Developing new medicines is essential, but ensuring people actually benefit from these solutions is even more important. This involves not only addressing the reasons why people cannot obtain new medicines, but also involves combating trade in falsified medicines. Systems are needed to rid the medicines supply chain of falsified medicines and track down the criminals who put people’s lives at risk.
A falsified medicine is a fake medicine designed to mimic real, authorised medicines. Falsified medicines may contain ingredients of low quality or in the wrong doses; be deliberately and fraudulently mislabelled with respect to their identity or source; have fake packaging; or contain low levels of the active ingredients or the wrong ingredients altogether. Falsified medicines do not pass through the usual evaluation of quality, safety and efficacy, which is required for the European Union (EU) authorisation procedure. Because of this, they can pose a serious health threat.
Great efforts have been put into updating the legislative framework on falsified medicines. However, approximately 30 million fake medicines were seized at EU borders in 2011 alone, and the risk of falsified medicines entering the legitimate supply chain is now greater than ever before – in part due to the impact of the Internet. It is vitally important that a proper tracking system for medicines be in place to guarantee the reliability of the supply chain. To this end, the pharmaceutical industry has been involved in setting up an ambitious EU-wide coding and serialisation system, the European Stakeholder Model (ESM). This project brings together EFPIA, EAEPC (the European Association of Euro-Pharmaceutical Companies), GIRP (Groupement International de la Répartition Pharmaceutique), and PGEU (Pharmaceutical Group of the European Union) – respectively representing Europe’s research-based manufacturers, the pan-EU licensed parallel distribution companies, wholesalers and pharmacists.
The ESM partners are working to implement the European Medicines Verification System (EMVS), a point-of-dispensing verification system, in which each pack of medicine is checked individually before it is dispensed to the patient, ensuring that the patient receives a genuine product.