2010 pharmacovigilance legislation

New pharmacovigilance legislation (a Directive and a Regulation) amending existing legislation was adopted in the European Union (EU) in December 2010. The legislation aims to save lives by strengthening the Europe-wide system for monitoring the safety of medicines.

Role of the European Medicines Agency

The European Medicines Agency, the EU Member States and the European Commission are responsible for implementing much of the new legislation. The Agency plays a key role in coordinating activities relating to the authorisation and supervision of medicines, including safety monitoring, across this network.

The Agency is working with a wide range of stakeholders including the European Commission, pharmaceutical companies, national medicines regulatory authorities, patients and healthcare professionals to ensure effective implementation. Most of the legislation had to be implemented within 18 months of becoming law or by July 2012.

Background to the new legislation

A strong factor in the development of the new Directive and Regulation is the incidence of so-called adverse drug reactions (ADRs) - responses to a medicine that are ‘noxious and unintended’. ADRs are estimated to cause 197,000 deaths per year in the EU. A strengthened European safety monitoring system aims to reduce the number of ADRs.   

The European Commission began a review of the European system of safety monitoring in 2005 including an independent study sponsored by the European Commission and extensive public consultation in 2006 and 2007. The legislation was adopted by the European Parliament and Council of Ministers in December 2010.

The new legislation forms part of a three-piece ‘pharmaceutical package’ and amends existing pharmacovigilance legislation contained in Directive 2001/83/EC and Regulation (EC) No. 726/2004.

Impact of the new legislation on EU citizens and patients

For patients and EU citizens, the new legislation has a number of goals:

• to inform them on the benefit-risk aspects of taking a medicine;
• to provide the opportunity for them to report perceived problems with a medicine through online reporting forms and take part in public hearings;
• to raise awareness of safety issues through the creation of new websites with information on medicine safety issues;
• to increase public confidence in the safety-monitoring system and the positive-risk benefit of medicines.

The activities introduced with the new legislation fall into four main areas:

For more information on the impact of the legislation on pharmaceutical companies, see 2010 pharmacovigilance legislation.

Stakeholder meetings

The Agency is hosting a series of stakeholder meetings to raise awareness of the requirements of the new legislation and promote the exchange of ideas, concerns and opinions:

• Stakeholder meetings: 2010 pharmacovigilance legislation