Anthroposophic medicinal products
Anthroposophic medicinal products include substances mostly from natural origin, i.e. from minerals, plants or animals, prepared in different levels of concentration for different routes of application, external, oral or parenteral. Some medicines are similar to herbal medicinal products, and some are prepared according to the guidelines of homeopathic pharmacopoeias. However the essential anthroposophic specialities are produced using specific pharmaceutical procedures according to the anthroposophic understanding.
The products are defined according to their (1) development, (2) manufacture and (3) use.
- developed in accordance to the anthroposophic knowledge of man and nature (anthroposophic knowledge includes common scientific knowledge)
- defined by their manufacturing procedure, that can be common to homoeopathic medicinal products (e.g. European Pharmacopoeia or German Homeopathic Pharmacopoeia) or specifically anthroposophic (Pharmacopoeia Helvetica, Anthroposophic Pharmaceutical Codex)
- intended for use according to the principles of Anthroposophic Medicine.
Registration of anthroposophic medicinal products
The EU Community code relating to medicinal products for human use, Directive 2001/83/EC, does not recognise anthroposophic medicinal products as such. Some can be registered as homeopathic and others as herbal medicinal products. However the most typical and widely used anthroposophic medicinal products cannot be authorised either as homeopathic or as herbal medicines. As a consequence they should be authorised by the ‘normal rules’ governing pharmaceutical medicines. However, these rules are not appropriate for the special characteristics of the products and their use in the practice of anthroposophic medicine.
Countries with a full range of anthroposophic medicinal products
To date, the only European countries that have authorised a full range of anthroposophic medicinal products are Germany and Switzerland. In both countries the medicines legislators as well as the competent authorities have developed and implemented appropriate rules to allow a feasible market access to the wide range of anthroposophic medicinal products guaranteeing a high level of quality, safety and effectiveness.
Anthroposophic medicinal products have a long established use in several EU/European countries; on the basis of this long-term use, they have proven safe use. They are also produced to a high quality. They should be made available to all EU patients/users on the base of an appropriate rational regulatory scheme.
Scientific basis for a permanent regulatory framework
Recently work has been started to develop the scientific basis for a permanent regulatory framework for anthroposophic medicinal products in Europe. For this task, the “European Scientific Cooperative on Anthroposophic Medicinal Products”, ESCAMP, has been established as an independent non-profit organisation. ESCAMP works to develop standards for the scientific assessment of safety and efficacy/effectiveness of these products, following a system approach. This comprises [a] a description of the therapy system, [b] an empirical evaluation of the whole system and [c] an evaluation of its components, the anthroposophic medicinal products themselves. Based on this scientific work, and taking into account existing regulatory provisions in the EU, a rational regulatory scheme can be developed.
It is intended that the ESCAMP initiative will contribute substantially to the process of inclusion of anthroposophic medicinal products into the Community code relating to medicinal products for human use.