ABSTRACT: The homoeopathic remedy is a medicine in the legal sense of the word; the pharmaceutic definition of the homoeopathic remedy and the resulting application; the pharmacologic definition of the homoeopathic remedy and the need for its introduction.

(Papers of the Transnational Conference: "THE HOMOEOPATIC REMEDY-NON-MEDICINE. A PROPOSAL FOR RECOGNITION" - Rome 12th and 13th december 1988).

The peculiar nature of the Homoeopathic Remedy justifies a special treatment as regards legislation and regulation. To reach this, three theses are being developed:

FIRST THESIS

According to article I of law 65/65 EEC, the homoeopath remedy is a medicine: this means that this product falls, as regards sale and distribution, under the pharmaceutic monopoly.

According to a market survey, homoeopaths l.s. may be classified under three categories:

- Specialities having a particular appellation (homoeopaths

l.s.).

- Specialities with a common name (homoeopaths s.s. and l.s.).

- The magistral products (homoeopaths l.s.).

It must be mentioned that most of the homoeopaths l.s. have a legal statute in certain EEC member countries.

SECOND THESIS

Two applications as regards regulation derive from the pharmaceutic definition of the homoeopathic medicine, that is medicine defined by the way it is prepared and classified in an official homoeopathic pharmacopoeia (for example HAB, HPUS, etc.):

1. The possibility of regulating the manufacturing on the basis

of an official pharmacopoeia of magistral preparations.

2. The possibility of establishing a regime of authorization for

the trade of common name specialities.

Such a regulation has already been introduced in Belgium, Germany and France.

THIRD THESIS

The purely pharmaceutical approach cannot solve the problem of the sale of pseudo-homoeopaths (toxic and non toxic), nor can it regulate the statute of specialities having a particular denomination or the information on homoeopaths s.s. and l.s.: a pharmacologic definition on the basis of the HPUS has thus been proposed:

"medicine created according to the law of similitude

employed in doses insufficient to cause an active

(classical) physiological effect and prepared

according to particular procedures established by an

official homoeopathic pharmacopoeia".

This definition can regulate the problem of the sale of pseudo-homoeopathics and can establish a particular regime for the authorization of the sale of special denomination specialities and regulate the information regarding homoeopathics in general.

Besides Switzerland, Germany too has adopted this pharmacologic definition by establishing particular commitees with the task of instituting authorization documents for the sale of all homoeopathic s.s. and l.s. products.

The particular nature of the homoeopathic remedy - all the speakers seem to agree on this - jutifies some special treatment as regard regulation and legilation.

This regulation must be clear, devoid of misunderstandings and, above all, - I insit on this point - applicable: it must, moreover, merge into the national pharmaceutical law and the European reality of tomorrow. This last point is important in view of a free circulation of products foreseen by the Rome treaty.

The important question, therefore, is: "How to achieve this?"

Considering the complexity of the problem, the legislator's task will certainly not be an easy one.

This is the reason why I thought it interesting to develop three important basic themes for the elaboration of the above regulation. These are the following:

1. The homoeopathic remedy is a medicine in the legal sense of

the word.

2. The pharmaceutic definition of the homoeopathic remedy and

the resulting application.

3. The pharmacologic definition of the homoeopathic remedy and

the need for its introduction.

First Thesis : THE HOMOEOPATHIC REMEDY IS A MEDICINE.

According to article I of the Bill of Law 65/65 EEC, the homoeopathic remedy is without doubt a medicine: it is, in fact, described as having curative and/or preventive properties.

Moreover, the preface and article 34 of the Bill of Law 75/319 EEC, mention the existence of homoeopathic "specialities".

According to a market survey l.s. homoeopathic medicines may be classified under several categories:

1. Specialties with a particular denomination.

2. Common name specialties.

3. Magistral preparations.

I intentionally used the word l.s. homoeopathic: the above classification englobes s.s. homoeopathics true and proper in conformity to Hahnemann's law, as well as products derived from therapies associated to homoeopathy. These products, besides certain aspects regarding the manufacture, have little or nothing to do with Hahnemann's doctrine. In view of elaborating a regulation, the legislator cannot ignore their existence, especially because they represent an important part of the market. Moreover, most of these products so-called homoeopathic l.s. have a legal statute in certain EEC member countries.

