A critical analysis of Directive 2011/62/EU

Abstract

The thesis examines Directive 2011/62/EU which was drafted in order to tackle several issues, by identifying any criticisms or potential loopholes. One of the principal questions this thesis aims to answer is whether or not Directive 2011/62/EU is sufficient to prevent falsified medicines from entering the legal supply chain? The first Chapter traces the development of Directive 2011/62/EU, starting from the initial Commission Communication. The identification of those lobby groups which had some influence over the end result also gives a clearer picture of the situation within the EU regulatory framework. Since Directive 2011/62/EU is amending Directive 2001/83/EU, upon which EU law regarding medicinal products for human use is based, its effects are very far-reaching. All areas of the pharmaceutical industry involved in the manufacture, release and procurement of active pharmaceutical products, excipients and finished dosage forms are affected. Significantly, for the first time in European Union law, brokers are included within the medicinal supply chain and are required to comply with good distribution practice. The thesis also takes note of practical issues such as the detainment of falsified medicinal products in transit and whether the new Directive does enough to promote the inclusion of customs enforcement officers and police officers. The thesis also attempts to compare the Directive and other anti-counterfeiting strategies from European Institutions, particularly the Medicrime Convention, as it is the other main European initiative which specifically aims to tackle falsified medicines along with many other practical training and legislative programmes.