The Pharmaceutical Journal
Vol 275 No 7367 p327
17 September 2005

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Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/83/EC and Regulation (EC) No 726/2004

Properly tested medicines for children come a step closer

Better development of medicines for children has come a step closer with the acceptance by the European Parliament of a proposal to give extended patents to medicines that are tested in children (PJ, 20 March 2004, p341).

Some MEPs opposed the fixed patent extension period. Instead, they suggested a three-month patent extension for large drug companies, with a six-month extension being available only to companies with a turnover of less than €100m.

The final legislation, in the form of a European Regulation with immediate effect, is expected in the spring of 2006.