HEAL Committee Report
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- CHAPTER 11 - INFORMED CHOICE
- CHAPTER 12 - NHP PRACTITIONERS
- CHAPTER 13 - OTHER ISSUES
- CHAPTER 14 - TRANSITION
PART VI: RELATED ISSUES
The Committee takes the position that informed choice is fundamental. We believe that Canadian consumers are intelligent, independent, and capable of making responsible choices with respect to their health. When it involves their own bodies, people have the right to make decisions, provided that such decisions do not cause serious harm to themselves or others. To ensure successful decision-making, we feel that people must have both knowledge and authority. We believe that both are essential for individual autonomy, empowerment, and meaningful health judgements.
For us, individual knowledge and authority have two prerequisites: first, ready availability of relevant and comprehensive information about various options and their implications; second, accountability on the part of regulators who make decisions about the products and the practitioners who use the products in practice. In relation to NHPs, consumers need access to information from the beginning to the end in order to understand what they are and which ones are appropriate for health.
Most consumers advocated deciding for themselves on the basis of adequate information or advice. Since the sale of many NHPs is restricted on the Canadian market, a growing number of consumers feel they are being denied access to beneficial products by their own government, against their will and their wishes. They argued that, if the regulators have evidence of harmful outcomes, these should be communicated clearly and immediately. Overall, consumers wanted to be more aware of, and involved in, proposed changes on product availability.
Committee members feel that the availability of substantive, accurate, and up-to-date information about products is the prerequisite for true freedom of choice. Nonetheless, while acknowledging the high motivation of many NHP consumers, we are cognizant that the reliable and consistent data needed for informed decisions is not readily available. The Committee envisions greater responsibility on the part of organizations representing practitioners to ensure wider public education and information dissemination on appropriate product use. It sees more extensive research and data analysis on the part of industry and wider efforts to provide this to regulators, practitioners and the general public.
We support the view that Canadians should be in a position where they can educate themselves about their health and about any interventions to maintain or promote well-being
But, in the Committee's opinion, the regulator has a particularly significant role in facilitating informed choice. In this regard, we see the need for greater accountability, transparency and openness in federal decision-making around NHPs. Consumers (as well as practitioners and industry) have a right to be told which products are not available or have been removed from the market and to receive full public explanations about why various actions were taken. The continuing refrain from witnesses about the perceived secrecy surrounding the list of "banned products" causes great concern for the Committee members. The regulator must do a better job at dispelling any perception of concealment of information or of aversion toward wider use of the products.
From the Committee's perspective, there is a dual role for the regulator; first, in ensuring that full and accurate information is readily available and second, in facilitating consumers' ability to make reasonable decisions about product use. These objectives can be achieved in two ways: through research and through information dissemination.
On research, the federal government has a role, not only through its internal departmental capacities, but also through its various research funding bodies. While bodies like the Medical Research Council have a clear role in clinical trials, there is also a place for the Social Science and Humanities Research Council in providing culturally sensitive interpretations of product use. In addition, Health Canada provides funding for various projects related to Aboriginal peoples, seniors, children, etc that could be directed to this area. Providing incentives to conduct research in the area of NHPs would be commendable.
On information dissemination, Health Canada can play a key role and has several possible avenues already available for furthering its role. On the department-wide scale, there has been a strengthening of the electronic mode of information dissemination through the Canadian Health Network. As well, the 1997 Federal Budget provided funding for a population health clearinghouse and a national health surveillance network. Integrating information on natural health products into existing systems can provide the general public and health practitioners with up-to-date, credible information that will enhance informed health decisions. At the branch level, there are communication formats (press releases, warnings, information sheets, doctors' letters) that could be adapted to ensure that the information is issued in a timely fashion to a wider audience.
This thinking is in line with several of our principles; first, that NHP consumers must be provided with pertinent information about the products that they buy and second, that information regarding decisions and the regulatory system must be readily available to NHP stakeholders.
Therefore, the Committee recommends that:
Health Canada immediately utilise existing formats and forums for more open and transparent communication on NHPs with the broader public and practitioners;
Communication efforts include details about decisions and actions regarding NHP products (removal from market, change of status, etc.);
Relevant consumer, industry and practitioner groups be consulted on a regular basis about the nature of the required information;
The federal government research bodies, including Health Canada, begin immediately to encourage research on NHPs. This could include studies focusing on the interactions of herbal products with conventional medications as well as studies that explore different uses by various groups in Canada;
Health Canada undertake, through its various established avenues, the dissemination of the resulting information to health care professionals and consumers.
