Medicines and Medical Devices Bill

Baroness Cumberlege Excerpts

2nd reading & 2nd reading (Hansard) & 2nd reading (Hansard): House of Lords
Wednesday 2nd September 2020 Lords Chamber

[Baroness Cumberlege (Con)]

My Lords, I stand before you as a person who was shaken by the experience of personally listening to over 700 women and their families, who have been damaged by the healthcare system. Their testimonies actually haunt me. Their bravery impels me to right their wrongs.

In our report, First Do No Harm, we examined and researched two medications. First, Primodos, already very well explained by the noble Lord, Lord Alton, was a hormone pregnancy test taken between the 1950s and 1970s and associated with terrible damage to some newborn babies. Those newborn babies now need care and support as adults while their surviving mothers, now elderly, have lived a life wracked by guilt. Secondly, there is sodium valproate, an effective medication to control epilepsy. When taken in pregnancy, there is a 50% chance of a severely damaged child being born. Even today, that medication is still being given to women who are unaware of the consequences. Then there is pelvic mesh: a plastic net which can migrate, disintegrate and wrap itself around vital organs, severing some and causing appalling suffering and pain.

The root cause was the failure of the healthcare system as a whole, and by some in the medical profession who ignored the concerns of women and their families. These women knew what was wrong but they were dismissed. They were told it was all in their heads—just a woman’s problem, not to be taken seriously. This made me furious. As Sir Cyril Chantler, the review’s vice-chairman, reminded us, for whom is the healthcare system run? We pay for it; it is ours. It is run for us, the people and patients. Your Lordships all know, as I do, that when we are ill or in pain most doctors will listen. But if they sense that a mistake has been made, they clam up, become defensive and act irrationally.

Now for the good news. The report has raised a clarion call for action and I thank all parliamentarians who have been so supportive—particularly your Lordships, but you are not alone. There are the 15 patient groups, the Royal College of Surgeons, the Royal College of Obstetricians and Gynaecologists, the Royal College of Physicians, the Royal College of General Practitioners and the British Society of Urogynaecology—all with their medical membership—along with the BMJ, in its stunning editorial last week. All these and so many more want to see our recommendations implemented and we can start right now, with the safety Bill.

I intend to put down an amendment to appoint a patient safety commissioner—a voice for, and listener to, patients. If a product raises concern, that commissioner must say “Stop—this is a worry. We need to investigate and research to ensure safety”. It is better to have a few false alarms than the tragedies we have witnessed, which have cost lives, caused suffering and family break-ups, and damaged children. These are personal costs beyond price, with millions of pounds to be paid from the public purse.

We parliamentarians are establishing a parliamentary group called “First Do No Harm”. Its purpose is to ensure that all our recommendations are implemented. The only cloud on the horizon is the Department of Health and Social Care, which simply does not get it. Asking everyone, as it does now, to work together better in the future simply will not work, any more than it has in the past. We need someone and something new: a patient safety commissioner. Yesterday, we heard that the First Minister of Scotland, Nicola Sturgeon, has announced that Scotland is to have a patient safety commissioner on our lines. But in England, rumours are absolutely rife of a ritual burial and answers to the PQs are evasive. I say to my noble friend the Minister: this is his opportunity to give an assurance that this report will be implemented with a taskforce and timetable, as set out in our Recommendation 9. Please can the families who have been hit so tragically hard have that assurance?

Medicines and Medical Devices Bill

Baroness Cumberlege Excerpts

Committee stage & Committee: 2nd sitting (Hansard) & Committee: 2nd sitting (Hansard): House of Lords
Monday 26th October 2020 Grand Committee

[Lord Sharkey (LD) [V]]

I shall speak briefly to Amendments 9 and 13. I should start by saying that I enthusiastically support Amendment 8, moved by the noble Baroness, Lady Thornton. We all know that the phrase “have regard to” lacks any real force. Like her amendment, our Amendments 9 and 13 are intended to strengthen Clause 1(2), whose opening words read

“In making regulations under subsection (1), the appropriate authority must have regard to”,


followed by a list of the things to which it must have regard. Amendment 9 would change those opening words to read, “In making regulations under subsection (1), the appropriate authority must have regard to, and in the case of regulations not subject to section 42(6), (7) or (8), must publish with the draft regulations an assessment of their impact on,” and then the list of things to which regard must be had.

Clause 42(6), (7) and (8) are excluded because they contain urgency provisions and may now anyway make use of the “made affirmative” procedure. The purpose of the amendment is to ensure that there must be a full assessment of the impact of any regulation on the three specified areas. This applies to all three of the areas and is of particular importance in the assessment of safety and how it is to be prioritised, in subsection (2)(a).

Amendment 13 addresses the issue of assigning priority to the safety of human medicines, as do other amendments in this group. It would rewrite subsection (2)(a), so that instead of reading,

“the safety of human medicines”,

it would read “the priority of ensuring the safety of human medicines”. Other noble Lords have tabled amendments suggesting different ways of ensuring this priority and I look forward to hearing their contributions. But whatever the variations in approach, it is obvious that a strong, clear and unambiguous statement of the priority of the safety of human medicines needs to be inserted in the Bill.

[Baroness Cumberlege (Con)]

I shall speak to Amendments 10, 12, 74 and 75 on the second Marshalled List, and I thank the noble Lords who have supported these amendments—the noble Baronesses, Lady Burt of Solihull and Lady Hollins, and the noble Lords, Lord Patel and Lord Hunt of Kings Heath.

This Bill chimes perfectly with the review that I led into two medications and a device. The review culminated in the report First Do No Harm, which states:

“Innovation in medical care has done wonderful things and saved many lives. But innovation without comprehensive pre-market testing and post-marketing surveillance and long-term monitoring of outcomes is, quite simply, dangerous.”


In conducting the review over two and a half years, my team and I listened to hundreds of women and their families, with their stories of anguish, acute suffering, destroyed relationships and parents whose children have been harmed, deformed and had their potential lives ruined.

I have been told that this Bill is not a safety Bill. If it is not, what is it, for goodness’ sake? How can safety not be the overriding purpose of the Bill? My modest amendments, and those of other noble Lords, seek to make it so.

In paragraphs (a) to (c) of Clause 1(2), safety is not the primary consideration but is on an equal footing with the availability of medicines and the UK as an attractive place in which to conduct clinical trials and the supply of medicines. These aspirations are of course important but in the way in which the Bill is drafted safety is simply an “also ran”. It should not be; it should be of overriding importance. As the noble Lord, Lord Patel, said in his amendment on the first day of Committee, the construction of this clause needs improvement.

My review found safety seriously wanting. We were commissioned to review two medications given to women. The first was Primodos. Between the 1950s and the 1970s, two little pills were given to women to test whether they were pregnant. From the late 1950s, concerns were raised that these tests could harm and cause abnormalities in a developing baby. Although disputed, there is a body of opinion that has linked these hormone pregnancy tests to a wide range of various malformations. We discovered opportunities where action should have been taken and was not.

These pregnancy tests were taken off the market in 1978 following concerns over their safety—more than a decade after safety concerns were first raised. No one listened. The risk to patient safety was not prioritised, one result of which has been a 40-year battle to get an independent review of the regulations that were found wanting. I accept that regulation was in its infancy in the 1960s and 1970s, but patient safety should have been the overriding consideration then, as it must be now.

In the course of our review, we met the children—now adults—who suffered so much and their families. Many dreadful impacts have been associated with these pregnancy tests, such as loss or shortening of limbs—we have seen other examples of this happening in the past—heart defects, spinal issues, seizures, dysmorphic facial features, digestive and bowel issues, and so on. We were struck by the unremitting guilt felt by the women who took the pills. They feel to blame for their children’s disabilities. They suffer enduring psychological harm, and although we told them, “It wasn’t your fault; you weren’t told; how can you be blamed?”, I fear that we did not convince them.

The second medication reviewed was sodium valproate. It is a very effective drug for controlling epilepsy but it has a history that should never be repeated. When first licensed in 1972, it was known to be teratogenic in animals. Prescribing doctors were warned that it should be used only in severe and resistant cases of epilepsy in pregnant women. In the 1980s, academic literature drew attention to the risks. In the 1990s, the risks of neural tube defects and other congenital malformations were known. Even then, women were saying that exposure to sodium valproate had caused damage to their offspring.

In early 2000, doctors were again warned of an association with delayed development in children, with delayed speech, IQ affected and reports of autism. Throughout this tragic history, clinicians have been warned and women and their families have not been listened to; they have been dismissed and had their knowledge denied. It took 40 years after sodium valproate was introduced to the market to produce a toolkit, the purpose of which was to provide information to women of childbearing age and healthcare professionals about the harm that could be caused. Two years later, in 2018, a pregnancy prevention programme was introduced; it stipulated three measures that were designed to prevent further harm.

You would suppose that this is the end of a tragic story—problem solved—but that is not so. It is truly shocking that, today, epileptic pregnant women on sodium valproate have a one in two chance of having a disabled child. They are still exposed to huge risks because they are not told what those risks are. Babies continue to be been born with lifelong disabilities due to exposure to this drug. We know that the results are catastrophic.

The third and final area that we were asked to review was surgical mesh, a device inserted to support pelvic organ prolapse and to treat stress urinary incontinence. For many women, mesh surgery is trouble-free and leads to improvements in their condition, but that is not the case for all. A BMJ article published on 10 October 2018 had the arresting headline “How mesh became a four letter word”. In the article, Jonathan Gornall charts the rapid rise and fall of vaginal mesh; it is, as he says,

“a story that offers lessons for the entire medical community, and for manufacturers and regulators”.

Unlike many other devices, polypropylene mesh is intended to remain in situ for life. We heard from countless women who sought to have it removed but were unsuccessful; sometimes attempts even caused further serious damage.

Why would they want it removed? Because mesh ruins their lives. We were told by hundreds of women that they suffer excruciating pain, recurrent infections and haemorrhages, bowel issues, recurring or new incontinence, and nerve damage that restricted their mobility. Fit young women were confined to a wheelchair for the rest of their lives. I will always remember one little boy telling us, “I just want my old mum back.”

We heard about sexual difficulties leading to the loss of a sex life and broken marriages. We heard from women how the constant pain resulted in the loss of employment—that is, their job—so they lost their income. Because of that, they could not afford the mortgage or rent so they lost their homes, and because they were homeless, they were fearful that their children would be taken into care. One woman told us:

“This is not a life. It is an existence.”


We were so shaken by what we heard that, in July 2018, we recommended that vaginal mesh should be paused. Our recommendation was immediately accepted by NHS England and the Department of Health and Social Care. The scandal is that our recommendations were not new; all had been suggested before, but no action had been taken. It should not have been for us to recommend this. If safety was of paramount importance, the healthcare system should have picked this up decades before. After all, mesh was first used in the 1960s. It gathered pace in the 1990s; by 2001, it was the most common operation used for ameliorating stress urinary incontinence—a very unpleasant condition, but not life-threatening.

