Health Law and Ethics in Relation to the Use of Complementary and Alternative Health Care and Natural Health Products: An Invitational Roundtable (December 1-2, 2001)

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Table of Contents

• Executive Summary
• Introduction
  • Objectives
    
  • Process
• General Themes
  • Balancing Interest
    
  • The Value of Ethical Frameworks
    
  • The Importance of Public Information and Informed Choice
    
  • The Importance of Professional Formation
    
  • Access to Products and Services
    
  • The Person-Provider Relationship
• Practitioner-related Legal and Ethical Issues
  • The Practitioner and the Person Seeking Care
    • A Principle of Beneficence
      
    • A Principle of Autonomy
  • The Practitioner and Other Professions
    
  • The Practitioner and Settings of Formation and Practice
    • Settings of Formation
      
    • Settings of Practice
• Product-related Legal and Ethical Issues
  • Data Protection
    
  • Regulation of Claims Related to Schedule A
    
  • Sales of Natural Health Products by Practitioners
    
  • Sampling
    
  • Ethics Review of Clinical Trials
• Legal and Ethical Issues Related to Persons Who Use Complementary and Alternative Therapies
  • Naming People Who Use Products and Services
    • Patient or Client
      
    • Participant in or Recipient of Care and Services
      
    • Consumer
  • Making Choices
    
  • Information and Advertising
    
  • Costs and Coverage
• General Legal and Ethical Issues
  • Ethical Frameworks: A Potential Resource
    
  • Deficiencies in Informed Consent
    
  • Legal Recourse to Improve Access
    
  • Innovation in Clinical Practice
    
  • Direct-to-Consumer Advertising
    
  • Peer-review of Practice and Research
    
  • Comparable Requirements for Comparable Products
• Conclusion
• Appendix A: List of Participants
• Appendix B: Agenda
• Appendix C: Participants Replies to Questionnaire about Five Top Challenges

Executive Summary

On December 1-2, 2001, Health Canada convened an invitational roundtable on health law and ethics in relation to the use of complementary and alternative health care (CAHC) and natural health products (NHPs). The meeting was one of several convened in 2001 and 2002 by the Health Human Resource Strategies Division, Health Care Strategies and Policy Directorate, Health Policy and Communications Branch, and the Natural Health Products Directorate, Health Products and Food Branch, on issues related to CAHC and NHPs.

The participants in the roundtable included lawyers, ethicists, practitioners, academics, manufacturers of NHPs and policy analysts. To provide an international perspective, a participant was invited from the United States.

The objectives of the roundtable were:

• to provide a multisectoral forum for discussion
• to identify key legal and ethical issues related to the use of CAHC and NHPs
• to suggest ways to address these issues
• to produce a report on the roundtable for public distribution

The roundtable considered four broad areas of concern:

1. practitioner-related legal and ethical issues
2. product-related legal and ethical issues
3. legal and ethical issues related to persons who use CAHC and NHPs
4. general legal and ethical issues

Participants identified issues and challenges in each of these areas of concern. Several general themes emerged from the discussion:

• Balancing Interests. Complementary and alternative health care, like conventional health care, is beset by conflicting or competing interests. Principles and procedures developed over time in health care to disclose and manage such conflicts of interest should and can be applied to CAHC.

• The Value of Ethical Frameworks. When dealing with issues raised by increasing interest in and use of complementary and alternative therapies, ethical frameworks help to contextualize the problems raised by an issue, lend coherence to the direction taken on the issue, and mediate differences of views on the issue. Several current ethical frameworks could help to address issues raised by the use of complementary and alternative therapies. It is important to draw on these frameworks.

• The Importance of Public Information and Informed Choice. When people are well informed about complementary and alternative therapies, they are better able to make informed choices about the products they might use or the procedures they might consent to. What is needed is an environment that provides robust support for informed choice. This requires, for example:

  • that practitioners be knowledgeable about the range of options available to people and that they advise people about the risks and benefits in a respectful way
  • that labels of products convey the information people need in clear and simple language
  • that providers of products provide good information about their use

  • control of direct-to-consumer advertising

• The Importance of Professional Formation. The formation of practitioners - which includes not only education and training in an area of practice, but also the development of professional character and ethical awareness - is key to their ability to provide information to people and to deal with the ethical questions that might arise in clinical practice.

  It is important that conventional practitioners become sufficiently knowledgeable about complementary and alternative therapies, and that complementary and alternative practitioners become sufficiently knowledgeable about conventional medicine. However, the formation of attitudes and behaviours is needed in addition to the development of knowledge.

• Access to Products and Services. There are ongoing concerns about constraints on access to products and services. These constraints include:

  • lack of public insurance coverage for complementary and alternative therapies
  • inadequate knowledge among practitioners about the products and services that might be helpful to people
  • delays in uptake of new knowledge into clinical practice guidelines
  • inequities between the regulations for drugs and those for NHPs or between the regulations for NHPs and those for functional foods
  • prohibition of making claims with regard to diseases listed in Schedule A of the Food and Drugs Act

  While these concerns need to be addressed, the goal is not necessarily unlimited access to products and services. There is a role for regulatory controls and professional judgement.

• The Person-Provider Relationship. The relationship between the person seeking care or service and the provider of care or service varies according to the circumstances of the person seeking care or service, and the nature of the care and service provided. It is difficult to settle on language to describe this relationship. Each of the terms commonly used - 'patient,' 'client,' 'consumer' - has its connotations with respect to the disposition of the person seeking care or service, and the disposition of the provider of care or service.

  However, it was generally agreed that health care is not a commodity like other commodities. While it might be appropriate to call people who buy NHPs 'consumers,' it would be misleading to suggest that the relationship that people have to health care providers is the same as the relationship they have to other goods and services.

• Ongoing Ethical and Legal Deliberation. Several observations can be made about the need for further ethical and legal deliberation in relation to the use of CAHC and NHPs.

  First, the increasing use of complementary and alternative therapies is bringing about, and will continue to bring about, changes to the health system in Canada. Some of the changes identified by participants in the roundtable included:

  • changes in the formation of practitioners
  • evolving policy regarding the use of complementary and alternative therapies in health care institutions
  • assessment of evidence regarding the effectiveness of complementary and alternative therapies
  • changes to clinical practice guidelines
  • reconsideration of products and services covered by public and private health insurance plans

  Such changes will need to be accompanied by ethical and legal reflection. While it might not be necessary to develop entirely new ethical or legal frameworks, there will be adjustments and perhaps comprehensive reconsideration. This is an exciting prospect, but also one that requires sustained and thorough attention from all participants.

  Second, a key relationship in health care is the relationship between the person receiving care or service and the provider of care or service. There are many ways in which this relationship can and should contribute to informed decisions in the use of complementary and alternative therapies. The fact that it does not always do so should be a subject of ethical and legal deliberation. It is important to identify, from an ethical and legal perspective, how the person-provider relationship - whether in conventional health care, CAHC, or in some form of joint or integrated health care - should contribute to informed decisions in the use of complementary and alternative therapies. It is also important to identify any justifiable conditions on or limits to the provider's responsibilities to the person using complementary and alternative therapies.

