Anthroposophic medicinal products

The legal status of anthroposophic medicinal products within the framework of pharmaceutical legislation in the EU is less clear-cut than that of homeopathic medicinal products.

If an anthroposophic medicinal product is described in an official pharmacopoeia and prepared by a homeopathic method, it should be treated, as regards registration or marketing authorisation, in the same way as a homeopathic medicinal product (recital 22 of Directive 2001/83/EC).

There is no special legal provision for anthroposophic medicinal products which are not manufactured according to homeopathic manufacturing methods. Depending on the kind of active substances, the indication, the long-standing use and the available clinical data the provisions for traditional herbal medicinal products (Articles 1(29) and16a of Directive 2001/83/EC) or for well-established medicinal use (Article 10a of  Directive 2001/83/EC) could apply for specific anthroposophic medicinal products. But a number of limitations exclude the large majority of these specific anthroposophic medicinal products from the application 'traditional herbal' or 'well-established use.' In cases where these specific categories do not apply, anthroposophic medicinal products are covered by the general definition of medicinal product as laid down in Article 1(2) of Directive 2001/83/EC, which means a full marketing authorisation procedure similar to that for allopathic medicinal products. This was confirmed in a European Court of Justice ruling that those anthroposophic medicinal products, which cannot be registered or authorised as traditional herbal or homeopathic medicinal products, are covered by the general authorisation procedure laid down in Article 6 of Directive 2001/83/EC.¹ 

'the suitability of a separate legal framework for products of certain traditions should be assessed'

Thus, the EU regulatory picture for anthroposophic medicinal products is fragmented, and a very substantial number of these products are not yet part as such of the legislation in place in the European Union, nor in most of the Member States.

The European Commission is fully aware of this legal gap and as early as 2008 suggested that 'the suitability of a separate legal framework for products of certain traditions should be assessed.'

Legal framework in the Member States

Nevertheless these products are available on the market in Europe - the figures in ECHAMP’s Regulatory Status Survey show the presence of anthroposophic medicinal products on the market in Germany (1041), Belgium (1360), Finland (109), Portugal (2) and the United Kingdom (362).

Germany

German medicines law contains a definition of anthroposophic medicinal products in Article 4.33, referring to the special anthroposophic manufacturing procedures and the principles of anthroposophic medicine. In Germany, the medicines agency publishes detailed and regularly updated statistics on its website specified per category, including anthroposophic medicinal products (1041 in February 2012).

Switzerland

The Regulatory Status Survey also indicates that anthroposophic medicinal products have a full legal status in Switzerland and that about 2200 anthroposophic medicinal products are on the market in this country. In its detailed answer, the Swiss agency referred to the different regulatory procedures for anthroposophic medicinal products in Switzerland. 680 anthroposophic medicinal products have been granted a marketing authorisation, the other ones are registered, notified (a procedure foreseen in Swiss medicines law) or still in the application procedure.

Other Member States

In most Member States there are no specific definitions or suitable references for anthroposophic medicinal products. Therefore, in practice, there is no possibility for marketing authorisation or registration for a substantial number of anthroposophic medicinal products. This legal situation significantly impedes the market development and availability of anthroposophic medicinal products in Europe, especially those that cannot apply for homeopathic or traditional herbal status.

[1] Case C-84/06