European Commission Report on Penalties Provision of Falsified Medicines Directive

• 26/01/2018
• Articles

On 26 January 2018, the European Commission published a report (the “Report”) discussing the implementation of the penalties provision of the 2011 Falsified Medicines Directive (“FMD”). The Report, in turn, relies on a study commissioned from outside contractors which examined the transposition into national law of the amended Article 118a of Directive 2001/83/EC, which established the Community Code of medicines for human use (the “Study”).
 
Article 118a of Directive 2001/83/EC requires Member States to ‘lay down the rules on penalties applicable to infringements of the national provisions adopted pursuant to this Directive and [to] take all necessary measures to ensure that those penalties are implemented. The penalties must be effective, proportionate and dissuasive’. Such rules address:

• the manufacturing, distribution, brokering, import and export of falsified medicinal products, as well the sale of falsified medicinal products at a distance to the public by means of information society services;
• non-compliance with the provisions of the Directive on the manufacturing, distribution, import and export of active substances; and
• non-compliance with provisions of the Directive on the use of excipients.

Even though the penalties vary widely, the Report indicates that the laws of the Member States which enforce the  EU rules on falsified medicines are “satisfactory”.

Maximum prison sentences for falsified medicines range from a year in Finland, Greece and Sweden to 15 years in Austria, Slovakia and Slovenia. In terms of fines, the maximum varies from EUR 4,300 in Lithuania to EUR 1 million in Spain. In the U.K. there is no maximum limit. Despite its overall positive assessment, the Report recommends that certain countries should “consider introducing additional criminal penalties or administrative sanctions” to reinforce the FMD.