Jump to 9 Recommendations

First Do No Harm: The Report of the Independent Medicines and Medical Devices Safety Review

National
Published 08 Jul 2020
Investigator Baroness Julia Cumberlege

Independent review commissioned by the Secretary of State for Health and Social Care in 2018 to examine how the healthcare system responded to patients harmed by three medical interventions: hormone pregnancy tests (Primodos), sodium valproate (epilepsy drug causing birth defects), and pelvic mesh implants. Led by Baroness Julia Cumberlege. Published July 2020. Found the healthcare system to be "disjointed, siloed, unresponsive and defensive". Made 9 strategic recommendations and 50 Actions for Improvement. Government rejected recommendations 3 and 4 (redress and compensation), accepted or accepted in principle the remainder.

Report PDF NHS England Source
Acceptance Status
Accepted 5
Partially Accepted 2
Not Accepted 2
Total Recommendations 9
About this data

Acceptance Status tracks whether the trust accepted or responded to each recommendation.

Independent health investigation reports and reviews commissioned by government or NHS England.

Recommendations (9)

1 HM Government
Accepted
Recommendation
The Government should immediately issue a fulsome apology on behalf of the healthcare system to the families affected by Primodos, sodium valproate and pelvic mesh.
Accepted. Apology delivered by the Secretary of State for Health on the day of publication, 8 July 2020.
2 HM Government
Accepted
Recommendation
The appointment of a Patient Safety Commissioner who would be an independent public leader with a statutory responsibility. The Commissioner would champion the value of listening to patients and promoting users' perspectives in seeking improvements to patient safety around the … Read more
Accepted. Legislated via the Medicines and Medical Devices Act 2021. Professor Henrietta Hughes OBE appointed as the first Patient Safety Commissioner for England in September 2022.
3 HM Government
Not Accepted
Recommendation
A new independent Redress Agency for those harmed by medicines and medical devices should be created based on models operating effectively in other countries. The Redress Agency will administer decisions using a non-adversarial process with determinations based on avoidable harm … Read more
Not accepted. The government stated it has no plans to establish an independent redress agency. This decision was widely criticised by patient campaign groups including the Sling the Mesh campaign, INFACT, and others.
4 HM Government
Not Accepted
Recommendation
Separate schemes should be set up 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.
Not accepted. The government declined to establish separate compensation schemes. The Patient Safety Commissioner subsequently published the Hughes Report (2024) calling for a financial redress scheme.
5 HM Government / NHS England
Partially Accepted
Recommendation
Networks of specialist centres should be set up to provide comprehensive treatment, care and advice for those affected by implanted mesh; and separately for those adversely affected by medications taken during pregnancy.
Accepted in part. Eight specialist mesh centres were established across England. Specialist centres for those affected by medications taken during pregnancy were not established; the government stated new centres were not the most effective approach.
6 HM Government / MHRA
Accepted
Recommendation
The Medicines and Healthcare products Regulatory Agency (MHRA) needs substantial revision particularly in relation to adverse event reporting and medical device regulation. It needs to ensure that it engages more with patients and their outcomes. It needs to raise awareness … Read more
Accepted. MHRA committed to a programme of reform including enhanced patient involvement, improved adverse event reporting, and updated medical device regulations.
7 HM Government / NHS Digital
Accepted
Recommendation
A central patient-identifiable database should be created by collecting key details of the implantation of all devices at the time of the operation. This can then be linked to specifically created registers to research and audit the outcomes both in … Read more
Accepted. Legislated via the Medicines and Medical Devices Act 2021 for a Medical Device Information System (MDIS). £11m allocated for scoping in 2021/22.
8 HM Government / GMC
Partially Accepted
Recommendation
Transparency of payments made to clinicians needs to improve. 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' particular clinical interests and … Read more
Accepted in principle. The government agreed with the principle of transparency but does not consider the GMC register the appropriate place to hold this information. It intends to make transparency of financial interests a regulatory requirement published at employer level.
9 HM Government
Accepted
Recommendation
The Government should immediately set up a task force to implement this Review's recommendations. Its first task should be to set out a timeline for their implementation.
Accepted. A Patient Reference Group was established to support implementation.