Roche Avoids Sanctions under EU Penalties Regulation
- 18/12/2017
- Articles
On 15 December 2017, the European Commission (the “Commission”) announced that it has closed an infringement procedure which it had started against Roche Registration Ltd and Roche Holding AG (“Roche”) for an alleged failure to meet specific obligations that are related to Roche’s marketing authorisations. The Commission noted that this was the first case initiated under Regulation N° 658/2007 “concerning financial penalties for infringement of certain obligations in connection with marketing authorisations granted under Regulation (EC) No 726/2004” (the “Penalties Regulation”). It indicated that it did not pursue the case because it was satisfied with Roche’s remedial actions.
The Penalties Regulation empowers the Commission to impose financial penalties on marketing authorisation holders (MAHs) which infringe any of 23 obligations contained in Regulation No. 726/2004 “laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency” and 8 obligations under Paediatric Regulation No. 1901/2006. The Penalties Regulation thus covers a broad set of obligations, such as the requirement to update the marketing authorisation dossier; specific pharmacovigilance requirements; and the obligation to complete deferred paediatric studies. The penalties regime only applies to centrally approved products. Fines are decided by the Commission after an infringement procedure carried out by the European Medicines Agency (EMA). The EU enforcement system applies in parallel to national enforcement systems.
Following a routine inspection of Roche's pharmacovigilance system conducted in 2012, the Commission asked EMA to investigate suspicions that Roche had failed to meet its pharmacovigilance obligations for 19 centrally authorised medicines. The inspection had identified breaches with regard to pharmacovigilance information stemming from market research and patient support programs within and outside the EU. EMA submitted its final report to the Commission in July 2016.
According to the Commission, Roche fully and explicitly recognised the findings of the review of its pharmacovigilance system. It also remedied the identified deficiencies and provided a long-term commitment to enhance its pharmacovigilance activities in accordance with applicable rules. On that basis, the Commission concluded that there was no risk to public health or patient safety.
In showing its willingness to look for pragmatic solutions and accept robust remedial action on the part of investigated companies rather than pursuing an infringement procedure until the end, the Commission sends a welcome signal that the Penalties Regulation is not a means in itself but is rather intended to enhance compliance levels generally. Under the Penalties Regulation, the Commission has the power to impose financial penalties of up to 5% of the MAH’s EU turnover in the preceding business year.
More details on the case against Roche can be found here.