Medicines and Medical Devices Bill

Baroness Cumberlege Excerpts

Committee stage & Committee: 3rd sitting (Hansard) & Committee: 3rd sitting (Hansard): House of Lords
Wednesday 28th October 2020 Grand Committee

Taking these amendments together, we seek to make the UK an innovative and safe marketplace for trialling and developing medicines and medical devices. I believe these objectives are entirely consistent with those of the Government as described by the Minister. I hope that the Government will look very carefully at these amendments, which have been drafted with the support of the esteemed medical Royal Colleges that I have mentioned. I beg to move.

[Baroness Cumberlege (Con) [V]]

My Lords, I will speak briefly in support of Amendment 84 in the name of the noble Baroness, Lady Finlay. I also wish to raise a question on Amendment 97 in the names of noble Lords, Lord Kakkar and Lord Patel, and to ask the Minister a question on equivalence, of which I have given him notice.

During my review, we heard much that greatly concerned us about the way that medical devices reach the market. Our focus was on pelvic mesh, but similar concerns apply to devices more generally. When mesh for stress incontinence and pelvic organ prolapse first came into use, the safety data available was woefully inadequate. It relied on very short-term studies, often funded by manufacturers with vested interests, with limited follow-up. Mesh is a product that is designed to remain inside the body, which presents a problem, because it is designed not to be removed. Removal can be done, on rare occasions, but it is very difficult and dangerous. Implanting a device such as this into so many patients with such a lack of safety data is, as we said in our report, foolhardy.

I recognise that some risks of new treatment options may become apparent only when they have been in use for some time. I agree with the noble Lord, Lord Hunt, that surgeons need to be able to offer new, innovative treatments. That is how medicine has made such tremendous progress in our lifetimes. We must not stifle innovation, but we must do all we can to improve patient safety and to prevent avoidable harm. We had a full discussion of this on our previous day in Committee.

In clinical trials of medicines all adverse events are reported, whatever their cause, and that is good. In the case of mesh, if selected cohorts of patients had undergone enhanced reporting, it is most likely that the adverse impacts we heard about would have been detected sooner. Thousands of ruined lives, in this country alone, could have been avoided.

In the field of medical devices, better, more thorough trials with long-term follow-up are vital, but they are not the whole answer. We also need transparency. It is one thing for trials to be conducted, but quite another to ensure that the findings they produce, and the concerns they may give rise to, are made available to the public and to potential patients. Patients have the right to know about trial outcomes and safety concerns that arise in trials. They have the right to know who is conducting the trial and who is funding it. Without that knowledge, there cannot be an informed decision about an individual’s treatment options.

Many common themes arose during our review, but one that is particularly powerful, and relevant to today’s discussions, is the phrase that so many women with terrible mesh complications used. They said to us: “If only I had known”. If only they had known the risks, perhaps they would never have had the procedure and their lives—and those of their families—would not have been ruined.

This amendment would ensure that medical device trials are entered on a publicly available database and would bring devices into line with medicines. This is much needed, which is why I support the amendment.

I turn to Amendment 97, proposed by the noble Lords, Lord Kakkar and Lord Patel. One of the issues that we encountered during our review was that the full safety implications of an implantable medical device may become obvious only once the device is inserted. Some women told us that they sensed immediately that something had gone wrong; for others it was not until years later. Trials need to be sufficiently long term to detect safety concerns some years after the device is implanted.

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[The Deputy Chairman of Committees (Baroness Fookes) (Con)]

I have received a request to speak after the Minister. I call the noble Baroness, Lady Cumberlege.

[Baroness Cumberlege (Con) [V]]

My Lords, it has been a really interesting debate. One of the things that I have found so wonderful in this House is all the professors. I did not go to university and, when I listen to the professors and the way they care for their students—and in this case I am something of a student—I really value it. I thank the noble Lord, Lord Patel, for pointing out the dilemmas that we face. They are very difficult. I am sure that the Minister also feels that: it is how you balance what we are trying to achieve as a successful United Kingdom in innovation, marketing and all the rest of it, and the dilemma of safety as well.

I thank the noble Lord, Lord Kakkar, very much. I need to read very carefully in Hansard what he said and then come to some conclusions. I am not sure that we have quite cracked it, but I believe we are working towards it. The noble Lord, Lord O’Shaughnessy, had some really interesting ideas about how we can take this forward, and we need more work to be done on it.

I want to say one thing. In the review, we were so horrified by the stories that we heard that we said we had to do something to prevent further surgeries taking place in women who were suffering so deeply. We called it the pause; we went to NHS England and the department and very quickly they agreed to our pause, with six safety conditions that had to be introduced if it was to be lifted—and, of course, they still have not been introduced. That was in July 2018.

The interesting thing about the pause is that, because surgeons were prevented from using what they would see as the normal solutions to stress urinary incontinence, with pelvic mesh, they started to think of different ways in which to do things and help women, ensuring that the discomfort that they had through these conditions was ameliorated. We are getting innovation in a very interesting way. I am convinced that such innovation would not have taken place if we had not introduced the pause. But it should not have been us, the review team, who introduced it. It should have been the healthcare system, which had put forward some measures and thoughts about it years before, but nothing happened. Of course, that was one of the burdens that I carried throughout the review—that promises were made and nothing happened. We called the healthcare system glacial; it just did not move. There are some hugely bright people in this country and throughout the healthcare system and beyond, in universities and everything else. Surely, if we could only utilise the wonderful brains that we have in this country, we could do much better.

I thank my noble friend for the very full summing-up today. The categories of risk relevant to devices have been so badly used in the past in terms of how pressure has been put on to change the risk when people knew that harm was being committed. We have a meeting with the MHRA, and I am sure that a lot of these issues will be discussed.

I thank the noble Lord, Lord Hunt, for introducing the amendment. It is very difficult to pick up somebody else’s work, but he did it with his usual tremendous skill.

[Lord Bethell (Con)]

I completely endorse the words of the noble Baroness, Lady Cumberlege, about the failings around some of the medical device regulatory regimes, which failed to pick up many of the problems with mesh. I am grateful for the interventions from the review team on that matter.

I remind noble Lords that the Bill seeks not to lay down the policy on what precise regime will suit the future of medical device regulation but to set up the framework in which those regulations are put together. The Bill meets the need on that matter. I cannot urge enough how important it is that we get the Bill on the statute book as soon as possible.

Medicines and Medical Devices Bill

Baroness Cumberlege Excerpts

Committee stage & Committee: 5th sitting (Hansard) & Committee: 5th sitting (Hansard): House of Lords
Wednesday 11th November 2020 Grand Committee

[Lord Ribeiro (Con) [V]]

My Lords, it is a pleasure to follow the noble Baroness, Lady Finlay, who made a powerful case for knowing what happens to medical devices once they have been inserted. This was at the very centre of the Cumberlege review and to which I am sure my noble friend will draw our attention again, as well as to the key findings in this respect. Amendment 86 draws attention to the need for unique device identification information to be added to all packaging of medical devices, while Amendment 88 deals with the tracking of devices once inserted, as Clause 13(1)(h)(ii) requires information relating to the use of medical devices in individual procedures to be tracked and entered in a register or within hospital episode statistics data.

In my speech at Second Reading, I referred to Scan4Safety, which the noble Baroness, Lady Finlay, has just noted. In 2016, the Department for Health and Social Care awarded a total of £12 million to six hospital trusts in England for Scan4Safety demonstrator sites to investigate how the consistent use of point-of-care barcode scanning might improve efficiency and safety within the NHS. The noble Baroness also outlined the benefits of the GS1 barcodes. The result of the GS1 is a comprehensive, real-time view of stock, including that which is about to expire, as well as a complete audit trail. An audit trail is key to identifying problems with devices when they occur and to keep track of them in the future, as it may be many years before complications occur. Total hip replacements are one example. I have two of them, so I have a vested interest in knowing about the long-term future of those prostheses.

In June 2020, Scan4Safety published a report entitled A Scan of the Benefits. It gave two examples that are worthy of note and of repeating. In the North Tees and Hartlepool NHS Foundation Trust hospital orthopaedic department, barcodes helped to ensure that the correct patient is listed for the correct operation on the correct side. All items and implants are scanned before use. If the incorrect prosthesis is selected, for example a right knee implant for a patient who is supposed to be having an operation on the left knee, the barcode scanner buzzes and flashes, immediately notifying the potential error. At Leeds Teaching Hospitals NHS Trust, following the introduction of Scan4Safety, the average time taken to recall a product has fallen from 8.33 days to less than 35 minutes. The organisation reported £84,411-worth of staff efficiency savings on recall between January 2016 to December 2017 alone.

In Clause 16 on information systems, while I welcome the provisions, surely they are worthy of being strengthened by not using “may” so often. We need to move away from “may”, and its implied “perhaps”, to “must” and the implication that it will actually happen.

I shall end by restating my comments at Second Reading. The Government must undertake to mandate the tracking of all medical devices that are used in the UK, rather than a select few. I hope that these amendments will provide a means to do so. The Cumberlege review rightly recommended that a central patient identifiable database should be created, collecting key details of the implantation of all devices at the time of the operation. In the light of this, we strongly urge the Government to apply the powers provided for in Clause 16 as well and as widely as possible.

To give assurances in the context of this amendment, the Royal College of Surgeons believes that the Government should publish their intended regulations under Clause 16 in draft before Report, as they have for the various regulations on medicines. Early sight of the regulations would establish whether the Government intend to apply the powers covered by Clause 16 widely enough to satisfy the recommendations of the Royal College of Surgeons and those of the Cumberlege review.

In closing, perhaps the Minister would update us on the future of the medical devices information system and its application to the private sector.

[Baroness Cumberlege (Con) [V]]

My Lords, I very much appreciate the support that I have already received today from the noble Baroness, Lady Finlay, and my noble friend Lord Ribeiro. I am going to go into a bit of detail on what we found during the review, but I want to say to both noble Lords that I strongly support their views on Scan4Safety. Indeed, I spent a day in Derby going through the whole process with the clinicians, support staff and policymakers, and it was very impressive.

The noble Baroness, Lady Finlay, is absolutely right to say that we should look at more than just one example. Her research, which she has told us all about today, took on the six different areas, which is excellent. However, I agree with her that we should think seriously about introducing this system across the country.

Medicines and Medical Devices Bill

Baroness Cumberlege Excerpts

Committee stage & Committee: 6th sitting (Hansard) & Committee: 6th sitting (Hansard): House of Lords
Tuesday 17th November 2020 Grand Committee

[The Deputy Chairman of Committees (Lord Duncan of Springbank) (Con)]

I have received a single request to speak after the Minister, so I hope that we can now go to the noble Baroness, Lady Cumberlege.

