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The Maternity and Newborn Safety Investigations (MNSI) programme is part of a national strategy to improve maternity safety across the NHS in England. MNSI has completed over 3500 independent safety investigations, using system focused methodology, into maternity events, including direct and indirect maternal deaths in pregnancy and up to 6 weeks postpartum. This webinar will explore a thematic analysis of safety investigations into Sudden Unexplained Death in Epilepsy (SUDEP). Speakers: Dr Charlotte Frise Dr Louise Page Joanna Girling Emily Barrow Register for the webinar

This week the Department of Health and Social Care released the UK Government’s response to the recommendations of the Independent Medicines and Medical Devices Safety Review, sometimes referred to as the Cumberlege Review. In this blog Patient Safety Learning sets out its reflections on this.   A year on from the publication of First Do No Harm, the report by the Independent Medicines and Medical Devices Safety (IMMDS) Review, the Government released its full response to the Review's recommendations.[1] [2] Published alongside this was the report from the independent Patient Reference Group, established to provide advice, challenge and scrutiny to the work developing the Government’s response.[3] The IMMDS Review examined the response of the healthcare system in England to the harmful side effects of three medical interventions: Hormone pregnancy tests, Sodium valproate and Pelvic mesh implants. These interventions had resulted in a truly shocking degree of avoidable harm to patients over a period of decades, with the Review describing the healthcare system’s response to this as ‘disjointed, siloed, unresponsive and defensive’.[1] Responding to the Review in full this week, the Government has accepted four of its over-arching recommendations, accepted two in part, accepted one in principle, and rejected two. It has also accepted or accepted in principle 46 of 50 ‘Actions for Improvement’ included in the Review. In this blog we will consider the Government’s response in more detail, setting out our initial reflections on this. Structure of this blog In outlining our reflections on the Government’s response to the IMMDS Review, we have focused on several key areas: Redress Support, care, and treatment Medicines and Healthcare products Regulatory Agency Transparency of industry payments to clinicians and organisations Implementation for impact When discussing each area above, we will briefly outline the relevant recommendations of the Review and the Government’s response on these issues. We will also note the reflections of the independent Patient Reference Group, which our Chief Executive, Helen Hughes, was a member of in a personal capacity.[4] It should be noted that in setting out our initial reflections on this one area we have purposely not included is recommendations for the establishment of a Patient Safety Commissioner. We have previously set out our thoughts on this responding to the consultation for establishing such a role in Scotland and in the coming weeks we will be sharing our full response to the proposals currently being consulted on in England.[5] Redress The IMMDS Review made two recommendations on the issue of redress: 1. Creating a new independent Redress Agency for those harmed by medicines and medical devices. 2. Establishing separate redress schemes for patients adversely affected by Hormone pregnancy tests, Sodium valproate and Pelvic mesh. The Government response rejects both these recommendations. Concerning a new Redress Agency, they say that this is not necessary as they can already establish redress schemes without this, and state that they do not believe that this ‘would necessarily make products safer or drive the right incentives for industry’.[2] In explaining their refusal to establish separate redress schemes for the three medical interventions, they point towards patients instead having the right to take healthcare providers to court through clinical negligence, or manufacturers through product liability. The Government’s response here was directly at odds with the feedback it received from the independent Patient Reference Group. In their report, they: Disputed the notion that litigation is a viable substitute for redress for those who have suffered from avoidable harm. They highlighted that many patients do not know how to seek compensation for harm and can’t access the required legal support. Noted the importance of setting up separate schemes for each intervention, stating that ‘redress is more than financial compensation; it shows regret and willingness to accept responsibility’.[3] Our reflections Patient Safety Learning believes the Government’s response to the recommendations of the IMMDS Review concerning redress is wholly unsatisfactory. The Government say they can provide redress on specific issues where this is ‘considered necessary’.[2] However for patients and the public there does not appear to be a clear rationale or set of criteria for making these decisions. It has taken 40 years of campaigning for the Government to just recently announce a process to consider compensation for victims of the contaminated blood scandal.[6] It is hard to see how harmed patients can have confidence that the existing approach to considering decisions on redress is transparent, fair, consistent, or timely. Turning to decision not to set up separate schemes for each intervention, we were particularly dismayed by the statement: ‘While the government is sympathetic to the experiences of those patients who gave evidence to the report, our primary focus is on improving future medicines and medical devices safety’[2] We do not accept the implication that providing appropriate redress for harmed patients and making future patient safety improvements are mutually incompatible. It is insulting to those that have suffered to suggest that the Government and the healthcare system should only focus on future changes needed and not be concerned about those have been harmed. If the Government is to make its apology to patients genuine and meaningful, there must be redress as well as learning for action and improvement. As noted by the former Prime Minister Theresa May MP in the recent House of Commons debate on this: ‘… redress is about far more than compensation. It is about relating to the real impact that the use of these medicines and medical devices has had on people’[7] Support, care, and treatment In its response the