The Cumberlege report: two years later

The Government has published an update on progress to implement its 2021 response to the Independent Medicines and Medical Devices Safety review published two years ago.

The independent review was led by Baroness Julia Cumberlege who was tasked with looking at how the health system in England responds to reports from patients about side effects from treatments including Primodos, sodium valproate and vaginal mesh. Baroness Cumberlege’s review also looked at the processes followed by the NHS and its regulators when patients report a problem and how to ensure communication between different groups involved is good.

Our earlier blog provides further context on the report of the Independent Medicines and Medical Devices Safety review following its publication in July 2020 which contained nine strategic recommendations and 50 actions for improvement. The Government’s full response to the review was published a year later in July 2021 where it accepted four of the nine strategic recommendations in full and 46 of the 50 actions for improvement in full or in principle.

The Government’s Implementation report with a foreword written by the Rt Hon Steve Barclay MP, Secretary of State for Health and Social Care and Maria Caulfield MP, Parliamentary Under Secretary of State (Minister for Mental Health and Women’s Health Strategy) and Parliamentary Under Secretary of State (Minister for Women) provides an update on the steps it is taking to improve patient safety.

It is divided into several key sections with action for improvement and progress for each:

• Putting the patient voice at the centre of patient safety
• Redress
• Pelvic mesh
• Improving the safety of medicines taken during pregnancy
• Sodium valproate
• Medicines and Healthcare products Regulatory Agency transformation
• Medical Device Information System
• Conflicts of interest

It says it has made “good progress on all fronts” including the appointment of Dr Henrietta Hughes as England’s first Patient Safety Commissioner. NHS England has set up nine specialist centres across England to provide treatment for women affected by implanted mesh and the Medicines and Healthcare products Regulatory Agency has tightened the restrictions around prescribing of sodium valproate. The regulator is also undergoing an organisation-wide transformation to ensure it becomes a progressive and patient focused regulator of medical products.

One of the key recommendations accepted by the Government concerned improving the transparency of payments made to clinicians, with the GMC register expanded to include a list of financial and non-pecuniary interests for all doctors as well as doctors’ particular clinical interests, and their recognised and accredited specialisms. Progress is ongoing says the government update with a current pilot system in place for doctors to declare their interests in the NHS and independent settings across the UK. Full implementation is planned for 2023, subject to a successful review of the pilot systems. It adds that the Health and Care Act 2022 enables the Secretary State for Health and Social Care to make regulations requiring companies to publish or report information about their payments to the healthcare sector.

The Government’s rejection of the independent redress scheme for those harmed by medicines and medical devices did come as a disappointment for women affected by mesh implants but was expected with its stated priority to make medicines and devices safer through a range of activities. NHS Resolution launched in June 2022 two claims gateways to provide support to patients who may wish to bring a clinical negligence claim in relation to pelvic mesh and sodium valproate.

You can take stock of the progress the government has made on all nine recommendations here.