The Natural Health Products Directorate (NHPD), the government body responsible for regulating natural health products (NHPs), published their most recent draft of the proposed regulations for NHPs in September. This document is the culmination of many years of proactive lobbying, negotiations, and consultations with the government that began in November 1996, and is based on the final report of the Office of Natural Health Products Transition Team¹. The proposed regulations should be published in Canada Gazette Part I by the end of December 2001². This is the first step in the process of making them into law. Once published, there will be a 90-day period during which the public and other stakeholder groups can comment on them. They will then be modified, if necessary, and published in Canada Gazette, Part II. After a final consultation period, the proposals will go before parliament for approval. The approved regulations will then be published in Canada Gazette, Part III. These proposals will have a powerful impact on the regulation of herbs and other NHPs in Canada. If you would like more information on these proposals and other documents such as the Transition Team report, check out the NHPD website at: http://www.hc-sc.gc.ca/hpb/onhp/welcome_e.html. Recent publications of the Canada Gazette can be accessed at: http://canada.gc.ca/gazette/gazette_e.html.

These regulations are just one level of the transition process. At a higher level, Health Canada i currently engaging in a major review of health protection legislation and regulations with the intent of updating and reorganizing them³. Some of the proposals of the Transition Team impact a higher level of health legislation and will ultimately be implemented as part of this overriding process. If you would like more information on this legislative reform process it can be obtained at:
http://www.hc-sc.gc.ca/hpb/transitn/3pager_e.html.

The regulations that are currently being proposed for NHPs are broad in scope. At a lower level of the regulatory process are the policies that actually give substance to the regulations.

The NHPD has created working groups to develop policies based on the recommendations of the Transition Team and the Standing Committee on Health. These working groups have been helping the NHPD to develop policies in key areas such as good manufacturing practices (GMPs), labeling, and standards of evidence for claims and safety. As a member of the standards of evidence working group, I am pleased to report that things are continuing to move in the right direction. Within a year or two, consumers will finally be able to purchase herbs and other NHPs that have better guarantees of product quality and safety, and have sufficient information on their labels to allow for informed choices. This is an ongoing process, and it is hoped that these policies will be in place by the time the regulations become law.

On another front, the NHPD hosted a meeting last October attended by researchers, practitioners, and representatives of the NHP industry, aimed at determining the role of the NHPD in health research. I attended on behalf of the OHA and the Canadian Coalition of Herbal Associations (CCHA). At that meeting, we recommended policy decisions that will hopefully lead to a larger percentage of funds being channeled into research on NHPs and complementary and alternative medicine (CAM). This year, additional meetings are planned on specific areas of research including topics such as the role of NHPs and CAM in pediatrics, and interactions between NHPs and pharmaceuticals.

In November of 2001, Human Resources Development Canada (HRDC) hosted its second meeting to determine the feasibility of conducting a sector study on CAM in Canada. I attended this meeting along with CCHA members from Quebec and British Columbia. Also in attendance were representatives of seven other groups of CAM practitioners who have a relatively cohesive representation at the national level - a prerequisite of participation in this study. If this sector study goes ahead it will gather very important information on CAM in Canada, including herbalism, that will help us to establish industry standards and create an infrastructure in which to implement these standards. Although a sector study does not have any direct regulatory impact, it has the potential to help raise the standards and credibility of herbalists, and can be used to help support our regulatory initiatives. All of the CAM groups represented at the meeting have decided to move forward in this process. We have created a coordinating group that is developing our proposal, which will be submitted by the end of March 2002 in the hopes that the sector study will be approved.

On the provincial regulatory front, a number of initiatives have been moving forward that will directly impact our future negotiations with the Ontario government regarding the regulation of herbalists. Last year traditional Chinese medical (TCM) practitioners became regulated in British Columbia. This is an important step that will undoubtedly open doors for other practitioners across the country. In the wake of this event, the Canadian Herbal Association of B.C. has advanced to the next level in their negotiations toward the regulation of herbalists in that province.

Closer to home, in Ontario the Health Professions Regulatory Advisory Council (HPRAC)⁴ completed its reports on the regulation of naturopaths (January 2001) and TCM practitioners (April 2001). HPRAC is recommending that both of these professions become regulated in Ontario under the Regulated Health Professions Act. If their recommendations are accepted, it will further the potential of herbalists obtaining regulation in this province. However, there is reason for concern relating to the interplay between the regulations being proposed for NHPs in Ottawa, and the proposals for the regulation of naturopaths and TCM practitioners in Ontario. It is likely that some NHPs, including some herbs, will be considered too risky for use by consumers without the guidance of a "qualified practitioner". Medical doctors would not be the appropriate practitioners to administer these substances in most cases, as they do not have any knowledge or experience in their use. This means that any restricted NHPs will not become prescription drugs, but may end up in their own regulatory category. The question is, how do we define who are the "qualified practitioners" who will administer these substances as most CAM practitioners are still unregulated?

