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Related reading Patient Safety Spotlight interview with Marie Lyon, chair of the Association for Children Damaged by Hormone Pregnancy Tests

The Independent Medicines and Medical Devices Safety (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 have 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] Over two years on from the publication of the IMMDS Review’s report, First Do No Harm, the Health and Social Care Select Committee has today published a new report reviewing the implementation of its recommendations to date.[2] The Review made nine overarching safety recommendations, of which the Government accepted four in full, two in part, one in principle and rejected two.[3] Following an evidence session held on 13 December 2022, the Health and Social Care Select Committee’s report focuses specifically on two of the three medical interventions considered by the IMMDS Review, sodium valproate and pelvic mesh implants, and makes recommendations for Government action on these issues. Implementing recommendations The Committee’s report highlights the need to ensure that the below recommendations of the IMMDS Review, which the Government accepted, are fully implemented: That the Medicines and Healthcare products Regulatory Agency (MHRA) substantially revises its approach, particularly in relation to adverse event reporting and medical device regulation and ensures that it engages more with patients and their outcomes. A central patient-identifiable database should be created by collecting key details of the implantation of all devices at the time of the operation. That it sets up a register of clinicians’ interests and ensures this includes financial and non-pecuniary interests for all doctors. That it establishes a register of industry payments to clinicians. Ensuring that the MHRA is responsive to patients and their outcomes is a long-term piece of work. The MHRA has come forward with numerous activities aimed at improving its approach in this respect, including the introduction of a new Patient Involvement Strategy.[4] While the jury is still out on what the impact of this will be, Patient Safety Learning believes that to meet the Review’s recommendation will require more than just increased patient involvement; it will mean meeting patients’ expectations that healthcare products are safe and that patients are free from avoidable harm. Turning to the creation of a central patient-identifiable database and a register of industry payments, there has been a lack of significant progress on these recommendations to date. However, pilot work on the register of clinicians’ interest has taken place and it has been stated by the Minister Maria Caulfield MP that implementation of this will begin in 2023. On each of these recommendations, we support the Committee’s calls for increased urgency by the Government in regards to their implementation. We also believe that there should be openly published timetables setting out plans for this. You can read more about the importance of registering of clinicians interests, industry payments to clinicians and the need for greater transparency and reporting around financial conflicts of interest in healthcare in a blog on the hub by Sling the Mesh founder Kath Sansom.[5] Redress A central focus of the report is the need for greater support for the women and children affected by the medical interventions covered by the IMMDS Review. Related to this, one of the key recommendations of the Review was to establish a new independent Redress Agency for those harmed by medicines and medical devices. It was envisioned that: “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.”[1] However, the Government rejected this recommendation, along with a recommendation to establish separate redress schemes for patients adversely affected by hormone pregnancy tests, sodium valproate and pelvic mesh. Instead they pointed towards patients having the right to take healthcare providers to court through clinical negligence, or manufacturers through product liability. Patient Safety Learning believes, like many individual patients and patient groups, that this response was wholly unsatisfactory. A new blog published on the hub this week highlights how for many harmed patients affected by the interventions considered in the report the clinical negligence route simply is not viable.[6] In the absence of any system of redress, this leaves them with no assistance to help meet the cost of any additional care and support they may need. The Committee’s report notes that the Minister Maria Caulfield MP has indicated that she is willing to look at the idea of a Redress Agency, as well as separate redress schemes. We would welcome this and support the Committee’s call for a formal statement on this with “more details on what such a review would include and seek to achieve, and timeline for completion”.[2] Audit of mesh patients Another recommendation of the IMMDS Review was for a retrospective audit of women who had pelvic mesh surgery, to help gain a fuller understanding of the nature and extent of mesh associated complications, with this data informing decisions over future pelvic mesh surgery. The Committee’s report notes that while this audit is underway, there are significant concerns that it is failing to adequately capture mesh related complications due to the data it draws on. The report therefore recommends that the Government “consider an alternative strategy for how to pro-actively contact those who have had the procedure about their post-operative experiences and possible side effects.”[2] Patient Safety Learning supports this recommendation, which echoes the IMMDS Review’s intentions that as part of this audit: “Every effort should be made to obtain sufficient data, and the audit results (assuming it is feasible) should be used to inform decisions over the future of pelvic mesh surgery.”