Safety of Medicines and Medical Devices

Baroness Finlay of Llandaff Excerpts

Thursday 28th February 2019 Lords Chamber

[Baroness Finlay of Llandaff (CB)]

My Lords, like others I congratulate the noble Lord, Lord O’Shaughnessy, on securing this debate, and welcome the illuminating contribution from my noble friend Lord Carrington in his maiden speech.

I will focus in this debate on the role of the National Institute for Health and Care Excellence, which is building on its 20 years of experience, and will look forward to what needs to be done. I declare that I am vice-chair of a guideline review group on ME and chronic fatigue syndrome, a review that was precipitated by patient voices and has good patient representation on it. I should also declare that my husband has done a great deal of work on patient and family-reported outcome measures, which may be relevant here.

NICE guidance covers, as we all know, the safety and efficacy of interventional procedures and the managing of specific conditions and medicines in different settings. Its technology appraisals of new pharmaceutical and biopharmaceutical products, procedures, devices and diagnostic agents are recognised around the world. Any device under consideration must have a valid and current certification, which comes from the EU at the moment, and be registered with the Medicines and Healthcare products Regulatory Agency. But the EU certification process itself seems at times to be flawed.

NICE has now gone into formal partnership with the MHRA to try to share intelligence and understanding, and to monitor key issues. However, adverse event reporting is a major problem for them in this work because it relies on clinicians notifying such events, as through the yellow card scheme. As with any voluntary reporting system, reporting is incomplete—sometimes woefully so. There is an inherent bias to report the positive benefits of interventions in research papers and underreport adverse effects. There were 62,000 adverse incidents reported over the last three years, a third of which had serious repercussions. However, this is only a small number compared with those that have happened across Europe.

In recognition of this, NICE rigorously reviews its current guidelines and seeks the sources of adverse events. Unfortunately, safety outcomes are poorly addressed in randomised trials; large numbers of treated patients are needed to reliably detect uncommon yet serious events from sources such as large case series, surveys, registers and individual case reports. Sometimes unpublished evidence is the sole source of such information. There are databases, including the US Food and Drug Administration’s manufacturer and user facility device experience database, called MAUDE. Importantly, this is available to the public and is used by sources in this country.

It is essential that safety information and evidence of harm are collected and rapidly disseminated. NICE’s medicine awareness service, with its network of prescribing associates and monthly digest of important new evidence in medicine, aims to reach out widely. But it must be strengthened, and it must have a database to draw on.

Changes to NHS structures in recent years have made dissemination more difficult because responsibility for the implementation of such guidance does not fall to any single body—hence NICE’s agreement with the four nations, a document on safely introducing new procedures. But we need to do much more to strengthen this. All NHS providers should ensure their governance structures require reporting of outcomes, including adverse events, as well as dissemination of information. Clinicians undertaking any interventional procedure, and the suppliers of devices and equipment, should be routinely asked whether any complications have arisen in the short or longer term rather than just leaving it up to them to decide whether such complications are serious enough to report. Patients must be asked too.

All this data can be entered on a mandatory relevant national register, maintained to a sufficiently high standard to deliver evidence to clinicians for decision-making and for informed funding decisions. The quality of registers at the moment seems to be disappointingly variable. Without efficacy and safety information, problems will continue to go undetected and unpublicised.

I turn briefly to another aspect of the control of medical equipment, which is the problem of purchasing. The review by the noble Lord, Lord Carter, highlighted the wastage of duplication and variable pricing—but price is not the only determinant. I will relate a simple problem that concerns syringes. The bulk buying of cheaper syringes seemed to be a good idea. However, they had to be discarded because the plunger was loose-fitting, which meant that, on injection, the contents of the syringe were bypassed and we did not know how much of the drug had been injected into the patient. Contracting had to revert rapidly to a previous, reliable supplier.

Many pieces of tubing, wiring, cannulae et cetera are used every day in clinical practice. They must be of the highest standard and must not break or fracture inside a patient, because major surgery might be required to remove them. I suggest that the light-touch regulation that we have had in the EU should be replaced by a tighter, more rigorous system, so that things are manufactured to a higher standard and we know where the components have come from.

