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.

Organ Donation (Deemed Consent) Bill

Lord Hunt of Kings Heath Excerpts

2nd reading (Hansard): House of Lords
Friday 23rd November 2018 Lords Chamber

Moved by

[Lord Hunt of Kings Heath]

That the Bill be now read a second time.

[Lord Hunt of Kings Heath (Lab)]

My Lords, I should first like to declare an interest regarding my forthcoming appointment to be a member of the General Medical Council.

[Noble Lords]

Oh!

[Lord Hunt of Kings Heath]

It is a good start, my Lords—just have to keep going.

Every year, NHS Blood and Transplant holds a number of very moving ceremonies with donor families. These occasions are wonderful celebrations of the gift of a loved one’s organ, to give life to others. Last year in England, there were over 1,300 deceased organ donors and over 3,300 transplants. That is a wonderful achievement but we could do so much more. My Bill aims to increase the number of organ donations while maintaining strong family involvement in the decision which, I stress, will remain a remarkably altruistic act of giving. Nothing in this Bill will change the concept of giving.

It is thanks to the tireless work of a number of people to promote the Bill, especially my honourable friends Geoffrey Robinson and Dan Jarvis, who secured unprecedented cross-party support, that we are today a step closer to putting it on to the statute book. I extend my thanks to the Prime Minister and my right honourable friend the leader of the Opposition, and to other leaders of the political parties in Westminster, for their continuous support for the Bill, and to the Daily Mirror, for its unflagging and enthusiastic support. I also pay tribute to the noble Baroness, Lady Randerson, who took forward subsequent legislation in Wales to allow organs and tissues under deemed consent to be used in transplants in the rest of the UK countries. I am hoping that she may inform the House of the latest progress in Wales regarding the legislative changes that occurred there.

The Bill is often referred to as Max’s and Keira’s Bill, in honour of a recipient, 10 year-old Max Johnson, who recently received a “Pride of Britain” award from the Prime Minister for his immense bravery while waiting for a heart transplant, and the donor, Keira Ball, who tragically died in a road accident. I pay tribute to both of them.

There is currently a record 20 million people in England recorded on the organ donor register, but 400 people died last year while waiting for transplants, and a further 755 people were removed from the transplant list as they were just too ill to receive treatment and a transplant. This is partly down to the fact that only 1% of people die in circumstances where their organs are suitable for donation. It is also partly because members of the family are often not aware of their loved one’s wishes, and sometimes find it safer to say no. Our ambition is to achieve an 80% consent rate in England. This will not happen overnight; the experience in Wales is clear in that respect. However, if we reach that target and 80% of families allow donation to go ahead, there will be 280 donors a year, which could lead to as many as 700 more transplants a year. The Bill, if enacted, will be a significant step forward. Starting from the basis of presumed consent, the family would still be fully involved in the decision. The aim essentially is to spark in England the positive culture change that many nations in Europe have experienced, following their change to an opt-out position. It will mean more people being inspired to have that incredibly important conversation with their loved ones, knowing that the life of a person waiting for a transplant could be saved.

In countries where deemed consent systems are in place, there are generally higher numbers of organ donations when supplemented with wider measures. I will return to that later. It is particularly pleasing to note that Wales has now reached a consent rate of 70%, and the first few months of 2018 showed that rising to 73%.

I would like to give a summary of the Bill, which consists of three clauses. First, however, I would like to clarify a few things about its scope. The proposed consent system only covers deceased donations—it does not apply to living donations or donations for research purposes. The Bill would make changes to the Human Tissue Act 2004, which covers England, Wales and Northern Ireland, but it would make the changes to consent in England only. The system of deemed consent in England will be consistent with the Welsh opt-out system. Transplants which currently take place under the current system—heart, lung, kidney, liver, pancreas, bowel and tissues such as corneas, skin, bones and tendons—will fall under the deemed consent provisions. Excluded from those provisions will be the less common organs and tissues, often called novel transplants. These will still require express consent.

