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Independent Medicines and Medical Devices Safety Review

Volume 804: debated on Wednesday 15 July 2020


The following Statement was made on Thursday 9 July in the House of Commons.

“With permission, Mr Deputy Speaker, I would like to make a Statement about the independent medicines and medical devices review. This review was announced by my right honourable friend the Member for South West Surrey (Jeremy Hunt) in February 2018, in response to public concern about the safety of medicines and medical devices used by the NHS. It focused on three areas. The first is Primodos, a hormone-based pregnancy test that is claimed to have led to miscarriages and birth defects during the 1960s and 1970s. It was prescribed to more than 1.5 million women before it was withdrawn from use in 1978. The second is sodium valproate, an anti-epilepsy drug that has been definitively linked to autism and learning disabilities in children when taken during pregnancy. The third is the vaginal mesh implants used in the treatment of pelvic organ prolapse and stress urinary incontinence, which have been linked to crippling, life-changing side-effects.

Baroness Cumberlege was asked to conduct a review into what happened in each of those three cases, including whether the processes that were followed were sufficient when patients’ concerns were raised. She was also asked to make some recommendations for the future, such as: how to consider the right balance between the criteria or threshold for a legitimate concern; how best to support patients where there might not be a scientific basis for their complaint, but where they have still suffered; how we can enhance the existing patient safety landscape; and how we can be more open to the insights that close attention to patient experience can bring.

The report has now been published, and a copy has been deposited in the Library of the House. It makes for harrowing reading. Every page makes clear the pain and suffering that has been felt by so many patients and their families. As Baroness Cumberlege herself said, they suffered ‘avoidable harm’. She said that she had listened to the heart-wrenching stories of acute suffering, of families fractured, of children harmed and so much more.

On behalf of the health and care sector, I would like to make an apology to those women, their children and their families for the time the system took to listen and respond. I would also like to thank every single person who has contributed to the review. I know that some of them wanted to be here in the House today. They felt as though their voices would never be heard, but now they have been, and their brave testimony will help patients in the future. I have watched and read some of their testimonies. They left me shocked, but also incredibly angry and most of all determined to make the changes that are needed to protect women in the future. It is right and proper that the victims were the first people to see this report. As a Government, we have now received its findings and, as honourable Members will understand, we are taking time to absorb them before we respond. That is the least that the report deserves. We will update the House at the very earliest opportunity.

I would like to thank Baroness Cumberlege, who has carried out her work with thoroughness and compassion. She has worked tirelessly to ensure that patients and their families have been heard, and I would like to pay tribute to her and her team. I know that the patients’ stories that they have heard have been harrowing and, at times, frankly beyond belief. She has done us all a great service by highlighting them, along with the suffering of so many women and their families. I know that there will be strong feelings across the House about the report, and that honourable Members will be eager to hear a fuller response. However, it is imperative for the sake of those who have suffered so greatly that we give the review the full consideration that it absolutely deserves.

It is clear, as I am sure the whole House will concur, that the response to these issues from those in positions of authority has not always been good enough. The task now is to establish a quicker and more compassionate way to address issues of patient harm when they arise. We must ensure that the system as a whole is vigilant in spotting safety concerns, and that we rapidly get to grips with the concerns identified by the report. We must make sure that different voices are invited to the table and that patients and their families have a clear pathway to get their answers and a resolution. The issues tackled in this report are, from one perspective, complex—matters of regulation, clinical decision-making and scientific judgment—but there is one simple core theme that runs through all of this, and it goes to the heart of our work on patient safety. It comprises just two words: listening and humility. So much of the frustration and anger from patients and families stems from what they see as an unwillingness to listen—for us to listen and for them to be heard. We need to make listening a much stronger part of clinical practice and to make the relationship between patients and clinicians a true and equal partnership.

While the review has been progressing, the Government and the NHS have taken a number of steps relating to the concerns it has raised. However, there is always more that we can do, and it is clear that change is needed. We owe it to the victims and their families to get this right. I commend this Statement to the House.”

My Lords, I thank the Minister for the Statement. I start with the words of the chair of the review, our colleague, the noble Baroness, Lady Cumberlege, who said when she launched the report last week that she was shocked by the sheer scale and intensity of suffering. She said:

“I have conducted many reviews and inquiries over the years, but I have never encountered anything like this … Much of this suffering was entirely avoidable, caused and compounded by failings in the health system itself.”