Government stated that it partially accepted a recommendation from the IMMDS Review to set up networks of specialist centres for those affected by implant mesh and separately for those adversely affected by medications taking during pregnancy. Their response notes there are now eight specialist mesh removal services. However, on the issue of medications taken during pregnancy, they say that such centres are not the best approach, indicating that instead they are focused on improving care pathways and ensuring that valproate is only prescribed when clinically appropriate. Commenting on this area of the IMMDS Review, the Patient Reference Group noted: There is significant work still needed to improve the specialist mesh centres, such as ensuring that data is collected on patient outcomes from these services. They expressed their support for some type of ‘local or at the very least regional’ services for those affected adversely by medications taken during pregnancy, to help ensure that those affected received the same care and treatment no matter where they live.[3] Our reflections Patient Safety Learning agrees with the points made by patient groups such as Sling the Mesh on the need to resolve further issues relating to specialist mesh removal centres. They have flagged several issues around the existing services that need to be looked at, including: Training requirements for mesh removal. Patient outcome logging after mesh removal. Addressing patient concerns about the surgeons responsible for implanting mesh being the same surgeons undertaking mesh removal on the same patients. Patients are not being provided with assurance of their clinical competence on this highly specialised remediation work and that adequate training and clinical review is in place. Concerning support for those adversely by medications taken during pregnancy, if specialist centres are not the way forward then we believe the Government needs to be make clearer what action it is taking to address patient concerns about existing access to diagnosis and treatment. There must not be a postcode lottery of these services. It is important in our view that the Government engages and works closely with patient groups related to Sodium valproate and Hormone pregnancy tests on this issue. Medicines and Healthcare products Regulatory Agency The IMMDS Review highlighted several patient safety concerns relating to the role of the Medicines and Healthcare products Regulatory Agency (MHRA). It stated that the adverse event reporting and medical device regulation required significant revision and advised that the MHRA needed to ‘ensure that it engages more with patients and their outcomes’.[1] The Government’s response fully accepts the Review’s recommendation calling for change at the MHRA. It then proceeds to outline a range of activities now being undertaken by the MHRA to improve its approach to patients, adverse event reporting and strengthening its regulatory approach. Discussing the need for reform of the MHRA, the Patient Reference Group in its report noted: The MHRA’s approach to patient engagement needs to become meaningful, to avoid being seen as simply a ‘tick box exercise’.[3] Reporting of adverse events for all devices and medicines must be mandatory. The importance of clear financial penalties for non-compliance to ensure manufacturers act in the interests of patients. Our reflections We have recently responded to the MHRA directly with our patient safety reflections on one of the activities associated with the Government’s response, their proposed Patient and Public Involvement Strategy.[8] Our Chief Executive Helen Hughes has also provided comments directly to the MHRA as a member of the independent Patient Reference Group on their proposed Delivery Plan for 2021-2023 which is referenced in the Government’s response.[9] The MHRA now has a stated ambition to become ‘a Patient focused regulator’.[10] Patient Safety Learning believes that achieving this will require more than just increased patient involvement, it will mean meeting patients’ expectations that healthcare products are safe, and patients are free from avoidable harm. Patient safety is not just about the safety of the product but its “safety in use”. There needs to be greater clarity about MHRA’s role and how it engages with the wider healthcare system to achieve this. We also note that there has been a failure to acknowledge or address the serious criticism of the MHRA's organisational culture in the IMMDS Review. Culture change is about more than staffing, governance, structures, and processes. It is also about leadership, behaviour, and psychological safety. There isn’t yet a clear picture of how the much-needed cultural change will be delivered. The MHRA has recently appointed a new Chief Safety Officer to support its work.[11] While this is a welcome development, there also needs to be explicit commitment to a focus on patient safety by the senior leadership of the MHRA; organisational culture is a Board and Executive leadership responsibility. Transparency of industry payments to clinicians and organisations Another key issue raised by the IMMDS Review is the need for great transparency around payments made to clinicians, as well as a call for mandatory reporting of pharmaceutical and medical device industry payments made to teaching hospitals, research institutions and individual clinicians. In their response, the Government agrees that all healthcare professionals should declare their relevant interests, with this information published locally at an employer level. On industry reporting it says it that it accepts the need for stronger reporting and is ‘exploring options to expand and reinforce current industry schemes, including making reporting mandatory through legislation’.[2] However there are no specific actions associated with the latter point in their response. Reflecting on this issue, the Patient Reference Group noted: Mandatory reporting for industry should be a priority. The importance of enforcing compliance, that ‘patients need to know there is intent to make this recommendation mandatory and enforce penalties’.[3] Our reflections Patient Safety Learning concurs with the Patient Reference Group about the need for mandatory reporting and clear systems of compliance and accountability. Recently on the hub we shared a blog where Kath Sansom from Sling the Mesh outlined a range of recommendations to strengthen the regulatory approach in this area.