With the definition special denomination specialities, we mean every homoeopathic remedy, prepared in advance, present under particular conditions and characterized by a particular denomination. They are clearly l.s. homoeopathic products.

Obviously, these specialities are subject to an authorization of sale (abbreviated in AMM) and thus to the introduction and institution of an AMM documentation.

Such products exist in Germany, France and Belgium.

By the definition common name specialities we mean every homoeopathic product prepared in advance or on the moment and listed by the Ministry of Health of a EEC member country.

This list includes homoeopathics called unitarian and complex products.

In France, this list was published by the Official Gazette of 24 May, 1967 (law of 8 May) and includes 1.180 unitarian or single products and 39 complex remedies.

The latter are called according to the name of the principal product followed by the term compound (for exzmple: Aconitum cpd). In the list of the single or unitarian products we find both l.s. and s.s. homoeopathic products, as for example the organotherapeutics, the glycerinated steeped products.

In Germany and in Belgium similar lists have been established by Working Teams which include government representatives as homoeopathic laboratories.

By magistral preparations we mean every preparation issuing from an l.s. homoeopathic prescription which is neither a particular denomination specialty nor a common name specialty. The adjective "magistral" means that these products are designed for a single patient, that they must be prepared on the moment and cannot be prescribed on other occasions. As these include compound and unitarian products (especially the stubs which are not included in the government lists) they represent a very important part of the market.

The magistral unitarian products differ from the common name unitarian products because the regulation concerning, for example, the stockage of dilution which can be preserved only for a limited period of time is much more strict. Obviously, these preparations should be manufactured by the chemist: however, as most chemistries do not have the necessary infrastructures, the homoeopathic laboratories manufacture these products. They therefore play a role in the interest of the diseased. It is a tacit or official derogation which wxists in several EEC member states, especially in France, Germany, Belgium and the Netherlands.

In order to achieve some regulation, it is necessary to elaborate specific modalities designed to regulate the authorization to manufacture, the manufacture true and proper, the quality control, the sale authorization (for special denomination and common name specialities), the distribution, the sale and the information to the public and the medical and pharmaceutical environment.

The problem is no easy one as it is actually a matter of regulating three different classes of products, which are moreover very peculiar as regards their manufacture (pharmaceutical aspect) and their employment (pharmacological aspect).

It must be mentioned that this peculiarity is aknowledged by article 34 of the Bill of Law 75/319 which states that suitable and particular measures must be taken. Therefore, we are going to show that these measures are the natural and logic result of the pharmaceutical and pharmacological definition of the homoeopathic remedy.

It is essential that the l.s. or s.s. homoeopathic product be considered a medicine. This means that as regards distribution and sale they can fall under the pharmaceutic monopoly thus making a strict and severe control possible.

This control is ever more necessary as it regards, in general, products which cannot be controlled analytically.

Second Thesis: THE PHARMACEUTICAL DEFINITION OF THE HOMOEOPATHIC

MEDICINE AND THE RESULTING APPLICATIONS.

Though the peculiarity of the homoeopathic medicine is legally well-known, the term "Homoeopathic" is not specified in European or national pharmaceutical law.

However, the term "Homoeopathic" is stated in certain official pharmacopoeia which, as everyone knows, are legally recognized as law. Thus, the homoeopathic medicine is legally defined by the manner of preparation defined by official pharmacopoeiae.

It must also be mentioned that this pharmaceutical definition is also stated in the Bill of Law of EEC regarding homoeopathics.

Article 1, point 2 establishes that the preparation of homoeopathic products must be carried out according to the principles of the pharmacopoeia of a member state and/or according to the homoeopathic tradition of the member state.

Only Germany and France have an official homoeopathic pharmacopoeia:

1. The HAB (1978) with annexes in 1981 and 1983 and two annexes

in 1985, replaces the Schwabe homoeopathic pharmacopoeia

which became official in 1934.

2. The French Pharmacopoeia, 1965 and 1983 editions included a

general monography: the 1988 edition, besides a general

monography, has specific monographies on several stubs.

Moreover, there are other homoepathic pharmacopoeiae, official and/or which have become official in time:

1. The HPUS (Homoeopathic Pharmacopoeia of the United States) of

1964 with a supplement A appeared in 1982.

