c. Post-approval surveillance
d. Enforcement of the regulatory framework
2. International trade agreements
III. LEGAL ISSUE RE PRACTIONERS
1. Regulation of practitioners
Exclusive scope of practice
Controlled acts
Title protection
Which system of statutory regulation?
Issues commonly addressed in statutory regulation
Statutory regulation, CAM and multi-disciplinary health care practices
b. No regulation - reliance on common law
c. Voluntary self-regulation
d. Support for establishment of educational programs in Canada
e. Regulation of conventional practitioners providing CAM to their patients
a. Standard of care for CAHC practitioners
b. Standard of care for conventional practitioners providing CAM
c. Duty of conventional practitioners when providing referrals to CAHC practitioners
a. Capacity
b. Informed consent
Conventional professional's knowledge of CAM
Ability of health professional to provide information where the risks and benefits are not necessarily known
Non-disclosure of use by patients - duty on professional to inquire as to CAM or conventional use?
Duty of conventional practitioners to provide information regarding "alternative alternatives"
Duty of CAHC practitioners to provide information regarding conventional alternatives
Conflicts of interest
c. Criminal liability
d. Consumer protection legislation
IV. PRODUCT/PRACTIONER LEGAL ISSUES
1. Income tax treatment of expenses associated with CAM
2. Public health insurance and CAM
3. Private health insurance and CAM
4. Negligence - damages related to CAM
5. Family law - custody and child support, and CAM
1. General ethical principles of autonomy, beneficence, non-maleficence and justice
2. Ethical issues and NHPs
3. Ethical issues and CAHC practice
a. Adhering to ethical codes of conduct
b. Duty to obtain information and provide it to the patient
c. Conflicts of interest
d. The regulation of CAHC practitioners
4. Ethical issues and CAM research
a. What types of evidence should be required?
b. Research funding for CAM
c. Respect for cultural diversity in research
In reviewing the potential sources of information on Complementary and Alternative Health Care (CAHC), or Complementary and Alternative Medicine (CAM) as it is often called, it becomes clear that there is both a vast quantity of information available (though much of it of questionable reliability) and an enormous lack of records in the area, particularly relating to sources on relevant legal and ethical issues. There are many excellent resources, most of which have been recently developed, which discuss various issues. It is evident, however, that much work remains to be done in thinking about the various legal and ethical aspects of CAM/CAHC and in the development of policy in this arena. This synthesis is an attempt to plot out many of the issues that have been raised to date and organize them into a framework which can hopefully be utilized as a starting point in this expedition.
One recurring theme in many of the writings is the struggle to accurately define CAHC and to delineate what will and will not be included in such a definition. In this synthesis of others' thoughts on this subject, products (such as herbs, homeopathic preparations, vitamins, etc.) will be referred to as Natural Health Products (NHPs). The terms Complementary and Alternative Health Care (CAHC) and Complementary and Alternative Medicine (CAM) encompass both product, practice and practitioner components. Throughout this synthesis, we have chosen to use the term CAHC to reflect this broad view.
This compilation covers a broad range of topics. The legal issues are broken down as much as is practicable into those dealing with products, practitioners and, finally, a blending of the two. The section on ethics begins with the four main ethical issues used in conventional western medicine and then covers the following areas: products, practitioners and research. Some may opine that a further section should be added on ethics and policy issues, however, this synthesis has sorted various policy topics under the previous headings. It is important to remember that there are many different ways these could be organized and that there is much overlap between the areas. Most ethical issues have a legal dimension and vice versa.
One last item to address before embarking on this journey are the respective areas of authority in Canada in this field. The federal government has jurisdiction over food and drugs, including NHPs, and can therefore regulate in regards to products. However, delivery of health care services is primarily within the scope of the provinces and territories, including legislation with respect to health care professionals. While the federal government can certainly play a role in facilitating cooperation and joint work amongst the provinces and territories, it cannot enact federal plans to ensure consistent treatment across the nation.
When considering what regulatory regime should be implemented in approving NHPs for sale in Canada, it was clear that the Standing Committee on Health held that safety was "of primary concern". However, it was also clear that most NHPs are regarded as inherently safe and that they should not face the same requirements as pharmaceuticals in order to reach the marketplace. The issues that have been considered in discussions as to what type of approval process should be implemented include a balancing of safety with greater access to NHPs by consumers, although it was acknowledged that not all NHPs are harmless and that a different approach may need to be developed with respect to various products. It has been suggested that the pre-approval process correlate with the "known or reasonably foreseeable risk of harm from the product"1.
Another issue raised was that of the types of claims to be attached to products. The manner of approval should depend on the seriousness of the treatment claims to be attached to it2. Further, the manner in which the product is manufactured or produced should be a factor in this consideration. Concerns were expressed to the Standing Committee on Health that herbal products be identified correctly, be pure and have a reliable potency.
A review of the literature made it clear that relevant information about the products available for purchase is greatly needed. It also became evident that there are two related issues which are pertinent. The first is that more research regarding the efficacy of products is needed, including studies on the interaction of NHPs with conventional medications. The second issue is providing enough accurate information on the label and through other means of dissemination so that consumers can access the information they need to make informed choices about products on the market. The issues to be debated include how much and what type of information needs to be gathered with respect to efficacy, safety and quality before certain claims can be placed on labels and in other places for access and reliance by consumers. A further consideration involves the types of research that should be relied on in this area and when this can vary from the standard clinical trials of conventional medicine. Once it has been determined what will be deemed sufficient information, it must then be asked how the regulator of natural health products should go about educating consumers about the information that has been gathered and is considered reliable3.
