Date: 22/11/2002
In short:
On 21 November, MEPs voted in favour of creating a new registration system and labelling regime for traditional herbal medicinal products.
Background:
In January 2002, the European Commission proposed a new directive to establish a harmonised legislative framework for traditional herbal medicinal products. The Commission's main objectives with the proposal were:
Issues:
On 21 November, MEPs adopted a resolution in first reading under the codecision procedure, drafted by Giuseppe NISTICO (EPP-ED, I), with the aim of setting basic quality and safety standards for herbal medicinal products in the EU. The new rules supported by Parliament center around the following main issues:
Positions:
The Association of the European Self-Medication Industry, representing the European manufacturers of non-prescription medicines, welcomed the outcome of the vote in Parliament. Director of AESGP Dr. Hubertus Cranz greeted the new rules as a "missing piece of legislation which will clarify the legal basis for traditional herbal medicinal products in the European Union."
The Alliance for Natural Health, on the other hand, expressed disappointment with the vote. Dr. Rob Verkerk, speaking on behalf of the organisation that represents herbal medicine practitioners, said he feared some herbal medicines with a proven safety record would disappear off the shelves of health food stores.
Next steps:
The proposal will be discussed by the Council in a next meeting.
Links:
Official documents:
International organisations:
EU Actors' position:
Press articles: BBC, The Independent.
© EurActiv 2000
Mr Erkki Liikanen Member of the European Commission, responsible for Enterprise and the Information Society "Traditional herbal medicines" European Parliament, Mr Nistic̣'s report Strasbourg, 20th November 2002
DN: SPEECH/02/579 Date: 21/11/2002
Mr Erkki Liikanen
Member of the European Commission, responsible for Enterprise and the Information Society
"Traditional herbal medicines"
European Parliament, Mr Nistic̣'s report
Strasbourg, 20th November 2002
Before briefly introducing the Commission proposal, I would like to thank and congratulate the Rapporteur, Mr Nistic̣, as well as the Committee on Environment, Public Health and Consumer Policy for the work and efforts put on the finalisation of the report.
Let me start with the objectives. What are the main objectives of this proposal? These are three:
As far as the concrete proposals are concerned, I will concentrate on three key issues.
First, the scope of the new simplified procedure.
There is a long tradition to use herbal medicines in Europe. Already back in the middle ages, there was considerable knowledge and use of such medicines.
In today's environment, for new medicines, providing fresh scientific data is indispensable to ensure that the patient is treated with safe and efficacious medicines.
But if we have already sufficient knowledge about a medicine, new pre-clinical and clinical tests mean unnecessary burden and unnecessary testing on humans and animals.
To protect the patient's health it is essential that the information on the product's traditional use must be so reliable that it allows us to conclude on the product's safety.
Such information exists for many traditional medicines of a herbal character. For this reason, the new procedure should be limited to herbal medicines in a first step.
Secondly, the minimum time of use.
To ensure a reliable basis for the information, we consider 30 years to be appropriate. Such a period should enable us to decide whether the product can be considered safe and efficacious.
The assessment has to be done for the use in the EU. I stress this since the effects of a medicine do not only depend on the product itself but also on the setting in which it is used.
At the same time, we recognise that there are important medicinal traditions outside the EU. For this reason, we propose that up to 15 years can have taken place outside the Community.
And finally, the new scientific committee.
Herbal medicines are different from other categories of pharmaceuticals in various aspects.
For a number of years now, an informal working group has been working on herbal medicines at the European Medicines Evaluation Agency.
Our proposal offers the occasion to lay down an explicit legal basis for this working group. And to give it a clear mandate for herbal medicinal products.
This will also allow us to rely on the specific national expertise to ensure quality, safety and efficacy of herbal medicines on a European level. And it helps at the same time to improve the free circulation of these medicines.
I am looking forward to the debate in the House today and call on the European Parliament to provide its support for this initiative.
Thank you!
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