Brussels, 26/02/2007 (Agence Europe) - On Monday 26 February, the vice president of the Commission, Günter Verheugen, announced that in 2008 the European Commission is expected to propose a new legal framework that is simpler and clearer, for enhanced monitoring of medicines in the EU.
Prior to a medicine being authorised it has to undergo extensive studies to demonstrate that it is safe, effective and of high quality. Although all medicines have some risks (side-effects / adverse reactions) medicines are authorised when they are judged to have benefits that outweigh risks in the population to be treated. However, the safety profile of a medicine cannot be fully known prior to authorisation because of the established limitations of clinical trials, for example inclusion of a limited number of patients, limited duration and careful control of how the medicine is used and what patients are selected. The Commission explained that this meant that new or changing safety issues are detected once a medicine is on the market. The Commission wants to improve application of the current system and amend the legal framework for pharmacovigilance in the EU.
Improving implementation of the current framework will include: - working with the Commission's DG Research on funding of studies into the safety of medicines; working with the member states to resolve implementation issues, including administrative practices that complicate reporting rules for industry; working with the EMEA to strengthen its coordinating role including supporting full compliance and maximum utilisation of the EU pharmacovigilance database “Eudravigilance”. Proposals for changing the legal framework will focus on: strengthening the rules on transparency relating to pharmacovigilance data, assessment and decision-making and involve stakeholders (e.g. patient and healthcare professional groups) in the processes including reporting (including patient reporting); establishing clear standards ('Good Vigilance Practices - GVP') for the conduct of pharmacovigilance by both the industry and regulators; freeing up resource by rationalising and simplifying the reporting of suspected adverse drug reactions (ADRs), both expedited and periodic reporting, making best use of current information technology (including Eudravigilance) and matching the reporting requirements with the level of knowledge about the safety of a specific product; making clear the respective roles and responsibilities and minimise duplication of effort, while maintaining the current split of competences between the mMember states and the EMEA. The Commission services will be working on an impact assessment during the course of 2007 with a view to a legal proposal in 2008. (oj)