Local view for "http://purl.org/linkedpolitics/eu/plenary/2002-11-20-Speech-3-318"
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"en.20021120.10.3-318"2
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". – Mr President, I wish to begin by thanking the rapporteur, Mr Nisticò, as well as the Committee on the Environment, Public Health and Consumer Policy, for the work and effort they have put into this report. Mr Nisticò is a well-known expert in the field, but it has been quite a challenge for me and my services.
Let me start with the objectives. What are the main objectives of this proposal? There are three. First and foremost, to guarantee a high level of health protection for European patients. They will have access to the medicines of their choice, as long as all necessary safeguards are met. Secondly, to promote the Single Market for herbal medicines. Laying down harmonised rules and procedures will facilitate the cross-border trade in herbal medicines, which currently is very limited. Thirdly, to create a clear and favourable environment for the mainly small and medium-sized companies working in this sector.
As far as specific proposals are concerned, I will concentrate on three key issues. First, the scope of the new simplified procedure. The use of herbal medicines is a long-standing tradition in Europe. Back in the Middle Ages they were already well known and widely used. For new medicines, providing fresh scientific data is indispensable if patients are to be treated with safe medicines.
But if we already know enough about a medicine, new pre-clinical and clinical tests impose an unnecessary burden and unnecessary testing on humans and animals.
To protect the patient’s health, the information on the product’s traditional use must be reliable enough to enable us to conclude that the product is safe. Such information exists for many traditional herbal medicines. For that reason, the new procedure should initially be limited to herbal medicines.
Secondly, the minimum period of use. To ensure that the information is soundly based, we consider that 30 years should enable us to decide whether the product can be considered safe and effective. The assessment has to be for use in the EU. I stress this because the effects of a medicine depend on the setting in which the product is used as well as on the product itself. As a rule, therefore, the product should have been used for 30 years within the EU. At the same time, we recognise that there are important medicinal traditions outside the EU. For that reason, we propose that up to 15 years of the use can be outside the Community.
Finally, the new Scientific Committee. Herbal medicines are different from other categories of pharmaceuticals in various respects. For some years now, an informal working group has been working on herbal medicines at the European Medicines Evaluation Agency. Our proposal offers an opportunity to establish 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 specific national expertise to ensure quality, safety and efficacy of herbal medicines on a European level. At the same time it helps 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 support this initiative."@en1
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