[12] Specifically considering the Government’s comments on industry reporting requirements, while we welcome the recognition that these need to improve, we believe the next steps outlined in this response are too vague. There need to be clear actions, deliverables, and timeframes that form part of a wider implementation plan, which we discuss further below. Implementation for impact The Government did agree to implement a recommendation by the IMMDS Review that it ‘should immediately set up a task force to implement this review’s recommendations’.[1] In their response they said that as is standard practice with such inquiries, they would review the recommendations and decide how they were taken forward. This IMMDS recommendation was not put forward for consideration by the Patient Reference Group. Discussing the implementation of the recommendations, the Department of Health and Social Care state: ‘The government is committed to making rapid progress on all of the areas set out in this response, and we will publish an update on progress to implement the government response in 12 months’ time’[2] Our reflections They set out several key deliverables over the next 12 months, only some with suggested completion dates. We believe at present this is too little information to provide patients with assurance that a robust response to this report has been developed or put into action. Patient Safety Learning believes that implementation of the IMMDS Review’s recommendations needs clear oversight and leadership. As noted in the introduction, in addition to the key recommendations the Government has accepted 46 of the Review’s ‘Actions for Improvement”’. However, outside the deliverables mention in the previous paragraph, the implementation of a number of these remains unclear, for example in the two cases below: Creation of a system-wide healthcare intelligence unit – the Government accept this in principle, and in their response state they ‘will look into this matter further in collaboration with other system wide healthcare bodies’.[2] There is no indication about the process or timeline for this. Further research into the safety of pelvic mesh – the Government accept this in principle and mentions that the National Institute for Health Research welcomes funding applications into such issues. However, in the next steps it refers to a broader study of urogynaecological services funding by the NIHR, but offers no action or timeframe related to research plans specifically into the safety of Pelvic mesh. Too often in the past twenty years we have seen important patient safety reports published with a range of recommendations that are accepted by the Government of the day, but years later, many of these remain only partially implemented. Worse still, future reports into avoidable harm reach the same conclusions and suggest similar recommendations for action. We believe it is vital that this does not happen in the case of the IMMDS Review. There needs to be a clear implementation plan which includes all actions that have been accepted, accepted in principle, and accepted in part. For each action, there needs to be: Details of which individual/team/organisation is responsible for the activity. An indication of which organisations are required to deliver this. One or more clear deliverables that would indicate this has been completed. A timeframe for completing each deliverable. An evaluation framework that assesses impact and whether the action taken has delivered the results needed to prevent future avoidable harm. This information should be publicly reported so that harmed patients and the public can see the actions that have been taken, identify where more is needed and evidence that commitments have been delivered. We believe this is crucial if harmed patients and the wider public are to be confident that the healthcare system can learn from these experiences and act to improve patient safety. Patient Safety Learning believes that a formal implementation plan needs to have the commitment of the organisations tasked with acting as part of effective safety system, with clear accountability and arrangements. It is vital that this is monitored by a specific team within the Department of Health and Social Care, if Ministers are to live up to their statement at the start of their response when they say that the Government will ‘learn the lessons and get everyone the care and protection they deserve’.[2] References 1. The IMMDS Review, First Do No Harm, 8 July 2020. 2. Department of Health and Social Care (DHSC), Government response to the report of the Independent Medicines and Medical Devices Safety Review, 21 July 2021. 3. The IMMDS Review Patient Reference Group, Independent Report of the Patient Reference Group, 21 July 2021. 4. Traverse, Independent Medicines and Medical Devices Safety Review: Patient Reference Group – Group Membership, Last Accessed 23 July 2021. 5. Patient Safety Learning, Patient Safety Commissioner for Scotland: Consultation Response, 9 July 2021. 6. Cabinet Office, Infected blood compensation framework study: consultation on terms of reference, 14 June 2021. 7. House of Commons, Independent Medicines and Medical Devices Safety Review – Volume 698, 8 July 2021. 8. Patient Safety Learning, Becoming ‘a patient focused regulator’? MHRA Patient and Public Involvement Strategy, 1 July 2021. 9. MHRA, Medicines and Healthcare products Agency Delivery Plan 2021-2023, 4 July 2021. 10. MHRA, Proposed Patient and Public Involvement Strategy 2020-25, 24 May 2021. 11. MHRA, MHRA announces appointment of Chief Safety Officer, 4 May 2021. 12. Kath Sansom, No such thing as a free lunch – why recording conflicts of interest must be mandatory, 9 April 2021

This report is from the Patient Reference Group established to provide advice, challenge and scrutiny to work to develop the government response to 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. The Department of Health and Social Care established a Patient Reference Group to provide advice, challenge and scrutiny to work to develop the government response to the First Do No Harm report. Its independent end-of-project report sets out the Patient Reference Group’s reflections on the IMMDS Review report’s recommendations and patient experience and engagement more widely. The report below has been published alongside the government response to the recommendations of the IMMDS Review. Related reading 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)

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. Related reading 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)