Safety of Medicines and Medical Devices
(5 years, 8 months ago)
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Lord O’Shaughnessy
That this House takes note of the steps being taken to improve the safety of medicines and medical devices.
Lord O'Shaughnessy (Con)
My Lords, I am delighted to be able to lead this debate today. I thank all noble Lords who will speak in it and wish the noble Lord, Lord Carrington, the best of luck in delivering his maiden speech—an auspicious occasion that we are all looking forward to.
I also express my gratitude to all those who have provided briefing for today’s debate: In-FACT, Sling The Mesh, The Royal College of Surgeons, the Nuffield Council on Bioethics and others. We are deeply fortunate in this country to have well-informed patient groups, professional organisations, charities, trade bodies and others. Their knowledge provides an indispensable contribution to our national conversation. The same is true of our superb House of Lords Library, which has produced a typically comprehensive and incisive briefing, for which I am grateful.
The reason for this debate stems from my time as a Health Minister, when I had responsibility for medicine and medical device regulation, and for promoting innovation in the NHS. That experience introduced me to the amazing benefits that come from life-changing and life-saving new therapies, but also exposed me to the dreadful harm that can occur—however rarely—as a consequence of the innovations on which we all rely. There is an innate tension between innovation and safety, and that is the principal idea I wish to explore today: how to balance that risk and encourage innovation—especially for those most in need of hope and help—but also act faster, be more agile and more compassionate when things go wrong.
We all have reasons to be grateful for the medical innovations that have become available through the NHS over its 70-year history, many of which were pioneered in this country. From mass vaccination programmes to joint replacement surgery, from organ transplantation to the creation of monoclonal antibodies —the medical and life science research community in the UK has saved and improved the lives of hundreds millions of people around the world. It is a record of which we should be immensely proud, and which the Government are supporting through the Life Science Industrial Strategy.
Our regulatory system can also be seen as a strength. As a Minister, I spent time with many European colleagues, who were always complimentary about the quality of medical regulation in this country, led by the MHRA, CQC and other bodies. They were right to be so, but the experience of the last two years—and the fact that we are having this debate—shows me that we can and must do better.
As I mentioned in responding to her superb maiden speech, my noble friend gave me some excellent and wise advice in 2017, when I joined her as a colleague in the department. She told me to watch my postbag, because it could provide warning signals about problems in the system. How right she was. Among the many letters I had from MPs and noble Lords raising concerns about problems associated with medicines and medical devices, there was a steady stream on two particular areas, which I want to focus on today: mesh, a device often used in a variety of procedures to fix prolapses, incontinence, hernias and other related conditions; and sodium valproate, a highly effective medicine used largely to treat people with severe epilepsy.
It is one thing to read about the problems suffered by patients when medicines and devices cause harm, but it is another thing entirely to meet in person those affected. I have had that opportunity on many occasions, and some of the stories I have heard have been truly heart-wrenching. I will never forget meeting for the first time two remarkable women to discuss the issues associated with sodium valproate. They are here as my guests today: Janet Williams and Emma Murphy of In-FACT, supported by their friend and fellow campaigner Mikey Argy. I was horrified to hear that, despite the risk of the drug’s teratogenic effects—that babies exposed to it in utero ran an unacceptably high risk of developing a range of physical and mental impairments—being known since the 1970s, thousands of women, already vulnerable because of their epilepsy, were still being exposed every year.
I was deeply impressed by the quiet but iron determination of these two women, whose own children have been significantly affected by valproate, and their commitment to reducing risks of other women in this situation. Following that meeting, I worked closely over two years with In-FACT, the APPG and the MHRA—I pay tribute to Dr June Raine and Sarah Morgan for their work—and the heads of the relevant Royal Colleges and other learned societies, to try to do something about this issue. We made a number significant policy changes, including mandating pregnancy prevention programmes for women of child-bearing potential on valproate, and insisting that “do not take in pregnancy” images ought to be put on every prescribed pack.
Change is happening, but despite everyone’s good intentions, the pace is glacial. According to In-FACT, around 30,000 women nationally are prescribed valproate, which is roughly the same as in 2015. While the number of in utero exposures is falling, during a recent valproate stakeholder network meeting, the MHRA stated that some 200 babies have been affected by valproate since April 2018, which was when the pregnancy prevention programme came in. Professor Thangaratinam, professor of maternal and perinatal health, stated in evidence to the Cumberlege review team that every year 350 to 400 women prescribed valproate get pregnant—this for a drug that has a perhaps 50% risk of harming the baby in some way.
I also very clearly remember, following an Oral Question from the noble Lord, Lord Hunt, who I am delighted is speaking after me today, meeting a large group of women whose lives had been ruined by mesh. Some were confined to wheelchairs and all had suffered or were suffering considerable pain as a result of what they had been told at the time was a minor and uncomplicated procedure: the insertion of synthetic mesh. I had several further meetings with affected women and parliamentary campaigners on this issue, and I take this opportunity to thank Kath Sansom and the Sling The Mesh campaign for highlighting the human costs of some of these mesh procedures and for working constructively to change the policy and the regulatory environment to reduce the risks to women.
Again, change has happened—the number of procedures involving mesh is falling and certain categories of use are now effectively banned—but the health system has been too reactive in dealing with a problem that has been apparent for at least 15 years. Faced with the anguish and determination of these women, it was obvious that the Government had to do more. I had also been dealing with the results of the Commission on Human Medicines inquiry into the historic Primodos case, where again a number of families, led by the redoubtable Marie Lyon and her husband, were convinced that their children had been adversely affected by this hormone-based contraceptive.
These cases—Primodos, mesh and valproate—were very different in many ways, but it was also clear, in dealing with these and other issues, that they had critical factors in common. First, our methodology for discovering and verifying adverse events needs to improve. While the UK has one of the best pharmacovigilance regimes in the world, it is still dependent on old-fashioned ideas, such as the voluntary yellow card scheme. Furthermore, the process for regulating devices is not always as rigorous as that for medicines.
Secondly, as must have been obvious from my speech so far, all three cases largely affected women. Of course, women are the greatest users of health services, a fact intimately linked to the fact that they give birth, so we would expect more adverse events to be experienced by them, but there is much more to it than that. In all these cases, I heard women reporting patronising and often patriarchal attitudes from a largely male medical workforce administering a pat on the head, sometimes literally, and telling them that the pain was all in their minds.
Thirdly, and related to the previous point, all these women had been campaigning for years to have their voices heard, their pain and suffering recognised, and it had often fallen on deaf ears. In this respect, the parallels with scandals like the one at Mid-Staffordshire could be seen: a system that too often turns its back when criticised, rather than offering a compassionate and understanding face that seeks to help those affected and prevent the problems occurring for others. It was this insight—that there were common themes that warranted further explanation—that led to my suggesting to the then Health Secretary, Jeremy Hunt, whose abiding principle was that patient safety should always come first, that we needed an independent review into our medicine and medical device safety regime. I was delighted when he and the Prime Minister supported the proposal, and even happier when my noble friend Lady Cumberlege was appointed to lead it. It is fantastic that she is able to speak in the debate today. The work she is doing is so important, and I believe that the way she has engaged patient groups around the country through her review has been truly exemplary. She has already made a big difference, because it was on her recommendation that a pause was instigated on certain mesh procedures in England.
Up to now I have focused on areas where patients have been put at unnecessary risk and provided with inadequate information, and where the system has been too slow to respond. It is certainly my belief that, for medical products with wide usage, where patients expect to live long and broadly healthy lives, we need to do better, but the tension between innovation and safety can manifest itself very differently for people whose outlook is poor. In these cases, the boundary between risk and reward can fall in a very different place. Last January, we in this House were privileged to bear witness to one of the most extraordinary speeches in living memory from our friend, the much loved and much missed Baroness Jowell. I had the honour of responding for the Government to the debate she initiated on improving cancer outcomes. The noble and courageous lady raised many important ideas that day. One of the most significant was that when you do not have long to live, you have little to lose by trying experimental therapies that, in ordinary circumstances, no clinician would dream of giving a patient.
This insight was, of course, also behind my noble friend Lord Saatchi’s Medical Innovation Bill, considered some years ago and inspired by the tragic experience of his own late wife. In these situations, when sadly and frankly the prospects are grim, it is right that the balance between risk and benefit is flexible. In our efforts to improve the safety of medicines and medical devices in general, we must not prevent those willing to take great risks to extend their lives from doing so—quite the opposite. The regulatory regime we need to create must be able to draw a much more sophisticated distinction between the balance of safety and innovation, so that it is dependent on the needs of each individual patient.
There are some really encouraging developments in this area. Next week I will visit Professor Colin Watts and his team at the University of Birmingham. Together with the Brain Tumour Charity they have created BRAIN-MATRIX, a clinical trials platform for people with brain tumours that is the first of its kind. It not only allows patients with a very poor prognosis to access experimental therapies, but also uses adaptive techniques and other methodological innovations to make sure that outcome data is gleaned from every intervention and used to improve each patient’s course of treatment, as well as that of those who will follow them.
I strongly encourage my noble friend the Minister to look at what is happening in Birmingham, and other similar approaches such as Precision Panc, because they have the potential to offer a new way to make sure that patients with these dreadful diseases can quickly access experimental therapies in an ethically acceptable way that generates better treatments for all.
I will conclude by making a few suggestions for how things might change. The current system can be bewildering for patients who do not know where to turn when things go wrong. I think that we need a new national office of patient safety—a compassionate, patient-facing agency that is the first port of call when harm is suffered, that can provide the analytical rigour needed to look at cases on their merits, and that can provide a single focal point for action among the many professional and product regulators that operate in the system.
I am sure that my noble friend the Minister will rightly want to see the results of the Cumberlege review before fully setting out the Government’s own plans, but I am keen to know her thoughts on this proposal. Can she also use the opportunity of this debate to reassure the House—and the many interested patient groups—that the department is fully behind the review and will look at its recommendations later this year with an open and constructive mind?
But we do not have to wait for my noble friend’s review to conclude before we act. It is imperative that the Government support the MHRA and other agencies to use technology and other innovations to improve post-licensing surveillance of medicines and medical devices. This should include using the upcoming EU medical device regulation, the NHS’s own “scan for safety” system and the application of machine learning to the NHS’s unique data resource. It must also include new registries for high-risk devices, such as the one the Government have already committed to for mesh. Can my noble friend the Minister inform the House how the department intends to move forward on this agenda?
For families affected by valproate, does my noble friend agree with me that the ambition should be to limit in utero exposure to as near zero as possible, and to make sure that every eligible woman should be on a pregnancy prevention plan and able to make an informed choice about whether to have a baby?
For women affected by mesh, as well as further strengthening the regulatory regime, will my noble friend ensure that there is a properly funded and staffed national network of expert removal centres and surgical teams who can try to repair some of the damage that has been done?
As medicine evolves and becomes more personalised, and as patients become better informed and more active in managing their own care, the balance between innovation and safety needs to evolve as well. I hope I have set out some of the questions we need to answer as we make these changes, and eagerly anticipate the contributions of noble Lords, including my noble friend the Minister, as we collectively seek to achieve the highest standards of patient safety, care and innovation in our NHS. I beg to move.
Lord Hunt of Kings Heath (Lab)
My Lords, I am very grateful to the noble Lord, Lord O’Shaughnessy, for initiating this debate. I remind the House of my health interests as set out in the register, specifically my membership of the GMC and presidency of GS1 UK and the Health Care Supplies Association.
