EU Drug Safety – FAQs

This implementation assessment “Pharmacovigilance in the European Union: Practical Implementation across Member States” is the result of intensive teamwork. Commissioned by AbbVie, it was directed by Prof Michael Kaeding, Professor for European Integration and European Union Politics at the Department of Political Science at the University of Duisburg-Essen, Germany and managed by Julia Schmälter, research assistant at the Jean Monnet Chair for European Integration and European Union Politics at the Department of Political Science, at the University of Duisburg-Essen. The assessment was written by Dr Michael Kaeding, Julia Schmälter and Christoph Klika, lecturer at the Department of Political Science at the University of Duisburg-Essen. The group of collaborators included, Roxana Dürsch, Annika Körner, Stella Malliara and Charline Ulrich.

The research for this assessment involved discussions, interviews with key stakeholders and collaboration with colleagues and implementation scholars over the course of 10 months. It was characterised by positively benchmarking countries as examples for others to follow.

This study focuses on adverse drug reaction (ADR) reporting of biological medicines and on specific EU Member States following the new European legislative framework. Assessing the timely transposition and accurate practical implementation of the European pharmacovigilance framework as laid out in the EU Pharmacovigilance legislation (Directive 2010/84/EU) helps to identify major drivers impeding and incentivising appropriate ADR reporting across Europe. The in-depth comparative study offers a detailed and rich account of ADR reporting systems across Member States and identifies perceived challenges and best-practices to formulate recommendations on the conditions conducive for robust and efficient systems, ensuring accurate identification and rapid traceability of biologicals.

The report focuses on the practical implementation of pharmacovigilance in six EU Member States - the UK, Finland, France, Poland, Portugal, and Germany.

It is estimated that ADRs account for 5% of all hospital admissions, cause around 200,000 deaths per year in the EU, and cost roughly €80 billion. This is why ADRs must be reported quickly and accurately for all medicines, but particularly for biological medicines.

The EU pharmacovigilance legislation mandates that all new medicinal products (small molecule and biological medicines, including biosimilar medicines) approved after 1 January 2011 are subject to closer monitoring for safety. Since the 1990s, legislation at the EU level has strengthened medicinal safety in general, and particularly the reporting of ADRs. As a result of this legislation, national pharmacovigilance systems should now be in place in all EU countries.

EU Directives are binding to EU Member States but are not directly applicable, in that they require Member States to implement them by making changes to their national laws – referred to as transposition. Transposition problems remain in some EU Member States when it comes to medicinal safety. Almost 85% of EU rules are not transposed on time, and occasionally come with a delay of more than two years. Moreover, the levels of transposition are extremely varied across EU, with some countries seen to be slower off the mark, whilst others are identified as “champions”.

Although progress has been made, underreporting of ADRs is present in all six countries analysed in the report. This is explained by a variety of reasons including lack of awareness of ADRs, complexity in terms of the reporting process, fear of litigation and/or failure, and budgetary limitations. A key solution identified in the report is to put in place awareness raising programmes aimed at both patients and healthcare professionals to increase knowledge about medicinal safety and highlight the role they can play to ensure public health. Training of healthcare professionals has also been identified to help them report ADRs with regard to biologicals.

Although patients are given a strong role within the new EU pharmacovigilance legislation, the study found that they often lack awareness, and this leads to ADRs going unreported. This is why European, national, and regional authorities should invest in awareness-raising campaigns to increase public knowledge about medicinal safety and ADR reporting. This awareness raising could be done through websites, social media, and leaflets, as well as cooperation with schools to educate future generations.

Healthcare professionals should also be targeted by awareness-raising campaigns to ensure they are aware of the importance of medicinal safety to public health and are encouraged to act. Medicinal safety should also be included in the curriculum for all medical and pharmacy students, and advanced post-graduate training should be introduced. Healthcare professionals should also receive the necessary training to ensure that underreporting of batch numbers is prevented and that the traceability of biologicals is strengthened. It is further recommended that countries should put in place safeguards to ensure that healthcare professionals feel comfortable in reporting ADRs without fear of liability and/or failure, as this acts as a deterrent.

ADR reporting is often perceived to be time-consuming and incompatible with other tasks. Healthcare institutions should therefore make efforts to streamline internal processes and strive for close cooperation with competent authorities, industry, patients, and research institutions. To facilitate ADR reporting, Member States should enable patients to report ADRs online. In parallel, connectivity of IT systems between general practitioners, hospitals, pharmacies, and the national competent authority should be improved. Countries should also ensure a culture of care and patient safety in which ADR reporting is considered as a key responsibility of healthcare professionals and not as a failure or cause for reputational damage.