Statement on Independent Medicines and Medical Devices Safety Review

The Independent Medicines and Medical Devices Safety Review, chaired by Baroness Julia Cumberlege, has today published its report.

Titled “First Do No Harm”, it comes after 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.

“First Do No Harm” sets out nine major recommendations to bring much-needed help and support to those who have suffered as a result of these interventions, and to reduce the risk of avoidable harm from medicines and medical devices in the future.

The Review’s major recommendations include:

• That the Government immediately issues a fulsome apology on behalf of the healthcare system to the families affected by Primodos, sodium valproate and pelvic mesh.
• That a Patient Safety Commissioner is appointed. This person would be the patients’ port of call, listener and advocate, who holds the system to account, monitors trends, and demands action.
• Separate schemes should be set up for Hormone Pregnancy Tests, valproate and pelvic mesh to meet the cost of providing additional care and support to those who have experienced avoidable harm and are eligible to claim.
• A Redress Agency for those harmed by medicines and medical devices in future should be established.
• The establishment of two types of specialist centres, located regionally – for mesh, and separately for those affected by medications taken during pregnancy.
• The regulator of medicines and medical devices, the MHRA, needs to put patients at the heart of its activity, and to overhaul adverse event reporting and medical device regulation.
• That a central database should be created by collecting key details including the patient, the implanted device, and the surgeon.
• That the register of the General Medical Council (GMC) should be expanded to include a list of financial and non-pecuniary interests for all doctors, as well as doctors’ clinical interests and specialisms.
• Finally, that the Government immediately sets up a task force to implement the Review’s recommendations.

The IDEAL Collaboration has released the following statement on the occasion of the publication of the Cumberlege report:

“The report of the Independent Medicines and Medical Devices Safety Review (the Cumberlege Review) documents the serious suffering caused by three treatments intended to help patients but which ended up injuring many. The lessons emphasised by the report include the establishment of better ways of allowing the patient’s voice to be heard, improved informed consent procedures and the implementation of remedies to help those who have suffered harm. As with all enquiries into failure, the most important of its several objectives is to ensure that reform occurs which will prevent the story from being repeated. In the case of vaginal mesh, the focus of attention must be on improving the systems for licensing, regulating and monitoring medical devices. Without better methods for ensuring that the safety and effectiveness of medical devices is evaluated thoroughly, further scandals of this type are sadly inevitable.

The IDEAL Collaboration has developed recommendations for scientific study of devices which provide an integrated evaluation pathway throughout their life cycles. This begins with maximum transparency about the device, its use and the outcomes from the very first case. We advocate a Total Product Life Cycle (TPLC) approach to evaluation and licensing, in which permission to market a device is widened in stages as more clinical evidence is provided. At each stage in the life cycle, sponsors should be required to conduct studies following a standardised template designed to provide the highest quality and most important evidence relevant to that stage. This is much more likely to identify safety issues early than current arrangements. The Cumberlege report references some of these important ideas, and makes recommendations for evidence development at both early stages (Para 5.52) and during longer term follow up (Para 1.48) aligned with IDEAL recommendations, which we very much welcome.

The report correctly points out the current opportunity for reform of device regulation in the UK in the wake of Brexit. The notified body system used in the EU drastically limits the power of national regulators to specify evaluation methods and to see the results of tests done for regulatory purposes. A new framework in which sponsors of new devices will be required by the MHRA to provide data from prospective ethically approved studies using standardised formats in return for progressive degrees of market access (and to contribute to the costs of maintaining a long term device registry) would make repetition of the mesh story much less likely. IDEAL provides an explicit framework for achieving this”

Prof Peter McCulloch, Chair, IDEAL Collaboration on behalf of the IDEAL Council