ECHAMP's symposium on 18 November in Brussels sought to answer a pressing question on homeopathy and anthroposophic medicine: ‘Is EU legislation fit for purpose?’

More than 100 participants from the whole sector, including representatives of European patients' and doctors' associations and from the pharmaceutical industry, joined ECHAMP to listen to, and debate with, several prominent political, legislative and business stakeholders.

Nand de Herdt, President and co-founder of ECHAMP ten years ago, welcomed the participants by looking back to the first steps and achievements made in the field of homeopathy and anthroposophic medicine in the last two decades. He went on to describe today’s regulatory situation in the EU, pointing to severe inequalities between the EU Member States and the increasing obstacles experienced by doctors, patients and industry. He invited all speakers to seriously consider whether there was a place for complementary and alternative medicine in the EU in the coming years, and what concrete measures would help build an appropriate regulatory environment.

MEP Dagmar Roth-Behrendt, Vice-President of the European Parliament, who was represented by a Cabinet member, stated that homeopathic and anthroposophic medicines were successfully used by over 100 million citizens in the EU but that nevertheless inappropriate regulation was restricting their availability. She was therefore calling on the EU institutions to take action and to create a harmonised and workable legal and regulatory environment.

This view was supported by former MEP, and author of the 1997 European Parliament Resolution on the Status of Non-Conventional Medicine, Paul Lannoye. Mr Lannoye underlined that the current disparity was detrimental for both patients and practitioners and since his previous request for adapted legislation had not been heard, he had decided to launch the debate again on the wider basis of medical pluralism and preventive medicine. He is therefore taking part in an initiative to submit a petition, requesting the Commission to take the required legislative steps for the recognition of non-conventional medical disciplines.

The disparities in non-conventional medicine were also acknowledged by Ms Irene Sacristan-Sanchez, Deputy Head in the Pharmaceuticals Unit of European Commission DG Enterprise. She reminded the audience that legislation had nevertheless recognised the ‘well-established use’ of products with a long tradition, and a ‘simplified procedure’ for homeopathic products. She added that the approach followed by Directive 2001/83 was to wave the need to prove efficacy but that it came with the price that these products are not allowed to claim therapeutic indications. She recognised the severe lack of harmonisation today, as already stated in the 1997 Commission report, and indicated that the first step was a strong implementation effort by certain Member States. She encouraged the stakeholders present to put more pressure on the countries, on the European Parliament and in certain cases on the Commission itself. Importantly, Ms Sacristan-Sanchez then mentioned that the Commission was considering extending the scope of the simplified registration that exists for herbal medicines, to include any substance which could prove a longstanding or traditional use as stated in the specific ‘herbals’ Directive. Her conclusion was a real door opener as she said that it might be necessary for the Commission to embark on an assessment for a separate legal framework for products of certain medical traditions such as anthroposophic medicine.

The speech of Dr Emiel Van Galen, Chair of the Homeopathic Medicinal Products Working Group (HMPWG) of the Heads of Medicines Agencies (HMA), was definitely and very positively turned towards the future as he drew a picture of what could be achieved in the next five years. In terms of legislation he hoped for a more harmonised simplified procedure, covering all homeopathic products, with better work-sharing among Member States; for a single European marketing authorisation; and also for specific legislation covering anthroposophic use.

Dr Margot Spohn from SwissMedic, the Swiss Medicines Agency and Dr Mónica Mennet-von Eiff, from SVKH, the  Swiss Association for Complementary Medicine Products then presented the Swiss model as an example of recent pharmaceutical legislation which intended to be integrative and keep the diversity of complementary medicines. Dr Spohn concluded that the current system enabled industry and the authorities to deal with many products in an adequate time period. Dr Mennet-von Eiff confirmed that the law respected the specific therapeutic systems, took into account traditional use and allowed the use of complementary medicine, thus answering a strong demand from patients.

Enlarging the debate at the end and demonstrating once more the growing interest for complementary medicine in the EU, Professor Weidenhammer from the University of Munich came to present the first EU-wide project to start research in the field of complementary and alternative medicine. This project, called CAMbrella, had just been granted significant funding by the European Commission under the Seventh Framework Program for Research, with the mandate to inter alia develop basis for future research for this field of medicine in Europe.

As another high point and final note to this symposium, ECHAMP was honoured by the presence of Ms Laurette Onkelinx, Belgian Vice-Prime Minister and Minister for Social Affairs and Public Health, who confirmed her commitment to the sector. She said, “We have to guarantee to the patients an optimal framework to allow them to use the medicines of their choice.” The President of ECHAMP closed the symposium by concluding 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. He asked Ms Onkelinx to seriously consider bringing the topic on the agenda of the Council of Ministers during the Belgian EU Presidency in the second half of 2010. He reminded the speakers and the audience that there was no reason to doubt the legitimate requests of the more than 100 million citizens wanting easy and safe access to the medicines and therapies of their choice.

Valérie Golden
ECHAMP General Secretary