[Baroness Cumberlege (Con) [V]]

No, that is a mistake. Somebody else involved with the conversation that I have been having thought that I wanted to come in on this occasion. I thought that I would give noble Lords a rest—they hear enough from me, so on this occasion I did not want to come in.

[The Deputy Chairman of Committees (Lord Duncan of Springbank) (Con)]

I thank the noble Baroness, Lady Cumberlege—that is very gracious. On that basis, we have nobody else to come in after the Minister at this point so I come directly to the noble Baroness, Lady Finlay of Llandaff.

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[Baroness Cumberlege (Con) [V]]

I put my name to Amendment 108 and, when listening again to the noble Lord, Lord Patel, and my noble and learned friend Lord Mackay of Clashfern, it was so good to hear this tremendous commitment to the safety of patients. The public must be paramount and know where there are issues, conflicts and risks. It seemed to me that if there really are concerns that a medical device, for instance, may pose a threat to safety, surely the public have a right to know?

We should have the right to make informed decisions about our healthcare, our treatment options and the medicines and medical devices available to us. Too often—we have heard this and written about it in the report, First Do No Harm—the healthcare system has shown itself to be unwilling, or even unable, to be transparent. There are too many examples of cases where people have had treatments or medical devices inserted without really being aware of the known safety concerns surrounding them. That is quite unacceptable.

My hope and expectation is that, once we have an independent patient safety commissioner—of course, we are coming on to that in the next amendment—these safety concerns will be more swiftly and thoroughly identified and communicated so that patients and the public know what is going on. I fully support the amendment. It would provide another layer of transparency and assurance, which is why I am very happy to support my noble and learned friend and the noble Lord, Lord Patel, who I consider my noble friend, on this amendment.

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Moved by

[Baroness Cumberlege]

117: After Clause 38, insert the following new Clause—
“Independent Patient Safety Commissioner
(1) An independent Patient Safety Commissioner is established.(2) The Office of Patient Safety is to be hosted and funded by the Cabinet Office.(3) The Patient Safety Commissioner must publish a business plan, reviewed annually, which sets out, in relation to the discharge of the Commissioner’s functions—(a) the Commissioner’s proposed main activities for the period covered by the plan (including the matters he or she intends to consider or investigate), and(b) the Commissioner’s proposed strategic priorities for that period.(4) The Patient Safety Commissioner must appoint an advisory board to provide the Commissioner with advice and assistance relating to the discharge of his or her functions, consisting of persons who (taken together) represent a broad range of interests which are relevant to the Patient Safety Commissioner’s functions, and must from time to time publish a report on the procedure followed and the criteria used when making appointments to the advisory board.(5) The Commissioner’s functions are to—(a) promote and improve patient safety with respect to the use of medicines and medical devices;(b) promote the views and interests of patients and other members of the public in relation to the safety of medicines and medical devices;(c) make recommendations to the Secretary of State;(d) establish and, when deemed appropriate, revise Principles of Better Patient Safety;(e) receive direct reports from patients and other members of the public, any other persons (whether natural or corporate), and the Secretary of State and, when the Commissioner deems appropriate, share those reports with relevant organisations and the Secretary of State;(f) produce and lay before Parliament for the attention of any committees of either House whose remit covers medicines and medical devices—(i) an Annual Report and Accounts, and(ii) any other reports regarding patient safety, which may include recommendations to improve patient safety with respect to the use of medicines and medical devices.(6) For the purposes of subsection (5)(d), the Principles of Better Patient Safety must—(a) describe expected patient safety outcomes relating to the safety of medicines and medical devices; and(b) be drafted in consultation with the public.(7) For the purposes of subsection (5)(f), the Commissioner may require a public body and other persons (whether natural or corporate) to provide such information as is reasonable in order to fulfil that function relating to the safety of medicines and medical devices.(8) In fulfilling his or her functions, the Commissioner may do anything which appears to be necessary or expedient for the purpose of, or in connection with, the performance of his or her functions.(9) The Commissioner has the duty to involve and inform patients and other members of the public in carrying out his or her functions.(10) The Commissioner may make recommendations to the Minister for the Cabinet Office for any additional powers which the Commissioner considers may be necessary to fulfil the duties and functions under this section.(11) The Minister for the Cabinet Office may by regulations make any other provision relating to the establishment of the Commissioner, including—(a) the appointment of a Commissioner,(b) the terms of office,(c) remuneration and financial and other assistance,(d) staff, and(e) any other matters the Minister for the Cabinet Office considers appropriate.(12) A statutory instrument containing regulations under this section may not be made unless a draft of the instrument has been laid before and approved by a resolution of each House of Parliament.”Member’s explanatory statement
This new clause would establish the Patient Safety Commissioner on a statutory basis, as recommended in the report of the Independent Medicines and Medical Devices Safety Review.

[Baroness Cumberlege (Con) [V]]

My Lords, this proposed new clause, which would implement one of the most important recommendations in our report, First Do No Harm, is about the independent patient safety commissioner. I am conscious that you cannot change history, but you can plan for the future; that is what we seek to do through the independent commissioner.

I thank noble Lords from all sides of the House who have put their names to this amendment, particularly the noble Baroness, Lady Jolly, and the noble Lords, Lord Hunt of Kings Heath and Lord Patel. I also thank the noble Lords who spoke in favour of the commissioner at Second Reading and have done so often since then.

Many people outside Parliament have also voiced their support. It really gladdens my heart, when we live in such troubled times, to have a rock-solid consensus. Of course, I await the response from my noble friend the Minister but I really do hope that he will choose not to stand apart but to be instrumental in improving safety and the lives of thousands of people by supporting this amendment, even if it requires a bit of redrafting.

I think that noble Lords will be grateful that I will not go through the amendment subsection by subsection, paragraph by paragraph, because that would take all night and it is all there for noble Lords to see. First, though, let me put a question. Why do we need this independent patient safety commissioner? It is quite simple: because there is no one person whose task it is to listen to the voices of patients, to stop the trends and patterns that give rise to safety concerns, and to encourage or require the healthcare system to act on those concerns when they are not being recognised and realised.

The healthcare system has failed to listen to patients’ concerns. Our review vividly and tragically illustrated that. Thousands of people have suffered. Lives have been ruined. I am absolutely convinced that, had we had a patient safety commissioner—that is, if that person had existed—much of the harm done could have been prevented.

It is not only what we found in our review that proves the need for this. Think of the recent Paterson inquiry. Its findings echoed ours, with patients voicing concern but their voices not being heard and avoidable harm going undetected. Sadly, we all know that there is a long line of similar examples; indeed, Essure, a contraceptive device that has caused many women terrible suffering, was reported on by the BBC last weekend.

We know our own bodies. We know when something is not right. We know when a treatment is causing a problem. We are the first to know, yet patient voices and experiences are all too often simply referred to as anecdotes and written off. They are not; they are serious research. We think that a patient safety commissioner would put an end to that—an end to anecdotes simply being written off.

There have been suggestions that existing organisations are already responsible for patient safety so we do not need another one. I want to tackle that fallacy head on. If it is true that organisations in the healthcare system are performing this task and doing it effectively, why has so much avoidable harm occurred?

The system simply is not working. Yes, the organisations within the healthcare system are doing their job; people are working very hard as individuals, and in the organisation, but they are disjointed and siloed, and patient safety is not their overriding purpose. They did not prevent the avoidable harm that we discovered. While some organisations have elements of safety within their remit, not one has patient safety as their total focus, and not one considers that they have the responsibility to listen, spot trends, raise concerns and get the system to act.

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[Lord Bethell (Con)]

I take the encouragement of the noble Baroness to heart. I would be very happy to think further on it. She makes a very good point: we know about the terrible incidents of the past and the very substantial responses that they had. I share with her the frustration that these problems continue to arise. For that reason, as I said, we are looking for a really thoughtful, considered response to the review overall. As I said in my earlier remarks, the case for a patient safety commissioner is one that we are looking at. I listened to absolutely everyone who has spoken in its advocacy, but we do not regard it as a silver bullet or a single point of catalysis, which I do not think the noble Baroness was alluding to. We are looking for a broad response to the review that would ultimately take on all the different points that the noble Baroness and her review team have made.

[Baroness Cumberlege (Con) [V]]

My Lords, I will come to the Minister’s summing up at the end, but I thank all noble Lords who have taken part in this debate. I have not heard anything really contrary or disturbing against a patient safety commissioner. It has been supported, and I am very grateful for that.

I first thank the noble Lords, Lord Patel and Lord Hunt of Kings Heath, and the noble Baroness, Lady Jolly. I know that the noble Lord, Lord Patel, has been a champion of safety both in Scotland and in this country. I share his impatience. He considered some of the interesting reports that have been produced and we hope that they all have made a little difference—but not enough. He is so right to say that we are searching for independence, as other noble Lords have mentioned. The person who we appoint to this position is so important. We do not want a patsy or someone who is just going to do what the department and Ministers want. We want an independent voice. I thank all those who also talked about a patient safety commissioner and the Children’s Commissioner, who, as we all said, has been outstanding. I also thank the noble Lord, Lord Patel, for his revealing statistics, which were interesting.

I understand the cynicism of the noble Lord, Lord Hunt of Kings Heath, about NHS England. I say just one thing about it, but I should have declared my interest at the start of the debate because I am employed by NHS England in the context of maternity services. The chief executive took our report, Better Births, and said, “I am giving you five years to implement it”. He gave us the people, resources and everything else. We were making real progress until March. The virus has really knocked us back—we did not expect it. However, in the four years that we have completed, we have changed much of the culture within maternity services and improved the lot of many women. We have not had that response from the Government on this report. They have not said, “We will give you five years and some resources. See what you can do”. No, they have been silent. Today, the Minister told us a bit about what he has been doing. However, none of that was news to us. We know all that already.

Moving on, I refer to what the noble Lord, Lord Hunt of Kings Heath, said about the tension within boards. I chaired the Brighton health authority board when the Grand Hotel was bombed. It was a tragedy—lives were lost—but when one looked at the whole system, it worked. Why was that? It was because we had a good leader in A&E who conducted a rehearsal three weeks before the bombing. That rehearsal paid off. Preparation is extremely important. The noble Lord was of course right about the financial problems that must be weighed up within trusts.

We are so lucky to have in our House my noble and learned friend Lord Mackay of Clashfern, a previous Lord Advocate and Lord Chancellor. I remember working with him on debates about the family and all sorts of matters. If you want somebody with true wisdom, understanding and foresight, you go to him. He has done it all, knows about it and always has such integrity. I thank him very much for his support and his impatience, which I share. We know today that babies are being born deformed. One in two have a chance of having a disabled child if they are on sodium valproate, and they do not know about it. We are impatient. We do not want to see more of that. We want to see safety become a reality.

