Unpaid Carers: Support

Lord Hunt of Kings Heath Excerpts

Thursday 13th June 2019 Lords Chamber

[Baroness Blackwood of North Oxford]

I completely agree with the noble Lord, Lord Patel, who is absolutely right that we must ensure that we sustainably fund social care. The Government have provided £3.9 billion more in dedicated social care funding, but we recognise that there is a need for a sustainable financial footing for social care as a whole, which is what we are working towards with the spending review. Nevertheless, carers will continue to play an important part in our healthcare system, as they do within our society. Many people consider that they are making a rewarding and important contribution within their family and community, and we must be grateful to them for that.

[Lord Hunt of Kings Heath (Lab)]

My Lords, the implication of what the noble Baroness has just said is that the work around the Green Paper on a sustainable mechanism for funding long-term care is focused on the medium and long term. If that is so—and I think the Minister could say something about the actual remit of the work—the question then arises, what about the short term? We know that the money she talked about is a drop in the ocean compared to the money that has been taken away from social care, alongside the increasing demographic pressures. Can she tell me whether, as part of the spending review, which I assume will occur at some point, the immediate pressures are also going to be taken care of?

[Baroness Blackwood of North Oxford]

The noble Lord will know that the spending review has not yet started, so I cannot tell him what is happening in the negotiations. What I can tell him about is the work that has already gone on to improve social care funding: giving local authorities access to around £10 billion more in dedicated funding for social care from 2017-18 to 2019-20; an additional £410 million of new money to improve social care for older people, people with disabilities and children; and £240 million more for winter pressures. However, the noble Lord is absolutely right that it is no good improving the medium to long-term outlook for social care if we do not ensure that we also address the immediate challenges that it faces.

People with Learning Disabilities

Lord Hunt of Kings Heath Excerpts

Thursday 6th June 2019 Lords Chamber

[Lord Hunt of Kings Heath (Lab)]

My Lords, as I shall refer to some workforce issues, I refer noble Lords to my membership of the General Medical Council. I am grateful to my noble friend for instituting this debate. The questions she has posed are very significant. As she said, the “Panorama” programme depicted shocking events. The depressing thing, of course, is that it follows not only Winterbourne View but a series of reports published in the last few years identifying the scale of the problems. My noble friend went through some of them; I will mention three.

One is the Children’s Commissioner for England report of 2019, published only two weeks ago, which found that there are 250 autistic children or children with a learning disability in mental health hospitals in England, who on average had spent six months there. Many, she said, are far away from their homes, friends and families. One in four had not had their care plan reviewed in the last six months. Despite the fact that restraint and seclusion should be only a last resort, many staff in mental health hospitals spoke as if they were routine matters. Last year the CQC was asked to carry out a review into the use of restraint and seclusion in mental health hospitals. It really was a shocking situation: 31 of the 39 people found in long-term segregation whose cases investigators assessed were on the autism spectrum; some were on wards that did not have the appropriate environment for autistic people; many staff lacked training; in the cases of two-thirds of the people the CQC assessed, staff had stopped trying to reintegrate them into the main ward; and a third of the people it assessed were experiencing a delayed discharge because there was not a plan for appropriate care in the community. The National Autistic Society has laid bare many of the problems that these reports have identified.

There was also the very interesting National Audit Office report in 2017, which raised a number of complex challenges that the various partners involved in supporting people with learning disabilities face in making the system work much more effectively and delivering what my noble friend has asked for: appropriate care in the community. It identified that the flow of patients into mental health hospitals was not working effectively and that, shockingly, in December 2016, 28% of such patients had still never had a care and treatment review. Fundamentally to the financing of this, money was not being released from mental health hospitals quickly enough to help pay for the kind of community support we need to see.

We also know, from a report published two days ago by Health Education England, that the learning disability nursing headcount could hit critical levels in the next five years—some would say it has hit those levels already—with vacancies upwards of 30%. In addition to some of the issues we have in recruiting nurses—including bursaries, et cetera—I believe there is a huge crisis in the learning disability field and, so far, no real, tangible means of trying to deal with it.

I know government Ministers are and have been committed to doing something about it, as my noble friend says. We are not short of reassurances that Ministers have given to this House and the other place, and I do not doubt Ministers’ sincerity. It was only on 21 May that the Secretary of State announced a number of initiatives on,

“the model of care for autistic people and people with learning disabilities”,

and the appointment of,

“specialist, independent advocates who will … work with families … join up services … work to move people to the least restrictive care and then out into the community … a new working group for learning disabilities and autism, bringing together experts, clinicians, parents and carers to develop a new model of care … a new awareness campaign, to encourage staff, families and friends to come forward if they have concerns about care”.

I could not disagree with any of that; I am sure it is welcome. The question is: where is the beef? What is going to make this really happen? Is this just a continuation of, frankly, a system of scandals that have been with us for decades?

I could not help going back just over 50 years to Geoffrey Howe’s report into Ely Hospital in Wales, which was the start of a series of inquiries into hospital care for people with learning and mental health disabilities. It led the movement towards more community care. At the time, it caused great shock that our fellow country men and women could be treated so badly in institutions ostensibly established to care for and support them. I make the connection between what was exposed so recently by “Panorama” and what was found by Geoffrey Howe just over 50 years ago in Ely Hospital. I do not think that we, collectively, can be proud of what has happened. Of course improvements have been made, but an awful lot more needs to be done. Ministers often make the glib statement, “We want to make sure this can never happen again”. The Government have been wise not to make that statement in relation to people with learning disabilities. At the moment, I do not believe there is anything to guarantee that it will not happen again.