The noble Lord has focused on the review of the noble Baroness, Lady Cumberlege. I will concentrate on surgical mesh, but I recognise that the review has a much wider significance, assessing the actions of relevant authorities over the years when safety concerns have been raised. On surgical mesh, what is so striking is how long it has taken to get any action. The excellent campaign group Sling The Mesh, led by Kath Sansom, has fought a sustained campaign to draw attention to the problems that we have heard about, with many women left in permanent pain, unable to walk or work and feeling totally neglected by the National Health Service.
Not only have these problems been known about for years, they have been recognised in a series of official reviews. As far back as 2012, the Department of Health reported that, while surgery for stress urinary incontinence and pelvic organ prolapse using mesh can be effective for most women, a small percentage will suffer significant side-effects. The department established a working group between 2014 and 2017—for three years—that came to no hard conclusions at all. At the time of the publication of the final report, the MHRA said that it was committed to addressing the serious concerns of patients, but that it was not aware of a robust body of evidence that would lead to the conclusion that mesh was unsafe if used as intended.
In a Statement that the noble Lord repeated to the House in February last year, he referred to advice from the Chief Medical Officer that experts here and abroad had said that, when the treatment is 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”.—[Official Report, Commons, 21/2/18; col.164.]
Even after the early findings of the noble Baroness, Lady Cumberlege, the Government instituted a pause, but significantly not a ban, on the use of vaginally inserted mesh to treat prolapse, and on the use of tape or slings to treat stress urinary incontinence.
So we have had a series of reviews. All have recognised the problem, although there is disagreement about its scale. However, they have all tended to recognise the benefits of the procedures and have resisted the ban called for by campaigners. This ambivalent approach has been very frustrating, and I wonder whether the ambivalence lies behind the very poor way in which the NHS has treated those women for whom mesh has been a total disaster. They feel abandoned by the National Health Service and, frankly, the service seems to be in denial about the problem. There are no support mechanisms and precious few opportunities to have the operations reversed—nowhere near the kind of approach that the noble Lord, Lord O’Shaughnessy, has called for today.
This continues. I do not know whether noble Lords have looked at the draft consultation by NICE that it has yet to finalise. I was struck in particular by section 1.10, entitled “Managing Complications Associated with Mesh Surgery”. It states that the decision to remove mesh for any indication needs to be made in the context of an explanation to women that such surgery may not relieve symptoms and may have significant complications, including organ injury, worsening pain, and urinary, bowel and sexual dysfunction. So this leaves a woman damaged by having mesh inserted with little prospect of amelioration at all.
I received an email this morning from a woman member of Sling The Mesh. She is currently in Germany for a non-mesh hernia repair, following two removals of an incontinence mesh. Why did she have to go abroad and pay for it herself, and why is the NHS so hopelessly inadequate in dealing with the issue?
The issue is not confined to vaginal mesh. Last week I met a senior lawyer in Birmingham who spoke to me about his experiences following a hernia mesh implant in 2011 that left him in constant pain. Before the mesh implant operation, he was very active and ran half-marathons. Now, sadly, because of his pain, his mobility has been greatly reduced and he struggles to sit at his desk for any significant time. His life has changed for the worse. Again, the response from the NHS has been wholly inadequate.
I am uncertain whether the problems are caused by poor diagnosis and poor clinical performance, or whether a certain percentage of patients can expect to suffer harm from the intervention. Alongside the challenge the noble Lord raised about the balance between risk, safety and innovation, this raises moral and ethical questions as much as regulatory ones. The question is whether it is right that these operations should continue when we know that, on one hand, many patients will benefit, and on the other, it seems inescapable at the moment that a number of women will suffer. There is disagreement about the percentage but some campaigners think that it is as high as 10%. If this was a medicine, of course it would not receive approval, based on that balance between risk and benefit. However, a device is different, and the regulatory system approaches it in a different way.
I do not know the answer to that—I hope the noble Baroness, Lady Cumberlege, does. I echo what the noble Lord, Lord O’Shaughnessy, said. It would be a great pity if the Government did not listen very strongly to what she has to say, and I hope that they will consider her recommendations in full. I also hope that she will say something about the need to develop a system of safety culture in the health service. This goes much wider than surgical mesh or the issues that she is looking at for the review. As Ken Lownds, a safety expert, put it to me, our approach to safety compared to other safety-critical sectors has the feel of a cottage industry. That has to change, and I hope that the noble Baroness’s review and this debate will be a catalyst for that.
Baroness Walmsley (LD)
My Lords, I also congratulate the noble Lord, Lord O’Shaughnessy, on achieving this debate and on his passionate opening speech. There can be no greater issue in relation to medicines and medical devices, apart from whether they work, than whether they are safe. I hope that the House will not be bored by the fact I agree with him, as I agree with the noble Lord, Lord Hunt. I will focus on similar issues but I also want to talk about the role of community pharmacies in ensuring the safe and cost-effective use of medicines and medical devices.
As we know, sodium valproate is a medicine prescribed for certain kinds of epilepsy and bipolar disease, and we know about the dreadful rates of birth defects in the babies of women taking these medicines during pregnancy. Despite the fact that clinicians were advised to prescribe valproate only to patients who had effective contraception and for whom no other medicine worked, and guidance was given about patient information and consent, questions arise about whether that is happening. In October 2016, a group of epilepsy charities surveyed nearly 3,000 women and reported that 20% of those who were taking sodium valproate were not aware of the risks in pregnancy. The survey was repeated a year later, when it was found that 18% of women taking the drug still did not know the risks, and 28% of women said that they had not been informed of the risks in pregnancy despite the availability of the MHRA toolkit produced in February 2016. More than two-thirds of women taking sodium valproate said that they have not received the toolkit. Philip Lee, the chief executive of Epilepsy Action, is calling for a mandatory discussion of the risks with a health professional for all women with epilepsy on valproate so that they can make informed choices before they conceive. Does the Minister agree with that?
On 30 November 2016, in answer to a question from my right honourable friend Norman Lamb MP in another place, the Minister in her former incarnation said:
“In order to monitor the effectiveness of the valproate toolkit, the MHRA has sought feedback from all stakeholders and will continue to work with the Royal Colleges, professional bodies, patient groups and relevant charities to increase awareness of the toolkit among general practitioners, pharmacists and patients. The MHRA’s current priority is working to ensure that women taking valproate are fully aware of the risks in pregnancy”.
Can the Minister now say what percentage of women taking valproate are receiving the MHRA materials? That is absolutely crucial to their informed decision. In addition, what lessons have been learned about how effectively to cascade down information and materials produced centrally? If they are produced centrally, however good they are, they are no use at all unless they get to the patients.
I turn from one medicine with considerable risks that have not been sufficiently taken into account to others for epilepsy where the risks are very low, as has been proved in other countries, yet their accessibility for patients with epilepsy in this country is not very good. I am talking about cannabis-based medicines, which, despite the change in their regulatory position last year, are still not getting to adults and children with epilepsy and other conditions which could benefit from them. Can the Minister update us on that?
The other issue mentioned by the noble Lord, Lord Hunt, is the use of vaginal mesh for pelvic organ prolapse. He is absolutely right: the NHS was very slow to listen to patients with complications after surgery and options were not available to them. Eventually, the Mesh Oversight Group was set up, which consisted of relevant professionals but, crucially, also included patients. One of its recommendations was addressing the knowledge of GPs, because it is to GPs that women go first. They go to GPs when they first realise that they may have a prolapse but, after the surgery, they go back to the GP when they feel that they have complications. The problem is that GPs do not necessarily realise what the cause might be.
As the noble Lord, Lord Hunt, mentioned, this report has particular focus on women who have developed complications. It is very important that they have access to specialist centres with multidisciplinary teams able to advise them and treat complications. I support the call of the noble Lord, Lord O’Shaughnessy, for those to become specialised commissioned hospital services. The Royal College of Surgeons, in its rather late briefing for this debate, also called for clinical trials and traceability by barcoding for all medical devices for implantation. That is important across a wide range. Can the Minister update us on the progress of those recommendations and tell us what lessons have been learned about patient involvement in policy-making? Finally, can the Minister or the noble Baroness, Lady Cumberlege, tell us about the progress of the Cumberlege review?
Given the shortage of time that GPs have to spend with their patients, community pharmacies have a big role to play in ensuring safe and cost-effective use of medicines. The New Medicine Service provides support to patients who have been newly prescribed medicines for long-term conditions. It is intended to improve medicines adherence and is focused on a small range of conditions. It has been assessed on its effectiveness and come out very well, but pharmacists are now suggesting that the service should be extended into other medical conditions where there is significantly poor adherence to the medicines regime. Is that proven intervention to be extended to other medical conditions?
Baroness Masham of Ilton (CB)
My Lords, when the noble Lord, Lord O’Shaughnessy, gave up his position at the Department of Health, many people were dismayed, as he was doing an excellent job. I am so pleased that he is still involved with the health service, and today is an example, as he has brought up the vital matter of safety in the NHS, particularly at this difficult time. I thank him for that. I also congratulate the Minister on taking on the mammoth task of looking after the interests of the NHS and social care.
In the past year, I have taken part in several All-Party Parliamentary Health Group evidence sessions on cancer and other disabling conditions. I found the overriding similarities between them to be late diagnosis of the condition and the problems arising from not having the correct medicines and treatment at the right time. At a recent seminar on safety, one of the main dangers highlighted was fatigue of doctors and nurses, risking them giving patients the wrong dosage or the wrong medicines. I understand how that can happen on a busy ward with a shortage of experienced nurses or during a 12-hour shift.
It is sad that the European Medicines Agency has already left London and gone to Amsterdam. Medicine regulation in the UK will be affected by our departure from the EU. With the EMA having left London, it has already begun. The Royal College of Surgeons is pleased to hear that the Government are considering the establishment of a national medical devices registry. Can the Minister give your Lordships a progress report on that matter?
I am so pleased to hear that NHS Improvement is delivering a new patient safety strategy. So many bodies work for the NHS that it is sometimes difficult to know which is doing what. Will that strategy look at the dangers of counterfeit medicines, many of which are available on the internet? Addiction to medicines is a growing problem.
It is estimated that 52,000 people in the UK die every year from sepsis, a serious complication of an infection. I declare an interest as I had it in the summer; I have been on antibiotics for more than six months. A new rapid test for the early diagnosis of sepsis is being developed by researchers from the University of Strathclyde. The device, which has been tested in a laboratory, may be capable of producing results in two and a half minutes.
In a recent report, NHS Improvement stated:
“Treating pressure damage costs the NHS more than £3.8 million every day”.
It also noted:
“Despite extensive prevention programmes, evidence suggests about … 2,000 patients a month develop pressure ulcers”.
Bruin Biometrics has produced an SEM scanner, which is used to address the problem of pressure ulcers. It is a wireless, hand-held device designed to be an adjunct to clinical assessments; it can alert clinicians to incipient pressure damage not visible at the skin’s surface. It is encouraging that these useful devices are being developed so that prevention can avoid many medical problems.
