Local view for "http://purl.org/linkedpolitics/eu/plenary/2002-11-20-Speech-3-319"
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"en.20021120.10.3-319"2
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".
Mr President, Mr Liikanen, we are delighted that, at last, after so many years, the Committee on the Environment, Public Health and Consumer Policy has adopted the proposal for a Commission directive on traditional herbal medicinal products, which I am pleased to see takes a responsible, scientific approach.
First of all, I must thank the shadow rapporteurs of all the groups, particularly Mrs Roth-Behrendt for her competent amendments, as well as my other colleagues, Mr Bowis, Mrs Doyle, Mr Schnellhardt, Mrs Müller, Mrs Oomen-Ruijten and Mr Whitehead, for their constructive help in improving the directive.
Thanks to the directive we are examining, it will, at last, be possible to register traditional medicinal herbs in the individual European Union Member States through a simplified procedure, provided that – as the Commissioner stated – they meet certain effectiveness and safety requirements.
The directive both recognises the full worth of medicinal products of plant origin and, at last, puts some order into a highly confused and controversial field. For instance, the scope of the directive is specified and the use of traditional herbs in other areas, such as foods, food supplements and cosmetics is excluded. In addition, for the sake of safeguarding consumer health, certain features of quality and good manufacturing practice are specified that must be complied with by both medicinal herbs produced in European Union Member States and those imported from third countries.
Parliament has decided to recognise that medicinal herbs are still an inexhaustible source of active ingredients for therapeutic use. Nonetheless, while the therapeutic value of drugs of plant origin must be recognised, it must not be forgotten that improper use can give rise to a whole range of undesirable and seriously toxic side effects, which, I am afraid, may even be lethal. In this respect, Commissioner, the US Food and Drug Administration has so far recorded about 2 900 cases of toxic effects, including 104 deaths, principally due to the misuse of ephedrine, a drug that releases catecholamines, causes tachyarrhythmias and can lead to heart failure. The Food and Drug Administration has also stressed the lack of quality control for such herbs that come onto the market from distant countries like China and India: most of them are, I regret to say, adulterated with a number of contaminants.
This is why Parliament and the Commission have attempted to ensure that the directive will be directed mainly at consumer health protection, both by requiring high quality and safety standards and by making it compulsory for labels and information leaflets to provide citizens with simple, clear information on the product’s potential toxicity and possible interactions with other drugs and foodstuffs.
We draw the Commissioner’s attention to the fact that, by traditional medicinal herbs we mean those that have been used for at least 30 years, at least ten years of which within the Community and 20 outside, as suggested by Parliament. As a specialist in the area – I am a pharmacologist – I believe that ten years’ use in Community Member States added to 20 years’ use outside the Community is sufficient to assess any potential toxic effects. I am therefore in favour of reducing the 15 years laid down in the initial Commission proposal, but I do not agree with Chris Davies’s amendment, which does not provide for at least ten years’ use in the European Union, not least in that, given the genetic make-up of different populations, without extensive use in the Member States severe toxic effects might still emerge.
Another positive aspect is the creation of a Committee for Herbal Medicinal Products at last. As you will have noticed, Commissioner, Parliament is concerned that this committee should be independent and given the same powers as the Committee on Proprietary Medicinal Products. I hope Parliament’s request will be accepted so that the EMEA can, as always, carry out its work calmly and efficiently."@en1
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