It is clear, for a start, that there does not seem to be any national leadership. In the end, who is in charge of making a new service work effectively? I cannot see anybody one can identify as being in charge unless it is Ministers, but Ministers do not—or say they do not—have the levers to make the system work effectively. It is clear that commissioners are not up to the task. The lack of interest that many commissioners take in those people, once they have been allocated to these places, is so striking. Given that many of the people in those places come from long distances away, it is almost impossible for their home commissioners to monitor what is going on.

The current system is simply not capable of stopping this. Ministers must appoint someone centrally with the powers to dictate what will happen. Unless we do that we will simply come back here year after year with yet another scandal. The measures taken so far are sensible, but will not cut the cake.

National Institute for Health and Care Excellence (Miscellaneous Amendments) Regulations 2018

Lord Hunt of Kings Heath Excerpts

Wednesday 1st May 2019 Lords Chamber

Moved by

[Lord Hunt of Kings Heath]

That this House takes note of the National Institute for Health and Care Excellence (Miscellaneous Amendments) Regulations 2018 (SI 2018/1322).

Relevant document: 12th Report from the Secondary Legislation Scrutiny Committee (Sub-Committee B)

[Lord Hunt of Kings Heath (Lab)]

My Lords, I am glad to lead a short debate about NICE and the introduction of charges. I was NICE’s first Minister and have long taken an interest in the work of the national institute. Overall, it has done a fantastic job; its methodology has been followed by many other countries and, clearly, it has had an impact on judgments about clinical and cost effectiveness.

However, its role has changed over the years. It was brought into being to encourage and speed up adoption of proven, innovative new medicines and treatments because of a concern at the time that the NHS was slow to adopt new treatments and innovations that had been shown to be better than existing treatments and drugs.

To start with, that worked. However, despite the legal requirement on the NHS to implement the technology appraisal decisions of NICE, right from the start it proved remarkably reluctant to do so. As time has gone on and money has been squeezed, NICE has become more a rationer of treatments than a pusher of the introduction of new, innovative products. My concern about charges is frankly not so much to do with the principle of charging, because it follows a well-known model and principle used throughout government endeavours, as with some specific issues, particularly in relation to small companies and the current or future review of NICE’s methodology, which I wanted to raise.

We know from the helpful paper produced by your Lordships’ Secondary Legislation Scrutiny Committee that the government grant to NICE has fallen from £66.4 million in 2013-14 to £51.2 million in 2018-19 and that the Government have argued that NICE needs to identify other sources of funding to enable it to continue its full programme of work.

Obviously, there was consultation. One issue raised in it was the impact of charging on the relationship between NICE and the pharmaceutical industry—but it is important that we recognise that NICE is concerned not just with medicines and the pharmaceutical industry. In the consultation, the potential for conflicts of interest and the public perception of such conflicts were identified as risks. In other words, because the pharmaceutical industry will now be paying for the work being done by NICE, will it have undue influence on the work of NICE? Looking at the robust approach of NICE, I think we can dismiss that fear, but it would be good if the Minister could say something on the record about how we can avoid any perceived conflict of interest.

The second issue I want to raise is the mechanism for reducing the impact on small companies. The original proposal was for a 25% discount but, as a result of concerns raised, the Government decided to provide a subsidy of 75% for small companies. That is welcome and I accept that the Government moved a long way, but the Ethical Medicines Industry Group, which represents a number of small pharmaceutical companies, says that despite that, there is concern among those companies about the impact on them when they have a number of other issues and challenges at the moment, including Brexit and the rebates associated with statutory and voluntary medicines pricing schemes. It thinks that the NICE charges still present a significant cost for small companies and asks the Government to consider whether further measures could be introduced to help mitigate the impact of this on SMEs. One of its suggestions is a fee exemption for companies bringing their first product to market. I think that is an interesting suggestion in terms of encouraging new entrants into the market, which I believe is government policy.

More generally, it is important that, with the extra resources that will be going to NICE, we take the opportunity to ensure that NICE modernises its approach to medicines assessment. When the Government introduced the concept of cost recovery they said the charging would provide a more sustainable model, enabling NICE to flex its capacity in response to the pipeline of technologies that require assessment by NICE. That is welcome, but I want to refer to a briefing I received from a company called AbbVie, which says that it is imperative that NICE fulfils this commitment to adapt and update its methodology and modernise its approach to assessing new technologies.

One example it gives is that we know that medicines are increasingly targeted at smaller patient populations developed through clinical trials. Inevitably, these will embrace patients in smaller numbers. The problem is that regulatory agencies tend to approach this with some caveats. Inevitably, the clinical trials result in smaller datasets and regulatory agencies are certainly demonstrating significant flexibility to approve such medicines, often conditional on that data. However, the approach of health technology assessment bodies such as NICE is often challenged by such datasets, resulting in delays and highlighting a disconnect in the medicines approval pathway. AbbVie-commissioned research shows that medicines, such as those specifically expedited through the regulatory approvals system, due to their addressing areas of high unmet medical need, take longer, on average, to receive subsequent approval from NICE than those medicines that have not been expedited, thereby making the whole process very difficult. The upcoming NICE methodology review, due to commence through 2019-20, provides an opportunity to look at this again and I would be grateful if the Minister would say one or two words about that.

I also raise an issue raised with me by Alexion, a company focused on the development of medicines for rare and ultra-rare diseases. It has concerns about the potential unintended consequences of introducing charges for appraisals without action to address the significant challenges these treatments face in NICE assessments.

In conclusion, I do not object to the principle of charges: I think it is quite proper and the Government’s approach is to be supported. I have concerns about the small companies. I know that the 75% rebate is generous on any count, but any additional costs on those companies is something to be concerned about. The core of my question to the Minister is around the methodology review, to ensure that NICE keeps up to date with developments in science and technology. That is very important.

