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House of Commons Hansard

Medicines and Medical Devices Safety Review

21 February 2018
Volume 636

  • With permission, Mr Speaker, I would like to make a statement setting out the action the Government are taking to address public concerns regarding the safety of medicines and medical devices used by the NHS.

    On Friday, I will host campaigners, clinicians and safety experts from across 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 is claimed to have led to miscarriages and birth defects during the 1960s and ’70s and was prescribed to more than 1.5 million women before it was withdrawn from use in 1978, partly due to more modern pregnancy tests becoming available.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 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 people 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 to share their concerns, and I thank everyone who has written 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 too 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 available directly to clinicians at the point of care; and stronger and more joined-up messages on safety.

    The issue of valproate extends beyond the UK. 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 National Institute for Health and Care Excellence 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 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, this 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.

    Those actions will improve the way the 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 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 bought 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 the 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 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. Baroness Cumberlege will make recommendations on the right process to make sure that justice is done and to maintain public confidence that such decisions have been taken fairly.

    Although I am deliberately leaving the terms of this model open for Baroness Cumberlege, I have asked that she consider how we 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 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 existing bodies including NHS Resolution, the Healthcare Safety Investigation Branch and the ombudsman. Recognising that this is an issue that many hon. Members have been concerned about, I have asked Baroness Cumberlege to meet relevant all-party parliamentary groups and campaign groups early 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.

    It must be said that our regulatory system is, in many ways, 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 this statement to the House.

  • I thank the Secretary of State for the advance copy of his statement. I welcome the tone of his remarks and generally welcome his commitment to a review of medical device safety, although I note that the 2017 Labour manifesto called for an inquiry into medical devices and product licensing and regulation. Today’s announcement is an acknowledgement that there are major problems, going back decades, to do with safety and lack of proper scrutiny and research.

    In debate and Committee, Members in all parts of the House have offered moving testimonies about the devastating impact of mesh, Primodos and sodium valproate on the lives of thousands of women and children in our constituencies. I wish to put on record my thanks and tribute to all the campaigners and the MPs from across the House, but especially those who have worked so hard with the all-party groups, including my hon. Friends the Members for Pontypridd (Owen Smith) and for Bolton South East (Yasmin Qureshi), and the right hon. Member for North Norfolk (Norman Lamb), who have all spent many years campaigning for justice on these issues.

    We have heard how mesh implants have left women in permanent pain, unable to walk, unable to work. This is an ongoing public health scandal, and we hope the Government will do much more to support those who are affected. Mesh has been suspended in Scotland and banned in other countries around the world. I understand that mesh has been paused for use in cases of prolapse. Will the Secretary of State consider fully suspending mesh use while the review is carried out?

    On Primodos, the Secretary of State indicated that the Department will drive forward and “accelerate” the recommendations of the expert working group, but does he accept that that report was met with concern on both sides of the House? Indeed, campaigners branded it a whitewash.

    I am grateful to the Secretary of State for including sodium valproate. My constituent, Emma Friedmann, took sodium valproate during and after her pregnancy, leaving her son, Andrew, with severe autism along with hearing and sight problems. Andrew, who is now 18, needs round-the-clock, full-time care. Emma, like thousands of others affected, was never fully informed of the risks of taking sodium valproate during pregnancy. Last year, a charity survey found that almost one fifth of women who are taking the drug still do not know the risks that the medicine can pose during pregnancy. I welcome the Government’s efforts to raise awareness of the dangers of sodium valproate, but will the Secretary of State tell us whether the review will look at the guidelines for clinicians who prescribe it to women of childbearing age?

    We offer the review our support, but note that it falls short of the calls for a full public inquiry, which campaigners have been demanding. Will the Secretary of State give the House an absolute reassurance that the review will gain access to medicine regulation files held in the National Archives, access to any valuable evidence cited in unsuccessful legal actions and access to documents and information held by pharmaceutical companies and that all such material will be made public?

    Does the Secretary of State agree that those affected must have trust and confidence in the review? Who will the noble baroness report to, and who will provide the secretariat to the review? I say this with no discourtesy to the Department or the Medicines and Healthcare Products Regulatory Agency, but does he agree that the review must be independent to avoid any sense of conflict of interest that has hampered previous inquiries? I understand the steer that he has given to the noble baroness on setting the terms of reference, but I press him to ensure that victims agree with the terms of reference to maintain trust and confidence in the review.

    Is the Secretary of State now ruling out a full public inquiry, or is he saying to victims that they should wait for the review’s outcome? When can we expect it to report back to the House? More broadly, can he reassure us that the inquiry will have three separate strands that will look in depth at each issue to ensure that nothing gets watered down and lost?

