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Medicines and Medical Devices Safety Review

Volume 789: debated on Thursday 22 February 2018


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and birth defects during the 1960s and 1970s and was prescribed to more than 1.5 million women before it was withdrawn from use in 1978, partly due to more modern pregnancy tests becoming available.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.

My Lords, I thank the Minister for repeating the Statement. I should also like to thank him personally for meeting representatives from the mesh campaign group two weeks ago, which is much appreciated.

Today’s announcement is an acknowledgement that there are major issues which go back decades in areas that concern safety and a lack of proper scrutiny and research. We have heard how mesh implants have left women in permanent pain, unable to walk and unable to work. Welcome as the Statement is, the Government need to do much more to support those affected. Mesh has been suspended in Scotland and banned in other countries. The most recent interventional procedure advice from NICE on prolapses states that it should be used only for research purposes and not as a front-line treatment, but I ask the Minister whether he thinks we need to go further and suspend the use of mesh until NICE has completed its review into the safety and efficacy of the product. If the Government are not prepared to go as far as suspension, will he at least write to all trusts and indeed private hospitals to remind them that the Health and Social Care Act 2015 requires them not to cause avoidable harm? The review in itself signals that mesh is now acknowledged to cause harm.

I refer the Minister to Owen Smith’s comments in the other place; he chairs the All-Party Group on Surgical Mesh Implants. He said that:

“Lessons must be learned from the awful complications many women have experienced since undergoing mesh surgery and proper processes must be put in place to stop this happening in the future … The mesh scandal shows what can go wrong when devices are aggressively marketed to doctors and then used in patients for whom they were unsuited or unnecessary”.

Will the review chaired by the noble Baroness, Lady Cumberlege, look into that particular aspect?

The Minister mentioned in the Statement the investment of £1.1 million, part of which will go to improving clinical practice. Clearly, one should always seek to improve clinical practice, but mesh campaigners would say that the real issue is not the clinical practice but the product itself, which is not fit for purpose.

The retrospective audit is very welcome indeed, but there is a real question about whether it will capture all the women affected. I have certainly received evidence to suggest that some women suffering greatly from mesh implants are not aware of the reasons and therefore do not approach the health service. Will the Minister also say whether the mesh audit concerns only hospital statistics and records or whether it will cover GPs and primary care as well? Also, will the review extend to when men and women are affected by hernia mesh?

The Secretary of State has said that the review will not go into the science of mesh. But most studies do not use quality-of-life questionnaires, so they do not pick up the devastation of pain, lost sex lives or constant urinary infections. Studies concentrate on whether the mesh has cured the problem of prolapse or incontinence. Many studies are short-term or compare mesh to mesh. Trials should compare mesh to the old-fashioned natural tissue repair to get a proper evaluation of whether the use of these products should be continued in the future. Many trials have low numbers and any woman who has had a mesh implant can feel like a ticking time bomb, as the product can shrink or twist years down the line. No amount of surgeon training can counteract that.

Will the review extend to those with mesh bowel prolapses? Will it also look at what help the NHS needs to give to people currently affected as mesh sufferers? Obviously each country in the UK is taking a slightly different approach but, in his role as the Minister responsible, will he work with Scotland, Wales and Northern Ireland to pull together research and co-ordinated action, which would make great sense?

I hope that the noble Baroness, Lady Cumberlege, will be asked to look at whether device regulation needs to be tightened up. As the Minister knows, it is much less stringent than medicines regulation and there has been an ongoing debate about that. I hope that that will be included within her review.

On Primodos, the Minister indicated that the department would drive forward and accept the recommendations of the expert working group. But in the other place when the report was published in October, it was met with concern from all sides of the House. I hope that he will take that into account.

I am grateful that the Secretary of State has included sodium valproate in this work. The Minister will know that last year a charity found that almost one-fifth of women taking the drug still did not know the risks that this medicine could pose during pregnancy. I therefore welcome government efforts to raise awareness of the dangers of valproate. I also hope that the House can be offered an assurance that the review will gain access to medicine regulation files held in 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.