I congratulate the noble Baroness on conducting an inquiry over the last two years that has been praised by everyone concerned, particularly the patient groups and those affected.

Some of us have been discussing the problems addressed in this report for many years. We have heard about the hormone pregnancy test Primodos, the anti-epileptic drug sodium valproate and, in recent years, use of vaginal mesh in surgery. It is important to pay tribute to the bravery and persistence of the patients and patient groups, but also to the parliamentarians whose work helped to persuade the Government to establish the inquiry two years ago. The All-Party Groups have been vital, as have Yasmin Qureshi MP, Norman Lamb MP, Owen Smith and Sharon Hodgson MP, to name but a few.

On the surface, the three medical issues are separate. What links the medicines and devices is that they were all taken or used by women—in two cases, by pregnant women. As my honourable friend Alex Norris MP said last week in the Commons,

“these cases reek of misogyny from top to bottom—and ageism and ableism as well.”—[Official Report, Commons, 9/7/20; cols. 1148-49.]

We also have to look at the reaction of the healthcare system, which, according to the report, failed to monitor the use of these medicines and medical devices, then failed to identify and acknowledge the things that had gone wrong, then failed to work to improve. The review sets out the missed opportunities when something could or should have been done to prevent harm. Instead, there was a culture of denial, disjointedness and defensiveness that failed to listen to patients’ concerns.

Our NHS failed to protect these women and their families. It is therefore right and welcome that the Minister’s first reaction has been immediately to offer an unqualified apology, which is the first of the nine recommendations in the report. The Secretary of State said that listening and humility are in order. That is right, but it now needs to be followed by action to make the process worth while and to address the suffering. I hope that in this discussion the Minister will be able to outline what the Government will do to implement the rest of this report and to what time- scale. The most sensible way forward is the ninth recommendation, which is to set up a task force to implement the other recommendations. Will this be done, and by when?

On recommendation 2, I can see that progress has already been made. But can the Minister explain what legislative underpinning would be needed for a patient safety commissioner? Some of us are very puzzled as to where the delightfully named HSSIB is—the patient safety Bill—and whether that would have been a good complementary vehicle.

Recommendation 3 calls for:

“A new independent Redress Agency for those harmed by medicines and medical devices”

to create a new way of delivering redress in future. It suggests that manufacturers and the state should share the costs. Would the Minister care to tell us how that might be achieved?

Recommendation 4 suggests:

“Separate schemes … for each intervention—HPTs, valproate and pelvic mesh—to meet the cost of providing additional care and support to those who have experienced avoidable harm”.

How might that be achieved? I also have one question relating to mesh and all other implants. How will the Government ensure that they are safe to use? A register is obviously a good step forward and is in the Bill that we will discuss in the next few months, but why do the regulations on implants not provide for trials, as with medicines?

On recommendation 6, will the Minister commit to amendments to the Medicines and Medical Devices Bill to strengthen the Medicines and Healthcare products Regulatory Agency’s regulatory regime? On these Benches, we are committed to implementing the nine recommendations in this excellent report. We will seek to use the forthcoming MMD Bill to do so, and we wish to work with the Government to explore how best to achieve that.

My Lords, on behalf of the Liberal Democrat Benches, I too thank the noble Baroness, Lady Cumberlege, and her team for such an outstanding report. It is not only comprehensive but blunt in its language, so that no one can misunderstand the failings of all levels of the healthcare system, whether in our NHS or other health and research settings, over many years. We too pay tribute to those women, and their children and families, for continuing against all the odds for years when too many ears, including the Government’s, were deaf. I also pay tribute to the many parliamentarians, including Norman Lamb, who over the years supported them. They pushed for this review in Parliament and raised it in any way they could.

Ministers have apologised for these failings, including for the system not listening and for not acting soon enough, over the decades since patients first started to raise the problems with these three medical interventions. Last week, when I asked the Minister about the timetable for implementing the recommendations, he said that

“it will take some time for the Government to study these recommendations … and to come back on the timetable”.—[Official Report, 9/7/20; col. 1224.]

The noble Baroness, Lady Cumberlege, says in her letter introducing the report:

“Over the past two years we have found ourselves in the position of recommending, encouraging and urging the system to take action that should have been taken long ago.”

