Reflections on Health Law and Ethics in Complementary and Alternative Health Care

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Table of Contents

• Introduction
• Regulation of Products
• Regulation of Practice
• Interface between product/practice regulation
• Research
• Creating the Political Will to Support Complementary and Alternative Health Care
• Consumer Choice/Public Protection
• Appendix 1

Introduction

On February 22, 2002, Health Canada hosted a meeting of a group of experts in the area of legal and ethical issues in complementary and alternative health care (CAHC). The intent was to discuss issues pertaining to CAHC practice and practitioners, and related issues for natural health products (NHPs).

The purpose of the meeting was to:

• review and reflect on health law and ethics issues with respect to CAHC and related current activities and initiatives
  
• propose and prioritize areas for continuing or future attention, in a 2002/2003 and 2003/2004 time frame - particularly focusing on the interface of products and practice
• suggest priority areas for future attention in relation to the above

The participants of the meeting are found in Appendix 1.

To begin the meeting, Joan Simpson brought greetings from Health Canada and reiterated the purpose of the meeting - to reflect on the work that has been accomplished in legal and ethical issues in CAHC and to look ahead at what needs to be done. The meeting was intended to inform Health Canada's planning process and, from that point of view, was very timely. Joan went on to review the current changes in structure in Health Canada relating to CAHC and NHPs and the work that Health Canada has been involved in to date. Individual participants then outlined the work that they have personally been involved in specifically relating to health law and ethics issues in CAHC. The issues arising from these introductions were as follows:

• Caution was expressed that the perceptions from outside of government could be that Health Canada is no longer interested in CAHC and providers, but only in products.
• The expectations are that the area of health human resources in CAHC needs to be a priority - that is, particular attention needs to be paid to this area by government and by the sector itself.
• There will be many opportunities in the Natural Health Products Directorate. For example, the development of the information framework that will accompany the NHPs regulations will include CAHC practitioner groups.
  
• It will be particularly important to focus on the relationships between product and practice.
• Within the Health Human Resources Strategies Division, there will be a continued focus on nursing, medicine and allied health professionals. This work is conducted in cooperation with the provinces and territories - the Ministers of Health see health human resources as a top issue.
• There is recognition that the division has done a tremendous job in moving the issues related to CAHC forward with limited resources.
• There is concern that, in a formal sense, CAHC is not at the top of the priority lists of the provincial/territorial governments. The sense is that many of them do not want CAHC on the agenda at all.
• There is some concern that the provinces/territories have not engaged themselves in the consultations regarding the NHPs regulations. In addition, third party insurers have not been commenting on the regulations, nor have they asked for personal dialogue. There has not been a lot of dialogue from regulated professions and there has not been much articulation of what consumers want.

Through the process of a pre-meeting consultation, and as a result of the meeting discussion, the group identified the following priority issues:

• regulation of products: education of the public, development of/clarification of standards of evidence, mass media use
• regulation of practice: restricted use of titles, input/output regulation, linking regulation to good evidence
• the need for structure and funding for research: infrastructure, funding, research capacity and literacy
• creating/seizing the political will: making the case, establishing credibility and voice, taking the opportunity
• consumer choice <> public protection

The summary of this information is described below.

Regulation of Products

Education of Consumers

Michelle Boudreau reported on the development of the NHP regulations. The proposed regulations were published in the Canada Gazette, Part I, December 22, 2001, which were circulated at the meeting. The regulatory framework for NHPs outlines the labeling information that will have to appear on the products. However, there was a sense that what is needed now is comprehensive education of consumers about these labels and what they mean. For example, labels will include information about the part of the plant that is in the product. However, this will be meaningless to the consumer unless they know what that means - e.g., that different plant parts could have different potencies.

The group discussed various methods of educating consumers and concluded that it will be important that the approach be multi-faceted - through print, radio, television, the Internet and pharmacies. A number of suggestions were discussed.

• The first message could be very simple, stating that there are new regulations. One approach might be to have very simple ads saying "There are new regulations for NHPs - go to www.naturalhealthproducts.ca for more information." Then, a website would have more in-depth educational information about the regulations and the products.
• To take an NHP to market, there will have to be a product monograph. One approach to consumer education might be to make these monographs available publicly on a Website. That would address approved use of the products, side effects, interactions and effects. The monographs are being developed in-house by the NHPD through existing committee structures.
• Another approach that has been suggested is that a compendium (like the CPS) be developed.