What systems of monitoring should be established for products approved and for sale in the marketplace? The Standing Committee on Health said this depends on the safety of the individual product. If the product is inherently safe, makes no serious claims, and is manufactured in a way that safety and quality of product are reliable, post-market follow up should be less stringent. If, however, a lower-safety product is in issue, more care should be taken in surveillance, including the establishment of an adverse event reporting mechanism for industry, health care practitioners and the public4. However, at least one other source suggested a uniform system be established to include such things as mandatory reporting of adverse reactions from licence holders and practitioners5.
What type of regulatory body should be established to enforce the regulatory framework that is established with respect to NHPs? Some issues that were raised before the Standing Committee on Health were the need for members to have experience and expertise in the area of NHPs, the necessity of those affected by decisions to have access to information about those decisions, and the importance of an open and transparent appeal process after decisions have been rendered. Further, any enforcement of the regulations must be consistent, in both practice and appearance, and education with respect to steps taken under the system should be undertaken so that stakeholders know why a step or position has been taken by the enforcement body6. Other issues to be considered are how stringent penalties for a breach of the regulatory scheme should be, and whether the regulator should be completely independent from the industry7.
International trade agreements may affect access to NHPs by both consumers and CAHC practitioners8.
One of the predominating legal issues in the literature concerns the regulation of CAHC practitioners. This includes the issue of whether or not they should be regulated at all, and if so, how this should be managed.
When considering which method of regulation would be most appropriate for a particular group of CAHC practitioners, many factors arise for consideration. Some of the more common ones are the need to protect the public from incompetent or unethical individuals (ie should common standards of practice and codes of ethics be developed?), the desire to provide choice for consumers and enable them to exercise their autonomy (consumers want access and choice but also want to be able to determine whether or not they are dealing with a qualified practitioner), the establishment of appropriate scopes of practice for individual disciplines, and the practice of more than one discipline (be that numerous CAHCs or the intermingling of CAHC therapy and conventional medical practice). While the goal of regulation is the provision of safe, competent provision of services, some of the questions which arise include how one goes about measuring this and by what standards?
The first method outlined, that of regulation by statute, is the method most commonly discussed in the literature reviewed and is the method used to regulate conventional health professionals. Indeed, some may argue that the other suggested methods of regulation could not really be categorized as regulation at all. The following are the three methods of statutory regulation in Canada currently though they are not always utilized exclusively but may be used in combination with each other.
Exclusive scope of practice
The prevalent model used in Canada to date has been based on setting out an exclusive scope of practice for a particular profession. In other words, only registered members of that profession can provide the services that have been established as within their exclusive scope of practice. Where overlap occurs between professions, exceptions are carved out so that each professional who is qualified can provide the service.
Controlled acts
This arrangement sets out one list of controlled acts which does not make any reference to a particular health profession or discipline. In separate legislation or regulations dealing with specific professions, it is then established whether a registered member of that particular profession can perform a certain controlled act on a patient. If a controlled act is not listed in the regulation dealing with a profession, then members of that profession cannot provide that health service. If a health service is not listed in the list of controlled acts, then, generally speaking, anyone may provide this service (not only registered members of a health profession).
Title protection
Title protection legislation provides that only registered members of a health profession may use a particular title. The intention related to public safety is that consumers will know by the use of certain titles whether or not a particular individual is regulated and has been required to meet certain standards of competency with respect to the health services they are offering. However, the ability of consumers to make such an assessment depends on the information they have about a particular title and what that implies. Inadequate information, or an inconsistent system of title protection, could be misleading to the average person unfamiliar with the regulation of particular health professions, or, indeed, of the system generally.
Which system of statutory regulation?
Discussions in the literature have taken place regarding some of the pros and cons of each of the three models of statutory regulation9. At least one source made the comment that although most statutory models that regulate health professionals in Canada today are based on the exclusive scope practice scheme or the protection of titles (or some combination thereof), there appears "to be a trend in Canada away from exclusive scopes of practice towards controlled acts models"10. From a policy perspective, however, "[i]t has been suggested that the form of regulation which adequately protects the public at the least cost should be chosen and that policy makers ought to select more restrictive regulatory structures such as exclusive scopes of practice only if less restrictive methods such as controlled acts or right to title will be ineffective in protecting the public ... [I]t must also be recognized that there is the potential for an unacceptable degree of risk to the public arising from the absence or reduction of regulation"11.
While the form of regulation is one issue which needs to be investigated, it has also been recognized that regardless of the type of regulation in effect, it will be somewhat meaningless in terms of consumer protection unless those consumers have adequate information about the system of regulation which is in place. If consumers do not understand which groups are regulated and which are not, or whether or not there are practice standards in place, the system may be ineffective in some respects.
The financial burden on government in undertaking reform in this area, and on small professional groups in establishing self-governing colleges has been acknowledged12. It has been recommended, however, that research is needed in this area and should be undertaken through consultation with both conventional and CAHC practitioners, and those involved with the regulation of NHPs13.
