Medicines and Medical Devices Safety Review

Baroness Brinton Excerpts

Thursday 22nd February 2018 Lords Chamber

[Lord Hunt of Kings Heath (Lab)]

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

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

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

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


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

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

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

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

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

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

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

I am grateful that the Secretary of State has included sodium valproate in this work. The Minister will know that last year a charity found that almost one-fifth of women taking the drug still did not know the risks that this medicine could pose during pregnancy. I therefore welcome government efforts to raise awareness of the dangers of valproate. I also hope that the House can be offered an assurance that the review will gain access to medicine regulation files held in national archives, access to any valuable evidence cited in unsuccessful legal actions and access to documents and information held by pharmaceutical companies, and that all such material will be made public.

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

[Baroness Brinton (LD)]

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

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

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

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

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

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

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

[Lord O'Shaughnessy]

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

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

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

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

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

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

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

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

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

Disabled People: Social Care

Baroness Brinton Excerpts

Tuesday 20th February 2018 Lords Chamber

[Lord O'Shaughnessy]

I thank the noble Baroness for her question. She is quite right to highlight the importance of reform for this group of people. We are talking about 250,000 people now, but that is projected to rise to 400,000 working-age adults in the next 15 years. I want to reassure her that, while the Green Paper itself is focused on care reform for older people, a parallel programme of work is going on. There is an important round table coming up which is being chaired by both the new Minister of State for Care, Caroline Dinenage, and the Parliamentary Under-Secretary for Communities and Local Government, with Mencap, Scope and others. We are giving the issue equal seriousness, as it deserves.

[Baroness Brinton (LD)]

My Lords, the charity Together for Short Lives last year put in a Freedom of Information Act request and found that one in five local authorities and one in six CCGs have absolutely no provision for respite care short breaks for the most seriously ill and disabled children. Since then we have received reports from across the country of more and more centres under threat or actually closing, such as Nascot Lawn, which I have raised in your Lordships’ House before, which is in court again tomorrow to try to save it. What is happening about this social care and nursing care provision for children? Normally, for adults, there is a negotiation between the NHS and the local authority about what is nursing and what is social care. But for these children there seems to be no such relationship; both local authorities and the NHS just point fingers at each other, and the result is children and their families not getting breaks.

[Lord O'Shaughnessy]

I am very aware of this issue. Indeed, we have had the opportunity to speak about it in specific cases. Local authorities of course are obliged to provide respite care. The noble Baroness highlights an important point about care, which seems in a way to slip between the boundaries of the two. I shall write to her about the general policy work that is going on, but I know that we need to solve this because we have children who are now living longer who before might not have lived so long and who require care, as do their families. It is essential that they get the care that they deserve.

NHS: Winter Crisis

Baroness Brinton Excerpts

Wednesday 7th February 2018 Lords Chamber

[Lord O'Shaughnessy]

I totally reject the accusation of meanness. If noble Lords look at the spending on the NHS, not only has it gone up in real terms every year while a massive fiscal retrenchment has had to take place to deal with £150 billion of borrowing bequeathed by the previous Government, but it now accounts for the highest percentage share of public spending that has ever been in place. We have found the money in difficult circumstances. We all agree that more is needed. More was found in the Budget; I am sure more will be found in the future.

[Baroness Brinton (LD)]

My Lords, in 2015 the King’s Fund warned the Government that the NHS would experience a “full-blown crisis in care” if the Government did not act early enough. That crisis has now materialised, with the additional funding announced in November’s Budget having arrived too late for hospitals struggling to cope with the accepted increase in demand from patients at that time of year. If the planning is to be published in July, when will the announcement about money to support that planning also be announced?

NHS: Clinical Negligence

Baroness Brinton Excerpts

Wednesday 31st January 2018 Lords Chamber

[Lord O'Shaughnessy]

The noble Lord knows more about this issue than anyone in the House, I think. The issue of reform to tort law is difficult. We have to be very careful when stepping across the idea of full compensation. It is one of the issues we are looking at. Other countries, such as Australia, have looked at this and we are considering it as part of the cross-government strategy. As I said, we will report by September this year on our plans in this area.

[Baroness Brinton (LD)]

My Lords, it is estimated that a relatively small number of clinical negligence cases end up as claims filed with the NHS. Has the NHS undertaken additional efforts to understand what factors cause certain cases to be escalated, in particular the attitude of lawyers in the NHS and trusts? How can escalation be prevented and, if so, when might the results be published?