My noble friend Lord O’Shaughnessy has, of course, been a Minister in the House and he knows the tensions and difficulties. One of the things that I know about him is that he listens to patients: he takes time out to do that. He appreciates, almost more than all of us, how people have waited for decades in terrible conditions, suffering terribly. I know that he has done a lot with sodium valproate and the patient groups there, and I thank him for that. What he was telling us about Jeremy Hunt and the way that this review was first commissioned was really helpful, because Jeremy Hunt set the parameters. He was invited to take on three different areas by the Prime Minister, Theresa May. It was really her initiative first, and then Jeremy worked extremely well. I am of course delighted that he appointed me to chair the team.

I want to say a word about the noble Lord, Lord Blunkett. I am very pleased that he is taking part in this Committee; he apologised for not being at Second Reading. Whenever he comes in on a debate, we welcome him. Again, with him having been a really strong leader in his own area and then in the Commons, it is really good to have had him join us today. He talked about the Health and Safety Executive and how we have to work with it. He is of course right.

The Minister, in his summing up, asked who this patient safety commissioner is going to work with. We do not know exactly—of course not. He can read the amendment, which sets out quite a lot. He can read the report and see there what we were thinking about, but of course this needs more work. In fact, one of the members of our team said to us, “Do not lose out on the coroners’ courts; you learn a lot from them”. Her husband is a judge, so she knows a bit about it. We are saying that you have to map the whole horizon and see where things are not quite right. Why is something going wrong? That is something we ought to look at more carefully.

It is about listening to patients but, much more than that, it is about working with all the different healthcare systems. My noble friend Lord Sheikh and others talked about the NHS. We are thinking much more broadly than the NHS. We are thinking about it, of course, and we know it has done a fantastic job with the coronavirus, but we are also thinking about private providers. I was very interested that the noble Baroness, Lady Masham, brought in private providers. We need to think about other public bodies and certainly about the royal colleges, the pharmaceutical and devices industries, the manufacturers and of course the policymakers—the politicians. I appreciate that it is a broad area but that is the problem with it at the moment: it is disjointed and siloed, it is unresponsive and defensive. We need some person who is going to get into all of that and call all the organisations to account—encourage them but call them to account when things are not working right.

Medicines and Medical Devices Bill

Baroness Cumberlege Excerpts

Committee stage & Committee: 7th sitting (Hansard) & Committee: 7th sitting (Hansard): House of Lords
Thursday 19th November 2020 Grand Committee

Moved by

[Baroness Cumberlege]

121: After Clause 38, insert the following new Clause—
“Independent medicines and medical devices safety review: task force for implementation
(1) Within three months of this Act being passed, the Secretary of State must appoint an independent task force.(2) The task force must—(a) have an independent Chair;(b) be accountable to an oversight governance board; and(c) include representatives of the Independent Medicines and Medical Devices Safety Review, published on 8 July 2020.(3) The task force’s functions are—(a) to deliver a timeline for the implementation in full of the recommendations of the Review in subsection (2)(c); and(b) to implement the recommendations of the Review in subsection (2)(c).(4) Once the task force has fulfilled the functions in subsection (3), it will cease to exist.”Member’s explanatory statement
This new clause would establish the task force whose role it would be to implement recommendations set out in the report of the Independent Medicines and Medical Devices Safety Review.

[Baroness Cumberlege (Con) [V]]

My Lords, as noble Lords are well aware, First Do No Harm, the report of my review, was published in July of this year. Our ninth and final recommendation was that the Government should set up a task force to implement the other recommendations and the many actions for improvement contained in the report. That task force has not been set up, and the Government remain silent on whether they will agree to do so and, indeed, on the report as a whole.

This proposed new clause would require the Secretary of State to set up a task force within three months of the Bill becoming law. I would much rather not find myself tabling it; I would much rather the Government saw the urgency and had already set up the task force, because it is designed to help the department and the wider healthcare system to do the thinking, to make sure we get the details right and to set out a pathway and a timeline for implementing the report’s recommendations.

I believe it must be a collaborative venture; it should involve not just the department and its arm’s-length buddies but also patients. It would be a missed opportunity were it not to include the representatives of my review, because we have the knowledge and the expertise, acquired over two and a half years of work. To inspire confidence among people who have suffered, it needs to be independently chaired and overseen by a government board.

We feel that the task force is the right way to approach the job of implementing the review’s recommendations. My noble friend the Minister may well tell us that the Bill is not the right place for this measure—that is as may be—in which case, if he were able to reassure me that the task force would be set up separately by the Government, as we envisage in this proposed new clause, and on a similar or shorter timescale, I would be more than satisfied.

These matters are pressing. Our recommendations need to be implemented if we are to help people who have suffered so much already, many of them for decades. We must try to prevent further avoidable harm to more patients and families in the future. The task force is the key to making this happen, and those of us who have run organisations know that they need some discipline and something like a task force—a body that will ensure that the task set out is actually implemented and that it happens. I beg to move this amendment, and I look forward to the Minister’s reply.

[Lord Hunt of Kings Heath (Lab) [V]]

My Lords, it is a great pleasure to follow the noble Baroness, Lady Cumberlege, and to support what she is saying. At the heart of her argument is the concern that, although the Minister said earlier in Grand Committee that the Government are weighing it up with all “seriousness and intent”, the Government are not going to run with the core of the noble Baroness’s recommendations. Because the Government have been so reluctant—very unusually—to respond immediately to the thrust of her report, there remains a lot of uncertainty about how far the Government are prepared to implement it.

Of course, the opportunity given to us with the medicines Bill enables us really to press the Government to be more detailed about what they are going to do. On Tuesday, we had a very good debate on the recommendation for the appointment of a patient safety commissioner. The Minister made a very extensive response, which essentially set out the measures that the Government are taking to embed patient safety throughout the NHS. I shall just mention a few: promoting a positive learning culture at the heart of the NHS; taking steps to help staff to speak up when things go wrong; establishing the Healthcare Safety Investigation Branch to examine the more serious patient safety incidents and promote system-wide learning; appointing medical examiners to provide much-needed support to bereaved families and improve patient safety; introducing a duty of candour, so that hospitals tell patients if their safety has been compromised, and apologise; and commissioning the NHS national director of patient safety, Dr Aidan Fowler, to publish a strategy, which, of course, has been done.

--- Later in debate ---

[The Deputy Chairman of Committees (Lord Brougham and Vaux) (Con)]

I do not believe that anyone wishes to come in after the Minister, so I call the noble Baroness, Lady Cumberlege.

[Baroness Cumberlege (Con) [V]]

I thank all those noble Lords who have spoken in this debate. I am extremely grateful to them. I have listened to what the Minister had to say, and I do not deny that meetings are taking place—I understand that they are—but I have no idea what is coming out of those meetings. But we will come to that in a minute.

The noble Lord, Lord Hunt, is quite right that actually implementing policy is the most critical thing and is extremely difficult. The Paterson report was a very interesting report on things that had gone terribly wrong with an individual surgeon who acted inappropriately, and, as I said when we debated the patient safety commissioner amendment on Tuesday, I understand that the Paterson report’s recommendations echo what our report said. What has happened to the Paterson recommendations? I do not believe that anything has happened. If things have happened, I would like to know what they are. I can show shelf upon shelf of wonderful reports that have been drawn together by people who have put their heart and soul into them, but, actually, nothing has happened. I am not going to let that happen with my report—I really am not—because there are too many people who have been so badly hurt and who deserve redress, which we will come on to in the next amendment. The noble Lord, Lord Hunt, is right that there is a missing piece in the jigsaw—the most important piece—because safety has to be a system.

--- Later in debate ---

[Lord Hunt of Kings Heath (Lab) [V]]

My Lords, this is a probing amendment. Although I am a member of the GMC board, I make it clear that I am not speaking on behalf of the GMC.

It is very difficult to move on to the nitty-gritty of a redress agency after the hugely eloquent and moving speech made just now by the noble Baroness, Lady Cumberlege. The Minister said in his response to the noble Baroness that this is not the Bill to respond to the report. What I say to him is that this is the only Bill in town. Medicines and medical devices are at the core of patient safety. He promised that the Minister responsible for patient safety would make a Statement on the report in December. My assumption is that that will be made after the Bill has passed through the House of Lords, and therein lies the problem: we will not be told the Government’s response before we come to the critical Report stage. We just have to work on the assumption that, as the noble Baroness, Lady Cumberlege, said, the Government are not going to embrace her core recommendations. We will therefore have to take action on Report on that basis. I do not see what other course of action the House of Lords can take, unless the Government are prepared to bring forward their Statement so that we can see it before we reach Report.

I have just one other point. I listened to the Minister, and he has been very helpful in setting out some of the initiatives that the Government are taking. However, as with the patient safety strategy—we have been here before—the department seems to have collected all the examples of good practice it can find, bunged them into a report and called it a strategy. That is the problem, because it ain’t a strategy. It does not address the fundamental crunch that the NHS has been run far too hot and is unsafe. When you really tackle that, you have to tackle the issues of resources, work force and targets. That is a huge challenge to the Government, which is why they are so reluctant to go down that course.

What does that have to do with the redress agency? I will try to come to that in a moment. However, I want to ask the Minister whether he can say anything about this recommendation. The noble Baroness, Lady Cumberlege, argued powerfully for a redress agency to be set up on an avoidable-harm basis that looks to systematic failings, rather than blaming individuals, encourages reporting and should provide faster resolution for claimants. She argues that it should be a consensual process rather than a judicial one. Redress would be offered, not awarded, and proceedings under the scheme would be voluntary. She also said that the redress agency would have an important role to play in harm prevention as claims for adverse events would be centralised, enabling data to be provided that would help regulators detect signals earlier.

This is not the first time that a redress scheme has been proposed. Indeed, 17 years ago, an NHS redress scheme was unveiled by the then Chief Medical Officer, Sir Liam Donaldson. It included no-fault compensation for babies born with severe brain damage, and payments of up to £30,000 without litigation for patients whose treatment went wrong. Under the scheme, parents would get a managed medical care package for their child, monthly payments for other care of up to £100,000 a year, lump sums for home adaptations and equipment of up to £50,000, and compensation for pain and suffering capped at £50,000. The other arm of the redress scheme, for smaller negligence claims, would have provided a package including an explanation and apology, remedial treatment, rehabilitation and care where needed and financial compensation up to £30,000 where authorised. Legislation followed in 2006, but 14 years later it has, as I understand it, yet to be implemented. The aim of the Act was to provide a genuine alternative to litigation, but it has languished on the statute book. I would be grateful if the Minister would tell me whether that is it and whether the Government do not think it the appropriate way forward.

I also ask the Minister to say something about the increase in negligence costs to the NHS. The latest annual report from NHS Resolution shows that the total cost of payments made in respect of clinical negligence in 2019-20 was £2.32 billion. Of that figure, a substantial amount was paid in legal costs: nearly £500 million to claimant legal costs and £143 million for NHS legal costs. We know that it often takes years for cases to be resolved.

