Local view for "http://purl.org/linkedpolitics/eu/plenary/2005-09-07-Speech-3-123"
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"en.20050907.15.3-123"2
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".
I welcome the Commission proposal which aims to improve the health of European children by facilitating research, development and authorisation of medicines for use in children. I am delighted that such an important opportunity has arisen for children to enjoy the same access to innovative new medicines as adults already enjoy.
I recognise and agree with the need for rewards and incentives to industry which will encourage the development of paediatric medicinal products. I have closely reviewed the discussions and debates on how best to achieve this and I can support the Commission’s proposal regarding the SPC extension, in tandem with the review mechanism proposed in the Regulation.
I agree with the principles of transparency and public accessibility which are at the heart of the proposal to amend Article 40 to include a provision for public access to paediatric clinical trial information. However concerns raised by industry regarding the possibility that public expectations may be raised prematurely with regard to some products and commercial sensitivity of information are also valid."@en1
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