In an attempt to deal with this issue, HPRAC has recommended the creation of a new controlled act: that of "prescribing, dispensing, selling and/or compounding restricted natural health products". A controlled act is an act that can only be practiced legally by a representative of a regulated profession for which the act is permitted in the regulations. If you would like to learn more about HPRAC or review any of their reports, check out their website at: http://www.hprac.org/english/index.asp.

The recommendation for a "new controlled act" is problematic. Firstly, it is referred to twice in each of the aforementioned reports (one concerning naturopaths, the other concerning TCM), but the wording is inconsistent. In some cases the recommendation refers to "natural health products" instead of "restricted natural health products". If the recommendation were to be accepted without the qualifier "restricted", it would effectively mean that no practitioners in Ontario except naturopaths and TCM practitioners will be able to "prescribe, dispense, sell and/or compound" any NHPs, including herbs. If this were to occur, herbalists and other CAM practitioners will be effectively out of business in Ontario unless we become regulated. It is likely that this inconsistency is the result of poor editing and the recommendation will not appear in the regulations in this form. However, even if the recommendation is approved based on the narrower interpretation (i.e. in reference to "restricted" NHPs only), it could still have a tremendous negative impact on the ability of herbalists to practice. This, of course, depends on what NHPs ultimately end up being restricted. If they include herbs like foxglove, water hemlock, or deadly nightshade, not too many herbalists will be concerned. But if this list is broader and includes herbs like lily-of-the-valley, pokeweed, or mayapple, it will have a much more significant impact on the practice of herbalism.

Ultimately, the only way we will ever overcome these kinds of restrictions is by becoming regulated. The OHA is committed to working in that direction, but the process will likely take years. In the interim, this issue still needs to be addressed. (More details about HPRAC and their reports are available from their website at: http://www.hprac.org/english/index.asp)

In October I sent a letter to HPRAC on behalf of the OHA outlining our concerns about these recommendations. The commentary period ended in October 2001; however, it is still important that we speak out on this issue⁵. You can send your comments directly to the Ontario Minister of Health,
Tony Clement:
- fax: 416-326-1571
- e-mail through the Ministry web site: http://www.gov.on.ca/health/english/ministry/clement.html
- or e-mail directly:
clement@titan.tcn.net
Indicate that you did not become aware of these reports until after the end of the commentary period. Be sure to request a reply and ask him his position on this issue.

In my remarks, (see, below, "Appendix: Future of Herbalism in Ontario") I elaborate on some specific issues of concern for herbalists in HPRAC's proposed new "controlled act".

As you can see, there are many important initiatives currently in progress that will greatly impact the future of herbs and herbalism in Canada, and it is vital that we keep abreast of these issues so as to influence their outcomes. I strongly encourage all herbalists and herbal enthusiasts to get involved as much as you can. The OHA will continue to keep you updated on future developments.

Michael Vertolli,
President OHA

A summary of web sites referred to in this report:
1. Transition Team report: check out the NHPD website at:
http://www.hc-sc.gc.ca/hpb/onhp/welcome_e.html
2. Recent publications of the Canada Gazette can be accessed at:
http://canada.gc.ca/gazette/gazette_e.html
3. "Health Canada is currently engaging in a major review of health protection legislation and regulations with the intent of updating and reorganizing them" - If you would like more information on this legislative reform process it can be obtained at:
http://www.hc-sc.gc.ca/hpb/transitn/3pager_e.html
4. If you would like to learn more about HPRAC or review any of their reports, check out their web site at:
http://www.hprac.org/english/index.asp
5. You can send your comments directly to the Ontario Minister of Health, Tony Clement (fax: 416-326-1571; e-mail (available through the Web site http://www.gov.on.ca/health/english/ministry/clement.html) or e-mail:
clement@titan.tcn.net. Although the official commentary period ended in October 2001, you still have time to comment on them, as they cannot be implemented until accepted by the Minister of Health and approved by the provincial legislature. It is important that we speak out on this issue. Indicate that you did not become aware of these reports until after the end of the commentary period. Be sure to request a reply and ask him his position on this issue.

