First Do No Harm The report of the Independent Medicines and Medical Devices Safety Review © Crown copyright 2020 This publication is licensed under the terms of the Open Government Licence v3.0 except where otherwise stated. To view this licence, visit nationalarchives.gov.uk/doc/open-government-licence/version/3 Where we have identified any third party copyright information you will need to obtain permission from the copyright holders concerned. This publication is available at www.gov.uk/official-documents. Publication date: 8 July 2020 Printed on paper containing 75% recycled fibre content minimum Printed in the UK by the APS Group First Do No Harm – The report of the Independent Medicines and Medical Devices Safety Review Letter to the Secretary of State from Baroness Cumberlege 8th July 2020 Dear Secretary of State I publish this report at a time when the NHS has been facing enormous challenges arising from the Covid-19 pandemic. NHS staff have risen to those challenges, proving day after day their ability to provide excellent care often in the most testing of circumstances. All of us have, quite literally, applauded them for their tireless commitment. This Review, however, has been about people who have suffered avoidable harm. Our report is entitled “First Do No Harm”. Having spent two years listening to heart wrenching stories of acute suffering, families fractured, children harmed and much else, I and my team thought it an appropriate title. It is a phrase that should serve as a guiding principle, and the starting point, not only for doctors but for all the other component parts of our healthcare system. Too often, we believe it has not. Throughout I have valued the commitment, wise advice and integrity of Sir Cyril Chantler and Simon Whale. The three of us were the Review Panel and the decision makers. Dr Valerie Brasse, our gifted secretary, led the small support team to whom we are hugely grateful. The three areas we were asked to explore, Primodos, sodium valproate and pelvic mesh, were new to us so we travelled the country, not only England but Scotland, Wales and Northern Ireland. We met and listened to over 700 people, mostly women, often accompanied by their partners, other family members and sometimes their children. We are indebted to all of them. Their dignity and courage in telling us intimate and harrowing details of their damaged lives has made a great and lasting impression on us. The patient groups, some of whom have campaigned for decades, have been invaluable to us; well informed, knowledgeable, and research based. They never failed to ensure we learnt from them and were up to date with emerging developments. They are outstanding communicators and expert in the subject matter. We have found that the healthcare system – in which I include the NHS, private providers, the regulators and professional bodies, pharmaceutical and device manufacturers, and i First Do No Harm – The report of the Independent Medicines and Medical Devices Safety Review policymakers – is disjointed, siloed, unresponsive and defensive. It does not adequately recognise that patients are its raison d’etre. It has failed to listen to their concerns and when, belatedly, it has decided to act it has too often moved glacially. Indeed, over these two years we have found ourselves in the position of recommending, encouraging and urging the system to take action that should have been taken long ago. The system is not good enough at spotting trends in practice and outcomes that give rise to safety concerns. Listening to patients is pivotal to that. This is why one of our principal recommendations is the appointment of an independent Patient Safety Commissioner, a person of standing who sits outside the healthcare system, accountable to Parliament through the Health and Social Care Select Committee. The Commissioner would be the patients’ port of call, listener and advocate, who holds the system to account, monitors trends, encourages and requires the system to act. This person would be the golden thread, tying the disjointed system together in the interests of those who matter most. Secretary of State, we are entering a new world, in which innovation and technology will bring exciting change. There is potential to do so much good, but we must ensure the risks of increasingly complex healthcare are understood and where the system is not sure of the risks it must say so. Had it done so in the case of our three interventions, I have no doubt that much anguish, suffering and many ruined lives could have been avoided. My team and I are clear that our recommendations will improve the lives of people who have been harmed and make the system safer in the future. Implementation needs to be approached with a new urgency and determination, founded on the guiding principle that our healthcare system must first do no harm. Yours sincerely, ii First Do No Harm – The report of the Independent Medicines