    In the broader context of Brexit, when profound uncertainty remains about medical and device regulation as we leave the European Medicines Agency, does the Secretary of State agree that the review must inform future regulatory mechanisms and take into account how we best co-operate with other national and international regulators post Brexit? What assurances can he offer the House that the medicines and devices that women use today—especially pregnant women—will not become the tragic and desperate scandals of the future?

    On the treatment of the victims involved, the Secretary of State will know that many women have been denied access to legal aid to pursue compensation claims. Does he agree that women and children deserve full compensation and support? Is that not the Government’s responsibility? Will they establish a compensation fund, and what consideration has he given to compelling the pharmaceutical industry to support a compensation fund for those affected?

    Finally, mesh, sodium valproate and Primodos have devastated the lives of hundreds of thousands of women and children. Is it not time that they were given a full apology? Surely, that is the very least they deserve.

  • I thank the hon. Gentleman for his considered response and for its tone. Like him, I thank all the all-party groups who have worked incredibly hard to raise this incredibly difficult issue. Let me go through the points that he raised; he asked detailed questions, which I want to give a proper answer to.

    When it comes to mesh, no EU country has banned its use. In my understanding, Australia and New Zealand have not introduced a full ban. We have taken very clear advice. We obviously have a responsibility to all patients, and the medical advice from the chief medical officer is clear that some women benefit from mesh, if it is appropriately used, so we are following that advice. However, the review will look at all the processes around mesh. We will publish NICE guidelines on persistent pain and ventral meshes—it is also important to say that meshes are used in men as well as women—and we absolutely have to get this right.

    I fully accept the point that the hon. Gentleman made on the concerns of many patients and families about the findings of the expert working group. He will know that this is a very difficult, hotly contested area. We are not proposing to revisit the science, but we are giving Baroness Cumberlege full freedom to look at what the expert working group did and to come to her own views. We are not excluding her from looking at what happened, even though we think that it is important to accept throughout that we have to follow the science at every stage to get this absolutely right. We will be going forward with some important recommendations of the expert working group regardless, such as the yellow-card system.

    One thing that is clear is that when people, whether clinicians or patients, have an immediate concern about a medicine, there is no easy way to raise that quickly. If women are raising these concerns all over the country, we need to find that out very quickly at the centre, so that we can take action more quickly than happened in this case. We will also be offering genetic testing to families who have suffered, or who think that they have suffered, as a result of Primodos.

    On valproate, we will issue guidelines to clinicians. We also want to make sure that there is greater awareness among patients. We are changing the NICE guidelines and the labelling. When it comes to valproate, we want to push for this to be a contra-indication for women of childbearing age who are not taking effective contraception, because it is so important to get this right.

    The hon. Gentleman made very important points about the public inquiry. We are asking Baroness Cumberlege to give us her considered view on the appropriate way forward in this case, and that, of course, has implications for the issue of compensation. What I would say is that we have a problem in our system, in that there is no proper process for deciding what next steps are appropriate. Is it an investigation by the Department of Health and Social Care and NHS England, or do we need a full statutory public inquiry? We particularly want her to look at whether we should have an independent process to evaluate what happened. In my time, and in the hon. Gentleman’s time, we have been approached by a lot of people who want public inquiries, but it should not simply be about the strength of lobbying. There needs to be a process, because there may be people who do not have a loud voice, who are equally worthy of a public inquiry, but who do not get considered in our system at that moment. That would not be right.

    Baroness Cumberlege will report to Ministers, not to the MHRA, and there will be full consultation with the families affected by the three issues over the terms of reference. That is absolutely the right thing to do.

    The hon. Gentleman made a final very important point about how we regain the trust of families deeply scarred by these issues. We can do it in two ways: first, by being open and transparent in everything we do in this process so that they can see we want to get to the bottom of it as much as they do; and secondly by recognising the fundamental issue that in the past when we have assessed these clinical medical safety issues the voice of patients has not been as strong as it should have been. We have to put that right, and I know that everyone in the NHS, as in the House, is committed to doing so.

  • I welcome the Secretary of State’s statement and his ongoing focus on patient safety, which has added so much to the patient experience. I also welcome the fact that he is clearly representing the voice of patients when learning lessons. Many of those who, courageously, have come forward, including many of my own constituents, have been harmed in the private sector. Will he confirm that all patients, wherever they were treated, will be included within the review and that there will be a focus on clinical governance, not only in the NHS but in the private sector?

  • I can absolutely give that assurance. We are considering how to strengthen oversight, because a tragedy is a tragedy wherever it happens, and we should be demanding the highest standards of care throughout our healthcare system. We are particularly considering the issue of data sharing, because often clinicians operate in both the NHS and the private sector, and we want to make sure that we do not have two datasets but that we share data in a way that makes patients safer.

