On 8 July 2020 Baroness Julia Cumberlege published her Independent Medicines and Medical Devices Safety Review, which looked into the health care system’s response to patients’ reports of harm from drugs and medical devices – including Primodos.
Titled ‘First Do No Harm’, it concluded the health care system is “disjointed, siloed, unresponsive, and defensive”. It set out nine major recommendations to support those affected and reduce the risk of avoidable harm from medicines and medical devices in the future.
Here is a summary of the nine key recommendations from the report.
1. Apology
“Our first recommendation is that the Government must immediately issue a fulsome apology on behalf of the health care system to the families affected by Primodos, sodium valproate and pelvic mesh.”
2. Commissioner
“Our second recommendation is that a Patient Safety Commissioner is appointed. This person will be the patients’ port of call, the listener, the advocate, who holds the system to account, monitors trends, and above all demands action. This is the golden thread, tying the disjointed system together in the interests of those who matter most – the patients.”
3. Financial redress
“The state and manufacturers have a moral responsibility to provide ex gratia payments to those who have experienced avoidable damage from the interventions. We are therefore recommending that 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. Patients have waited far too long for redress. These schemes must be set up at speed.”
4. Agency redress
“Our fourth recommendation is the establishment of a Redress Agency. Rather than blaming individuals, its decisions will be based on whether there has been avoidable harm. The support it provides should be both non‑monetary and financial. The costs of running the Redress Agency should be met by contributions from manufacturers and the state, but it must be situated outside the current organisations and it must be independent.”
5. Specialist centres
“Those who have been harmed deserve better care and support. We are therefore recommending the establishment of two types of specialist centres – one for mesh, and another for those affected by medications taken during pregnancy. They will be located regionally. As well as meeting clinical needs, these centres should act as a one stop shop, able to signpost and refer patients to other services.”
6. MHRA overhaul
“A regulator must work both for patients and with them. This hasn’t been the case in the past. We are recommending that the regulator of medicines and medical devices, the MHRA [Medicines and Healthcare products Regulatory Agency], is overhauled. It needs to change and radically improve the way that concerns about medicines and devices are detected and acted upon. The regulation of devices in particular needs urgent change. The MHRA needs to engage more with patients and track how medicines and devices improve – or fail to improve – patients’ health and quality of life. It needs to raise public awareness of its role and it needs to ensure that patients have a core role in its work.”
7. Central database
“Every successful organisation knows that good data is essential. Detecting concerns over medical devices, tracking patient outcomes and acting swiftly to prevent harm, is impossible without good data. Currently no one knows the number of patients implanted with pelvic mesh, their surgeon, the mesh product used, or the outcomes. We are recommending that a central database should collect these details, including retrospective details. We asked the Secretary of State to make the collection of this information mandatory and he has agreed. The database will be linked to registries to research and audit outcomes in terms of both device safety and the patient’s experience.”
8. Declaration of interests
“There is no central register of clinicians’ financial and non‑financial interests. We are concerned by doctors who have financial and other links with manufacturers. So our eighth recommendation is 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. The public has a right to know. Likewise, manufacturers should report payments made to teaching hospitals, research institutions and individual clinicians under a new law similar to the similar to the Physician Payments Sunshine Act in the US.”
9. Task force
“We hope this Government, and all those bodies that comprise the health care system, will take heed of what we have to say, and that our recommendations will be implemented with determination and urgency. That leads me to our final recommendation, which is about implementation. We want the Government to immediately set up a task force to implement this Review’s recommendations. Its first task should be a timeline for implementation.”
To read the full report, click here.