In August 2018, NHS Improvement issued a patient safety alert after 35 people died from cardiac arrest due to hyperkalaemia, or elevated potassium levels. What support is the Department of Health and Social Care giving providers to ensure that they can comply with requirements to test for and treat that condition? Should not guidelines go out to trusts and GPs? High potassium is a danger to kidney patients because their medication can cause high serum potassium, which is dangerous for the heart and can cause cardiac arrest. On the other hand, low potassium levels can be a danger for people with spinal injuries, so more attention should be paid to potassium levels.
Sodium valproate has been discussed by two noble Lords. It is a drug which has put pregnant women with epilepsy in danger of having children who are autistic. This unfortunate case illustrates the need for clear and honest information along with accurate data. Good communication should be set up between hospitals and GPs, patients and carers, voluntary organisations and public health, and prison health and regulators. All stakeholders should communicate where necessary and should work in harmony, not in isolated silos. What is difficult for patients is when they are given conflicting advice and views. This has been a big issue on the Patients Association helpline. There is much to do, and I look forward to hearing the maiden speech and the Minister’s reply.
Baroness Cumberlege (Con)
My Lords, my interests are in the Lords’ register. I thank my noble friend for securing this debate. There are few who are better informed on this subject or more knowledgeable and committed than he is, as we have heard today. As has been said, I chair the Independent Medicines and Medical Devices Safety Review. It is focused on how the healthcare system has responded to concerns about medicines and devices raised by patients.
When the review reports later this year, we will make recommendations to improve matters, but in terms of what has happened up to now, three medical interventions are in our scope. The first is Primodos. This drug was withdrawn from the market in 1978 but concerns had been raised years earlier. Babies were born damaged. Those that survived are disabled. The second is sodium valproate. The link between sodium valproate and birth defects has been known for many years, yet women and babies continue to be exposed to the risk. Experts suggest that around 20,000 people have been harmed. For the families involved, it is life-changing and extremely distressing. For those women who took Primodos and sodium valproate, there is an intense feeling of guilt. They took the medication and they blame themselves. However hard one tries to persuade them that it was not their fault, the guilt remains.
The third intervention is surgical mesh. Many thousands of women have had mesh inserted for incontinence or prolapse. The majority have not reported any problems, but a significant and growing minority have suffered terrible complications, including: excruciating chronic pain, which has been described as feeling like razors inside the body; damage to organs; autoimmune problems; the loss of mobility; the loss of a sex life; and depression and suicidal thoughts. The impact of mesh is not only on the woman herself but on her family. The physical and mental pain has led to the break-up of marriages and partnerships, and many cannot work. If they lose their job, they face losing their home. Children have become their mothers’ carers and some women even face the prospect of their children going into care.
So concerned were we by what we heard about mesh that as an interim measure we recommended a pause in its use until the stringent conditions that we set have been met. That pause has been in place since last summer. I have carried out a number of reviews into health-related matters, but I have to say that this is the most troubling and the most harrowing. The suffering of so many people and their families is heart-breaking. The pain, both physical and emotional, is almost impossible to imagine. My team and I made it our priority to do something that the system has failed to do for all these years: to listen and to learn from what we hear.
We have travelled the length and breadth of the UK. We have met many hundreds of people who have been directly affected, and their families. We have heard from many more by email or phone. I pay tribute to all those we have met. Their courage and dignity in the face of such suffering are truly remarkable. It has been a privilege to meet them. The campaign groups that support them do simply wonderful work. I have been deeply saddened, not just by the personal stories but by the constant reminder that this harm was avoidable. Their lives have been turned upside down, but they did not need to be.
We will continue to listen to those affected. We have also received a huge amount of written evidence, all of which is on our website. We are now in the midst of our oral hearings, taking evidence from regulators, medical colleges, manufacturers, the NHS and others. These evidence sessions are video recorded and available via the review’s website. We are looking not to blame but to ensure that we learn.
Our starting point has been some simple questions. Could and should things have been done differently? Could actions have been taken more quickly? What needs to happen now, and who needs to do it? We have more evidence to hear before we write our report, but there are some emerging themes: the lack of proper warnings about risks; the lack of informed consent; a system whose first inclination is to deny there is a problem or simply to ignore concerns; where concerns are eventually heard, the sluggishness of a proper response; the dismissiveness and arrogance of some—I stress only some—in the medical profession; the byzantine complexity of a regulatory system that few within it, let alone patients and the public, seem to fully understand; the fight for diagnosis and support when things have gone wrong; and the inadequate resources available, whether for follow-up surgery in the case of mesh, or medical, social and educational care in the case of sodium valproate and Primodos.
Most troubling to me is that these issues have come to our attention not because they have been raised by regulators, doctors or the NHS but because of people power. People affected have organised themselves into campaign groups and, with the help of Members of Parliament, push the issue up the agenda until finally someone takes notice. That tells me something is seriously wrong; the system is not working as it should. People who have been harmed should not have to fight to be heard or to access the care they need.
Of course, no medical procedure is without risk, and innovation is crucial in healthcare; we must not stifle it. But it is vital that an individual is able to make an informed decision, based on a clear and full explanation of the benefits and risks, about a medicine or procedure. It is vital that regulators act with independence and impartiality in approving a medicine or device, that safety comes before commercial interest, and that they listen carefully to patient-reported concerns and act swiftly on them. It is vital that surgeons carry out operations for which they are suitably trained, that they have the right level of experience, that they show compassion and that a comprehensive database exists. When things go wrong and avoidable harm is suffered, the test of a good healthcare system—indeed, of a good society—is our ability to listen, to say sorry, to learn and to provide the right care and redress.
Noble Lords would be forgiven for thinking that these points are a statement of the obvious. A year ago, before I started this review, I would have thought so too. Having heard and seen what happens to people when the system fails, I now know they are not. There is much to be done before we can be assured that the system listens to concerns and responds as we would wish. I am determined that my review plays its part in making that happen, but this is a challenge for all of us in this place and in the healthcare system. Noble Lords taking part in this debate and others in this House possess expertise and experience that will be invaluable in ensuring we have a system fit for the future. I hope my review can draw on that as we continue our work.
Lord Brennan (Lab)
My Lords, the topic of today’s debate is well chosen by the noble Lord, Lord O’Shaughnessy. He is to be commended on his enthusiasm, both as a Minister and as a future Back-Bencher, in raising it. I give my best wishes to the noble Lord, Lord Carrington, in anticipation of his maiden speech. I would like to mention Norman Lamb, the honourable Member in the other place, and his indefatigable leadership of the APPG on Epilepsy.
As a barrister, I have been engaged over the years in many cases involving medicines and medical products with general consequences for those who use them. I have no current professional interest in any such case. However, I am the possessor and user of a pacemaker and had a double hip replacement a few months ago, so noble Lords will forgive me if I show enthusiasm for the topic in question. Improving safety, and not accepting it as a given, is a serious topic. We have to work for it, and I want to concentrate on the problem, the scale and some solutions.
On the problem, since the 1960s, the NHS and the international scope of medicines and medical devices have led to better medical treatment, but that development has had consequences. First, a far greater variety of products is produced and marketed internationally. Secondly, there is a wider impact of adverse consequences from some of those products, causing damaging conditions, both physical and mental. Thirdly, such disabilities and illnesses have a devastating effect on the families involved. This is a problem that will not go away. The greater the expansion of medical knowledge and the more demands that are placed on health services by patients, the bigger the issue will become. At the heart of this, the problem we need to bear in mind—and this is a direct point on epidemiology and causation—is who in our society will own medical big data? Will it be the media giants, the Government or institutions, or is it a public good to be owned by everybody and administered by the full gang? This is a critical aspect of the problem.
On the scale, in introducing the review led by the noble Baroness, Lady Cumberlege, Jeremy Hunt, the then Health Secretary, spoke of the “widespread harm” within the health service that had been occasioned by medicines and medical products. That is the scale domestically. Internationally, similar systems, common suppliers and the international exchange on the marketing front have become ever the greater. The problems are physical and mental. They are not gender specific, although certain of the products mentioned are particularly applicable to mothers and children of either gender; they are not age-specific. Look at the present opioid epidemic in the United States, which could occur in other countries if proper steps are not taken.
Then there are the effects in our country. Thalidomide came to light essentially because you could see what it had caused. The haemophiliac HIV/AIDS disaster came from giving haemophiliacs, mostly children, contaminated blood with the wrong factor 8 composition, leading to them getting HIV/AIDS and often dying of it. We may have forgotten mad cow disease and CJD, and the panic it produced, although the problem appeared to be small numerically.
Lastly, there is causation. How do we prove these cases? Doctors rely on academics and scientists to reassure them about use from what they observe in their own practice, but they need data. Scientists and academics must have data to show that a product is safe, so big data comes back into play. The problem is not going to go away and the scale of it is serious.
On the solution: I say yes to everything that the noble Lord, Lord O’Shaughnessy, and my noble friend Lord Hunt have said. I say yes to changes and to patient safety records, but that should be as well as—not instead of—a national, no-fault compensation fund. It is just outrageous that people who have suffered this kind of problem are driven to go to court. New Zealand and Sweden have their systems, and nobody can say that they do not work, but such a system requires interim payments, final payments and the protection of state benefits. It can be paid for by a levy—I have yet to come across a poor pharmaceutical giant that cannot afford to pay a levy, which is the same as insurance—coupled with government money and, if possible, private donations and an independent agency.
To finish quickly, causation is everything in this regard. Clear and authentic diagnostic pathways that doctors can rely on form an essential first step—the quicker you get to it, the less the problem will be. A retrospective audit process should go backwards, so that older people who develop things late are caught. We need the involvement of families and carers, some of whom are present today as observers, along with reliable management of the scheme, adequate resources, long-term financial planning, integrity and independence.
I will conclude. Because of their bravery and dignity, the people who have suffered—patients and the families who look after them, including children and older people—deserve our respect and admiration. But they demand, in justice and morality, our help through the community and society. In giving it, let us not listen to that bureaucratic homily we always get: “It takes a long time; it involves a lot of money”. On the morning of 12 December 1990, I got a phone call in my chambers. As lead counsel in a haemophiliac case, I was told that the case had been settled. I said, “What do you mean?” I was told that the Prime Minister was going to announce it in Parliament at 2 pm, which he did, and it was settled. It can be done quickly and efficiently. I thank noble Lords for their patience for my enthusiasm.
Lord Carrington (CB) (Maiden Speech)
My Lords, in 1797 my four times great grandfather, the banker Robert Smith, was introduced to the House of Lords on the recommendation of William Pitt—that is, Pitt the Younger—to King George III. The result was that a goodly proportion of the House walked out because he was the first person in trade to be elected to your Lordships’ House. I can only hope I do not stir the same reaction.
I am really privileged to be here today making my maiden speech. Like others, I have sat quietly for some weeks observing the workings and customs of the House. I cannot say that I am yet confident about every aspect of being a newly minted Peer, although I have received endless help and attention, from the doorkeepers up to the Convenor of the Cross Benches, from the attendants up to Black Rod and, of course, from my mentor, my noble friend Lord Aberdare. I have also received help from Peers from every side of the House.
Furthermore, I am most grateful for the splendid services available to Peers, in particular, for the incomparable Library which magicked up a copy of my father’s first speech in your Lordships’ House. I fear this was not very helpful, as he did not make a maiden speech but instead asked an Oral Question—God forbid! The subject was the use of prisoners of war on farms, as they accounted for 40% of farm labour in 1945. I doubt that that is the solution to current agricultural employment issues. Many noble Lords knew my father, and it is therefore a frightening experience to follow in his huge footprints.
