Director of the Institute of Forensic Medicine

University of Naples.

ABSTRACT: Regulation of homeopathy in the various countries whee it is practiced: control of pharmaceuticals, professional qualification, programmes of study and ethical and legal responsibility of the physician.

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

The subject cannot be reduced to a mere glance, but must take us to evaluate and observe the situation in our country without frontiers, from 1992 onwards.

Homoeopathic Medicine has been practiced in our country for a long time: consumers already have certain rights and bills of law are being examined by the Italian Parliament. The European Council on alternative medicine included homoeopathy; observation, though aimed at 1992, cannot ignore the present situation.

I shall give the general lines of the situation of the Homoeopathic practice in our Country and in other European countries.

However, it must be said that many legislative texts lack a definition of Homoeopathy, lack the differentiation between homoeopathic treatments and traditional medicine. I shall not use the term "official medicine" because according to me (we are all graduated, in the List od Practitioners and qualified to practice the medical profession) both are "official".

We suppose that the legislator is acquainted with the concept of homoeopathy and that reference is made in the following terms: "treatment with dynamized drugs" or "made from herbs" or "administered according to homoeopathic principles" or simply "the curative method introduced by Doctor Hahnemann". There are however remarkable differences in the professional legal statute of those who practise homoeopathy.

There are two basic questions which we must ask ourselves as regards legislative regulation:

1) Has the Homoeopathic method been accepted and legally

recognized in the country? What is the regulation regarding

the Homoeopathic treatment? (these are the questions lying

at the base of this Meeting).

2) Can the homoeopathic practice be carried out by those who do

not have a degree in medicine? And under what conditions?

This is not a problem in Europe, but it is in Africe in the sub-Indian continent, etc.. In these countries there is a rather interesting division of tasks, but it would take too long to speak about it here.

In most Western countries, instead, we seldom find juridical regulations on the basis of which certain methods of treatment are either admitted or forbidden. In exceptional cases, a method, or more often the use of certain drugs, may be forbidden by law, but, as a rule, the admissibility of a particular curative treatment is determined "ex lege artis", according that is to the principles accepted by the medical science.

Even the evident duty of doctors to practice according to the principles accepted by the medical science, though unanimously acknowledged, is seldom prescribed explicitly by the law and when the court is summoned to judge the relative issues, for example, professional responsibility - thus the choice of the method of treatment, the choice of drugs made by a doctor or a team of doctors - the court appoints experts (as well as the forensic doctor) to get opinions on the respect of the "lex artis".

It is thus generally admitted that doctors are compelled to be informed on the progress of the medical science. Law 833/78 passed on the National Health Service in Italy makes an adequate information compulsory. The Orders of Practitioners have tried to carry on the subject of adjournment but decisions on the kinf of treatment are up to the single doctor. In sum, we must reaffirm all refusal of therapeutic patterns.

I remember the debate developed within the regional committee on drug addiction in Campania among those who organize a therapeutic pattern for all drug addictis and those who defended the need for a personalization of the therapeutic choice.

Opinions on the medical value of Homoeopathy are in disagreement. Some state that the allopathic methods oppose homoeopathic methods with the same rights even if the Australian Parliamentary Committee, in 1977, stated that the homoeopathic practice is not supported by any scientific evidence. However, doctors working in Europe are generally authorized to employ homoeopathic methods. Several groups of homoeopathic doctors carry out their profession is most countries of Western Europe. About one thousand practice in the Federal German Republic where Homoeopathy was born. In Federal Germany the additional indication "Homoeopathy" may be employed by doctors who have followed a specific training which includes the theorethic or practical examination of Homoeopathic treatments for at least a year and a half (guided by a qualified Homoeopathic doctor); or, as an alternative, six months' work in an officially acknowledged homoeopathic doctor; or yet a participation to three official perfectioning courses or thr

ee months' teaching in homoeopathic therapy.

In the United Kingdom a homoeopathic faculty was legally established in 1950. In France a university course in homoeopathy for students of medicine was established, but there is no official academic title of homoeopath specialist. The presence at this meeting of colleagues coming from the above countries will further allow to detail and verify with reference to the present situation the indications of the literature I am quoting.

In some countries the legislative authorization of the homoeopathic pharmacopea is a kind of official acknowledgement of Homoeopathic Medicine.

