Regulatory Controls on Herbal Medicines

Herbal medicinal products 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 65/65/EEC, a medicinal product is defined as ‘any substance or combination of substances presented for treating, or preventing disease in human beings or animals’ or ‘any substance or combination of substances which may be administered to human beings or animals with a view to making diagnosis or to restoring, correcting or modifying physiological functions in human beings or animals is likewise considered a medicinal product’.⁽¹³⁾

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 below), 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 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.⁽¹⁴⁾ The centralised procedure is mandatory for biotechnology products, and optional for high–technology products and medicinal products containing new active substances. The decentralised procedure or mutual recognition system involves agreement of assessment between the member states involved; this procedure became compulsory from 1 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, in view of the difficulties posed by lack of harmonisation, the European Commission has agreed that national procedures can continue for the time being for bibliographic applications, including those for herbal products.

In 1997, upon the initiative of the European Parliament, the European Commission and the European Medicines Evaluation Agency (EMEA), an ad hoc Working Group on Herbal Medicinal Products (HMPWG) was established at the EMEA. The main thrust of the HMPWG has been 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 CPMP (Committee on Proprietary Medicinal Products) 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.⁽¹⁵⁾ 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 4.8a (ii) of Council Directive 65/65/EEC), 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 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.⁽¹⁶⁾

ESCOP now comprises 13 national associations across Europe, and the American Botanical Council. The ESCOP Scientific Committee has published 60 monographs for individual herbal drugs; the monographs follow the European Summary of Product Characteristics (SPC) format.⁽¹⁷⁾ To date, four ESCOP monographs (frangula bark, senna fruit: angusti foliae and acutifoliae, senna leaf) have been adopted by the CPMP as the basis of core SPCs for herbal medicinal products.⁽¹⁸⁾ The EMEA Herbal Medicinal Products Working Party (HMPWP, formerly the ad hoc HMPW Group) is continuing the work with developing core SPCs from ESCOP monographs. Draft documents are available for valerian and ispaghula.⁽¹⁹⁾