I ask the Minister to invite the noble Baroness, Lady Cumberlege, to meet victims to see whether consensus can be agreed on the terms of reference, to maintain trust and confidence in it. That would be a very valuable first step to gaining the confidence of campaigners who have worked so hard and have been gratefully acknowledged by the Secretary of State in his Statement.

From the Liberal Democrat Benches, I am very grateful and thank the Minister for the Statement. I am particularly pleased about its tone, which moves on the Government’s debate with campaigners, families and clinicians about these very serious issues. It makes a break with the past.

I am particularly concerned that there should be regular assessments and updates for people with problems from Primodos and sodium valproate, because we know from our experience with thalidomide that everybody thought that everything had been sorted from the initial diagnosis of the children, but as they entered adulthood and more mature years further medical issues appeared. It will be important to recognise that we need to make sure these young people—and adults as they are now—get that protection.

The yellow card system was not available in its current format for these two drugs. One of the things that concerns me most about the Statement is the assumption that the only people involved with the yellow card are clinicians. Speaking as a patient who has been on a drug that has very serious yellow card incidents, I have been trained to recognise that if I get a side-effect I do not just go back to my hospital; I report it to the pharma company. The pharma companies are notable by their absence in this Statement. Will there be specific links back for clinicians and patients on some of the side-effects of drugs? That is easy to say for those who are formally expert patients. I absolutely accept the point made by the noble Lord, Lord Hunt, that some patients are inexpert for all the right reasons.

There needs to be a real focus on all the other health professionals that these patients come into contact with. Reporting a yellow card incident to a GP when it is very difficult to see your own GP these days means that it could quite often be missed. In the case of sodium valproate this certainly needs to include midwives and people involved in the obs and gynae departments as well. What training is to be provided for these non-specialist healthcare people to make sure that they understand, when a patient talks about a problem, that this may need to trigger a yellow card response? To that end, I welcome the proposal for an electronic yellow card. That will be extremely helpful. Printing out a yellow card, filling it in and sending it in is an absolute deterrent to it happening.

On Primodos and sodium valproate, will the longer-term effects also be covered by the Cumberlege review? It is important to have a reference back there. I am also concerned about the vaginal mesh issues, specifically those reported in the Statement. It would be useful to know what percentage of those who have had vaginal mesh implants have faced problems. It is fine to say that many have benefited. I completely accept that, but one needs to understand what the ratio is between those facing problems and those for whom it has benefited them, to understand whether a ban should be in place. What is the date for publishing the retrospective audit? It is fine to say that it will be done. I have no idea how far along the line the process is. Then there is the timescale for creating that computer database for vaginal mesh to improve clinical practice. When will it be not just commissioned, but completed and used in analysis? Will interim reports go to the noble Baroness, Lady Cumberlege, by the people doing this review if evidence emerges that she will need to take account of?

I am concerned about the idea of the creation of a patients’ champion. We already have panels and expert groups. Yet another person that patients may or may not know about, and may or may not be able to turn to, seems problematic. I urge the noble Baroness, Lady Cumberlege, to look at what is available now rather than creating yet another body.

Finally, I echo the concerns expressed by the noble Lord, Lord Hunt, about whether we should move to a public inquiry at this stage. I wonder whether the evidence that the noble Baroness, Lady Cumberlege, will undoubtedly turn up means that she may come back to Ministers and say, “Actually, this is the point at which this needs to go public”. Campaigners have highlighted for years that there are problems.

I thank both noble Lords for their extensive, well-informed and probing questions; I will try to deal with all of them. I want first to take the opportunity to pay tribute to those involved in each of the three campaigns. They are almost exclusively women. A factor that needs consideration is not only that users of healthcare services are disproportionately women but that women seem to be disproportionately on the end of things when things go wrong—that issue needs investigating in itself. I have had the chance to meet not only the mesh campaigners but campaigners on sodium valproate and Primodos. They have gone to extraordinary lengths to raise these issues; they are remarkable women.