Turning to my final point, I know that the noble Baroness has taken a great interest in this over the years, representing her old constituency, particularly the life science sector. On the one hand, government policy is about encouraging UK life science and biotech companies to develop, to innovate and to invest in the UK. However, the National Health Service is set up to ensure that those innovations are not adopted by it. Despite a number of welcome government initiatives, they are all what I would call upstream, because the downstream is too difficult. This is a real problem so long as we have an NHS dedicated to stopping innovation. I fear that, despite all the warm words from Ministers that we have heard over the years, the NHS response is to dampen down investment in these new technologies and medicines. My argument is that, post Brexit, we cannot afford for this to happen. One way or another, we have to find a way to get the early adoption of new medicines and new techniques, where they can be shown to do better than the existing ones, and NICE has to play a part in that.

This is really my usual rant about innovation and getting patients access to the fantastic things being developed in the UK. I look forward to the Minister’s response and I beg to move.

[Baroness Jolly (LD)]

My Lords, I thank the noble Lord, Lord Hunt of Kings Heath, for giving us the opportunity to ask the Minister some questions. As I expected, it was really interesting, starting with NICE from its inception. Those of us who have been involved with the NHS for some while know the standing that NICE has within the NHS community and how it is changing and adapting to changing circumstances, new technologies and the importance of really exciting new pharma, including pharma for specialised conditions. It also gives us the opportunity to better understand the motivations and reasons behind some of the changes.

As I see it, this SI does two things. It enables NICE to recruit experts from across the UK to its appeal panel, as opposed to individuals only in England. This aspect of the SI appears to represent a sensible change. Secondly, it will allow NICE to charge industry for the cost of making technology appraisals—TAs—and highly specialised technology, or HST, recommendations. I see this aspect of the SI as potentially contentious. How will the anticipated savings from the SI be used? To whom will they be allocated? Will they be used to support growth of the life sciences sector in the UK, or will they just become part of the income stream and then go some way towards the possible privatisation of NICE? Is not the reason for this SI that NICE’s government-funded budget is decreasing? The documents with this SI note that in 2013-14 NICE received £66.4 million in government funding, and that by 2018-19 this had dropped to £51.2 million. I wonder how many other NHS-funded organisations have faced cuts of 23% over five years and quite considerable growth in their business.

--- Later in debate ---

I close by stressing that the Government share the view that we have heard today about the vital importance of NICE’s work. These matters are very important to all of us. With the changes we have made in response to the consultation comments, I am confident that the introduction of charges and the charging regime for NICE recommendations will enable it to continue to be sustainable and develop its recommendations with the same authority, transparency and impartiality that have been the backbone of its world-leading reputation, and that the UK life sciences sector will remain as strong as it has ever been, if not stronger.

[Lord Hunt of Kings Heath]

My Lords, I am grateful to the noble Baronesses who have taken part in this short debate. I echo what the noble Baroness, Lady Jolly, said about ensuring that NICE continues with a full work programme, which is very important indeed. I want to reinforce my noble friend Lady Thornton’s vital point about the rare diseases strategy and the issue of access across the UK. Twenty years on, NICE can be congratulated on its work. Remarkably, its first chief executive, Sir Andrew Dillon, is still chief executive. I extend my tribute to him. Not only has he done a great job, but he has also always been accessible to parliamentarians and held open debates, which is much appreciated by Members of your Lordships’ House.

First, I am quite clear that I do not think that there will be a conflict of interest. We can rely completely on the integrity of the NICE progress in relation to that point.

Secondly, uptake and access are fundamental issues. The noble Baroness pointed out that the UK’s position in relation to the speed of regulation is very good, which is pleasing. The problem is that the health technology assessment side is not fast. It is particularly clear from some of NHS England’s interactions with NICE that it is keen to slow down the introduction of many of these new products because, I am afraid, it is concerned about the overall financial package. The problem is that NHS England has no responsibility whatever for UK plc, nor for the health of our life sciences sector; indeed, it has often refused to meet that sector. Given who the chair of NHS England is and given how instinctively sympathetic he is to the issues we are discussing, I hope that we will see a change in attitude. If we really are concerned about the quality of patient care, we must be concerned that access to new medicines and drugs in this country is way behind that in France, Germany and other countries. Most decisions are made in North America, although the pharma industry has other global headquarters. Our reputation for being behind other countries in the adoption of such products is a big problem for future investment.

I have one suggestion. It is very disappointing that, under the original voluntary rebate scheme, the rebate money was essentially paid into the Treasury because the amount to be rebated was discounted in advance. In Scotland, some of that rebate has been used for funding that has been fed back into the Scottish health service to fund new medicines and treatments. Thinking about how we might move on, given that we now have a new rebate scheme, that money should be seen as additional money to be used to encourage the health service. I hope that the Government might think about that in future. The debate has been short but really good.

Motion agreed.

Access to Medicinal Cannabis

Lord Hunt of Kings Heath Excerpts

Tuesday 9th April 2019 Lords Chamber

[Baroness Blackwood of North Oxford]

I thank the noble Baroness for her question, and I know that she has campaigned on this issue for some time. NHS England has clarified that clinical guidance does not remove or replace the clinical discretion of the prescriber to act. I know that the process review will look at the impact of clinical guidance, which will hopefully be helpful. We will also look at the role of second opinions. I hope that that has answered some of the noble Baroness’s questions; she made a number of points, and I will write to her on the rest.

[Lord Hunt of Kings Heath (Lab)]

My Lords, I want to come back to the point about NICE made by the noble Baroness, Lady Walmsley. My understanding is that, at the moment, the evidence on which doctors can base a decision to prescribe these medicines is very limited. Clearly, relying on the NICE guidance is one way through. My problem is that, if we look at another area such as cataract operations, we see that despite NICE guidance many patients are now being denied treatment that has absolutely proven to be effective. My concern is that the Government seem to be trying to find a way round the evidence relating to these medicines when, up and down the country, patients are being denied interventions that we know will be successful and that can help thousands of people. Can the Minister comment on that?