In the last moments of my speech, I remind the House of a speech by Baroness Jowell, to which the noble Lord, Lord O’Shaughnessy, also referred in his opening remarks. She was inspiring on 25 January last year when she called for adaptive clinical trials and the right of patients to try novel therapies. The parents of Charlie Gard, who had type 2 mitochondrial DNA depletion syndrome, wanted him to try nucleoside therapy, which had been tested on type 1 but not type 2 of the condition. The drug would have been taken orally and dissolved in milk—with the only known side-effect being diarrhoea—at an estimated cost of around £5,000. Charlie died before his first birthday, having been denied the possibility of trying this, and his parents, with whom I have had several conversations, live in their bereavement with the haunting thought, “If only we could have tried it”.

In her speech calling for a new approach to novel therapies, Baroness Jowell said:

“It is about the power of kindness, support for carers, better-informed judgments by patients and doctors, and sharing access across more and better data to develop better treatments”.—[Official Report, 25/1/18; col. 1169.]


Sometimes we must allow people to take risks for the benefits of others, because data is critical. Safety sometimes means that we have to allow carefully assessed risks rather than resort to inactivity, so that we can develop new evaluation processes.

Mental Capacity (Amendment) Bill [HL]

Baroness Finlay of Llandaff Excerpts

Tuesday 26th February 2019 Lords Chamber

[Baroness Tyler of Enfield (LD)]

My Lords, I take this opportunity to welcome the Minister to her new role. I am very much looking forward to working with her, and thank her for meeting me yesterday.

I was pleased that the Government listened to the concerns that many of us raised when this Bill was on Report, and that they agreed to introduce a statutory definition in the Bill. They subsequently brought forward a new clause in the other place, introducing what some have termed an exclusionary definition of deprivation of liberty.

I believe that there are serious problems with the government definition. My overriding concern is that as it currently stands, the government amendment defines only when a person is not being deprived of their liberty. A definition based on someone not having their liberty restricted does not, in my view, allow for a clear assessment of whether a cared-for person is currently being deprived of their liberty. The whole of the definition is couched in the negative, and splattered with double negatives, which I consider very difficult to understand.

I also have concerns over Clause 1(4) in the government definition, which I believe is unnecessary. When it is in someone’s best interest to receive emergency or routine medical care, there is already a clear consent procedure—even when that patient lacks capacity. As currently worded, it is discriminatory between physical and mental illnesses. I have taken much advice, and I am grateful to people in the sector—charities, lawyers, human rights groups, academics and others—who have offered invaluable expertise in this very complicated issue. I note that some leading academics have described the Government definition as too complicated, unclear and out of step with Article 5 of the ECHR, and therefore likely to lead to costly litigation. I accept that my last two points run contrary to what the Minister has said, but this demonstrates what a highly complex, contested and difficult-to-interpret area this is. Nothing is that clear-cut.

What is needed is a definition which is simple, easy to understand and provides practitioners, and above all, families and cared-for people, with a clear understanding of where they stand. The purpose of any definition is to provide absolute clarity to practitioners. Perhaps more importantly, it should tell cared-for people and their families when they are deprived of their liberties and thus have certain rights which they can call upon. It is, frankly, of little use if people cannot use it to make such a determination, and my conclusion at the moment is that the definition does not serve that purpose.

We need a definition which, as well as being simple and easy to understand, allows guidance and information to be developed for families and practitioners that will allow them to make a real-world determination of whether the care arrangements they are putting in place when their loved ones lack capacity amount to a deprivation of liberty.

The definition that best captured the recommendations from the Cheshire West case of the noble and learned Baroness, Lady Hale is that the person concerned is under continuous supervision and control and is not free to leave. I believe that the wording in Amendment 1B meets these vital tests. My definition of what constitutes a deprivation on liberty is based on the principles outlined in the noble and learned Baroness’s judgment in the Cheshire West case. I believe that it would allow practitioners and family members to clearly test their individual circumstances against that definition.

This is complex and I think many of us have found it difficult to get our head round it, but it is so important that the definition is compliant with Article 5 of the ECHR. The definition that I have put forward meets that test. It may not be perfect but it provides a basis for moving forwards. I beg to move.

[Baroness Finlay of Llandaff (CB)]

My Lords, I commend the noble Baroness, Lady Tyler, for the amount of work that she has put into her amendment, along with others of us who have worked on it. I do not want to take a lot of time repeating what she has already said in explaining it. However, I would like to pick up on some criticisms made by the Minister and question them.