As for myself, because of my father’s political presence, I decided to follow a different career path, which I hope has given me sufficient experience in a number of areas to enable me to contribute to the work of this House. I am a banker by way of background, specialising in the world of investment, both direct and portfolio, and I still pursue this career as an independent adviser. I have lived in Asia and travelled widely. I have also worked in the Middle East and have been involved in Saudi Arabia since 1974. Currently, I sit on boards and have advisory appointments in the United States, Europe, the Middle East and the Far East. At home in England, I am an active farmer and a lover of the arts. I am privileged to be a governor of the Royal Shakespeare Company.
I thank the noble Lord, Lord O’Shaughnessy, for introducing this debate. Although I cannot claim to be an expert in the detailed subject of the safety of medicines and medical devices, I am fairly conversant with the importance of the regulatory aspects of the factors which govern the overall environment in which healthcare is brought to the general public. The patient safety aspect of medicine and medical devices is paramount and is constantly evolving with the assistance of new technology, innovation, data capture and identifying worldwide best practice. I am pleased to note that the independent medicines and medical devices safety review is under way and will bring invaluable recommendations to the Government.
I would, however, like to raise a broader issue which needs to be borne in mind throughout our deliberations, since healthcare accounts for some 10% of gross domestic product. In order to satisfy all patients, the provision of healthcare needs to be driven by innovation, demand, affordability and government regulations. The challenge for regulators worldwide, whether the European Medicines Agency, our own MHRA or, in the US, the Food and Drug Administration is to facilitate innovation without lowering standards. Whether we are in Europe or outside, the same issues arise. Innovation enables new, more efficient medicines and devices to be brought to patients at a more affordable cost. It is important that, while not compromising on safety, regulations do not inadvertently inhibit the all-important innovation.
In a small way, I have been involved in the analysis of a number of healthcare companies, particularly in the United States. Over the years, therefore, I have had cause to study the workings of the US FDA which, for many innovators, was seen as a regulatory roadblock. This has changed since the current commissioner took over; unusually in today’s environment, he is thought of positively on both sides of the US political divide. The FDA is now collaborating with companies in a more proactive way during the development process. It is offering more guidance and engaging in more interactive exchanges with companies prior to filings.
The importance of an innovation-friendly regulator cannot be overstated when the results are new products coming to the healthcare industry at a rapid pace, enabling patients to benefit faster than ever before. This is demonstrated by a 168% rise in drug approvals between 2016 and 2018 in the United States. There has been a similar improvement in the approval of medical devices. The regulation of medical devices differs from that of drugs, but the end goal of both approaches is the same: to ensure patient safety and performance. I would be interested to hear from the Minister whether the MHRA has been following these exciting developments at the FDA, and whether there is a process in place to learn from them.
The purpose of bringing these experiences of the FDA to your Lordships’ attention is to demonstrate the value of adopting best practice in the overall field of healthcare, from innovation to manufacture and delivery to safety. The FDA has its issues, and no doubt follows carefully the work of the EMA and MHRA, but I would urge that, in a field where the overall interests of patients are paramount, we can all learn from each other. Will the Minister please assure us that the principal regulators worldwide are communicating regularly and closely to achieve this essential balance between safety and innovation?
Lord Bethell (Con)
My Lords, I start by congratulating the noble Lord, Lord Carrington, on a really touching and thoughtful maiden speech. We are all hugely moved by memories of his father, and many here will remember him with great fondness. He was a man who embodied the values of the House: courage, professionalism, public service and, very famously, a strong sense of discretion. From the evidence of his splendid maiden speech, the new Lord Carrington should have no fear of following in his father’s huge footsteps. I am sure he will make a powerful impression on the House, particularly in his chosen fields of finance, the rural economy and the arts.
I thank the noble Lord, Lord O’Shaughnessy, for bringing this important debate to the House. I also thank the Library, which has produced a massive, 20-page blockbuster that tackles this technical subject with huge helpfulness. My main interest in the debate is in the area of drug development and the potential for a more agile approach to drug regulation. I am very grateful to those who have already spoken about medical paternalism and the growing scepticism of patients about medical and scientific authority.
It has been my experience of human nature that, when facing an adverse condition, people are prepared to suspend normal attitudes to risk. My father, the late Lord Bethell, suffered severely from Parkinson’s disease. I remember sitting with him in the office of the eminent Professor Tipu Aziz, a great expert in Parkinson’s. My father had avoided all contact with the medical profession for his entire life as an article of faith, but there was Professor Aziz suggesting that he wanted to drill a very large hole in the top of my father’s head and then inject his brain with an untested dopamine mixture. My father, a cautious man at best, thought this was an incredibly exciting idea and was 100% up for it. He was enormously frustrated when he did not qualify for the pilot. I think that is an indication of the changing attitudes that people have, as my noble friend Lord O’Shaughnessy mentioned, when they face medical adversity.
I must declare an interest as a trustee of the Scar Free Foundation. I shall tell the House another story: last year I visited the Centre for Conflict Wound Research, where I met members of the Casevac Club, which is like a modern-day World War II Guinea Pig Club. They are lending their bodies to medical research. There was an amazing veteran with no legs who had a massive scar across his entire torso. He was having a laser puncture his scar 400 times a second in a lattice formation on one side of his body but not the other, in an excruciatingly painful treatment, in order to get important data on the effectiveness of this new skin-healing process. I felt that this was an incredibly moving metaphor for the determination that some people show and the sacrifice that they are prepared to make for medical science.
My noble friend Lord O’Shaughnessy put it very well when he talked about those who live normal lives who expect a regime of safety. I want to talk about that. No one wants an uncontrolled Wild West approach to medical regulation. In fact, that would be utterly counterproductive to investment; I am aware that under certain circumstances when drugs are tested, early problems might prevent investment in later trials.
I highly recommend the report of the Panel on Monitoring the Social Impact of the AIDS Epidemic. That epidemic is fascinating, as the rulebook was essentially thrown out of the window in the mad dash for a cure, and there was essentially a patient mutiny. There was incredible progress and innovation, but there were also terrible mistakes. There were cul-de-sacs and snake oil, and less fortunate, poorer people did not get access to the right treatments. The financial costs were enormous, and the political pressure and risk tolerance were probably unrepeatable. I think we should try to learn the lessons of that episode.
I am very grateful for a briefing from Professor Derek Alderson, president of the Royal College of Surgeons, who talked me through its recent Commission on the Future of Surgery. Its report speaks about the rising use of medical devices and the urgent need for a unified national medical devices registry to make it easier to keep track of what products are on the market and to measure performance and issues. I instinctively lean away from new regulations and registers, and I am aware of the #WeAreNotWaiting movement, which some noble Lords may have followed. However, given recent experiences, which have been spoken about so touchingly by Members of this House, including the noble Lord, Lord Hunt, and the noble Baroness, Lady Cumberlege, it would be wise to support this measure. I was utterly persuaded by his argument, and I urge the Minister to move forward on these recommendations, as indicated in the words of Jackie Doyle-Price in another place earlier this month.
By way of conclusion, I want to make the case to the Minister for an energetic approach to medicine development and data generation that allows for early and progressive patient access to medicine. The European Parliament has handily called this “adaptive pathways”. For me, that phrase encapsulates a really good mixture of three essential ingredients: a thorough, data-driven approach to evaluation; a compassionate attitude to the natural human desire for cures; and a pragmatic recognition that patient feedback is an essential component of the research process. I am excited by the results of the European Medicines Agency pilot and by the UK’s accelerated access review, but my heart sank when I read about the slow pace of change. I urge the Minister to exert her considerable persuasive powers to put a red-hot fire under this process.
Baroness Bryan of Partick (Lab)
My Lords, I thank the noble Lord, Lord O’Shaughnessy, for tabling this debate and for his continuing interest in the issue. As a relatively new Member, I welcome the noble Lord, Lord Carrington, and congratulate him on his maiden speech.
To confirm how important this debate is, I note that the Medicines and Healthcare products Regulatory Agency has issued three medical device alerts during February—for a pacemaker, an ophthalmic implant and an orthopaedic implant. This has to give us cause for concern. The helpful briefing paper from the Royal College of Surgeons points out:
“The vast majority of medical devices are manufactured and used to high standards”.
However, it goes on:
“Gaps within the current regulatory process … could be putting patients at risk of serious complications and harm”.
One of the examples the royal college gives is of transvaginal mesh implants. I am pleased that, over the past few years, this issue has been taken more seriously. There was a debate in the other place recently, and Members there reported the harrowing experiences of their constituents. Most importantly, the review of the noble Baroness, Lady Cumberlege, will include this issue and I am pleased to see that she will make a return visit to Glasgow later this year. Her comments today were both moving and reassuring for the future.
Last year in Scotland, a woman who died of multiple organ failure was reported to be the first Scottish woman to have had a mesh implant listed as an antecedent cause of death. For a long time, Scottish women who were experiencing debilitating symptoms following mesh implants felt they were not being listened to or even, in some cases, believed. Women made multiple visits to their GPs, taking time off work or giving up work altogether. Many were becoming more disabled and some needed wheelchairs. Women felt that the lack of treatment, continual pain and, for some, the attitude of doctors caused stress and anxiety, which often led to depression.
These women set up a campaign in Scotland, Hear Our Voice, and took the issue to the petitions committee of the Scottish Parliament. From that, a Scottish independent review was established. The review’s final report was, however, not without controversy. Two of the women who had experienced mesh implant surgery resigned before it was published, because they felt it had been watered down from the draft version. It was a real pity that women who had brought the issue to public, media and political notice then felt let down by the final publication.
The Scottish review made the following recommendations: mesh should not be offered routinely to women with prolapse; reporting of all procedures and adverse events should be mandatory; extra steps should ensure that patients have access to clear, understandable advice to help them make informed choices; all appropriate treatment should be available, subject to informed choice and assessment; there should be improved training for clinical teams; and there should be improved research into the safety and effectiveness of the products. How often do patients have to campaign, sometimes for years, to have their concerns addressed? In the meantime, they are often dismissed by so-called experts as overreacting.
We must be able to have confidence in the independence of research. Just this year, a senior medical consultant and researcher acknowledged that he failed to declare £100,000 received from the manufacturer of a type of vaginal mesh implant that he assessed. There is no evidence that his study was influenced by the support he received but it has added to concerns about the lack of transparency from the manufacturing companies.
Obviously, mesh implants are not the only area of concern; breast implants and hip replacements have also had their problems. The Royal College of Surgeons makes the point that, in contrast to drugs, many surgical innovations are introduced without clinical trials or centrally held data. This has resulted in a lack of information and often a considerable time delay in giving a diagnosis, leaving women experiencing chronic pain and sometimes inappropriate treatment.
Women were not given clear information about the risks involved, so they could not have given adequately informed consent. How could the surgeons have provided that information when they did not have the details of clinical trials? Can the Minister assure us that, for the future, will there be more effective clinical trials and faster and more effective action when adverse reactions are reported, and that the people affected will be given sufficient financial compensation, along the lines mentioned by my noble friend Lord Brennan, so as to take at least one worry off their shoulders?
Lord Alton of Liverpool (CB)
My Lords, I join others in congratulating my noble friend Lord Carrington on his very well-judged maiden speech today.
