Cumberlege Review: where are we now?
Zahra Nanji considers what progress has been made with Baroness Cumberlege’s recommendations following the Independent Medicines and Medical Devices Safety Review which reported almost a year ago.
Posted on 18 May 2021
Now that Baroness Cumberlege’s call for a Patient Safety Commissioner has been answered with a change in the law, it is a good opportunity to consider where we are with all of her nine recommendations in the Independent Medicines and Medical Devices Safety Review (IMMDSR).
The commissioner role was the second of Baroness Cumberlege’s IMMDSR recommendations and is included in Section One of the Medicines and Medical Devices Act 2021.
The Cumberlege Review came in the wake of longstanding campaigns, some lasting decades, by patient groups to raise awareness of serious shortcomings in the regulatory landscape regarding the authorisation and monitoring of medicines and medical devices. They also wished highlight the lack of redress received by victims of allegedly defective medical products where they allege that avoidable harm had been caused to them and their families.
The Cumberlege Review was charged with appraising England’s healthcare and regulatory system, chiefly responding to concerns regarding two medicines and one medical device:
- The pregnancy test Primodos, which is alleged to cause serious birth defects
- The anti-epileptic medication, Sodium Valproate (Epilim), which can cause birth defects and developmental delays
- Pelvic mesh, a surgical material implanted in thousands of women to treat issues such as urinary incontinence which has been under scrutiny globally following reports of serious long-term effects from it migrating, disintegrating, and damaging tissues.
Following two years of investigation, the Cumberlege Review was published on 8 July 2020, and made nine recommendations. Many have not been implemented or the Government have indicated they will not be implementing.
The following recommendations were made with the following outcomes:
An immediate and fulsome apology on behalf of the healthcare system to families affected by Primodos, Sodium Valproate and Mesh.
An apology was issued by Nadine Dorries, Minister of State for Mental Health, Suicide Prevention and Patient Safety on 8 July 2020. Despite the apology, the Government did not commit to any immediate action to implement the recommendations and stated that they would issue a full response to the Review ‘as soon as possible’.
The appointment of an Independent Patient Safety Commissioner (IPSC)
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. The Cumberlege Review highlighted that a IPSC should have powers to advocate and act from a patient perspective. The principal objective of the MMDA is that regulations relating to human medicines and medical devices must safeguard public health. The MMDA states the IPSC’s core duties will be:
- Promoting the safety of patients with regard to the use of medicines and medical devices
- Promoting the views of patients and other members of the public in relation to the safety of medicines and medical devices.
Given the importance of the role of the IPSC, Baroness Cumberlege requested reassurances that the IPSC should be able to seek information from any public body, and that manufacturers of medicines and medical devices should be required to cooperate and share information with the Commissioner. These requirements, together with other core duties including preparing and publishing a set of principles and taking reasonable steps to involve patients in the discharge of the Commissioner’s core duties, are set out in Schedule 1 to the Act.
Although we do not yet know who will be appointed and when the appointment will be made. The creation of the IPSC is a significant step forward for patient rights. The First Do No Harm All Party Parliamentary Group has indicated that The Department of Health & Social Care expects to soon (likely in May 2021) launch a public consultation on the matters that will be contained in the secondary legislation pertaining to the IPSC role and scope.
A new independent Redress Agency for those harmed by medicines and medical devices, administered on a non-adversarial process
In 1979 the Pearson Commission envisaged some form of ‘no-fault’ compensation scheme for drug injury and the Vaccine Damage Payment Scheme (VDPS) was the result. The range of vaccines covered by the Scheme has been extended to include COVID-19 vaccines. However the vaccine damages payment maximum of £120,000 is only available to a person who suffers 60 per cent disability as a result of a vaccine (and does not make payment for damage caused by other medicines or devices). Commentators have argued that the payment is woefully inadequate when compared to the redress which would be provided via a civil claim.
At the time of its creation the VDPS was set to be a temporary measure intended to be expanded by a later more comprehensive scheme involving contributions by manufacturers to fund a pool which would be used to compensate those injured by medicines. That expansion of the VDPS never came into fruition and is unlikely to do so. In a written statement to Parliament on 11 January 2021, Nadine Dorries set out that the Government has “no current plans to establish a redress agency” on the basis that the Government and industry have previously established redress schemes without the need for an additional agency.
It has been highlighted for decades that pharmaceutical companies who derive significant profits from having access to the UK market do not contribute to the costs of redress when their products cause harm. Those costs are met by the family and the tax payer in the form of benefits and medical services provided by the NHS.