The increased demand for NHPs has translated into a growing number of practitioners. The Committee heard from conventionally-trained medical physicians who use herbal remedies, homeopathic preparations and vitamin and mineral supplements as part of their regular practice as well as from a number of pharmacists who increasingly are gaining knowledge of these NHPs. However, it became clear that these products are more likely to be recommended by individuals who practice as herbalists, homeopaths, naturopaths or within the realm of traditional Chinese, Ayurvedic or Aboriginal healing.
The Committee was told that regulating NHPs without regulating practitioners would not be appropriate. Of particular importance is the fact that, although products used by all health care providers are regulated federally, the way that they are put to use by individual professionals in their practice falls under provincial jurisdiction. Witnesses argued that access through practitioners is often limited because of the lack of standardization of education and practice for the practitioners and also because legislative restrictions on the use of certain NHPs prohibit many practitioners of complementary health from providing the products to clients.
For the Committee, it became clear that complementary practitioners provide a crucial avenue of access to NHPs.
Many witnesses were concerned at the lack of appropriate and consistent training and education for practitioners using NHPs. Because there is little standardization among provinces in their approaches to registering herbalists, homeopaths, naturopaths, consumers have no assurance of common standards of practice. With regard to established or conventional medical practitioners, the concern related to their lack of specialized knowledge about the products and on occasion, their open aversion to their use. In the sphere of provincial regulation of complementary practitioners, the Committee heard that only naturopathic practitioners are regulated under provincial law and through a licensing board in four provinces - Ontario, British Columbia, Manitoba and Saskatchewan. Witnesses felt that actions to standardize education, training and practice would simultaneously ensure higher quality services and protect the public from unscrupulous individuals who might masquerade as genuine health professionals. In addition, once standards were established, they suggested that it would be easier to work towards the development of a more integrated health care system. Witnesses suggested that the federal government press the provinces to take the immediate and necessary steps to regulate NHP practitioners or that a joint federal/provincial committee be established to examine this issue with national and regional associations.
Another dimension of the practitioner issue involves access to products. Many witnesses called for some NHPs, particularly those presenting a higher risk, to be prescribed only by qualified practitioners or taken on the advice and/or supervision of NHP providers. Presently, the Food and Drugs Act through its reference to provincial designation of practitioners places some restrictions on product use by complementary practitioners. It does not acknowledge traditional Chinese doctors, naturopaths, homeopaths, herbalists as practitioners unless they have provincial recognition. Some practitioners told the Committee that they are restricted from prescribing substances under various Schedules of the Controlled Drugs and Substances Act; do not have access to the Special Access Program (formerly emergency drug release program); and cannot import substances that they require to treat their patients. In addition, Schedule A of the Food and Drugs Act hinders the practice of complementary practitioners by limiting the labelling of practitioner-produced products that state the purpose of the products.
Witnesses argued repeatedly that standards for education, training and practice should be established for all NHP practitioners.
The subject of regulation of NHP practitioners was a continuing theme during Committee hearings. As members, we agreed that we would like to see a future where NHP practitioners are appropriately qualified and required to adhere to established standards regarding the provision of NHPs. We are, however, aware that the process of achieving this goal is complex. In addition to the federal and provincial jurisdictional issues, it involves major participation and organisation on the part of practitioner groups. We encourage a study of international efforts that might provide useful models. For example, Germany regulates practitioners who provide NHPs; thus, non-medical practitioners can be licensed to practice but cannot provide prescription-only products. In Australia, there are state-driven efforts to provide some form of accreditation for practitioners of traditional Chinese medicine with the aim of allowing them access to certain controlled substances.
The Committee feels that the question of access to the products through qualified practitioners is obviously tied to the issue of their education, training and licensing. We want to emphasize that established medical practitioners are not exempt from the need to standardize their own professional approach to the provision of natural health products. Not only do they need education about the products so that they can provide them or work with practitioners who do, but they also need to be aware of their patient's current or potential usage of such products. Overall, the issue of practitioners is tied to our principles on safety, access, and cultural diversity. However, the Committee recognizes that this matter falls under provincial jurisdiction.