and Medical Devices Safety Review Acknowledgements This report and all the work that led to it would not have been possible without the advice, support and knowledge of numerous individuals and organisations.1 First and foremost, I wish to thank all those people affected by the medical interventions we examined who met with us and had contact with us in writing and by telephone. It has been vital for us to hear their stories and understand their concerns. I am acutely aware that sharing such painful experiences with us has been traumatic for many, but my team and I are immensely grateful to each and every one of them. We heard their voices, and we listened. I pay a special tribute to all of the patient groups for their insight and support throughout this Review. Their knowledge of these medical interventions and the effect they have had on those they represent is extraordinarily comprehensive. The support they provide to those who have suffered is quite remarkable, all the more so given that many of the groups are led by people who have themselves suffered harm. I wish to thank everyone who gave us evidence in writing, appeared at our oral hearings and provided information to us through the course of the Review. We appreciate the time and expertise of everyone concerned, and the willingness with which it was given to us. And Sir Cyril Chantler, Simon Whale and I wish to thank our talented secretariat team, led so ably by Dr Valerie Brasse. This small team has managed a sensitive, complex and demanding task with enthusiasm, good humour and complete dedication. They have been truly exceptional, and we owe them a great debt of gratitude. 1 Further information on the patient groups the Review team interacted with, on those who provided written and/or oral evidence during the course of the Review and the members of the Independent Medicines and Medical Devices Safety Review team can be found in Appendix 5. iii First Do No Harm – The report of the Independent Medicines and Medical Devices Safety Review How to read the report Chapter 1 provides a summary of our findings and our Recommendations. Chapter 2 considers overarching themes relevant to all three of the interventions the Review was asked to look at. Chapters 3, 4, and 5 consider these interventions in more detail. Throughout these chapters are ‘Actions for Improvement’. Chapter 6 considers the role of public inquiries. In chapter 7 we present our suggestions for driving forward implementation, and chapter 8 is a summary of our Recommendations and Actions for Improvement. More detail related to our Recommendations can be found in the Appendices. We also have online resources which support this report. iv First Do No Harm – The report of the Independent Medicines and Medical Devices Safety Review Contents Letter to the Secretary of State from Baroness Cumberlege i Acknowledgements iii How to read the report iv 1 Introduction and Overview 1 2 Overarching themes 17 Theme 1: ‘No-one is listening’ – The patient voice dismissed 17 Theme 2: ‘I’ll never forgive myself’ – Parents living with guilt 21 Theme 3: ‘I was never told’ – the failure of informed consent 22 Theme 4: Redress – ‘We want justice’ 25 Theme 5: ‘We do not know who to complain to’ –Complaints 29 Theme 6: Duty of Candour – ‘preventing future errors’ 31 Theme 7: Conflicts of interest – ‘we deserve to know’ 33 Theme 8: ‘Holding to account’ – Guidelines and Quality 39 Theme 9: ‘Collect once, use often’ – Data capture and the electronic record 42 Theme 10: ‘Collecting what matters’ – Databases and Registries 44 Theme 11: ‘Time to change focus’ – Regulation of medicines and devices and potential reforms 49 Theme 12: Patient safety – doing it better 55 3 Hormone Pregnancy Tests 62 4 Sodium valproate use in pregnancy 98 5 Pelvic Mesh 138 6 Public Inquiries 180 7 Implementation 185 8 Summary of Recommendations and Actions for Improvement 187 Appendix 1: Terms of Reference 195 Appendix 2: The Patient Safety Commissioner 200 Appendix 3: Redress 212 Appendix 4: How we Worked 219 v First Do No Harm – The report of the Independent Medicines and Medical Devices Safety Review Appendix 5: The Review in facts and figures 239 Appendix 6: Abbreviations 260 Appendix 7: Glossary 265 vi First Do No Harm – The report of the Independent Medicines and Medical Devices Safety Review 1 Introduction and Overview ‘It is an essential principle of patient safety that the regulatory environment gives sufficient voice to legitimate concerns reported by patients, families and campaigners, works alongside them and responds in a rapid, open and compassionate way to resolve issues when they are raised. My view is that that did not happen in the way I would expect in these three cases.’2 Rt Hon Jeremy Hunt MP, former Secretary of State for Health and Social Care 1.1 This Review was announced in the House of Commons on 21st February 2018 by Jeremy Hunt, the then Secretary of State for Health and Social Care.