News about GMP/cGMP

13.02.2018

EC: Report on Transposition of Falsified Medicines Directive

The European Commission (EC) has published a report that takes a closer look at the implementation of the Falsified Medicines Directive 2011/62/EU in the European member states which

introduces mandatory safety features on prescription medicines from February 2019 on
strengthens good distribution practices and requirements for wholesale distributors
reinforces rules on importation, controls and inspections of active substances and their manufacturers, and
established an EU-wide logo to allow the identification of legal online retailers of medicines (as of 1 July 2015).

Meanwhile, the EU member states have implemented national laws according to the Falsified Medicines Directive. But the penalties for breaking those laws vary widely from one country to another. Current penalties for falsifying medicines, APIs or excipients are imprisonment, fines and/or administrative sanctions. 26 out of 28 member states have introduced those penalties to their legislation. According to the EC, they should be effective, proportional and dissuasive.

Here are some findings described in the report:

The maximum prison sentence for the falsification of medicinal products varies from one year e. g. in Finland up to 15 years e. g in Austria.
The maximum fines for falsifying a medicines vary from 4300 € in Lithuania to 1 Mio € in Spain or are even unlimited in the UK.
The prison sentences for misconduct regarding APIs vary from ½ year to 15 years and the maximum fines from 1500 € up to unlimited.

With this variations, it is not surprising that not all experts were able to give a statement on the effectiveness of the actions taken. This makes it difficult for the EC to draw any final conclusions. The general opinion given was that at least some effect on a reduction of falsified medicines in the legal supply chain can be observed but rated administrative penalties as the most effective deterrent. In contrast, to combat illegal medicines sales criminal penalties were considered to be more effective.