February 18, 2002

To: ALL HOMEOPATHIC ASSOCIATIONS ACROSS CANADA
Re: REGULATIONS FOR NATURAL HEALTH PRODUCTS

On Nov. 27, 2001 a meeting was held at the Toronto Civic Centre to meet with Marie Lemaire, B. Pharm., D. Hom., from Health Canada to review the new regulations for natural health products as being proposed by Health Canada. This meeting, which was open to all homeopaths, was organized by Rosemary Tayler, an executive officer of the Ontario Homeopathic Association.

Since then the important points that have emerged are as follows:

1. Health products in general will fall under the Food and Drugs Act but have been put into a separate regulatory category and are now regulated by a new entity within Health Canada known as Natural Health Product Directorate (NHPD). Over the last 3 years the NHPD has been developing these proposed regulations. To the best of our knowledge there has been almost no input from practicing homeopaths or their associations during this developmental period. 
2. The proposed new regulations were pre-published on December 22 in Canada Gazette, Part I. There is a 90 day feedback period which will end on March 22. This document may be reviewed at www.hc-sc.gc.ca/hpb/onhp. 
3. Homeopathic products will fall under this new act.

To summarise the proposed regulations as we understand them:

1. Low potency complex remedies that are labelled for specific conditions and sold over-the-counter will require Drug Identification Numbers (DIN). The manufacturers of these products will have to submit to reviews in order to substantiate the claims of the labelling and to obtain these DIN numbers.
2. Single remedies in all potencies that are prescribed by homeopaths will continue to be manufactured and distributed as before but with the following exceptions: There are 2 categories of products, falling under Schedule D, that will be restricted until they receive future approval, namely:

1. Remedies derived from toxic biologics such as Lachesis.
2. Remedies derived from disease products & tissues such as Medorrhinum.
   

It has been made clear to us that these substances cannot be exempt from the categories of substances under which they fall. This problem arises from having placed homeopathic remedies under Natural Health Products. This means such substances (even though they are in potency) fall under a very tightly regulated category requiring Good Manufacturing Practice (GMP) licensing. This could create difficulties for the availability of such products to homeopaths as the manufacturers do not want the considerable expense of this extra licensing.

There are possible solutions for this problem and we may be able to help resolve this issue once we have further dialogue with the parties involved. We have contacted the Canadian Homeopathic Pharmaceutical Association for this purpose.

Other problems may arise as these matters unfold and we will keep you informed.

It is evident that Canadian homeopaths need to become a participant in this whole process. What is most important is that we act as a strong united voice in these matters. This is the only way we have a chance of having influence. Health Canada is not interested in responding to small scattered groups.

Currently the key area of concern is for the homeopathic products that fall under Schedule D as listed above. We will require broad support to help convince NHPD that homeopaths must have access to these products. We welcome all ideas as to how to resolve this issue. For example, if no other way can be found to have full access, we could propose that such remedies be made available from 15C and up (on the basis of Avogadro’s Law).

In Ontario we have recently formed the Ontario Board of Homeopathic Doctors (OBHD) for the purpose of creating a united voice in dealings with provincial and federal issues. This umbrella organization comprises many Ontario homeopathic associations and schools. Within the OBHD are individuals who have political connections with the federal government, a member located in Ottawa that has easy access to NHPD and a homeopath who, until recently, was working within the department of NHP, Health Canada that is responsible for homeopathic product regulation.

How can you help?

Since it is most important to act from a broad base in these matters it is best to work from a group platform. Several ways to do this are:

1. Contact NHPD and indicate you would like to participate in discussions on these proposed regulations. Asked to be kept informed of any developments.
2. A much more effective approach is to form an umbrella organization in your province for this purpose.
3. Give us your support to represent you in this matter if you feel comfortable about it. We would need a written letter from you to include you in our support list. We will seek your opinion and approval on our proposals and keep you updated on all developments. Due to our proximity to Ottawa and our current involvement we are in a good position to keep on top of the process. We can keep each group and/or province up-to-date and make informed suggestions when action is required.

The NHPD has recently been compiling a list of Canadian homeopathic associations. The purpose of our communication is to alert you that you may be contacted soon, to inform you of the issues, and to suggest a plan of action. These are issues that affect all homeopaths and the future practice of Homeopathy in Canada.

Sincerely,
Don Nichol, DHMS, on behalf of the Ontario Board of Homeopathic Doctors.

For information please contact: Rosemary Tayler at rosemary@ottawahomeopathy.on.ca, 
(613) 237-4777;
Don Nichol at donnichol@sympatico.ca; Aamer Namdar at aamer@primus.ca

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