The Minister spoke critically about the concept of “valid consent” yet, as far as I have understood, consent must always have three pillars to it: the person must have capacity to make that decision; they must have accurate information on which to make a decision; and it must be made voluntarily and free of coercion. With those three pillars in place for all types of consent, I was slightly confused by the Minister’s suggestion that this could somehow apply if people did not have capacity to provide consent. The other area where I was confused when she spoke relates to the Government’s own amendment, where we have a double negative. Amendment 1 says:

“A person is not deprived of liberty in a particular place if … the person is not subject to continuous supervision”.


However, the amendment tabled by the noble Baroness, Lady Tyler, has turned the two negatives into a positive as while a person would be “subject to continuous supervision”, she has added the very important words “and control”.

A lot of people who are supervised one way or another are free to do what they want, but there is a safety barrier around them. They are not being controlled in the way that they behave; it is simply that to protect them from dangers to which they may be subject, there is a degree of supervision. That is called good care of another citizen, and we all do it all the time in relation to each other if we see someone about to get into a situation which is dangerous, whether or not they have mental capacity. The difference in this situation is that if somebody is deprived of their liberty, something is being taken away from them and controlled by another person. The amendment from the noble Baroness, Lady Tyler, has captured that difference between a duty-of-care supervision and that control.

I know that there are difficulties in defining a negligible period of time but I note the concept, in the Government’s own amendment, of whether somebody is free to leave a place permanently. How long would we determine “permanently” to be? Is it days, weeks, months or years when, again, it is a concept but is not defined specifically? With those questions, I am concerned that the Government’s criticism of the noble Baroness’s amendment does not stack up equally with the criticisms that have come from many quarters over the Government’s amendment, which is indeed quite difficult to understand, particularly because of the double negatives in it.

I draw the House’s attention to the fact that, if I am correct, the Law Commission’s original report did not include a recommendation of a definition. Perhaps what we see here is that it is incredibly difficult to come up with a definition that applies across the enormous range of circumstances that people who lack capacity may find themselves in. I am concerned that the Government’s amendment is intended, in the words of the Minister, to be able to respond to evolving case law. I suggest that that is a recognition that there will be legal challenges to the Government’s own definition, just as much as to any other, and I am unsure how that will be avoided by anything in the Bill. I will therefore strongly support the amendment in the name of the noble Baroness, Lady Tyler.

--- Later in debate ---

[Baroness Meacher (CB)]

I shall speak very briefly. I welcome very much Amendments 13 and 22 in particular in relation to independent hospitals. In Committee, a number of us raised that issue and were very concerned that independent hospitals, which are often hundreds of miles away from a person’s home, could act as the responsible body and make crucial decisions where perhaps they have a commercial interest in keeping that person on their premises.

With the permission of the current Minister, I will applaud the noble Lord, Lord O’Shaughnessy, because I feel I know that he played a key role in making sure that these amendments found their way into the Bill. The stipulation that the local authority shall be the responsible body is important. Although I understand what the noble Baroness, Lady Thornton, is saying, it seems to be a huge step forward to take the responsible body away from the independent hospital. I would like to feel that local authorities—the professionals dealing with the assessment of such cases—would have a real interest in making sure that those people returned home, if at all possible, as soon as possible. That is what all this should be about.

The other matter I will raise briefly is that of people in domestic settings, where deprivation of liberty is at stake. At our recent meeting with the Bill team we were assured that such cases would be dealt with under this new piece of legislation in the course of the normal care planning process, rather than requiring a reference to the Court of Protection. When an elderly person is caring for a demented husband or wife, the last thing they need is some bureaucratic requirement. This seemed very important, and I was delighted when the Bill team gave us an assurance that this, too, was being dealt with.

There is nothing in the Commons amendments on this, but I wonder whether the Minister could give the House an assurance that it will indeed be the case that people in domestic settings will be dealt with within the local authority planning process, and will not require a reference to the Court of Protection.

[Baroness Finlay of Llandaff]

My Lords, I apologise—I should have declared my interest as chair of the National Mental Capacity Forum at the beginning of the previous debate. Like others, I thank the noble Lord, Lord O’Shaughnessy, for having made sure that the Bill is now in much better shape than it was when it came to us.

I am very grateful to the Minister for confirming that the whistleblowing amendments are there, and in fact are, if I have understood correctly, stronger than when they left this House. I have a couple of questions for her, though. One relates to the group of people who can become approved mental-capacity professionals. I was concerned that she did not include speech and language therapists in her list. People who have communication difficulties can be extremely difficult to assess. Those with a brain injury affecting the speech area can be very difficult indeed to assess because they may also have frontal-lobe disorders, as the noble Baroness herself well understands.

