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PHARMA - PAEDIATRIC DRUGS

EU to decide on sops for developing kids drugs

 

BY OUR PHARMA  CORRESPONDENT

 July 14, 2005: 

The European Parliament will decide whether it should incentivise pharmaceutical companies for paediatric drug research this week. 

This crucial decision, which could eventually alter the course pharmaceutical research conducted in Europe, will be shaped by a Members of Europe's Environment Committee, who will cast their vote on draft regulation. 

The industry leaders have been urging to give incentives for developing pharmaceutical products meant for use in children, for sometime now.

Traditionally, pharma firms' lack of interest 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. 

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'. 

Pharma companies are keen on the proposal for a six-month extension - “as a minimum” - 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.

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