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Promoting simple paediatric R&D

The future fate of paediatric research conducted by pharmaceutical companies in Europe will be shaped by a crucial European Parliament vote later this week

The future fate of paediatric research conducted by pharmaceutical companies in Europe will be shaped by a crucial European Parliament vote later this week.

Industry leaders have urged Members of Europe's Environment Committee, who will cast their vote on draft regulation seeking to incentivise and monitor the development of pharmaceutical products for use in children, to keep it simple and effective.

They say that the `devil's in the detail' and it is the potential complication of the specifics of new regulation that is a concern to pharma firms and which may result in ìunpredictable, over-beaurocratic and inoperableî incentive systems.

Pharma's traditional lack of interest and motivation to develop new children's medicines stems from the disincentives of slippery ethical arguments surrounding clinical trials, the limited market size and the stiff regulations governing the promotion of products. Paediatrics has been seen as an area where it is very difficult for pharma to recoup R&D costs.

Henceforth, the key principles of the draft regulation aim to provide `predictable and effective incentives' for firms to investigate children's medicines, `encourage the development and authorisation' of paediatric medicines in Europe, and `create a paediatric R&D infrastructure in Europe'.

A key part of pharma companies' interest is the proposal for a six-month extension - ìas a minimumî - of the Supplementary Protection Certificate, which currently lasts for up to five years and covers a combination of the claims in the marketed drug patent, as well as the parameters set out in the marketing authorisation.

This extension is essential to strike a balance between the ìobligation for companies to conduct often complex, costly and lengthy paediatric research and the need to stimulate innovationî, according to EFPIA (European Federation of Pharmaceutical Industries and Associations). A similar move has already increased the intensity of children's medicines R&D in the US.

Overall, the shake down and the instigation of a new universally recognised framework for conducting paediatric R&D in Europe aims to not so much help the region get ahead, as ìcatch up, particularly with the US, and to bring back research capacity already lostî, according to the board members at EFPIA.

The European Parliament's vote is scheduled for July 12-13 this week.

30th September 2008

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