Is the Minister confident that we are getting this right? Does the noble Baroness’s recommendation not deserve examination, at least? I beg to move.

[Baroness Cumberlege (Con) [V]]

My Lords, it is hard to follow the very well-researched contribution to this whole issue from the noble Lord, Lord Hunt. It was interesting to hear about Sir Liam Donaldson’s report, which got on to the statute book but was not implemented. Is that not a disgrace? It is really dreadful.

Very near to where I live is the centre for Chailey Heritage, now the Chailey Heritage Foundation, for children who suffered through their mothers having taken the drug thalidomide. I chaired its governing body for years. It is interesting that that redress system still continues; it is supported by a trust, which inherited the disaster of the medication, and it has honoured that and receives government support. So we have examples where this is working.

The redress agency that we recommend is really about the future. My amendment is about the present. We know that so many patients and their families have suffered such harm, and we need a system that is more compassionate and a much more certain route for obtaining redress to compensate them. We are talking not about compensation as such, but about redress. You have to go to the courts to achieve compensation, and it is a very miserable experience—we have heard that from patients. It also takes a very long time and, as the noble Lord, Lord Hunt, said, very often the people who benefit most are the lawyers.

We are talking about Primodos, sodium valproate and pelvic mesh—the three interventions through which people have suffered avoidable harm. The suffering they endure now is terrible. All three have caused and are causing avoidable psychological and, of course, physical and neurological harm. These families really need a little help with the conditions they are living with. Indeed, some are looking after some very disabled children. We do not believe that their needs are adequately met by the healthcare, social care or benefits systems. Some of these people are actually very elderly—the parents of the children who took Primodos. It would be a scandal if those people were to live their lives unable to access the redress they need and the outcome they deserve. After all, the harm was caused not by them, but by the state.

In the case of these three interventions, there is a moral and ethical responsibility to provide ex gratia payments in respect of the avoidable damage that occurred. That responsibility falls on the state and the manufacturers of the products in question. The schemes that would be established through this proposed new clause would provide discretionary payments, and each of the three schemes would have tailored eligibility criteria.

The payments the schemes make would not be intended to cover the cost of services that are already available free of charge, such as healthcare and social security payments. They would be for other needs—for example, the cost of travel to medical appointments. We have met and talked to many of those people, and they have said that it is a significant cost burden. The payments might be for respite breaks or emergency payments where a parent has had to stop work to cover care. These redress schemes would not be in place of litigation, nor will they be to deliver compensation. People should retain the right to take legal action if they wish to obtain compensation—of course they should; that is in our law. The schemes I am talking about should be set up in such a way that they can be incorporated into the wider redress agency that the noble Lord, Lord Hunt, spoke about, once it is established.

These people have suffered for decades. They have tried to obtain compensation through the courts. That action has failed in the case of valproate and Primodos, although I am aware that a new Primodos action is under way. I have been told by solicitors that, in fact, the report does not in any way affect that action. There have been some awards and settlements in the case of mesh, but legal action takes time, as the noble Lord, Lord Hunt, said. It creates added stress and much more personal cost can be involved.

I believe that a measure of a decent society is how well it looks after those who have suffered harm, especially when that harm was avoidable. From having met many hundreds of people who have suffered and heard from many more, I am clear that help is needed and deserved. People should not be made to wait any longer. I hope my noble friend the Minister will agree with that.

[Baroness Bennett of Manor Castle (GP) [V]]

My Lords, I shall speak to Amendments 122 and 123, to which I attached my name. The first is in the name of the noble Lord, Lord Hunt of Kings Heath, and the second in the name of the noble Baroness, Lady Cumberlege. They have both introduced these very clearly, so I will make only three points to add some extra, different perspectives.

The first point I wish to make is that there is what I can describe only as a heart-rending report in the Guardian today about Windrush compensation two years on. The headline talks about

“long waits and ‘abysmal’ payouts”.

The story mentions an agency that talks about five people waiting more than 18 months for compensation. If this—as high-profile a scandal as we can possibly imagine, which attracted far more attention than the issues covered by the report from the noble Baroness, Lady Cumberlege—is going so badly, surely we have to address this issue, which in many ways is smaller, more limited and perhaps much less complicated, to create a situation via Amendment 123 to deal with these three issues. Amendment 122 would create a situation to deal with all cases, so that we would have a system and framework that, I hope, would do better than the Home Office is doing. I hope that such an agency in the health framework would not suffer from the same hostile environment in the Home Office that the Windrush compensation scheme has to act within.

Medicines and Medical Devices Bill

Baroness Cumberlege Excerpts

Report stage & Report stage (Hansard): House of Lords & Report: 1st sitting & Report: 1st sitting: House of Lords
Tuesday 12th January 2021 Lords Chamber

[The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Bethell)]

My Lords, patient safety is very much at the heart of the Bill, and while we have an enormous amount to get through this afternoon, I beg the Chamber’s forbearance if I talk in some detail about this extremely important amendment. Patient safety is the golden thread that runs through this entire Bill. Safety has been our guiding force in amendments that have made it to the Bill, from the changes to decision-making on regulatory change and the new safety lock amendment—which we will debate later—to the enforcement powers for medical devices to make clearer what the MHRA can do to take action, through to the medical devices information system.

The Government have heard the calls, including the strong cross-party support, to establish an independent patient safety commissioner for the health service in England. Of course, this was the centrepiece recommendation of the Independent Medicines and Medical Devices Safety Review helmed by my noble friend Lady Cumberlege, to whom I pay profound tribute for her tireless championing on behalf of patients. I am delighted that Amendment 1 in my name—with which it is convenient to debate Amendments 54, 65, 70 to 72, 74, 86, 87, 91, 95 and 97—delivered upon that recommendation. These amendments provide for an independent advocate to champion the safety of patients. The patient safety commissioner will promote their interests and those of other members of the public in relation to the safety of medicines and medical devices.

We acknowledge that the patient’s voice can advance safe care and system improvements but that it needs to be strengthened, as explained in my noble friend’s review published six months ago. Listening to patients is central to preventing the kinds of issues which that review brought so clearly into focus. If we do not strive to listen to patients, their families and to staff, we limit our ability to learn from mistakes, be innovative and continually improve. I pay testament to the extensive listening and the passionate advocating by my noble friend, her supporters and all patient groups.

Patient safety is a system-wide concern. It cannot be tackled by a single individual but needs to be rooted in all the branches of our health system. Good progress has been made: for example, we are improving system-wide learning through measures such as the Healthcare Safety Investigation Branch and the implementation of the 2019 NHS Patient Safety Strategy with our National Director of Patient Safety, Dr Aidan Fowler, in charge. That strategy has been listening to patients.

Staff are also encouraged and protected to speak up if they have concerns about anything they believe is harming the services their organisations deliver or commission. They are supported by the NHS People Plan, which envisages a health service that is compassionate and inclusive, not hierarchical, and where staff are listened to. The Government’s emphasis on patient safety will also be reinforced by the establishment of a new patient safety programme board. The board will take an overview—with pace and rigour—of measures and actions across the health system to improve patient safety.

The Government fully support sharpening our focus on the safety of NHS-funded services to patients and the public. We accept that the patient safety system needs to get better at identifying issues and listening to patients’ experiences of avoidable harm. Better co-ordination across and between regulators and other oversight bodies is also needed.

A patient safety commissioner will help us to champion the views of people who have been harmed by treatments provided by the health service. He or she would reinforce a culture of humility, openness and learning. The role is essentially about prioritising the insights of patients as a vital source of learning.

The Government’s amendment puts this new part of the Bill first. Amendment 1 provides for the appointment by the Secretary of State of a patient safety commissioner who is an independent statutory officeholder funded by the Department of Health and Social Care. It sets out the commissioner’s core duties, which are to promote both the safety of patients and the importance of ensuring that they are heard.

Patient engagement will be integral to the role of the commissioner. Proposed new Schedule A1 outlines the ways in which the commissioner must inform, consult and involve patients. This will ensure that patients’ concerns are being heard and that the work of the commissioner has focus and relevance for the people he or she is being set up to serve.

We have reflected carefully on the patient safety commissioner model set out by my noble friend’s comprehensive report. We agree on the importance of the commissioner’s role; it is a critical new part of the map of patient safety. But there are other areas of significant importance to the Government. The commissioner is one part of the whole system—the fundamental change that it required to tackle unsafe care and empower patients. A step change is required in how the health service transforms itself in a joined-up way to put patient safety at its core. Significantly, the introduction of the commissioner should not create overlap or confusion within that health service architecture, thereby reducing the potential to deliver patient safety improvements for patients. Indeed, my noble friend’s report rightly made it clear that the duplication of the roles of other regulatory bodies should be avoided.

In view of this, the patient safety commissioner will not act as an ombudsman. He or she will not carry out functions in pursuit of specific cases. But they can consider individual cases in their role as an overarching advocate for all patients and of making thematic and systemic recommendations. These areas are where we believe the commissioner can have greatest impact.

We have also given the patient safety commissioner deliberately intrusive powers, as called for by my noble friend Lady Cumberlege. He or she will be empowered to request and share information from relevant public authorities or a “relevant person”, meaning anyone providing health care, in relation to medicines and medical devices in England. The commissioner’s ambit will cover both the public and the independent sector.

Where my noble friend and I differ is on the process of the appointment and sponsorship of the commissioner. The patient safety commissioner will be appointed by the Secretary of State for Health and Social Care and funded by the Department of Health and Social Care. It is absolutely right that this should be the case. For example, the Secretary of State is able to initiate action on reports and understands, and has strategic oversight of, the system the commissioner is looking at.

Some noble Lords have expressed concerns about how such a commissioner might maintain their independence, but I believe that such concerns are unfounded. I am encouraged by the precedent of the Office of the Children’s Commissioner, which drew praise from several noble Lords in Grand Committee for its independence. As noble Lords know, the Children’s Commissioner is sponsored by the Department for Education and guards its independence very well. The Victims’ Commissioner does exactly the same and is sponsored by the Ministry of Justice.

It is critical—that is agreed—that the patient safety commissioner is able to speak out without fear or favour. He or she must have the powers and functions to act independently to maximise their impact and confidence. That is absolutely the case here. It is also critical that the right calibre individual with a strong voice for patients is appointed to the role. I do not think any such person would accept such a role if they felt they would in any way be constrained in that role. Nor do I think they would remain silent. Furthermore, we would expect the Secretary of State to work with the commissioner to establish how they will safe- guard and secure the commissioner’s independence. Independence is not static but an active objective, which we would expect the patient safety commissioner to be prepared to approach continuously.

The commissioner will have the power to make reports to both the public sector and independent sector, and to the Department of Health and Social Care if they so wish. Those reports are entirely independent. There is no intention—and indeed no restriction—that would allow for the Secretary of State to edit those reports. As an independent public appointee, the commissioner will also be subject to the scrutiny of Parliament, including through the Health and Social Care Select Committee.