  Third, many people use complementary and alternative therapies as a form of self-care. This means that access to safe and effective products and services, as well as access to clear, easy-to-understand, and reliable information about these products and services, will continue to be a central concern. Undoubtedly, there will be differences in perspective among regulators, practitioners (both conventional and complementary/alternative), manufacturers, policy makers and people who use complementary and alternative therapies as to how to address issues regarding access to products and services in self-care. The discussion at the roundtable suggests that ethical and legal reflection should be a part of the process of clarifying or resolving such differences in perspective.

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A Note On Terminology

During the roundtable, participants at times addressed their remarks generally and inclusively to all aspects of complementary and alternative health care, including an overall approach to health, the practices employed in that approach, the services provided and the products used. In this report, the phrase complementary and alternative therapies is used to refer to all these aspects: overall approach, practices, services and products. The terms practices, services and products are used to refer to more specific aspects of complementary and alternative health care, as required by the discussion.

Introduction

On December 1-2, 2001, Health Canada convened an invitational roundtable on health law and ethics in relation to the use of complementary and alternative health care (CAHC) and natural health products (NHPs). The meeting was one of several convened in 2001 and 2002 by the Health Human Resource Strategies Division, Health Care Strategies and Policy Directorate, Health Policy and Communications Branch, and the Natural Health Products Directorate, Health Products and Food Branch, on issues related to CAHC and NHPs.

The participants in the roundtable included lawyers, ethicists, practitioners, academics, manufacturers of NHPs and policy analysts (see Appendix A). To provide an international perspective, a participant was invited from the United States.

Objectives

The objectives of the roundtable were:

• to provide a multisectoral forum for discussion
• to identify key legal and ethical issues related to the use of CAHC and NHPs
• to suggest ways to address these issues
• to produce a report on the roundtable for public distribution

Process

The agenda of the roundtable is provided in Appendix B.

Prior to the roundtable, participants were asked to identify five top challenges with regard to health law and ethics related to the use of CAHC and NHPs. The responses were collated and made available to all participants (see Appendix C).

During the first session of the roundtable, participants described the perspective they were bringing to the roundtable, and the challenges they identified from this perspective. In the remaining sessions of the roundtable, participants discussed four broad areas of concern in small groups (two groups running concurrently with one area of concern per group):

1. practitioner-related legal and ethical issues
2. product-related legal and ethical issues
3. legal and ethical issues related to persons who use CAHC and NHPs
4. general legal and ethical issues

Each group reported on its discussion to the roundtable in plenary, with opportunity for questions and comments from the roundtable as a whole.

This report summarizes the general themes that emerged from the discussion, and reproduces the substance of the discussion of each of the four broad areas of concern.

A Note On Terminology

During the roundtable, participants at times addressed their remarks generally and inclusively to all aspects of complementary and alternative health care, including an overall approach to health, the practices employed in that approach, the services provided and the products used. In this report, the phrase complementary and alternative therapies is used to refer to all these aspects: overall approach, practices, services and products. The terms practices, services and products are used to refer to more specific aspects of complementary and alternative health care, as required by the discussion.

General Themes

The discussion at the roundtable was more a preliminary overview of areas of concern than a focused examination of the issues. It would be premature, therefore, to draw specific directions from the discussion. Nevertheless, several general themes emerged:

Balancing Interests

Complementary and alternative health care, like conventional health care, is beset by conflicting or competing interests:

• The desires of a person seeking care might conflict with the responsibilities of the practitioner providing care.
• A practitioner who sells products as well as provides services might be in a conflict of interest between earning an income and serving the interests of the client.
• A population-based assessment of the need for public funding of a given service or product might differ from an individual's assessment.
• The provision of free samples by manufacturers might conflict with the government's interest in public safety.

In general, it appears that principles and procedures developed over time in health care to disclose and manage such conflicts of interest should and can be applied to complementary and alternative therapies health care.

The Value of Ethical Frameworks

When dealing with issues raised by increasing interest in and use of complementary and alternative therapies, ethical frameworks help to contextualize the problems raised by an issue, lend coherence to the direction taken on the issue, and mediate differences of views on the issue.

There is not necessarily one answer or approach to an issue. Different ethical frameworks might yield different insight into and direction on an issue. Several current ethical frameworks could help to address issues raised by the use of complementary and alternative therapies:

• principle-based ethics, which determines a course of action in light of basic principles of ethical conduct along with reasonable and circumscribed exceptions to those principles
• case-based ethics, which determines a course of action on the basis of precedents established in previous cases
• virtue theory, which focuses on the moral agent and the qualities that an agent should cultivate in order to interpret a situation and act appropriately
• ethics of care, which is rooted in the relationship between the care-giver and the recipient of care
• feminist theory, which views a situation from the standpoint of the oppressed, and contributes an analysis of the power relationships in the situation
• narrative theory, which views the situation as an encounter, as a moment in the story of the participants whose futures will be affected by whatever action is taken

The Importance of Public Information and Informed Choice

Many of the ethical and regulatory concerns associated with complementary and alternative therapies have to do with determining efficacy, ensuring public safety and supporting informed choice. When people are well informed about complementary and alternative therapies, they are better able to make informed choices about the products they might use or the procedures they might consent to.

What is needed is an environment that provides robust support for informed choice. This requires, for example:

• that practitioners be knowledgeable of the range of options available to people and that they advise people about the risks and benefits in a respectful way
• that the labels of products convey the information people need in clear and simple language
• that providers of products provide good information about their use
• the control of direct-to-consumer advertising
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The Importance of Professional Formation

The formation of practitioners - which includes not only education and training in an area of practice, but also the development of professional character and ethical awareness - is key to their ability to provide information to people and to deal with the ethical questions that might arise in clinical practice.

It is important that conventional practitioners become sufficiently knowledgeable about complementary and alternative therapies to be able to answer questions from people who consult them and to advise about potential risks and benefits. It is also important that complementary and alternative practitioners become sufficiently knowledgeable about conventional medicine to be able to refer people to conventional practitioners when required.

The formation of attitudes and behaviours is needed in addition to the development of knowledge. What is needed are practitioners who are practiced in, for example:

• ongoing learning and modification of clinical practice
• understanding and respecting people's approaches to their health and well-being
• supporting people in making informed choices
• communicating the boundaries of the practitioner's responsibilities
• conveying disagreement or contra-indication

Access to Products and Services

There are ongoing concerns about constraints and limitations on access to products and services. These include:

• the lack of public funding for complementary and alternative therapies
• inadequate knowledge among practitioners about the products and services that might be helpful to people
• delays in the uptake of new knowledge into clinical practice guidelines
• inequities between the regulations for drugs and those for NHPs or between the regulations for NHPs and those for functional foods
• prohibition of making claims with regard to diseases listed in Schedule A of the Food and Drugs Act.

While these concerns need to be addressed, the goal is not necessarily unlimited access to products and services. There is a role for regulatory controls and professional judgement.

The Person-Provider Relationship

The relationship between the person seeking care or service and the provider of care or service varies according to the circumstances of the person seeking care or service, and the nature of the care and service provided. It is difficult to settle on language to describe this relationship. Each of the terms commonly used - 'patient,' 'client,' 'consumer' - has its connotations with respect to the disposition of the person seeking care or service and the disposition of the provider of care or service.

