BfArM in Dialogue:
Homoeopathic Medicinal Products - Perspectives in Europe
18 June 2007, Bonn, Germany
Selected Contributions of Interested Parties
The Relevance of Homoeopathic Medicinal Products for
German Naturopathic Practitioners within the European Context
by Arne Krüger
Naturopathic Practitioner & Veterinarian
Deputy Spokesman of the Committee on Medicinal Products of German
Naturopathic Practitioners
Die Deutschen Heilpraktikerverbände (DDH)
History and Legal Situation of Naturopathic
Practitioners
The origins of the naturopathic profession lay in medicine based solely on
experience and cover the healing traditions of shamans, druids, and medicine
men as well as the whole spectrum of ancient medicine (as performed by
Imhotep, Hippocrates, Galen, Hildegard of Bingen, Paracelsus, Kneipp, etc.).
There was no legal separation between a medical doctor and a traditional
healer in antiquity. The first educated “academic” medical doctors appeared
in Germany in the 12th century. Emperor Friedrich II. enacted a law on
medicinal rules and regulations in 1240, which regulated the course of
studies, examinations and payment of physicians. There was no medical
university training in Germany before the 14th century. Karl IV founded the
German University in Prague in 1348, which indeed had a medical faculty.
That was also the time of the first prohibitions of occupational activity by
non-certified healers in German speaking countries. However, due to the
specific political situation in Germany, there was no standardized
regulation valid throughout the country. Hence, very old healing traditions
survived and evolved. Besides phytotherapy, it was mainly Hahnemann’s
homoeopathy that was practised by traditional healers.
Hahnemann’s wife Melanie as well as Clemens von Bonninghausen and Arthur
Lutze belonged to this circle of homoeopathic practitioners. Arthur Lutze
had worked as non-certified healer in the field of homoeopathy for many
years before officially becoming a medical doctor in Cöthen.
The first naturopathic unions were founded in the 20th century. By 1931, 22
organisations were established. Although this demonstrated a high diversity
in organisation, it unfortunately also constrained political strength.
Naturopathy was acknowledged as a profession in Germany in 1936. It was
acquitted from turnover tax. On February 17th 1939, the German regime
enacted the “Naturopathic Practitioner Law” (Heilpraktikergesetz) and its
first executive order, which are the legal basis of the naturopathic
profession in Germany up to today.
Naturopathy is an independent medical profession regulated by German law.
Naturopathic practitioners work without assignment by a medical doctor and
are thus to be distinguished from medical assisting professions or
paramedical personnel such as physiotherapists and others.
Naturopathic practitioners diagnose medical conditions and apply
naturopathic practices for therapy, such as homoeopathy, phytotherapy,
acupuncture, massage, Bach flower remedies, chiropractic, osteopathy, and
others.
Naturopathic practitioners are allowed to apply medicinal products in
practice and to prescribe them to patients. However, the application or
prescription of prescription-only drugs is not permitted. Furthermore,
fabrication and sale of medicinal products is forbidden for naturopathic
practitioners as it is for medical doctors.
The committee of medicinal products of German naturopathic practitioners
The committee of medicinal products of German naturopathic practitioners
(“Arzneimittelkommission der deutschen Heilpraktiker”, AMK) is carried by
the six organisations associated in the German Naturopathic Practitioner
Organisations, DDH (“Die Deutschen Heilpraktikerverbände”). These six DDH
organisations have 22.000 members and represent the majority of German
naturopathic practitioners. The AMK is involved in the plan of stages
(“Stufenplanbeteiligte”) according to § 63 of the German Medicines Act
(“Arzneimittelgesetz”, AMG). The tasks concerning this matter result from §
62 AMG: The AMK notifies the Federal Institute for Drugs and Medical Devices
(“Bundesinstitut für Arzneimittel und Medizinprodukte”, BfArM) in cases of
risks or side-effects of medicinal products noticed by members of DDH. The
AMK further informs members of the profession about risk potential, recall
of marketing authorisation, and/or recalls issued by BfArM. The AMK is
concerned with expert reports and statements in cases of plan of stages
proceedings.
The organisations of the DDH – and therefore the members of the profession -
assigned further tasks to the AMK. It is the expert board concerning all
questions about medicinal products. It has to conserve the freedom of
prescription as well as the diversity within the profession of naturopathic
practitioners. It furthermore has to impede all constrictions, such as
extension of prescription-only drugs or unwarranted actions concerning
application for marketing authorisation as well as renewal or recall of
marketing authorisation. The AMK coordinates the expertise of the committee
members at BfArM and discusses and evaluates the information given by BfArM.
The aim is to prepare the basis for well-founded decisions, which are
relevant for the whole profession, and to present alternative options for
future action of the DDH.
The AMK represents the supporting organisations in the political public and
at federal institutions in questions relating to medicinal products or the
drug law, for example in hearings or via statements.
The AMK represents the interests of the profession solely regarding drug
related issues. It does the preliminary work for those members who are
experts in the single commissions and who are appointed by the ministry of
health for three years. These commissions are competent boards, which have
to be consulted by BfArM regarding the several drug-related issues. Members
of these boards are experts of the medical and pharmaceutical sciences as
well as naturopathic practitioners, amongst others.
There is an expert panel for pharmacy-only drugs (“Sachverständigenausschuss
für Apothekenpflicht”), one for prescription-only drugs (“für
Verschreibungspflicht”) and one for standard application for marketing
authorisation (“für Standardzulassung”). Furthermore, there are three
specific commissions: Commission C for anthroposophic medicinal products,
Commission D for homeopathic medicinal products and Commission E for herbal
medicinal products. The commissions usually consist of 10 to 15 experts.
Among these experts there are pharmacologists, toxicologists, medical
statisticians, and one expert with practical experience in the field. One
member each of the commissions C and E belong to the naturopathic profession.
Two naturopathic practitioners sit in Commission D. Furthermore, the two
deputies can join the consultations during the committee sessions. For the
sake of completeness it should be mentioned that there also are committees
on the German Pharmacopoeia and the German Homoeopathic Pharmacopoeia.
The committee on medicinal products is based in Bonn.
The Relevance of Homoeopathy for the Naturopathic Profession
Homoeopathy has a long tradition in Germany, the native country of Samuel
Hahnemann. Homoeopathy is the most important kind of therapy for German
naturopathic practitioners. Next to the classical form there are many
alternatives of single or complex remedies. In addition to oral application
in form of globuli, dilutions and triturations, naturopathic practitioners
apply homoeopathic products as ointments or as homoeopathic injection
preparations.
Hence, the preservation of the whole spectrum of homoeopathic products is of
paramount importance for all German naturopathic practitioners. It is
imperative for the responsible and successful treatment of patients.
The quality of homoeopathic products is sufficiently assured by potentiation
as well as by the confirmation of quality of manufacture and of
toxicological safety. Regulations concerning autoclaving and the safe
provenience of the drug, in consequence of BSE, banish the danger of a
possible prion transfer.
It is important that the entire range of traditional drugs is maintained in
the course of the harmonisation of the different pharmacopoeias. It should
not be diminished or disappear in the process of formal harmonisation of
homoeopathic drugs. For German naturopathic practitioners, homoeopathy is
the most important of all drug therapies and represents the backbone of the
profession.
Arne Krüger
Deputy Spokesman of the Committee on Medicinal Products
of German Naturopathic Practitioners
Die Deutschen Heilpraktikerverbände (DDH)
Maarweg 10
53123 Bonn
Tel. 0228 / 962 899 00
Fax 0228 / 962 899 01
