Strengthening and rationalizing pharmacovigilance in the EU: where is Europe heading to? A review of the new EU legislation on pharmacovigilance.

Amendments to the European pharmacovigilance legislative framework are expected to come into force in 2011, following the adoption of the proposed amendments to Directive 2001/83/EC on the community code relating to medicinal products for human use (hereinafter referred to as the Directive) and to Regulation (EC) No. 726/2004 laying down community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (EMA) [hereinafter referred to as the Regulation]. The Regulation shall apply 18 months after publication in the Official Journal of the European Union. The amendments to the Directive and the Regulation will induce changes in the EU in terms of evaluation of risk associated with medicinal products as well as the framework on how the EU takes harmonized regulatory action on drug safety. In this review, the text agreed between the European Parliament and Council is examined and compared with the pharmacovigilance legislative framework currently in force. We argue that the new legislation has improved numerous uncertainties in current legislative framework and provides for the following: (i) clear roles, responsibilities and obligations for the key responsible parties; (ii) rationalization of EU decision making on drug safety issues in order to deliver measures that are equally and fully implemented for all relevant products across the community with a view to preventing unnecessary patient exposure to risks; (iii) strengthening medicine safety transparency and communication so that the understanding and trust of patients and health professionals in the safety of medicines will improve, as well as the penetration of key warnings; (iv) strengthening companies' pharmacovigilance systems, allowing companies to improve their systems constantly while reducing administrative burden; (v) ensuring the proactive and proportionate collection of high-quality data relevant to the safety of medicines through risk management and structured data collection in the form of Post-Authorization Safety Studies (PASS), together with rationalized single-case and periodic reporting of suspected adverse drug reactions (ADRs); (vi) involvement of stakeholders in pharmacovigilance through direct patient reporting of suspected ADRs and inclusion of patients and healthcare professionals in decision making; and (vii) simplification of the current community pharmacovigilance procedures with consequent efficiency gains for both the pharmaceutical industry and medicines regulators. For the first time, companies can be made legally liable to carry out PASS and Post-Authorization Efficacy Studies. The amendments to the Regulation and to the Directive will strengthen the European network on pharmacovigilance. A Pharmacovigilance Risk Assessment Committee (PRAC) based at the EMA will be set up, which will be responsible for all matters related to pharmacovigilance at an EU level. Three European databases will be strengthened (EudraVigilance, EudraPharm and the European Pharmacovigilance issues Tracking Tool) as well as the setting up of an EU safety portal to better inform the public on all safety issues being discussed at an EU level. Public hearings at the PRAC will improve transparency in the decision-making process, whilst details and results of all PASS agreed to by the PRAC will also be made publically available.