Local view for "http://purl.org/linkedpolitics/eu/plenary/2003-12-16-Speech-2-259"
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"en.20031216.6.2-259"2
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"Mr President, I am extremely satisfied with the exceptional results achieved by this Parliament and in particular with the work that has been carried out in recent days, which has shown significant, positive interaction between the various institutions. My warmest thanks therefore go to Mrs Grossetête and Mrs Müller, Commissioner Liikanen, and Mr Brunet, as well as to Mr Silano from the Italian Presidency who intelligently and openly contributed to drawing up these compromises that have finally been accepted.
As we know, the main aim of all of the institutions is finally to have new legislation that allows European citizens to have equal opportunities and to have access, as soon as possible, to new, more powerful drugs, which are more selective
and more easily tolerated than existing ones, hopefully at a reasonable price.
I will focus on just a few points. As regards the composition of the management board of the European Drugs Agency, the current compromise proposal is preferable both to the initial Commission proposal and to the one from the rapporteur Mrs Müller, which, in my view, contains major deep-rooted conflicts. The management board, as approved, will be predominantly institutional – as I had personally wished for on a number of occasions – with the addition of two representatives from the Patients’ Association and two from the Doctors’ Association.
Furthermore, I am satisfied with the length of the data protection period because this agreement is, in my view, very well balanced and will, on the one hand, give new impetus and incentives to European industries to invest more in scientific research and, on the other hand, will allow them to respond to ethical requirements, by implementing a solidarity policy towards developing countries and also towards some of new Europe’s accession countries. The agreement reached to see a further data protection period in the case of a ‘switch’, as well as in the case of new therapeutic indications for well-known medicinal products, is also a step in the right direction.
Another point of the agreement regards the development of an EMEA centralised procedure for the marketing authorisation of new medicinal products. As I have stressed on numerous occasions, I agreed with the initial Commission proposal and I am convinced that new medicinal products should in future be subject to authorisation by the EMEA.
Finally, I hope that in Europe the pharmacovigilance system, which I outlined as a pharmacologist and that guarantees maximum protection of citizens, will be made more efficient and transparent."@en1
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