Article: Should anthroposophic medicinal products be regulated in Europe?

A new research article published in the prestigious European Journal of Health Law argues that the 95-year European tradition and good safety profile of anthroposophic products justify giving them an easier access to market.

The article describes the status of anthroposophic products; it explains the current regulatory framework in the EU for these products, how it works and its deficiencies, whereby some anthroposophic products cannot be placed as such on the European market because they cannot meet the marketing authorisation or even registration requirements set out by European or national pharmaceutical law. The article shows how the Commission has recognised and highlighted that these products should be better regulated in the EU. It discusses the need to regulate anthroposophic products and considers options to do so. It concludes by recommending that market access can be efficiently achieved by encouraging the Member States to better apply the existing rules on marketing authorisation procedures or on registration of homeopathic and traditional herbal medicinal products, or by including anthroposophic substances, manufacturing methods or uses in monographs.

ECHAMP welcomes this article which provides a clear summary of the difficult situation for anthroposophic products, highlighting the challenges faced by industry in meeting the demand from patients and prescribers and proposing some positive concrete solutions.