On the position relating to mesh, I have asked the MHRA and NICE as the two regulatory bodies to get in touch with their counterparts in Australia and New Zealand. There is some quite long, technical advice which I will not attempt to repeat, except to say that perhaps the simplified public view of what has happened in each of those countries is not entirely accurate. I shall certainly write to all noble Lords taking part in this debate and place a copy of that evidence in the Library. It is quite important. It is detailed, but it is well worth looking at.

I emphasise that collaboration is going on not only internationally but within the four corners of the United Kingdom. The CMOs of those four countries have met. I am meeting the Scottish Cabinet Secretary for Health—I think, next week—to talk about this specific issue and other things as well, so we are cognizant of the need for a joined-up UK approach.

On the scope of the review, it is very open. In the noble Baroness, Lady Cumberlege, we have an ideal chair: someone who has campaigned on safety issues, who is deeply knowledgeable, well respected and fiercely independent—as we know. She has the opportunity to look not just at issues around marketing, as the noble Lord, Lord Hunt, mentioned, but around the private sector. She will be able to look, too, at whether there should be public inquiries or other types of inquiry and to make recommendations. She will be able to look at pharma companies and gather evidence from wherever it is required. I want to emphasise that the review is very broad in scope. As the noble Baroness, Lady Brinton, said, we are trying to mark a break from the past. We know that we have not dealt with these things well. We are beginning to address that in the clinical and medical space in terms of medical practice; we now need to move on to medicines and devices, which is what we hope to do with this process.

On issues around the mesh, the audit and the registry, the audit is obviously retrospective. It will not be a perfect exercise, because the data is not always perfectly gathered, but it will be quite extensive in scope. It will be able to pick up not just complications associated by women, or indeed men, with having mesh but whether they have turned up in pain at another setting. We are confident that it will paint a much broader picture than we have had. The intention is to publish that in the spring. Obviously, if any interim reports relating to it come out, they will be shared with the noble Baroness, Lady Cumberlege, but clearly there needs to be robustness to them.

On the registry, this is an important moment. We have found the money to do this; it will be funded for the set-up and then for the first three years, which is the normal way in which registries are done. I do not yet have a timeline for how it will be delivered, but clearly we want to get it up and running as quickly as possible. It needs to be commissioned, but it is in everyone’s interest to do that.

Primodos presents a challenging issue, because it is not available on the market and has not been for 40 years, so it is not possible to carry out studies on what is happening to women now. However, new evidence has come to light which will also need to be considered and which was not available for the expert working group. Again, my noble friend Lady Cumberlege will be able to consider that as she looks at what needs to happen in each of those three cases.

One thing that we have to do—this moves on to the expert working group’s recommendations from the Primodos review, which is obviously very germane for women taking sodium valproate—is make sure that there is proper training for health professionals, not just in the yellow card scheme but for obstetricians in terms of their pharmacological advice and expertise. Indeed, that is one of the recommendations I will be taking forward, as was set out in the Statement. The valproate issue is very difficult, because it is an extremely effective anti-epilepsy drug but it can have very bad consequences for pregnant women and their children. I have met one of the campaigners; four or five of her children are affected and it is having a devastating impact on her life. We need to get to a position where no women of childbearing potential are using it. That needs to be done in the context of recognising that it does work for epilepsy.

Finally, I absolutely agree with the noble Lord, Lord Hunt, about meeting the groups to define the terms of reference. Again, we have learned from past experience that that has not always been done well and it is best done independently of government, with that degree of objectivity. I think that that is what this review will bring. As I say, the overall hope is that not only do we deal with the issues under each of these three headings, historical and current, but that we put in place a system that means that patients do not have to go through this tortuous process to get their concerns heard in future.

