Peter Liese: Improved readability of package leaflets helps patients

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.


Now, the EU takes the consequences of the scandal. Henceforth a company that withdraws a drug from the market has to specify the reasons why this happens. Via the European Medicines Agency automatically all other member states get automatically informed and if a Member State or the Commission takes safety measures (for example the withdrawal of the license), an urgent procedure on the European level is automatically opened. "The acting of the corporation Servier was irresponsible. Unfortunately, the legal framework made it impossible for the European Union to have the information or the authorization to intervene. This has to change immediately! With the new law patient protection would be considerably better", says Liese.

The European Parliament used the opportunity to introduce more improvements. "There are always complaints from citizens about the package leaflets: Too hard to understand, too illegible, too confusing. It is high time that package inserts get patient-friendly", Liese adds. Amongst others, the package leaflets shall be more readable, and a "drug fact box" shall describe the most important information and side effects of the drug. This drug fact box is to be graphically enhanced and shall be written in easy language. Details are to be determined by the Commission in a report not yet compiled.

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