Local view for "http://purl.org/linkedpolitics/eu/plenary/2002-10-22-Speech-2-012"
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"en.20021022.1.2-012"2
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"Mr President, I should like to thank the two rapporteurs for the exceptional reports they have tabled here for debate, especially Mrs Grossetête, with whom we had an excellent and highly productive working relationship.
As regards the proposal to revise pharmaceutical legislation in order to maintain high standards of public health and complete the single market and, in the field of medicinal products, to meet the challenges of enlargement, apply a more functional and simplified procedure for authorising and supervising medicinal products – by which we mean medicinal products at affordable prices – and, finally, guarantee transparency and access to information on medical products for patients, I should like to comment briefly on the following points.
Innovation: we depend on scientific research and innovation for new combinations of substances and new drugs to fight and cure disease. But this sort of research needs bold investment by the pharmaceutical industry and this is only feasible if we provide a framework of financial incentives.
Incentives: these are based mainly on exclusivity, by which we mean protecting industrial property rights and inventions. As a result, the cost of developing a medicinal product is borne by the market and social security systems which, because of the ageing population, are now under tremendous pressure. So we need to strike a balance here between patented exclusivity, the price of medicinal products and the period of protection. This is a hard balance to strike. However, I think that the arrangements achieved in the regulation and now being proposed do strike a balance between exclusivity on the one hand and a reasonable period of protection on the other.
Safety of medicinal products: this is also a serious requirement and the elements of quality and vigilance are also taken into account in this excellent report.
Authorisation: I am in favour of a centralised procedure with a degree of decentralisation to the Member States.
Finally, subsidiarity: this is a very important factor because it is the Member States that foot the bill and provide medical and medicinal care. Yesterday President Bush made a move precisely because the Member States are under huge financial pressure in this sector."@en1
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