The Independent Medicines and Medical Devices Safety Review has published its report this week. Titled “First Do No Harm”, it follows a two-year review, led by Baroness Cumberlege, on patient safety.
The report focuses on three medical interventions: Primodos, sodium valproate and pelvic mesh. On the back of the findings, it sets out nine major recommendations that could fundamentally restructure the healthcare system. Therefore, it might have a wide-ranging impact on the Life Sciences industry if the Department of Health and Social Care, NHS and arms-length bodies adopt the recommendations. This would particularly impact MedTech as the report calls for an overhaul of the operations of Medicines and Healthcare products Regulatory Agency (MHRA) and the marketing approval process for devices.
The Government has provided an initial response in a debate led by the Minister for Patient Safety, Mental Health and Suicide Prevention, Nadine Dorries MP. She fulfilled the first recommendation of the review by offering a fulsome apology on behalf of the healthcare system. However, she was unable to inform the House whether the Government will adopt the recommendations of the report, as they plan to review them closely before officially responding.
Read our briefing to learn more about how the recommendations could affect regulation, marketing surveillance, reporting of Industry activity, and more: First Do No Harm – The report of the Independent Medicines and Medical Devices Safety Review
By Sebastian Guterres