Issues commonly addressed in statutory regulation
One of the main subjects addressed in statutes dealing with the regulation of health professionals is that of education and training requirements before one will be registered as a member of that profession or discipline. The idea is to ensure that only those who have successfully completed sufficient educational requirements and are competent will be able to practice in the community. This often entails continuing education as well. Currently, one of the concerns that has been raised due to the lack of statutory regulation of CAHC practitioners is the "lack of appropriate and consistent training and education for practitioners...."14. It has been suggested that actions to standardize education, training and practice would simultaneously ensure higher quality services and protect the public from unscrupulous individuals who might masquerade as genuine health professionals"15.
Another issue often dealt with when regulated professionals are registered within their discipline is that of insurance. The requirement that they carry malpractice insurance offers their patients the prospect of compensation in the event they are harmed by the actions of the practitioner. There would obviously be no requirement to carry such insurance if the practitioner was unregulated by statute.
Standards of practice and codes of ethics are commonly established as a result of a legislated regulatory scheme. The existence or non-existence of these has impacts in many areas of the law and ethics.
A further benefit of statutory regulation is the creation of a process to investigate and discipline members accused of unprofessional, unethical or incompetent conduct.
Statutory regulation, CAHC and multi-disciplinary health care practices
The possibility of multi-disciplinary practices, where conventional and CAHC practitioners would work together, has been raised. Changes would be required to various pieces of legislation, among other things, to enable this to occur16.
The common law has been discussed as one type of "regulation" that could be used in this area17. For the majority of CAHC practitioners, this is in fact the current status for most at present; that is, there is no regulation whatsoever and if a person were to suffer damages as a result of the treatment they have engaged in as a result of the recommendations of their CAHC practitioner, their only option would be to commence legal proceedings. There would be no college, in most cases, to file a complaint with or to address any ongoing issues of competency or unethical behaviour. It is debatable whether and how much of an effect the possibility of litigation has on the practices of health professionals. Does potential civil liability and the prospect of facing a judgment for damages promote competent practice and ethical behaviour on the part of health professionals? This is an issue to be considered.
If no legislation is enacted to regulate a particular group of CAHC practitioners, it is always possible that a group from a particular discipline may band together and form a voluntary organization through which they would manage many of the same issues that an organization under a statutory scheme would18. This has occurred to some extent in some areas of CAHC19. Specific recommendations have been made with respect to this, including the development of a guide to assist CAHC practitioners in this regard20.
It has been suggested that the government could play a role in encouraging educational institutions to establish more schools of various CAHCs and that this could indirectly serve to regulate those disciplines in Canada through greater opportunities for training in particular disciplines, as well as more consistency in the development of health practitioners.
A related issue is how conventional practitioners who are providing CAHC within their practice, or who wish to do so, should be regulated. Again, due to this being a matter of provincial jurisdiction, the way in which this has been dealt with to date has varied a great deal across the country21. The way in which this is regulated in the future could allow for an ever-increasing integration between conventional medical practice and CAHC, or could be severely restrictive.
Regardless of how CAHC practitioners will ultimately be regulated, whether through statutory means, voluntarily or not at all, standard of care issues will have to be addressed in one way or another. If a particular discipline is regulated by statute or voluntarily, this is a consideration which members of that discipline will have to undertake. What should the standard of care for a practitioner be in a given set of circumstances? In other words, they will have to address what a reasonable CAHC practitioner from that particular discipline would do within various scenarios of practice. This is important not only in determining whether or not a practitioner has fallen below the required standard and should therefore be disciplined, but also in setting expectations for the profession in general to aspire to and adopt as the level to adhere to in order to provide the best care they can to their patients.
In addition to standards of practice, it has been argued that codes of ethics need to be developed for CAHC practitioners and should address issues such as "advertising or marketing unproven practices [and the] sale of products not widely available"22. While not standards of practice per se, codes of ethics or professional conduct are often considered in helping determine the standard of practice in certain situations.
Regardless of whether a particular discipline is regulated, either voluntarily or statutorily, this issue will be relevant with regards to litigation before the courts where a patient alleges that their CAHC practitioner fell below the standard of care they should have met and as a result they have suffered damages. What standard of care will the courts apply? The answer will depend, in part, on whether or not there is regulation and what standards have been adopted, although that is not necessarily determinative for a court. This issue has been said to be unsettled23. It has been suggested that if one is holding oneself out as having an "ability or willingness to diagnose or treat any human disease, illness, deformity, defect or injury"24 and is not a member of a "profession", then one should be held to the standard of care of a medical doctor25. However, there would be many who would disagree with such a suggestion and argue that to hold a CAHC practitioner to the standards of a physician would be unreasonable. If held to the standard of care of a CAHC practitioner within a particular discipline, what standard will a court use if not that of a medical practitioner and there is no standard which has been developed for that particular discipline?
A related question which has been addressed is whether physicians (or other practitioners from distinct disciplines) could give evidence in court as to the standard of care that a CAHC practitioner should have lived up to. According to the case of Penner v. Theobald, "the general rule is that the evidence by the exponents of one system of health care expressing disagreement with, or disapproval of, a particular procedure or method of treatment followed by the exponents of another school should not be accepted as proof of negligence26. In other words, normally a physician, for example, would not be able to testify as to the proper standard of care for a CAHC practitioner. However, courts in the U.S. and Canada have created exceptions to this generality in certain circumstances27.
