Pharmacovigilance in the EU is going to be improved and package leaflets will be more readable, the European Parliament decided today in Strasbourg.
In 2011 it emerged that the drug "Mediator" by the company Servier is responsible for at least 500 deaths (other estimations even assume up to 2000 cases). Experts had already warned about the drug's dangers in 1998. In 2003, the producer already decided not to apply for a new permit for the Spanish and Italian market, supposedly for economic reasons. Today we know that this statement was pretext. However, due to the at that time insufficient legal situation no further inquiries were made. "This scandal has shaken many patients across Europe. With today's decision, we solve the current shortcomings in the EU pharmacovigilance and protect patients", says Peter Liese, Coordinator for the EPP in the Committee on Environment and Health.
Read more: European Parliament in favour of better patient safety - Consequences of drug scandals