[Baroness Blackwood of North Oxford]

The noble Lord is right that it is important that guidance is provided. The point of bringing the guidance forward is to look at the most up-to-date evidence available across the country. The challenge with medicinal cannabis is that the evidence base is developing. Currently, more than 100 clinical trials are ongoing worldwide. We are bringing the NICE guidance forward in the autumn to take all that clinical evidence into account in the most up-to-date guidance, so that patients can benefit and clinicians can have more confidence in prescribing. The NIHR call for clinical trials has been brought forward so that the evidence base can be strengthened even further as we go forward because, in the long term, the only way for us to move from an unlicensed prescribing route, which is where we are now, to a licensed route is through clinical trials and a greater evidence base. That is what the Government are keen to encourage.

Child and Adolescent Mental Health Services

Lord Hunt of Kings Heath Excerpts

Monday 25th March 2019 Lords Chamber

[Lord Hunt of Kings Heath (Lab)]

My Lords, on pace, will the Minister acknowledge that this Government and their predecessor, the coalition Government, have made any number of promises about investment in and prioritisation of mental health services, particularly for children and young adults, but that when it comes to the decisions made by clinical commissioning groups, the reality is that they have not brought them to fruition? What guarantees do we have that this time clinical commissioning groups will do what they have been asked?

[Baroness Blackwood of North Oxford]

The noble Lord, Lord Hunt, is very experienced in this area and has been involved with local clinical commissioning groups. The NHS has already opened 117 additional new mental health beds, and we have introduced new waiting standards for psychosis and eating disorders among children. Progress is already being made, but we should not dismiss the frustrations of those trying to access services. That is why we have put in place ambitious new targets with the long-term plan: we want to see 100% of children able to access the care they need.

European Qualifications (Health and Social Care Professions) (Amendment etc.) (EU Exit) Regulations 2018

Lord Hunt of Kings Heath Excerpts

Thursday 7th March 2019 Lords Chamber

Thirdly, let us assume that there is some kind of deal, whether the Prime Minister’s deal or something else. Presumably, these SIs lapse. Is that correct, or do they stay on the statute book, given that Parliament will have passed them? How do we explain to the outside world whether it is supposed to take notice of these SIs or whether the status quo continues—which seems to be the Government’s policy for the period of transition or implementation? What is the status of these SIs in those circumstances? How will the Government communicate their status with the wider world if there is in fact a deal? We, and the world outside, need a bit of clarity about what happens to these SIs in some of the foreseeable and possible scenarios, even if there is no no-deal exit on 29 March.

[Lord Hunt of Kings Heath (Lab)]

My Lords, it is very tempting to follow the noble Lords, Lord Warner and Lord Deben, in their remarks. I do not know whether the noble Lord, Lord Deben, has studied the document issued by the US Government last week on their requirements for a trade deal, but there is a contrast between what Brexiteers told the public about how easy trade deals would be and the demands of the US Government, which this Government will have to accede to in their desperation to get a trade deal, and their implications for the National Health Service. Apart from anything else, they will mean that voluntary control on prices of branded drugs will go and the market which the Government now want to legislate to remove, amending the Health and Social Care Act 2012, would fall foul of the requirements of the US Government on public services, which are very explicit about the areas they want US corporations to bid for.

As the noble Lord, Lord Deben, said, I wonder how those on the Front Bench feel about being members of a Government which will be excoriated for decades to come, perhaps as was the pre-war Government in the 1930s, for the lack of preparations they made for the disaster into which they are now taking this country. Of course, this SI is a sort of backstop which, it is hoped, will never come into being. But do we really think the vote will take place next week or will it, as some people feel, be postponed yet again to a cliff edge, when there is no guarantee whatever that there will be an agreement to enter talks about an agreement? This order takes on considerable importance.

I should at this point declare my interests as a member of the General Medical Council and a trustee of the Royal College of Ophthalmologists, and say that the GMC welcomes the order on its narrow terms. I should say to the noble Lord, Lord Deben, that it is the GMC’s view that it can administer the new arrangements effectively without additional substantive burdens being placed on its day-to-day operations. I do not know whether that reassures him; I hope it may.

I should like the Minister to comment on one area which is relevant to what my noble friend and the noble Baroness, Lady Jolly, said. It relates to page 9 of the order, where new powers are afforded to regulators effectively to determine what should and should not be comparable clinical qualifications to those gained in the UK. This is clearly of great importance given the way we are going. Instead of the current automatic recognition given to qualifications gained by, for example, doctors, dentists and nurses in another EEA country, the powers allow them to be deemed non-comparable by a regulator if it felt that necessary for patient safety reasons. The order states that the Privy Council would have to approve any such decision by the regulator. On what basis would the Privy Council approve or not approve a request to do so? Without some idea of the criteria to be used, it will be difficult for regulators to adopt the powers in the order in this area with confidence. Do the Government expect to issue guidance to advise regulators on the basis of a Privy Council judgment? Can they do so as quickly as possible, and will they consult the regulators in so doing?

[Baroness Hayman (CB)]

I also declare an interest as having been a member of the General Medical Council until that post was taken up by the noble Lord, Lord Hunt of Kings Heath.

Many of the points I wanted to make have already been made by the noble Baroness, Lady Jolly, and the noble Lord, Lord Hunt. I follow up his point about the ability to remove a qualification from automatic acceptance. When she introduced the SI, the Minister said that the Government would not issue guidelines. If there are no guidelines, one regulator may decide to remove an automatic qualification. The Minister said that it is in the best position to do so, but the SI lays down that there must be approval by the Privy Council. How is the Privy Council to make its decisions and against which criteria? There must either be criteria for the regulators to abide by and the Privy Council to supervise, or you give power completely to the regulator. I do not see how that process has any power or heft without guidelines.