More and more, conventional health professionals are incorporating some alternative practices into the treatment of their patients. For example, the Standing Committee on Health found that some physicians are using herbal remedies, homeopathic preparations, vitamins and mineral supplements. As well, pharmacists are also becoming more knowledgeable about NHP28. The legal issue which will ultimately confront these conventional professionals should a patient allege that they suffered harm as a result of the CAHC therapy or recommended NHP is what standard of care should the conventional practitioner be held to? For example, if a physician was treating a patient with herbs, should they be required to meet the standard of care of the reasonable physician or the standard of care of the reasonable herbalist in those particular circumstances? It has been suggested that there are problems associated with each of those choices29.
Within conventional medical practice, there is a duty on physicians to make referrals under certain circumstances, as well as obligations as to where a patient should be referred. Case law suggests that one of those circumstances is the situation where there has been no response to the treatment which has been prescribed30. Will this duty ever encompass referrals to CAHC practitioners? It has not yet been extended outside of conventional medicine but is a potential issue in the future assuming CAHC use continues to grow as it has been and becomes more integrated into the health care system generally.
A more pressing issue is that of referrals, not out of a duty to refer, but as a result of the conventional practitioner providing alternative suggestions she/he feels may be useful to a patient when conventional therapy is not having the desired effect, or in the instances where patients ask their physician (or other conventional health care professional) for referrals to CAHC practitioners. Should physicians, who have traditionally been the gatekeepers to the majority of the resources of our public health system, have the same obligations regarding referrals to CAHC practitioners as they do to referrals within the conventional system?
Two general scenarios for potential liability in this area have been referred to. The first is the possibility of liability because the referral itself is negligent. "...[I]f, for example, a physician refers a patient to an alternative medicine practitioner instead of to some other, more appropriate practitioner and the referral delays, decreases, or eliminates the opportunity for the patient to receive important care, the referring physician could be held liable."31 The second general set of circumstances where liability with respect to a referral could be found is that where the treating practitioner to whom the patient was referred negligently harms the patient and the referring professional is found liable for their negligence, either because they supervised the treatment, provided it jointly with the negligent practitioner or made the referral knowing that the treating practitioner was incompetent32.
Of the four elements required in order for an individual to have provided a legally valid consent to treatment (those being capacity, voluntariness, referability and informed consent), the two elements of capacity and informed consent seem to bear some further reflection in the context of CAHC and NHPs. This issue is of importance to both conventional practitioners providing CAHC or referring their patients to CAHC practitioners, as well as CAHC practitioners themselves.
When considering CAHC and NHPs rather than conventional medical treatment, adults with capacity can obviously make decisions for themselves just as they are able to in the conventional setting. The legal basis for this rests on the ethical principle of autonomy. However, it can be argued that different considerations must be taken into account when making decisions on behalf of a minor or an incompetent adult. Decisions on another's behalf must usually, though not always, be made in the "best interests" of that individual. This is quite a different test than merely deciding what treatment one wishes for oneself. As there is a dearth of research into the efficacy and adverse effects of many NHPs and much of CAHC, some have said it should be viewed in the same light as experimental treatment in the conventional sense. This means that the health care professional must disclose all risks, not only those that are deemed to be material. If a therapy is treated as such, it may be more difficult to justify consenting on behalf of another, particularly if that is being done in the context of foregoing conventional, proven treatment, or if there are risks attached to the alternative therapy being sought.
In situations where the CAHC or NHP is harmless, there is some benefit or perceived benefit to the patient, and effective treatment for a serious condition is not being bypassed, there would likely be no challenge to such a decision. However, health care providers may be reluctant to provide NHPs or CAHC without the consent of a legal substitute decision-maker unless this issue is clarified in terms of potential liability. The more difficult issue would arise in cases where an alternative treatment was being consented to in the face of a serious or life-threatening condition while conventional, efficacious therapy was being bypassed33.
Inextricably linked to the ethical principle of autonomy is the prerequisite to treatment of informed consent. Physicians are required to discuss with a patient what a reasonable person in this patient's circumstances would want to know34. This has been held to include the patient's diagnosis, the nature and purpose of the proposed treatment, any "material risks", responding to the patient's questions, the possible outcomes or prognosis of proceeding with or refusing the proposed treatment, any reasonable alternatives, conflicts of interest and any other relevant information. If the treatment is experimental or elective, the standard is higher and essentially all risks, not only material ones, must be disclosed35. While most of the case law in this area has focussed on physicians, all health care providers, including CAHC practitioners, would likely be covered by the same general criteria. Given the standard of disclosure which must be made to patients, there are a number of related issues which have come up in the literature on CAHCs and NHPs.
Conventional professional's knowledge of CAHC
In cases where information is available, there is a concern that despite the increase in awareness among conventional practitioners of certain CAHCs and NHPs, many are not informed and are unable to assist their patients in this regard. What obligation is there on conventional professionals to inform themselves about NHPs and CAHC so that they can provide information to their patients?
Ability of health professional to provide information where the risks and benefits are not necessarily known
Witnesses addressing issues related to NHPs to the Standing Committee on Health expressed the need to have information on the safety, risks, side effects, quality and efficacy of products. It could be assumed that all of these would be important to consumers of CAHCs as well and would all be items a reasonable person would want to know about before undergoing CAHC therapy or consuming NHPs. The literature time and time again pronounces a dearth of research and evidence in many areas of CAHC practices and products.