  • I thank the Secretary of State for advance sight of his statement, although I am sure that some of the women affected by these medicines or medical devices will be sceptical and might wonder whether the Government have not just announced a review of reviews, especially given the outrage among patients and the wider public over the review process and its outcomes in the past.

    Medicines safety and licensing are reserved matters, and although we welcome the fact that the Government are not just doing nothing, it is disappointing that the review will not really consider the scientific evidence on Primodos, valproate and surgical mesh. Given the recent shambles over the Primodos expert working group, everyone needs confidence that this will not turn into a Government whitewash. How can patients be assured of the chair’s independence? Who will take a final decision on who advises the chair? Will those affected and those who took part in the initial reviews be able to participate? I am sure the Secretary of State is aware that Professor Alison Britton is already leading an independent review in Scotland of vaginal mesh. Will he and his officials seek to take advice and soundings from her findings and expertise in this process? Finally, having as much information and background as possible on women’s experiences is extremely important in getting justice and improving patient safety, so does the Secretary of State think that setting up a mechanism within his Department to collate extensive qualitative research for patients would be useful?

  • With respect to the hon. Gentleman, he is being a little uncharitable in describing this as a “review of reviews”. We have announced immediate action in each of these three cases—it will happen right away and will be of huge significance in the use of valproate, help for families who think they have suffered as a result of Primodos and the use of mesh. A lot of things are happening right away. These are complex issues, however, and if we are to step back and look at the systemic failures we think have happened, it is important that we ask what changes are needed. That is why we need someone of Baroness Cumberlege’s experience: she has a huge track record of campaigning on women’s issues; she was a Minister at the Department of Health for five years; she did the “Better Births” review for NHS England in 2015. She is hugely experienced and passionate about patient safety and making sure that the patient voice is heard.

  • I welcome the review and the announcement of Baroness Cumberlege as its lead. I am sure the whole House will agree that she is, as the Secretary of State said, highly qualified and trusted. I pay tribute to the many hundreds of thousands of women who have suffered in silence and campaigned so effectively. As the Minister who surprised a few in announcing the Primodos working group, setting up the sodium valproate taskforce, with my right hon. Friend, and brokering the deal on the Saatchi Bill, I have seen the passion and the silent suffering with which so many women have had to live. He is absolutely right that for too long the medical establishment has tended to link arms and act very protectively when challenged, and we need to make sure that the patient voice is put right at the heart of this.

    Will the Secretary of State agree with two points? First, does he agree that it is important that this does not become some legal witch hunt, but starts as a review of the evidence, the science and the clinical data in order to avoid future patient suffering? If it is couched in terms of legal liability, everyone will draw in and resist the sharing of evidence that is so key. Secondly, will he look at training? On mesh, the MHRA has licensed the device, but my understanding is that the problem is often with the training of clinicians in its installing. We need an intelligent healthcare system that uses everyday data to support patient safety.

  • I would like to put on the record my thanks to my hon. Friend for the work he did as a Minister in my Department that led to the setting up of the expert working group, which I think has taken this issue forward and which he championed. His experience of the life sciences industry was incredibly helpful. I take on board both his points. It is absolutely right that this needs to focus on patient safety and how we put in place processes that help people suffering now and avoid it happening in the future. His point about training is a very good one.

  • I welcome the Secretary of State’s statement, though it would have been nice for the victims to have heard a little more about the legal aid and compensation issue. He was absolutely right to describe our regulatory framework as world leading. It is, of course, European and precautionary based. Will he dissociate himself from the Foreign Secretary’s comments last week in which he included medicines regulation in the list of those areas for which he favoured full regulatory divergence?

  • As the right hon. Gentleman knows—we have had these discussions at the Health Select Committee—this country makes an enormous contribution to medicines regulation across Europe, because of our extensive scientific base, and we very much hope that those links continue.

  • I welcome the review of the yellow card process. The first responsibility of the doctor is always to do no harm, and every doctor, when making any prescribing decision, always balances the potential improvement in patient care with the known risks. Sometimes, as more drugs are given to more people, rarer side effects will come through, and the improvements in the yellow card system will mean that those are identified earlier.

    My other point is about Roaccutane. It is a drug given to treat acne but is known to be exceptionally toxic in pregnancy. I remember from my time working in dermatology that to get a prescription women had to attend monthly and have a negative pregnancy test before the next prescription was issued. I wonder whether that approach could be more widespread in the prescription of some of these drugs, which do provide some benefit but are known to be harmful.

