THE USE OF HERBAL MEDICINE IN EUROPE
Herbal products are available in all Member States of the European Union (EU), although the relative size of their markets varies between countries. Since the late 1980s, the regulation of herbal products has been a major issue within the EU because of the differences between Member States in the way herbal products are classified and the difficulties this might present in the completion of the single market for pharmaceuticals.
According to Council Directive 2001/83/EEC, as amended, a medicinal product is defined as 'any substance or combination of substances presented as having properties for treating or preventing disease in human beings or any substance or combination of substances which may be administered to human beings with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a diagnosis.'(31)
Herbal products are considered as medicinal products if they fall within the definition of the Directive. However, the legal classification is complicated by the fact that in most Member States herbal products are available both as medicinal products with therapeutic claims and also as food/dietary supplements without medicinal claims.
The situation is further complicated in that some Member States, including the UK (see Current regulatory position of herbal products in the UK), have national provisions which permit certain herbal medicinal products to be exempt from the licensing provisions under specific conditions. In general, in all Member States, herbal products are classified as medicinal products if they claim therapeutic or prophylactic indications.
The advent of the new pan-European marketing authorisation system in 1993 raised questions with regard to herbal products and, in particular, concerns that major differences in their classification/assessment would hinder free circulation within the EU. The new systems for marketing authorisations involve three procedures: centralised, decentralised (mutual recognition) and national.
The centralised procedure is mandatory for biotechnology products and since November 2005 was mandatory for orphan medicinal products and any medicinal product for human use containing new active substances (i.e. one not previously authorised in the Community) for the treatment of AIDS, cancer, neuro-degenerative disease and diabetes.
The decentralised procedure or mutual recognition system involves agreement of assessment between the Member States involved; this procedure became compulsory from January 1998, for products requesting authorisation in more than one Member State. Since then, simultaneous national applications have been
possible, but the mutual recognition system automatically becomes involved once an authorisation has been granted in the first Member State.
The original intention was to retain existing national procedures for medicinal products requesting authorisation in a single Member State only. However, the European Commission agreed that national procedures could continue for bibliographic applications, including those for herbal products until the harmonisation issues could be resolved.
In 1997, upon the initiative of the European Parliament, the European Commission and the (then) European Medicines Evaluation Agency (EMEA), now European Medicines Agency, an ad hoc Working Group on Herbal Medicinal Products (HMPWG) was established at the EMEA. The main thrust of the HMPWG was the protection of public health by preparing guidance to help facilitate mutual recognition of marketing authorisations in the field of herbal medicines, and to minimise CHMP (Committee on Human Medicinal Products) formerly the Committee on Proprietary Medicinal Products (CPMP) arbitrations.
A major study undertaken by the AESGP (Association of the European Self-medication Industry) in 1998 at the request of the European Commission confirmed the different approaches taken by Member States in the regulation of herbal medicinal products. Different traditions in the therapeutic use of herbal preparations, coupled with different national approaches to their assessment, have resulted in differences in the availability of some herbal medicines.
For example, ginkgo (Ginkgo biloba) is available as a prescription-only medicine in some EU countries, but as a food supplement in others. Similarly, St John's wort (Hypericum perforatum) is accepted as a treatment for depression in some Member States, but not in others.
The AESGP study revealed that, in general, herbal medicinal products were either fully licensed with efficacy proven by clinical trials or by bibliography (in accordance with Article 10.1 a (i) of Council Directive 2001/83/EC), or that herbal products had a more or less simplified proof of efficacy, according to their national use. Furthermore, the study found major discrepancies between Member States in the classification of individual herbal preparations and products into one of these categories, as well as in the requirements for obtaining a marketing authorisation (product licence).
The report highlighted the need for clarification of the regulatory framework and harmonisation of the regulatory requirements to ensure that herbal medicinal products could have access to the single market for pharmaceuticals.
An important initiative in the harmonisation process has been the formation of the European Scientific Cooperative on Phytotherapy (ESCOP), an organisation representing national associations for phytotherapy. ESCOP was founded in 1989 by six EU national scientific associations with the objective of establishing
a scientific umbrella organisation to provide harmonised criteria for the assessment of herbal medicinal products, to support scientific research and contribute to the acceptance of phytotherapy in Europe.
ESCOP now comprises 13 national associations across Europe, and the American Botanical Council. The ESCOP Scientific Committee has published 80 monographs for individual herbal drugs; the monographs follow the European Summary of Product Characteristics (SPC) format.
The EMEA Herbal Medicinal Products Working Party (HMPWP) formerly used the ESCOP monographs as a basis for its work in developing core SPCs from ESCOP monographs. The HMPWP has now been superseded by the Herbal Medicinal Products Committee (HMPC) as discussed below and the collaboration with ESCOP continues in accordance with the new EU regulations.
If symptoms persists consult you doctors!
No comments:
Post a Comment