Re: Natural Health Products Workshop on Homeopathic Products ­ May 15 and 16, 2002

First, I would like to thank you for setting up such an excellent consultation workshop. The meetings were well organized and well run. It created a forum that allowed everyone an opportunity to participate.

I am writing at this time to provide you with a summary of the important understandings that I gained from my vantage point during these meetings. I would also like to add certain points of view to the discussions that I was unable to voice during the workshop due to time constraints.

Mark Phillips’ presentation was very informative. He explained that in the U.S. a homeopathic product is defined as a drug. As such, it is regulated as a drug but has a separate and distinct category. Homeopathic products must meet drug manufacturing standards and be labelled with National Drug Codes. Combinations of homeopathic products with natural health products are not allowed in the USA.

The HPUS (Homeopathic Pharmacopoeia of the United States) is now reviewing the German, French and European Pharmacopoeias to gather data. They are rewriting their standards where necessary to make them accurate to international standards. They wish to create international harmonization and avoid duplicating existing standards and monographs.

Mark Phillips said that the HPUS takes the view that “any substance is capable of becoming a homeopathic product” and as such “should not carry the baggage of its drug counterpart.” Any single ingredient product can be on the market without restriction as long as it is proven safe and has no claims on its label.

Mark also offered the following advice: Do not ignore our homeopathic history. Utilize what has been done already.

Schedules D and F discussions were most informative. Representatives from Health Canada provided some interesting observations and suggestions. For example;

1. All the substances listed in Schedules D and F may not require approval from Biologics and Genetic Therapies Directorate (BGTD) and these lists should be re-examined.

2. The substances in these schedules could be dealt with as classes or groups when applying for approvals, i.e., Vaccines, snake venoms, etc.

3. DIN fees are not fixed fees and are negotiable.

4. One can be creative in regulating these products. For example, by using existing precedents for obtaining approvals. In this regard a suggestion was made to refer to the sperm regulations under Division 5 that recognizes an outside reference source in setting standards. It was further suggested that the HPUS could be used as a recognized outside reference source in setting standards for Schedules D and F substances. This would set a precedent for achieving a distinct category of DINs and thereby retain a special separate category.

5. Finally, it was suggested that one or two remedies from Schedules D and F be selected and used to make a trial application for BGTD approval. This would provide everyone with a clearer idea of how Schedules D and F remedies could be approved and what fees might be required. The BGTD representatives indicated that they are open to finding new and simpler ways to regulate Schedules D and F and are also open to accepting foreign data as part of the submission.

In my view these discussions have provided some very workable suggestions for ways of achieving approval for Schedules D and F remedies under the Natural Health Product regulations. If they do achieve approval from BGTD they will then have obtained DINs as part of that approval.

The Discussion on DINs included comments from several people during their presentations and a short discussion group towards the end of the conference. The primary points that arose from the pharmaceutical representatives were as follows:

1. They have spent many years and much money to register homeopathic remedies as drugs with DINs and to maintain these registrations. They point out that homeopathic remedies currently have old drug status. The Pharmaceutical Association members indicated a reluctance to abandon their achievements and to take on the costs and time of starting the whole process over again.

2. With the existing DINs there are no import duties on homeopathic medicines. There may be approximately an 8% duty when they become registered as natural health products.

3. Insurance costs will go up on such products if there is no DIN list.

4. They wish to retain the international status of homeopathic products as drugs. DINs give them pharmaceutical standards, which are recognized as the highest level of manufacturing standards, safety and acceptability throughout the world. Most countries will not recognize homeopathic products in this status if they are labelled as natural health products.

5. In particular, they are concerned about the acceptability of their OTC Homeopathic Complexes in pharmacies if they do not have drug status with DINs. They point out that the sale of these types of remedies is their “bread and butter” and helps offset the cost of maintaining the many single-ingredient remedies with low sales.

Although I was present at the DIN discussion table, I was unable to add my views due to the intense participation and short time. Since no one voiced these particular views I will do so now.

The issue of DINs from the viewpoint of the homeopathic practitioner:

Today most countries are working to create international standards in the regulation of homeopathic products. If we try to regulate them in a unique way in Canada we may create unnecessary problems for our homeopaths. In particular, we need to harmonize our regulation system with those of Europe and the U.S. as this is where all the traditional references and Materia Medicas used as standards of evidence are found and where most manufacturers who supply Canada with homeopathic medicines are located.

With such a small market in Canada it is clear that these international companies will not want to register a complete range of homeopathic medicines here. It is a certainty that homeopaths will have to order many remedies from other countries as we do today. But will we be able to import remedies identified as drugs with DINs when Canada is regulating them as Natural Health Products with Natural Health Identification Numbers or NHINs? There will be no problem for medical doctors, dentists and veterinarians to obtain these products but there may be for homeopaths.

Homeopathy is in process of becoming a regulated profession in Canada. If homeopaths should become regulated in a manner that requires us to prescribe only licensed Natural Health Products with NHINs, it is possible that we will be restricted from prescribing Homeopathic Products labelled with Drug identifications.

Our primary objective is to have a regulatory system that allows complete availability of old and new remedies in a full range of potencies. Obviously this is most important for our work. We are quite happy to have homeopathic medicines regulated under the Natural Health Products Directorate. However, it is our opinion that not only is it most important to retain DINs for the remedies but also it will solve some of the current regulation problems; in particular the problems associated with regulating the substances in Schedules D and F.

We understand that DINs are not exclusive to any one Directorate. One of the Health Canada representatives informed us that DINs are used by a number of Directorates. It would appear that the new NHPD could also use DINs in regulating homeopathic medicines. There is a good case for doing this since they are unlike any other natural health product. They are also not a conventional drug which makes it appropriate to classify them as natural health products. Homeopathic remedies are quite unique products with a long history of safety due to their method of manufacture in high dilution and therefore they require a unique category within the NHPD with a distinct category of DINs.

Once again thank you for the opportunity to participate in the recent conference.

Sincerely,

D. J. Nichol, D.H.M.S., H.D.
Director, Ontario Board of Homeopathic Doctors

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