She also said:

“Implementation needs to be approached with a new urgency and determination, founded on the guiding principle that our healthcare system must first do no harm.”

When the interim report was published, leaving this House in no doubt about the direction in which the review group was proceeding, many people expected action at that point.

I am grateful to Epilepsy Action for its briefing, which demonstrates exactly why urgent action must be taken now. Epilepsy Action, the Epilepsy Society and Young Epilepsy jointly surveyed over 500 women and girls who had taken sodium valproate since the pregnancy protection plan was introduced two years ago. One in 10 was unaware of the possible risks of birth defects. Almost half said that they had not discussed the risks of taking medicine with their health professional in the last 12 months, and only four in 10 said they had signed the annual risk acknowledgement form. For patients and families who have suffered as a result of these interventions, urgent action needs to be taken on government departments such as the DWP regarding the way it assessed the damage caused, and on how government as a whole compensates them for this gross injustice.

So I ask the Minister again: when will the Government return to those affected and to Parliament with clear recommendations and a timetable to do honour to the report and to all those affected? And when will the various bodies in our healthcare sector be set a deadline to publish the list of recommended actions that they will take that will not need parliamentary action? Last week, the Minister told your Lordships’ House that the Government had moved ahead on one of the recommendations—the creation of a patient safety commissioner—but their version is not independent, as asked for in the report.

So much of this report is about changing cultures: we still have not learned from Mid Staffordshire, East Kent and Shrewsbury maternity care, all of which Ministers have rightly been appalled by. For all the excellence and commitment of the individuals who, singly and collectively, provide our unique healthcare in the United Kingdom, there remains an unhealthy culture in some parts that does not listen to patients, does not understand conflicts of interest and resists change. That must change, it must change soon and it must be led from the top by the Government.

The report quotes Professor Ted Baker, chief inspector of hospitals for the CQC:

“I have to say 20 years later it is very frustrating how little progress we have made. It’s clear to me we still have not got the leadership and culture around patient safety right. As long as you have that culture of people trying to hide things, then we are not going to win this.”

Armed with this blunt and excellent report, I hope that the Minister can demonstrate the Government’s support with firm actions and dates, and not just with warm words that will drift away. The hopes of patients and their families and the future safety of our healthcare system depend upon it. When, Minister, when?

My Lords, I start by reiterating the tributes from both noble Baronesses, Lady Thornton and Lady Brinton, to my noble friend Lady Cumberlege and her team, who have worked indefatigably on a high-quality report that does justice to this important cause. Most of all, I pay tribute to the patient groups, the specialist groups and those who campaigned on these important issues and who have brought attention and a huge amount of official focus to causes that had been overlooked for years and decades. I pay tribute to their patience, their expertise and their stamina in bringing these important causes to attention. It is entirely right that the Minister, my colleague Nadine Dorries, made an apology to those groups, and I reiterate that apology on behalf of the healthcare system to all the families affected by the report, for the time it has taken to listen and to respond to their concerns.

Both noble Baronesses referred to the culture that led to these issues being overlooked. I think that that is one of the most important learnings from this report. As Nadine Dorries said, I thought very movingly, in her speech in the House of Commons, the system has to learn to listen much more clearly. Listening must happen not just from the top but also at the level at which patients engage with the system itself. I think that trying to change that culture is one of the most important challenges facing us today. It is not just a question of bringing in punishment and retribution for those in the professional world who have failed; it is trying to create a culture where mistakes are recognised and accepted and where people address and take on board the concerns of patients themselves—and on that important cause we are hugely focused.

The noble Baroness, Lady Brinton, asked what we are doing. Already, much has been done. There has been progress in lots of areas. We already have 12 different types of patient safety function in place within the NHS: the Patient Advice and Liaison Service; commissioners of NHS services; the Parliamentary and Health Service Ombudsman; Healthwatch; the NHS Complaints Advocacy service; the CQC; the NHS Friends and Family Test; the professional regulators; the Healthcare Safety Investigation Branch; the Professional Standards Authority; the National Director of Patient Safety; and the complaint systems within individual trusts.