I know that the regulations will be brought forward, and I hope that the Minister will be able to consider additional training—not part of general undergraduate training but additional, postgraduate training for speech and language therapists to be able to develop a full set of competencies and undergo the same training as other people. I think that, without it, we will end up with duplication of assessments and duplication of costs.

My other question relates to portability. I hope that the Minister can confirm that the portability concept, which was so welcomed in the liberty protection safeguards, remains and will be applicable so that people can move between different settings without needing a reassessment. Obviously, emergency medical treatment can arise at any time with anybody, and that is covered separately for someone who lacks capacity and must be treated: that would come under a best-interest decision-taking process anyway.

My last query relates to the determination conditions and the assessment. I have a slight concern on reading the amendments that the assessments seem to be separated from the determination. If I heard the Minister correctly, she said that the care-home managers would not be making either the assessments or the determinations. We had a lot of concern over care-home managers and conflicts of role in previous debates, and I would be grateful if she would confirm that this is my correct understanding, and that we have not had a way whereby the care-home manager can undertake the assessment, and then somebody else, based on that assessment, will make a determination, because the validity of the assessment will determine the validity of the later determination.

Those are my queries in relation to this, and the determination and assessment question relates in particular to Amendments 28 to 38, to which the Minister has already spoken.

[Baroness Barker (LD)]

My Lords, I will make three quick points. One is to thank the Minister for the way in which she set out the ways in which the Government listened to the debates at an earlier stage in this House. We had deep misgivings about the lack of attention that we have been able to pay to independent hospitals. I am very glad that the reassurance that they will no longer be the responsible bodies has been given by the Government in another place.

Anybody who has followed our deliberations in great detail, as some people have, will know that we have had to spend an awful lot of time during the passage of this legislation focusing on care-home managers and the inappropriate responsibilities that they were given in the initial draft of the Bill. I am not entirely convinced that in relation to independent hospitals or local authorities we have entirely separated responsibility for assessment, responsibility for determination of what constitutes a care package and deprivation of liberty, and responsibility for the financing of those care packages. If the Bill had started off in a better shape, perhaps we would have been able to spend much more time on that, as we should have done. Therefore, it is important that at this stage we take on board the points made in Amendment 41A tabled by the noble Baroness, Lady Thornton, and make sure that we have not left a conflict of interest anywhere in the Bill.

Mental Health: Eating Disorders

Baroness Finlay of Llandaff Excerpts

Monday 25th February 2019 Lords Chamber

[Baroness Blackwood of North Oxford]

First, at the beginning of Eating Disorders Awareness Week, I pay tribute to mental health professionals, charities, researchers and campaigners who have done so much to raise awareness, fight stigma and help the Government and the NHS improve mental health services over recent years. The noble Baroness is absolutely right that, while we have made a lot of progress with children’s eating disorder services, we must not forget adult services. That is why the NHS Long Term Plan has committed to test four-week waiting times for adults and older adult community mental health teams. We have not exactly pinned down what the scope of these pilots will be, but we expect that areas in receipt of new funding will be those that will expand those services.

[Baroness Finlay of Llandaff (CB)]

My Lords, given the high mortality and morbidity in both adult males and adult females—particularly university students who may be postgraduate students and who, at the time of presenting, may not have significantly changed their body mass index but whose risk of dying actually goes up enormously if they are not referred at that point—will the Government undertake to request that contracts from NHS England to services no longer require body mass index as a referral criteria? I declare my interest as chair of governors at Cardiff Metropolitan University.

[Baroness Blackwood of North Oxford]

The noble Baroness is exactly right. NICE clinical guidance is clear that people should not be rejected for treatment solely on the grounds of their weight or body mass index. This is an issue that Hope Virgo in particular has campaigned on very effectively to improve awareness of treatment of eating disorders. She has discussed her campaign with NHS England and the department, and I am pleased to confirm that my ministerial colleague Jackie Doyle-Price will meet her in the coming weeks to see what more can be done.

Healthcare (International Arrangements) Bill

Baroness Finlay of Llandaff Excerpts

Committee: 1st sitting (Hansard): House of Lords
Tuesday 19th February 2019 Lords Chamber

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

My Lords, I point out that if Amendment 4 is agreed, I cannot call Amendment 5 by reason of pre-emption.

