Safety of Medicines and Medical Devices

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.

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.

“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?

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.

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.

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.

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?

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.