By Fabrice Dejoux
Falsified medicines are fake medicines that pass themselves off as real, authorized medicines. They may contain ineffective or incorrect doses of active ingredients and pose a major threat to public health and safety. As falsifications become more sophisticated, the risk of falsified medicines reaching patients in the EU increases every year. Not only do falsified medicines present an incalculable health risk for patients, they also damage the corporate image of pharmaceutical manufacturers and can lead to large financial losses.
To control the increasing number of falsified products in the European Union, in 2011 the EU adopted Directive 2011/62/EU entitled “Directive for prevention of the entry into the legal supply chain of falsified medicinal products”, or in short “Falsified Medicines Directive”. The Directive requires all EU Member States to implement a system to protect consumers from falsified medicines by February 9, 2019 at the latest. Failure to comply will result in pharmaceutical companies being unable to supply their products.