This report from the Department of Health and Social Care sets out the Government's response to the recommendations of the Independent Medicines and Medical Devices Safety (IMMDS) Review, sometimes referred to as the Cumberlege Review.
The IMMDS Review examined how the healthcare system in England responded to reports about harmful side effects of medicines and medical devices, focusing on three specific interventions: Hormone pregnancy tests, Sodium valproate and Pelvic mesh implants.
Its findings and recommendations were published in the First Do No Harm report on 8 July 2020.
Summary of the government response to each of the recommendations
Recommendation 1: 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.
Government response – accept. On 9 July 2020, the day after publication of the Review, the government issued an unreserved apology on behalf of the healthcare system to the women affected, as well as their children and their families, for the time the system took to listen and respond.
Recommendation 2: 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 use of medicines and medical devices.
Government response – accept. We have legislated for a Patient Safety Commissioner through the Medicines and Medical Devices Act 2021. The Patient Safety Commissioner will act as a champion for patients in relation to medicines and medical devices, adding to and enhancing the existing work described above. We are now consulting on the proposed legislative details that will govern the Commissioner's appointment and operation.
Recommendation 3: 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 looking at systemic failings, rather than blaming individuals.
Government response – do not accept. We have no plans to establish an independent redress agency.
Recommendation 4: 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.
Government response – We do not accept this recommendation. Our priority is to make medicines and devices safer and the government is pursuing a wide range of activity to further this aim.
Recommendation 5: 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.
Government response – accept in part. NHS England and Improvement has led work to establish specialist mesh services. There are now 8 specialist centres in operation. Regarding specialist centres for those adversely affected by medicines taken during pregnancy, the government's view is that a network of new specialist centres is not the most effective way forward. We will in instead take forward work to improve the care pathways for children and families adversely affected by other medicines in pregnancy. On valproate specifically, we are taking forward significant work to ensure that valproate is only prescribed where clinically appropriate.
Recommendation 6: 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 of its public protection roles and to ensure that patients have an integral role in its work.
Government response – accept. The MHRA, reflecting its corporate Delivery Plan for 2021-2023 "Putting patients first - A new era for our Agency", has initiated a substantial programme of work to improve how it listens and responds to patients and the public, to develop a more responsive system for reporting adverse incidents, and to strengthen the evidence to support timely and robust decisions that protect patient safety.
Recommendation 7: 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 be linked to specifically created registers to research and audit the outcomes both in terms of the device safety and patient reported outcomes measures.
Government response – accept. We have legislated to create a power for the Secretary of State to regulate for the establishment of a UK-wide Medical Device Information System (MDIS) through the Medicines and Medical Devices Act 2021, which creates. Alongside developing regulations, a package of work is underway to build, test and cost options for how an MDIS could be embedded into the UK healthcare system, as well as complete a business case for a 5-year programme of work.
Recommendation 8: 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 their recognised and accredited specialisms. In addition, there should be mandatory reporting for the pharmaceutical and medical device industries of payments made to teaching hospitals, research institutions and individual clinicians.
Government response – accept in principle. We agree that lists of doctors’ interests should be publicly available, but we do not think that the GMC register is the best place to hold this information. Our approach is to ensure it is a regulatory requirement that all registered healthcare professionals declare their relevant interests, and that this information is published locally at employer. Regarding industry reporting, we agree with the need for greater transparency and we are exploring options to expand and reinforce current schemes.
Recommendation 9: 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.
Government response – accept in part. We have no current plans to establish an independent task force to implement the government response. We established a Patient Reference Group to work with the government to develop this response.
- Independent Report of the Patient Reference Group – response to the report of the Independent Medicines and Medical Devices Safety Review (21 July 2021)
- Analysing the Cumberlege Review: Who should join the dots for patient safety (Patient Safety Learning)
- Consultation: The appointment and operation of the Patient Safety Commissioner for England (Department of Health and Social Care)
- House of Commons Debate – Independent Medicines and Medical Devices Safety Review: 8 July 2021
- No such thing as a free lunch – why recording conflicts of interests must be mandatory (Kath Sansom)
- Regulatory flaws: Women were catastrophically failed in the mesh, Primodos and Sodium Valproate tragedies (Kath Sansom)
- Sodium Valproate: The Fetal Valproate Syndrome Tragedy (Sharon Hartles)