A more sceptical attitude as regards homoeopathy is found in the health legislation of those countries which we were accustomed to define "socialist countries" or of "Eastern Europe" where the duty of a doctor to cure the patients, "lege artis" is expressly prescribed by law more often than in Western countries.

In the Soviet Union, article 34 on the basic rules of the health law provides that doctors "must", not "can", employ methods of diagnosis, prevention and treatment and prescribe drugs authorized by that Ministry for Health.

The same rule exists in the Bulgarian health code in which neither homoeopathic drugs nor curative methods are authorized. In Hungary, as a rule, the freedom of the doctor to decide on the treatment is acknowledged, but homoeopathic methods are considered not scientific.

Likewise in Czechoslovakia where the basic sanitary law provides that medical treatment must be prescribed on the basis of the present state of the medical science and mention must be made of the fact that in this country chiropractice and agopuncture, practised by specialized doctors, have been regulated by the Ministry for Health while no similar steps have been taken as regards Homoeopathy.

Instructions on the prescription and distribution of drugs state that homoeopathic drugs cannot be prescribed or distributed freely despite the fact that in Czechoslovakia almost all other drugs are free.

As regards the countries of Eastern Europe, it must be mentioned that in the Democratic German Republic the situation is more complicated, due to the survival of old traditions. Here too there is no law directly or indirectly explaining whether Homoeopathy is or is not a scientific method.

An indication may be got from the conclusions drawn by a famous expert on forensic medicine: "on the basis of scientific knowledge, Homoeopathy cannot be employed for the treatment of severe disease, especially organic disease". This graduation of the employment of Homoeopathic Medicine is according to me rather significant.

The chance that Homoeopathy be practised by non doctors in the tolerant countries of Western Europe may be deduced from the following examples:

- In the United Kingdom and in certain Scandinavian countries

any citizen may practise treatment, but he certainly may not

prescribe drugs or cure certain diseases;

- In the Federal Republic of Germany and to a lesser degree also

in the Democratic German Republic, only "authorized

practitioners" may cure the diseased as non graduated

homoeopathic healers.

The homoeopathic therapy - even if meant as a "metaphore of homoeopathy", on which for the sake of brevity I cannot here indulge, has spread throughout Europe and it would be reductive to say that it is only a fashionable wave.

Moreover, we must look at the matter from the homoeopathic point of view and turn to what homoeopaths say of themselves: and I should say that all that has been said so far during this meeting authorize us to state that homoeopathic medicine is the medicine which considers man as a human being, identifies him in the state of health to be thus able to recognize him in the state of ill-health.

However, if every disease may be cured by considering the diseased in the correct manner, as some speakers said this morning, there are at least four limits we must be aware of:

1) The first limit is within the doctor who is uncapable of

"seeing the diseased" and thus falls into the "fear of the

disease" and does not recognize the reactive and subjective

symptoms; that is those symptoms which he will have to find

in the experimentation by similitude.

2) A second limit lies within the diseased who, though against

pharmacologic therapies, does not understand how the disease

may be treated with a single Remedy made of sugar pillules.

He thus makes mistakes due to his knowledge of medicine.

3) The third limit lies within the Unique Remedy which does not

act because it does not correspond to the correct Hahnemann

technique of preparation; I would also wish to underline that

this Meeting is trying to overcome this "limit" and to say

how the preparation of the Unique Remedy should be regulated.

4) The fourth limit is represented by the "severe" state of

disease, the "irreversible" condition; mention must here be

made, however, that if all the experimental methodology, both

clinical and therapeutical, has been correctly applied, the

irreversible condition may employ to the end, that is to the

moment of death, to the exitus, all his biological potential.

This brings us to further interesting corelations between

"the unable to recover" and the "incurable", modern lie of

the sanitary practice opposed by article 32 of the draft of

the new deontologic code which says: "the doctor cannot

abandon the diseased deemed incurable, but must continue to

assist him even if with the sole aim of diminishing his

physical and psychological sufferings, helping and comforting

him".

As regards the "curability" is has been said during this Meeting that Homoeopathic Medicine, correctly applied, also cures animals (fish, birds), cures plants and this only and always with a single Remedy at a time.

How is Homoeopathy practised nowadays in Italy? This aspect needs looking into also to regain the "challenge of complexity" mentioned by Mr. Ziantoni and see how in 19992, the exsercise of this medical activity can flow into a single ocean.