However, it was generally agreed that health care is not a commodity like other commodities. While it might be appropriate to call people who buy NHPs 'consumers,' it would be misleading to suggest that the relationship that people have to health care providers is the same as the relationship they have to other goods and services.

Practitioner-Related Legal and Ethical Issues

The group felt that it might be premature to focus on specific legal and ethical questions in relation to complementary and alternative practitioners (such as the requisite components of a regulatory regime), given the preliminary nature of the roundtable. Rather, the group decided to articulate some general principles that might guide practitioners (conventional and complementary/alternative) in regard to complementary and alternative therapies.

The group identified a number of dimensions to the practitioner's responsibilities - in relation to the person seeking care, to other practitioners, to various settings, to regulatory bodies or jurisdictions, and with regard to prescribing or recommending products - and suggested principles that should inform the exercise of those responsibilities, insofar as time permitted.¹ This led to a discussion of further questions or issues raised by the proposed principles.

The Practitioner and the Person Seeking Care

A Principle Of Beneficence

A first general principle proposed was that the practitioner is committed to act in such a way as to maintain or restore the health and well-being of the person seeking care.

This principle is a specific application in the area of health care of another principle; namely, that the practitioner is committed to act in the best interest of the person seeking care (a principle of beneficence). This principle raised a number of questions for the group:

• How does one determine the best interest of the person seeking care?
• Who is best placed to determine the person's best interest?
• What role does the person seeking care have in determining his or her best interest?
• What role do other health providers have in determining the best interest of the person seeking care?
• What will be the balance between acting in the best interest of the person seeking care (beneficence) and doing what the person wants (autonomy)?
• How are health and well-being defined?

In raising and discussing these questions, participants suggested that the determination of a person's best interest occurs (or should occur) in a process that includes the person seeking care. While the autonomy of the person seeking care is not unlimited (the practitioner might disagree with the person on the best course of action), the practitioner must, nevertheless, respect the person's capacity for self-determination in achieving or maintaining health and well-being.

It was also observed that the determination of a person's best interest entails an obligation on the part of the practitioner to be aware of the range of options that might advance the health and well-being of that person. For conventional practitioners, these options might include complementary and alternative therapies. For complementary/alternative practitioners, these options might include conventional therapies.

A Principle of Autonomy

A second general principle proposed was that a person has a right to bodily integrity and self-determination, and from that flows the right to make decisions about the health care that she or he will choose, accept or reject.

This principle aims to recognize that persons seeking care should be usually presumed to have a capacity to make choices with regard to the care they receive, and that this capacity should be acknowledged and respected in the process of providing care (a principle of autonomy).

In ethical terms, this principle is often expressed in rules and procedures designed to ensure that a person makes an informed choice with regard to his or her health care. In legal terms, this principle is expressed in the requirement, established in common law or by statute, that practitioners obtain the informed consent of a person before proceeding with a medical intervention.

In the ensuing discussion, the question arose as to the relationship between the obligation of the practitioner to seek the best interest of the person seeking care (the principle of beneficence) and the person's right to bodily integrity and self-determination (the principle of autonomy), particularly in situations when the person seeking care might be considering therapies about which the practitioner (conventional or complementary/alternative) is uninformed or skeptical.

It was observed that the relationship between the two principles would vary according to the nature of the practices in question and the knowledge and attitudes of the practitioner. The relationship would have to be worked out in an implicit or explicit understanding or agreement between the practitioner and the person seeking care.

Participants recognized that there might be situations where a practitioner might not offer or recommend certain therapies, and might thereby limit the options to which a person might consent. Whether this represents a warranted or unwarranted limitation of the practice of informed choice would have to be determined according to the circumstances of the case.

In general, the group suggested that practitioners have an obligation to be sufficiently informed and respectful to enable persons seeking care to make truly informed choices with regard to both conventional and complementary/alternative therapies.

The Practitioner and Other Professions

Participants agreed that, as a general principle, it is necessary that all practitioners (conventional and complementary/alternative) be aware that there are a range of practices that can work in the best interest of the person seeking care.

The growing practice and use of complementary and alternative therapies expands the scope of possible therapies that a person seeking care might require or that a practitioner might be asked to advise upon. In this context, it is necessary that conventional practitioners become more familiar with complementary and alternative therapies, and that complementary and alternative practitioners become familiar with conventional therapies. Alternatives to the practitioner's approach to health and healing might have to be considered and might, in fact, be required. Practitioners should have an understanding of where harm or benefit could occur and, in the absence of such understanding, should consult with persons who have such an understanding.

The question arose about circumstances in which the person seeking care might not want a practitioner to confer with others. While the group did not pursue the question in depth, it was noted that lack of consultation among practitioners, in fact, limits the possibility of making an informed choice (the person seeking care is less informed because less information is available).

It was noted that practitioners do not have a legal obligation to inform or advise about therapies that are deemed by the courts to be at the periphery of medical practice (therapies that the courts have characterized as "fringe" therapies). However, the boundary between "mainstream" therapies and "fringe" therapies has not been defined in case law.

Participants recognized that both conventional and complementary/alternative practitioners might be convinced that their approach and knowledge alone are in the best interest of the person seeking care. It was suggested that, in spite of such convictions, practitioners must come to recognize and understand other approaches and knowledge. Otherwise, people are at a disadvantage when seeking advice and integrating their health care.

The Practitioner and Settings of Formation and Practice

Settings of Formation

As a general principle, the group agreed that the formation of practitioners should provide them with sufficient knowledge to be able to support people in making informed choices about their health and well-being, and should cultivate an attitude of tolerance and respect for alternative approaches to health and healing.

This two-fold principle recognizes that the formation of practitioners - which includes not only education and training in an area of practice, but also the development of professional character and ethical awareness - has an enormous influence on how they will relate to persons seeking care and to other professionals. As such, this principle flows from the other principles suggested above and is necessary for their realization.

Participants recognized that there will be occasions when a practitioner will express profound reservations or even disagreement about a given therapy. (Such reservations and disagreements arise not only with regard to therapies deemed 'other,' but also those deemed 'one's own.') To deal with such occasions, what is required is formation about the limits of a practitioner's responsibilities in providing care, and the limits of a person's autonomy in seeking care.

It was also acknowledged that the transition to comprehensive, joint or integrated education and training (e.g., common years for students in different professional programs) could be difficult. Resistance might come not only from conventional medicine with regard to complementary and alternative approaches, but also from one complementary and alternative approach toward another. Like practitioners, students often prefer to 'live in their own world.' Educational and training programs contribute to the formation of a student's professional identity. It was observed that first-year students are often more open to 'alternative worlds;' by third-year, their professional identity has become more fixed and exclusive (they have 'joined the club').

Settings of Practice

There is a range of settings in which practitioners provide care: acute care/trauma care; 'half-way' care (follow-up to acute care); ambulatory care; chronic care/residential care; walk-in clinics; private practice; stores that also offer some treatment services; treatment centres that also sell products; etc.

