EU legislation for homeopathic and anthroposophic medicines is not fit for purpose (2009)

MedicinesIn November 2009 politicians and key stakeholders have concluded that severe deficits in the current European rules for homeopathic and anthroposophic medicines mean that they are unworkable, and that EU legislation in this field is not fit for purpose. Participants at the ECHAMP Symposium, ‘Homeopathy and anthroposophic medicine – Is EU legislation fit for purpose?’, which included European associations of patients, doctors, and practitioners, and representatives of European industry, have called on the European institutions to take action to improve the situation for homeopathic and anthroposophic medicinal products in Europe.

Mrs Dagmar Roth Behrendt MEP, former Vice President of the European Parliament, said “Homeopathic and anthroposophic medicines are successfully used by over 100 million citizens in the EU, yet inappropriate regulation is severely restricting their availability across Europe. It is time for the EU institutions to take action to create a harmonised and workable legal and regulatory environment for these products in order to meet the legitimate demands of patients and prescribers across the EU.”

The European Union is the major world producer of homeopathic and anthroposophic medicinal products. The industry for these products represents 1% of the European pharmaceutical market and 7% of the European non-prescription market (In 2005 this was equal to €1 771 million at consumer prices).

Severe over-regulation in this field means that the goals of harmonization and free circulation of homeopathic medicinal products, the intention of the original legislation for these products in 1992, are still far from being achieved. Many categories of homeopathic and anthroposophic medicines are excluded and due to the divergent legal and regulatory approaches in the 27 EU Member States, European citizens are confronted with differing products and in many cases, lack of availability.

Ex-ECHAMP President, Mr Nand De Herdt has described the situation four years ago faced by this industry: “The global know-how on this category of medicinal products is in the European Union, including production sites working to the highest standards of manufacture, and we urgently wish to maintain this position of world leadership. This industry needs a proportionate and workable legal and regulatory environment in order to keep these safe medicinal products available for the whole world as well as for the 100 million users in the EU. This request is totally in line with the Lisbon strategy.”

He went on to describe the restrictions faced by the industry: “Homeopathic and anthroposophic medicines are safe, but over-regulation means that many safe products are excluded from the market; they are manufactured to the highest quality standards - but inappropriate quality assessment criteria mean that products which have been safely on the market for many years are rejected for registration or authorisation; they have been successfully used by patients in Europe for up to two hundred years – but manufacturers may not include their traditional and well-known indications for self- medication on the label.”

The meeting has been also joined by Laurette Onkelinx, Belgian Vice-Prime Minister and Minister for Social Affairs and Public Health, Mrs Irene Sacristan Sanchez, Deputy Head of the Pharmaceuticals Unit from DG Enterprise and Industry of the European Commission, Mr Paul Lannoye, former MEP and rapporteur for the 1997 European Parliament Resolution on the status of non-conventional medicine, Dr Emiel van Galen, Head of Unit of the Dutch Agency of Medicines Evaluation Board and Chair of the Homeopathic Medicinal Products Working Group and Dr Wolfgang Weidenhammer, co-ordinator of the Commission–funded CAMbrella project 2009-2012.

Four years later:
EU legislation for homeopathic and anthroposophic medicines is still not fit for purpose…..

(This text was transferred into August 2013 and taken from a ECHAMP Press Release).