Pefots

Speech on the Launch of Pan European Federation of Traditional Chinese Medicine Societies

Mr. Emiel van Galen, MD, Head section Homeopathic,
Deputy-Secretary of Dutch Medical Evaluation Board

Mister Ambassador, mr. Chairman and members of the Pan European Federation of TCM Societies, ladies and gentlemen, It is a privilege and a pleasure to be invited here this evening. On behalf of the Ministry of Health, Welfare and Sports of the Netherlands I welcome you to Amsterdam. I would like to thank also mr. Dong for his kind invitation. As representative of the Dutch Minister of Health I have the honour to meet with members of your delegation, and to share your thoughts on past and future of Traditional Chinese Medicine in the Netherlands and in Europe.

I am working at the Agency of the Medicines Evaluation Board in the Netherlands, which is the regulatory authority for the assessment of the quality, safety and efficacy of all medicines. I have the privilege to act as deputy-secretary to this Board, and I am head of the department for the evaluation of Homeopathic and Herbal medicines, as well as of Traditional used products. I am a member of the Herbal medicinal products working group at the EMEA, the European Medicines Evaluation Agency in London, and I have participated in a working group which prepared a first draft for a separate Regulation for Traditional Use.

The fact that PEFOTS has been established is indeed on a very appropriate moment. In spite of the popularity of the so-called complementary therapies in European countries, I must admit that until now there has been little interest and involvement of official Health Authorities in these issues. But recently a gradual change has been noticed.

The European Union now includes 15 different European countries, but in the next years several new countries will extend this number, and will join the European Union, which plays a very important role in establishing new legislation, which will be implemented in each member states national regulations. This harmonized approach is focused very strongly on maximum Health protection for all European citizens. This applies in particular to all regular medicinal products, but on the same moment to full extend to all herbal medicines including Traditional Chinese herbal medicinal products. Every citizen is free to choose the treatment he prefers, but he can rely on the equal standards for safety and health protection. This will be the core of European health policy next years. Which initiatives have been taken to achieve this for herbal medicines?

Traditional Chinese Medicine is built on a extensive tradition which last for centuries, and with such a respectable background it is hard to imagine that European Administration still has a problem how to face the therapeutic achievements within that tradition. In pharmaceutical regulation a gap exists between our admiration for your confidence in the tradition of healing, and at the other side our scientific way of thinking has the tendency to ask for scientific proof also in case of tradition. The solution which now is being explored to establish separate regulations for traditional medicines, which not automatically implies scientific tests and trials, but with respect to other ways of proof. However, the same emphasize on a safe use and protection of health remains.
Four years ago a new Working group on Herbal Medicinal Products was established at the EMEA in London. During discussion on the legal status of herbal medicines in Europe, and considering the current legislation it became obvious that for herbal medicines which have a traditional use, no specific way for evaluation exists, and the advice was given to establish new legislation. On this moment a new European Directive on "Traditionally used medicinal products", in particular applying to herbal medicinal products is ready to enter the European democratic process.

Which elements are especially relevant for Traditional Chinese herbal medicine? First of all the scope of this Directive: all herbal medicinal products for human use, of which can be demonstrated by bibliographical and expert evidence that the medicinal product has been in use in the European community throughout a period of at least thirty years. But as an alternative for submitting evidence of use, the applicant may submit evidence throughout a period of 15 years within Europe, if the product is used for thirty years in a specified territory elsewhere in the World. This could be very important to Chinese Herbal medicines which have not been used within Europe for at least thirty years, but can demonstrate a much longer presence as a medicinal product elsewhere in the World. This clarification which is now part of the first draft of this new legislation, applied directly to all herbs which are part of the Chinese Tradition.

It may be expected that it will last a few years before this approach to traditional medicines will be established, and I expect that we have a lot to learn from each other during the everlasting process of East meets West, and exchange of mutual experiences and interests. It may be expected that in the near future legal requirements will influence by example the declaration of the constituents of traditional products, traditional use should be substantiated, the pharmaceutical quality must be in accordance with European regulations and Pharmacopoeia standards, and from a regulatory point of view most important: all herbal products must be safe in the normal conditions of use. This will be the overall framework of regulations for medicinal products in Europe: minimizing serious risks to Public Health. And of course we already have this in common: medical doctors all over the world should not harm the health of their patients at first instance, but in particular about curing disease by enforcement of patients own healing power, we had a lot to learn from Traditional Chinese Medicine.

On behalf of the regulatory authorities in the Netherlands, I congratulate the chairman and board members with the initiative to establish PEFOTS, and wish you success in achieving recognition of safe medicines. Thank you for your kind invitation and it is a privilege to enjoy your company this evening.