There are important distinctions between practice settings with regard to legal status and insurance coverage. These distinctions have significant implications, especially for funding and liability. Participants noted, for instance, differences between:

• Public institutions. Public institutions, such as hospitals, are governed by legislation and are subject to rules concerning who can obtain privileges to practice. When people in hospitals or residential institutions wish to use complementary and alternative therapies, questions arise for the institution. What are the implications for the institution if it allows a complementary/alternative practitioner who does not qualify for privileges to practice in the institution? What are the implications when a conventional practitioner with privileges provides an unregulated complementary/alternative service or product?
• Private clinics. Private clinics that offer diagnostic services and perform some invasive procedures are becoming more prevalent. Some of the services they offer are covered by public insurance; other services are not. The regulation of private clinics might be delegated to an existing regulatory body such as, in Ontario, the College of Physicians and Surgeons. It was suggested that the regulation of private clinics might not interact with complementary and alternative therapies as much as the regulation of hospitals and residential care facilities because overnight or extended stays are not common in clinics.
• Private practice. Some forms of private practice are regulated by legislation and are publicly funded (e.g., physicians, chiropractic). Other forms of private practice are not. What liability might a regulated practitioner incur in referring a person to an unregulated practitioner?
• Telemedicine and electronic medicine. The technology is available, and is increasingly used, for practitioners to provide advice at a distance, via telecommunications or electronic media. From a legal perspective, it is important to establish the legal regime that would apply to the practice, given that the practitioner might be in one jurisdiction and the person receiving care in another. The law in this area is not settled as yet.

In general, participants agreed that the obligations of a setting, with regard to combinations of conventional and complementary/alternative approaches, differ according to the level of potential or known risk. Participants identified three types of scenarios:

• no interaction between the therapies (e.g., chemotherapy and prayer)
• interaction between the therapies (e.g., the ingestion of various kinds of substances)
• exclusion of a therapy (e.g., prohibition against using a therapy)

The level of risk involved in each of the scenarios depends on the circumstances in each case. While a primary principle in every case should be to do no harm, it was suggested that the application of the principle is a complex and subtle operation.

Product-Related Legal and Ethical Issues

After an initial round of naming key themes of interest to participants, the group agreed to focus on five areas:

• data protection
• regulation of claims related to Schedule A
• sales of products by practitioners
• sampling
• clinical trials

Data Protection

There was general agreement that it was important to provide incentives to industry to develop new NHPs and to conduct health research, and that some protection for their resulting data was a key incentive. Data protection, it was stated, would be appropriate for new entities and for new claims on existing products if the new claim were the result of original research. There currently is no market exclusivity for new claims in Canada.

The amount of data protection and market exclusivity should be related to the standard of evidence for the product or claim. A literature review, for example, should not receive protection because it is information that is already in the public domain. By contrast, data from original clinical research should benefit from greater protection.

Participants recognized that there is a conflict of interest between data protection and consumer choice and information. Some participants feared that once data protection or market exclusivity had been granted for a claim, a company might delay bringing its product to market until the timing was seen to be most profitable.

It was noted that standards of evidence should include research data on the effects of products on different populations, particularly children.

Regulation of Claims Related to Schedule A

The Food and Drugs Act prohibits labelling products with claims of prevention, treatment or cure related to diseases listed in Schedule A, regardless of the level of evidence to support such a claim. The prohibition was designed to prevent fraudulent claims and to avoid self-medication on the basis of such claims.

However, participants suggested that the prohibition prevents truthfulness in claims and is contrary to the principle of informed choice. The prohibition also creates a hierarchy of who gets to know about the evidence and who does not. People who are well connected to sources of information will likely find out about the evidence on their own. This points to the ongoing need for public education and information about NHPs.

Regulation in this area should be related to the strength of the claim (how boldly the product claims to be effective) and the strength of the evidence (how clearly the evidence demonstrates effectiveness). Regulations should mandate appropriate caveats and warnings regarding any claims on labels. Participants noted a connection here to regulations designed to ensure truthful labelling.

Sales of Natural Health Products by Practitioners

Participants were concerned about conflict of interest when practitioners sell products. The sale of products can be lucrative for practitioners. A practitioner's interest in selling products might conflict with the interest of the person seeking their care, and in such a conflict the balance of power and information lies with the practitioner.

It was noted that, in the past, it might have been more necessary for practitioners to sell products because that was the only way the products would be available. Now, however, NHPs are widely available through outlets such as health food stores and pharmacies.

Participants expressed a concern that some practitioners might market their own 'exclusive' products, and that these products are more likely to be unregulated. However, it was noted, in some therapies, practitioners do legitimately make their own specific mixtures.

It was felt that it is not a conflict of interest for practitioners to visit pharmacies or other outlets to provide information about products, provided that their advice remains generic and they are not marketing a specific brand.

It was suggested that prohibiting or limiting sales by practitioners could cause some practitioners to increase their fees for visits, and that this could have an adverse impact on accessibility. Other participants suggested, however, that revenue should not be the first goal in a healing profession.

It was noted that the capacity to regulate the sale of products by practitioners would be limited if the practitioners themselves are unregulated.

The issue of sales by practitioners is linked to the issue of the ability of the public to read and understand information on product labels. It is important to make it easier for the public to read and understand information on product labels. Even so, it cannot be assumed that clear and simple language on product labels alone will be enough. Retailers of products will continue to have a role in explaining information on product labels. Therefore, it is important to have well-informed and well-educated retailers of products.

Sampling

The Food and Drugs Act prohibits the distribution of free samples (known as 'sampling') except to health professionals. Currently, it is not clear where the line should be drawn between drugs and NHPs with regard to sampling. It was observed that manufacturers of NHPs are now doing demonstrations to the public at trade shows.

Participants noted that people might assume that free samples are 'innocent' or safe. However, there are safety considerations. For example, one of the reasons for regulating sampling is the risk of children ingesting inappropriate products or inappropriate quantities of products. Participants felt that public safety should trump commercial interests in regulating sampling. The degree of regulation or the limitation of sampling should be related to the risk of the product and the claims of the product (e.g., claims that might dissuade consumers from pursuing other medical treatment).

Some participants wondered what the risk to safety would be if the product being distributed were properly approved and labelled. It was noted that the regulation of sampling is linked to the regulation of packaging and labelling. It is also linked to public education, since consumers would be less vulnerable to inappropriate sampling if they were well educated about NHPs.

Ethics Review of Clinical Trials

It is an ongoing challenge to devise effective, appropriate and ethical clinical research processes for NHPs. In Canada, all research involving human subjects is subject to an ethics review. It is currently proposed that existing university-based Research Ethics Boards be asked to approve clinical trial protocols for NHPs. It is expected that the Research Ethics Boards would recruit one additional member with expertise in NHPs to assist with these reviews. It is unclear whether these additional members would be permanent members, or would only participate in specific reviews.

Participants noted that the knowledge and judgement required to assess clinical trial protocols for NHPs are significantly different from those in trials of allopathic products. Some participants feared that members of Research Ethics Boards might not be sufficiently knowledgeable about NHPs and might be too conservative when assessing innovative research methodologies. It will be challenging for Research Ethics Boards to recruit the proper expertise in NHPs.

It was noted that there are unresolved or controversial methodological issues for research in NHPs. There is a limited history of quantifying risk in this research. In some cases, it is not clear what the comparable standard of care should be.

There is a general lack of professional and experienced researchers in NHPs. Participants observed that medical researchers might not be experienced with complementary therapies, while natural health researchers might not be experienced with the protocols and processes needed for ethics approval.

