The European Parliament voted on 16 April in favour of an EU Regulation on fees payable to the European Medicines Agency (EMA) for the conduct of pharmacovigilance activities for medicinal products for human use, which lays down the level and structure of these fees. This Memo explains the meaning and importance of pharmacovigilance in the EU, and why this legislation is necessary.
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What is pharmacovigilance?
Pharmacovigilance is a key public health function. It is the process and science of monitoring the safety of medicines and taking action to reduce the risks and increase the benefits of medicines.
Once a medicinal product has been authorised in the EU and placed on the market, its safety is monitored throughout its entire lifespan to ensure that, in case of adverse reactions that present an unacceptable level of risk under normal conditions of use, it is rapidly withdrawn from the market. This is done through the EU system of pharmacovigilance, which is one of the most advanced and comprehensive systems in the world aimed at ensuring a high level of public health protection throughout the Union.
EU pharmacovigilance legislation underwent a major review that lead to the adoption of new laws in 2010 and 2012 that strengthen and rationalise the system for monitoring the safety of medicines on the European market. The new rules improve patient safety and public health through better prevention, detection and assessment of adverse reactions to medicines, and patient empowerment by allowing patients to report adverse drug reactions directly to the competent authorities. Furthermore, the legislation simplifies tasks and streamlines efforts at EU and national level.
Who is involved in pharmacovigilance?
Many groups and individuals are directly involved in pharmacovigilance, e.g. patients who are the users of medicines, and can now report adverse events directly; doctors, pharmacists, nurses and all other healthcare professionals working with medicines; regulatory authorities, including EMA and those in the Member States responsible for monitoring the safety of medicines; and companies that are the marketing authorisation holders.
At the level of the EU, the regulatory network, consisting of the national competent authorities of the Member States, the European Commission and EMA has a key role. The actors in this network are responsible for authorising and supervising medicinal products, overseeing the conduct of pharmacovigilance and taking regulatory action when necessary.
EMA has a core role in coordinating these activities. For example, EMA’s scientific committees analyse adverse drug reaction reports and their impact on the known safety profile of a product. This assessment is carried out at EU level and can lead to modifications regarding the authorised use of a product or even its withdrawal, if necessary.
National competent authorities provide the EMA with expert advice by nominating members to its scientific committees. ‘Rapporteurs’ are appointed amongst those members for the carrying out of the assessments.
Why are fees being charged?
The pharmacovigilance legislation adopted in 2010 assigns new pharmacovigilance activities to EMA, including new EU-level procedures for the review of medicines’ safety. It further provides that EMA’s pharmacovigilance activities are to be financed from fees charged to industry. It defines two types of fees, in view of the diversity of the pharmacovigilance activities: procedure-based fees and an annual fee. The procedure-based fees are aimed at covering the cost of the EU-wide assessments including financial compensation of the national competent authorities for the rapporteurships. The annual fee covers mainly EMA’s information technology-related activities for pharmacovigilance.
When will the new legislation become applicable?
The legislation enters into force 20 days after the publication in the Official Journal of the EU and becomes applicable 40 days later. Therefore, the first procedure-based fees should be charged around August or September 2014. The annual fee will be charged as of 1 July 2015.