If physicians are providing information about NHPs or CAHC as part of a perceived duty to advise a patient of all reasonable alternatives, due to their integration of certain CAHCs into their own practice, or as a result of inquiries by their patient, one may argue that they have a duty to provide accurate information so that the individual may make an informed choice. This implies the necessity to educate themselves on various CAHCs and NHPs, particularly with respect to research regarding efficacy and potential material risks. This may cause a dilemma in many situations as research is lacking in much of the CAHC and NHP arena. Will it be enough, then, to state that they do not have information that the "reasonable patient" would want to know in these circumstances?
The same issue faces CAHC practitioners who would likely be held to the same disclosure standards as physicians are, given the relationship of trust and dependency that exists between a health care professional and their patient.
Non-disclosure of use by patients - duty on professional to inquire as to CAHC or conventional use?
Another concern in this area is the frequent non-disclosure by patients to their physicians of their CAHC use, or to their CAHC providers of the conventional treatment or other CAHC therapy which they are undergoing. One looming issue is whether there is an obligation on the part of health professionals to inquire as to their patient's use of other therapies or products. Is there a duty on conventional practitioners to ask whether their patient is using CAHC? Alternatively, does a CAHC practitioner have a duty to find out what conventional therapies and medications, or what other CAHC therapies, their client is utilizing before proceeding with a plan of action?
Duty of conventional practitioners to provide information regarding "alternative alternatives"
Within the context of conventional medicine, a physician has an obligation to discuss reasonable alternatives to the treatment they are proposing to their patient. This is particularly the case where the alternative may be less risky or may in some ways be more beneficial. It is not necessary if the alternative would be of no benefit to the individual36. How will CAHC be dealt with in this context? Will physicians be expected to become educated about CAHC and be in a position to educate their patients about the existence of these alternatives? If an analogy can be made to case law in the conventional medical field, it may be argued that this duty would only be extended based on two conditions: first, whether a reasonable physician should know of these alternatives, and second, what kind of evidence exists to establish the efficacy of that alternative.
Duty of CAHC practitioners to provide information regarding conventional alternatives
A similar question bears consideration for CAHC practitioners. If they are obligated to provide their patients with pertinent information to enable that individual to provide an informed consent to treatment, should this include information on conventional alternatives?
Conflicts of interest
While some have made the argument that health services are merely a commodity like any other, arguments have been made that this is not the case. One of the main reasons for this is the imbalance of information that health care professionals and their patients have and the difficulties one would face in order to place oneself in a like position to one's health care provider with respect to information37. While it has been argued that most health care professionals would not make decisions or seek to influence a patient to act in a way that would be harmful to them, "practical health care situations are sufficiently complex and uncertain that the provider's perceptions of patient interests can readily adjust themselves to accommodate provider interests as well."38
Various provisions of the Criminal Code are likely to apply to CAHC practitioners just as they do to conventional practitioners.39
This type of legislation could apply to NHPs and CAHC practitioners.40
The issue that arises in case law and other resources is whether the Income Tax Act should be amended to allow individuals to deduct expenses associated with NHPs or CAHCs from their income.41 This issue is based on the current definition of "medical service" as defined in that Act and how this has been interpreted.42
Across the country, most CAHC services are not covered by public health insurance plans, however, some are and coverage varies.43 In addition to the question of whether or not such services should be included in such plans is the issue of the manner in which they should be covered should an affirmative decision to do so be made. In some cases, services are paid on a fee for service basis, often with a limit on the amount or number of visits which will be paid for. The fee for service method is not, however, the only form such arrangements could take.
Most private health insurance is provided under plans purchased by employers who decide what services the plan they purchase will cover. Some plans currently provide coverage for various CAHC therapies.44 The main reason that has been given by insurance companies for providing coverage for these services is not efficacy of the therapies but demand for them.45
Have courts provided or should they provide compensation to successful plaintiffs in a negligence action for personal injury for CAHC, either as a result of expenses already incurred on CAHC (special damages), or for future cost of care.46 This issue, again, may be related to evidence of the efficacy of the CAHC being discussed.
How will the judiciary take CAHC into account in disputes related to child custody where one parent utilizes CAHC for their child rather than conventional medicine?47 Will the courts allow expense claims related to CAHC therapy for children to be included in child support payments?48
These are issues to be considered and are likely to be related to the discussion of efficacy, as so many of these issues are.
When discussing ethical principles in the context of conventional health care, four key principles are often utilized as a base for discussion and decision-making. Those four principles are autonomy, beneficence, non-maleficence and justice.49
Autonomy refers to each individual being able to make choices for themselves, based on their own values, and health care professionals having respect for that right to choose. This is thought to be so regardless of what the professional may think is in the individual's best interests. Our respect for the autonomous choices of individuals presupposes that the person has the capacity to understand relevant information relating to the choice, that they are making the decision freely and not under coercion or duress, and that they have the information they need to base their decision on.
Beneficence is the ideal of helping those who have come for care whenever possible. This would include the provision of treatment that would be efficacious to that person and increase their well-being or relieve them from suffering.