The issue of review after two years has also been raised. There is concern that that review should be wide-ranging, because the process for recognising the qualifications of non-EEA and Swiss medical professionals is not satisfactory at the moment. It can be very long, drawn-out, bureaucratic and take a lot of money and time, as opposed to the streamlined system that we have had with EEA and Swiss nationals, which we are throwing away if we go for a no-deal Brexit. It is really important that that review is wide-ranging and does not leave us at the end with another cliff edge, which is that these health professionals on whom we depend so much become translated into international medical graduates and subject to an extremely unsatisfactory process.

In his wonderful speech the noble Lord, Lord Deben, referred to how the Government say that we will have wonderful flexibility but never quite explain what that is. Actually, the Government have flexibility on international medical graduates, because those procedures are not governed by the European Communities Act or by our membership of the EU. For many years, regulators have wanted to make progress on the issue but have not been given the legislative time or space and policy commitment from the Government so to do.

Alongside this work on EEA graduates, can we make sure that we look at the wider issue of doctors and other medical professionals coming here from outside the EEA? If the overall immigration trends are mirrored in the people coming to this country as medical professionals, we will see fewer EEA medical professionals but more IMG medical professionals coming here. I believe that we are seeing that already. Therefore, how we recognise their qualifications will be even more important.

Safety of Medicines and Medical Devices

Lord Hunt of Kings Heath Excerpts

Thursday 28th February 2019 Lords Chamber

[Lord Hunt of Kings Heath (Lab)]

My Lords, I am very grateful to the noble Lord, Lord O’Shaughnessy, for initiating this debate. I remind the House of my health interests as set out in the register, specifically my membership of the GMC and presidency of GS1 UK and the Health Care Supplies Association.

The noble Lord has focused on the review of the noble Baroness, Lady Cumberlege. I will concentrate on surgical mesh, but I recognise that the review has a much wider significance, assessing the actions of relevant authorities over the years when safety concerns have been raised. On surgical mesh, what is so striking is how long it has taken to get any action. The excellent campaign group Sling The Mesh, led by Kath Sansom, has fought a sustained campaign to draw attention to the problems that we have heard about, with many women left in permanent pain, unable to walk or work and feeling totally neglected by the National Health Service.

Not only have these problems been known about for years, they have been recognised in a series of official reviews. As far back as 2012, the Department of Health reported that, while surgery for stress urinary incontinence and pelvic organ prolapse using mesh can be effective for most women, a small percentage will suffer significant side-effects. The department established a working group between 2014 and 2017—for three years—that came to no hard conclusions at all. At the time of the publication of the final report, the MHRA said that it was committed to addressing the serious concerns of patients, but that it was not aware of a robust body of evidence that would lead to the conclusion that mesh was unsafe if used as intended.

In a Statement that the noble Lord repeated to the House in February last year, he referred to advice from the Chief Medical Officer that experts here and abroad had said that, when the treatment is used appropriately,

“many women gain benefit from this intervention, hence a full ban is not the right answer in the light of the current evidence available”.—[Official Report, Commons, 21/2/18; col.164.]

Even after the early findings of the noble Baroness, Lady Cumberlege, the Government instituted a pause, but significantly not a ban, on the use of vaginally inserted mesh to treat prolapse, and on the use of tape or slings to treat stress urinary incontinence.

So we have had a series of reviews. All have recognised the problem, although there is disagreement about its scale. However, they have all tended to recognise the benefits of the procedures and have resisted the ban called for by campaigners. This ambivalent approach has been very frustrating, and I wonder whether the ambivalence lies behind the very poor way in which the NHS has treated those women for whom mesh has been a total disaster. They feel abandoned by the National Health Service and, frankly, the service seems to be in denial about the problem. There are no support mechanisms and precious few opportunities to have the operations reversed—nowhere near the kind of approach that the noble Lord, Lord O’Shaughnessy, has called for today.

This continues. I do not know whether noble Lords have looked at the draft consultation by NICE that it has yet to finalise. I was struck in particular by section 1.10, entitled “Managing Complications Associated with Mesh Surgery”. It states that the decision to remove mesh for any indication needs to be made in the context of an explanation to women that such surgery may not relieve symptoms and may have significant complications, including organ injury, worsening pain, and urinary, bowel and sexual dysfunction. So this leaves a woman damaged by having mesh inserted with little prospect of amelioration at all.

I received an email this morning from a woman member of Sling The Mesh. She is currently in Germany for a non-mesh hernia repair, following two removals of an incontinence mesh. Why did she have to go abroad and pay for it herself, and why is the NHS so hopelessly inadequate in dealing with the issue?

The issue is not confined to vaginal mesh. Last week I met a senior lawyer in Birmingham who spoke to me about his experiences following a hernia mesh implant in 2011 that left him in constant pain. Before the mesh implant operation, he was very active and ran half-marathons. Now, sadly, because of his pain, his mobility has been greatly reduced and he struggles to sit at his desk for any significant time. His life has changed for the worse. Again, the response from the NHS has been wholly inadequate.

I am uncertain whether the problems are caused by poor diagnosis and poor clinical performance, or whether a certain percentage of patients can expect to suffer harm from the intervention. Alongside the challenge the noble Lord raised about the balance between risk, safety and innovation, this raises moral and ethical questions as much as regulatory ones. The question is whether it is right that these operations should continue when we know that, on one hand, many patients will benefit, and on the other, it seems inescapable at the moment that a number of women will suffer. There is disagreement about the percentage but some campaigners think that it is as high as 10%. If this was a medicine, of course it would not receive approval, based on that balance between risk and benefit. However, a device is different, and the regulatory system approaches it in a different way.