Following consultation, regulations will be set out by the Secretary of State in an affirmative statutory instrument, which will specify which organs or tissues will be excluded from deemed consent. A Written Ministerial Statement will be part of the process every time the regulations are amended. It is important we have an approach consistent with Wales and Scotland on these issues to make sure that nurses and clinicians working across borders follow the same approach.

There are other important safeguards in the Bill. First, all children below 18 will be excluded from deemed consent, although they will still be able to register as now to donate their organs. People who are not ordinarily resident in England for at least 12 months immediately before their death will be exempt from the new arrangements. In practice, this means that people living in England in the short term will not be affected by changes in the consent system. The Bill also provides a safeguard for people who lack the capacity to understand the concept of deemed consent for a significant period before their death. The decision on whether a person lacks capacity will continue to be established in accordance with the Mental Capacity Act 2005.

Very importantly, the Bill sets out the role of the deceased family and friends under the proposed arrangements. It makes it clear that they may provide information suggesting the deceased would not have consented, to prevent donation proceeding. This is very important. I reassure noble Lords that the family of the deceased will continue to be involved in discussions with specialist nurses about their loved one’s wishes and how best to support those wishes, also taking account of faith and cultural considerations. Clinicians will never proceed if the family object strongly. I know the Government have worked hard with different faiths to ensure that they are comfortable with how deemed consent will work. As Kidney Care UK put it, changes in the law on consent do not change the importance of people talking to their families about their wishes in respect of organ donation.

To support the smooth implementation of the provisions in the Bill, it places a duty on the Human Tissue Authority, the regulator, to update its code of practice and issue practical guidance for professionals. The new codes will be consolidated in a single code, to be consulted on and laid in Parliament. The Bill will also allow all organs removed in England for transplantation purposes to continue to be used across the UK, to save as many people in need as possible.

Clause 3 sets out that the Bill extends to England, Wales and Northern Ireland as it will be amending the Human Tissue Act 2004, which extends to those countries. It sets out that Clauses 1 and 2 will come into force on the day or days that the Secretary of State appoints in regulations made by statutory instrument, so in effect the Secretary of State will have to set out what the commencement date is for deemed consent in England. Clause 3 automatically comes into force on the day that the Act is passed.

I recognise that a change to the consent system is not a panacea. The Bill needs to be accompanied by an assurance that capacity in the NHS in terms of transplant teams, intensive beds and specialist nurses will be sufficient. I particularly mention the need for good-quality training and greater numbers of specialist nurses. They are remarkable people who have the extremely difficult role of initiating discussions about potential organ donations with families at such a sensitive time. The Spanish experience is that investment in specialist nurses is one of the major factors in their success and the transformation that has occurred in Spain.

It will be essential to have a strong communications strategy to ensure that the public are fully aware of the changes, and I look forward to the Minister’s response on that. I would also say—and I think this is the Welsh experience—that it is important to have follow-up campaigns because clearly, the cultural change we want to see will not happen overnight.

I end by saying that I am clear that the gift of giving will be as strong a part of organ donation as ever. I thought the Minister in the other place, Jackie Doyle-Price, put it well when the Bill went through its Commons stages:

“The most important thing any of us can do if we want to increase organ donation is ensure that we all have those conversations with our families, so that they understand our wishes … One of the great virtues of the Bill and the surrounding campaigns is that we have encouraged people to have those conversations. It has been a real driver of cultural change in that sense”.—[Official Report, Commons, Organ Donation (Deemed Consent) Bill Committee, 12/09/18; cols. 11-12.]


I think that puts it very well. I am confident that, if enacted, the Bill will play a significant role in changing the culture towards organ donation in England and help hundreds of lives in the years to come. I beg to move.

--- Later in debate ---

[Lord Hunt of Kings Heath]

My Lords, I thank the Minister for that very authoritative response and to echo what he said about the time pressure that we face. I also thank all noble Lords who have taken part in what the noble Lord, Lord Carlile, was surely right to describe as a very moving but also ethically and intellectually based debate. Where else indeed could we do it? I am also grateful to the noble Lord for his advice on the GMC. I realise I am not going to be short of advice, but I am in that glorious honeymoon period where I am not actually responsible yet. On 1 January, I might hide round some corners if I see the noble Lord coming.