The Committee therefore recommends that:
Health Canada inform its provincial and territorial counterparts of the regulatory changes with regard to NHPs and of the concerns raised by practitioners.
The Committee has heard that, while some of the enforcement of the legislation is done through proactive inspection by regulators, much of the enforcement in based on reactions to complaints by either consumers or competitors with respect to a specific product. Other enforcement action can be based on information gathered by the regulators regarding the safety of a product.
The Committee was told that more consistent enforcement of the legislation was needed and that it was not appropriate that competitors be required to denounce each other in order to have the legislation enforced.
The Committee agrees. We feel that the legislation should be enforced in a regular and consistent manner. This would help ensure that only products that satisfy Canadian standards are allowed on the market. Canadians must be guarded against products that do not satisfy the requirements of the new framework. This is consistent with the Committee's principles regarding the safety of products and the transparency of the system. All those involved should be aware that there are rules and that they will be applied. In addition, consistent enforcement creates a level playing field between competitors. Enforcement activities should be undertaken in conjunction with education to inform stakeholders of the reasons why a product is being removed from the shelves, why a company has not satisfied GMP requirements, etc. A heavy-handed approach is not appropriate unless there are significant violations to the regulatory framework.
Therefore, the Committee recommends that:
The new regulatory framework for NHPs be enforced in a regular and consistent manner and done in conjunction with education;
Sufficient resources be provided for enforcement activities.
Witnesses representing Aboriginal communities expressed their concerns to the Committee regarding the application of a new regulatory framework for NHPs on their traditional use of natural products. They felt that this framework should not apply to products prepared by healers within the Aboriginal community and requested an exemption from the legislation.
It is the Committee's understanding that the regulatory framework would not apply to products prepared by Aboriginal healers where the product was prepared for an individual patient. Thus, the legislation only applies when there is an attempt at commercialisation and not when a product is extemporaneously compounded for a particular person. Thus, Aboriginal healers can prepare medicine from raw herbs without being concerned about the effect of the regulatory system, unless the product contains ingredients that are otherwise restricted. The Committee notes that these comments also apply to others that prepare products extemporaneously compounded for a particular person.
The Committee was told that such an exemption is provided in Australia. In relation to herbal, traditional and natural medicines, practitioners who are dispensing for individual patients are exempt from the need to put their products on the register. Thus, pharmacists and natural practitioners do not need to register products if it is for the individual patient.
If the products described above are not exempt from the regulatory framework, the Committee would recommend that the legislation be modified to provide for such an exemption. This is consistent with the Committee's principles regarding access to products and respect for different cultures.
Therefore, the Committee recommends that:
If a product that is extemporaneously compounded for a particular person is not exempted from the regulatory framework, that such a product be exempted.
The Committee is concerned about the protection of herbs and plants in developing countries because of the upsurge in demand by developed nations. This is an important issue because not only are these products valuable world-wide, but they are also, in developing countries, often the only source of treatment.
In addition, we must ensure that we do not deplete natural resources used by Aboriginal peoples in this country. It is important that those harvesting these products be respectful of Aboriginal traditions and practices.
Therefore, the Committee recommends that:
Health Canada work with Foreign Affairs and International Trade to ensure that existing International Agreements that currently protect biological diversity are not violated and that additional strategies are developed if needed to prevent depletion of these valuable health resources.
Because of the scope of this report and the complexity of the subject matter, we realize that the required changes cannot be accomplished overnight. Thus, we suggest that the interim enforcement policy regarding NHPs should continue to be applied until the new framework is in place. Many witnesses indicated that the interim policy had been very helpful. The public must continue to be protected from unsafe products while industry must be in a position to market their products while the new framework is implemented.
In addition, the Committee sees an urgent need to act and recommends that the Minister immediately appoint a transition team. This team would be responsible for ensuring that the steps required for establishing this new framework be undertaken as quickly as possible. This team should consist of experts in the field on NHPs and appropriate personnel from Health Canada.
Therefore the Committee recommends that:
The interim enforcement policy regarding NHPs continue to be applied until the new framework is in place;
The Minister appoint, immediately, a transition team responsible for ensuring that the new framework is established quickly.