Medicines and Medical Devices Safety Review — House of Lords, 2018-02-22
Topic: Health
James O’Shaughnessy (Conservative, Centre-right): My Lords, with permission, I will repeat a Statement made by my right honourable friend the Secretary of State for Health and Social Care on the action the Government are taking to address public concerns regarding the safety of medicines and medical devices used by the NHS. The Statement is as follows: "On Friday, I will host campaigners, clinicians and safety experts from around the world as part of the world patient safety, science and technology summit, which is being held for the first time outside the United States here in London. As part of that, we will release a landmark report on the extent of medication errors in modern healthcare systems, as well as the NHS’s plan to tackle them. Alongside those in the report, there are three areas of potential medication error that I wish to update the House on today where serious concerns have been raised by patients and their families. The first is Primodos, a hormone-based pregnancy test which, it is claimed, led to miscarriages and birth defects during the 1960s and 1970s and was prescribed to more than 1.5 million women before it was withdrawn from use in 1978, partly due to more modern pregnancy tests becoming available. The second is sodium valproate, an effective anti-epilepsy drug which has been definitively linked to autism and learning disabilities in children when taken during pregnancy. Campaigners have suggested that up to 20,000 children may be affected. The third is vaginal mesh implants, often used in surgical interventions to address complications after childbirth, which have been linked to crippling life-changing side-effects Of course, our first thoughts are with the individuals and families whose lives have been turned upside-down by these issues. Many have endured, and continue to endure, severe complications and tremendous pain, distress and ill health, alongside a strong sense that their concerns have not reached a satisfactory resolution. I pay particular tribute to those who have responded to such experiences not just with understandable anger, but with resolute determination to campaign for change on behalf of others. Many of them have met Ministers and Members of this House to share their concerns, and I thank everyone who has written to or spoken to me personally to raise these concerns on behalf of their constituents We must acknowledge that the response to these issues from those in positions of authority has not always been good enough. Sometimes the reaction has felt overly focused on defending the status quo, rather than addressing the needs of patients, and as a result patients and their families have spent too long feeling that they were not being listened to, making the agony of a complex medical situation even worse. So today, in addition to practical steps for each of the three cases, I am setting out plans to establish a fairer, quicker and more compassionate way to address issues when they arise, bringing different voices to the table from the start and giving individuals and their families a clear path to answers and resolution Immediate action is being taken in each of the three cases. On Primodos, I have asked my ministerial colleague Lord O’Shaughnessy to drive forward, and where possible accelerate, the recommendations of the expert working group, further strengthening our systems for monitoring the safety of medicines in pregnancy. That will include: offering the families of the Association for Children Damaged by Hormone Pregnancy Tests a full and up-to-date genetic clinical evaluation; better information for pregnant women and their families; better training and support for obstetricians; better evidence around dosing recommendations; making electronic yellow card reporting easier for both women and clinicians throughout pregnancy; and stronger and more joined-up messages on safety On valproate, the issue is broader than the UK, and the outcome of the EU review, expected in March, will strengthen our regulatory position. In preparation, we have tasked system leaders with delivering a rapid, co-ordinated response. Directly responding to calls from patients, we are introducing a new warning symbol on valproate packaging; updating NICE guidance on valproate; pushing for valproate to be contraindicated for women of childbearing potential not using effective contraception; strengthening alerts across all GP systems and community pharmacy systems; and, for those women for whom valproate is an effective treatment, offering stronger and more tailored advice on risks and contraception On vaginal mesh, I have asked the Chief Medical Officer for advice in the light of calls for a full ban. She has been clear that clinical experts here and abroad agree that, when used appropriately, "many women gain benefit from this intervention", hence a full ban is not the right answer in the light of the current evidence available. However, that is not to minimise the suffering many women have experienced, which is why today I can announce that we will be publishing a retrospective audit to investigate the links between patient-level data to explore outcomes, and investing £1.1 million to develop a comprehensive database for vaginal mesh to improve clinical practice and identify issues These actions will improve the way regulators and the NHS deal with issues related to vaginal mesh and valproate, as well as improve monitoring of the safety of medicines in pregnancy. But the fact that it has taken so long to surface these issues also raises much bigger questions. 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 these are raised. My view is that that did not happen in the way I would expect in these three cases To do better in the future, we need to ensure that patient voices are brought to the table as systematically and consistently as other voices in the system, so today I have asked Baroness Julia Cumberlege to conduct a review into what happened in each of these three cases, including whether the processes pursued to date have been sufficient and satisfactory and to make recommendations on what should happen in future. She will assess, first, the robustness and speed of processes followed by the relevant authorities and clinical bodies to ensure that appropriate processes were followed when safety concerns were raised; secondly, whether the regulators and NHS bodies did enough to engage with those affected to ensure that their concerns were escalated and acted upon; thirdly, whether there has been sufficient co-ordination between relevant bodies and the groups raising concerns; and fourthly, whether we need an independent system to decide what further action may be required either in these cases or in the future This is because one of the judgments to be made is whether, when there has been widespread harm, there needs to be a fuller or even statutory public inquiry. The noble Baroness, Lady Cumberlege, will make her recommendations as to the right process to make sure that justice is done and to maintain public confidence that such decisions have been taken fairly. While I am deliberately leaving the terms of this model open for the noble Baroness, Lady Cumberlege, I have asked that she consider how we can strike the right balance on the criteria or threshold for a ‘legitimate concern’; how best to support patients where there might not be a scientific or legitimate concern, but they may still have suffered harm; how we can be more open to the insights that close attention to patient experience can bring, including whether a patients’ champion could help to act as a point of contact for people or families raising legitimate concerns, ensuring that these are heard and responded to; and how any new entity interacts with the existing bodies, including NHS Resolution, the Health and Safety Investigation Branch and the ombudsman. Recognising that this is an issue that many honourable Members have been concerned about, I have asked the noble Baroness, Lady Cumberlege, to meet with the relevant all-party parliamentary groups and campaign groups early on in the review process We are rightly proud of the NHS and all it has achieved and will achieve in the future. Much of this has been built on the strong connections between scientific discovery and medical progress, but innovation requires safeguards, including a culture of learning to protect against the unintended consequences of new technologies and treatments, and a clear focus on the experience and treatment of patients and their families affected by these consequences. From Mid Staffs to Morecambe Bay to Southern Health, patients and their families have had to spend too much time and energy trying to access, lobby and influence NHS leaders and Ministers to get a hearing for their concerns. The stress and frustration of campaigning, sometimes in the face of closed ranks and a defensive system, has added insult to injury for too many families. We need to establish a fairer and quicker way to resolve such concerns when they arise in the future Our regulatory system is in many respects world-leading, but it too needs to adapt to a changing environment and to draw intelligently on multiple sources of feedback to protect the safety of patients. Today’s announcement will build a system that listens, hears and acts with speed, compassion and proportionality, strengthening the commitment to patient safety which is at the heart of this Government’s and this House’s priorities for our health and care system. I commend the Statement to the House" My Lords, that concludes the Statement.