I do not know the answer to that—I hope the noble Baroness, Lady Cumberlege, does. I echo what the noble Lord, Lord O’Shaughnessy, said. It would be a great pity if the Government did not listen very strongly to what she has to say, and I hope that they will consider her recommendations in full. I also hope that she will say something about the need to develop a system of safety culture in the health service. This goes much wider than surgical mesh or the issues that she is looking at for the review. As Ken Lownds, a safety expert, put it to me, our approach to safety compared to other safety-critical sectors has the feel of a cottage industry. That has to change, and I hope that the noble Baroness’s review and this debate will be a catalyst for that.

Tobacco Products and Nicotine Inhaling Products (Amendment etc.) (EU Exit) Regulations 2018

Lord Hunt of Kings Heath Excerpts

Tuesday 4th December 2018 Lords Chamber

[The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord O'Shaughnessy) (Con)]

My Lords, in introducing the regulations before the House today, I want to stress how critical they are in maintaining the UK’s commitment to be a world leader in tobacco control as we leave the European Union. The Government strongly believe that tobacco control legislation is crucial for stopping people smoking and reducing the harms associated with smoking. Whatever the outcome of the Brexit negotiations, that belief is unwavering.

As noble Lords know, the Government are focused on the successful passage through Parliament of the deal which has now been reached with the EU. Nevertheless, we continue to plan for all scenarios. The regulations before us have been laid for a no-deal scenario. If the UK reaches a deal with the EU, the department will revoke or amend this instrument to reflect that deal.

This instrument will ensure that the UK domestic legislation that implements the two main pieces of EU tobacco legislation—the tobacco products directive 2014/40/EU and the tobacco advertising directive 2003/33/EC—functions effectively after exit day. The instrument, made under the EU (Withdrawal) Act 2018, makes appropriate amendments and revocations to correct deficiencies in UK legislation and retained EU legislation.

Regardless of one’s views on Brexit, I see no reason why the amendments we are proposing through these regulations should not be supported. The proposed amendments are critical to ensuring that there is minimum disruption to tobacco control in the event that we exit the EU without a deal in March 2019. I would like to draw the attention of noble Lords to three main changes that this instrument would introduce.

First, in the event of a no deal, the UK will need to develop its own domestic notification systems for companies that wish to sell tobacco products and e-cigarettes to the UK market. The notification process is essential for ensuring that companies are complying with legislation on product standards. Both Public Health England and the Medicines and Healthcare products Regulatory Agency have commenced work to ensure that domestic notification systems are in place and functional by exit day.

Secondly, in the event of no deal, the UK will not hold copyright to the EU library of picture warnings for tobacco products. Requiring the industry to continue to use these pictures would breach copyright law. Picture warnings are a key part of tobacco control, and it is therefore extremely important that we continue to require the inclusion of graphic picture warnings on tobacco products. The UK has therefore recently signed an agreement with the Australian Government to obtain picture warnings free of cost, and I want to take this opportunity to express this Government’s gratitude to the Australian Government for their assistance in this matter. I would also note that this approach has received endorsement from Action on Smoking and Health, which has said about our proposals on notification systems and picture warnings that they are, “pragmatic and practical, minimising the amount of additional work involved if there were to be a no deal Brexit. We support the Government proposals for dealing with this short-term issue”.

Thirdly, this instrument proposes a transfer of powers from the Commission to the Secretary of State, permitting the Government to respond to emerging threats, changing safety and quality standards and technological advances.

In introducing this instrument, I must be clear that it will have some impact on the tobacco and e-cigarette industry. The department ran a short technical consultation in October to seek feedback on the practical issues that will affect the industry in a no-deal situation. We received 32 responses. Tobacco control stakeholders showed support for the continued use of picture warnings and amendments to the notification system as an effective way of stopping people smoking and as a means of harm reduction. The tobacco industry did raise concerns about the timing of implementation and cost, primarily in relation to the changes to picture warnings. However, I would stress that we did not receive detailed evidence or a breakdown of costs.

As noble Lords know, we have no control over timing issues—or at least this government department does not—as the implementation timetable is dictated by the timing of EU exit. The Department of Health and Social Care has therefore consulted with external experts, who have confirmed that the change in timescale is likely to be difficult but manageable. To mitigate these issues raised in the consultation by the industry, we intend to publish detailed guidance on picture warnings and the notification process in January 2019.

Before closing, I would also like to stress that the devolved Administrations have provided consent for the elements of this instrument which are considered devolved.

I hope that noble Lords can see that this instrument constitutes a necessary and important measure to ensure that our tobacco control regulations continue to work effectively after exit day in the event of no deal. I must emphasise that, due to the instrument being made under the withdrawal Act, the scope of the amendments in it is limited to achieving this objective. At an appropriate point in the future, the department will review whether the UK’s exit from the EU offers us opportunities to reappraise current regulation to ensure that we continue to protect the nation’s health and so that the UK remains a global leader in smoking cessation and tobacco control for many years to come. I beg to move.

[Lord Hunt of Kings Heath (Lab)]

My Lords, I am grateful to the noble Lord for this opportunity to discuss e-cigarettes. It is also a great opportunity to press the Minister on the Government’s Brexit situation. I do not think that we have heard him on this matter before. It is interesting to reflect on the confidence set out in the Explanatory Memorandum that,

“as a responsible government, we will continue to proportionately prepare for all scenarios”.

That is just as well because I do not share the Minister’s confidence that the future is at all clear or, indeed, that all scenarios have been planned.

I am sure the regulations are sensible but the Explanatory Memorandum takes us back to our debate when they originally came through your Lordships’ House, during which a number of us expressed concerns that the directive on which they were based takes too draconian a view on e-cigarettes. I happen to think that e-cigarettes are one of the most successful public health measures to help reduce smoking that we have ever seen. It is a great pity that some elements of the public health community that I know well and love have such a downer on e-cigarettes that they have encouraged a disproportionate approach to their regulation. In Grand Committee, the argument was put that e-cigarettes should be regulated in a completely different way from tobacco-based products. I remain convinced of that.