2. The HPI (the Homoeopathic Pharmacopoeia of India) which now

includes 4 volumes: vol. I of 1971, vol. II of 1974, vol. III

of 1978 and lastly vol. IV of 1978. According to Dr. Chang

other volumes are bieng prepared.

3. Lastly we must mention the FHB (Farmacopoeia Homeopatica

Brasileira) published in 1976.

The pharmaceutical approach, strictly limited to the preparation true and proper, sometimes encounters difficulties which at first seemed too hard to overcome, but which were later solved. These difficulties derived from the fact that the true nature of homoeopathic products is still misunderstood.

France was the first country to question itself on immaterial dilutions: for exzmple, the Codex only accepted dilutions up to 9CH because still theoretically material; later the 1983 and 1988 Codex accepted the dilutions up to 30CH, thus most certainly immaterial.

Moreover, seeing that deconcentration according to Korsakov's procedure, measured by radioisotopes, was neither linear nor reproducible, the Commission de la Pharmacopée Francaise rejected these dilutions. This is still the situation though application has been made to restore them.

Two applications derive directly from the pharmaceutic notion of the homoeopathic remedy:

1. The opportunity of regulating the manufacture by summoning an

official pharmacopoeia.

2. The opportunity of establishing a regime of authorization of

sale (AMM) for at least one class of products: the common

name specialties.

1. The opportunity of regulating the manufacture.

In principle, it is sufficient to refer to a pharmacopoeia to regulate the manufacture. In practice, the matter is not as simple as this because the various pharmacopoeia differ on the matter of the manufacture of stubs, the definition of the latter and the authorized dilutions.

Thus, the HAB tha Pharmacopée Francaise do not agree on the manner of preparing the s.s. homoeopathic stubs. The same is true for l.s. homoeopathic products, especially the organotherapeutics (HAB, paragraph 42) and the isodes (HAB, paragraphs 43 and 44), products also mentioned in the HPUS supplement A, the HPI (vol. IV) and the FHB. The HAB (paragraphs 16, 40a and 40b) and the Pharmacopée Francaise officialize the compounds of the l.s. homoeopathic products: on the contrary, the Pharmacopée Francaise is the only one together with the FHB to introduce the glycerinated steeped products, the HAB the antroposophic and spagyric tinctures, unknown in the HPUS and the HPI.

If every pharmacopoeia acknowledges decimal and centesimal dilutions this is not so for the fiftieth-thousandth and the korsakovian dilutions and no pharmacopoeia whatever mentions dilutions obtained by continuous flow (Fincke and Skinner methods) so dear to the Anglo-Saxons.

The fiftieth-thousands are metioned by the HAB and the HPI, the korsakovian by the FHB.

Each country must thus make its own choice.

We must here mention as an example that in Belgium, on a proposal of the Working Group "Homoeopathie", the Commission des Médicaments recognized the HAB and the Pharmacopée Francaise and the Ministry for Health accepted all kinds of dilutions except the continuous flow dilutions which are still at issue.

2. The opportunity of establishing an AMM regime.

If we limit ourselves to the pharmaceutic documentation (that is the galenic and analytical parts), the establishment of a particular AMM regime for the common name specialties may be considered. It is the regime existing at present in Belgium and in Germany.

In Belgium, common name specialties are provided for by article 28 bis, ter and quater of the Bill of Law of 05/08/1985. They are subject to an application for an AMM limited to a galenic and analytical documentation and the attribution of therapeutic indications is forbidden because the pharmacologic notion of the homoeopathic product is not known officially. The stability of stubs (mother tinctures, chemical tinctures) must be proved and documented. This latter requirement, actually very much justified, represents an obstacle for many laboratories.

In Germany, German pharmaceutic law applies a similar AMM regime. It is appliable only to common name specialties and is governed by paragraphs 38 and 39 of the law 76 modified by the decrees of 24/02/1985 and 16/08/1986. As regards costs, Germany makes a clear difference between the "Standardregistrierungen" (registration on the basis of a monography HAB) and the "Einzelregistrierungen" (registration with the monography of the producing firm), the latter being more expensive.

In conclusion, there is no doubt that the pharmaceutic approach has allowed matters to advance and has regulated the problem of manufacture and of the AMM of common name specialties.