[Baroness Finlay of Llandaff (CB)]

My Lords, I listened to the first part of the debate today, and I add my welcome to the Minister to her new post. I regret that I was unable to be here at Second Reading because of a commitment that I could not cancel, and I declare that I am a member of the European advisory group to the Wales Assembly Government. I added my name to the amendment because the Bill goes far beyond its purported remit by providing the ability for the Government to create new policy relating to healthcare agreements with countries outside the European Union, the EEA and Switzerland.

We all understand that there is need for speedy passage of the Bill because of the approaching deadline, but the question arises: why not restrict it to the problem that it has to solve? Given that the purpose of the Bill is to ensure that reciprocal healthcare arrangements are in place once we have left the EU, it is appropriate that the Secretary of State’s powers are limited to do just that and nothing more. As I understand it, that is what the amendment is intended to, and does so for three reasons, because it aims to achieve three things.

First, it aims to ensure that UK patients in the EU and vice versa can continue to access healthcare easily, including those with long-term conditions. Secondly, our NHS is protected from a dramatic increase in demand for services that a failure to reach an agreement could generate. We anticipate that 190,000—some figures say 180,000—UK pensioners in Europe are currently reliant on reciprocal healthcare. They may otherwise have to return to the UK for treatment if healthcare agreements are not replicated. Thirdly, the General Medical Council has already pointed out that the medical profession could be deemed to be at breaking point. Those working in healthcare need to be able to focus on providing care rather than on cost-recovery and complex administration.

I have questions for the Minister on that. In the event that we do not have an agreement and cannot get reciprocity, as we would like, how will the identity for eligibility be confirmed? How many people will need to be employed to make the relevant checks? Do the Government plan to issue current NHS cards that must be presented to prove eligibility, and would such NHS eligibility be incorporated in visas to work, study or be resident here?

Clause 2 authorises the Secretary of State to make regulations,

“in relation to the exercise of the power conferred by section 1 … for and in connection with the provision of healthcare outside the United Kingdom … to give effect to a healthcare agreement”.

I fully accept the Minister’s sincere confirmation that this is not a trade Bill, but I have a question about that. We have had firm confirmation here but, in the other place, something contrary was said and recorded. Which has precedent? Does what was said in the other place take precedence over any assurances given here? I accept that they are given after the event but, as far as I am aware, we have not received anything in writing or had placed before us anything from the Minister to say that that was not the case.

Another issue, raised in previous debates by the noble Baroness, Lady Jolly, concerns the risk of the Bill being used as a political tool to promote a global healthcare strategy by enabling the Secretary of State to make arrangements with countries across the world, without restrictions on the terms under which that would happen. As a clinician working in the NHS, my concern relates simply to overburdened NHS services. At the same time, I understand that the Welsh Government have not yet provided a consent Order in Council on the Bill. Has there been consultation? How do the Welsh Government anticipate the Welsh NHS coping in the event of no deal and the failure of reciprocal arrangements?

[Lord Foulkes of Cumnock]

My Lords, I apologise to the noble Lord, Lord Lansley, and accept his assurance, which was given in good faith. I support the amendment very much. In his intervention, the noble Lord, Lord O’Shaughnessy, said that anyone in their right mind would not do the kind of deal indicated by the noble Lord, Lord Marks. Anyone in their right mind would not be moving us towards a no-deal Brexit, which I am afraid the Government are doing, so sometimes we do not believe them. We expect all our politicians, particularly the current ones, to be in their right mind.

I am not a Corbynista, as my noble friend Lord Liddle knows very well, but I am still in the Labour Party because it is my party. I had the awful experience of 16 years in the other place with the Conservatives in office, so I have become increasingly wary of what they get up to. I watch them very carefully indeed. I listen to their assurances and see them broken. I listen to what they say about the health service and see it undermined, slowly but surely. It would have been further undermined if we on these Benches and those on the Labour Benches in the other place had not done as much as possible to protect it, which is why I am suspicious of what is proposed.

Our current reciprocal arrangements work very well; my son works in New Zealand where, as in Australia, they work very well. They have been dealt with through current legislation so why do we need additional legislation? The Minister has not explained that properly. If we can have such arrangements now—not just with New Zealand, Australia, Bosnia-Herzegovina and Serbia, whose arrangements were achieved under the current legal framework—why do we need something new? I am sure the Minister understands why we are suspicious of this being tacked on to a Bill originally planned to deal solely with the problems that would arise in the health service and our reciprocal arrangements with the European Union in the event of a no-deal Brexit.

