Decision follows EMA inquiry on company’s compliance with its pharmacovigilance obligations
The European Commission has announced that it has closed the infringement procedure taken against Roche for failure to meet certain pharmacovigilance obligations. The Commission explained that after considering all the available evidence and being satisfied with the company’s remedial actions, it has decided to close the case. Further information is provided in the Commission’s statement published today.
The infringement procedure was started by the European Medicines Agency (EMA) on 23 October 2012 at the request of the European Commission in the context of Commission Regulation (EC) No 658/2007, the so-called Penalties Regulation. The aim of the inquiry was to investigate allegations that Roche failed to comply with its pharmacovigilance obligations in relation to 19 of its centrally authorised products.
This inquiry was triggered by a pharmacovigilance inspection carried out in 2012 by the United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA), which identified serious shortcomings of the pharmacovigilance processes of Roche.
The initial EMA investigation report was finalised on 14 April 2014 and forwarded to the company, the Member States and the European Commission. Upon transmission of the investigation report, the procedure continued at European Commission level. In July 2015, the European Commission returned the file to EMA for an additional inquiry and for further examination of certain facts. The Agency then sent, on 1 July 2016, the final updated report to the European Commission summarising its findings.
The Commission has now closed the case.In a written statement submitted to the Commission, Roche said:
“Roche accepted all the inspection findings. It took them extremely seriously and fully understands the EMA’s and Commission’s concerns. It has worked diligently to remediate the deficiencies as quickly as possible and also to enhance the company’s medical compliance and PV systems to prevent any recurrence. While it has come a long way, the company knows that its efforts to enhance its systems and to maintain the trust of all stakeholders must continue. It is committed to working with the authorities to ensure it becomes, and then remains, a leader in the field.”