Development of/clarification of standards of evidence for products

The group discussed a critical question: How do you define evidence when regulating products? Concerns were raised regarding the lack of understanding regarding evidence for existing products by consumers and professionals. For example, there is a lack of understanding about the evidence necessary for pharmaceutical products to be approved; consumers need more education regarding that situation as well. In some instances, the effect needs to be 51% better than placebo. The question raised was, Are the standards of evidence for NHPs going to be more rigorous than those for pharmaceuticals?

It can also be argued that very few health professionals have a good understanding of standards of evidence. Even reviews of evidence that are presented by top epidemiologists around the world often disagree in their conclusions. Standards of evidence appear to be very porous.

A number of suggestions were made:

• Evidence could be defined in broad categories - moderate to strong, some evidence, and little evidence. From a consumer's point of view that may be all that is required.
• There is a need for standardization/categorization of NHPs (like pharmaceuticals), putting them into therapeutic classes. For example, immunostimulants might be a class. Otherwise, claims for products will be broad and very far reaching - everyone can call them anything - which will be very confusing for the consumer
• The evidence related to products could be divided into two types. First, there is the evidence regarding what the active ingredients are, and what they do physiologically in the body. Secondly, there is the evidence regarding the health claims for the product. For example, physicians prescribe certain medications for infant colic - it is known that the product has a physiological effect in the infant's digestive tract, but there is no evidence that it helps colic. You can have pretty good evidence that it does something physiologically but not that it affects a health condition. This would probably meet consumer needs, as the average consumer wants to know that a product has an active ingredient and that it does something.

The group recognized that the factors that influence the effectiveness of NHPs are complex. Their effectiveness is partially connected to practitioners. Many would claim that if there is a connection to a practitioner, the NHP will have a bigger effect. That is, there is a 'placebo' effect related to the relationship with the practitioner. If you simply look at a particular product or service in isolation, and try to determine its effect, you lose the synergy effect - and that is important in the healing. This goes further than the relationship between the practitioner and the product, but is also related to a synergy of different types of treatments and services - it is more than the sum of the parts. How do you establish the evidence related to this?

Regulation of Practice

Whether or not CAHC practitioners should be regulated in Canada has been, and will continue to be, a central policy challenge to the continuing development of CAHC. Some CAHC practitioners are self-regulating in Canada through conventional professional regulatory models. However, it has been noted that the majority of CAHC practitioners are not - some are regulated in other ways and some are not regulated at all.

The group noted that it is important to consider the social context of regulating health care professionals. When self-regulation began, it was tied to 'professional monopolies,' particularly in medicine. Today, the reason for granting that kind of state power - i.e., self-regulation - to professionals is to protect the public and promote their (the public's) best interest. However, there are many challenges associated with this.

Two groups that have been making extensive use of CAHC - people infected and affected by HIV and those living with cancer - are particularly concerned about the regulation of CAHC practitioners. They are strongly consumer led. They feel that people have the right to choose whatever they think they need or will help them, and they see a need for the regulation of practitioners for assurance of credibility and accountability. These groups are approaching the issue in a holistic health context - in a quality of life context. Currently, there is research being conducted through cancer bureaus in six provinces to examine the kinds of complementary and alternative products and therapies cancer patients are using.

The group identified a number of challenges that need to be considered/addressed:

• It is important to ask the question, Who gets to interpret what constitutes the public interest? Health care is not a product like other products - for example, computers. Consumers expect health care providers to watch out for their (the consumers') interests. That is a different responsibility than when you buy a computer. This can mean that there are different expectations about how professionals should be regulated.
• Since the regulation of CAHC is not currently being dealt with to a large degree at the provincial level, there is concern that, at some point, there is bound to be a crises in the health care context. For example, a practitioner overstepping his or her scope of practice, misrepresenting himself or herself, or consumers believing they had a certain service which was not the case. It would be unfortunate if decisions are made as a result of a crisis rather than as a result of a planned process and discussions. The group felt that it will be important to take advantage of opportunities as they arise through federal/provincial/territorial mechanisms.
• The reluctance of provinces and territories to address regulation of CAHC practitioners is very much tied to the current climate in the health care system. Policy makers have been in reduction, not expansion, mode, and it is perceived that there is a concern that if CAHC practitioners are regulated, there will be pressure to pay for their services.
• There are conflicts between regulated and unregulated practitioners. These conflicts influence progress to regulation. It is critical for the various professions to understand each other - their roles, competencies and places in the system. This has implications for education - undergraduate and continuing.
• Linking the regulation of practitioners to evidence is theoretically an important notion. However, it is difficult to implement in practical terms. It is important to note that a great deal of health care and practitioners' services are not based upon good standards of evidence. It seems, in fact, unrealistic that there will be good evidence for everything. Added to this is the whole notion of economics - the resources are not available to do really good randomized clinical trials. The experience of third party insurers in the United States has been such that they do not base their decisions to insure on evidence - in fact, they respond to pressure exerted by 'early adopters'. That is, what is insured is very much a response to consumer demand, without requiring evidence that it is effective.
• Self-regulating professions have tended to over-emphasize 'input' regulations such as education, qualifications and continuing education. There is not enough of an emphasis on 'output' regulations such as discipline proceedings and quality of service. Those who are examining self-regulating professions are recommending that the quality of the work/job that they are doing for the consumers be given serious consideration.
• The upsurge of CAHC has been a consumer-driven phenomenon and it is thought that it will likely continue to increase at a great pace. There is consensus that the utilization trend has been led by demand rather than by evidence. Some individuals, particularly conventional providers, are concerned about this. However, it is also argued that there little evidence for much of conventional practice. This consumer driven phenomenon must be seriously considered when considering regulatory options for the regulation of CAHC practitioners.