Non-maleficence would direct health care professionals to refrain from harming their patients. A practitioner would not intentionally provide a product or treatment to a person that would cause them harm if acting in accordance with this principle. However, this principle applies to situations other than those involving harm caused directly by an NHP or a CAHC therapy. This could also entail harm such as the foregoing of effective conventional treatment for a serious condition while utilizing CAHC, financial harm for therapy that is ineffective, as well as emotional harm.50
Justice usually involves a discussion of how resources should be distributed in an equitable way. This can include a consideration of which health care services are publically funded or covered by private insurance, as well as allocating research funds in an ethical manner. Justice can also encompass the provision of compensation when individuals are harmed by products or treatments.
Though these four principles are considered key in the context of conventional medicine, they have been criticized by some as lacking clarity as to which of the principles should carry more weight in a given situation when they come into conflict. Often, choices must be made between the principles and this can come down to the balance the individual decision-maker believes should be struck.51 In addition to this, it has been argued that these principles may not be the appropriate starting point when discussing CAHC.52 Given this rationale, it is useful for one to keep in mind these four principles when considering ethical dilemmas and CAHC, but the issues identified in the resources have not been broken down in accordance with those principles. There are resources, however, where the framework for discussion of ethical issues and CAHC has been established in accordance with these four guiding principles.53
The consideration of NHPs inevitably leads to a discussion of the balancing of access to these products (based on the autonomous individual properly informed being able to access the health products of his/her choice) and the need to ensure the safety of the individuals consuming them (beneficence/non-maleficence).54 The Standing Committee on Health, reporting on NHPs, stated that this approach was taken "keeping in mind the uniqueness of NHPs and their general low risks to health and safety."55 This was not to say that all products have low risks to safety but, rather, that many NHPs were seen to be relatively harmless, as long as serious treatment claims were not attached to them.
Other issues that were discussed were the importance of determining efficacy, risks and potential adverse interactions with other products (either conventional or alternative) and the need for this information to educate the consumer.56 For users of the products, there should be regulations governing the labelling of products as well as the provision of information through additional means (inserts, monographs, additional information provided by the vendor, referrals to reliable sources of information) so that informed choices can be made.57
Respect for other cultures is an issue where some NHPs are not seen to be alternative, but conventional in nature.58 As many CAHC therapies are not standardized but developed, at least to some extent, to treat the individual at hand, the Standing Committee on Health recommended that products "extemporaneously compounded for a particular person" be exempted from the regulatory framework.59
The issue of cost has been discussed as this impacts access by consumers, the ability of certain members of the industry to survive, and the burden on governments to regulate in this area thereby utilizing a portion of its finite resources. It has been suggested that any NHP regulations that are implemented should be drafted with this factor in mind and should not place an undue burden on any of these entities.60
Another consideration discussed in relation to NHPs was that of plant conservation, both in developing nations as well as Canada. The concern expressed was that the demand for herbs and other natural health products could be so great that those who rely on them exclusively, having no access to western medicine, could be without their only resources for treatment.61
As with NHPs, ethical discussions surrounding CAHC practitioners and their therapies have involved analysis of the risks versus benefits (and the information that is, or is not, available), the costs to both consumers, practitioners and governments, and the need to respect not only the choice of autonomous individuals but other cultures as well.62
It has been suggested that the absence of codes of ethics or standards of practice for many CAHC providers creates an ethical dilemma for conventional practitioners wanting to make referrals for their patients to CAHC practitioners. This is a further argument for the development of these documents, whether a discipline is statutorily regulated or not.63
Another issue which has also been discussed is the ethical dilemma for the conventional practitioner attempting to integrate CAHC into his/her own practice where he/she would be bound by his/her own code of ethics to do certain things which may be difficult, if not impossible, to do in the context of CAHC due to the general lack of evidence regarding efficacy and risks. An example of this would be the obligation to obtain an informed consent from a patient prior to providing treatment to that individual.64
The discussion comes back, once again, to the principle of autonomy, as inevitably it is reiterated that individuals need information to make informed decisions and that they should be treated ethically and with respect.65
Irrespective of the existence of codes of ethics, health care practitioners have an ethical obligation to inform themselves about CAHC, to provide relevant information to their patients so they can make informed decisions, and to inquire as to their use of other therapies to assist them in avoiding harm (whether that be a conventional practitioner asking about CAHC use, or a CAHC practitioner inquiring about conventional or other CAHC treatment).66
While a health care practitioner has a fiduciary duty to do what is in the best interests of their patient67, there is an inherent conflict of interest when that same practitioner decides to sell the NHPs they are recommending to their patient, assuming they are making a profit from the sale of these products. This is one example of a conflict of interest practitioners may find themselves in.