By adapting chapters IV, V and VI of Law 75/319 to the demands of the homoeopathic laboratories, it is quite easy to find a solution as regards infrastructures, technical and analytical equipment, control by qualified personnel, etc.

This is why the Working Group "Homoeopathie" in Belgium has already made a list regarding technical and analytical equipment and has introduced a series of regulations regarding the manufatcure of homoeopathic products.

THIRD THESIS:

The pharmacological definition of the homoeopathic remedy l.s. and s.s. and the need for its introduction.

The pharmaceutical approach has one major inconvenient: it does not allow the following:

1. To solve the problem of the sale of pseudo-homoeopathic

products (toxic or non toxic).

2. To regulate the statute of particular denomination

specialties and still less regulate information regarding

s.s. and l.s. homoeopathic products.

The solution of these two problems will not be possible unless we incorporate pharmacologic notions in the definition of the homoeopathic remedy.

This is why the international dialogue "The homoeopathic remedy: the non pharmaceutic" with sub-title "A proposal to acknowledge it" is so important and an exchange of ideas on this subject is more than desirable, indeed absolutely necessary.

Let us now outline the two above problems:

1. The sale of pseudo-homoeopathics (toxic and non toxic).

There is no doubt that certain tinctures, mother solutions or triturations as well as some low dilutions are toxic. Their employment may be dangerous and, moreover, misleading because if may somentimes be a true and proper "allopathic" product presented in an l.s. homoeopathic manner. Examples of this are the Cortisonum D3 in tablets, the Penicillinum D3 in injections and the vitamin D4 in drops. And what about some magistral prescriptions define "slimming" which, besides true homoeopthic dilutions, also contain massive doses of thyroid extracts, digitalin, amphetamines, etc., all properly classified in homoeopathic language?

In fact, nothing prevents the chemist from selling these preparations when covered by a prescription. The true victim will be the diseased who thinks he is taking a harmless product presented in a homoeopathic manner.

All this is against a basic principle of s.s. homeopathy and of all associated therapy: "premium non nacere".

And who could prevent a homoeopathic laboratory which has obtained an AMM for a common name specialty regarding non speficic products (e.g. Cortisonum, vitamins9, to manufacture "allopathic" tablets in big quantities, thus avoiding in an elegent manner all legislation on non specific products?

These two examples show that something is wrong, not quite logic: actually, this is because the pharmacologic notion is not incorporated in the definition of the homoeopathic remedy.

It is a fact that the correct albeit blind application of legislation regarding poisonous substances does not settle the problem of the pseudo-homoeopathics and indeed involves ridiculous situations. In France, for example, the labelling must comply with the legislation regarding toxic substances listed under table A, B, C. As a result, a homoeopathic remedy whose source is listed under table A, B, or C in doses not mentioned in the exemption list must have the label required for toxic substances. For example, Mercurius Cyanatus, Phosphorus and bismuth salts must bear a label with the saying: "Do not exceed the prescribed dose" and the red rectangle up to 30CH. Moreover, these remedies cannot be sold legally without a prescription and must be registered in the prescription book.

The following is a further example: Opium comes under table B (drug narcotic) and by the law of 8 March, 1972 does not benefit from any exemption at any dilution: this means a narcotic label. A special law had to be issued on 20 January, 1977 to attribute an exemption as from 30CH. A similar situation exists in Germany for this same product.

2. The statute of special denomination specialties and the

regulation of information.

For the same reason (scarce knowledge of the pharmacologic notion), no special denomination is tolerated. It is feared that this denomination (a made up name) may be connected with some precise indication and this is to be avoided because then it may not be possible to tell the difference between the l.s. homoeophatic remedy and pharmacology.

How then are we going to solve the problem of the special denomination specialties which have been on the market for years? We know that a revision is foreseen for all specialities (allopathic and homoeopathic alike) by EEC. Nobody knows, however, what this revision consists in and what is going to be demanded: this shows that it is absolutely necessary to establish a dialogue between the parties concerned: the competent authorities on the one side and the homoeopathic laboratories on the other.

I would like to suggest the following: in all EEC countries information on the medical product is regulated as all information true and proper (news, prescriptions and advertisements). In Belgium, for example, particular provisions in thi respect are foreseen by the Royal Decree of 9 July, 1984 and it is clear that the authorities control information adequately. This system, however, is limited solely to classical medicines.