Of course, we must be very careful about the potential impact on young people. I know there are those who think that attractive advertisements and the way e-cigarettes are marketed can sometimes lead young people to take up smoking. The evidence for that is very dubious. We know that e-cigarettes are attractive to people over whose heads most public health campaigns completely fly. Although I fervently hope that we do not exit the EU next March, if we do and if the Government bring forward at some point new regulations on tobacco products in general, I hope they will take note of our debates and look at e-cigarettes in a completely different way.

[Lord Rennard (LD)]

My Lords, there are those—I am certainly not among them—who welcomed the idea of Brexit because they did not like the restrictions on the promotion of tobacco that we agreed across the EU. Contrary to the biased and selfish claims made on behalf of the tobacco industry, these regulations have been successful in reducing significantly the prevalence of tobacco smoking and its related diseases. We should never forget that tobacco products shorten the lives of half the people who smoke.

The tobacco lobbyists will be disappointed with the regulations because they show that they have lost the argument and there is now cross-party consensus on tackling tobacco-related problems. As the Minister said, even if we have the disastrous no-deal Brexit that some of those people want, the regulations will allow for a set of pictures, as currently used in Australia, to continue to appear on cigarette packs in the UK to warn smokers of the terrible damage done to their health by smoking.

As the Minister said, the regulations have the support of the excellent Action on Smoking and Health, of which I am a former director. Of course, they have my support too, but I would like to remind the Minister that the Tobacco and Related Products Regulations 2016 require the Secretary of State to review those regulations and publish a report before 20 May 2021. Some of the important points made by the noble Lord, Lord Hunt of Kings Heath, should be examined when that report is made. Some of us also feel passionately that e-cigarettes can and must be promoted effectively as an alternative to smoking tobacco, but in such a way as not to encourage people who have never smoked tobacco to take up an addiction to nicotine. I would like the Minister to confirm as well as he can that there will be no going back on our successful tobacco regulation policies, which are doing so much to improve the health and life expectancy of so many people. We should do nothing that reverses the excellent progress being made on this issue.

Health: Cancer

Lord Hunt of Kings Heath Excerpts

Thursday 29th November 2018 Lords Chamber

Asked by

[Lord Hunt of Kings Heath]

To ask Her Majesty’s Government what steps they are taking to improve (1) early diagnosis of, and (2) survival rates for, cancer.

[The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord O'Shaughnessy) (Con)]

My Lords, we know that early cancer diagnosis improves survival. Last month, the Prime Minister announced a package of measures to be rolled out nationally with the aim of seeing three-quarters of all cancers detected at an early stage by 2028. Since 2010, cancer survival rates have improved annually and are currently at a record high. Around 7,000 people who are alive today would not have been had mortality rates remained at the 2010 levels.

--- Later in debate ---

[Lord Hunt of Kings Heath (Lab)]

My Lords, the targets set by the Prime Minister and the progress made are obviously welcome, but the Minister will be aware that data from the national cancer registration service has shown that the early diagnosis rate for cancers has been static for the past two years, with 16 CCGs showing a decline in the rate. Patients are reluctant to go their GPs, GPs refer less than in other countries and hospitals are overwhelmed by referrals. How are we going to see a step change in the approach so that our success rates are more closely aligned to those of comparable countries, and does the Minister agree that we need to see the spread of rapid diagnostic centres?

[Lord O'Shaughnessy]

I do agree with that point, and indeed it was one of the policies announced by the Prime Minister in October. Of course we need to make more progress on early diagnosis. One-year survival rates have improved in the past 10 years but we still lag behind our continental neighbours, as we have done for decades. The noble Lord mentioned GP referrals, which have been in the news this week. The threshold for referrals from GPs to specialist cancer doctors has been reduced in line with the NICE guideline. The consequence has been that in the past seven years, the number of people referred to a specialist cancer doctor has increased by 1 million—that is, an increase of 115%. Therefore, we are seeing more referrals at an early stage. We are seeing many more appointments and of course those will feed through over time into our survival figures.

Mental Capacity (Amendment) Bill [HL]

Lord Hunt of Kings Heath Excerpts

Report: 2nd sitting (Hansard): House of Lords
Tuesday 27th November 2018 Lords Chamber

Moved by

[Lord Hunt of Kings Heath]

140: After Clause 3, insert the following new Clause—
“Requirement before commencement: consultation
Before any provisions of this Act other than those which come into force on its passing can come into force, the Secretary of State must publish a report listing the names of organisations consulted by the Government in preparation of the Mental Capacity (Amendment) Bill since 13 March 2017.”

[Lord Hunt of Kings Heath (Lab)]

My Lords, I have three substantive amendments in this group, Amendments 140, 141 and 143. Amendments 145, 146 and 147 are linked to and consequential on the first three.

Amendment 140 states that before the Act comes into force, the Secretary of State should publish a report listing the names of organisations consulted by the Government since March 2017 in preparing the Bill. I am very surprised that the Government have refused to list the organisations they consulted. I understand they refused an FoI request because it would be too expensive, which is difficult to understand. I think the Government and the Department of Health and Social Care are clearly embarrassed about the consultation they undertook. It was clearly one of those selective consultations, and I am afraid it reflects the rushed nature of the Bill.

The Law Commission undertook extensive work and published a draft Bill. Instead of discussing that with stakeholders and having the proper pre-legislative scrutiny for a mental capacity Bill, the Government essentially cherry picked the Law Commission Bill, did a rushed consultation, ended up in trouble and have now had to produce a load of amendments to try to put the Bill as right as possible.