In Italy, the practice of Homoeopathy is entrusted to those who have a degree in medicine and surgery just as the sale of homoeopathic drugs is carried out at the chemists'. There have been attempts at involving the public structure; Mr. Ziantoni referred to this in his talk. I shall mention that in some hospitals in Campania (Cardarelli, Fatebenefratelli) a Homoeopathic Medicine team has been established together with an agopuncture centre; however, Homoeopathic Remedies are not found in municipal and hospital chemistries.

The survey on the Italina situation may be accomplished in different ways: I shall first try from a deontologic viewpoint and then from a medico-legal point of view and than I shall leave the floor to Professor Ventre who will talk of the educational, pedagogic and vocational aspects.

It is believed that the doctors working on the professional plane and apply the homoeopathic diagnostic criteriology and the Homoeopathic Remedy, contradict the provisions of article 4 of the present deontologic code which is the one established in 1978. (It should be said that the new version of the already mentioned Deontologic Code is already far advanced). Article 4 requires that within his professional practice the doctor be in accordance to the scientific knowledge. The joint document drafted in 1986 by the faculty of medicine and the Padua order of doctors is of the same opinion.

In particular, this document reads: in his practice the doctor must not employ those doctrines the contents of which are not included in the experimental science as the latter is meant by the academic teachings of the Italian State".

Personally I do not share this attitude because on 16 February, 1981 the Court of Perugia discharged a non doctor agopunturist of the accusation of abusive practice of the medical profession (ex. art. 348 of the Penal Code in force), stating among other things, that the contents of the sanitary profession may be extracted from the present regulation on study programmes, and the subjects which form the appropriate state examination. The Court of Cassation repealed this sentence; it ignored the Court of Perugia's argumentation according to which the contents of the medical profession are limit3ed to those which are subject to the verification by the state, that is to the contents of the examination of the degree course and of the examination qualifying for the medical practice.

The importance of this sentence is not so much in the fact that it confirms the principle that a non doctor agopuncturist practises the medical profession abusively (this is obvious), but in the fact that it underlines a particular aspect, that is the one regarding the freedom of the medical act and the illegality of forming a therapeutic pattern to be administered to anonimous consumers (such as for example the pattern designed for drug addicts mentioned above).

It is true that the doctor, as prescribed by the present Deontologic Code ex art. 5 and as not denied by any other regulation, is free to indicate the means of prevention and diagnosis investigation considered most suitable and to prescribe drugs considered most suitable to the circumstances. As already said he is bound to adjourn his knowledge in the diagnostic and therapeutic field, to safeguard the patient's right to health in the best possible way allowed by the most recent scientific acquisitions (ex art. 21 of the Deontologic Code in force).

From the above considerations we may gather that the magistrates of the Court of Perugia had probably borne in mind the second paraggraph of article 61 of the Deontologic Code which does not consider the freedom of diagnosis and treatment, but considers medical publicity and states: "medical practices which though of current use are not included in the university study programme and in those for specialistic vocational training, though legal, may not be exhibited or publicized as an autonomous branch of the sanitary activity".

We may thus conclude that if Homoeopathic Medicine is legal in Italy, it may not be publicized as a self-governing branch of the sanitary activity.

I insist on thi aspect because we often seen headed prescriptions with the name of Centres, etc., which most certainly do not come within this regulation which is most surely in force.

In Federal Germany one may add the word "Homoeopathy" to one's name surname, but under particular conditions, to have followed certain courses, have practiced in a hospital and so forth as already mentioned above.

In Italy nothing of the kind exists: there is no way one may qualify himself "homoeopath". However, the heart of the matter lies in the fact that Homoeopathic Medicine has been put in suit, in the context of alternative medicines, by the Padua document which urges the doctor "to apply on patients all those therapie which do not derive from physico-chemical, biological and clinical knowledge accepted by the international scientific community and which theoretically speaking seem to have no solid base".

In support of the above we must mention the provisions of article 18 of the Deontologic Code which forbids the administration of pharmacologic products contents of which are kept secret and which has been taken up also as regards dietologists. As for the statement that the doctor must stick to proven scientific acquistions we must go back to the previous sentence regarding sanitary information which may cause false hopes and unnecessary fears such as for example information regarding anti cancer remedies. This is also mentioned in the draft of the new Deontologic Code at article 19; moreover in the second paragraph of article 91 the doctor is urged to: "avoid practising the profession in sites annexed to structures autonomously designed for other sanitary for other sanitary or paramedical activities: chemistry, herbalists, alternative medicine institutes and similar structures".