Appendix: Future of Herbalism in Ontario
Anyone who is concerned for the future of herbalism in this province must speak out against these recommendations in order to influence their outcome. You can do this by sending a letter, fax or e-mail to the Ontario Minister of Health, Tony Clement. In your letter, be sure to include the following information:
(a) Identify yourself in a way that links you to the issue. Are you a professional herbalist? A CAM practitioner other than a naturopath or TCM practitioner? A user of the services of professional herbalists or other CAM practitioners? A supporter of herbalism? A consumer of herbal products?

(b) Clearly describe your concerns about the recommendations. I have included the letter that I sent on behalf of the OHA. It clearly describes the issues and where in the documents the passages of concern can be found. You can use this letter as a guideline, but it is important that you write a letter in your own words. If you would like to see the whole documents, they are available at the HPRAC web site, indicated above.

(c) Indicate that you found out about this issue only after the official commentary period ended, but felt you had to express your concerns directly to him (i.e. the Minister of Health).

(d) At the end of your letter, ask him what his opinion is on this issue or what he plans to do about it. If you ask an MPP a question they must respond to you, otherwise they can just throw your letter away.

Send your letter directly to the Minister at:
Hon. Tony Clement
Minister of Health
80 Grosvenor Street
Hepburn Block, 10th Floor
Toronto, Ontario
M7A 2C4

Telephone: 416-327-4300
Fax: 416-326-1571
E-mail: clement@titan.tcn.net

The OHA LETTER:

Dear RHPA Project,
I am writing to you on behalf of the Ontario Herbalists Association because we have significant concerns regarding one of your recommendations that appears in your reports on "Naturopathy" and "Traditional Chinese Medicine and Acupuncture".

The recommendation that elicits our concern is the one regarding the creation of a new controlled act in the Regulated Health Professions Act which deals with the ability of a practitioner to "prescribe, dispense, sell and/or compound" natural health products (NHPs). Our concerns are two-fold:

Firstly, we are very concerned with the clarity and consistency of these reports. There are inconsistencies in the way your proposed new controlled act is stated that significantly affects the scope of this recommendation. Although the accompanying summary in each case refers to "restricted" NHPs, the recommendation is not always stated as such:
- On page iv of the Executive Summary of the "Naturopathy" report, it is recommended that naturopaths be able to "prescribe, dispense, sell or compound natural health products."
- On page 46 of the "Naturopathy" report, the recommendation is stated as "Prescribing, dispensing, selling and/or compounding restricted natural health products" (emphasis added).
- On page iii of the Executive Summary of the "Traditional Chinese Medicine" report, the recommendation refers to "prescribing and dispensing a Natural Health Product."
- Page 42 of the "Traditional Chinese Medicine" report states the proposed controlled act as "prescribing and dispensing natural health products as prescribed in regulation."

These inconsistencies are very significant. Firstly, it is not clear which activities you are proposing to control. Only "prescribing and dispensing" are mentioned in all four references. It is not clear whether or not you wish to also include "selling and compounding." Both naturopaths and TCM practitioners sell NHPs, however, only TCM practitioners compound as an integral part of their practice. Secondly, if the intent is to control access to "restricted" NHPs (as defined by the Natural Health Products Directorate), why is it that in only one of the four references to the proposed controlled act stated as such?

Our second major concern is that any attempt to control the "prescribing, dispensing, selling or compounding" of NHPs will have a serious impact on the ability of all other complementary and alternative medical (CAM) practitioners to continue practicing as none of the other professions in this field are currently regulated in Ontario. Also, if the proposed controlled act were to refer to all NHPs instead of only "restricted" NHPs, it would be impossible for any of these professions to continue to practice. Therefore, any attempt to implement such a recommendation is very premature until the Ontario government, through HPRAC, has completed efforts toward the regulation within the RHPA of all CAM practitioners that are currently practicing in Ontario who "prescribe, dispense, sell or compound" NHPs.

The ability to "prescribe, dispense, sell or compound" botanical medicines, including those that may ultimately be restricted by the NHPD, is essential to the practice of herbalism. Herbalists receive extensive training in these areas and are fully qualified to perform these acts.

In summary, the Ontario Herbalists Association strongly urges you to reconsider the implementation of any controlled act relating to NHPs until the issue of regulation of other CAM practitioners, not just naturopaths and TCM practitioners, has been thoroughly investigated.

Sincerely,

Michael A. Vertolli B.Sc. R.H.
President, Ontario Herbalists Association