On 18 December ECHAMP was invited by Emiel Van Galen (Chair) and Antoine Sawaya (Vice Chair) of the Homeopathic Medicinal Products Working Group (HMPWG) to join an information session during one of its regular meetings under the French presidency in Paris. The aim of the information session was provide expertise to help the assessment work of the competent authorities as regards the justification of ‘anthroposophic use’ as mentioned in Article 15 and considerant 22 of Directive 2001/83/EC.

This 90-minute information session was attended by delegations from the homeopathy units of 21 EU Member States and representatives or observers from the European Commission, the European Medicines Agency (EMEA), the European Directorate for the Quality of Medicines and Healthcare (EDQM), Switzerland and Norway.

Nand De Herdt, pharmacist and member of the Board of Management of ECHAMP, introduced the status of anthroposophic medicine in the European Union stressing the medical infrastructure for this therapy - doctors, therapists, hospitals, training programmes and research activities. Referring to the quality and safety of the products, he presented the long medical tradition, the current requirements for quality of production and the manufacturing procedures outlined in official pharmacopoeias.

The other three speakers outlined the therapeutic concept of anthroposophic medicine.

Dr François Hibou, from IVAA, the anthroposophic doctors’ association, and the Medical Department, Weleda, France, explained the basic principles of anthroposophic medicine; he demonstrated that the choice of medicine is based on the knowledge of substances and processes in nature and that the choice is validated by the existing bibliography on anthroposophic concepts and on records of clinical anthroposophic use and experience.

Christiaan Mol, pharmacist and member of the Board of Management of ECHAMP, focussed on all aspects of manufacturing, the preparation of a particular anthroposophic stock and the official Pharmocopoeia monographs and monographs of the Anthroposophic Pharmaceutical Codex. All preparations and stocks have their own specifications and are thus quality controlled according to Good Manufacturing Practice (GMP).

He identified a four step approach to justify ‘anthroposophic use’ within the framework of simplified registration: the first two steps are of anthroposophic pharmaceutical relevance (the starting material and the manufacturing method). These can be substantiated by the European Pharmacopoeia, the official pharmacopoeias of the Member States or the Anthroposophic Pharmaceutical Codex. The third step is of conceptual relevance (reliable description of the link between the substance and the human being), which can be substantiated by extensive bibliographic sources and pharmacy and the fourth step is related to documentation on experience and clinical use, which can be substantiated in the German Commission C monographs, the ‘Merkurstab’, the ‘Vademecum’ or others.

Finally, Thomas Breutkreuz, Head of the Department for Internal Medicine in the hospital in Herdecke and Chairman of Commission C at BFArM, explained how an (allopathic) disease oriented approach can be combined with an (anthroposophic) pathological process oriented approach leading to a better understanding of ‘anthroposophic use’ as described in both the Commission C monographs and the first Vademecum on anthroposophic medicine.

The Commission C Monographs and the first Vademecum on anthroposophic medicine explain ‘anthroposophic use’ as an enlargement of the general medical approach that takes account of the anthroposophic concept of pathological processes. Conventional medicine deals particularly with disease related indications independently of the pathological process or mechanism. Anthroposophic medicine also deals with pathological process related indications independently of the medical condition. An integrative approach to the indication brings us to a medical condition with specific modalities due to understanding of the pathological process.

The German Commission C Monographs focus on specific pathological processes so that the indications are rather general. Anthroposophic medicine literature on the other hand focuses on an understanding of the anthroposophic therapeutic concept, giving differentiated indications for the remedies according to the constitution and the type of imbalance.

The third approach, which has resulted in the publication of the Vademecum on anthroposophic medicines focuses on the results of therapeutic experience combined with clinical judgment for the specific medical conditions that looks at both the pathological process and the anthroposophic understanding.

Thomas Breutkreuz concluded that a pragmatic regulatory approach for anthroposophic use could use the existing Commission C monographs in Germany, complete with literature on anthroposophic medicine and expertise from the institutions and associations as necessary. He offered the expertise of a core group of his association to help the competent authorities.

Nand De Herdt
ECHAMP General Secretary