In this welcome debate, my remarks will centre on Primodos—an issue I raised with the noble Lord, Lord O’Shaughnessy, while he was a Minister. Like the noble Lord, I pay tribute to Marie Lyon, who chairs the Association for Children Damaged by Hormone Pregnancy Tests. Assiduously and tenaciously, she has fought for justice for those whom big pharmaceuticals have often treated with irresponsible contempt. She and her husband have travelled down from Wigan today and are watching our debate.
Marie Lyon wishes me to thank the noble Baroness, Lady Cumberlege, and the Independent Medicines and Medical Devices Safety Review for taking the campaigners seriously. She tells me:
“The sensitivity shown to our members by the”,
review,
“team is appreciated and commended. I really do feel that”,
they and,
“Baroness Cumberlege … are committed to discovering the truth about the failures of the Drug Company and the Government Regulators and have a genuine desire to ensure justice is served”.
I add my own thanks to the noble Lord, Lord O’Shaughnessy, for his role in encouraging the establishment of the independent review, and I wholly endorse what he said earlier about the desirability of creating a national office for patient safety.
My interest in Primodos began in 2010, when a gentleman born with severe birth defects asked to see me at my university office in Liverpool. He believed that his disabilities were attributable to Primodos, a hormone-based pregnancy test first marketed in the UK in 1959 and produced by Schering AG, which was subsequently taken over by Bayer AG. Withdrawn from sale in the United Kingdom in 1978, tellingly it was also used in South Korea to abort the child in the womb.
Dr Isabel Gal’s 1960 research at Queen Mary’s Hospital for Children demonstrated a link between the drug and severe birth defects, and a review by the Committee on Safety of Medicines concluded that pregnant women should not use it. However, subsequent court cases failed to provide a conclusive outcome, as did a 2014 review by the Medicines and Healthcare products Regulatory Agency.
On 26 October 2010, I asked the Government several Questions. One was about the dosage of the constituents of Primodos; one asked for any documents that the Government held about its dangers to be placed in the Library; one was about the nature of the disabilities; one was about the help given to those affected; and one requested Ministers to meet the Association for Children Damaged by Hormone Pregnancy Tests.
In his reply at the time, the noble Earl, Lord Howe, said that the regulatory agency had no information on the number of children who are born with disabilities, nor did it have evidence. If there was no evidence, why did they ban the drug? As for meeting the victims:
“The MHRA therefore has no current plans to meet members of the Association for Children Damaged by Hormone Pregnancy Tests, people suspected to have been adversely affected by the drug Primodos, or with the pharmaceutical company, Bayer”.—[Official Report, 26/10/10; col. WA 265.]
Despite further letters and Questions, a 2017 report of an expert working group of the UK Commission on Human Medicines continued to state that there was no causal association. Yet in that same year, Sky News broadcast “The Secret Drug Scandal”, which found that evidence of an association had been destroyed by a UK regulator in the 1970s. I asked the Government for their response and,
“whether they will consider establishing a public inquiry into the alleged failure of the regulator at that time to protect public safety”.
In another Question, I asked whether they would examine why,
“no toxicology or testing was undertaken prior to the drug Primodos being licensed”,
and whether they were aware that,
“Primodos was being used as an abortifacient in some parts of the world whilst being sold in the UK for the purposes of pregnancy testing, and … that there may have been collusion between the drug manufacturer and the regulatory bodies”.
In another, I asked why Primodos had stayed on the market and no tests had been,
“ordered by the Committee for the Safety of Medicines under the Medicines Act 1971”.
In another, I asked them to,
“meet with Marie Lyon and representatives of the Primodos victims support group”,
and in another, asked why they were not funding research in Aberdeen and Cambridge examining the,
“likely effects on the child in the womb”.
Then, in February 2018, the right honourable Jeremy Hunt announced his welcome review to be led by the noble Baroness, Lady Cumberlege. I hope that when the Minister replies, she will tell us when it is likely to report and—perhaps more importantly—who will be responsible for taking forward its recommendations. Among other things, as we heard from the noble Baroness, the review will investigate any association between hormone pregnancy tests and their teratogenic effects, and whether the regulatory bodies could, and should, have acted on concerns sooner—and if they did not, why.
Meanwhile, a team at Oxford, led by Professor Carl Heneghan, the scientist responsible for identifying Thalidomide association, has discovered that pooled data show “a clear association” with several forms of malformation. Professor Neil Vargesson has carried out other work on zebrafish, which revealed anomalies that mirrored the adverse effects on victims of Primodos. Their studies were peer-reviewed and remain in the top percentile of scientific studies.
In the House of Commons, the Prime Minister said:
“Ministers are aware of the new study that has come out … and … that study will be looked at very carefully”.—[Official Report, Commons, 16/1/19; col. 1160.]
I welcome that. However, the raw data that Professor Heneghan needs to complete his review has not been made available. The All-Party Parliamentary Group on Hormone Pregnancy Tests, chaired by Yasmin Qureshi MP, and of which I am vice-chairman, has sent a freedom of information request for the data, but to date has not received a response.
Mrs Lyon has twice emailed the Medicines and Healthcare products Regulatory Agency, but has not received a response. I gave the Minister notice of my intention to raise this question today. This is tardy and unco-operative on the part of that body. I hope the Minister will be able tell us whether more can be done to take that forward.
Severely disabled children, cared for by family members now in their late 70s, are increasingly becoming the responsibility of their siblings. While their health deteriorates, many battle every day to support themselves. Some have died fighting to the very end to reveal the truth about the failures of the drugs company and the regulatory agencies. They have faced the implacable determination of regulatory bodies spending huge amounts of public money on ad hoc scientific reviews to cast doubt on the work of highly reputable scientists. Those who have suffered so grievously deserve much better than this.
Lord Suri (Con)
My Lords, I am very pleased to participate in today’s debate and privileged to have heard the maiden speech of the noble Lord, Lord Carrington, who brings the wealth of knowledge of senior Carringtons to this House. The debate is of great importance to all of us here, and serves as one of the most pressing cautionary tales for what might happen if the other place does not pass the withdrawal agreement that will be coming before it in due course.
The safety of medical devices and medicines is not a present issue in the minds of the electorate and does not get the attention it deserves. Part of this is down to the incredible luck we all have to live in a country with an excellent health service which guarantees consistently strong treatment across all of its hospitals and surgeries, with investment decisions taken after thorough consultation and planning. We are particularly lucky to have a national regulator with great depth of expertise in particular fields of treatment and medicines—from toothpaste to gene therapy. It is a great shame that, post-departure, the likelihood of the MHRA receiving commissions from the EMA will considerably diminish. One-third of the income of the MHRA is linked to EMA funding, and unless government support is guaranteed there is a serious and pressing risk that the MHRA will suffer a loss of income and reputation and an outflow of specialists to other European regulatory agencies, taking a sizeable proportion of the UK’s comparative advantage with them.
This is important, as it underpins investment by pharmaceutical firms in our universities and labs. It is natural that they would be keen to be close to the leading researchers and benefit from their expertise throughout the development process. I therefore ask the Minister to confirm ongoing government support for areas of specialist research traditionally funded by the EMA for the MHRA, such that the UK maintains our lead in the areas in which we excel. If this cannot be guaranteed, will the Minister commit to seeking a close continuation of the existing relationship in the next stage of Brexit talks focusing on the future relationship? I also wish to add my approval of the ongoing Cumberlege review. The NHS is funded out of general taxation to serve the population, and it is of paramount importance that the people’s voices are heard as soon as concerns are raised about medicines or medical devices.
Too often in the past we have relied on clinicians raising concerns with NICE or the MHRA and then letting action be taken, even when there has been a substantial degree of concern in the patient community. A great deal can be learned from the mechanisms enshrined in statute in Section 11 of the Enterprise Act. So-called super-complaints allow representative consumer bodies to make a well-researched complaint about some feature of the market, to which the responsible regulator or a Minister must respond within a given timeframe. The principle was extended to financial markets by the Financial Services and Markets Act 2000, and the mechanism operating via both of these statutes has been endorsed by consumers and industry alike as an effective means of ensuring accountability and maintaining high standards. I know, of course, that the yellow card scheme operates in a similar way, but there is no guarantee of a fast-track process for responsible nominated groups operating on behalf of consumers. Having had the advantage of reading some of the submissions made to the review online, I have been impressed with the quality of submissions made to the group and I therefore think that they should be given super-complaint powers.
Baroness Finlay of Llandaff (CB)
My Lords, like others I congratulate the noble Lord, Lord O’Shaughnessy, on securing this debate, and welcome the illuminating contribution from my noble friend Lord Carrington in his maiden speech.
I will focus in this debate on the role of the National Institute for Health and Care Excellence, which is building on its 20 years of experience, and will look forward to what needs to be done. I declare that I am vice-chair of a guideline review group on ME and chronic fatigue syndrome, a review that was precipitated by patient voices and has good patient representation on it. I should also declare that my husband has done a great deal of work on patient and family-reported outcome measures, which may be relevant here.
NICE guidance covers, as we all know, the safety and efficacy of interventional procedures and the managing of specific conditions and medicines in different settings. Its technology appraisals of new pharmaceutical and biopharmaceutical products, procedures, devices and diagnostic agents are recognised around the world. Any device under consideration must have a valid and current certification, which comes from the EU at the moment, and be registered with the Medicines and Healthcare products Regulatory Agency. But the EU certification process itself seems at times to be flawed.
NICE has now gone into formal partnership with the MHRA to try to share intelligence and understanding, and to monitor key issues. However, adverse event reporting is a major problem for them in this work because it relies on clinicians notifying such events, as through the yellow card scheme. As with any voluntary reporting system, reporting is incomplete—sometimes woefully so. There is an inherent bias to report the positive benefits of interventions in research papers and underreport adverse effects. There were 62,000 adverse incidents reported over the last three years, a third of which had serious repercussions. However, this is only a small number compared with those that have happened across Europe.
In recognition of this, NICE rigorously reviews its current guidelines and seeks the sources of adverse events. Unfortunately, safety outcomes are poorly addressed in randomised trials; large numbers of treated patients are needed to reliably detect uncommon yet serious events from sources such as large case series, surveys, registers and individual case reports. Sometimes unpublished evidence is the sole source of such information. There are databases, including the US Food and Drug Administration’s manufacturer and user facility device experience database, called MAUDE. Importantly, this is available to the public and is used by sources in this country.
It is essential that safety information and evidence of harm are collected and rapidly disseminated. NICE’s medicine awareness service, with its network of prescribing associates and monthly digest of important new evidence in medicine, aims to reach out widely. But it must be strengthened, and it must have a database to draw on.
Changes to NHS structures in recent years have made dissemination more difficult because responsibility for the implementation of such guidance does not fall to any single body—hence NICE’s agreement with the four nations, a document on safely introducing new procedures. But we need to do much more to strengthen this. All NHS providers should ensure their governance structures require reporting of outcomes, including adverse events, as well as dissemination of information. Clinicians undertaking any interventional procedure, and the suppliers of devices and equipment, should be routinely asked whether any complications have arisen in the short or longer term rather than just leaving it up to them to decide whether such complications are serious enough to report. Patients must be asked too.
All this data can be entered on a mandatory relevant national register, maintained to a sufficiently high standard to deliver evidence to clinicians for decision-making and for informed funding decisions. The quality of registers at the moment seems to be disappointingly variable. Without efficacy and safety information, problems will continue to go undetected and unpublicised.