[1] Patient Safety Commissioner The Committee’s report also stresses its support for the work of the new Patient Safety Commissioner for England, Dr Henrietta Hughes, urging the Secretary of State to ensure her duties and responsibilities are not impeded by a lack of resource for and within her office. It suggests that any additional work she may be tasked with relating to reviewing redress arrangements should be accompanied by additional resources. Patient Safety Learning supports this recommendation. The Patient Safety Commissioner can play an important role in helping to tackle unsafe care and empowering patients; however, her office must have the necessary resources and support to achieve this as indicated by the Select Committee. Engaging with patients At Patient Safety Learning, we believe that patient engagement is key to improving patient safety and identify this as one of the six foundations of safer care in our report, A Blueprint for Action.[7] Patients should be engaged for safety at the point of care, if things go wrong, in improving services, advocating for changes and in holding the system to account. We concur therefore with the Committee’s calls for the Department of Health and Social Care to improve its approach to this, following concerns raised by patients and patient groups: “We are concerned that although the letter from the Department seems to outline various interactions and consultations with stakeholders, and mentions Sling the Mesh by name, this is not the experience of some patients. Patient input is vital in setting up care schemes such as this one. We therefore urge the Department to reflect on the experience of some of the stakeholders with lived experience in this instance, and to consider how to improve engagement with them in the future.”[2] Hormone pregnancy tests One area of disappointment though that we would note with the Select Committee’s report is that it does not consider any of these issues in relation to patients and family members affected by hormone pregnancy tests, one of the three interventions covered by the IMMDS Review. They state that they were unable to do so due to ‘ongoing litigation’. Patient Safety Learning does not believe this is acceptable. Many of the issues covered by this review, such as reforms to the MHRA, a register of clinicians’ interests and industry payments and potentially revisiting proposals for an independent Redress Agency, equally concern those affected by hormone pregnancy tests. While this may be complicated in some areas by ongoing legal proceedings, the exclusion of this group of patients is in our view impossible to justify. You can read more about this issue, and the work being done by patients and groups to fight for justice and improve patient safety, in an interview on the hub with the Chair of the Association for Children Damaged by Hormone Pregnancy Tests, Marie Lyon.[8] References The IMMDS Review, First Do No Harm: The report of the Independent Medicines and Medical Devices Safety Review, 8 July 2020. Health and Social Care Select Committee, Follow-up on the IMMDS report and the Government’s response: Sixth Report of Session 2022-23, 20 January 2023. Patient Safety Learning, A year on from the Cumberlege Review: Initial reflections on the Government’s response, 23 July 2021. MHRA, Patient Involvement Strategy 2021-25, 1 October 2021. Kath Sansom, No such thing as a free lunch – why recording conflicts of interests must be mandatory, 9 April 2021. Kath Sansom, The difficult of medical negligence cases and why financial redress from the Government is so important for mesh victims, 17 January 2023. Patient Safety Learning, The Patient-Safe Future: A Blueprint for Action, 2019. Patient Safety Learning, Patient Safety Spotlight interview with Marie Lyon, chair of the Association for Children Damaged by Hormone Pregnancy Tests, 22 February 2022.

This report follows on from an evidence session held by the Select Committee on the 13 December 2022 to assess the Government’s progress against recommendations made in the Independent Medicines and Medical Devices Safety (IMMDS) report, First Do No Harm. This featured contributions from the Government Minister Maria Caulfield MP, patients and patient groups, and representatives from NHS England and the Medicines and Healthcare products Regulatory Agency (MHRA). Summary of the reports recommendations The Government should: Urgently ensure that the accepted recommendations 6 and 7 of the IMMDS review are fully implemented. Consider an alternative strategy for how to pro-actively contact pelvic mesh patients who have had the procedure about their post-operative experiences and possible side effects. Make the arrangements necessary to ensure the register of clinicians’ interests can be set up swiftly, subject to the pilot phase concluding, to prevent further delay. Move at pace to bring in the necessary secondary legislation to set this up a register of industry payments to clinicians. Ensure that the Patient Safety Commissioner for England’s ability to carry out her important role, as her duties and responsibilities is more clearly defined, is not impeded by a lack of resource for and within her office. The Department of Health and Social Care should: Respond to concerns raised about interactions and consultations with stakeholders around care schemes stemming from the review, reflecting on this experience and considering how to improve engagement with them in the future. The Secretary of State for Health and Social Care should: Make a statement detailing the Patient Safety Commissioner’s review of redress schemes for the medical interventions dealt with by the IMMDS review, and what additional resources will be made available to her to undertake it. The Minister for Mental Health and Women’s Strategy should: Make a statement on the review of redress and a possible Redress Agency, with more details on what such a review would include and seek to achieve, and timeline for completion.