  • My hon. Friend’s question demonstrates how useful it is to have people with medical experience in the House. To be honest, I am slightly overwhelmed by the detail in her question, but her broad point is absolutely right. The difficulty with the issues today is how much they affect women, particularly pregnant women. Through the review, we want to establish whether we are doing less well than we should on women’s health issues. Given that Baroness Cumberlege has done more campaigning on women’s health issues than pretty much anyone else in either House, I think she is the right person to take the review forward. My hon. Friend is absolutely right about strengthening the protections for pregnant women.

  • As the chair of the all-party group on oral hormone pregnancy tests, I am disappointed with the wording of today’s announcement. What happened with Primodos was a scandal similar to the Hillsborough, contaminated blood and sexual abuse scandals. Victims of Primodos and their families have waited 40 years for an answer to this grave historical injustice. It was a deliberate criminal cover-up by the statutory authorities of the day. The scientific evidence now shows a link between Primodos and deformities that was known to the drugs companies and our regulatory bodies 40 years ago. Will the Secretary of State ensure that the review—we want a full public inquiry—looks at the regulatory failures that took place 40 years ago? There was a systematic and deliberate cover-up, including the destruction of documents, by our health bodies as well as the drugs manufacturers. Primodos is, therefore, perhaps different from some of the other cases. We demand a proper inquiry and proper compensation and that the victims be put at the heart of the inquiry. They were completely ignored by the expert working group—that document was not worth the paper it was published on.

  • The hon. Lady and I may not agree on every part of my statement, but I thank her for her campaigning on this issue, and for the voice that she has given to thousands of women who believe that they have suffered badly as a result of Primodos. The things for which she has asked were not ruled out in the statement; in fact, what I have announced will create a process during which someone will look very carefully at the issue.

    The hon. Lady has made some very serious allegations, and it is absolutely her right to do so as a Member of this House, but they differ from the conclusions reached by the expert working group. It is precisely because of that disagreement that we have asked Baroness Cumberlege to look carefully at the issue and form her own view of the right way forward. However, I assure the hon. Lady that regulatory failures are at the front of our minds, and we are absolutely determined to ensure that victims’ voices are heard.

  • I thank the Secretary of State for the compassionate tone that he has struck today, and for taking account of the years for which many campaigners, such as Janet Williams and Emma Murphy, have tried to make their voices heard, on valproate in particular. If, following the review, various medicines or medical devices are found to be unsafe—or, indeed, to have been taken unsafely—will there be legal consequences for the regulators who should have acted differently?

  • The simple answer to that question is yes: there are legal consequences for regulators who have failed. In that instance, it would be the responsibility of the Government, or of the drugs companies who failed in their responsibility to inform patients of the dangers of taking drugs. The priority is to establish the facts. Some of those are clear now, but some are not, and that is why I think that the review will help us.

  • Constituents of mine have been affected by both sodium valproate and Primodos. The Secretary of State has already heard the dismay expressed by my hon. Friend the Member for Bolton South East (Yasmin Qureshi) at the outcome of the review by the expert working group, but may I ask him another specific question? What he has announced today will not give a great amount of satisfaction to people, and confidence that his Department will take notice of Baroness Cumberlege’s review will be reduced by a written response that I received yesterday which stated that the Department had no plans to fund any independent scientific research on hormone pregnancy tests. We know that Dr Vargesson produced a report last week. Will the Secretary of State ensure that Baroness Cumberlege looks very carefully at this particular issue?

  • I can give the hon. Gentleman an absolute assurance that she will do so. In the case of valproate it is very clear what the next steps should be, because there is no dispute over the science. When there is controversy over the science—and I appreciate how distressing that is for the families involved—the first thing we must do is establish the truth of the situation, and that is why we have given Baroness Cumberlege a free hand to look at the whole issue.

  • I welcome the statement, which is consistent with my right hon. Friend’s track record of driving the NHS to stop causing harm to patients. May I ask him to continue to focus on encouraging, requiring and supporting all healthcare professionals to make the shift from a defensive to a learning mindset, so that they listen and learn not just from NHS experience, but from patients as well?

  • My hon. Friend, who has huge experience in healthcare, is right to say that at the heart of dealing with these very complex issues is the need for us to be careful not to inadvertently encourage a culture of defensive medicine. If doctors feel unable to be open about mistakes that may have happened because they are worried about legal consequences, we will not benefit from the learning that is so incredibly important, and one of the purposes of the review is to ensure that we support that open learning culture.

  • On behalf of my constituents whose families have suffered from the effects of Primodos, I thank the Secretary of State for taking a step in the right direction. He has announced that there will be another review with another remit. Can he reassure the House that one of the reviews will be able to investigate the cover-up over Primodos that we know has taken place for decades, and that if a crime has been committed, it will be dealt with?