This has been a very moving debate. Essentially, it is a celebration of the gift of donations to help others. I thought that my noble friend Lord Elder put so aptly what this really means to so many people in our country. It is also interesting that the noble Lords, Lord Patel and Lord Lansley, said that they had changed their minds. I am in the same camp. I was responsible for organ donation between 1999 and 2003. I also had to deal with the aftermath of the Alder Hey debacle and I well remember some parents having to go through three or even four burial ceremonies as more organs and tissues of their children were found. I have therefore always taken a very cautious approach to this issue but, like the noble Lords, Lord Lansley and Lord Patel, I have become convinced that it is time to make a change. The evidence for presumed consent is stronger, I think, and I am very grateful to the noble Baroness, Lady Randerson, for what she had to say. Public opinion has changed, and the infrastructure has improved immeasurably. We should acknowledge that in relation to capacity, transplant teams and specialist nurses, there have been very significant improvements. I welcome what the Minister said about future developments, particularly the increase in the number of these key specialist nurses.

All noble Lords—the noble Lord, Lord Ribeiro, the noble Baronesses, Lady Finlay and Lady Chisholm, and my noble friend Lady Crawley—have emphasised that alongside the change, we need to have a public campaign. The noble Baroness, Lady Brady, said something which I thought was really important: no one should be surprised by the change. I think we should set that as our aim in the campaign. This is not a waste of money; this will have a big impact to the good on the public.

I echo what the noble Lords, Lord Patel and Lord Ribeiro, said about the shortage of donors from black and minority ethnic communities. I welcome the campaign this summer; we just need to build on it. I also welcome the discussions with faith leaders and the assurances given by Ministers. I echo and endorse those assurances and the contents of the letter that the Minister referred to.

The noble Lord, Lord McColl, and the right reverend Prelate the Bishop of Carlisle expressed some concerns that this Bill will have the opposite effect to its intended one. The noble Lord, Lord McColl, has grave doubts about the figures used for outcomes. Clearly, this is a significant step change; I acknowledge that. The right reverend Prelate thinks the balance between individual families and the state will be disturbed by it. It is a change, of course, but I believe that, with the safeguards, there is still balance in the provisions, and the change is being made in line with public opinion and the improvements in the infrastructure.

On organ trafficking, I agree with the noble Baroness, Lady Finlay, but I do not think this Bill is the right place to debate it. I pay tribute to the noble Baroness, Lady Deech, whose distinguished work in the area of human tissues is unequalled. I agree with her about the need to maintain trust. She referred to the Nuffield Council and its comments about how to make this work ethically; I agree with the points about easily accessible information, families being at the heart of decision-making and the network of specialist nurses. We heard a really reassuring view from the Minister about how that will be taken forward; clearly, we need to hold the Government to account on that.

As my noble friend Lord Elder said, this Bill is not a panacea. It will not, by itself, lead to a large increase in donations. However, it is a step change. It will help to raise awareness, encourage family conversations and change the culture, and that will lead to a higher consent rate in England. In that way, hundreds of lives will be saved. I am convinced this is the right way to go.

Bill read a second time and committed to a Committee of the Whole House.

Mental Capacity (Amendment) Bill [HL]

Lord Hunt of Kings Heath Excerpts

Report: 1st sitting: House of Lords
Wednesday 21st November 2018 Lords Chamber

[Baroness Hollins (CB)]

My Lords, I welcome the replacement of “unsound mind”, but I ask the Minister to consider adding a safeguard to ensure that no one has their liberty denied because of a mental disorder without first being seen by a qualified doctor. It is essential that individuals are assessed for a mental disorder and not another condition presenting as a mental disorder, such as delirium or the side-effects of medication, which are common among older people. It is important that consideration is given to whether the disorder can be managed without depriving the person of their liberty. This requires assessment not only of their mental state but of their past and current physical health and medication. The assessment is a core part of this process. It has great significance because it relates to the deprivation of a person’s liberty. Who can carry this out should be stipulated in the Bill rather than in a code of practice. I ask the Minister to reconsider bringing forward an amendment to add this requirement to the Bill.

