8 July 2020.
The Independent Medicines and Medical Devices Safety Review, chaired by Baroness Julia Cumberlege, has published its report “First Do No Harm” today. In a letter to the Secretary of State dated 8 July 2020, Baroness Julia Cumberlege acknowledges that this report is being published at a time when the NHS are facing “enormous challenges” arising from the Covid-19 pandemic.
The Report runs to 277 pages and is accompanied by additional documentation which is downloadable. The Terms of Reference outlined how the Review would engage with patient campaign groups and other stakeholders. The Review’s approach was to “listen, learn and recommend” stating that they would listen to those who had suffered harm.
The three areas we were asked to explore, primodos, sodium valproate and pelvic mesh, were new to us so we travelled the country, not only England but Scotland, Wales and Northern Ireland. We met and listened to over 700 people, mostly women, often accompanied by their partners, other family members and sometimes their children. We are indebted to all of them. Their dignity and courage in telling us intimate and harrowing details of their damaged lives has made a great and lasting impression on us.”Baroness Cumberlege (2020)
My summary of the nine recommendations
An immediate and fulsome apology should be issued by the Government on behalf of the healthcare system to the families affected by primodos, sodium valproate and pelvic mesh.
A Patient Safety Commissioner should be appointed who would be an independent public leader with a statutory responsibility. The Patient Safety Commissioner would champion the value of listening to patients and promoting users’ perspectives in seeking improvements to patient safety around the use of medicines and medical devices.
Creation of a new independent Redress Agency for those harmed by medicines and medical devices based on models operating effectively in other countries. Administration of decisions using a non-adversarial process with determinations based on avoidable harm looking at systemic failings, rather than blaming individuals.
Setting up of “cost of care” schemes for each intervention – HPTs, 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.
Setting up of networks of specialist centres to provide comprehensive treatment, care and advice for those affected by implanted mesh; and separately for those adversely affected by medications taken during pregnancy.
Substantial revision of the MHRA particularly in relation to adverse event reporting and medical device regulation. More engagement with patients and their outcomes required and ensure patients have an integral role in its work.
A central patient-identifiable database should be created by collecting key details of the implantation of all devices at the time of the operation.
Improvement of transparency of payments made to clinicians. The General Medical Council (GMC) register needs to be 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.
Mandatory reporting for the pharmaceutical and medical device
industries of payments made to teaching hospitals, research institutions
and individual clinicians.
Task force to be established by the Government to implement this Review’s recommendations.
First Do No Harm (2020) The report of the Independent Medicines and Medical Devices Safety Review. Available from: http://immdsreview.org.uk/downloads/IMMDSReview_Web.pdf [Accessed 8 July 2020]