What is an Early Day Motion? Early Day Motions are motions submitted for debate in the House of Commons for which no day has been fixed, and as such very few are debated. They are used to put on record the views of individual MPs or to draw attention to specific events or campaigns. By attracting the signatures of other MPs, they can be used to demonstrate the level of parliamentary support for a particular cause or point of view. Early Day Motion 349: Financial redress for victims of surgical mesh, sodium valproate and hormone pregnancy tests This Early Day Motion has been signed by Sarah Green, Jim Shannon and Jonathan Edwards. It reads as follows: That this House regrets the avoidable harm caused by the use of surgical mesh, Primodos and Sodium Valproate; acknowledges the need to support the hundreds of victims in the UK suffering as a result of these interventions; welcomes the recommendations made by Baroness Cumberlege in her 2020 report on the IMMDS Review; notes that recommendation 4 of this report calls for the establishment of separate schemes to meet the costs of additional care and support to those who have suffered avoidable harm; regrets that in the two years since the report's publication, the Government has refused to accept this recommendation; further regrets the suggestion that victims should pursue legal routes to compensation, which fails to recognise the adversarial nature and inaccessibility of litigation; and calls on the Government to establish separate schemes to provide financial redress to the victims of surgical mesh, sodium valproate and hormone pregnancy tests, as recommended by the Cumberlege report. Related reading Independent Medicines and Medical Devices Safety Review, First Do No Harm, July 2020 Independent Medicines and Medical Devices Safety Review: A joint letter from the Association for Children Damaged by Hormone Pregnancy Tests, Sling The Mesh and In-Fact, 17 February 2022 Patient Safety Learning, A year on from the Cumberlege Review: Initial reflections on the Government’s response, 23 July 2021 Early Day Motion - Implementation of the Independent Medicines and Medical Devices Safety Review recommendations

If you have had vaginal mesh surgery as an NHS patient in England and have suffered any of the above symptoms/problems, you may be able to make a claim against the NHS. In addition to side effects, you may be able to claim for implants that were not inserted correctly and/or on the basis that you were given the wrong information or advice. On the NHS Resolution website you can find more information on making a claim and details of organisations which can help you find a medical negligence solicitor who can guide you through the process and let you know if you have a valid claim.

On 22 September 2021 the Health and Social Care Select Committee launched a new inquiry examining the case for reform of NHS litigation, identifying concerns regarding a significant increase in clinical negligence costs and missed opportunities for learning to improve patient safety. The Committee stated that the existing system was “failing to meet its objectives for both families and the healthcare system”.[1] Here we will provide an overview of our response to this Inquiry, which focused on four key areas: Learning from avoidable harm in healthcare Improving redress for patients The role of the Healthcare Safety Investigation Branch Financial burden of avoidable harm and resulting litigation You can read our written evidence in full here [2] Learning from avoidable harm in healthcare In our report, A Blueprint for Action, we set out what we believe is needed to progress towards a patient-safe future, identifying six foundations of safe care.[3] Sharing learning to improve patient safety is one of those six foundations. For patients to be safer, we believe that people and organisations need to share learning when they respond to incidents of avoidable harm, and when they develop good practice for making care safer. Incidents in healthcare that result in clinical negligence claims often present a significant opportunity for learning, through the process of investigating what went wrong and the actions needed to prevent harm reoccurring. Insights from these cases may often be applicable beyond the organisation in which the incident took place and provide a point for wider system learning. NHS Resolution, the body responsible for providing expertise to the NHS on resolving concerns and disputes, play a key role in this. When clinicians are contacted as experts on litigation cases by a representative from the NHS Resolution ‘Panel of Solicitors’ they are asked to feedback any general points of learning to be shared across the NHS. In our response to the Inquiry, we explained that it is our understanding that NHS Resolution takes this learning and feeds it back into the system primarily: Through their members – sharing information with NHS Resolution member organisations on individual cases, which can be used to subsequently inform their own organisational clinical governance and patient safety processes. For wider learning – these inform NHS Resolution’s in-depth reviews and studies on specific subject areas, such as their guide published with the Getting It Right First Time programme to support learning from clinical negligence claims, and their thematic review Learning from suicide-related claims.