The medical act cannot be regulated by law by the establishing the means with which a certain illness must be treated nor can it experiment on man as unfortunately happens despite the Helsinki conventions.

The document of the Padua Order of Doctors ends by reccommending all its members not to indulge in esoteric or non scientific practices consisting in the administration of substances not recommended by the official pharmacopoeia of the Italian state and warns that the violation of this recommendation could be unbecoming for their profession, and this is provided for by article 3 of the Deontologic Code in force and ensues disciplinary sanctions provided for by article 40 of the Presidential Decree of 5 April, 1950, No. 221.

Kuwait is of an entirely different opinion. Some years ago this country defined the doctor - Francesco Introna, a Padua forensic doctor recalls it - as one who "by personally accomplished acts or by the help of other people, makes diagnosis, prescribes drugs, performs medical, surgical or psychological acts on another human being, requests laboratory examinations and evaluates the results thereof, employes energies of any kind of nature aimed at a therapeutic diagnosis and for the same aim employs physical factors such as sound waves".

"Divinum est sedare dolorem", no matter wheter the result is obtained in the shadow of pharmacopoeia or elsewhere: this seems the statement of a patient who through a homoeopathic procedure has ashieved his aim!

But before leaving the floor to Professor Ventre, we must look into another apsect of the matter and that is the medico-legal side.

The third paragraph of article 1 of law 833/78 regarding the National Health Service considers the functions, structures and services and the activities designed for the promotion, maintenance and recovery of the physical and psychic health of the entire population.

From this enunciation on principle which does not exclude any activity to the actual enforcement, the path is still long. In Italy, just as in Holland which is far ahead as regards Homoeopathy, the cost of the Homoeopathic treatment, even if prescribed by a doctor of the National Helath Service, are not refunded,

As regards private insurance companies, the matter is still open: those which provide for refundment of lying in days are beginning to consider Homoeopathic treatments.

A 75% refund is provided for medical treatment in the 90 days following hospitalization or treatment in the casualty department. However, I know of foreigners, NATO officials in Naples, who turned to the National Helath Service for Homoeopathic treatment which was denied them.

This does not favour the equality of citiwens in the face of the service as provided for by the already mentioned third paragraph of article 1 of law 833/78 and of this we could speak further.

However, to remain on the subject of medico-legal interest, we must underline that in the practice of Homoeopathy in Italy we see, ever more frequently, an abusive practice of the Homoeopathic activity. Indeed, there is a proliferation of pseudo-homoeopathic activity as the one which expects to cure the disease and not the diseased, employing more than one remedy at the same time.

The drive for this kind of practice comes - si exposita vera sunt - from the 15 laboratories which produce Homoeopathic preparation which attempt to increase the sale of their Remedies. This denies the principles of Hahnemann. Patients may be cured this way and symptoms eliminated, but patients will not be globally helped and valued. This means emarginating Hahnemann's principles according to which the body's mechanisms of defence are increased by the single Remedy chosen according to the principle of simillimum and the therapeutic activity of the Remedy even in very high dilutions, provided it is suitably dynamized.

Another aspect to be considered is the one regarding induction, in the first stage of the administration of the Homoeopathic Remedy, of a kind of worsening of the condition of the patient taking the Remedy. This aspect has already been mentioned during this meeting.

Vitoulkas, director of the Athenian School of Homoeopathic Medicine, emphasized this worsening. If this does not occur, risks from the administration of the drug may be feared. The choice of the treatment exposes the therapist to important responsibilities substantially similar to those of whoever practises the medical profession.

Professional responsibility ensuing form the choice and the enforcement of therapeutic treatments within a contractual relationship arises when damage to the patient is caused by an unpremeditated behaviour of the doctor.

Without mentioning the well-know concepts regarding unpremeditated responsibility, it may be useful to underline that as regards Homoeopathic Medicine, professional guiltiness may ensue more often from a mistaken diagnosis than from a mistake in the choice of treatment.

Mistaken diagnosis and treatment are closely linked together as the nosologic picture of the morbid process and the correct identification of the pathologic picture are essential for the identification of the modalities of the treatment itself, that is for the choice of the Remedy.

As regards the diagnostic mistake, it may be possible to envisage a damege in those cases in which a mistaken Homoeopathic methodoogy may have caused damage or the delay in enforcing a useful therapy or indeed its omission, have caused a worsening of the condition.