That patchwork quilt of patient safety and patient advocacy is an enormous function within the NHS. The report teaches us that it has not been enough to identify the major themes of failures—in this case, involving medical devices—and there has not been the patient advocacy necessary to see complaints through when they have really mattered. It is that question which we are turning to: how do we make these considerable and important efforts to put patient safety at the heart of the NHS more effective?

The noble Baroness, Lady Thornton, asked about the regulatory implementation of that response. The most important legal implementation is the registry of medical devices, which was in an amendment to the Bill on Report in the House of Commons, and it has enormous support from the Government. That registry, which is an incredibly important source of accountability and of clinical information, is the key to preventing such terrible events concerning medical devices in the future.

The report was published only last week, and it will take some time to focus on all its other recommendations. I can update the House on the specialist centres that the report quite reasonably recommended should be set up: NHS England is assessing bids from NHS providers to be specialist centres for mesh inserted for urinary incontinence and vaginal prolapse.

The noble Baroness, Lady Thornton, also asked about the MHRA regulatory review. The MHRA has begun a comprehensive and far-reaching programme of change, which will include enhancing its systems for adverse event reporting and medical device regulation. The MHRA has taken important steps to put patient advocacy at the centre of the work that it does.

There is nothing we can do today to make good the harm done in the past. However, as both noble Baronesses have rightly pointed out, there is much we can do to put patient safety at the heart of the NHS and to ensure that we have the technology, the systems and the culture to make sure that these mistakes never happen again.

We come now to the 20 minutes allocated for Back-Bench questions. I ask again that both questions and answers be kept brief, so that I may call the maximum number of speakers.

My Lords, I first thank the noble Baroness, Lady Cumberlege, for such a wonderful and constructive report, and all the members of the committee, especially Professor Sir Cyril Chantler, whom I have known for many years.

I have just two questions. Will the report encourage clinicians to consult the appropriate royal college before designing a new treatment? Secondly, after introducing a new treatment or a new operation, should the clinician be encouraged to wait for an appropriate interval to ensure that no complications occur?

I thank the noble Lord for his searching questions. The role of the MHRA on both medical devices and medicines has been massively upgraded, and the review process for new medical devices has been improved. However, medical devices have different criteria from medicines.

One of the most important things that we have sought to do is to include a registry of the medical devices themselves and a registry of the medical devices inserted into individuals. Compliance with both procedures is the most important step for clinicians embarking on new products.

My Lords, I thank the Minister for answering questions on this Statement and in so doing remind noble Lords of my registered interests. In her excellent report, the noble Baroness, Lady Cumberlege, identifies concerns about the lack of evidence that is required prior to the granting of marketing authorisation for many medical devices, where all that is often required is demonstration of equivalence to an already marketed product. The noble Baroness highlights the striking difference that exists with regard to the situation for medicinal products, where robust evidence of efficacy and safety is required before a medicinal product can be marketed. Are Her Majesty’s Government content with this situation—this difference between the level of evidence required before a product and a device can be marketed as regards patient safety? If there are concerns, what approach do Her Majesty’s Government propose to take with regard to ensuring that there is proper evidence of both the safety and efficacy of a device prior to its broad marketing and use in large populations of patients?

The noble Lord alludes to an extremely difficult balance that we have to seek to make. He is entirely right that medical devices and medicines operate on different criteria. The most important thing is that the MHRA resources for focusing on the approval of medical devices have been improved and the procedures enhanced. However, medical devices remain an important area of potential innovation, and we are concerned not to suffocate this area of potential improvement as it has been suffocated in other areas. At present, the Government believe that we have struck the right balance, but we remain keenly focused on it and it is under constant review.

I add my voice to the tributes that have been paid to those who produced this report, and especially to the women who persisted in having their voices heard. What came through to me very clearly was that the women themselves had not been listened to. It reminded me—I hope it will remind the House—that the complaints of women who were failed by the legal system were very much the same, about not being considered credible and about somehow exaggerating what they were describing and not being heard. It is about changing professional cultures. We have had this in the law and in policing, and we are now having to consider it in the medical professions and probably all our professions. How will the Government deal with embedded attitudes, and how will we change the training of our young medical professionals and change the attitudes inside our teaching hospitals? I want to hear about how you change cultures.

The noble Baroness is right: we do not listen to our women clearly enough. The medical health of women is more complicated than the medical health of men, and that point has been overlooked for too long. We are working hard to bring this into the education of young medics and to update the attitudes, procedures and knowledge of those who are already in the profession.

