Question to the Department of Health and Social Care:

To ask His Majesty's Government what assessment they have made of the impact on patient safety of the reported failures of the Sciensus medicine manufacturing unit.

Following a report of manufacturing error for a medicine called Cabazitaxel, inspectors from the Medicines and Healthcare products Regulatory Agency (MHRA) visited the manufacturing facility to determine the cause of the error and assess the number of patients who were impacted. Inspectors identified that four patients had received the products, and the products had been administered several weeks previously. MHRA’s review of the incident confirmed the company had already instigated measures to contact the clinicians who were responsible for the patients’ care.

MHRA has taken regulatory action by means of an immediate partial suspension of the licence to manufacture held by Sciensus. This action was taken in accordance with Regulation 28 of the 2012 Human Medicines regulations and ensures that the error is prevented from being replicated whilst further long-term corrective actions are taken by Sciensus assure ongoing patient safety.