Legal and Ethical Issues Related to Persons Who Use Complementary and Alternative Therapies

The group discussed the following issues related to persons who use complementary and alternative therapies:

• the language use to name people who use products and services
• limitations on the exercise of informed choice
• providing information to people
• conflicts of interest in advertising products and services
• the impact of costs and coverage of products and services

Naming People who use Products and Services

The terms used to refer to people who use complementary and alternative products and services have important connotations. Each of the terms suggests a certain relationship between the person and the provider, and this relationship entails a particular set of responsibilities. Moreover, different considerations apply when what is being provided is a product rather than a service or a form of care. Thus, the relationship of staff in a health food store to the person who buys an NHP (a 'consumer' or a 'client') is different from the relationship of a naturopathic doctor providing a diagnosis to a person seeking care (a 'patient' or a 'client'). The responsibilities of the two providers are also different.

Patient or Client

Participants discussed how the terms 'patient' and 'client' might be understood to convey different kinds of relationships between the person receiving care or service and the provider of care or service, each with their own rights and responsibilities.

For some, the term 'patient' conveys vulnerability in the person receiving care, while the term 'client' conveys the sense of someone who is participating in the decisions being taken. In each case, the person providing the care or service has responsibilities that correspond to the person receiving the care or service. For example, when the person receiving care is vulnerable, the care provider has an ethical responsibility to recognize this vulnerability and to exercise the power inherent in his or her role as a care provider in an ethical manner.

It was noted that the same person might be a 'patient' or a 'client' at different times with the same provider. It was also noted that in certain circumstances, when the person receiving care is a child or an incapacitated adult, the 'client' (in the sense of the person who participates in decision-making) might become the family or some other duly appointed person. (There is now clear law about substitute decision-making when someone is incapable of making a decision.)

For some, 'client' has become the preferred term. For them, it conveys the principle that people are entitled to make informed choices about their health care. However, participants recognized that there are questions about the usage of both terms. Does 'patient' necessarily convey the sense of someone who is sick or passive? Does 'client' introduce connotations from business that are not appropriate to health care? Does 'client' communicate a sense of entitlement to services?

Participant in or Recipient of Care and Services

'Participant' in care and services or 'recipient' of care and services are possible alternatives to 'patient' or 'client.' It was noted, however, that a person's ability to participate in care and services might be limited by a person's age, health status or other characteristics. Moreover, neither term might be appropriate in situations involving the use of products (e.g., when people purchase NHPs off the shelf in a health food store or pharmacy).

Consumer

'Consumer' might be the appropriate term to designate a person who is buying NHPs. However, participants had some reservations about designating all people who use complementary and alternative therapies 'consumers,' because health care is not a commodity like other commodities.

Making Choices

What is involved in respecting a person's right to choose complementary and alternative therapies? What procedures and conditions are needed to support this right to choose? What limits on this right to choose might be justified?

In considering these questions, participants noted that a person's right to choose is shaped by the menu of choices that are offered and the information that is provided about these choices. It was suggested that the menu of choices should not be limited to services or products provided by regulated practitioners. However, it was noted that the ethical obligations might be different when referring to unregulated practitioners.

Participants observed that sometimes people resort to complementary and alternative therapies because of limited access to or success with conventional therapies (e.g., in managing chronic pain). In these situations, choices are already limited in ways that might not be justifiable.

A lack of recognition and of insurance coverage also limits people's access to complementary and alternative therapies. In some cases, the regulatory system and the public insurance schemes are adjusting to meet the desires or needs of the public (e.g., the recognition and funding of midwives). However, a population-based assessment of the range of choices that should be available and funded might differ from an individual's assessment. Population-based assessments might result in justifiable limitations on the choices available to an individual.

An important principle in any circumstance is to protect people from potential harm. The effort to enable access to products and services must be balanced with the responsibility to protect people from harm (e.g., in regulating the manufacturing, labelling and sale of products).

Information and Advertising

Participants emphasized that the environment in which people learn about and select or purchase products or services must provide robust support for informed choice. This is especially important because self-care is very common among people who use complementary and alternative therapies (particularly NHPs). For example, health food stores should be required to have knowledgeable staff on hand to provide information and to answer questions about products. The seller has a responsibility to provide high quality information so that the purchaser's choice of the product is fully informed and her or his use of the product is safe.

All practitioners (conventional and complementary/alternative) might be in a conflict of interest when they prescribe, promote or sell products. For example, practitioners might be unconsciously and unduly influenced by the 'perks' that manufacturers provide when promoting their products. Practitioners might influence their patients or clients by providing free samples. Practitioners might benefit directly from advertising services or selling products to their patients or clients. In all of these circumstances, other interests - besides the best interest of the person seeking care - are at work.

The group agreed that complementary and alternative practitioners should operate according to conflict-of-interest guidelines, as do conventional practitioners. All practitioners should be obliged to disclose conflicts of interest. However determining how to practically ensure or enforce compliance with conflict-of-interest guidelines among complementary and alternative practitioners is a challenge, given that many are unregulated.

It was also agreed that there should be standards for all practitioners (conventional and complementary/alternative) with regard to advertising. It would be helpful to have harmonized standards across all jurisdictions, but it was recognized that there would be differences between the provinces and territories, given provincial jurisdiction over health care.

Costs and Coverage

The costs of complementary and alternative therapies might make them inaccessible to many people. Often those who most need these therapies (e.g., people with chronic conditions or disabilities) can least afford them. (There is public insurance coverage for some therapies in some jurisdictions, and people might benefit from private insurance coverage for some therapies.) It was observed that many providers of products and services locate themselves in relatively well-to-do neighbourhoods, where people can pay for therapies either out of their own pockets or through private insurance coverage. The result is a 'two-tier' system of health care.

While this problem cannot be resolved without taking into account the costs to government and society in funding complementary and alternative therapies, it was suggested that some 'out-of-the-box' thinking is required to weigh the costs of coverage against the potential benefits of access, particularly in promoting health and preventing illness. This would include determining how to assess and measure benefits to health from various types of therapies - complementary and alternative as well as conventional.

Participants observed that some lessons might be learned from the experience of existing public insurance coverage for health care. Participants felt that compensation on a fee-for-service basis encourages practitioners to see as many people as quickly as possible. Compensation arrangements that allow practitioners to spend adequate time with patients should be encouraged in any payment scheme that reimburses complementary and alternative practitioners.

General Legal and Ethical Issues

The final group had the opportunity to consider issues that related to all of the areas under consideration at the roundtable (practitioners, products, and people who use complementary and alternative therapies), as well as issues that had not yet been addressed. The group discussed:

• the potential contribution of different ethical frameworks
• deficiencies in the exercise of informed consent
• legal recourse to improve access to complementary and alternative therapies
• the uptake of new knowledge into clinical practice
• direct-to-consumer advertising; peer-review of practice and research
• equitable regulatory requirements for NHPs

Ethical Frameworks: A Potential Resource

A number of ethical frameworks are employed today in bioethics. Briefly described, these include:

• principle-based ethics, which determines a course of action in light of basic principles of ethical conduct along with reasonable and circumscribed exceptions to those principles
• case-based ethics, which determines a course of action on the basis of precedents established in previous cases
• virtue theory, which focuses on the moral agent and the qualities that an agent should cultivate in order to interpret a situation and act appropriately
• ethics of care, which is rooted in the relationship between the care-giver and the recipient of care
• feminist theory, which views a situation from the stand-point of the oppressed and contributes an analysis of the power relationships in the situation
• narrative theory, which views the situation as an encounter, as a moment in the story of the participants whose futures will be affected by whatever action is taken
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Principle-based ethics is probably the most common form of ethical reasoning used in health care. While it remains valuable and perhaps indispensable, other ethical frameworks can contribute important insights, particularly with regard to issues raised by complementary and alternative therapies.