The powers in the Bill are accompanied by a regulation-making power about the terms of office of the patient safety commissioner, the appointment of staff, and other operational matters. But while this power is exercised by the Secretary of State, we are not proposing that the Secretary of State would have any power over the commissioner regarding the fulfilment of his or her functions. However, it is right that the detail is left to regulations so that we can publicly consult on this, as we are obliged to do so under Clause 45. It is important that we get the details right. That is also why the regulations will be subject to the draft affirmative procedure.

Other amendments make minor changes to ensure that the patient safety commissioner clauses work well with the rest of the Bill.

From the First Do No Harm report by my noble friend Lady Cumberlege, to earlier, well-known inquiries and investigations, we have heard numerous harrowing stories with terrible examples of how patients have been let down badly by our most loved institutions. As noble Lords have said, now is the time to act. The Government have listened to the impassioned and compelling arguments from all sides, and I thank my esteemed colleagues for their help in shaping this amendment.

We have no doubt that restoring patient trust will be at the heart of the patient safety commissioner’s role and that he or she will advance patient safety. Our commitment to amplifying and acting on the voices of patients in our health service is paramount. To that end, I beg to move.

[Baroness Cumberlege (Con) [V]]

My Lords, I thank the Minister for his huge support throughout this whole process—all the times we have had to meet and I have met with his officials. I also thank him for the way in which he has so comprehensively introduced his amendment today. To be honest—“O ye of little faith!”—there were times when I thought the patient safety commissioner would not see the light of day. However, I underestimated my noble friend and thank him for agreeing to the concept and for bringing it to fruition with his officials.

--- Later in debate ---

[The Deputy Speaker (Lord McNicol of West Kilbride) (Lab)]

I have received one request to ask a short question. I call the noble Baroness, Lady Cumberlege, to ask a short question for elucidation.

[Baroness Cumberlege (Con) [V]]

My Lords, I want to say one or two things very quickly. I thank those who have spoken; it has meant such a lot to me. The noble Baroness, Lady Jolly, and the noble Lords, Lord Patel and Lord Hunt, have been there since the very beginning of this journey.

I say to the Minister, as I should have said at the very beginning, that I will withdraw my amendment. I have no wish to take it further. I do think that the Cabinet Office would have provided us with more independence, but my noble friend the Minister said at the very beginning that this was a red line and it was no good my pursuing it. I took that hint and I have not argued it anywhere. Hearing the Minister talk about independence today—getting it on the record—has been really important. However, as the noble Lord, Lord Lansley, said, of course influence matters as well, and I take that.

I will say a very quick word about the timetable, which is critical. In our recommendations we wanted to set up a task force to implement this under the aegis of the Department of Health and Social Care. That has been rejected by Ministers. That is a tremendous pity. Noble Peers are concerned about the timetable; so am I.

It has been said that this has been very quick. No, it has not. Those of us who have run companies know what “quick” means: if your company is to survive you have to act very quickly. This is not quick. I will put pressure on through other means, particularly the all-party group, to get this implemented as soon as possible, because people are suffering. People are in dire straits and we have to stop this awful damage that is being done to lives. The quicker we can do this, the better. I am sure my noble friend will agree with that.

I know when I am beaten, but I also know what needs to be done. I do not want to go through the point of view of the Cabinet Office, but it is absolutely critical that this appointment is made speedily, because people are suffering and we should avoid that if at all possible. I believe that the patient safety commissioner will grasp this issue and ensure safety, which, as my noble friend the Minister said, has run through the Bill. I thank him for that, but it will not happen until this appointment is made. I am afraid that I will press very strongly on that.

I thank all noble Lords for taking part. I wish I could go through this in detail, but it is not my remit to do so. I thank noble Lords so much for their support.

[Lord Bethell (Con)]

I thank my noble friend for her very kind and generous words, and for making it clear that she will not move her amendment. I reassure all noble Lords that their words are on record and will have a bearing and influence on the development of the patient safety commissioner as it is rolled out.

My noble friend’s question was about timing and speed. I hear her admonishments loud and clear. She knows that once we have committed to something we will deliver it. I ask for her forbearance. There is a global pandemic on. I cannot guarantee that this is the number one priority because we need to do the vaccine and we have to get Britain back on its feet. Those are distractions that I cannot hide from the House, but I reassure my noble friend and all those involved in the debate that a commitment has been made very clearly and we are now moving to deliver it.

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[Baroness Bennett of Manor Castle (GP) [V]]

My Lords, I will save up some of my time for my next amendment, Amendment 7, so I will be very brief. I will chiefly speak to the non-government amendments in this group. It is encouraging that the Government have taken onboard so many of the contributions from Committee, but that shows what an unbaked condition the Bill came to us in.

To address the somewhat related Amendments 12, 34 and 48, all in the name of the noble Baroness, Lady Thornton, we are talking about publication of the data, information and assessment of benefits versus risks. We heard powerfully from the noble and learned Lord, Lord Judge, and many others in the previous group of amendments how great a concern there is about a lack of scrutiny of this whole procedure in the House. Public scrutiny is surely the best scrutiny of all. I commend all those amendments to the House.

Amendment 5 is very interesting. My innate reflex is to go towards public health as a systems-thinking, sustainable development goal kind of approach to looking at the whole. But to build on the remarks the noble Baroness, Lady Thornton, made in introducing the amendment, which is also back by the noble Baroness, Lady Jolly, when we talk about the immensely financially powerful and often very opaque pharmaceutical industry, with its very large multinational companies, we have to worry about what lawyers call equality of arms and the degree to which economic and financial arguments might be deployed in potentially damaging ways. I am interested in the Minister’s response to Amendment 5, but I can certainly see the strength of the argument of the noble Baroness, Lady Thornton.

[Baroness Cumberlege (Con) [V]]

My Lords, I will speak to government Amendments 11 and 47, and those that follow on from them, Amendments 12 and 48 from the noble Baroness, Lady Thornton. The first lot refer to medicines and the second to devices. But first I thank the Minister for his strong emphasis on safety in all the amendments. He certainly has listened to noble Lords. In Committee we stressed the objective of making sure that the Bill is a safety Bill. I believe that safety now permeates throughout the Bill, which is so encouraging, and I thank him and his colleagues for that.

Although I welcome the government amendments, I really do not envy a Secretary of State’s task in weighing up the risks versus the benefits. This will require the wisdom of Solomon. At least once the Bill is enacted we will have the data, which is all-important and has just been referred to. Our review’s report shone the light on our frustration of not knowing what was happening to whom, by whom, when and where. This will, of course, become apparent, which will be very useful once we have these processes in place.

But we are still left with weighing up the benefits versus the risks. Surely this depends on where the threshold is set concerning any medicine or medical device. For instance, if 99 people benefit from one of these products but one dies, what weight do we give to the 99—or, perhaps more importantly, to the one who died? Does the Minister see thresholds as important? If so, does he envisage the application of a threshold for an individual medicine or device, or would there be a threshold to cover a similar range of products, or indeed a more overriding policy? I am not quite sure how this will be tackled.

Medicines and Medical Devices Bill

Baroness Cumberlege Excerpts

Report stage & Report: 2nd sitting (Hansard) & Report: 2nd sitting (Hansard): House of Lords
Thursday 14th January 2021 Lords Chamber

[Baroness Masham of Ilton (CB) [V]]

My Lords, I am speaking on the telephone, as something went wrong with my iPad.

I support Amendment 16, which is tackles anti-vaccination disinformation. For some years, this has created a problem. For example, there has been an epidemic of measles in many countries because many people, including the growing number of vegans, mistrust vaccines. Clear messages should go out about the benefits of vaccines and how they work. Some vaccines are very complicated and difficult to develop, but they are desperately needed for diseases such as HIV, TB and malaria.

Regarding these important coronavirus vaccines, I hope that the Government will be very careful that disinformation is not going out to the public about the Pfizer vaccine. Many health workers and elderly vulnerable people have had one dose, and the second dose should be given in three weeks’ time. People have signed up to that, as there are written instructions to do so, but the Government are trying to delay the second dose by up to three months, which is not recommended by Pfizer-BioNTech or the regulator.

There is a risk that with only one dose, people may become carriers and the virus may become resistant to the vaccine. The Doctors’ Association is not happy about the Government’s idea of a three-month delay. More careful monitoring and research is needed, but these mixed messages are extremely unhelpful. I hope that the Government will realise that people need to trust the information they receive.

[Baroness Cumberlege (Con) [V]]

My Lords, I congratulate the noble Baroness, Lady Thornton, on her comprehensive introduction, expressing the urgency of the situation, which was also stressed by the noble Baroness, Lady Masham, in another interesting contribution for which I thank her. This is a difficult and hugely important issue, and it needs serious consideration on two counts. We have to look beyond the present situation with anti-vaccine campaigners and decide very carefully what is information and how we should combat damaging information being spread. Secondly, how do we reserve the right of the individual to use social media to express their personal views?

I spent six years on the Press Council, dealing with complaints. It was taxing, but today the print media is regulated to a greater extent. Even then, accountability for what should be published and what should not lay with not only the journalist who had written the article but with the editor and, in some newspapers, the owner.

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[Baroness McIntosh of Pickering (Con) [V]]

My Lords, I am delighted to follow my noble friend, who speaks with such great authority both as a former Secretary of State for Health and as someone who has followed the Trade Bill and the Trade (Disclosure of Information) Act so closely.

At the risk of dancing on the head of a pin, the amendments in this group are quite close, and the Minister set out every reason why we should support his Amendment 17. He said that information would be shared only in the circumstances where there is perceived to be a public need. The amendments and explanatory statement of the noble Baroness, Lady Thornton, refine that by saying that, in the context of giving effect to an international agreement or arrangement concerning the regulation of human medicines, it should be disclosed only provided that it is in the public interest to do so. A number of noble Lords have spoken with great eloquence and passion on these issues, including the noble Lords, Lord Patel, Lord Clement-Jones and Lord Freyberg, and my noble friend Lord Lansley. I have to say that I personally would draw the line at disclosing information for a commercial need as opposed to a public one.

I have a particular question about Amendment 19, which clearly states that patient information cannot be disclosed where the patient could be identified and that that information cannot be given without their consent. I remember that I was once asked to participate in a study; I signed the form and was delighted to do so, and never heard any more about it. I would just like to know how Amendment 19 would work in practice. At what point, and by whom, would the patient be contacted if that information was about to be disclosed and their consent sought?

I have reservations about this group. I remember the important debate that we had on the Trade Bill in this regard, and I am delighted to see that those issues are being considered in the context of this Bill as well. I have two concerns that I hope can be allayed. The first is that public need should not be deemed to collude with commercial need where it might not be in the interests of the patient. The second is about informed consent: how will the patient be consulted within the provisions of Amendment 19?

