Local view for "http://purl.org/linkedpolitics/eu/plenary/2002-10-22-Speech-2-031"
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"en.20021022.1.2-031"2
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"Mr President, the reports by Mrs Grossetête and Mrs Müller which we are discussing today share an implicit but fundamental premise: medicinal products are products like no other, which affect health, and health is non-negotiable. I do not know if it is a divine right, as has been said, but it is, in any case, an unassailable right.
That said, the rapporteurs have – virtually – achieved the impossible. In other words, first of all, they have reconciled the interests of the patient in terms of independent information, safety and rapid access to generic products, even though, in my view, we could certainly have gone much further. That said, the compromises in this area are still acceptable. Next, they have helped to control the budget of insurance companies and health insurers, because, although health is non-negotiable, it comes at a price which is rocketing, due to the progress being made in medicine, the army of pharmaceutical products available and the ageing population. Last, but by no means least, they have managed to preserve the interests of the pharmaceutical firms whose concerns over data exclusivity and financial resources invested in research have been taken on board. I do not believe their competitiveness will suffer as a result, because I know that, through competition, we are also protecting the jobs that these firms provide.
The compromises reached in the Committee on the Environment actually manage to reflect the specific nature of the European social model, which attempts to ally social issues with competition. I am particularly pleased by the rejection of all advertising of prescription-only medicines, which acknowledges their unique character and prevents a dramatic rise in their use.
There are still two contentious points, but these merit our attention as they are more scientific in nature. The first concerns the renewal of the five-yearly revision of the marketing authorisation of the medicinal product, which is yet to be resolved. Too many previous examples, however, such as thalidomide, show us that the side effects of a medicinal product can last for much longer than five years and, in addition, developments in medicine happen so quickly that treatment for the same condition can swiftly change. This problem cannot always be prevented by pharmacovigilance, even though it is very important.
The second point is the idea of added therapeutic value for a new medicinal product. This simple idea, very different from the cost-benefit ratio, should however be understood by researchers within the pharmaceutical industry. Since, what use is an innovation if it cannot demonstrate its therapeutic advantage? If we agree to allow pharmaceutical companies to recoup their investment in research through the cost of the product, we have a right to expect that they will do this by adapting to the most widely-used scientific criteria."@en1
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