The noble Baroness, Lady Cumberlege, recognised the importance of regulation in her excellent report. Our regulation system is in a transitional stage. Regarding the European Medicines Agency and the Medicines and Healthcare products Regulatory Agency, the text of the political declaration accompanying the withdrawal agreement stated only that the UK and EU will “explore” the possibility of co-operation. Can the Minister confirm what exploratory talks have been made to ensure that the EMA and MHRA remain strong and convergent post Brexit, and that the MHRA is adequately staffed?

The noble Baroness is right that regulation is important, but so is culture. I emphasise the importance placed by the Cumberlege report on a change in attitude in the healthcare service as much as on a change in regulation. I cannot guarantee that the EMA and the MHRA will be aligned on regulation in all matters, but I can guarantee that the MHRA will be given the resources it needs to do the job properly.

My Lords, as a former Secretary of State for Health, perhaps I may say that I and all my colleagues who have taken responsibility for the NHS over decades should join in expressing our deep regret at the systemic failures laid bare in the report of the noble Baroness, Lady Cumberlege. Will my noble friend reiterate the point about cultural change? It is not just about implementing the recommendations, important as that is, but about achieving cultural change. I direct that point in particular to patient involvement. By that I mean not just consultation, not just a patient voice, not just decision aids but patient-reported outcomes being a central part of the measurement of the performance of our health service and its accountability.

I completely endorse the comments of my noble friend. To embellish his point, it has been very interesting to see through Covid how patients have had to track their own symptoms, take advice on 111 for themselves and, in millions of cases, look after themselves at home, possibly with telemedicine to support them. This may be an inflection point in the attitude of many people to their health. I certainly welcome a revolution of patient power and putting patients first in our healthcare system.

My Lords, families and dedicated campaigners such as Marie Lyon have told the All-Party Parliamentary Group on Hormone Pregnancy Tests, of which I am vice-chairman, that they have unequivocal admiration for the noble Baroness, Lady Cumberlege, for compassionately understanding their pain and suffering and allowing them, for the first time in more than 50 years, to have hope. Does the Minister agree with the report’s conclusion that, when the first comprehensive study, in 1967, identified a link between congenital abnormalities and HPTs, Primodos should have been removed from the market and that this regulatory failure has seen justice delayed and denied? Will there now be an independent re-examination of the contested conclusions of the report of the expert working group? In implementing the Cumberlege recommendations without delay, what practical help and redress will be provided for families whose lives were irreparably blighted by Primodos?

My Lords, I completely share the view of the noble Lord and of the patient groups who have unequivocal admiration for the noble Baroness, Lady Cumberlege, who has done the nation a great service with this report. As he knows, the Primodos case is subject to legal dispute, so I cannot comment on it from the Dispatch Box, but no one can read the report without feeling great disappointment that those hardships were suffered by those women. It is of enormous regret to us all.

My Lords, I am pleased to speak today very briefly. I have known the noble Baroness, Lady Cumberlege, for years since I worked in the health scene myself. She is widely experienced, and no one could have done a better report. It is very impressive and certainly not to be ignored. The various points that she has made, including the nine major recommendations, are all sound and people are very aware of them. We must realise that, though the health service is much loved by everyone in the country, there are failings which we have to accept and work on. I congratulate the noble Baroness on this marvellous report and hope that, as she urged in her press conference:

“This report must not be left on a shelf to gather dust.”

I am pleased to commend the report and the remarks passed.

The noble Baroness is entirely right. The report must not be left on the shelf. We have already done much, and in the Medicines and Medical Devices Bill we will do more. The other recommendations will be taken extremely seriously.

My Lords, this wonderful but deeply disturbing report has so many points to make, but one point that has not been brought out in coverage as much as it might have been is the noble Baroness’s recommendation that the responsibility for ensuring transparency of interests should fall not only on the medical profession but also on manufacturers, who must take responsibility for ensuring that, where they are creating potential conflicts of interest with medical professionals and researchers, they show that. Can the Minister tell me what plans the Government have to make sure that manufacturers are being open, honest and transparent in all their dealings and that, should they not act in that matter, action is taken?