I am grateful to the Minister and his officials for what they have done, but I do not think anyone believes this is a good Bill that will work in practice. I am sure the reality is that another Bill will have to be produced when it is found that this Bill, too, cannot be implemented effectively in the field, for all the reasons we have suggested. A Bill in this kind of area, particularly when it starts in the House of Lords, cries out either for pre-legislative scrutiny or at least—as the noble Lord, Lord Norton, has suggested on a number of occasions—a Select Committee process to engage with stakeholders and question officials before it reaches Committee in your Lordships’ House. It is a matter of regret that this did not happen. I am sure this will come up again in the Commons, and I still think we ought to know for the record which organisations were consulted on the Bill.

Amendment 141 relates to outstanding applications under the current legislation, which I raised in Committee. We are told that the reason for the Bill is the huge backlog of applications that have not been dealt with at all. The question is: what will happen to them? In Committee, the Minister said that,

“existing DoLS authorisations can continue until they are due for renewal or review”.—[Official Report, 22/10/18; col. 758.]

I well understand that; it is sensible. When they come up for review or renewal, they will then need to be dealt with under the provisions of this Bill, once it is enacted. But I want to know what will happen to the tens of thousands of applications that have simply not started. Because they have not been started, will they have to be dealt with under the existing legislation, or, if not, how will the sector cope with these thousands of applications under the new system?

All evidence suggests that, when you start a new process and then immediately put on to it all the people who have not been through the old process, it leads to chaos, because the system cannot handle it. I have mentioned my wonderful experience as Minister for the Child Support Agency. Mrs Thatcher invented the CSA, thinking she could reduce benefit payments because, in essence, benefits were being paid in circumstances where people were not paying maintenance to their partner who was looking after the children. She had the great idea that, by bringing in the CSA and making everyone on benefits go through the system, suddenly a lot of money would be produced. Of course, what it produced was absolute chaos. On the vesting day, everyone who was claiming benefits in those circumstances was immediately expected to come on to the system. I want to make sure that we avoid a similar situation here—as well as wanting to share with noble Lords a second time my angst with the CSA.

Amendment 143, my third in this group, relates to the code of practice. We have talked about this code on many happy occasions during our debates. Will the Minister explain how he sees the timing for the code, and confirm that it will have to be laid before Parliament? Finally, I hope the Minister will accept my amendment. He has put so much emphasis on the importance of the code; surely it should be approved by affirmative rather than negative resolution. I know that the Minister has given quite a bit on this Bill recently; I hope he might just give on that. I beg to move.

--- Later in debate ---

[Lord O'Shaughnessy]

That would be correct at the point at which it came before the House, but it would be published for consultation before then. There will be an opportunity for everybody—noble Lords, Members of the other place and stakeholders—to consider a draft and to recommend changes. The final product would be laid before Parliament.

We discussed the Mental Health Act review a little bit last week. We await its conclusions. Many of us have had conversations with Sir Simon Wessely about what it is likely to conclude, and about the interaction between the Mental Health Act and the mental capacity Bill when enacted. Since we are expecting its recommendations in the middle of next month—I think the scheduled date is the 12th—we will have an opportunity to consider the review’s recommendations before we move to the new system. Indeed, given that those recommendations will be out at about the time the Bill moves to the Commons, they will clearly be the subject of debate there. The Government will need to respond to those findings as we go through the Commons stages.

Amendments 143A and 147A, tabled by the noble Baroness, Lady Thornton, would require the Government, before the new system could come into force, to conduct public consultation on the Act with vulnerable people and other stakeholders and publish a report on its findings, as well as to publish their response to the Mental Health Act review and an equality impact assessment. I hope that I have dealt with the issue of public consultation, as well as consultation on the code and, equally, on the Mental Health Act review. The noble Baroness is quite right to bring the equality impact assessment to the House’s attention. It was prepared prior to introduction and required amendment following input from the Welsh Government. It will now need to be amended further to reflect the changes made in the Bill. I can commit to publishing the equality impact assessment before the Bill makes it to the Commons so that there will be ample time for consideration before it is debated there.

If the House will allow me, I will finish by thanking all noble Lords for their perseverance and patience during a sometimes difficult and challenging debate. We know that we all want to achieve the same end to our journey; there has been disagreement at times on the right way to get there. I am deeply grateful to all noble Lords for their contributions. The Bill has been immeasurably improved already in its passage through this House. That is a very good thing in itself and will have a very positive impact—notwithstanding the slightly gloomy prospect given by the noble Lord, Lord Hunt—when it goes to the other place and on to implementation.

Once again, I extend my sincere gratitude to all noble Lords. I hope that I provided reassurances on the amendments in this group and that they will feel able not to press their amendments.

[Lord Hunt of Kings Heath]

My Lords, I am grateful to the Minister. After such an uplifting response from him I do not want to drag us down again into negative thinking as we move on to Third Reading. I will just say that the problem with selective consultation is that it disfranchises some key respondents, and the problems we had over the summer were a consequence of that; it is a lesson to be learned for the future. I am grateful for the information about the work that has been done on the backlog. It will be important that the sector is clear as to which application falls under which part of the law. It is also very good that we will see the draft code in good time. Will the Minister arrange a briefing for noble Lords, rather than just going through a formal process? That would be extremely helpful.

Finally, Sir Simon Wessely’s review is clearly very important. It is obviously important that there be consistency, and the only thing I would say is that there are lessons for all of us for a future Bill in the way this Bill has been dealt with. There is no doubt in my mind that the issues raised by Sir Simon’s review lend themselves to pre-legislative scrutiny. Pre-legislative scrutiny is not fashionable any more, but my experience with the Mental Health (Amendment) Bill 2007 suggests that it doesn’t half pay off in terms of coherent legislation.

With that, I am very grateful to the Minister for his very full response and I beg leave to withdraw the amendment.

Amendment 140 withdrawn.