Article 118a of Directive 2001/83/EC requires Member States to lay down “effective, proportionate and dissuasive” penalties for those who are involved in the manufacturing, distribution, brokering, import and export of falsified medicinal products. On 26 January 2018, the European Commission published a report on how this requirement has been met by individual Member States, based on a detailed study performed by external contractors, empirica and  ZEIS, on behalf of the DG for Health and Food Safety.

The report indicated that 26 Member States had amended their legislation to accommodate new penalties for the falsification of medicinal products. The exceptions were Hungary, which changed its Criminal Code as a result of the Council of Europe Medicrime Convention, and Finland, which already had penalties in place before Article 118a took effect.

In 21 Member States, the manufacturing, distribution, brokering, import and export of falsified medicinal products attracts criminal penalties. In the remaining Member States (Bulgaria, Finland, Latvia, Romania, Poland, Sweden and Lithuania) only certain infringements are considered criminal.


Continue Reading Commission Survey on National Penalties for Breach of Falsified Medicines Rules in EU Member States

Last week, the European Commission published its ten-year report on the implementation of the Paediatric Regulation 1901/2006 (together with a useful Questions & Answers document). The report provides an account of the Regulation’s achievements, both in public health and economic terms, and an analysis on the extent to which its objectives and aims have been met.

It concludes that positive advances in the development of medicines for children could not have been achieved without specific EU legislation, and that 260 new medicines (new marketing authorisations and new indications) have been authorised as a result. However, certain problem areas have been identified, in particular in relation to the interplay between the Paediatric Regulation and the Orphan Medicinal Products Regulation 141/2000. The report does not set out any proposals for amendments to the Regulation, but states it will be for the next Commission, after 2019, to implement any necessary changes.


Continue Reading Ten-year report on Paediatric Regulation published