[Lord O'Shaughnessy]

I point the noble Baroness in the direction of a five-year strategy that was published by NHS Resolution, the body that acts on behalf of what used to be the NHS Litigation Authority. The strategy looked at many issues, not only how we can prevent escalation. One of the drivers of cost is unsuccessful claims; more of those are going on. It also looked at how we can reduce incidents in the first place and learn from deaths and injury throughout the system, so that we can start to reduce the burden overall.

Social Care

Baroness Brinton Excerpts

Thursday 7th December 2017 Lords Chamber

[Lord O'Shaughnessy]

I thank the noble Lord for raising that point. I apologise again for the lateness of our response to the Lords committee. What I hope is now the final version is with me for approval, and I hope it will be provided very soon.

On the Green Paper, we all want more integration between health and social care. We know that is important for the people who are increasingly using those services who are in older age, have comorbidities and are moving in and out of different settings of the time. Social care is paid for on a different basis from the NHS. That is critical. We have to get a sustainable financial basis on which we distribute social care while thinking about how it interacts with the health service. The Green Paper is trying to crack a nut that, frankly, has eluded Governments for the last 20 years.

[Baroness Brinton (LD)]

My Lords, I am grateful to the Minister for referring to Nascot Lawn. I was not going to raise it today because that is about care for severely disabled children under 18, but I want to pick up on my noble friend’s point about adult care for people with disabilities and long-term conditions. As we know, their care needs are very different from end-of-life needs. Both the current social care system and the Dilnot proposals were focused on end-of-life care, so I welcome the parallel work stream, but will it operate to exactly the same timescale and report back?

I have a further question on housing. Your Lordships’ House will remember that the recommendations of the Lords Select Committee on the Equality Act 2010 and Disability included a whole chapter on housing. It is not just about the disabled facilities grant, which is important; it is also about Building Regulations ensuring that enough of our homes are built so that, as people age and their needs change, houses can be adapted easily if need be. Will that recommendation be forwarded to the group to look at?

[Lord O'Shaughnessy]

Once again, I thank the noble Baroness for raising this issue and I am pleased that she supports the parallel work stream. I will come back to her with details on the timing—I am afraid that I do not have those with me today—but I stress the importance given to it and the fact that it is reporting to the inter-ministerial group is significant.

The noble Baroness’s question on housing goes slightly beyond my remit. I know that building regs have changed over time to encourage more homes to be built, but I will have to come back to her with more details on that point.

Health and Social Care: Falls Prevention

Baroness Brinton Excerpts

Thursday 30th November 2017 Lords Chamber

[Lord O’Shaughnessy]

I will happily do so. Dance is very popular in my household, with “Strictly Come Dancing” on the television at the moment. Debbie McGee might not be quite over 65 but she is a great advert for older people dancing. I absolutely support what the noble Lord says. I have seen the evidence on the impact that was published as part of the APPG’s work on this; it is very convincing and we will certainly let health and well-being boards know that this is exactly the kind of thing—social prescribing, if you like—that they should be looking at to prevent falls.

[Baroness Brinton (LD)]

My Lords, the Royal College of Physicians estimates that between one-quarter and one-third of falls could be prevented through assessment and intervention. NHS Improvement ran 19 projects with volunteer trusts. There is not much evidence of those pilots working closely with local authorities, which is the nature of the Question of the noble Lord, Lord Jordan. What were the results of the pilots that started in January? One of the key findings of NHS Improvement was that two-thirds of trusts were still using outdated predictor equipment which NICE has recommended against. Can the noble Lord let me know, either now or later, whether he can confirm that those predictor instruments that NICE is now saying should not be used have been withdrawn, particularly from hospitals and general practice?

[Lord O’Shaughnessy]

I do not have the specific details that the noble Baroness has asked for; I will write to her. The figures are not good; there are still around a quarter of a million falls in hospitals and mental health trusts each year, which is equivalent to the emergency admissions, so it is still a significant problem. NHS Improvement is working with the poorest-performing trusts and is reporting that those interventions have seen improvements, but we clearly need to phase out some of the poor practice that exists in order to reach higher standards.

Nurses: Tuition Fees

Baroness Brinton Excerpts

Wednesday 29th November 2017 Lords Chamber

[Lord O'Shaughnessy]

My noble friend is quite right to point out that student debt is forgiven after 30 years. The point of that is to ensure there is an equitable system, where those who earn more pay back more over the course of their working lives. It is important to point out that, with the new threshold moving up to £25,000, a nurse earning £26,000 in band 5 of the Agenda for Change pay scale would pay back £7.50 of that loan per calendar month.

[Baroness Brinton (LD)]

My Lords, with the NHS reporting that 96% of hospitals are currently failing to meet their planned number of registered nurses, and UCAS reporting a decline in student nurse applications, as the noble Lord mentioned, as well as the further news that one in four post-qualifying nurses leave in their first year, what are the Government proposing to do to change the problem of recruiting new nurses, including returning to bursaries and abolishing tuition fees altogether? Specifically, what are the Government doing right now to attract nurses into our hospitals?