The consideration of the regulation of CAHC practitioners raises a number of ethical issues. These include whether or not any such health care providers should be regulated at all, and if some should be, which ones? It has been asked whether governments can ethically allow CAHC practitioners to be statutorily regulated while much of what they do has not been scientifically validated.68 While regulation can be a way of ensuring greater safety for consumers and a means of providing protection to the public, the regulation of professionals in the past has been seen as a "governmental seal of approval".69 If more CAHC disciplines become statutorily regulated, it has been suggested that such a move would put further pressure on governments to provide public funding for those disciplines. With the trend towards evidence-based medicine, this potential pressure may create an ethical dilemma for governments. There is the move towards a requirement to show efficacy in conventional medicine, however, with respect to CAHC, consumer demand is a huge driving force behind the move to regulate in much of this area. In the CAHC area, it has been stressed that striking the right balance between safety and access is important.70 "The ethical challenge before us, then, is to consider how our societies can create feasible mechanisms for deciding which practices ought to be regulated and formalized, and which are best left to the private and folk sectors."71
A current ethical issue at present is founded on the lack of attention to this area by governments across the country. Most of CAHC is unregulated and many jurisdictions do not have much information on the activities within their own areas, and whether any of those activities carry a risk of harm to their populations. Taking no action with respect to a particular matter is, of course, a decision about that matter, whether consciously done or not.72
Many ethical principles accepted within the confines of conventional medical research may not be appropriate or applicable in all cases of research regarding CAHC. For example, one such "accepted ethical principle" is that "innovations in therapy be measured against standard practice" to see whether the innovation is "more or less effective than the standard". This is a problem as many CAHC therapies are tailored to the individual, rather than one standardized method of treatment which is applied in the same manner to a number of different individuals.73 Other ethical research issues raised in the literature include the relevance of randomized clinical trials to some types of CAHC, and the applicability of the practice of conventional medicine to look at symptoms rather than the health of the individual as a whole.
It has been suggested by some that there is an ethical obligation to invest money in research in this area due to the increasing number of Canadians that are using CAHC.74 A related issue is whether educational assistance should be provided to those in the CAHC arena to enable them to access the funds that are available.75
Arguments have been made that consideration of research principles and protocols, and whether or not they should be altered when conducting research with respect to specific ethnic communities, is necessary before instigating research in those communities.76
1. Canada, Report of the Standing Committee on Health, Natural Health Products: A New Vision, (Ottawa: Public Works and Government Services Canada, 1998). (Chair: Joseph Volpe ) and Crouch R., Elliott R., Lemmens T., & Charland L. Canadian Strategy on HIV/AIDS, Complementary/Alternative Health Care and HIV/AIDS: Legal, Ethical & Policy Issues in Regulation (Toronto: Canadian HIV/AIDS Legal Network, 2001) 112.
2. Canada, Report of the Standing Committee on Health, Natural Health Products: A New Vision, (Ottawa: Public Works and Government Services Canada, 1998). (Chair: Joseph Volpe ) and Crouch R., Elliott R., Lemmens T., & Charland L, Canadian Strategy on HIV/AIDS, Complementary/Alternative Health Care and HIV/AIDS: Legal, Ethical & Policy Issues in Regulation (Toronto: Canadian HIV/AIDS Legal Network, 2001) 112.
3. Canada, Report of the Standing Committee on Health, Natural Health Products: A New Vision, (Ottawa: Public Works and Government Services Canada, 1998). (Chair: Joseph Volpe ) and Crouch R., Elliott R., Lemmens T., & Charland L, Canadian Strategy on HIV/AIDS, Complementary/Alternative Health Care and HIV/AIDS: Legal, Ethical & Policy Issues in Regulation (Toronto: Canadian HIV/AIDS Legal Network, 2001).
4. Canada, Report of the Standing Committee on Health, Natural Health Products: A New Vision, (Ottawa: Public Works and Government Services Canada, 1998). (Chair: Joseph Volpe) 22-26.
5. Crouch R., Elliott R., Lemmens T. & Charland L. Canadian Strategy on HIV/AIDS, Complementary/Alternative Health Care and HIV/AIDS: Legal, Ethical & Policy Issues in Regulation L.(Toronto: Canadian HIV/AIDS Legal Network, 2001) 113-114.
6. Canada, Report of the Standing Committee on Health, Natural Health Products: A New Vision, (Ottawa: Public Works and Government Services Canada, 1998). (Chair: Joseph Volpe) 65.
7. Crouch R., Elliott R., Lemmens T. & Charland L. Canadian Strategy on HIV/AIDS, Complementary/Alternative Health Care and HIV/AIDS: Legal, Ethical & Policy Issues in Regulation(Toronto: Canadian HIV/AIDS Legal Network, 2001) 114.
8. Crouch R., Elliott R., Lemmens T. & Charland L., Canadian Strategy on HIV/AIDS, Complementary/Alternative Health Care and HIV/AIDS: Legal, Ethical & Policy Issues in Regulation (Toronto: Canadian HIV/AIDS Legal Network, 2001) 4.
9.Casey J.T., Status Report and Analysis of Health Professional Regulations in Canada, (Edmonton: Federal/Provincial/Territorial Advisory Committee on Health Human Resources, March 1999) at 22-27.
10. Casey J.T., Status Report and Analysis of Health Professional Regulations in Canada, (Edmonton: Federal/Provincial/Territorial Advisory Committee on Health Human Resources, March 1999) 27.
11. Casey J.T., Status Report and Analysis of Health Professional Regulations in Canada, (Edmonton: Federal/Provincial/Territorial Advisory Committee on Health Human Resources, March 1999) 42.
12. Casey J.T., Status Report and Analysis of Health Professional Regulations in Canada, (Edmonton: Federal/Provincial/Territorial Advisory Committee on Health Human Resources, March 1999) 15.