[4] [5] NHS Resolution have advised us that due to the nature of the information involved in clinical negligence cases, for a combination of privacy, personal sensitivity, and legal reasons they are limited in the ways they can share these insights for learning and improvement. We stated in our response that although there is clearly a degree of complexity involved with sharing such insights more widely, Patient Safety Learning believes that we are missing an enormous and valuable opportunity to extract significant system-wide learning that should improve patient safety. We believe that that insights from litigation could be used to inform regular publicly available reports which could help to: Share rapidly valuable information and opportunities for learning from litigation. Enable the Department of Health and Social Care, NHS England and NHS Improvement, Care Quality Commission, Healthcare Safety Investigation Branch, the incoming Patient Safety Commissioner’s in England and Scotland, and others to identify emerging patient safety trends/concerns. Impact of the new Patient Safety Incident Response Framework Another area we highlighted in our Inquiry response concerned learning from avoidable harm in healthcare, and how this interacts with NHS litigation, in the context of how organisations are expected to investigate error and harm through the new NHS Patient Safety Incident Response Framework.[6] The implementation of this framework, as currently proposed, will result in fewer investigations into harm. NHS organisations are being invited to consider other methods for learning such as thematic reviews and After Action Reviews. Implementation arrangements will need to be carefully managed to ensure that opportunities for learning and improvement will not be compromised nor will patients and families be frustrated in being informed of what happened and why following a patient safety incident/event. If patients and families do not feel that the new arrangements provide them with the answers they seek and are expected to be provided with as part of the Duty of Candour, we noted that this could also lead to the unintended consequence of an increase in complaints and even an increased chance of patients and families choosing to pursue litigation. Improving redress for patients Bound up with reform of NHS litigation is the issue of redress for avoidable harm in healthcare. Responding to the Inquiry we noted that the Government had recently set out a formal position on this issue through its response to the recommendations of the IMMDS Review (also known as the Cumberlege Review). The Review proposed the creation of an independent Redress Agency for those harmed by medicines and medical devices.[7] It suggested that this should be set up on an avoidable harm basis, focused on systematic failings, rather than blaming individuals, and provide an approach to make decisions using a non-adversarial process. In their full response to the Review's recommendations in July, the Government rejected this proposal.[8] In our response to this Inquiry, we outlined our concerns about the Government’s two main reasons for rejecting this proposal: 1. There is already an existing process in place where the Government can establish redress schemes for specific issues. We believe the existing process is likely to create inconsistencies in how patients injured by avoidable harm are treated. It is particularly hard to see how such a system can be seen as fair when there is no publicly available rationale or criteria provided to clarify what issues are considered as appropriate for redress. In the case of the example provided of the Infected Blood Support Scheme, it has taken 40 years of campaigning before this has been eventually announced. 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. 2. This would not make products safe or drive the right incentives for industry. The IMMDS Review makes the case for an independent Redress Agency as improving patient safety by encouraging greater reporting and transparency, supported by a non-adversarial process which looks to systematic failings, rather than blaming individuals.[7] In its response the Government simply fails to engage with this point or argument in a meaningful way. The need to reconsider redress We told the Committee that Patient Safety Learning believes that to improve the redress process the Government should reconsider its approach and engage more meaningfully with the proposal in the IMMDS Review. We believe there are several issues it would be worth considering as part of this: Benefit to harmed patients in having a straightforward process and is accessible to all, equally. Potential for learning and identification of new and emerging issues because of having claims run through a central body. Potential benefits and drawbacks of introducing a no-fault compensation scheme. A cost-benefit analysis on the type of Redress Agency proposed, as opposed to the existing approach. How this may support a more open and supportive culture in relation to how NHS organisations respond to complaints and whether this may help to move away from a defensive response in some cases. Ensuring that redress is not just focused solely on financial compensation but should be part of openly acknowledging mistakes, learning for improvement and healing, for patients, families and staff involved. The role of the Healthcare Safety Investigation Branch Patient Safety Learning is strongly supportive of the role of HSIB investigations in identifying factors that have harmed or may harm patients, and their safety recommendations aimed at improving healthcare systems and processes. In its Terms of Reference, the Inquiry asked how HSIB can improve short term responses to patient safety incidents and therefore reduce the number of those who are forced to pursue litigation as a means of obtaining non-financial remedies.