This matter raises all sorts of issues with priorities. Which countries would come first? Would it be the EU 27, collectively or individually? Which other countries would be on the list of priorities? Would this be a priority for the hard-worked officials in the health department? The Minister did not answer that question properly in her intervention. Of course, as she knows, she can intervene in the debate in Committee just like the rest of us—as long as we are here at the beginning of the debate on a particular amendment, as I was reminded earlier and accept.

In her intervention, the Minister said that any deals would of course be scrutinised by Parliament. Yes, but we will come to debate later scrutiny and the negative procedure versus the “made affirmative” procedure, neither of which can amend instruments. That is the problem with the scrutiny here: it is not proper scrutiny. We are taking that up in another context to deal with it. We see it happening at the moment with statutory instrument after statutory instrument being pushed through without proper scrutiny as we rush towards the cliff edge of Brexit. That is why we are very suspicious.

Like the noble Baroness, Lady Finlay, I welcomed the Minister at Second Reading; the debate was very good and the Minister replied well to it. I hope that she will excuse me but I spent 26 years in the other place and have seen the differences between a Conservative Government undermining the National Health Service and a Labour Government expanding it, developing it and putting more resources into it. I hope that she understands why we get a bit suspicious sometimes.

--- Later in debate ---

[Baroness Thornton]

My Lords, I shall briefly reply to the remarks of the noble Baroness, Lady Jolly. I think the noble Lord, Lord Lansley, asked some very good questions and I looking forward to hearing the answers. These are genuine probing amendments to seek reassurance and understanding about the Bill. My noble friend Lord Foulkes and the noble Earl, Lord Dundee, spoke very well, so I do not intend to repeat their remarks.

I think I need to declare an interest as I have quite a large family in Cavan just the other side of the border in the Republic. They have asked me what I think is going to happen—not that I know the answer—and I imagine they are not alone among citizens of the Republic of Ireland and Northern Ireland in asking those questions because, as the noble Baroness, Lady Jolly, said, there is enormous cross-border traffic. We had a very useful briefing from the BMA, which firmly believes that continued access to medical care in Northern Ireland and the Republic of Ireland is very important. Cross-border arrangements have been established. They provide high-quality care for patients in a range of areas which the noble Baroness, Lady Jolly, mentioned, and it is important that those services are not destabilised during or after the Brexit process. We are seeking reassurance about some very practical issues regarding the treatment of children and other people in the Republic and in Northern Ireland.

[Baroness Finlay of Llandaff]

My Lords, I support the amendments in this group. They go to the very heart of the human aspect of healthcare provision. If you have a sick child who needs to go to a cardiology clinic, you may well have other children, and you need to be able to look after all of them as well as focusing on the one who is sick. Anything that endangers the services that have taken years to set up and which are known to be working well will have a major downstream effect not only on individual patients but on all others in the family when you have cross-border flow.

When we talk about people who are already ill travelling, quite often they are going to major family events or reunions. They are not going just for the sake of having a nice holiday. To deny them the ability to travel because the cost of insurance is prohibitive or because they will not have reciprocal cover could have quite severe downstream effects on the mental health and psychological welfare of some of the people who have been affected by it. While these are probing amendments, they go to the heart of why we need to have things in place.

[Lord O’Shaughnessy]

I shall follow the theme expounded by the noble Baroness, Lady Finlay, and talk about Northern Ireland and the Republic of Ireland. It will come as no surprise to noble Lords that with a name such as mine I have family in Ireland, but more importantly, I had several meetings with Irish Health Ministers during my time as Minister and I want to provide insight and reassurance from those conversations. Noble Lords will understand that during those conversations we had to discuss difficult issues—more challenging topics, shall we say—within the Brexit realm, but there was absolute clarity in every meeting about the intended outcome being continued cross-border delivery and co-ordination of healthcare. That could be done under the aegis of the common travel area and the Belfast agreement and there was no reason for the fact of the United Kingdom leaving the European Union to interrupt that. Clearly that needed to be established as well as the legal processes and basis, but that was deep, long-standing and productive work.

I wonder whether the Minister can update the Committee to give a flavour of where we have got to; it is not just about the Republic and the north, as people from the Republic of Ireland use tertiary healthcare services in the UK. This is an incredibly deep and long-standing relationship with huge benefits, and I am sure that the Minister will be able to confirm that we are at the right point in those discussions to provide reassurance. I can tell her that it has always been the intention of the UK Government, and it was clearly the intention of the Irish Government, to achieve that.