I turn briefly to another aspect of the control of medical equipment, which is the problem of purchasing. The review by the noble Lord, Lord Carter, highlighted the wastage of duplication and variable pricing—but price is not the only determinant. I will relate a simple problem that concerns syringes. The bulk buying of cheaper syringes seemed to be a good idea. However, they had to be discarded because the plunger was loose-fitting, which meant that, on injection, the contents of the syringe were bypassed and we did not know how much of the drug had been injected into the patient. Contracting had to revert rapidly to a previous, reliable supplier.
Many pieces of tubing, wiring, cannulae et cetera are used every day in clinical practice. They must be of the highest standard and must not break or fracture inside a patient, because major surgery might be required to remove them. I suggest that the light-touch regulation that we have had in the EU should be replaced by a tighter, more rigorous system, so that things are manufactured to a higher standard and we know where the components have come from.
In the last moments of my speech, I remind the House of a speech by Baroness Jowell, to which the noble Lord, Lord O’Shaughnessy, also referred in his opening remarks. She was inspiring on 25 January last year when she called for adaptive clinical trials and the right of patients to try novel therapies. The parents of Charlie Gard, who had type 2 mitochondrial DNA depletion syndrome, wanted him to try nucleoside therapy, which had been tested on type 1 but not type 2 of the condition. The drug would have been taken orally and dissolved in milk—with the only known side-effect being diarrhoea—at an estimated cost of around £5,000. Charlie died before his first birthday, having been denied the possibility of trying this, and his parents, with whom I have had several conversations, live in their bereavement with the haunting thought, “If only we could have tried it”.
In her speech calling for a new approach to novel therapies, Baroness Jowell said:
“It is about the power of kindness, support for carers, better-informed judgments by patients and doctors, and sharing access across more and better data to develop better treatments”.—[Official Report, 25/1/18; col. 1169.]
Sometimes we must allow people to take risks for the benefits of others, because data is critical. Safety sometimes means that we have to allow carefully assessed risks rather than resort to inactivity, so that we can develop new evaluation processes.
The Earl of Dundee (Con)
My Lords, it is a great pleasure to follow the noble Baroness, Lady Finlay of Llandaff; and, while listening to her guidance today, also to recall her enormous contribution to better health standards, made both inside and outside Parliament, not least in her capacity as a past president of the Royal Society of Medicine.
Intervening between Committee and Report on the Healthcare (International Arrangements) Bill, this debate comes at a useful moment. I join others in thanking my noble friend Lord O’Shaughnessy for introducing it. I congratulate the noble Lord, Lord Carrington, on an extremely interesting and well-informed maiden speech.
On the approved safety of medicines and medical devices, I will comment briefly on three aspects: current risks to the United Kingdom following Brexit; necessary expedients to help contain these risks; and, to raise medical safety levels both at home and overseas, initiatives and directions that the UK should pursue in any case.
Several adverse consequences appear to be threatened by Brexit. A recent government impact assessment already concedes that firms will be subjected to further costs arising from duplicate authorisations from the two regulatory bodies, the MHRA and the EMA. These extra costs in turn are also deemed to prevent or delay the availability of certain medicines in the UK.
Then the British Medical Association identifies an erosion of safety standards. That follows if the United Kingdom should fail to negotiate a withdrawal agreement next month. For, as alleged, much of what is now developed for the UK market would then go elsewhere instead, thus undermining the UK’s present access to new medicines; as well as setting back its own industries which produce medicines and medical devices. Additionally, it would become far more difficult for the UK and the EU together to supervise and monitor as competently as they now do. Safety standards would deteriorate as a result.
To seek to redress those unwelcome outcomes, the BMA offers sound advice. This calls for United Kingdom licensing to be consistent with that of the EMA, for a formal agreement between the MHRA and the EMA—a point also made by the noble Lord, Lord Carrington—so that they work closely together over medicine approvals, and for mutual recognition of medical device criteria.
Can the Minister endorse these recommendations? If so, that would give comfort to many who harbour misgivings, such not least deriving from a recent government Statement, which avoids mention of specific post-Brexit measures to uphold standards. Instead, it only comments rather vaguely that the UK and the EU would,
“explore the possibility of cooperation of United Kingdom authorities with”,
EU agencies,
“such as the European Medicines Agency”.
Post Brexit, to enhance medical safety at home and overseas, there are perhaps two relevant and parallel routes: that to be taken by the UK together with the EMA, and that to be directly followed here, thus in any case also benefiting the United Kingdom along with other countries internationally. The Royal College of Surgeons warns that the regulatory system across Europe is insufficiently thorough. Device manufacturers can quite easily shop around notified bodies in various countries until their own product receives approval. Therefore, the RCS advises that all new surgical procedures should be registered, with related data collected within relevant national audits before they are given to patients. Wisely too, the RCS urges the use of barcodes so that anything which might develop a fault in future can be traced to identify when it was used and by which surgeon.
Among various expedients to reduce other deficiencies, does my noble friend the Minister agree that here are two which the MHRA and the EMA together should be encouraged to deploy, and that the Government ought now to give that clear message pre Brexit and straightaway?
The EMA is to be congratulated on its launch of an adapted approach to clinical trials. By augmenting transparency of information its new provision, called the clinical trial regulation, will assist collaboration, information-sharing and decision-making between and within member states. However, the MHRA observes that this measure will not be enforced before the UK leaves the EU. In view of that, can the Minister assure us that the UK will definitely be part of this valuable scheme, nevertheless?
Several UK initiatives already stand to promote medical safety levels. Following much better data technology, the Royal College of General Practitioners correctly draws attention to the opportunity for simplification. To predictable advantage, a whole host of medical databases could be connected together. Equally, and where in the first place based on notes from doctors, reporting drug safety issues would become much more efficient whenever multiple systems are replaced by a single one.
To reflect a theme touched upon by my noble friend Lord O’Shaughnessy, so-called adaptive pathways, already alluded to by my noble friend Lord Bethell, represent the notion of bringing some new medicines to market more quickly than would normally happen otherwise—initially only for those in urgent need, yet where afterwards their results can supplement clinical trials all the same. On the preparedness in general to learn from medical errors and near mistakes, to which my noble friend Lady Cumberlege referred, there may now be, if perhaps belatedly so, a growing realisation that thereby not only will patients receive better treatment but vast sums of money can be saved.
All these are hopeful developments within the UK. However, what is needed is a pulling together of their different strands; and, not least, a proper attempt by the Government to achieve such co-ordination. A draft Bill to try to achieve this started in 2017, but that good intention may have drifted into the sands a bit, with a recent government comment that they will bring forward legislation when parliamentary time allows.
Does my noble friend concur that the introduction of such legislation, or, at any rate, an unequivocal commitment by the Government now, well before Brexit, to help promote essential co-ordination, as outlined, would be of considerable relevance and comfort to all concerned?
If also somewhat belatedly, at least there is too a new willingness to pay proper attention to feedback from patients about medical safety and its perceived inadequacies: a priority implied by the noble Lord, Lord Hunt of Kings Heath, the noble Baroness, Lady Masham of Ilton, and others. As a result, every NHS trust may be expected to appoint a patient safety director at senior level. Be that as it may, a final version of the strategy will not be published for another few weeks. Meanwhile, can the Minister assure us that the Government will give full backing to the proposal so it can still be expedited in the first part of 2019 without unnecessary delay?
In summary, my Lords, medical safety standards have to depend on solid and determined teamwork. To date, the Government may have been too laissez-faire. Instead, as necessary and to a far greater extent, they should now take a much firmer lead in assisting proper co-ordination, to the mutual advantage of all, both here and elsewhere.
Baroness Jolly (LD)
My Lords, the safety of medicines and medical devices is a cause in which we are all invested. I join others in thanking the noble Lord, Lord O’Shaughnessy, for instigating this debate and for his excellent opening speech. I was particularly interested in his account of treatment of cancer in the brain in Birmingham—my brother-in-law is an in-patient there as we speak.
In a context where important pharmaceutical and technical advances are being made, ongoing work must be undertaken to ensure that patient safety is never compromised. I am encouraged by some steps that the Government are taking, such as the independent medicines and medical devices safety review.
There are two key ways to keep people safe. The Government must improve regulatory oversight, and must advocate listening to and responding promptly to patients experiencing adverse effects from unsafe medication or devices. Many noble Lords will have received correspondence about the devastation caused by sodium valproate and the awful effect it has had on babies, now disabled adults. Their mothers took the drug while pregnant. Will the Minister hold a briefing session for interested Peers to update us on progress with that—perhaps when we have finished all the health legislation currently coming down the track? That would be hugely helpful.
The impact of Brexit on medicines and medical device safety has already been covered well by other noble Lords, so I will not spend too much time on the topic. I am worried, however, by the expertise we have lost through the relocation of hundreds of staff of the European Medicines Agency to its new headquarters in Amsterdam.
I note that numerous drug safety reports, and reports of suspected adverse reactions to drugs, previously submitted at the EU level will instead be submitted to the MHRA. I echo the concern of the BMA, which has warned about skills gaps in pharmacovigilance. Can the Minister confirm that there is a recruitment drive to ensure that the MHRA is sufficiently staffed to consider the broad range of medicines and medical devices that require scrutiny in the UK? Moreover, what are the Government doing to ensure that the relationship between the EMA and the MHRA remains strong and convergent post Brexit? Will the Government make stronger assurances than the text of the political declaration that accompanied the withdrawal agreement, which states only that the UK and the EU will,
“explore the possibility of cooperation”,
after the transition period? That is simply not good enough. A weak relationship could harm patients and stifle progress. I look to the Minister for assurance that she is aware of this and taking action.
I am pleased to note the work of the independent medicines and medical devices safety review currently under way, looking into how concerns about surgical mesh were handled, and the devastating effects of Primodos and sodium valproate. A lot of insightful evidence has been submitted so far. The noble Baroness, Lady Cumberlege, is investigating whether the NHS harbours enough of a listening culture. The Epilepsy Society raised this issue in its evidence. In the case of surgical mesh, it seems that there was a degree of gender bias, meaning that women’s pain was not taken seriously. My right honourable friend Norman Lamb MP was vocal on the subject of mesh implants, highlighting the years of life-altering pain experienced by affected women, compounded by the emotional trauma of not being listened to and believed. On the back of all that, he set up the APPG. With the review now one year old, does the Minister know whether affected patients finally feel listened to? The review’s impact must be wide-ranging; it should complement work happening upstream to improve review processes.
Several organisations, including the Royal College of Surgeons, have called for tighter regulation and oversight of devices. Looking forward, new devices may be more complex than those of old but, contrarily, some devices may become simpler. Both require vigorous testing. More importantly, we must build ever more comprehensive mechanisms for both regulation and patient feedback. These systems must speak to each other to ensure that every new medicine and medical device is safe for patients. Technology has a role to play in linking patient experiences with unsafe medicines and medical devices in a clear pattern. Just as John Snow—not that Jon Snow—related the spread of cholera to a single water pump, so we see now, through work to analyse multiple databases on patient and drug experiences, that symptoms can be traced to an inappropriate medicine or a faulty medical device. This is an expanding area of work that must be monitored.