[9] In our response we outlined two significant issues which may limit their ability of HSIB to reduce the number of incidents that lead to avoidable harm and thus reduce litigation: 1. Capacity for national investigations HSIB is significantly limited by its capacity, currently it is only able to conduct up to thirty national investigations a year. This requires a significant degree of prioritisation against their investigation criteria, which means that for many issues where avoidable harm continues to occur, they will simply not be able to investigate and make safety recommendations. In cases where HSIB does not have the capacity to investigate, patients and their families who raise issues are dependent on local investigations, where learning may stay siloed in the organisation in question, rather than shared more widely for national learning and action. 2. Implementation of recommendations When HSIB makes its safety recommendations, organisations are expected to respond within 90 days of publication of the investigation reports and HSIB subsequently shares these responses on their website. However, while organisations are required to respond, there is no compulsion for them to accept or implement HSIB recommendations. Furthermore, there is no system of oversight to monitor or assess the effectiveness or impact of implementation. Without such a system, it is difficult to assess the impact of a safety recommendation in terms of preventing a recurrence of patient safety incidents that may result in harm and then future litigation. We believe that this is a matter of huge importance; without this formal public accountability and oversight, it is difficult to see how patients can feel confident that action is being taken to address the systemic cause of errors that result in avoidable harm. Financial burden of avoidable harm and resulting litigation In our response to the Inquiry, we also reflected on the significant financial costs that accompanies avoidable harm in healthcare. The cost of settling claims in the NHS in 2020/21 came to £2.26 billion, with a further £7.9 billion spent on compensation claims settled in previous years.[10] We argued that the current costs of NHS litigation should be a clear signal to the Government that avoidable harm is not simply a serious health challenge, but also a major economic problem. The burden of costs are not only felt by the healthcare system in compensation costs, but also in the additional support that may be needed by harmed patients after an event and the indirect social cost of harm more generally.[11] While this remains unaddressed, scarce funds that could be spent to proactively improve the quality of care will instead be needed to deal with the cost of error and harm. We made the case that if we are to tackle the significant costs associated with this, we need to tackle the root cause of the problem. The most effective way to do this is to improve patient safety in healthcare, to reduce the level of avoidable harm, thus decreasing the associated costs of litigation, remedial support, and ongoing care. Conclusion In the conclusion of our response to the Inquiry, we noted that the issue of NHS litigation reform needs to be considered as part of a wider context, acknowledging that the main causes of unsafe care are systemic. Avoidable harm in healthcare has complex roots and to make real progress we need to address these underlying system issues. Patient Safety Learning believes that there needs to be a transformation in our approach to tackling this problem with patient safety being treated as core to the purpose of health and social care, not as one of several competing priorities to be traded off against each other. In our report, A Blueprint for Action, we set out an evidence-based analysis of why harm is so persistent and what is needed to deliver a transformation in our approach to patient safety.[3] Reform to NHS litigation forming a key part of this. 1. Health and Social Care Select Committee, New inquiry: NHS litigation reform, 22 September 2021 2. Health and Social Care Select Committee, NHS Litigation Reform: Written evidence submitted by Patient Safety Learning (NLR0059), 2 November 2021 3. Patient Safety Learning, The Patient-Safe Future: A Blueprint For Action. Report, 2019 4. GIRFT and NHS Resolution, Learning from Litigation Claims, May 2021 5. NHS Resolution, Learning from suicide-related claims: A thematic review of NHS Resolution data, September 2018 6. NHS England and NHS Improvement, Patient Safety Incident Response Framework, Last Accessed 19 October 2021 7. The IMMDS Review, First Do No Harm, July 2020 8. Department of Health and Social Care, Government response to the Report of the Independent Medicines and Medical Devices Safety Review, 26 July 2021 9. Health and Social Care Select Committee, NHS litigation reform: Terms of Reference, Last Accessed 1 November 2021 10. NHS Resolution, Annual report and accounts 2020/21, 15 July 2021 11. OECD and Saudi Patient Safety Center, The Economics of Patient Safety. From analysis to action, 21 October 2020