[Baroness Cumberlege (Con) [V]]

My Lords, this has been an interesting and well-informed debate, and I am quite reluctant to enter into it. I support government Amendment 19 and particularly Amendment 20 tabled by the noble Lord, Lord Clement-Jones. I hope I have got this right, although I am very happy to be put right if I have not. As I understand it, Amendments 19 to 25 concern consent, relating very specifically to the disclosure of information in accordance with international agreements. This is information that I think a relevant authority such as the MHRA holds in connection with human medicines.

As I listened to the noble Lord, Lord Freyberg, he raised a question in my mind about devices. We know that pharmaceuticals are much more closely regulated than devices have been, so can the Minister tell us a bit more about instances where there is a comparable agreement, and perhaps an amendment, for medical devices? I want to know whether they are on all fours with pharmaceuticals. I suspect not. Having listened to the noble Lord, Lord Freyberg, I think that there is more to hear on this.

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[Lord Hunt of Kings Heath (Lab) [V]]

My Lords, I want to come back to the debate on clinical negligence and the recommendation made by the noble Baroness, Lady Cumberlege, in her report for a redress agency. I declare my interest as a member of the GMC board.

We have reached a very serious position, with an exponential rise in clinical negligence costs. Twenty years ago, contingent liability was £3.9 billion; it is now £83 billion. Even allowing for inflation, I hardly think that we have become 20 times more negligent over that period. Indeed, the Minister, Nadine Dorries, told the House of Commons in a Written Answer last November:

“The continued rises in clinical negligence costs are eating into resources available for front-line care”.


It is not delivering for patients and their families, either. There are huge delays in getting cases settled and huge lawyers’ fees, in a quite remarkable situation where the NHS ends up paying damages in 80% of litigated clinical negligence claims. There is something wrong in the way we deal with these cases.

There have been endless reviews over the past 20 years, but precious little has happened. Seventeen years ago, an NHS redress scheme was unveiled by the then Chief Medical Officer, Sir Liam Donaldson. Legislation followed in 2006 but, 14 years later, it has yet to be implemented—and I doubt it ever will be. Since then, there has been much debate about the sustainability of Section 2(4) of the 1948 Law Reform (Personal Injuries) Act, which essentially promotes increased costs because it provides that

“there shall be disregarded, in determining the reasonableness of any expenses, the possibility of avoiding those expenses or part of them by taking advantage of facilities available under”

the NHS. In other words, the NHS tends to pay twice.

In 2017, the department and the Ministry of Justice commissioned the independent Civil Justice Council to draw up a new claims handling process for clinical negligence claims of up to £25,000, together with proposals for fixed recoverable costs for these cases. The report was published, with recommendations, in October 2019. Since then, there has been silence.

In that context, the noble Baroness, Lady Cumberlege, argued in her report First Do No Harm for a redress agency to be set up on an avoidable harm basis, which looks to systematic failings rather than blaming individuals. This, she thought, would encourage reporting and provide faster resolution for claimants. She argued that this

“would provide a standing structure to administer decisions using a non-adversarial process. This model is simple for patients to access as there is one point of contact. This structure enables flexibility to adapt and respond to situations as they arise.”

The proposed scheme of the noble Baroness, Lady Cumberlege, is well intentioned and has popular appeal. I recognise that details need to be spelled out in relation to eligibility, qualifying criteria or conditions of entitlement for her proposed redress scheme. Of course, causality is at the heart of any consideration of patient safety remedy. Causation is at the heart of tort. The Vaccine Damage Payments Act 1979 is limited to persons disabled as a result of vaccination. Even the NHS Redress Act 2006, to which have just referred, is concerned with arrangements for redress in relation to liability in tort. The noble Baroness’s approach is of course quite different from that.

The noble Baroness the Minister in Committee was not enthusiastic. In the past 48 hours we have heard the Government’s response that they have,

“no current plans to establish a redress agency”,

as set out in the recommendations of the noble Baroness, Lady Cumberlege. The reply went on to say:

“The government and industry have previously established redress schemes without the need for an additional agency.”


Well, that is a rather disappointing dismissal and misses the point, because the noble Baroness was essentially calling for a wholesale reform of the current clinical negligence system. I urge the Minister to reconsider this matter.

Can we really go on with the exponential rise in costs to the NHS—a system in which it loses 80% of cases that reach the courts, and where huge delays take place in patients getting access to an outcome? The system is completely bust. We need a new one and I hope that the Minister will, with his colleagues, consider what action needs to be taken to improve the current situation. I beg to move.

[Baroness Cumberlege (Con) [V]]

My Lords, I warmly thank the noble Lord, Lord Hunt. His determination is awe-inspiring. I am so pleased that he has not left this issue mouldering on the Committee Floor but has picked it up again.

I understand what the noble Lord said about the Government not being enthusiastic. However, I have known other issues on which the Government have been less than enthusiastic. It is the way in which we put forward persuasive arguments—although setting up this agency will take a lot of work, with a lot of detail to be considered. However, other schemes have been successful. I think about the one in my area—thalidomide. That trust is still running and getting redress for people who need it. So I strongly support the amendment of the noble Lord, Lord Hunt.

In our review, we tried to achieve a very simple and accessible structure for patients through the proposed redress agency. In an update on our recommendations, the Minister in the House of Commons, Nadine Dorries, said that the Department of Health and Social Care had delivered ex-gratia payments with individual schemes without the need for a redress agency. Indeed it has.

There are four or five schemes for infected blood alone, with eligibility based on whether the patient was a haemophiliac with HIV; a haemophiliac with hepatitis C; a non-haemophiliac with HIV; or a non-haemophiliac with hepatitis C. These different schemes addressed what type of payment should be awarded according to the patient’s need. What we—I am talking about my team and I—were advocating is a single point of contact for avoidably harmed patients. We felt very strongly that they had suffered enough without the necessity of finding out how to access the schemes that are relevant to them. The noble Lord, Lord Hunt, has said that something is wrong. He is right: it is wrong. This is not the way to help people who have been seriously harmed.

The problem is that, without a redress agency, each ex gratia scheme starts from scratch, which we felt was grossly inefficient. We need a standing administrative structure, funded by contributions from manufacturers and the state—both have a responsibility. At the moment, litigation is the only route, as the noble Lord, Lord Hunt, has said, for injured people to get serious compensation. We know that the process is very damaging to people. They do not like going to court, they do not like having to put forward all the information that is absolutely necessary—and sometimes not so necessary—and they do not like the fact that it is an adversarial system. We felt that the redress agency could remove the need for adversarial litigation that focuses on blaming individual doctors and nurses. The agency would be non-adversarial and would look at the systems failings that led to avoidable harm. This would help develop an open culture in healthcare and facilitate learning—we are not good at that. We know that the same mistakes happen over and again, and we felt that this was another tool to ensure that there would be much less of that.

Gathering information in one place—the agency—would make it so much easier to learn from the data that is collected and would strengthen the ability of the healthcare system to learn from the mistakes made. We have only to look at the cost of litigation of some £83 billion a year—I was very interested in what the noble Lord, Lord Hunt, said. We know that, often, the majority of those costs go to the law firms, not the individuals who have suffered so grievously. We felt that it would be much better if those huge sums of money, which are much needed by the NHS, should be used with a redress agency, which would have other advantages, as I have just outlined. A stand-alone agency, with a single entry point, would be a much better and more cost-effective way to award redress to those who suffer such avoidable harm—and many of them suffer for decades.

[Baroness Bennett of Manor Castle (GP) [V]]

My Lords, it is again my great pleasure to follow the noble Baroness, Lady Cumberlege, and the noble Lord, Lord Hunt of Kings Heath. I am pleased to attach my name to Amendment 67 in the name of the noble Lord.

I do not think the noble Baroness, Lady Cumberlege, will mind if I explain why I am coming in on Amendments 67 and 68 in particular. It is because I was in a meeting and asked her what her next priority would be after the broad achievement of the patient safety commissioner. She said that the redress agency was in her mind as the next priority, which is why I have chosen to make it a priority in this Bill, in which I have become considerably more involved than I was originally expecting.

Like the noble Lord, Lord Hunt, did, I have to describe the Government’s response to the noble Baroness’s review as very disappointing. Simply very curtly saying:

“The Government and industry have previously established redress schemes without the need for an additional agency”


really does not engage with the arguments put by the noble Baroness in her report or reflect the strong support seen in the British Medical Journal editorial on 20 August, which expressed growing support for the entire review but particularly for the idea of a redress agency.

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Moved by

[Baroness Cumberlege]

68: After Clause 40, insert the following new Clause—
“Redress schemes
The Secretary of State must, by the end of the period of three months beginning with the day on which this Act is passed, bring proposals before Parliament to establish redress schemes for those avoidably harmed by—(a) hormone pregnancy tests,(b) sodium valproate, and(c) pelvic mesh.” Member’s explanatory statement
This new Clause would require the Secretary of State to create redress schemes for those who have already suffered avoidable harm related to the medicines and medical devices specified in the new Clause, and would thus implement one of the recommendations made in the report of the Independent Medicines and Medical Devices Safety Review.

[Baroness Cumberlege (Con) [V]]

My Lords, it is interesting that these two amendments reflect each other, but I wanted them to be separate. The debate that we have had on the agency has been really interesting.

The noble Lord, Lord Hunt, has just talked about a further review of the whole system, which probably needs doing, but I am dealing all the time—through emails, letters and phone calls—with people who are suffering now. Rather than wait for a really good scheme, which I hope a redress agency would be, I feel that we should be compassionate and really understand how people are suffering today. They will suffer tomorrow. They have suffered for decades. It is time that they had some redress to help them in the very difficult and complicated lives that they lead, with huge suffering. It is not just the individual: it is the family and it is the children, especially with sodium valproate. One must think of the home. It is therefore important for society that we as a Government understand and are happy to supply some redress now.

I thank my noble friend Lord O’Shaughnessy, the noble Lord, Lord Hunt, and the noble Baroness, Lady Bennett, who have put their names to this amendment. I look forward very much to hearing what they have to say.

In the two and a half years that we spent travelling the country, listening to tragic stories from women and their families, there was absolutely no doubt in our minds that avoidable harm had been inflicted on those who openly, honestly and with great dignity told us their life stories. I have frequently mentioned what they and their families have told us, but I will spare your Lordships on this occasion because I do not need to reiterate it. Your Lordships know what we found. It is all in our report, First Do No Harm, if you want to dig a bit deeper. Hormone pregnancy tests, sodium valproate and surgical mesh are three interventions that have caused avoidable psychological harm in some patients. It is also clear that surgical mesh has caused significant physical harm and that sodium valproate has caused physical and neurodevelopmental harm.