  • I totally respect the right hon. Gentleman for airing his constituents’ concerns, but, as he will know from my answers to earlier questions, the difficulty in the case of Primodos—and this is incredibly distressing for the families involved—is that scientists do not agree about the issue, and as a result we do, unfortunately, find ourselves having to review what has happened. The review conducted by the expert working group was our first attempt. We are now giving Baroness Cumberlege a free hand to consider that and any other evidence that has come to light, and to draw her own conclusions.

  • Just an hour ago I met my constituent Carol Short and Emma Friedmann, a constituent of the hon. Member for Leicester South (Jonathan Ashworth), to discuss the next stage of the valproate campaign, but because of the statement, that meeting was adjourned. I am happy that they are now in the Chamber, and I am sure that they are pleased to hear about the review.

    Is it possible to ensure that GPs are giving out the excellent advice that the Medicines and Healthcare products Regulatory Agency has put together? I am sorry to say that it seems that far too many are not, and there appear to be no regulatory sanctions to ensure that they do.

  • Order. I mean no discourtesy to the hon. Gentleman, but I hope that the people whom he mentioned are in fact in the Gallery rather than in the Chamber. That would be greatly reassuring to us, and quite possibly to them.

  • I can give my hon. Friend the assurance for which he has asked. We have announced today that we are improving the system of alerting both general practices and community pharmacies to ensure that the right advice is given and the right safeguards are in place, so that people who are pregnant or might become pregnant do not take a medicine that is very powerful and very effective in the right circumstances, but incredibly dangerous in the wrong ones.

  • I welcome the Secretary of State’s intention to look further at these very concerning issues, but I fear that his putting them all in one place means that he may not be giving sufficient attention to the Primodos issue, which is a scandal of very many years’ standing. I do not think that the recent report of the expert working group is the basis on which Baroness Cumberlege or anyone else should look further at the matter, because it was a complete whitewash, and the Secretary of State needs to acknowledge that. I think that if he were to do so, the people affected by Primodos over the last 40 years or more would feel much more confident that the process that he has described today might enable them to secure some resolution.

  • I understand why the hon. Lady has asked her question in the way that she has, but we set up the expert working group after a lot of very careful thought because we honestly wanted an answer. We are faced with circumstances in which scientists disagree, and in those circumstances it would not be right for me, as Secretary of State, to announce a different scientific view. I think that the right thing to do is to allow someone the time and space in which to look at the issues that the hon. Lady has raised, and that is what Baroness Cumberlege will do.

  • I have a constituent whose quality of life has been completely ruined by a surgical mesh implant. What reassurance can we have that the Cumberlege review will ensure that the voice of the patient is listened to much more quickly in future, so that when things go wrong, we limit the number of patients who suffer the type of harm that we have heard about this morning?

  • That is the right question to ask. I suggested in the statement that we might need a patients’ champion whose job would be to collect the experiences and views of patients who think that they may have suffered as a result of medicine or medical devices. However, we want Baroness Cumberlege to look at the issue in much more detail. The central point is that if we are to avoid the agonies experienced by my hon. Friend’s constituents, the patient’s voice needs to be as strong as the clinician’s in discussions about the efficacy of medicines or medical devices. That clearly has not been happening to date, but I think that we are moving away from the paternalist system that has operated in the past, and the review will constitute a further step in that direction.

  • The Secretary of State will know the phrase

    “the patronising disposition of unaccountable power”,

    which applied in the Hillsborough families’ fight to get justice, and applies, it seems to me, in what has happened to the groups affected by today’s statement. Will the Secretary of State explain why Baroness Cumberlege’s report will not come straight to Parliament, so it can make a decision about how patients can get justice quicker than has happened in many cases such as the ones we are discussing today?

  • Those words about the patronising disposition of unaccountable power came from Bishop James Jones, who has made an extraordinary contribution as a voice for people whose voices have been ignored for too long. The House will have every opportunity to debate Baroness Cumberlege’s report. The Government will decide their actions and we will put them to the House, which will have every opportunity to listen, make suggestions for improvements, and to become involved at every stage of the process as we take this forward.

  • With their incredibly moving stories, my constituents Karen, a victim of vaginal mesh, and Angie, with Primodos, will have listened intently to what my right hon. Friend has said. May I underscore a point made by colleagues on both sides of the House? There are two key issues apart from the Cumberlege review. First, we must ensure that our medics, from med school up, realise that they are not gods, because that is how many patients feel when they have to deal with them and their concerns are too easily dismissed. That needs to change from the bottom up. Secondly, my right hon. Friend made the point that this is an issue not just for the NHS but for private health care too. It involves patients living in all quarters of the United Kingdom. How will this learning, and the learning of the review, spread, while respecting the devolved Assemblies, in those regions where the health service is not under the control of my right hon. Friend?

