Mr President, after this report on the legislative package regarding medicinal products – a report that, as we have seen, made veins and pulses tremor – my report is like drinking a relaxing cup of camomile tea. I am in fact extremely satisfied, and I would, therefore, like to thank both the Council and the Commission, and also all the shadow rapporteurs, in particular Mrs Roth-Behrendt who I am sorry to say is not here today because she has the flu – and she apologises for her absence – and of course all the Members who contributed to improving this directive. The directive, as adopted, finally brings order to an area that is very confused and much debated. On the one hand, it precisely states the scope of the directive and excludes the use of herbal products as provided for in the other directives; on the other hand, in the interests of consumers and their health protection, it specifies characteristics regarding quality and good production practice. Whilst the value of therapy with traditional herbal products must be recognised, it must also not be forgotten that inappropriate use can lead to the emergence of undesired side effects, sometimes serious ones. So far, for example, the ‘Food and Drug Administration’ has registered about 2 900 cases of toxic effects, including, if you look closely, 104 deaths predominantly caused by abuse of ephedra, as well as serious side effects of other products that are used daily such as St John’s Wort, ginkgo biloba and also ginseng. This is why it was important to adopt a directive that seeks to protect consumer health which, on the one hand, calls for better quality and safety standards, but also, on the other hand, for it to be obligatory for labels and illustrative leaflets to include rigorous scientific indications that are simple and clear for citizens about the potential toxicity of herbal medicines, as well as their interaction with food, drinks and other medicinal products when taken together. As you know traditional herbal medicines mean those that have been in use for at least 30 years, of which 15 years in countries of the Community. Nevertheless, at the request of an individual country – and this was a reason for improving the directive – and with a reasoned opinion from the Technical and Scientific Committee for Herbal Medicinal Products of the European Agency for the Evaluation of Medicinal Products (EMEA), the period of use of 15 years can be significantly reduced. Another positive aspect is the creation of a Committee for Herbal Medicinal Products as part of the EMEA. Parliament clearly indicated how this committee should be distinct from the Committee on Proprietary Medicinal Products. It should deal with classification, with preparing a list of traditional medicinal herbs, with updating lists, with preparing relevant monographs, and with assessing dossiers in the event of disputes at national level. At second reading, Parliament proposed and also adopted two amendments. In particular, an initial amendment inserted in the recital intends to clarify, somewhat unnecessarily, the scope of the present directive by specifying that this only regards traditional herbal medicinal products, whilst the use of plants or herbs for food use fall under the current specific European legislation for food products. The second amendment is merely a specification: it concerns inserting the word ‘traditional’ when talking about herbal products. Both of the amendments were then adopted by the Council, as appears from the communication to the Committee on the Environment, Public Health and Consumer Policy of 8 December 2003. After all, the current directive defines the harmonised legislative framework for all countries of the European Union in favour of free movement of traditional herbal medicinal products within the Community. This guarantees, furthermore, the maximum level of public health protection on the basis of documentation requested regarding quality, efficacy and safety.

Political group: PPE-DE