Some of the other theories are more open to the epistemological questions or relational issues raised by complementary and alternative therapies. For example, the question of what constitutes 'evidence' might look rather different when examined from the point of case-based theory, feminist theory or narrative theory. Or, the ethics of care might account more completely for the nature of the relationship between the complementary/alternative practitioner and the person seeking care than principle-based ethics does.

Participants asked what might this mean at the level of the practitioner. Practitioners (conventional and complementary/alternative) intuitively or habitually work within the ethical frameworks to which they have become accustomed. Exposure to different ethical frameworks might contribute to greater appreciation for or understanding of the perspective that other practitioners bring to a situation and the decisions that they take in that situation. Moreover, the issues raised by complementary and alternative therapies might lead practitioners to reconsider their customary ethical reasoning.

Participants also asked what this might mean at the level of the regulator. The regulation of health services and products serves certain general goals. These might include, for example, the prevention of harm (the principle of non-maleficence) and the furtherance of informed choice (the principle of autonomy). Different ethical frameworks might define these goals differently, and thus might modify the regulatory enterprise.

In general, it was suggested that ethical (and other) deliberations about complementary and alternative therapies would benefit from reflection in other fields of inquiry, such as epistemology, the history and philosophy of science, medical anthropology and sociology, health economics, discourse analysis, ethics, etc.

Deficiencies in Informed Consent

The use and practice of complementary and alternative therapies are pointing out deficiencies in the current norm and practice of informed consent. Conventional practitioners are obliged by their codes of ethical conduct and by law to obtain the informed consent of persons before proceeding with a medical intervention. However, the procedures that are recognized by their professional regulatory bodies are limited to those typically practiced by the members of the profession.

This approach does not provide an impetus for practitioners to take into account new knowledge or new modalities of care when supporting people in making informed choices. Nor does it accommodate interactions between the mainstream of the regulated practice and acts or approaches that are at the periphery, such as when a complementary practitioner is prohibited from performing acts that are within the scope of practice of a physician, or when a conventional practitioner is prohibited by his or her regulatory body from providing complementary/ alternative services. The net result is a limitation of the options available to the person seeking care, rather than a broadening of the scope of services that might be provided with informed consent.

There is a need for a means of assessing complementary and alternative modalities of care such that they can be included in the options made available to people seeking care.

Legal Recourse to Improve Access

It has been noted above that the cost of complementary and alternative therapies might be a barrier to their use or might impose a considerable financial burden on people who use them. This is particularly true of people who live with a chronic condition or disability. The expenses arising from their condition or disability might be numerous, while at the same time their income might be reduced. Participants considered whether governments are under a legal obligation to ensure that Canadians have equitable access to complementary and alternative therapies.

It was noted that the Canada Health Act establishes the criteria and conditions which provincial health insurance plans must meet to receive the full cash contributions under the Canada Health and Social Transfer. The act governs contributions for two types of services:

• Insured health care services: medically necessary hospital services, physician services and surgical-dental services provided to insured persons
• Extended health care services: certain aspects of long-term residential care (nursing home intermediate care and adult residential care services) and the health aspects of home care and ambulatory care services

The criteria that provincial plans must meet to receive the full cash contributions include public administration, comprehensiveness, universality, portability and accessibility. However, participants observed that these criteria apply only to the two types of services covered by the act; the act does not require public funding for complementary and alternative therapies.

The Canadian Charter of Rights and Freedoms might provide grounds for requiring governments to provide equitable access to health services. Two sections might be invoked - sections 7 and 15:

• Section 7: Everyone has the right to life, liberty and security of the person and the right not to be deprived thereof except in accordance with the principles of fundamental justice.
• Section 15: (1) Every individual is equal before and under the law and has the right to the equal protection and equal benefit of the law without discrimination and, in particular, without discrimination based on race, national or ethnic origin, colour, religion, sex, age or mental or physical disability. (2) Subsection (1) does not preclude any law, program or activity that has as its object the amelioration of conditions of disadvantaged individuals or groups including those that are disadvantaged because of race, national or ethnic origin, colour, religion, sex, age or mental or physical disability.

There have been a few cases in which the courts determined that governments were obliged to provide health services for people with disabilities. However, in general, the courts are reluctant to exercise close supervisory power over the administration of health services. It was suggested that it is unlikely that a claim requiring payment for complementary and alternative therapies by public health insurance plans would be successful.

Innovation in Clinical Practice

Clinical practice will always involve clinical judgment, which consists of applying general principles and a large body of knowledge to particular cases. However, this clinical judgment is shaped by the formation and the culture of the practitioner. Participants asked:

• What happens when a complementary or alternative therapy has been shown to be as or more safe and as or more effective than a conventional therapy (or vice versa), but the source of the evidence is foreign to the formation and culture of the practitioner?

This is a particular instance of the more general challenge of bringing about change in clinical practice. Participants observed that clinical practice guidelines are often not taken up into practice or there is a substantial delay before they are taken up into practice.

There are a number of reasons for this. One is the strength of habit among practitioners, which leads them to follow their earlier decisions when assessing a situation. Another is the volume of evidence that is produced; it is difficult for practitioners to stay on top of it all.
Participants noted that negative or skeptical attitudes on the part of practitioners could inhibit them from recognizing evidence and changing practice. This is true both of conventional practitioners vis-à-vis complementary and alternative therapies, and of complementary and alternative practitioners vis-à-vis conventional therapies. While evidence is necessary, it is not in itself sufficient to bring about a change in clinical practice.

Direct-to-Consumer Advertising

Direct-to-consumer advertising is not permitted in Canada. However, it is permitted in the United States, and advertisements might be transmitted to Canadians via electronic media such as United States television broadcasts. Moreover, claims about products and services on the Internet know no borders.

When a manufacturer or practitioner advertises his or her services or products, there is always a potential conflict of interest - and often a real conflict of interest - between serving the best interest of the client or consumer and selling the service or product. What is required to manage such potential or real conflicts of interest?

Participants noted that it is crucial that the public can turn to reliable sources of information that enable them to manage the quantity and quality of information provided to them through the media (print, television, Internet). While the group could not discuss this topic in detail (it has been the subject of a separate roundtable), it observed that networks of people seeking care, or health intermediaries (such as networks of survivors of breast cancer or of people with HIV/AIDS) have been very effective in enabling their constituencies to interpret and assess the quality of evidence and information. They are, in the words of one participant, very good "garbage detectors." Would this model transfer to a more general public, which is not necessarily motivated by a particular experience of health or illness, to develop networks and become better informed?

Peer-review of Practice and Research

The majority of complementary and alternative practitioners are not knowledgeable about or experienced in peer-review of practice. Some complementary and alternative practitioners are developing systems for peer-review of practice. According to those who have experienced peer-review, it has many advantages, provided that the reviewer is informed and fair. However, it is difficult to find reviewers with such qualities with regard to CAHC.

