Brussels, 26/05/2005 (Agence Europe) - On 25 May the European Parliament industry committee adopted its opinion on the draft regulation on the paediatric use of medicines. This opinion received 42 votes in favour, none against with three abstentions and was prepared by Margherita Patrizia Toia (ALDE, Italy) but was significantly amended during a particularly unexpected vote at the parliamentary committee on industrial policy and research. The European Commission's draft regulation calls for a system that will provide six months additional medical protection to clinical studies on paediatric use carried out by laboratories. Compared to the current mechanism in the USA, which has already been tested, this instrument should correct a situation in which paediatric posologies are generally set out on the basis of a weighty report based on adult prescribed doses. For some obscure reasons, paediatrics believe that better knowledge of the effects of medicines on children, and the pharmaceutical industry is better than the proposed system and MEPs followed the line of German Christian Democrat Peter Liese, who proposed that they broke with this system and set up a variable formula that is much more complex and difficult to apply. The industry committee therefore aims to set out the period for additional protection to four months (two months less than in the US) but if annual sales in the EU are under EUR 100 million, which could be certified by an independent audit, the period could go up to eight months. The environment committee and plenary now have to reach a decision before sending the dossier to the Council of Ministers as part of co-decision procedure.