Study Released on Pharmacovigilance Systems in Europe

Patients and doctors need to be better informed about the need for high quality monitoring around all biologic medicines, according to a new study published today.

An examination of the pharmacovigilance legislation in place across six EU countries has identified that patient reactions to biologic products are underreported in a number of EU countries. These new findings have reinforced the need for greater efforts to raise awareness among patients and doctors about the importance of medicine safety and how this can be ensured through robust pharmacovigilance systems.

This study was carried out by Professor Michael Kaeding, Professor of European Integration and European Politics of the University of Duisburg Essen. It included a detailed investigation of how EU law on medicine monitoring has been developed into national law and implemented on the ground in the United Kingdom, France, Germany, Finland, Poland and Portugal.

The study found that while progress has been made in tackling the underreporting of adverse drug reactions, a clear challenge persists in ensuring all adverse reactions to biologic medicines are clearly reported to medicine regulators and pharmaceutical companies. Any adverse reaction to a medicine must be reported quickly and accurately to ensure that any anomaly can be traced and other patients can be protected from experiencing a similar reaction to the medicine.

Both patients and healthcare professionals have an important role to play in all countries to ensure any reactions are quickly and accurately reported. Biologic and biosimilar medicines are subject to a more robust monitoring process, due to the size and complexity of the molecules involved in creating the medicine. However, consistent application of these rules – in a process known as pharmacovigilance – has been a challenge across all the countries examined.

The study found that almost 85 per cent of EU rules are not transposed (made into national law) on time and in some cases have been delay by around two years. This type of delay has placed patient safety at risk.

The study also found variation between the effectiveness of the monitoring systems from country to country. Professor Kaeding’s research suggests that the underreporting and variation could be explained through a number of factors, including: lack of awareness of adverse events, complexity of the reporting process, the fear of failure and limited budgets. Each country was found to have its own unique system challenges, but a common theme to emerge was low levels of awareness among healthcare professionals and patients in how to report adverse events accurately.

However the picture is not entirely negative, Professor Kaeding also highlights examples of best practice that he found in each country, where systems are quickly and accurately reporting issues and encourages countries to adopt some of these successful measures.

Professor Kaeding was kind enough to present some of his initial findings at an event in the EU Parliament in November 2016 on patient safety and advocacy, co-hosted by GAfPA and The European Federation of Crohn’s and Colitis Associations (EFCCA). At this event Professor Kaeding provided patient advocates from across Europe with an overview of how they can get involved with EU level pharmacovigilance procedures, from ensuring information provided on medicines is accessible for patients, to providing responses to consultations. Attendees heard how, as end users of these products, patients are uniquely placed to add value to EU pharmacovigilance systems.

GAfPA will continue to work with patient advocates across Europe to promote the importance of accurate reporting of adverse reactions to biologic and biosimilar medicines, and will continue educate patients on how they can engage on an EU and national level to achieve this.