Would it not be possible to establish a similar system for s.s. and l.s. homoeopathic products, information being based on the doctrine invoked and controled by acknowledged experts, accepted and appointed by the competent authorities.

For example, s.s. homoeopathics by homoeophatic experts, anthroposophics by anthroposophy experts, etc?

According to me this idea could work because it is already followed in certain countries.

Moreover, the O.I.C.M., that is the Office International du Médicament, an official organism in Switzerland, requires that as regards homoeopathic specialties the field of application be supplied or indicated.

This field of action must be determined according to particular criteria outlined in a note issued by the Office itself.

A similar system exists in Germany and according to certain information, the F.D.A. intends to establish a similar regime for the homoeopathic products.

It seems therefore convenient to think of a pharmacologic definition for s.s. and l.s. homoeopathic products.

Thus for the s.s. homoeopathics it would be sufficient to add the saying: "according to the law of similitude", the basic law of homoeopathy. As an example we could define it as indicated in the HPUS:

"remedy established according to the law of similitude employed in doses insufficient to cause an active (classic) physiological effect and prepared according to its own particular procedures defined by an official homoeopathic pharmacopoeia".

Let us now go back to the matter of the sale of pseudo-homoeopathics. By establishing this pharmacologic definition the problem of the pseudo-homoeopathics will be solved quite naturally: it would be sufficient to fix the does for each product (analytical concentration) under which the normal active physiological effect cannot be produced. Thus, the difference between the homoeopathic and the classic remedy coming from the same source will be once and for all clearly established and safety as regards toxic and side effects will be guaranteed.

The sale to be public of homoeopathic preparation (that is under the usual classification: indication of the dilution by the symbol TM, D, CH) which exceed the homoeopathic threshold should be forbidden. The employment of dilutions exceeding the above threshold should be limited solely to the chemist's to prepare magistral preparations.

It must be mentioned that such a regulation would not prevent the freedom of prescription for it would be sufficient to draw up the prescription under the classic classification (measures of weight, percentage).

We would thus avoid confusion between the homoeopathic and the classical remedy also in respect to the patient.

According to these data, the Belgian Homoeopathique Working Group has analysed this problem and has established the homoeopathic threshold of about 350 products expressed in maximum quantity in respect of the packing unit.

The Belgian Ministry of Health faced with the problem of pseudo-homoeopathics and toxicity, accepted our proposals.

Let us return to the issue of the statute of homoeopathic specialties and information.

Besides Switzerland, Germany too, on the basis of a pharmacologic definition, has established a true and proper AMM regime for homoeopathic specialties with (or without) a special denomination and with "indications" (articles 25 to 28 of the Bill of Law of 24/08/1976.

Contrary to Belgian and French pharmaceutic law, a special Commitee, (Kommission D) in entrusted with instituting the documentation.

For practical reasons, the Kommission D has established the "Standardzulassungen" and "Einzenlzulassungen" regimes, that is standard authorizations whose elaboration of the field of application has been achieved by the Kommission D itself (decree of 03/12/1982) and authorizations have been granted directly to the firms. The idea of fixing the field of application of certain remedies (unitarian) by a competent official commitee finds its equivalente in France where, for certain phytotherapeutics, a system has been developed: AMM suited to the phytotherapeutic specialities based on plants (Official Gazette 86/20 bis 1987).

We must ask ourselves if these ideas will pass at a national and European level.

And this brings us back to Europe and in this respect I would like to make a few concluding comments:

1. Due to the very existence of a Bill of Law regarding

homoeopathic products, the European Commitee clearly showed

its intention of harminizing the national provisions

regarding the manufacture and institution of the

authorization application.

We must bear in mind that this Bill of Law will have to be transposed in the national law of member states and this must be taken into consideration.

2. It is clear that the European Committee has decided to pursue

its consultations with member states and the circles

concerned. It will forward, for homoeopathic products,

particular and general proposals in view of the free

circulation of all remedies within the Community. These

proposals, foreseen for next year, will come into force on 1

January, 1993.

3. The strategy developed by the Commitee is that of passing

from one Bill of Law to another: the step by step policy.

We shall thus have to expect a series of Bills of Law as

regards homoeopathic products and probably also a series of

"Special recommendations for homoeopathic specialties". We

may therefore advance this development and establish a

dialogue starting from now.