The European Commission has closed its very first infringement procedure under the Penalty Regulation. During an inspection at Roche’s UK headquarters in 2012 the British MHRA found data on 80,000 not properly reported adverse events of approved Roche meds, 15,161 of which included deaths.
Additional 1.2 millions of datasets, stemming from Genentech's patient support programme Access Solutions, led to re-inspections by the MHRA. An appeal of Roche against the MHRA’s conduction of the re-inspections and information policy, however, was rejected in 2015 by the High Court of Justice Queen’s Bench Division. According to the High Court, "Access Solutions offered doctors and patients in the US assistance and advice relating to insurance coverage and funding for Genentech's products, which corresponded to 19 centrally authorised "products marketed by Roche in Europe". The programme was offered through "a number of service providers including…McKesson Speciality Arizona. Though Genentech had received reports of adverse effects in relation to relevant products, the company had failed to pass on these reports". Under the procedure, Roche could have been fined up to US$685m.
The deficiencies identified in an initial confidential report and an subsequent confidential report drafted by MHRA experts and finalised by the EMA, however, will not lead to any fines against the pharmaceutical company. On 15 December, the EMA reported that the European Commission sent an explanatory statement to Roche Registration Ltd and its parent company Roche Holding AG, informing them about the closure of the infringement procedure.
"After considering all the available evidence and being satisfied with the company's remedial actions, the Commission decided not to notify a statement of objections to Roche Registration Ltd and Roche Holding AG and to close the case", the EMA said in a press release. 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."
According to the EMA, all Periodic Safety Update Reports submitted by Roche between 23 May 2013 and 31 January 2016 have been assessed by EMA's Pharmacovigilance Risk Assessment Committee (PRAC) and that evaluation by PRAC did not lead to any change to the terms of the marketing authorisations for the products concerned. The main issue identified in the EMA Final Report therefore appears to be remedied and it appears that the previously unassessed information did not have any impact on the benefit-risk profiles of the products concerned. According to the EC, there is hence no actual risk to public health or patient safety.