WRITTEN QUESTION P-1188/00

by Giuseppe Nisticò (PPE-DE) to the Commission

(10 April 2000)

Subject: Medicinal herbs and plants

Because of the widespread distribution and abuse of medicinal herbs, without proper controls over either the marketing or prescribing of these products, this highly sensitive sector needs to be regulated as a matter of urgency, bearing in mind the possible effects on human health.

International scientific literature on the subject has revealed, as widely reported in the media recently in both the United States and Europe, that some of these medicinal herbs, when used without medical supervision, are responsible for thousands of cases of fatal poisoning, as well as causing a series of unwanted or toxic side-effects in the form of allergies or affecting the cardiovascular system, the kidneys, the central nervous system and other systems or organs.

Unfortunately, as a result of subtle and deceitful propaganda by the industries and operators concerned, the belief has taken root that herbs, being natural products, are useful and harmless and produce no toxic effects.

The uncontrolled use of medicinal herbs is dangerous for the following reasons:

- the concentrations and/or doses of the active principles present in herbs freely sold by herbalists are not properly standardised, with the result that it is never possible to be sure what dose has been taken;

- it is not known whether pollutants such as herbicides, pesticides or heavy metals may be present;

- little is yet known about interactions between herbs and other drugs or foodstuffs or caused by the administering of several herbs at the same time, with the result that the taking of some medicinal herbs may produce unforeseeable toxic effects;

- there is a danger that the use of medicinal herbs thought to be effective and innocuous by uninformed patients may lead to their abandoning conventional treatments such as antineoplastic drugs with serious consequences for their health.

Consumer protection is needed in the following areas:

- consumers must be informed of the active principles and possible pollutants present in the medicinal herbs they are taking;

- consumers must be aware of the exact dose they are taking;

- consumers must be informed of interactions between herbs and other drugs or foodstuffs;

- consumers must be informed of risks deriving from the toxicity of the active principles and possible pollutants.

In the light of the above considerations, what steps does the Commission plan to take to protect public health? Will it review the rules governing the marketing of medicinal herbs in the light of the documented scientific findings? Will it ask the EMEA to assess the information available on individual plants and herbs and provide the guidelines needed for the proper dispensing of these products, which are currently administered with hardly any controls?

Answer given by Mr Liikanen on behalf of the Commission

(10 May 2000)

According to Article 1 of Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products(1), any substance or combination of substances presented for treating or preventing disease in human beings or animals shall be regarded as medicinal product. Likewise, any substance or combination of substances which may be administered to human beings or animals with a view to making a medicinal diagnosis or to restoring, correcting or modifying physiological functions in human beings or animals, has to be considered a medicinal product. The decision whether a given product falls under the definition of medicinal product and therefore needs to be authorised as medicinal product must be taken by the national authorities on a case by case approach, taking into account both the ingredients and the presentation of a concrete product.

Community pharmaceutical legislation makes no difference between herbal or non-herbal medicinal products. Therefore, in the absence of any specific legislation on herbal medicinal products, medicinal products containing medicinal herbs and plants have to be assessed and authorised like any other medicinal product.

Community legislation acknowledges, however, the fact that long term experience with well established substances may offer help in the assessment of safety and efficacy of a given product. According to Article 4 paragraph 8 lit.a (ii) of Directive 65/65/EEC an applicant for a marketing authorisation for a medicinal product shall not be required to provide the results of pharmacological and toxicological tests or the results of clinical trials if he can demonstrate by detailed references to published scientific literature presented in accordance with the second paragraph of Article 1 of Directive 75/318/EEC that the constituent or constituents of the medicinal product have a well established medicinal use, with recognized efficacy and an acceptable level of safety.

Commission Directive 1999/83/EC of 8 September 1999 amending the Annex to Council Directive 75/318/EEC on the approximation of the laws of the Member States relating to analytical, pharmacotoxicological and clinical standards and protocols in respect of the testing of medicinal products(2) has specified in detail the practical application of this provision and may be of particular help for the authorisation of well established herbal medicinal products.

It is up to regulatory authorities in Member States to apply the above principles of Community pharmaceutical legislation and to take concrete decisions on authorisations and restrictions (e.g. medical prescription) for specific herbal products. The Commission is not considering a change to that approach.

The practical application of the above rules falls primarily in the competence of Member States. The attention of the Honourable Member is, however, drawn to the activities of the working party on herbal medicinal products at the European agency for the evaluation of medicinal products (EMEA) in London, which has been created with the aim of fostering gradual harmonisation of the safety and efficacy evaluation of herbal medicinal products in the Community. Reports on the activities of this working group can be accessed through the EMEA's website:

http://www.eudra.org/emea.html.

(1) OJ 22, 9.2.1965.

(2) OJ L 243, 15.9.1999.