EFA

In EFA's February ezine, you may remember that we reported EFA and the International Primary Care Respiratory Group (IPCRG) having made comments to the European Medicines Agency (EMEA) draft Guideline on conduct of pharmacovigilance for medicines used by the paediatric population outlining the danger of prescribing unlicensed medicines for children. This dossier has progressed: The leading committee in the European Parliament, the Environment Committee report compiled by the rapporteur Francoise Grossetete has been read for a second time and adopted by the committee on 4 May. This includes 20 amendments, including very importantly (Amendment 2) the provision that "Members of the Paediatric Committee should .. not have financial or other interests in the pharmaceutical industry which could affect their impartiality .. and should make an annual declaration of their financial interests." Additionally, on 12 May 2006, EFA and IPCRG sent a response to the European Commission (EC) consultation on the community system of pharmacovigilance; the process and science of monitoring the safety of medicines and taking action to reduce risks and increase benefits from medicines. The consultation is based on a study conducted for the Commission 'An Assessment of the Community System of Pharmacovigilance' and resulting recommendations.  The system is organized in such as way that all functions and responsibility as well as accountability is shared between Member State competent authorities, the Euroepan Medicines Agency (EMEA) and the European Commission. EFA and IPCRG's response outlined: the importance of data sources and safety issue detection particularly in view of patients and their rights; Supported the proactive use of legal framework and new legal tools to tackle safety issues; Stressed the importance of a clear decision making process regarding pharmacovigilance and the importance of stakeholder participation both in terms of reporting issues of concern and in terms of disseminating and receiving information on drug safety. EFA and IPCRG also expressed their concern regarding the monitoring of the obligations marketing authorisation holders to monitor drug safety “a policing role“ the need for quality management and improvement. A plenary vote in the European Parliament is expected on 1 June 2006. We will keep you informed.