[Lord Hunt of Kings Heath (Lab)]

My Lords, I support the noble Baroness on the assessments. The Minister’s amendment is very welcome, but clearly the assessment is crucial. My understanding is that in previous debates, as the noble Baroness suggested, he said that the code of practice will set out which competencies will be needed to carry out this assessment. Like the noble Baroness, I ask him to consider, perhaps between now and Third Reading, whether this might be better put in regulations than in the code of practice. I always worry a bit about the use of “competencies”. It is a word now used in many recruitment processes, but what exactly does it mean? Will it be done by a registered medical practitioner with sufficient expertise in this field? If not, what is the justification? The change the Government have made is enormously welcome, but it is very important that we are confident the assessment will be carried out appropriately.

[Lord Touhig]

My Lords, this group of amendments is most welcome. The term “unsound mind” is offensive in the extreme and historically has been used as a form of abuse to demean the dignity of the person to whom it is applied. These amendments mean that this old-fashioned term will no longer be in the Bill and that a phrase with no clinical meaning is rightly removed. Using the same term as the Mental Health Act, “mental disorder”—this link is explicitly made by the Government in Amendment 12—provides better diagnostic clarity.

Amendments 25 and 50 in the names of my noble friend Baroness Thornton and the noble Baroness, Lady Jolly, change “unsound mind” to,

“any disorder or disability of the mind”.

The Minister responded to those points in his opening speech. This is the language currently used under the DoLS in the Mental Health Act and it is to be welcomed.

Perhaps I may share with the House my personal experiences. My late mother suffered two nervous breakdowns in her life. One occurred before I was born, when she was put into an institution, where I do not think she was well treated. Later, she suffered a further breakdown when I was 16 and I had to take the lead, coping with and co-ordinating help and support for her, my father and our family. The consequences of her breakdown that I witnessed were traumatic not only for my mother, who was a loving, kind and thoughtful individual, but for our family, who witnessed times when she seemed to grow away from us.

My mother made a recovery and we all came through it, thanks to the devotion and understanding of our family doctor, our wider family and friends. However, our family experience has given me an understanding of some of the consequences of mental illness for individuals and their families. Families who experience what mine went through need support and understanding to cope, which is why I welcome the amendments.

I have said that the term “unsound mind” is used to cover many things. It is one that personally I find offensive, and I rejoice that those words are being removed from the Bill.

--- Later in debate ---

[Baroness Finlay of Llandaff]

My Lords, there is a tone of disappointment because I welcome all the government amendments, but the role of my amendment to government Amendment 52 was twofold. First, I am disappointed that speech and language therapists were not in that list read out by the Minister, because we had a debate about the importance of communication skills. When communication is impaired, particularly with disorders that affect any part of the speech or throat cycle, it is very difficult to assess someone’s capacity.

I included skills because I worry that experience and knowledge are sometimes just not enough. If the Government insist on “skills” going into the code of practice, I hope that the Minister will be able to confirm that the skills will be assessed and reviewed at appraisal, and that they demonstrate an understanding of the impact of fear—being frightened—on the way the person behaves.

The assessors must have a high level of communication skills and awareness of all the different ways that communication can be enhanced. I hope that they would also have an awareness of the impact of different types of medication on someone’s capacity, because sometimes changing the medication can really improve a person’s ability to make a decision for themselves.

Amendment 53 links to Amendment 74, which is in my name and will come up later. I am concerned that, without strong reassurance, some of these issues could slip by and we could inadvertently end up having superficial assessments of some people and not the thorough and in-depth ones they deserve. The whole principle of the Mental Capacity Act is to empower people to make their own decisions, and we are talking about trying to have the least restrictive option so that we can enhance a person’s liberty as much as possible. If that assessment is not meticulous with the appropriate skills, the wrong judgments could end up being made.

[Lord Hunt of Kings Heath]

My Lords, I realise that in the last group I mentioned general medical practitioners. I ought to inform the House of my forthcoming appointment to the General Medical Council.