The noble Baroness is entirely right that transparency is essential in order to have a fair and equitable healthcare system. The GMC has already considered these areas and has moved a long way. The world has changed considerably since many of these horrific events took place, but I am sure there is more to be done and this recommendation, like others, will be considered seriously by the Government.

My Lords, there is so much to be said about this excellent report, but I shall quote one devastating sentence on mesh implants, where it raises the question

“whether the modification of a device so that it required less skill to insert should have been the preferred option rather than improving the surgical skill base.”

Does the Minister agree that there is an urgent need for a robust surgical training programme for inserting mesh devices and, just as importantly, for their removal? Will resources be put in place for such a programme?

The noble Baroness is right to emphasise the dangers of the insertion of mesh. It is a procedure that is still taking place within the NHS. We are looking at bids for specialist units in relevant trusts to build up the kind of specialist skills necessary to deal with the problems that have emerged from mesh procedures that have gone wrong.

My Lords, this is yet another outstanding report from the noble Baroness, Lady Cumberlege. The beginning of the “Implementation” section reads:

“Our recommendations are designed to pave the way for a future healthcare system that looks and feels very different.”

This is not only an outstanding report; it is a revolutionary report. Do the Government accept that this is not just another committee of inquiry but an investigation that found the facts and came back with recommendations? Are they going to set up the task force?

I completely agree with the noble Lord, Lord Greaves, that this is an important report. I pay tribute to my predecessor my noble friend Lord O’Shaughnessy, who commissioned it. We take it extremely seriously. No one could possibly read about the hardships suffered by the women described in this report without wanting to move swiftly on it. It has only been a few days so I cannot announce a strict timetable for every measure, but I assure the noble Lord that it is taken seriously and we will be moving on it in the very near future.

My Lords, this important report must become core in every curriculum, because patients must be listened to. It is correct to say that there must be a culture change, but I would like to focus on the third recommendation about establishing a redress agency. How quickly will the Government progress that? Without that, and without changing the whole culture of compensation and complaints, we will not get the openness and listening whereby if somebody comes forward with something they should expect the answer, “Thank you for telling us,” not “Oh well, we’ll look into it.” Until that changes and every comment is welcomed and patient- reported and family-reported outcomes are used to move services forward, we will not get the culture change that is needed.

The noble Baroness is right about culture change, but we are aware that having a big, clunking fist of financial threat hanging over individuals who are considering the admission of mistakes is not the right combination to create a culture of self-awareness and acknowledgement. We have to move extremely delicately to encourage people and make them feel safe enough to acknowledge the mistakes that might have happened and to embrace the kind of dialogue with patients that is necessary to deal with these results. That delicate balance is one of the most important things to get right in our reaction to this report.

We have heard some of this before. Thirty-four years ago, I submitted to the then Secretary of State—now our Lord Speaker—a patients’ charter prepared by the association of CHCs, which talked about listening to patients, putting them at the centre of every decision, and having a proper system of redress. Since then, every White Paper published by every successive Secretary of State has paid lip service to those principles, as the Minister has today. But the noble Baroness, Lady Cumberlege, has shown how shallow the commitment has been. The Minister talked about a patchwork quilt of safety mechanisms; can he convince us that this time it will be different? When will the Government say not only that they accept her recommendations in full, but what robust arrangements there will be to make sure that action and culture change actually follow?

Let me reassure the noble Lord that this report is taken seriously. But I acknowledge the fact that some of these issues are extremely complex, and when dealing with issues such as sexism, bullying, racism and a failure to engage with patients, there are not single-shot solutions like patients’ charters that will somehow transform the ecosphere. We have to look at it in the round, and that is why there will be major interventions like the HSIB, the people plan and the focus on fairness in the workplace that will ultimately make a big difference.

The excellent report from the noble Baroness, Lady Cumberlege, puts patient safety at the heart of everything. I welcome the proposal in theme 3 on patient-informed consent to ensure that patients really understand and are able to co-sign their patient aid decision with the clinicians. Will the NHS ensure that professional translators able to assist patients who have English as a second language will be there at meetings and to discuss consent with them?

The noble Lord is right to focus on this. We have put in place enormous measures to address the issue of translation. Technology is being used in a much more thoughtful way to make sure that translation services can be put into a great many environments. One-to-one translation is also important, and that is why we have emphasised it.