  • Those are both important points. I will make one comment about the second one. The spreading of best practice is central. We must ensure that we do not just have a system where we have new NICE guidelines, but that we have confidence that it is being implemented across 30,000 GPs in 250 NHS trusts and so on, and I know Baroness Cumberlege will be thinking about that.

  • For my constituents Wilma Ord and her daughter, Kirsteen, the wait for action on this issue and to get truth and justice has been almost unbearable. While I welcome the Secretary of State’s candour and tone, the actions outlined today are not enough, and I fear that the baroness, as welcome as she will be to this process, will be doing her job with one hand tied behind her back. The Secretary of State said in his statement that we are not revisiting the science, but then said that we needed to be led by science. Unless I misheard him, there is a contradiction. Will he confirm that the victims affected by all these issues will be at the heart of this, as will the science, because there is an important new study by Neil Vargesson that must be considered in this process in relation to Primodos?

  • I do not accept that there is a contradiction. We have to be open to the science and we have to be led by the science at every stage, and if there is new scientific evidence, we must absolutely take that on board. We must also always be led by patients in what we do, and that is exactly what I am announcing.

  • It was a pleasure to lead the debate in the House when we secured time from the Backbench Business Committee to discuss this. I really appreciate the tone adopted by the Secretary of State, and by the Prime Minister when I asked her earlier if there was good news. May I also pay tribute to the Minister, my hon. Friend the Member for Winchester (Steve Brine), who is sitting next to my right hon. Friend the Secretary of State, for the work that he did, because I gave him really quite a hard time during the debate?

    However, there will be huge disappointment among the Primodos campaign team. The idea of being led by the science from the expert working group is fascinating, because it refused to allow some science to come forward as it had not been peer-reviewed, but then accepted a load of other evidence from the drug companies. On this review going back to the Department of Health and Social Care, it is implicated in this, in that these drugs were given out by GPs in surgeries without prescription, so that will give no confidence at all. I therefore think that the Baroness will have both hands tied behind her back when doing her work.

  • I commend my right hon. Friend’s campaigning, but I am afraid I have to disagree with him. This is an important step forward; we are absolutely going to be led by the science—we have to be led by the science—and we are giving Baroness Cumberlege full rein to look at what the expert working group did, and to challenge it if she thinks fit.

  • The expert working group that the Government set up on Primodos changed its own terms of reference. It refused to look at all the scientific evidence and it did not have the confidence of the families affected. How will the Secretary of State’s proposals be any different?

  • This is something for Baroness Cumberlege to consider, but the broader point is right. We have for too long in each of these three cases, and in others as well, had processes that have not had the confidence of patients. That is why we are proposing today not just specific measures on each of the three issues, but a broader look at the regulatory structure to make sure that patients’ voices are louder and we avoid precisely what the hon. Lady said.

  • I welcome today’s announcement, which I am sure will also be welcomed by my constituent who had surgical mesh implanted in 2008 during a hysterectomy, and, significantly, without her knowledge or consent, which has led her to suffer severe distress and significant pain. When she raised that with her doctors, she was told it was all in her mind and she was imagining it, and she believes that she is still not being taken seriously 10 years later. Does the Secretary of State share my hope that the very existence of the review will encourage a more sympathetic response to people such as my constituent from the medical profession?

  • I very much hope so, and the crucial point that has come out from the contributions of Members in all parts of the House is that the processes we have had in place to date have not had the confidence of the families affected. That applies to a whole range of issues, and I believe medicine is changing fundamentally: people who are passionate about medical innovation and life sciences know that we need to have a very close partnership with patients in order to make proper advances. But we have not always got this right, and that is what I hope Baroness Cumberlege’s review will help us to do.

  • I welcome the audit on vaginal mesh and the promised register, but there are a couple of things I want to raise. One is support for victims. My constituent Angie was referred from Hull to Manchester to see somebody, and has now been told she will have to wait months before anybody can properly analyse what has happened to her, so can more resource be given to help the victims of vaginal mesh? Also, will the Secretary of State look into the licensing process on how these things get into the market and are put out there for use by surgeons? Finally, we should not just look at training, because it is not just about the training for how we put these things in; I believe that the product itself is faulty.

  • We will certainly look at all those things, and the hon. Lady is absolutely right to draw attention to them. Licensing is one thing, but it is also important to ensure that proper information is available to clinicians and patients, because it appears from these cases that there are a number of drugs and devices that are safe but only in certain circumstances, and that knowledge might not have been properly disseminated. The database that the hon. Lady mentioned will help us to get that right.

