The legal position of anthroposophic medicines (“anthroposophic medicinal products”) in the EU’s current legislative framework programme (as at April 2007)

In relation to the question of providing legal safeguards for anthroposophic medicines we can in general say that there is a need to distinguish between homeopathic medicines used in the anthroposophic treatment approach and so-called “anthroposophic remedies” which are not produced according to homeopathic procedures. The first type is, legally, on an equal footing with homeopathic medicines. Currently, under Article 14.1 of guideline 2001/83/EC (passed on 6.11.2001) only medicines at a level of dilution of at least 1:10,000 (D4) are safeguarded by law for oral intake or external application without indication, and can be registered by the “simplified” procedure (i.e. without proof of efficacy provided by clinical studies). In relation to homeopathic-type remedies, guideline 2001/83/EC was extended by guideline 2004/27/EC (passed on 31.3.2004). This group of so-called homeopathic remedies however only comprises a small part of anthroposophic medicines.

For preparations produced according to homeopathic procedures (for both a homeopathic and anthroposophic treatment approach) but marketed with indications, there is no unified European legislative basis. Under Article 16.2 of guideline 2001/83/EC, it is left to member states to establish special permit conditions for such medicines. This has so far been done in only a few countries.

It is possible that one or other anthroposophic medicine still falls under Directive 2004/24/EC (extension of guideline 2001/83/EC) relating to “Traditional herbal medicinal products”, passed on 31.3.2004. Apart from the fact that only a few anthroposophic medicines are purely plant-based, very extensive documentation is required to fulfil the legal criteria for this guideline.

The so-called “anthroposophic remedies” are not covered by guideline 2001/83/EC. In numerical terms these represent a smaller but overall most significant part of anthroposophic medicines. Since they have usually been on the market for a very long time, some countries (e.g. Germany, England, Poland, Switzerland) have issued special conditions or long-term transitional rules for them. Overall the situation is very uncertain and currently also the subject of legal proceedings at the European Court (C84/06).

In summary we can say that currently under European and national law there are, in most cases, no legal framework conditions at all for the most

important anthroposophic medicines. Particularly at risk are the specifically anthroposophic remedies such as the so-called “-doron” preparations, and the medicines given in other ways as oral/external applications (e.g. ampoules).