It is also difficult to obtain an informed and fair review of research proposals or publications dealing with complementary and alternative therapies. When university-based investigators apply for research grants for projects investigating complementary and alternative therapies, they often use conventional disciplinary language to refer to themselves and their projects so that their proposals are not discounted out of hand. Scientific journals have also been found to discriminate against submissions that relate to complementary and alternative therapies.

Participants observed that the situation is changing with regard to scientific journals. Nevertheless, they also remarked that there is still a lot of work ahead to overcome bias, both on the part of scientific publishing against research in complementary and alternative therapies and on the part of complementary and alternative practitioners against research on their therapies.

Comparable Requirements for Comparable Products

According to the regulations of the Food and Drugs Act, products that people use in promoting their health may be classified as either drugs or functional foods. Concern was expressed that in either case, products of comparable risk or comparable efficacy might be evaluated and regulated differently.

A question was raised about the risk-assessment of NHPs relative to that of off-the-shelf or over-the-counter drugs. It was maintained that NHPs which, with regards to safety, are equivalent to low-risk drugs would be subject to a more elaborate and exigent regulatory regime than the low-risk drugs.

A question was also raised about the evidence required to support health claims of NHPs relative to that required to support health claims of functional foods. It was held that a product that could be classified as a food on account of its nutritional content would be able to make health claims more easily than a product that did not have sufficient nutritional content to be classified as a food but that had the same or similar active ingredients.

There was some disagreement on the latter point. At present, Health Canada is proposing that 'a food that is manufactured, sold or represented to have a direct, measurable effect on a body function or structure beyond normal growth and development or maintenance of good health be required to submit detailed information to support such an effect before being advertised or offered for sale.'

The group was not able to determine whether, in fact, the conditions that must be met before a food could be authorized to carry a claim or a representation conveying such an effect are identical to those that must be met by an NHP that is not classified as a food.

Conclusion

The roundtable was intended to be a forum for discussion, not a forum for decision-making. It was designed to raise and explore issues, not to examine them comprehensively or to resolve them.

Several observations can be made about the need for further ethical and legal deliberation in relation to the use of CAHC and NHPs.

First, the increasing use of complementary and alternative therapies is bringing about and will continue to bring about changes to the health system in Canada. Some of the changes identified by participants in the roundtable included:

• changes in the formation of practitioners
• evolving policy regarding the use of complementary and alternative therapies in health care institutions
• assessment of evidence regarding the effectiveness of complementary and alternative therapies
• changes to clinical practice guidelines
• reconsideration of products and services covered by public and private health insurance plans

Such changes need to be accompanied by ethical and legal reflection. While it might not be necessary to develop entirely new ethical or legal frameworks, there will be adjustments and perhaps comprehensive reconsideration. This is an exciting prospect, but also one that requires sustained and thorough attention from all participants.

Second, a key relationship in health care is the relationship between the person receiving care or service and the provider of care or service. There are many ways in which this relationship can and should contribute to informed decisions in the use of complementary and alternative therapies. The fact that it does not always do so should be a subject of ethical and legal deliberation. It is important to identify, from an ethical and legal perspective, how the person-provider relationship - whether in conventional health care, CAHC, or in some form of joint or integrated health care - should contribute to informed decisions in the use of complementary and alternative therapies. It is also important to identify any justifiable conditions on or limits to the provider's responsibilities to the person using complementary and alternative therapies.

Third, many people use complementary and alternative therapies as a form of self-care. This means that access to safe and effective products and services, as well as access to clear, easy-to-understand, and reliable information about these products and services, will continue to be a central concern. There will undoubtedly be differences in perspective among regulators, practitioners (both conventional and complementary/alternative), manufacturers, policy makers, and people who use complementary and alternative therapies as to how to address issues regarding access to products and services in self-care. The discussion at the roundtable suggests that ethical and legal reflection should be a part of the process of clarifying or resolving such differences in perspective.

Appendix A - List of Participants

Claude Arbour
Université du Québec à Trois-Rivières

Gwen Burrows
The Hospital for Sick Children Foundation

Richard Carpentier
National Council on Ethics in Human Research

Michael H. Cohen
Harvard Medical School Center for Alternative Medicine

Joan Gilmour
Osgoode Hall Law School

Christine Harrison
Toronto Hospital for Sick Children

Donna Herringer
Canadian Health Food Association

Nuala P. Kenny
Dalhousie University

Stephen Malthouse
Canadian Complementary Medical Association

Keith Pownall
The Canadian College of Naturopathic Medicine

Scott Sawler
Non-Prescription Drug Manufacturers Association of Canada (NDMAC)

Beverley Wellman
University of Toronto

Health Canada Representatives

Joan E. Simpson

Michael J. Smith

Michelle Boudreau

David Hoe

Facilitors

Theodore de Bruyn

Glen Brown

Glen Brown & Associates

Appendix B - Agenda

Saturday, December 1

6:00 p.m. Buffet dinner

Welcome and opening remarks from Health Canada.

7:00 p.m. Roundtable: Opening statements from the participants

Participants will introduce themselves and describe what they think are the top challenges for health law and ethics with regard to the use of complementary and alternative health care and natural health products. Each participant will have about 5 minutes.

9:00 p.m. Adjournment

Sunday, December 2

8:30 a.m. Introduction to the process for the day

9:00 a.m. Concurrent small group discussions on: (1) practitioner-related legal and ethical issues; (2) product-related legal and ethical issues.

Each group will identify and discuss key issues and suggest ways to address those issues.

11:00 a.m. Report-back and discussion in plenary

Each group will have an opportunity to report on its discussions and to comment on the report of the other group's discussions.

12:00 a.m. Lunch (to be provided in the meeting room)

1:00 p.m. Concurrent small group discussions on: (3) legal and ethical issues related to people who use complementary and alternative health care and natural health products; (4) general legal and ethical issues

The process will be the same as at 9:00 a.m., but the composition of the groups will be different.

3:00 p.m. Report and discussion in plenary

The process will be the same as at 11:00 a.m.

4:00 p.m. Description of next steps, evaluation, and wrap-up

4:30 p.m. Adjournment

Appendix C - Participant's Replies to Questionnaire about Five Top Challenges

Participant I

1. Some of the 'moral minefields' I have observed regarding conventional research, and physicians struggling to establish appropriate relationships with pharmaceutical companies. Some questions occur to me that should be answered in order to begin to avoid these minefields in the area of complementary and alternative medicine (CAM) research. Who controls the research funding? Who determines the research agenda?
2. Related to this: What are the potential conflicts of interest for practitioners, researchers, manufacturers, funders?
3. How will bridges will be built between conventional and CAM practitioners? It might help to try to articulate what the barriers to collaboration are, and what values are common (and not common) to these groups.
4. The challenge of involving the public: promoting informed choice, ensuring good public information is available, educating about health and health promotion more broadly, and finding a way to enhance inclusion in policy development process.
5. What are the educational needs of all relevant groups (e.g. conventional practitioners about CAM, CAM practitioners regarding research, public regarding 'critical appraisal' of products and information)?

