EFA

In their 9 December 2005 meeting, European Health Ministers reached political agreement on a draft European Parliament and Council Regulation on medicinal products for paediatric use. You may recall from our September ezine article, that this piece of EU paediatric legislation has been the subject of debate: The use of unlicensed and off-label medicine for children is widespread and it has been of increasing concern in recent years. This is of major concern in allergy and asthma, the most common chronic childhood diseases, and EFA has therefore supported the regulation, which will improve the availability of high quality medicines tested for use in children. In its meeting last week, the Council agreed on a combination of incentives and obligations for pharmaceutical industry. The main obligation is that a paediatric plan must be submitted as part of the procedure for marketing authorisation of a medicine. There will also be broader public access to information on paediatric clinical trials and three representatives from patient organisations will be invited to take part in the Paediatric Committee, which according to the regulation will be created with expertise in all aspects related to medicines for children is central to the proposal and its operation. The Paediatric Committee, which will be managed by the EMEA (European Agency for the Evaluation of Medicinal Products) will be responsible primarily for the assessment and agreement of paediatric investigation plans and requests for waivers and deferrals, whilst in all its work considering the potential significant therapeutic benefits of studies in children including the need to avoid unnecessary studies. This is good news for patient groups, though this agreement has yet to be formally adopted by the Council. It will then be passed to the European Parliament and enter into its second reading, as part of the EU legislative co-decision procedure. You can keep tracking the process also via EU Legislative Process website..