Research to help improve EU medicines safety monitoring
The European Commission has announced plans to reform the current EU system of medicines safety monitoring. Among the actions foreseen are a series of studies on the safety of medicines and the monitoring methodologies employed. The decision to introduce the new reforms follows a public consultation which found the current legal framework to be 'contradictory, confusing, unclear and complex'. Respondents raised concerns over the fact that the different Member States have slightly different rules, including requirements going beyond those in EU legislation. In addition to the cost implications of these differences, respondents suggested that this lack of harmonisation is detrimental to public health since it diverts resources away from safety monitoring towards meeting disparate administrative requirements. The announced plans are intended to help improve the implementation of the current medicines safety monitoring (pharmacovigilance) system. 'We will improve and strengthen the monitoring of the safety of medicines so that safety issues are rapidly detected, and effectively dealt with on the basis of more robust data. 'Rationalisation of the EU medicines safety system will free up resources which can then be directed to better protecting the health of EU citizens. This is an example of reducing administrative burdens for enterprises, without compromising safety,' commented Commission Vice-President Günter Verheugen, responsible for enterprise and industry. Proposals include working with the Commission Directorate General for Research on funding studies into the safety of medicines, as well as studies into methodologies used to conduct pharmacovigilance. Better coordinating administrative practices in Members States and supporting the full compliance with and maximum use of the EU pharmacovigilance database 'Eudravigilance' are also foreseen. In terms of improving the legal framework, the Commission proposes, among other actions, establishing clear legal requirements to conduct post-authorisation safety studies including those in risk management systems. This will help stimulate innovation, says the Commission. Other actions include strengthening the rules of transparency related to monitoring data, establishing clear standards, simplifying reporting and clarifying the roles and responsibilities of member States and the European Medicines Evaluation Agency (EMEA).