The noble Baroness, Lady Masham, mentioned sepsis. A few weeks ago, the noble Lord, Lord Grade of Yarmouth, told the House about the benefits of a national sepsis register. For medicine safety, the Royal College of General Practitioners has recommended a single system, with some similarities for reporting drug safety issues, which would be linked to GP notes. Will the Government consider this, while being mindful of data privacy? Perhaps it could be cross-referenced with the yellow card scheme, providing a stronger pool of data from which to draw conclusions. Multiple health sector experts, including pharmaceutical companies and health professionals, advocate strengthening knowledge of and access to the yellow card scheme.
Training health workers is a key way to keep patients safe—if the Government will provide funding. This could include broader “driving licence” training for the safe use of particular pieces of medical equipment, as well as the training of other health professionals. An obvious but important example is community pharmacists. We all agree that they play a key role in medical safety, for instance through medicine use reviews, new medicines services and keeping a look out for customers buying strong over-the-counter medications, or who appear to be suffering adverse side effects.
In conclusion, the debate has been excellent. I congratulate the noble Lord, Lord Carrington, on an outstanding maiden speech, and I thank the noble Lord, Lord O’Shaughnessy, for introducing the debate. I look forward to the Minister’s response.
Baroness Thornton (Lab)
My Lords, I congratulate the noble Lord, Lord O’Shaughnessy, on initiating this important debate—which, of course, a few weeks ago he would have been answering himself. I declare my interests, which are in the register: my long association with the British Healthcare Trades Association and as a lay member of a clinical commissioning group. I also congratulate the noble Lord, Lord Carrington, on his spirited maiden speech and welcome him to the House. I thank all the organisations which have sent us briefings on this issue, and indeed our own Library. They have been very helpful indeed.
While my sympathies are totally with the mesh campaign, I am not going to refer to it because several noble Lords have spoken about it with enormous passion. My heart is with them but I am going to talk about other issues. In that regard I particularly welcome the contributions of my noble friends Lady Bryan and Lord Hunt. The House is aware that these matters are close to the heart of the noble Lord, Lord O’Shaughnessy, and his record of taking action to deal with issues of safety is to be commended, including the establishment of the commission of inquiry which is being chaired and led so wonderfully by his noble friend Lady Cumberlege. She has given us an up-to-date briefing and, indeed, enormous cause for hope.
This is a good time to reflect on the infrastructure that safeguards the introduction of medicines and devices into the UK as Brexit looms. The noble Earl spoke knowledgeably about this and I am grateful to him for his remarks. Like other noble Lords, I believe that we have a legislative and regulatory structure in the UK which is designed to protect patients and which has been material to the development of Europe-wide regulation from which we have all benefited. Several noble Lords have suggested that it is creaky, which I think is right, and that it has to keep up. That sentiment was well expressed by the noble Baroness, Lady Masham. Following a question posed not so long ago by the noble Baroness, Lady Walmsley, about the protection of patients from counterfeit medicines after the UK has left the EU, it was quite clear from the briefings that arrived in my mailbox that the UK pharmaceutical and biotechnology industry and organisations such as the Association of the British Pharmaceutical Industry and the UK BioIndustry Association are warning that leaving the EU without a deal would increase the risk of counterfeit medicines entering both the UK and EU supply chains.
The first issue that I would like to raise with the Minister is this. She will know that the falsified medicines directive—FMD—was published on 1 July 2011 and the legislation became effective on 8 February this year. It introduces tougher rules to ensure that medicines are safe and that the trade in medicines is rigorously controlled. This directive is being introduced to tackle the counterfeit high-price medicines that are a threat to public health worldwide. Does the Minister agree that a no-deal Brexit is likely to see the UK’s access to EU databases revoked, including the European Medicines Verification System, which is the heart of EU-wide compliance with the falsified medicines directive? Those proposals also present a risk to UK patients as unilaterally revoking FMD legislation in the UK would make the country a target for counterfeiters. Both the bodies involved in this area are very concerned indeed. Post Brexit we need to be assured that keeping fake or fraudulent medicines out of our supply chain is an absolute priority.
In this context, three things are important: making specific reference to the importance of co-operating on the regulation of medicines in the political declaration; making it clear that the UK and the EU will co-operate on protecting citizens from infectious disease and counterfeit medicines; and making it clear that the UK and the EU will agree closer collaboration on science and innovation.
The second issue I wish to raise stems from my support over many years for the British Healthcare Trades Association, which, having been founded in 1917, is one of the UK’s oldest and largest healthcare associations. My connection with the association arises partly because many years ago I met stoma nurses and discussed with them the work they do. I had conversations with them about the design and importance of support for stoma patients. Those conversations led to me getting to know the BHTA and realising that a lot of the devices, innovation and design we have in this country rest with small and medium-sized enterprises, which need our support. The BHTA provides them with the controls and regulatory framework that are so important in their relationship with the NHS and individuals. It deals with class 1 and some class 2 devices.
I also want to ask the Minister about the suppliers of other equipment and devices. The wide availability of medical devices from places such as Argos and through Amazon, and the purchase of apps and other monitoring devices, concern me greatly. Last summer I was sent copies of an Argos leaflet, available in a GP surgery outside London, advertising a whole range of equipment, including monitoring devices available in its stores. There was no suggestion in any of these leaflets that it might be a good idea to get professional advice before forking out on these items. We would want a physio to assess us before using walking aids—sticks and rollators—and to be measured up to make sure that we get the correct ones. A shower stool could be dangerous if you had Parkinson’s or a one-sided weakness or found it hard to stand. You would need an occupational therapist to work out whether you needed a chair with a back or with arms.
While we wish people to take responsibility for preventive care and self-care, and monitoring your own health and progress is to be encouraged, effective self-help is a complex thing. It requires ongoing education and support from health and social care workers. Done well, it is fantastic. I ask the Minister her view of the ease with which people can buy medicines and devices, either online or in places such as Argos. For example, is there any research to inform issues of patient safety, knowledge, usage or whether there are enhanced outcomes in terms of prevention or well-being?
Thirdly, I will briefly mention access to new devices for diabetics. Technology plays a key role in diabetes care, particularly for people with type 1 diabetes but also for people with type 2. Over the last few decades new technologies have transformed that. However, it is a postcode lottery. I ask the Minister: what are the Government doing to ensure that there is fair distribution and access to these very important technologies?
Finally, I think I need to ask the Minister about a recent leak concerning the NHS app, which is designed to be a digital front door, and the fact that it would appear it is not able to connect with any other providers of online GP consultations. The leaked NHS Digital briefing shows that a survey of 32 online consultation suppliers, such as LIVI and Babylon Health, found that none of the technology was able to integrate with the NHS app. This is quite a serious matter, because the NHS Long Term Plan commits to building the app into a single digital front door for patients to,
“provide advice, check symptoms and connect people with healthcare professionals—including through telephone and video consultations”—
all brilliant stuff. This is a serious issue of patient safety. I would like assurance from the Minister, given that she, her predecessor—the noble Lord, Lord O’Shaughnessy—and their boss have embraced this technology with such huge enthusiasm. I hope we are not heading into another technological black hole.
I congratulate all noble Lords on their contributions. This has been an absolutely excellent debate, one that I hope will provide support for those people campaigning on a variety of very important issues around patient safety, and will take the debate forward.
The Parliamentary Under-Secretary of State, Department of Health and Social Care (Baroness Blackwood of North Oxford) (Con)
My Lords, I congratulate my noble friend Lord O’Shaughnessy on securing this debate and on what I know was a very personal commitment to this subject when he was Minister. I also congratulate the noble Lord, Lord Carrington, on a truly excellent maiden speech. We all recognise the significant contribution to the United Kingdom’s public life by his father, the late Lord Carrington, but I do not think the current noble Lord, Lord Carrington, will have any trouble following in his footsteps.
Indeed, I thank all noble Lords who contributed today. It has been a thoughtful and sobering debate on a really important subject. We should be proud of the world-leading role that UK researchers, clinicians, industry and regulators play in medical discovery and innovative treatment. We are the first country to introduce whole-genome sequencing to routine clinical care, the first in the world to approve Kymriah and the first in Europe to approve CAR T-cell therapy. As the noble Baroness, Lady Masham, rightly said, that is so important for patients with rare or hard-to-treat conditions, because it raises the hope of earlier diagnosis and more targeted treatments. That is at the heart of many of the measures in the long-term plan and the life sciences strategy, which is directed at improving the capacity of our life sciences industry and the NHS to improve the quality of care for patients.
As many noble Lords eloquently pointed out, medical innovation flourishes only on a firm foundation of clear and effective regulation and informed consent. That is not only about patient safety but about giving certainty to researchers and innovations. The noble Baroness, Lady Finlay, and my noble friend Lord Bethell movingly reminded us that there is an innate tension in the need to drive forward the frontiers of medical innovation to offer hope to those with rare and hard-to-treat conditions—perhaps it is appropriate that today is Rare Disease Day. But there is also the need in a complex and universal system such as the NHS to have effective and agile safety and consent systems. However, in that context, it is never an excuse for a patient’s voice not to be heard loudly, quickly and effectively when things go wrong and we must never tolerate any form of gender bias, as the noble Baroness, Lady Jolly, said.
We heard today of some of the successes and strengths of our current systems of regulation for both medicines and medical devices, but we also heard about instances where our regulatory and wider systems could go further. I pay tribute to all those patients, some of whom are here today, who have shared their experiences and have gone on with a resolute determination to campaign for change for themselves and on behalf of others, including groups that my predecessor met and worked hard with, such as INFACT and Sling the Mesh. Many of them have met Ministers and Members of this House and have, with great bravery, told their stories, many of which are heartbreaking for them and their families. To them I say: thank you for your courage and dignity. Please know that your voices are heard not only here today but across government and across the system.
Noble Lords have already debated many aspects of the role of the MHRA to be responsible for the regulatory compliance of medicines and devices. As noble Lords will be aware, no medicine or medical device is entirely risk-free. The possibility of a patient suffering an adverse reaction or incident, although limited, can never be eliminated. That is why the MHRA has powers to take action, including removing products and devices from the market or resisting their use if the risk and benefit profile changes as new evidence emerges. We need to ensure that we are capturing that evidence most effectively.
Recent examples of where the MHRA has made use of those powers include recalling some sartan medicines for high blood pressure and issuing new temporary measures for the uterine fibroid drug Esmya. The MHRA also initiated EU action on valproate and will continue to consider what further restrictions are needed to ensure that valproate is not used in pregnancy. I will return to that in more detail a little later.
The noble Baroness, Lady Finlay, is absolutely right that the MHRA and NICE are indeed working more and more closely together on these matters. I have heard her and others’ points about the use of registries to capture evidence more effectively. We need to consider how that would interact with local care health records, however, and whether they are the most appropriate place to capture that information. I will take that point away and consider it carefully.
I particularly thank my noble friend Lord Bethell for his truly eloquent account. I appreciate his impatience for progress on this matter, so I would like to focus for a moment on the system for regulating devices. As the House is aware, medical devices are not brought to the market in the same way as medicines. The regulation of medical devices is instead governed by three EU directives as part of the pan-EU system of conformity assessment, a system that sets out standards for pre and post-market assessment of medical devices, including categories of device and the role of notified bodies and the MHRA.