We have had a lot to read in the last few days, and are clearly going to have to take a lot of this on trust, but the thrust of the amendments is welcome, and I am grateful to the Minister for tabling them. As he said, they strengthen the role of local authorities and give them a clear remit to intervene where they feel that, for one reason or another, the care home manager cannot discharge the responsibilities given in relation to the authorisation application appropriately.

In the letter that the Minister sent to a number of noble Lords, he set out factors that might be considered by the local authority as a responsible body. These would be:

“Whether the person has a care plan with the responsible body … local intelligence about a local provider of care homes”,


which would suggest that the responsible body takes over the process;

“insight from local commissioners or concerns about performance … sustained absence of a registered manager”—

or presumably when the turnover of managers is high, as it can be; and—

“an increase in concerns raised by residents, their carers or families … a new service or category of care provision, and/or … provision of poor or incomplete statements”.

To me that sounds very comprehensive and welcome.

What arises from this is that the responsible body will have to make a considerable judgment and, to make it, will need a very clear understanding of the care homes in its area. Could the Minister say a little about how he thinks that local authorities might be supported in that role? Clearly, they now have a major role which they have found it hard to discharge, for reasons that have been discussed. It is important they are able to do this in a consistent way.

The Minister mentioned the code of practice. It is a statutory code of practice, which I think means that it must be followed unless the local body has very good reason not to do so. It would be interesting to know what plans the department has for checking with the local authorities—not in a heavy-handed way—how well it is going after time and implementation, and seeing whether there is consistency across the country as a whole.

[Baroness Barker]

My Lords, I too welcome the Government’s change of mind. They started with a very different understanding from ours of the current roles of care home managers, local authorities, best-interests assessors and DoLS assessors. I think we still have a difference of opinion about how life works in practice, but these amendments show a considerable movement, if not complete agreement on that part, and therefore we welcome them. I feel it is right to remind the Minister that when the Select Committee of your Lordships’ House did the post-legislative scrutiny on the Mental Capacity Act and its workings five years after its implementation, there was an overwhelming lack of information and data both in local authorities and throughout the health service. I rather think that we have been perhaps unnecessarily preoccupied in this Bill with who carries out a particular function rather than looking at the way those functions could possibly be streamlined and better audited.

I do not think that the work of a local authority best-interests assessor or a DoLS lead, however they may be termed under the new scheme, is actually going to change that much, but I welcome the attempt here to meet us half way, and I thank the Minister for that. Well, perhaps it is more than half way in terms of our assessment that what was being asked of care home managers was beyond their capacity to deliver. Big questions still need to be asked about their role in the overall scheme. If we had not spent quite so much time on this, we might have been able to look more closely at greater efficiencies in terms of reporting and so on. For the moment, however, I welcome these amendments.

Vaping

Lord Hunt of Kings Heath Excerpts

Tuesday 13th November 2018 Lords Chamber

[Lord O'Shaughnessy]

The FDA has certainly said that it is facing an epidemic of childhood use, but the numbers are quite stark in their difference. In America, many more young people use e-cigarettes compared to in this country, where only 2% of 11 to 18 year-olds are using once a week. Generally, those are young people who smoke already—around 7% of 15 year-olds smoke. America did not restrict tank sizes until recently, but we did; it did not restrict bottle sizes, but we did; it did not ban advertising, but we did; and it does not have restrictions on nicotine, but we do. We have a very sensible system. I am not complacent about the need to make sure that young people do not use, which we are not seeing yet, and there are severe restrictions and punishments for any retailer who sells such products to children.

[Lord Hunt of Kings Heath (Lab)]

My Lords, is it not clear from the evidence that, while we have to be very careful about use by young people, this is the most successful tobacco prevention or stopping measure we have ever had? It is important that we keep a measure of balance in our approach to this.

[Lord O'Shaughnessy]

I completely agree with the noble Lord, and I think that we have the right balance: 57,000 people a year quit smoking through e-cigarette use and that is just about the most important thing you can do to improve your health.