Participant II

1. The use of 'unproven therapies' - ethics of the College of Physicians (see College of Physicians and Surgeons of British Columbia, https://www.cpsbc.ca/cps) - the College considers it unethical to recommend unproven therapies, but the method of determining unproven status not clear.
2. Doctors firing patients who use complementary and alternative medicine (CAM) therapies.
3. Unsubstantiated claims by practitioners and for products.
4. Need for regulatory bodies; accountability.
5. Communication between professionals e.g. doctors and naturopaths - restrictions by the regulating bodies - restrictions by the patient.
   
6. Lack of CAM in medical school curricula.
7. Legality of medical doctors referring to non-medical doctors.
8. Selling products from a practitioner's office - conflict of interest/financial survival of practitioner/availability of best product.
9. Contents of natural health products -- do they contain what they advertise (ingredients).
10. Access to practitioners (autonomy of patients).

Participant III

1. Defining the scope of practice of various practitioners.
2. Ensuring the scope of practice/area of competence is understood by practitioners and patients.
3. Codes of conduct for practitioners re: patient confidentiality, provision of services, medical care, etc.
4. Overlap between practitioner and purveyor of products.

Participant IV

1. Dietary supplements: intellectual property protection issues; claims regulation; hospital policy.
2. Licensing and credentialing of complementary and alternative medicine (CAM) providers; regulation and policy vis-à-vis non-licensed healers.
3. Malpractice liability issues implicated in referrals and integrative clinical practices.
4. Regulation of physicians (issues of professional discipline).
5. Potential contribution of divergent CAM therapies and philosophies to various bioethical issues.
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Participant V

1. Improvements in and respect for legal acts for each complementary medicine.
2. Respect for treatment limits and referral of patients to other health care practitioners.
3. Differences in legal acts between the various provincial/territorial regulations.
4. Use of regulated and non-regulated products in health care.
5. Quality care regulations for products and for acts provided by practitioners.

Participant VI

1. Determining efficacy - identifying criteria: should these vary in different contexts?
2. Legal implications of complementary and alternative health care/natural health products for providers and institutions; legal mechanisms of control.
3. Practitioners and natural health products: who can/should provide, and on what basis?
4. Integrating complementary and alternative health care and conventional care: when and by whom?
5. Consumer choice and the nature of health care services; the consumer/provider relationship.

Participant VII

1. Equity of access is a tenet of the Canada Health Act. How can this be enshrined in the field of complementary and alternative medicine and health? Currently equity is more likely to be determined by personal economics and priorities, unlevel insurance coverage, lack of referrals from allopathic system etc.
2. Ensuring that legal and ethical interpretations consider the healing paradigm underpinning the respective complementary and alternative medical practices and beliefs.
3. Regulation of products/therapies and professions. Regulation can either be viewed as unwarranted government intrusion or as government acting on a duty to provide for the safety of products and people, including the standards of performance, what kind of regulatory agency would be recommended, evidentiary burdens, liability, etc. This elicits further questions about access, affordability etc.
4. Human rights implications arise around access and equity, both in terms of expense and availability of products that are under regulation, and the coverage of non-traditional 'medicines' by (traditional) insurance providers. Further human rights implications arise, notably around the constitutional status of Aboriginal peoples in Canada and the entire realm of Aboriginal healing and faith. Other issues arise as to ethnicity and disability that cross-categorical lines of access and human rights issues. The question, for example, might be, is there an adverse impact on Canadians of Vietnamese origin if their traditional health practices are regulated/stigmatized/driven under ground? (Or, will acupuncture for purposes other than back pain become the medical marijuana of the post-regulation era?)
5. If regulation is from the allopathic perspective of symptom removal and is intervention- specific (such as acupuncture treatment for back pain alone) rather than embracing the whole healing modality of the profession, would this raise a human rights claim under 'disability' if health promoting services/products are rendered inaccessible? If so, is there a duty to accommodate disability that would influence the standard medical models around questions like evidence of effectiveness?

Participant VIII

1. In order for this roundtable to fully consider the law and ethical implications of alternative and complementary therapy, it must consider these products in comparison with conventional low-risk therapies [i.e. over-the-counter (OCT) drugs]. Products with a similar level of risk/benefit must be regulated in a similar fashion. If the regulatory frameworks regarding labelling, advertising and availability are unreasonably different, this will influence their relative use, in spite of other factors such as demonstrated efficacy and historical use. As you might know, this inequity is currently the case. Recent suggestion that the OTC Division of the Therapeutic Products Division (TPD) will be rolled into the Prescription Drugs Divisions implies that the imbalance will worsen, that conventional OTCs will be reviewed like prescription products by TPD, but that natural health products will be reviewed from a low-risk perspective by the Natural Health Products Directorate (NHPD).
2. Data protection. One of the objectives of the legislative renewal exercise is to determine whether the Act should contain authorities beyond safety, efficacy and quality, for example ethical or economic interests. The discussion on data protection should be addressed. In the Transition Team report, A Fresh Start: Final Report of the ONHP Transition Team, section 5.2, Research initiatives, notes that most countries are moving toward legislation that protects data and related claims on products. The report goes on to say that with the creation of the NHPD, the opportunity exists for Canada to move forward on this issue.
3. Self-regulation. There are a variety of areas of self-regulation of the industry and the moral and ethical issues surrounding this can be discussed (adverse events reports, voluntary warning and cautions, etc).
4. Public health awareness campaigns. Complementary and alternative medicine should be given due diligence.

Participant IX

1. Concern for potential - and real - conflicts between the pressure for 'evidence-based' practice versus non- 'evidence' (of any kind)-based claims for many alternatives.
2. Concern regarding lack of information and standards in much that is alternative AND difficulties to patients when taken in combination with allopathic treatments.
3. Need for alternative practitioners to discern between serious alternatives and 'quackery'.
4. Need to provide a coherent justification for competing claims of evidence.
5. The very serious issue of direct advertising of all drugs and therapies BUT especially of alternatives with no responsibility to adhere to any norms of evidence or standards.

Participant X

1. Respecting consumer's right to seek alternatives while ensuring safety standards.
2. Providing reliable information to consumers regarding safety and efficacy, for both adult and child populations.
3. Need for research so that one can provide reliable information, including research into pharmaceutical/natural health product interactions.
4. Some regulation of cost of natural health products and consideration of which, if any, should be covered by insurance (and what sort of insurance).
5. Facilitating integration of different care providers, so that information on what patient is taking/being prescribed is shared.

Participant XI

1. The wide variance in the regulation of complimentary and alternative medical (CAM) professions in the individual provinces. My focus is primarily on the naturopathic profession.
2. The threat of the unregulated and less accepted CAM professions.
3. Ensuring co-operation between CAM practitioners and conventional health care providers.
4. Integrating the CAM professions into the existing healthcare funding model.
5. Persuading CAM professionals that they need to abide by the ethical codes and regulations that apply to them.

Participant XII

1. Distinguishing health law and ethics across regulated professions, voluntary regulated professions and unregulated professions.
2. Protecting consumers and regulating those who dispense and sell natural health products through mail order, direct marketing, advertising, natural health food stores, pharmacies, regulated and unregulated practitioners.
3. Balancing a course of treatment, selling related products, earning a living and ethical concerns.
4. Developing a framework in which to situate complementary and alternative therapies and products to cover a broad spectrum of issues brought up by all the participants' top challenges and discussion items on the weekend.