Having listened to these ruined lives, we believe that the state and manufacturers have an ethical responsibility to provide discretionary payments to those who have experienced avoidable damage in these three interventions. Each of them should have its own scheme and tailored eligibility criteria. When we have, as I hope we will, a redress agency, these schemes can be subsumed into the agency.

I make it clear that these payments are not intended to cover the costs of services that are already available free of charge. I am thinking of healthcare and social security payments, and in some cases education for children. This is rather for other needs, which could include things such as travel to medical appointments—we have heard a lot about the costs of that—respite breaks or emergency payments, when a parent has had to stop working to cover the care needed for that child or members of the family.

Patients have waited far too long for redress, some for decades, and any scheme must be set up promptly, as soon as possible. However, it should be structured so that it can be incorporated into the redress agency in future. Individuals who obtain compensation through litigation or out-of-court settlements—and we have heard of some, particularly from Johnson & Johnson and the Scottish pelvic mesh settlement—will not need recourse to these schemes. It is over and above what is already supplied by the state or is totally inadequate. So we are not setting a precedent: ex gratia payments have made by the Government to those suffering from infected blood, for example, as I mentioned in the last debate, as well as variant CJD and other areas, where treatments have caused avoidable damage.

In responding to the report’s recommendations, the Patient Safety Minister, Nadine Dorries, said that our recommendation that these schemes should be established is still under consideration. I am very heartened by her words, which give me—and, much more importantly, those who are suffering—cause for hope that the Government will do the right thing.

I ask my compassionate and noble friend the Minister if he could give us more information on this. If it has not been ruled out of court, can he tell us what plans are made to ensure that these schemes become a reality, and very soon, because they are much needed? I beg to move.

[Baroness Bennett of Manor Castle (GP) [V]]

My Lords, I shall be brief, since I am following the powerful case put by the noble Baroness, Lady Cumberlege, for Amendment 68, to which I am pleased to attach my name, along with the noble Lords, Lord O’Shaughnessy and Lord Hunt. This is not a lesser amendment than Amendment 67 but a more limited one. As the noble Baroness said, agreeing Amendment 68 would not stop Amendment 67 from happening in future. The scheme for each individual could be rolled into a broader redress agency. I join her in welcoming the initial response to her report from the Government, which says that proposals such as that in Amendment 68 remain under consideration.

The case has been made—and I am not sure that I am allowed to do this post Brexit, but I note that in France the Government already pay into a fund for valproate damage. There are other cases around the world which reflect what already happens in other instances of medical disasters that have been acknowledged.

I commend the amendment to your Lordships’ House. I do not think that we will be pressing it to a vote tonight, but I hope that the consideration that the Government continue to give will turn into action very soon.

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[Lord Bethell (Con)]

My Lords, what a moving and heartrending set of speeches on a very important amendment, which I take extremely seriously. It raises the issue of establishing a specific redress scheme for those medicines and medical devices considered by the review: sodium valproate, the use of pelvic mesh and hormone pregnancy tests. The stories in the review, which have been told here this afternoon, are extremely moving on every single level. I cannot but pay testimony to those who have conducted the campaign and given evidence about their own personal suffering—and who, quite reasonably, look for some form of redress.

I completely understand why my noble friend Lady Cumberlege has raised this issue and why she and other noble Lords have asked for progress on her review. I also completely understand the importance that she and her team attach to this recommendation. They rightly spent considerable time drawing on a wide range of complex evidence before reaching their recommendations. The Government feel it is only right that we also give that incredibly helpful report our full consideration before responding to its recommendations. I remind noble Lords about the timeline for a response to these kinds of reviews, which we have gone over before. I think we are well within the normal response time for such reviews, Covid notwithstanding.

In order to determine whether redress schemes should be established, the Government have a duty to ensure that the final decision is fair for patients and for citizens more generally—not just the patients and citizens affected by the three treatments that my noble friend Lady Cumberlege alluded to, but all citizens and patients; you cannot favour someone over another. This requires extremely careful consideration of any proposed scheme but also the precedent that any decision sets for future policy-making. We spoke in the previous debate about the £83 billion problem. That kind of financial impact has a profound bearing on this kind of discussion.

My noble friend Lady Cumberlege asked when the Government will respond to her review. The Written Ministerial Statement of 11 January sets out the Government’s interim response. I emphasise to anyone who may be confused that it is just an interim response to the report of the IMMDS review. We currently plan to respond to the report later this year; that is a commitment made by my honourable friend Nadine Dorries, the Minister in the other place. The report took over two years to compile and we therefore consider it absolutely vital for the sake of patients, especially those who have suffered greatly, to give this recommendation the full consideration it deserves.

The noble Baroness, Lady Bennett, asked why the Government have established redress schemes in the past but are unwilling to commit to the schemes proposed in this amendment. I think that one is too early to call. It is right and proper for the Government to carefully consider proposals for redress schemes on their own merits to ensure a fair outcome for patients, and citizens more generally.

The noble Lord, Lord Hunt, asked why it is taking so long to consider the recommendations. The report took over two years to compile, so we need to consider it very carefully. I do not want to use the Covid pandemic as a catch-all excuse, but the reality is that our hospitals are overwhelmed; the Department of Health has doubled in size in the last six months and even with that it is overworked and overstretched. The resources and capacity to respond to this kind of report are, I am afraid, distracted on other matters of national health crisis. However, I reassure the noble Baroness, Lady Cumberlege, and other noble Lords who have spoken that work is under way and we will set out the Government’s response to this report later this year.

I could not help but be enormously moved by the testimony of the noble Lord, Lord O’Shaughnessy. In essence, he asked why the Government do not recognise that the patients highlighted in the report of the medicines and medical devices review suffered unavoidable harm, particularly those who took hormone pregnancy tests. The Government absolutely do regard their suffering most seriously indeed and are considering the contents of the report. I am restricted in what I can see regarding hormone pregnancy tests in particular, given the live litigation, but I want to make clear the Government’s position regarding a causal association between HPTs and adverse outcomes in pregnancy. The scientific evidence has been reviewed on a number of occasions, most notably by the Commission on Human Medicines expert working group on HPTs, which, as noble Lords will know, reporting its findings in November 2017. The EWG concluded that the scientific evidence did not support a causal association and that remains the Government’s position.

Just as Covid-19 impacted the publication of the report, it has also had an impact on the timing of our response. I know, and recognise, that that is enormously frustrating. The Government are committed to responding and I assure the noble Baroness, Lady Cumberlege, that work is under way. Our upcoming full response will address recommendation number four. We are moved by the stories; I am totally and utterly sympathetic to the situation that the patients affected by these conditions find themselves in on a day-to-day basis. They are still living through it today. I would like to regard myself as a compassionate person, but it is not appropriate to make policy on this kind of matter through primary legislation. For that reason, I ask my noble friend to withdraw her amendment and await the Government’s full response to her report.

[Baroness Cumberlege (Con) [V]]

My Lords, I am so grateful to noble Lords who have taken part in this debate. It has been quite short, but it is very important. As the noble Baroness, Lady Bennett, said in the previous debate on the agency, she has been involved with this Bill in a way that she did not anticipate. She has been such a stalwart, coming to my rescue on occasions, and supporting so much of what has been in the Bill from other sources. I thank her for all of that. The noble Lord, Lord O’Shaughnessy, made a powerful speech about the individuals he has met. We know Susan Morgan well; we have worked with Janet and Emma and many others who have led their own organisations. We think of patient groups as being a few people who got together—when we did not have lockdown—to have coffee and just discuss life generally. That is not the case.

One of the groups I know has 8,500 members—from all over the world, in fact. Other groups have an equal number of members, or numbers of that order. So these are important organisations. They know what it is to have real research. They come up with not just experiences; they beaver away at all our institutions, they look at what they are producing and they challenge. They are so valuable. In the way they work, when they are people who are in considerable pain—very often, they have complicated and difficult lives, having to deal with constant pain—they are thinking of others all the time. That really is so uplifting.

Medicines and Medical Devices Bill

Baroness Cumberlege Excerpts

3rd reading & 3rd reading (Hansard) & 3rd reading (Hansard): House of Lords
Thursday 21st January 2021 Lords Chamber

[Baroness Jolly (LD) [V]]

My Lords, Bills come and go. This Bill started its life as one to tidy up regulatory issues to do with the new post-EU world. In 10 years’ time, the Medicines and Medical Devices Bill is one I may not list as one of the most important I have worked on; I hope that the forthcoming mental health Bill will fit that spot. If remembered at all, it will be for the introduction of a commissioner for patient safety, born out of the First Do No Harm report by the noble Baroness, Lady Cumberlege.

There will need to be changes in the House of Commons to make the Bill really fit for purpose. The Minister has indicated the Government’s intention to lay amendments, and I am grateful to him for involving Peers in that process. When does he anticipate Second Reading in the Commons?

As the Minister and the noble Baroness, Lady Thornton, said, many people make a Bill, and they do not all sit in the Chamber. In particular, I thank both the Minister and the noble Baroness, Lady Penn, for giving us time to talk to the Bill team and allow them to explain new government amendments. Of course, I should not forget the noble Baroness, Lady Thornton, and her team; the noble Lord, Lord Patel; my noble friend Lord Sharkey; staff in opposition offices; and others who certainly made the Bill better, turning it into a workable piece of primary legislation.

[Baroness Cumberlege (Con) [V]]

My Lords, I could not let this opportunity pass without expressing my gratitude to all those who have played such a vital part in drafting, scrutinising and improving this important Bill. I know that it will now return to the other place. I wish it a fair wind and hope that we will soon see it enacted.

Throughout, noble Lords from all sides of the House have, quite rightly, focused on using the Bill to strengthen patient safety. Safety is now threaded throughout the Bill. I do so welcome that; it is something that the noble Baronesses, Lady Thornton and Lady Jolly, have both just mentioned. We have enshrined a very important safety recommendation in the Bill: we will now have a proper database to record the medical devices that are used and on which we and patients will be able to track their outcomes and detect safety more quickly. I cannot overstate just how important that is. Without this data, the healthcare system has been flying blind.

I have been very touched by the kind and thoughtful expressions of support from so many noble Lords in general debates and, in particular, for my amendments, which were triggered by the recommendations in First Do No Harm. The report enshrined in me that, at every opportunity, we must be reminded that the NHS is run for the people and is paid for by the people. Right now, the NHS is demonstrating a total commitment to saving lives and defeating this deadly virus—a virus that, as it sweeps around the world, devastates lives, livelihoods, education, personal budgets and a national aspiration for a better world.

In the dark days of the Second World War, Beveridge was preparing for a better Britain. In these dark days, there is a need to make plans—not just to return to what was there before but to look forward to something better. I believe that the patient safety commissioner will provide something better and will improve patient safety and healthcare as a whole. I was thrilled that so many of your Lordships lent me their support in calling for this; I know that their voices made all the difference. I thank the Minister and the noble Baronesses, Lady Thornton and Lady Jolly, for their generous remarks today.