However, there is no direct authorisation of devices for the UK or EU markets conducted by the MHRA. Medical devices and the wider medical technology sector form an area of very fast technological innovation, as the noble Baroness, Lady Thornton, pointed out. This means that devices are routinely improved and replaced as technology is developed, with a view to improving patient safety and experiences. It also means that there are comparative limitations on the amount of pre-market assessment that can be conducted for devices—unlike for medicines—given that the evidence of their actual use by patients is critical to the overall assessment of their efficacy. This is why manufacturers, notified bodies and the MHRA conduct ongoing post-market surveillance and vigilance to respond to information about the safety of devices when in use, and take appropriate regulatory action to improve them. This includes issuing medical device alerts to the healthcare service and the restricting and recalling of products. The publication of more data and patient feedback is an evolving process, as more experience is gained from the use of medical devices.
While the overall system seeks to establish a balance between continuous innovation in medical technologies and patient safety, I fully accept that it is not easy to achieve. By its nature, the regulation of innovative sectors must respond with continuous improvement, while the sectors’ systems and processes need to be continuously reviewed in the interests of patient safety. This is something that I know the MHRA and others take seriously, and to which I am personally committed. It is why the UK has played a role in arguing for change at European level in recent years, and why the Government intend to fully align the UK with the new EU medical devices regulations and in vitro diagnostic medical devices regulations, which my noble friend Lord Dundee mentioned. We will do this even though we are leaving the EU institutions because we are confident that doing so will drive system-wide improvement, including to the levels of clinical data that are mandated before products can be placed on the market, the scrutiny placed on notified bodies, the level of post-market surveillance conducted and the traceability of medical devices. We think this will improve the safety of medical devices.
This approach will establish a stronger and improved baseline for any future system change that we implement after our departure from the European Union. We will proactively ensure that innovative technology and processes are utilised by the UK healthcare system where this can enhance the role of the MHRA, including in relation to data, as well as increasing patient safety and confidence. My noble friend referenced a strong example of this: the Scan4Safety pilot, which was conducted in six trusts. We hope to roll that out across all acute trusts in England. I am a strong supporter of this, given that I announced the pilot in the first place.
Despite these changes, I know that there are still patients who feel that their concerns or experiences are not adequately heard or considered by the health system, and that the response has not been agile enough. It is an essential principle of patient safety that the regulatory environment gives sufficient voice to concerns reported by patients, families and campaigners, and that it works alongside them to respond in a rapid, open and compassionate way to resolve issues. I offer my firm assurance now that, as a department, we will be neither complacent in our success nor ignorant of the possible opportunities to improve. Just as the landscape of medicines and medical devices is ever-changing, so too must be the regulatory frameworks in which they are marketed, monitored and used within our healthcare system.
It is this commitment to evolve and ensure that the patient voice is central to our healthcare system that led to the Independent Medicines and Medical Devices Safety Review, chaired by my noble friend Lady Cumberlege and introduced by my noble friend Lord O’Shaughnessy. We have already heard much about it, so I will not go into detail. However, it will be critical to improving our understanding and action on listening to and consulting patients in the UK healthcare system to ensure that informed choices can be made. We expect the review to report later in 2019, with my noble friend Lady Cumberlege’s assistance. As we have heard, I know it has been consulting in a detailed and patient-oriented manner across the UK. I specifically thank my noble friend for her great sensitivity and dedication when listening to patient groups and individuals. I have met her and her team and heard first-hand how she has travelled the country to ensure that those who want their story to be heard have had an opportunity to speak in a sensitive and appropriate environment. She has handled her work with great tact and compassion, and I thank her for all her hard work and dedication.
Baroness Blackwood of North Oxford
Without second-guessing her conclusions, we recognise that we need to look beyond regulation and take a system approach to patient experience, enhancing the culture of improvement and using data to identify and drive required change, as my noble friend Lord O’Shaughnessy and the noble Lord, Lord Hunt, rightly pointed out. As part of this, I note my noble friend’s reference to a new national office of patient safety. That will require much more detailed discussion and consideration in the light of the review’s recommendations, but even at this stage it has much to recommend it.
I shall move on to some of the specific questions about surgical mesh. There has been a detailed debate about it, so I do not want to repeat what has been said. As the noble Lord, Lord Hunt, pointed out, in July 2018 my noble friend Lady Cumberlege recommended that there should be a pause without delay in the use of surgical mesh for stress urinary incontinence. That was supported by the Chief Medical Officer and senior clinicians. It was implemented through a high-vigilance regime of restricted practice and communicated to NHS England trusts. I understand that a similar process is taking place in Wales. I understand the impatience for a full ban, but for some women this may still be the only option for treatment, so it was considered that, while awaiting the outcome of the review, it was the appropriate route to take. The current findings are that the pause has dramatically reduced the number of procedures while we await the findings of the inquiry by my noble friend Lady Cumberlege. This is being kept under very tight scrutiny.
With reference to my noble friend’s specific question on a properly funded and staffed national network of expert mesh removal centres, I can confirm that NHS England has consulted on a service specification. When it is in place, we expect the service specification will cover multidisciplinary team management and complex vaginal mesh removal surgery for women who have complex complications. We are taking extremely seriously the review’s wider interim recommendations and are taking appropriate action in response. We will fully consider the final recommendations on mesh that the review will make later this year. Our primary objective will be to prevent future recurrence of the pain and appalling distress that patients, such as those who have given evidence to the review, experienced. We want to ensure that lessons are learned from their experience that will help us to protect other patients from any further risk of harm.
Turning to valproate, I have tremendous sympathy for the families affected by its use. The Government’s priority is to ensure that women are aware of the risks of this medicine. I therefore agree with my noble friend that the Government’s ambition should be to limit in-utero exposure to as close to zero as possible. Our current goal is rapidly to reduce and eliminate pregnancies being exposed to valproate. This is being supported by a formal pregnancy prevention programme and annual specialist review, as well as clear valproate labelling and packaging. There is also a communication and awareness campaign for healthcare professionals and patients. In response to the question asked by the noble Baroness, Lady Walmsley, all pharmacies have been provided with materials and there have been repeated communications. The General Pharmaceutical Council has written to all pharmacists to remind them of their professional responsibility in providing information to women, while the Royal Pharmaceutical Society and pharmacy bodies have been very active in communicating with their membership and in auditing practice. I recognise that there are still concerns about performance, but action is being taken. Patient input and engagement with members of the patient group, INFACT—who I know my noble friend has met many times—have been invaluable in the feedback process. It remains the responsibility of every healthcare professional involved in the prescribing and dispensing of valproate medicines to make sure that women are aware of the risks and are on a pregnancy prevention programme.
I note the questions posed by noble Lord, Lord Alton, regarding Primodos. They were quite detailed so, if he will allow, I will come back to him in writing.
I hope I have covered the majority of points raised by my noble friends and others in this House. This has been an important debate and I reassure all noble Lords that, as a Government, we are fully committed to a system of regulation for medicines and medical devices which intelligently provides access to new, innovative and world-leading products to improve the lives of millions of patients—especially those with diseases that are rare and hard to treat—while simultaneously protecting UK patients from harm, and ensuring that patient voices are heard loudly and clearly throughout the system if something does go wrong.
I finish by thanking my noble friend Lord O’Shaughnessy and all noble Lords who have participated in the debate this afternoon. It is clear that we are united in our dedication to learning from the experiences of those who have been courageous in speaking out, and in our commitment to protecting and improving the safety of patients who use medicines and medical devices in the UK. I am sure that, if we work together on this matter, we will see not only better medicines, better support and better care for patients but a safer NHS that is more responsive when it needs to be.
Lord O'Shaughnessy
My Lords, it has been a privilege to be part of what has been a superb, incisive and moving debate. I pay tribute to noble Lords for their varied but always excellent contributions. As my noble friend Lady Cumberlege said, the quality of the debate is, in a way, testament to the courage of those who have been affected by medicines and devices when they go wrong—often, as the noble Lord, Lord Hunt, said, in the face of an unresponsive system. It is to them that we must truly pay tribute.
I thank the noble Lord, Lord Carrington, for his excellent speech. He will have found that he got a warmer welcome than his forebear, which I am sure he appreciates. I am struck by something he said: that patient safety is paramount but must be balanced with innovation; not to give someone a potentially effective treatment is also an issue of safety, because they could be harmed. This is what we have been grappling with today.
I am deeply grateful to my noble friend the Minister for her comprehensive answers, not only to my questions but to all those posed by noble Lords. She is quite right to applaud the UK’s record in innovation. How reassuring it was to hear from her about the importance of patient voices being heard, the commitment to an evolving regulatory system and the deep support for my noble friend Lady Cumberlege’s review. I am particularly pleased that she has been able to discuss the service specification for the network of experts on mesh, the commitment on valproate exposure in pregnancy and the comments on Scan4Safety and other matters. I thank her for all that.
I found the speech of my noble friend Lady Cumberlege particularly moving. She has spent time with hundreds of families who have been affected by these issues, and I know this affects her. She has shown great courage and perseverance. I hope she has been reassured by the broad support that her review received in the debate today; we look forward to it with great anticipation.
Noble Lords have covered all topics today. The noble Baronesses, Lady Walmsley and Lady Jolly, and the noble Lord, Lord Brennan, talked about valproate; the noble Lord, Lord Hunt, the noble Baronesses, Lady Walmsley, Lady Jolly and Lady Bryan, talked about mesh; the noble Lord, Lord Alton, talked about Primodos; and my noble friend Lady Cumberlege talked about all three. Of course, we have covered other topics too. There has been support for and discussion of many policy ideas. I hope my noble friend the Minister will go away with lots of suggestions about things that we could do next.
The mesh network was mentioned by the noble Lord, Lord Hunt, and the noble Baroness, Lady Walmsley; the National Patient Safety Office was supported by the noble Lord, Lord Alton; and device registries were mentioned by the noble Baronesses, Lady Masham and Lady Finlay, and the noble Lord, Lord Bethell. As the noble Baroness, Lady Thornton, said, we also need to think about what this means for self-care, as consumers become increasingly involved in their own healthcare. The importance of data was mentioned, to make sure that treatment is more targeted but also for better reporting and mandatory reporting—as mentioned by the noble Lord, Lord Brennan, the noble Baronesses, Lady Bryan, Lady Finlay and Lady Thornton, and the noble Earl, Lord Dundee.
The critical point was made that regulation must not inhibit innovation—the right to therapy, which the noble Baroness, Lady Finlay, spoke about—which relates to our attitude to risk and our need for a sophisticated system. After all, as the noble Lord, Lord Brennan, pointed out, as our medical knowledge expands, complications will only grow. We will need a different, better and more sophisticated system for dealing with those complications. As the noble Lord, Lord Bethell, and the noble Earl, Lord Dundee, pointed out, that includes having adaptive pathways so that we can take difficult, experimental treatments and make sure that they are properly targeted. We need to do that in common with our partners in the EU and around the world. That is particularly true for rare diseases, an area where the numbers of people are not big enough to do anything significant in one country but where we can really change treatment if we act together. I warmly endorse the intention that we should have a deep and lasting relationship with the EMA after Brexit, because that is for the good and the safety of patients in our country and across the European Union.
I finish by reflecting on three things that my noble friend Lady Cumberlege said, which are the lessons for today: we need to be better at listening, better at learning and better at caring. We owe patients in this country better on all those fronts, and I am sure that as a result of today’s debate we will do so. I thank all noble Lords for their contributions, as well as all those families and people who have been affected and have kept at us on these topics to make sure that change happens—critically, often not for their own benefit but for the benefit of those who are not yet affected. I thank them all and I commend the Motion to the House.