  • I pay tribute to constituents of mine who have had surgical mesh implants—their campaign has been quite extraordinary and I am humbled by their work. The truth is that there is little prospect of any improvement in their condition. I welcome the statement and I recognise the issue around the ban and why that might not be possible, but will the Secretary of State assure this House and my constituents in west Cornwall that surgical mesh will be used only when there is absolutely no alternative?

  • This is a complex procedure that can go wrong, so it would only ever be used if it was absolutely the right thing for patients. We have looked at this very carefully. Other countries have introduced restrictions on the use of mesh, but we have concluded that that would be disadvantageous to women in certain circumstances. However, that means that we have to take much more care in when it is used so that we avoid those truly horrific complications.

  • Those whose lives have been forever changed by the drug Primodos will be very disappointed today, despite there being a step in the right direction. Asking Lord O’Shaughnessy to drive forward the recommendations of the expert working group will not bring any confidence. That expert working group changed its terms of reference: it was asked to examine whether a possible association exists between Primodos and birth defects and it did not do that; it looked at a causal association. That is the crux of the problem, and that is what makes that working group’s findings unacceptable, aside from the fact that the scientific evidence not included existed before it even started its investigation. Unless these factors are taken into account in a wide-ranging independent inquiry, I doubt those victims will ever get the satisfaction and justice they deserve.

  • I hear what the right hon. Lady is saying. The reason it was important to ask whether there was a causal link was that it has an implication for the compensation to which people might be entitled, but I would like to reassure her that Baroness Cumberlege will have the freedom to look at all the issues that she has raised.

  • The pharmaceutical companies have consistently refused to accept a causal link between sodium valproate and autism. My right hon. Friend has now set out measures to warn people about this in the future, but that does not compensate the victims. What attempts is he going to make to ensure that victims are fully compensated for the dreadful impacts on the lives of their children?

  • In this country, the compensation system works through the courts. There are times when the NHS is liable and there are times when the drugs companies are liable. I hope that Baroness Cumberlege’s work will take us closer to understanding where the liability actually lies, so that we can give relief to the families who have suffered for too long.

  • Will the Secretary of State join me in paying tribute to my constituents, Emma Murphy and her colleague Janet Williams, for their courageous campaigning to highlight the risks presented by sodium valproate? As he and other hon. Members have acknowledged, victims are incredibly suspicious of the health establishment, and for very good reason. I ask him sincerely whether he is concerned by the fact that Baroness Cumberlege is the director of a company that specialises in advising pharmaceutical companies on how they can most effectively lobby Parliament. What will that do for victims who are already incredibly suspicious of us in this House and of the NHS establishment?

  • I understand the respectful tone in which the hon. Gentleman has asked this question. I do not think that anyone has a better track record than Baroness Cumberlege on campaigning for women’s health issues. In her career, she has shown an absolute willingness to take on the medical and scientific establishments when she thinks that that is the right thing to do, and she does so with a great deal of knowledge and a huge amount of passion, so I have every confidence that she will do a good job.

  • I welcome the statement today. The Secretary of State will be aware that we had a mesh review in Scotland, but unfortunately it quickly lost the confidence of patient groups, who branded it a whitewash after chapters were deleted and evidence was a re-presented. Can he assure me that patient groups will not be treated as an inconvenience, and that the real-life personal experiences of these women who have been crippled by mesh implants will be taken fully into account and taken seriously?

  • I wish I could say to my hon. Friend that those people’s terrible suffering has been taken as seriously as it should have been, but the truth is that we have a system that has not treated patients’ concerns with the seriousness that it should have done. That is why we want to make the important changes that we are announcing today.

  • Forty-four years ago, my constituent Lesley Holmes took two Primodos tablets that had been handed to her by her trusted GP, to check whether she was pregnant. She was, but the consequences for her son have been devastating. With the expert working group’s report having been stripped of its credibility, Lesley is still seeking answers and recognition of her family’s plight. The Secretary of State appears to agree that we need to recognise that fact and provide the answers, but how long is this going to take? How is he going to ensure that the outcome is actually credible this time?

  • All I can say is that we completely understand those concerns and the despair that many people feel about this issue, but it is difficult to resolve it quickly when there is disagreement among the scientists. What we are trying to do today is to create a process to resolve that disagreement, and that is what I very much hope will happen.

  • I welcome the announcement of this much needed safety review. All UK citizens should be confident that the most rigorous safety standards are in place. Can my right hon. Friend confirm that the review will not have an impact on initiatives such as the accelerated access review and the cancer drug fund, which have fast-tracked access to much needed drugs and treatments?

  • I can confirm that, although it is also important to say that if we discover changes in procedures that will improve the safety of medicine use or medical device use, the people who put those new drugs on the market would want to benefit from any changes in regulatory processes, but what we would not want to do is reduce the speed.