It was suggested that a practical first step might be to begin with protected titles. Under this model, both members of the profession and non-members can provide services to the public. However, only members of a legislatively recognized professional organization can use the titles identified in the legislation or hold themselves out as being registered.

Ethical implications arising from practitioner regulation

There are ethical implications for governments if they grant self-regulatory status to some CAHC groups of practitioners. Many members of the public perceive a grant of self-regulatory status to be a governmental seal of approval. Historically, it can be demonstrated that such a grant serves as an entrance to accessing insurance coverage for the modality and, in some cases, to inclusion in the public health funding system. Is it ethical for governments to grant self-regulation when much of CAHC may not have been 'scientifically proven,' whatever that means? On the other hand, withholding regulation may amount to a double-standard, since the efficacy of much of conventional medicine has also not been strictly proven. However, this did not serve as a roadblock to conventional health practitioners obtaining self-regulation.

Secondly, there are ethical implications for the inaction shown by many provinces with respect to CAHC. Do provinces really know what is being performed in the CAHC area in their jurisdictions? And, most importantly, which activities bear a significant risk of harm to the public? The complexity of CAHC from a policy and political perspective may have resulted in many jurisdictions adopting a stance of almost ignoring the issues. It will be important for provinces/territories to conduct a survey of CAHC activities within their own jurisdictions and then to conduct a type of controlled act analysis.

Interface between product/practice regulation

Provinces are primarily responsible for regulating practitioners, but products fall under the federal jurisdiction. It is unclear how the two systems will interrelate and the implications of taking a certain approach in one area will impact upon the other area. It is difficult to separate the practitioner regulation discussion from the product discussion. An example is the Schedule F drugs - or prescription only drugs. If drugs are placed on Schedule F, that limits which professionals can prescribe them - there are no other schedules.

There are issues relating to differing value systems in regulating products and practice. The value systems are quite different. Products are produced in a business environment - this influences manufacturing, selling, etc. The motive is profit. In terms of health practitioners, the first motives are to do good, to heal, to do no harm. There is not a profit value to the same extent (although there is the influence of generating revenue). And, for some practitioners, the two are being mixed - for example, the professionals may sell the products in their place of work and/or may refer to specific products.

If professionals are selling products or referring to products, they need the knowledge to do so effectively. A question raised was, Do pharmacists have any rules about what they can sell? They do not, but they are expected to be knowledgeable about the products that they sell. Some pharmacists have decided not to sell NHPs because they do not know enough about them. The knowledge about products is increasing: in many cases the industry is bringing educational opportunities to pharmacists. And there is a move among pharmacies to bring in naturopaths or homeopaths a day or two per week for consultations.

The controversy surrounding evidence

There is much controversy regarding the question, 'What is evidence?'. There is a continuum of evidence from randomized clinical trials to 'best practices' and to 'clinical wisdom.' There remains a lack of agreement within and among many groups as to what constitutes evidence.

It is argued that much of what goes on in conventional health care is not evidence-based, and yet it is entrenched in practice. Therefore, calls by conventional health care providers to scrutinize CAHC more closely are viewed with skepticism.

It is critical to look at a variety of methodologies and outcomes when trying to establish evidence. The hard core epidemiologists would argue that without the hard evidence of randomized controlled trials, there is no evidence. However, other kinds of trials can be just as effective. Moreover, a variety of outcomes must be examined - including client satisfaction.

