Last November ECHAMP’s expert seminar concluded that EU legislation for homeopathic and anthroposophic medicine is not ‘fit for purpose’. The current legislation has been tried and tested now for over fifteen years, and the experience shows an increasingly complex and inappropriate legal and regulatory environment. Far from bringing harmonisation to the market, it is resulting in limited availability of the medicinal products for the patients who demand them, and the doctors who prescribe them. 

There is no doubt that homeopathic and anthroposophic medicinal products do and should continue to reach high standards of quality, safety and effectiveness; however there are a number of factors that differentiate them from conventional medicines, in particular the way in which they are prescribed within a therapeutic setting. In this issue of E-News, we explore whether a better understanding of the therapeutic setting for homeopathy and anthroposophic medicine can help inform a new legislation for homeopathic and anthroposophic medicinal products that is more appropriate to their specific characteristics.

Johan Hulshof describes some of the problems encountered in the registration process, and explains why the current legislation is not sufficiently adapted to the specific nature of the products. Ton Nicolai looks at the therapeutic context for homeopathic medicinal products and what might be an appropriate regulation for these medicines, taking account of their specific characteristics, while Madeleen Winkler describes the therapeutic process for diagnosis and treatment of anthroposophic medicine. 

Clearly a review of this legislation is now well over due. Perhaps ECHAMP can take heart from the Commission’s justification for a review of the legislation for veterinary pharmaceuticals? The Commission itself identifies the restrictions and the unnecessary burden that this complex legislation places on the industry. It could be talking about the legislation for homeopathic medicinal products. 

ECHAMP hopes that the new start in September will bring better news for our medicinal products. In the meantime, we wish all our readers a happy and refreshing summer break, and a healthy return to work.

Nand de Herdt
President of ECHAMP

Consultation on veterinary pharmaceuticals – hope for homeopathic medicines?
Perhaps ECHAMP can take heart from the Commission’s justification for a review of the legislation for veterinary pharmaceuticals? The Commission identifies the restrictions and the unnecessary burden that this complex legislation places on the veterinary pharmaceutical industry. Christine Marking explains how these arguments could equally well be applied to the legislation for homeopathic medicinal products. Read more...

European Commission work programme – an update on activity. Read more...

The specific characteristics of homeopathic and anthroposophic medicinal products
A number of factors differentiate homeopathic and anthroposophic medicinal products from conventional medicines, not least the way in which they are prescribed within a therapeutic or medical setting. Dr Ton Nicolai, President of European Committee for Homeopathy, explains the therapeutic context for homeopathic medicinal products in his article Towards a more suitable regulation of homeopathic medicines, describing how a new regulation could be better tailored to their specific characteristics. Dr Madeleen Winkler, Vice President of the International Federation of Anthroposophic Medical Associations describes the process of anthroposophic medicinal diagnosis and treatment in her article, The specific nature of anthroposophic medicine – an integrative medicine. Read more...

How to catch nature in a bottle?
Homeopathic medicinal products are used in a medical setting which is fundamentally different from allopathic medicine. Furthermore, the active substances used in homeopathic medicinal products may generally not be compared to the substances used in allopathic medicinal products. Johan Hulshof describes some of the problems encountered in the EU pharmaceutical legislation on homeopathic and anthroposophic medicinal products, and explains why the current legislation is not sufficiently adapted to the specific nature of the products. Read more...