My Lords, I welcome the review that my noble friend has announced—I can think of no better person than my noble friend Lady Cumberlege to do it. One of the concerns of those who are campaigning and have received what they consider to be very inferior treatment is that when the mesh was originally introduced it was done, they think, without proper research, it was inserted with inadequate training, and inadequate warnings were given of the potential risks. Will my noble friend assure us that if an alternative is sought, that will not be the case but that it will be subject to rigorous testing, that there will be rigorous training of the medical professionals and that the risks will be explained to the patient?

They have also raised concerns about potential trade under any future trade agreement with the United States, where I understand a lot of the mesh comes from. They are concerned that we will not just waive any suspect mesh through but will ensure our own rigorous testing so that it meets the highest requirements of the UK.

I thank my noble friend for those points; she highlights some very important issues. Medical devices are regulated differently from medicines: they have to go through a safety procedure and they are not licensed in the same way as medicines are. They come onto the market, they are used and safety assessments are made as time goes on. We are now in the position with mesh that we will have a registry, so that every time it is used we will know what the consequences are. That will also give us a comparator, as will the audit, for effectiveness against alternative procedures. As I have said, there is still a view in the medical and regulatory communities that, when used according to guidelines in the appropriate way, it can be transformative for women. However, it can also be the wrong thing and NICE has been very clear that in some cases, in some surgeries, the risks outweigh the benefits, in which case it should not be used. It is important that there is absolute conformity with those guidelines and that is part of what the registry will ensure.

On the issue of trade, under no circumstances will our trade relationships with any country in the future dilute the regulatory rigour that we apply and have always applied in this country. We have a very well regarded regulatory system in this country but we also know that we can do better and it is absolutely our intention to continue to strengthen it.

My Lords, I am very grateful to the Minister for repeating the Statement but I put on the record my severe reservations about the safety of HPV vaccines. The noble Lord knows of my concern. I have had meetings with the MHRA but it seems to think that mañana is quite rapid enough to be dealing with it. The situation he described for those patients dealt with in the Statement is exactly the same as that of young girls and their families who have suffered bad reactions to HPV vaccines. Will the Minister ensure that the MHRA deals with some rapidity on this matter, as at the beginning of the Statement?

I thank the noble Countess for raising that point. We have met to discuss this issue and she has been a great campaigner on medicine safety issues. That dialogue is going on. As she knows, that view concerning the safety is not currently shared by the regulators. But I want to stress that the work that my noble friend Lady Cumberlege will be leading will try to set up a process which deals equitably, objectively and compassionately with these concerns when they arise. One of the problems in the past has been, frankly, that we have not dealt with these things in the same way. It is dependent on the strength of the lobby group, the type and strength of the Government and what is on their agenda at any one time. That is not good enough. We need a consistent and compassionate approach to listening to concerns, scrutinising them properly and dealing with the consequences, which may entail no further action or could be anything up to a full public inquiry. That is what my noble friend will be dealing with and that will be a huge step forward. It will be precisely that kind of process to which any concerns about HPV or anything else should be directed.

My Lords, I thank the Minister for the support he has given to the epileptic women who have taken valproate, resulting in them having children with autism. The marking and the advice were not there for them. Does the Minister realise that many people are concerned about the European Medicines Agency, which deals with safety in medicines? It was housed in London at Canary Wharf but has now gone to Amsterdam. Will we still be involved in that agency? We were leaders when it was here in London and we still have a lot to offer.

The noble Baroness makes an excellent point. Specifically on valproate safety, the MHRA has taken a leading role in pushing all the time for stronger responses to the concerns. We are pleased to see that other European countries are responding. That highlights a bigger issue, which is if you look across the entire continent and the work that our agencies do—whether it is the MHRA, the GMC or others—we are seen as a leader across Europe, and indeed globally, on patient safety issues. That is one reason why it is our desire that in our future relationship with the European Union, the MHRA and other agencies continue to play that role, for the good of patients not just here but across Europe.