Research

The group identified the need for increased structure and funding for research in CAHC. The federal government and the Canadian Institutes of Health Research (CIHR) were seen as holding the primary responsibility for making this happen. It was pointed out that currently, while there is not an office or Institute for CAHC, it is under the wing of three Institutes in CIHR, and there is interest in CAHC at CIHR, largely as a result of the work of the Advisory Group on Complementary and Alternative Health Care. There was discussion regarding the importance of CAHC having a very visible presence within CIHR. Some felt the only way that could be accomplished is through an office or Institute.

Historically, all of the research funds have been allocated according to major components and developments of the health care system and disease entities. Currently, surveys indicate that significant numbers of Canadians are using CAHC. Therefore, some expressed the feeling that there is a social obligation to put research dollars into the CAHC system. There will be spin-offs to doing so that will benefit the entire CAHC and conventional health care systems. The process of allocating funds to CAHC research will result in human relationships being created, and this will bring about better cooperation and understanding between and among practitioners. A structure will ultimately develop.

The example of the United States was put forward, where over $100 million has been allocated to CAHC research. There is a funded research consortium that supports meetings to set research priorities

The group identified cautions around the establishment of research funding, however. At the Roundtable on Health Law and Ethics, an American discussed the experience in the US. When money became available for research, the nature of the research changed - largely because the established players became major players, and they wanted to focus on a biomedical model.

There are also concerns about the capacity of those working in CAHC to secure research funding. People from CAHC may not know how to apply for research dollars. There is a need to build research capacity and literacy within the various groups. Some of this work has begun, and it was recommended that it be initiated with those practitioner groups who are most ready.

Creating the Political Will to Support Complementary and Alternative Health Care

The group noted that it is important to create the political will to support CAHC. While it is important to establish some evidence, including cost effectiveness, it is critical to stimulate political interest at the same time. The group had a number of ideas about how to accomplish this.

• Work with groups who have had a great deal of experience in the area already - e.g., those working in HIV and cancer.
• Identify champions, some of whom are high profile public figures, prominent Canadians.
• Continue to update consumer surveys that indicate the use of CAHC.
• Demonstrate the precedent - it was done in the US and it worked - it was safe.

Consumer Choice/Public Protection

The Health Systems Division invitational seminar on information and informed choice in the use of CAHC identified many difficulties in providing consumers with informed choice regarding CAHC. The information may not be available. Different sources of information may present different or conflicting views. The level of language may be difficult to understand. Traditional avenues for obtaining information and making decisions, such as consultation with a primary health care provider and referral to appropriate specialists, are not developed or accepted with regard to CAHC.

At the same time, the information needs and rights of consumers require attention if they are to be respected as informed, and if they are to be empowered to judge the safety and ethics of CAHC. It is important that any regulatory structures, while protecting the public, also maximize informed consumer choice and access. Certain models can actually reduce choice and access. It would be problematic to adopt regulatory regimes that significantly limit consumer choice and access to CAHC, given that CAHC has been a consumer-driven phenomenon with consumer demand currently unaffected by the lack of regulatory structures. The group's overall feeling was that with CAHC, choice is being enhanced. However, consumers want to choose among safe and effective options.

There is tremendous tension with regard to consumer choice and public protection in certain areas due to the lack of regulation (for example, in the area of cancer treatment). Consumers contact cancer information services asking about CAHC practices: what they are; who does what; does it work; where they are offered; and at what cost. Particularly worrisome are the treatments of cancer based on a vaccine, a biologic substance or a proprietary compound outside of conventional medicine.

Appendix 1

Meeting Participants

Steven Aung
President,
Canadian Medical Acupuncture Society
Edmonton, AB

David Chapman-Smith
World Federation of Chiropractic
Toronto, ON

Michelle Boudreau
Department of Justice
(currently assigned to Natural Health Products Directorate of Health Canada)
Ottawa, ON

Joan M. Gilmour
Osgoode Hall Law School,
York University
Toronto, ON

Corresponding members

James Casey
Field Atkinson Perraton
Edmonton, AB

Anne Vezina
National Cancer Information Service
Canadian Cancer Society
Toronto, ON

Richard Elliott
Policy and Research
Canadian HIV/AIDS Legal Network
Toronto, ON

Health Canada staff

Joan E. Simpson
Health Human Resource Strategies Division
Health Canada
Ottawa, ON

Carol Ann Côté
Health Human Resource Strategies Division
Health Canada
Ottawa, ON

Michael J. Smith
Natural Health Products Directorate
Health Canada
Ottawa, ON