European Commission's proposals for a Directive on herbal medicine products

United Kingdom
Medicines Control Agency consultation

The European Commission’s proposals for a Directive on herbal medicinal products have highlighted the difficulty in striking an appropriate balance between protecting the consumer and providing consumer choice in the traditional field of herbal remedies. The Medicines Control Agency (MCA) is seeking comments within the UK on the implementation of the Commission’s proposals.

Currently, most herbal medicines reach the market in the UK through an exemption to the Medicines Act 1968. ‘Exempt’ herbal remedies can be sold as medicine without the need for a medicines licence as long as no product claims are made and the herbs are not processed. The vast majority of suppliers of ‘exempt’ herbs to the British market are responsible and supply only the best quality products. However, safety concerns have arisen, particularly during the 1990s following reports of serious, even fatal, side effects in patients using traditional Chinese medicine and other herbal remedies. In October 2000, a European Medicines Evaluation Agency working party on herbal medicinal products issued a position paper on the risks associated with the use of herbal products containing a particular species, which had been shown to be nephrotoxic, carcinogenic and mutagenic.

These events have focussed attention on the need to ensure the safety of herbal remedies. The key concern behind reform is to restore consumer confidence and protect consumer safety whilst at the same time seeking not to undermine long practised herbal traditions or unduly limit the supply of these herbs to the practitioners and enthusiasts who rely upon them.

The proposed herbal medicines Directive would require a competent authority to introduce a simplified registration procedure for herbal medicinal products. Manufacturers would have to provide evidence of traditional use (for at least 30 years) of a product, but there would be no requirement to present pre-clinical or clinical data relating to efficacy.

Instead, the wording “the efficacy of the product has not been clinically proven but relies exclusively on long term use and experience would be used. A bibliographic review of safety data would be required and registration may be refused if this was inadequate or if the product was found to be harmful under normal conditions of use.

Applicants for a licence would be able to refer to a ‘positive’ list of herbal substances with therapeutic indications drawn up by a Committee for Herbal Medicinal Products, rather than provide data on traditional use and safety. However, the quality of manufacture will still need to be demonstrated.

It is anticipated that the European Directive could be in force by the end of 2004. The Directive is in the form of amendments to Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the community code relating to medicinal products for human use. The proposed Directive adds a new chapter 2A which includes specific provisions applicable to traditional herbal medicinal products. The Explanatory Memorandum gives the background, objectives and scope of the Directive. It notes that the legal framework for the authorisation of medicinal products set out in Directive 2001/83/EC is suitable for certain herbal medicinal products. It states “However, for many herbal medicinal products which are being used for a long period, sufficient published scientific literature is not available so that a well-established medicinal use cannot be demonstrated. New tests and trials are in theory possible, but lead to significant financial burdens for the companies concerned, often small or medium-sized enterprises, and entail also inevitable disadvantages of such trials for animals and human beings. These consequences are difficult to justify where the traditional use of the medicinal product is of such a nature as to allow sound conclusions on its safety and efficacy. As a consequence, the legal and practical situation of traditional, herbal medicinal products in the Member States varies significantly with negative impacts on the protection of public health as well as on the free movement of these goods within Europe.

As stated above, the new Directive would provide for a simplified registration procedure. The Explanatory Memorandum emphasises that those herbal medicinal products which can be authorised under Directive 2001/83/EC either on the basis of the results of new tests and trials on safety and efficacy or on the basis of reference to published scientific literature, shall not be eligible for the simplified registration. However, it is proposed that the existing legislation will apply equally to the new registration procedure, for example, in relation to time limits for the authorisation process, general provisions on manufacture and importation and provisions on pharmacovigilance.

For further information please contact Zelda Pickup by e-mail at zelda.pickup@cms-cmck.com or by telephone on +44(0)20 7367 2043