In order to combat the danger of falsified medicines entering the EU supply chain, the European Parliament and the Council issued a Falsified Medicines Directive (2011/62/EU). Article 118a specifies the requirement for Member States to introduce “effective, proportionate and dissuasive penalties” in order to combat falsified medicinal products, as well as to take measures to ensure their enforcement.
The study on the transposition measures introduced by Member States in relation to pharmaceutical legislation (TRANSPOSE) reveals how this requirement has been addressed across the EU28. The study was undertaken by the eHealth division of empirica in close cooperation with the ZEIS Centre for European and International Studies in Criminal Law – University of Osnabrück (Principal Investigators: Prof. Dr. Karl A. Stroetmann of empirica and Prof. Dr. Arndt Sinn of ZEIS).
The summary results of the study have been reported by the Commission to the European Parliament and Council in January 2018. The EU Commissioner for Health and Food Safety, Vytenis Andriukaitis, praised the legislative steps revealed in the report and urged continuous vigilance in enforcing such penalties effectively. Furthermore, he stressed the importance of keeping the public informed about the risk and how they can distinguish between legal online pharmacies and fraudulent ones by looking for the common EU logo which certifies e.g. online sellers of safe and authentic medicinal products.
The detailed report, available for download here, analyses the overall context and lists the penalties related to the falsification of medicinal products in each Member State, offers a Member State overview with regard to the respective transposition measures, an assessment of the measures’ effectiveness, and also provides recommendations on improving what has been achieved so far.