MHRA response to Independent Medicines and Medical Devices Safety Review

Image of a pharmacist holding tablets to show MHRA response to Independent Medicines and Medical Devices Safety Review

The Medicines and Healthcare products Regulatory Agency (MHRA) has published its response to the Independent Medicines and Medical Devices Safety Review.

In its response, the MHRA said: “Today’s publication of the Independent Medicines and Medical Devices Safety Review is of profound importance for the MHRA, since the safety of the public is our first priority.

“We therefore take this report and its findings extremely seriously. Throughout the Review’s work we have listened intently to the many distressing experiences of women and their families. We will now carefully study the findings and recommendations of the Report.

“We recognise that patient safety must be continually protected and that many of the major changes recommended by the Review cannot wait. We are therefore making changes without delay to ensure that we listen to patients and involve them in every aspect of our work.

“We are already taking steps to strengthen our collaboration with all bodies in the healthcare system and will strive to ensure that, working with these other bodies, the safety changes we advise are embedded without delay in clinical practice.

“We wholeheartedly commit to demonstrating to those patients and families who have shared their experiences during the Review, and anyone else who has suffered, that we have learned from them and are changing and improving because of what they have told us. We are determined to put patients and the public at the heart of everything we do.”

First Do No Harm was published on 8th August and is the culmination of a two-year review of harrowing patient testimony and a large volume of other evidence concerning three medical interventions: Primodos, sodium valproate and pelvic mesh. It sets out nine major recommendations to bring much-needed help and support to those who have suffered as a result of these specific interventions, and to reduce the risk of avoidable harm from medicines and medical devices in the future.