[Lord O'Shaughnessy]

It is important to point out that there are 10,000 more nurses on wards than there were seven years ago. One of the things that we are trying to do is encourage nurses to return to practice—3,000 of those nurses have been on the return to practice programme. In regard to attracting them to hospitals, the main thing is that we need to train more nurses to fill those places so that we fill the demand that we know that we have from a growing and ageing population. That is why there are going to be 5,000 more funded nursing training places from 2018 onwards.

Veterans: Mental Health

Baroness Brinton Excerpts

Tuesday 7th November 2017 Lords Chamber

[Lord O'Shaughnessy]

On the first point, there have been reviews at European level to improve the packaging and the patient information leaflets about any risk that might attend taking this drug or indeed any others. Status as a veteran is now recorded in the NHS and goes into the patient record.

[Baroness Brinton (LD)]

My Lords, the mefloquine help page for veterans and current serving officers is very good at explaining the signposting, but there is no mention in Meeting the Healthcare Needs of Veterans, which has not been updated since 2011. Only 2,000 GPs out of more than 50,000 have attended the day training course on working with veterans. Can the Minister ensure that at least one GP from every surgery has training, so that he or she can advise other GPs when they are helping to serve our veterans once they are back in the civilian workforce?

[Lord O'Shaughnessy]

The noble Baroness makes a good point. As I mentioned, that training is now in the curriculum, but of course that deals with the flow of new GPs as opposed to the stock of existing GPs. I shall certainly look at that and see what more can be done to make sure that GPs have up-to-date training.

Care Homes: Hospital Discharges

Baroness Brinton Excerpts

Monday 16th October 2017 Lords Chamber

[Lord O'Shaughnessy]

The point about integration is critical. The CQC’s report from last week, which we were discussing, is all about collaboration and integration. Someone in their 80s who is experiencing care does not distinguish between different bits of it as we do bureaucratically. They want to know that there is seamless care. That is what the sustainability and transformation process is attempting to do.

[Baroness Brinton (LD)]

My Lords, I am grateful for the right reverend Prelate’s comment about the National Audit Office’s report from February, which makes it clear that 43% of the multidisciplinary team meetings in acute hospitals began immediately, which is to be encouraged, but only 20% of local authorities were invited to those early meetings. What are the Government doing to ensure that the advice from NHS Improvement about getting that earliest intervention will actually happen?

[Lord O'Shaughnessy]

The noble Baroness raises an excellent point. She may know that the better care fund—the route by which the additional money goes into social care—reviews and holds accountable local authorities and the NHS for interacting with one another to deal with delayed transfers of care. There is something called the high-impact change model, which is designed precisely to bring people together to ensure that the number of delayed transfers in care are reduced. That is compulsory as part of the funding provided.

Health and Social Care

Baroness Brinton Excerpts

Thursday 12th October 2017 Lords Chamber

[Lord O'Shaughnessy]

I join the noble Baroness in paying tribute to voluntary sector providers and volunteers, whether family members or others, who support care throughout the NHS and social care. There need to be more paid staff to meet the needs of our growing and ageing population, which is why the Secretary of State announced a 25% increase in the number of training places and more nursing associates. That is being put in place to make sure that the system, which is described in the report as stretched, has the capacity it needs to meet patients’ needs.

[Baroness Brinton (LD)]

My Lords—

[Lord Davies of Stamford (Lab)]

I shall give the Minister another chance. He did not even begin to answer the question from my noble friend Lord Hunt. Why did the Government drop Dilnot?

--- Later in debate ---

[Baroness Brinton]

My Lords, the CQC report has shown that over the past two years there has been a reduction in beds in nursing and care homes, while the Lancet published the results of a research project in the summer showing that we will need an extra 9,000 beds per annum by 2025—that is more than 70,000 beds. What are the Government proposing to do to make it easier for more homes to be set up and run and to fund the beds we clearly need urgently, not just in 2025 but from now on?

[Lord O'Shaughnessy]

The noble Baroness will know that there has been a small reduction in the total number of residential nursing home beds, although it is a fairly flat picture over a long period of time. We have also seen an increase in the amount of domiciliary care. One of the things we need to get to the bottom of, and this is what the consultation will look at, is the imbalances that exist between the funding regimes for residential and domiciliary care. We have to get to the bottom of it, because it creates an imbalance on the provider side as well, so that we can have proper funding for the kind of care that people need regardless of whether it is in a residential nursing setting or at home.