A cost-of-care-scheme for the three products considered by the review: to allow for discretionary payments to meet the cost of additional needs caused by avoidable harm
The recommendation is that this should be set up promptly given “patients have waited far too long for redress”.
The redress schemes for Sodium Valproate, mesh, and HPTs remain under consideration. Careful consideration was undertaken by Baroness Cumberlege and her team when making these recommendations, without timescales of how and when reparations will be made, the suffering caused to injured people and their families is being compounded.
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
The Government continues to consider the second part of Recommendation five, in respect of those adversely affected by medicines in pregnancy. With the recent report from MBRRACE highlighting the multiple and complex problems that affect women in pregnancy including race, social circumstances, physical and mental health, in establishing a network of centres, the opportunity could be taken to create centres which take a holistic view of the provision of medical care, support and information in pregnancy.
Substantial revision of the MHRA, particularly in relation to adverse event reporting and medical device regulation
The MHRA should demonstrate how patient views have been taken into account and there should be a system-wide healthcare intelligence unit to facilitate early signal detection.
Similar recommendations were made for a Review of the MHRA by Lord Howe following the PIP Breast Implant Scandal (where implants had been filled with industrial grade rather a medical grade silicone). Lord Howe concluded that although the MHRA was found to have acted reasonably and appropriately, serious lessons had to be learned by the MHRA to:
- Identify ways of gathering better evidence on the safety of devices;
- Broaden its approach to analysing reported problems with higher-risk medical devices;
- Find better ways of communicating with the public.
Almost a decade on, the same calls are being made.
It has been highlighted that the MHRA has already begun a substantial programme of work to change the culture of the agency by listening and responding to patients, utilising scientific evidence and becoming more open and transparent.
Central, patient-identifiable databases: Publicly searchable database of adverse events for medicines and devices with a dual focus on reporting on device safety and patient reported outcome measures
It has long been the case that there is a need for proper monitoring of devices long-term. How the registries are kept, monitored, and funded will require ongoing scrutiny to ensure the systems which are to be put in place are fit for purpose. It is clear that the introduction of a new registration system to improve the oversight of medical devices in the UK is on the MHRA agenda this being part of the strategic goals detailed in the 2020-2021 MHRA Business Plan. The Department of Health and Social care has prepared a policy paper on ‘How a medical device information system might work in practice’. The policy paper sets out the intention that the registries will be comprehensive, and look not only at device usage and traceability, but also clinical outcomes.
Transparency of payments made to clinicians
The GMC register to be expanded to include non-financial and non-pecuniary interests, with mandatory reporting for pharmaceutical and medical device industries of payments made to teaching hospitals, research institutions and clinicians.
The review identified concerns that clinicians have been incentivised by manufacturers which may influence their practice and use of certain medicines or devices. A written statement from 25 January, 2021 sets out that the Government is considering this recommendation. Implementation of this recommendation is imperative. Transparency will ensure that patients can be better informed when making decisions regarding their treatment when they are able to consider all the factors.
Task force to implement Review recommendations
Patients across the NHS and private sector must have a clear, well-publicised route to raise their concerns about aspects of their experiences in the healthcare system. Review heard of “frustration at the lack of a clear pathway for them to make a complaint or raise concerns about aspects of their care”.
The Government’s written statement of 25 January, 2021 confirms that it has no plans to establish an independent taskforce and highlights that a working group has already been set up.
The above review on where we are with the recommendations highlights that despite a root and branches review which resulted in stringent recommendations, politicians have the ability to the ignore, dismiss or postpone the actions they take in the face of advice given to them.
An All Party Parliamentary Group named ‘First Do No Harm’ has been established following the Cumberlege review. The APPG carries with it the hope and weight of hundreds of families that their voices will be heard and their needs met.
Support in Lords for Cumberlege Review recommendations
Lawyers representing families who want to see the Cumberlege Review recommendations actioned as soon as possible say they are encouraged by support voiced in the Lords debate on the Medicines and Medical Devices Bill today.
Sodium Valproate patient groups will press for action on Cumberlege Review recommendations
Groups representing families affected by the use in pregnancy of the epilepsy drug, Sodium Valproate, are determined to press on to see the recommendations of the Cumberlege Review fulfilled as soon as possible.
Cumberlege Review: Sodium Valproate organisations' response to First Do No Harm report
Groups representing families affected by the use in pregnancy of the epilepsy drug Sodium Valproate have delivered their response to the Cumberlege Review, published July 8.