The fact that a longer survival is not achieved may cause a "perte de la chance de survivre", of which the doctor may be charged.

As regards dishonest activities bound to the Homoeopathic practice, the most important issue to be cleared is, provided this practice is entrusted to those practising the medical profession, whether, being Homoeopathy outside the so-called acknowledged medicine, it should be considered as an illegal practice carried out for personal gain, a sort of "Homoeopathy of the purse", even though altogether unfit to achieve useful results.

I deem it necessary to go back to the official recognition of the discipline - which has already been investigated during this Meeting as regards the freedom of the medical action - because its official recognition arises from a number of factors most important of which are those connected with the scientific nature of the discipline itsel which is subject of experimental verification and research.

However, as already said above, this is not the only characteristic which makes the discipline official for it expresses the guarantee that the State, responsible for teaching in all its aspects and for the safeguard of health, puts into the exercise of those activities based on the knowledge deemed necessary for the practice of the medical profession.

It is not easy to distinguish an official medicine from a non official medicine, in as much as the surveillance exercised by the State on the teaching and the practice of sanitary professions, spreads to all professional activity whether reached through official education or through other sources of education, and indeed, according to me more on the latter which are more liable to flow into non legalized activites.

In sum, we have to say that according to whether the guarantees provided for by our regulation for the practice of the profession exist, it will be more correct to distinguish for the health sector the medical activities legitimately practiced from those activities practiced illegally. And, as regards this conclusion, I believe that in the face of the development of activities regarding helath but not strictly scientific, the problem is that of defining which of these activites are to be considered legal and which not and establishing what requisites need be demanded from practitioners to practice within those activities subject to sanitary survelillance, that is within state recognized activities.

The provisions of article 99 and 100 of the single text of the present health legislation, gives a legitimate character to the health activities practiced by senior doctors who have passed the special qualification examination for the professional practice according to the present regulations each within the specific competence: health professions, euxiliary health profession, auxiliary arts of the health professions.

It ensues that the possession of the qualification for the professional practice gives the health activities subjected to surveillance the requisite of legality provided that the profession is practiced within the respective competence and that the provisions of articles 32 of the Constitution and 33 of law 833/78 exist.

The conclusion is, that is, that professional qualified to practice are authorized to effect any health treatment thay deem based on scientific knowledge, wheter connected with activities of official teaching or, such as Homoeopathy, those which do not find, in Italy at least, space in the organization of professional studies.

This, in practice, finds some limitations which reduce the field of discretionality within which the doctor operates.

A first kinf of limitation is found in carrying out the treatment and in the right of choice of the treatment.

These must not only have a scientific base, but must also be useful and necessary, not replaceable with other more advantageaous and less dangerous treatments and must be the most suitable and most appropriate under the circumstances in which they are applied.

A second kind of limitation is the one deriving from legislative provisions as regards sanitary assistance and that are referred to the patient's consent.

Limitations deriving from the availability of this consent work through a mechanism of information on the patient and thus relate with the same limitations mentioned above, that is the apreciation of the opportunity, of the necessity, of the suitability, of the non-replaceability of the sanitary treatment.

For all this complex subject we must go back to the medico-legal treatises and in particular to the work of INTRONA and BARNI, already mentioned above.

In this sector the doctor must inform the patient on the reasons for which he has chosen a treatment rather than another, by means of an information as accurate as possible, obviously related to the patient's understanding capacities and from which the contents of the doctrine at the base of the treatment must show clearly. I here wish to mention that in the two bills of law under examination there are some remarkable contradictions: in the Garavaglia proposal, article 5 refers to compound or complex Homoeopathic products, for which any denomination may be adopted provided it has no reference to physiological functions, pathologies, tissues, organs and human or animal apparatuses. Instead, the Rutelli, Aglietta, Faccio, etc. bill of law provides that the drug be accompanied by a note in which this information is given.

As a therapeutic value cannot be denied Homoeopathy and aknowledging the legitimacy of its accomplishment by those who practice sanitary professins, the hypothesis that dishonest activities may be possible remains bound to its accomplishment or for personal advantages thoug absolutely certain of the inefficiency and uselessness in the case of a perfrmance, or that is its accomplishment by people not having the requisites for the professional practice: the latter hypotesis includes also the crime of abusive practice of the profession provided for by art. 348 of the Penal Code according to the recent sentence of the Supreme Court mentioned above.