  • I welcome the Secretary of State’s statement. I have met and been contacted by many women in my constituency who continue to suffer excruciating pain and serious detrimental outcomes as a result of surgical mesh implants. I welcome these initiatives, but I suggest that there would be huge value in some of them, such as the database, being established at a UK-wide level. What discussions have he and his Department had, or do they intend to have, with the devolved regions to ensure that this could take place at a UK-wide level?

  • Our approach on safety issues is that we are happy to do anything on a UK-wide basis if that is what the devolved Administrations want, because we do not see any benefit in not sharing data. If the willingness is there among the other Administrations, we would be happy to play ball.

  • I welcome my right hon. Friend’s announcement of a review of these three important medical matters and his securing the much respected Baroness Cumberlege to lead it. I should like to focus on Primodos, which has affected around 1.5 million women throughout the United Kingdom. It has been a terrible long journey for those individuals and their families. They have simply been pursuing truth and justice, but to date they have received neither. I have heard much about the use of data and science in the review, but will my right hon. Friend ask the Baroness to introduce humanity into the review as well, and to take into account the peer-reviewed research carried out by Aberdeen University that is now available? I certainly hope that this review will be a stepping stone to a full public inquiry for Primodos victims. Maybe then, and only then, will they receive the truth and justice that they and their families so richly deserve.

  • That was very eloquently put by my hon. Friend. We also want to get closure on this issue, and that means getting the scientific consensus that has eluded us to date. I will certainly mention the Aberdeen research to the noble Baroness.

  • The Secretary of State was right to say that patients’ views have been neglected, and that they need to be central to this review. My constituents who have been impacted by Primodos lost faith in the working group’s review, not least because of that concern. How far will this review go? Will it, for instance, look into the fact that there might be a diminished amount of evidence available because the medical records of women who took Primodos were destroyed, including those of my constituents?

  • I am happy to do so, but this review is obviously separate from the things that are happening in Scotland. However, we will certainly look at all those issues.

  • This is the first chance I have had to thank the Secretary of State for visiting Kettering General Hospital last week, and I do so now. It is a laudable and oft-stated ambition that the NHS should be the world’s safest healthcare system. Are we there yet? If not, when will we be?

  • International experts from the Commonwealth Fund in New York say that we are the safest healthcare system in the world, but that gives me pause for thought because there is still so much avoidable harm and death in our system right now. If we are the safest, that says that healthcare everywhere needs to improve.

  • Campaigners on Primodos will be hugely disappointed by the Secretary of State’s statement and his failure to recognise the concerns they have raised about the expert working group. That aside, how many patients does he envisage being involved in the review, and how does he believe that they will be best accessed to ensure that those people who are quiet actually have their voices heard?

  • That is the entire purpose of the review. Obviously, Baroness Cumberlege will want to involve patients in the process right from the start, and I will talk to her about that. I will also write to the hon. Lady to spell out in detail the way in which the Baroness intends to involve patients in the process.

  • I thank the Secretary of State for his statement, which will be of comfort to vaginal mesh implants victims in my constituency. It is right that the review will be wide-ranging, but will he confirm whether those who have been barred from receiving compensation owing to the statute of limitations under the Consumer Protections Act 1987 will be included?

  • The Secretary of State will be aware that many of the women who took Primodos would not necessarily have known at the time that that was what they were taking or what the consequences were, and it is only later that they may have realised what took place. How will they be brought into the review? If there is to be compensation at some point, what will the test be? It would be unfair for them to have to prove that they were victims of the drug.

  • I wish it was easy to give the hon. Gentleman a straightforward answer, but the truth is that there is much scientific disagreement about whether there is a causal link, which makes it difficult to give clear answers to his constituents and, indeed, to mine. I hope that the review will shed some clarity on the situation, because that is what many people want.

  • What advice has the Secretary of State sought from the Royal College of Midwives, the Royal College of Obstetricians and Gynaecologists and the Royal College of Pathologists? What involvement will those bodies have in the review?

  • Baroness Cumberlege has honorary fellowships at the Royal College of Nursing and the Royal College of Physicians, so she is well connected with all the organisations that the hon. Lady mentioned.

  • I thank the Secretary of State for his statement. As he indicated, our products are world leading, and China and the UK have come to an understanding on medical device regulation, which is great news. However, does the Secretary of State have any information about further such understandings to ensure that we can export our medical innovations throughout the world safely and with as little red tape as possible?

  • It is fair and important to say that our regulatory system is admired the world over because we do safety extremely well and take it extremely seriously, but that does not mean that we cannot improve it. The lesson of today is that patients’ voices have not been strong in that process, and that is what we need to change.