13. York University Centre for Health Studies, Complementary and Alternative Health Practices and Therapies - A Canadian Overview. (Toronto, York University: Strategies and Systems for Health Directorate Health Promotion and Programs Branch, 1999) xvi.
14. Canada, Report of the Standing Committee on Health, Natural Health Products: A New Vision, (Ottawa: Public Works and Government Services Canada, 1998). (Chair: Joseph Volpe) 62.
15. Canada, Report of the Standing Committee on Health, Natural Health Products: A New Vision, (Ottawa: Public Works and Government Services Canada, 1998). (Chair: Joseph Volpe) 62.
16.Crouch R., Elliott R., Lemmens T. & Charland L., Canadian Strategy on HIV/AIDS, Complementary/Alternative Health Care and HIV/AIDS: Legal, Ethical & Policy Issues in Regulation (Toronto: Canadian HIV/AIDS Legal Network, 2001) 116.
17. Stone J. & Matthews J., Complementary Medicine and the Law, (Oxford: Oxford University Press, 1996) at 15
18.Crouch R., Elliott R., Lemmens T. & Charland L. Canadian Strategy on HIV/AIDS, Complementary/Alternative Health Care and HIV/AIDS: Legal, Ethical & Policy Issues in Regulation (Toronto: Canadian HIV/AIDS Legal Network, 2001) 77-79.
19.York University Centre for Health Studies. Complementary and Alternative Health Practices and Therapies - A Canadian Overview. (Toronto, York University: Strategies and Systems for Health Directorate Health Promotion and Programs Branch, 1999).
20.Crouch R., Elliott R., Lemmens T. & Charland L. Canadian Strategy on HIV/AIDS, Complementary/Alternative Health Care and HIV/AIDS: Legal, Ethical & Policy Issues in Regulation (Toronto: Canadian HIV/AIDS Legal Network, 2001) 115.
21. York University Centre for Health Studies, Complementary and Alternative Health Practices and Therapies - A Canadian Overview. (Toronto, York University: Strategies and Systems for Health Directorate Health Promotion and Programs Branch, 1999) 100-114; 117-132.
22. Thorne S., et al. "Ethical Dimensions in the Borderland Between Conventional and Complementary/Alternative Medicine" (2002) 8:6 J. Alt & Comp. Med. 907, 910.
23. Feasby C., "Determining Standard of Care in Alternative Contexts" (1997) 5 Health L.J. 45, 64
24. Medical Profession Act, R.S.A. 1980, c. M-12.
25. Feasby C., "Determining Standard of Care in Alternative Contexts" (1997) 5 Health L.J. 45, 56-57
26. Feasby C., "Determining Standard of Care in Alternative Contexts" (1997) 5 Health L.J. 45.
27. Feasby C., "Determining Standard of Care in Alternative Contexts" (1997) 5 Health L.J. 45, 59-62.
28. Canada, Report of the Standing Committee on Health, Natural Health Products: A New Vision, (Ottawa: Public Works and Government Services Canada, 1998). (Chair: Joseph Volpe) 62
29. For a discussion of this particular issue, see Timothy Caulfield & Colin Feasby, "Potions, Promises and Paradoxes: Complementary Medicine and Alternative Medicine and Malpractice Law in Canada" (2001) 9 Health L.J. 183, 198-203.
30. Picard E.I. & Robertson G.B., Legal Liability of Doctors and Hospitals in Canada, 2nd ed. (Toronto: Carswell, 1996) at 246.
31. Studdart D.M. et al. "Medical Malpractice Implications of Alternative Medicine" (1998) 280:18 JAMA 1610, 1612.
32. Studdart D.M. et al. "Medical Malpractice Implications of Alternative Medicine" (1998) 280:18 JAMA 1610, 1612.
33. See Somerville M., The Ethical Canary: Science, Society and the Human Spirit, (New York: Viking, 2000) at 175.
34. Picard E.I. & Robertson G.B., Legal Liability of Doctors and Hospitals in Canada, 2nd ed. (Toronto: Carswell, 1996) at 118.
35. Picard E.I. & Robertson G.B. Legal Liability of Doctors and Hospitals in Canada, 2nd ed. (Toronto: Carswell, 1996) at 149-152.
36. Picard E.I. & Robertson G.B., Legal Liability of Doctors and Hospitals in Canada, 2nd ed. (Toronto: Carswell, 1996) at 129-131.
37. Gilmour J.M., Regulation of Complementary and Alternative Health Care: Goals, Legal Frameworks, Implementation (October 2001) [unpublished] archived at Natural Health Products Directorate, Health Canada, 22.
38. Evans R., Strained Mercy. The Economics of Canadian Health Care (Toronto: Butterworths, 1994) at 72-73.
39. Gilmour J.M., Regulation of Complementary and Alternative Health Care: Goals, Legal Frameworks, Implementation (October 2001) [unpublished] archived at Natural Health Products Directorate, Health Canada.
40. Gilmour J.M., Regulation of Complementary and Alternative Health Care: Goals, Legal Frameworks, Implementation (October 2001) [unpublished] archived at Natural Health Products Directorate, Health Canada.
41. York University Centre for Health Studies, Complementary and Alternative Health Practices and Therapies - A Canadian Overview. (Toronto, York University: Strategies and Systems for Health Directorate Health Promotion and Programs Branch, 1999)
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