Perhaps I may reflect briefly on the amendments in the name of my noble friend Lord Lansley, which in a sense are about clarifying who benefits. I absolutely agree that that is necessary, and I am sure that the Minister will be able to respond.

I shall risk partially agreeing with the noble Lord, Lord Foulkes, and my noble friend Lord Dundee in the sense that they make a very strong case for our agreement with the European Union incorporating pensioners and those with long-term conditions, as indeed is the case now. I do not think that that needs to be in the Bill, not least because their amendments include the word “preserves”. Of course, these are ongoing and dynamic relationships that will change over time; nevertheless, that is the Government’s objective.

The noble Lord, Lord Foulkes, made a very compelling case for the Bill having a global reach when he talked about those with long-term conditions being unable to travel outside the EU because the arrangements are not in place. I hope that that is a sign that there might be agreement across the aisle about how it is necessary to formulate these agreements so that when our people travel to Australia, New Zealand, Serbia, Gibraltar, Guernsey and other places, they are able to do so with the same kind of reassurance with which they are able to travel in Europe now.

Healthcare (International Arrangements) Bill

Baroness Finlay of Llandaff Excerpts

Committee: 1st sitting (Hansard - continued): House of Lords
Tuesday 19th February 2019 Lords Chamber

[Baroness Brinton (LD)]

My Lords, I echo the points made by the two previous speakers and will just point to one further reason why having an annual report with this level of detail is important for the future of monitoring any reciprocal agreements. In 2016-17 the National Audit Office published its report on the recovery of the costs of NHS treatment for overseas visitors, which makes fascinating reading. It includes how the amounts recouped, whether by reciprocal agreement or direct payment by the patient, had increased and by which type of trust. It is clear that unless that sort of detail is monitored regularly, we will not understand the consequences of changes to reciprocal agreements. I propose to talk more about this report in the next group of amendments, but that transparency means that we need an understanding of exactly how having these agreements will work and if, as was apparent when the report was written, more than 22 trusts never reported any cases under the EHIC scheme. It shows that there is an enormous differential between trusts in how they collect money owed to the Government in one form or another.

[Baroness Finlay of Llandaff (CB)]

My Lords, perhaps I may add briefly to the very important comments made by the noble Baroness, Lady Brinton. I am concerned about not only how the data is collected in this country but how we can verify costs that may be charged to this country by other countries with which we have reciprocal arrangements. One of the difficulties with healthcare costs is the way they are calculated. There may be individual costs of bits of equipment and staff time, but then there will be overall management costs, which may simply be divided up among the number of patients or even in a more arbitrary way. I am concerned, and seek assurance from the Government, that verification procedures will be put in place to make sure that bills received by the UK fairly represent the terms of an agreement.

[Baroness Manzoor (Con)]

My Lords, in Amendment 15 the noble Baronesses, Lady Wheeler, Lady Brinton and Lady Finlay, and my noble friend Lord Dundee raise an important issue on the importance of financial reporting and facilitating parliamentary scrutiny, which I can assure noble Lords that the Government are committed to ensuring. As the noble Baroness, Lady Wheeler, said, this was also the subject of Labour Front-Bench amendments in the Commons and is an issue that the Government have carefully considered. I would like to reassure the noble Baroness, Lady Wheeler, and my noble friend Lord Dundee that—as the Minister, my noble friend Lady Blackwood, set out at Second Reading—the Government are committed to openness in managing public money. I understand the desire for transparency in this area. Noble Lords can be reassured that, as indicated by the noble Baroness, Lady Wheeler, there are existing robust annual reporting processes, overseen by the Comptroller and Auditor-General, that are used today and cover reciprocal health and other departmental spending.

Expenditure by the Department of Health and Social Care relating to EU reciprocal healthcare arrangements is currently published to Parliament in the form of annual resource accounts, and this will continue. This reporting allows for scrutiny by both Houses of Parliament, as well as the Public Accounts Committee. As now, the department’s future expenditure on reciprocal healthcare will be subject to the existing government reporting requirements. However, the Government have heard the need for greater transparency in our administration and implementation of reciprocal healthcare arrangements. The Government are also committed to transparency and the prudent use of public money. This is why we have committed to going beyond the current reporting requirements.

As explained by the Minister, my noble friend Lady Blackwood, at Second Reading, the Government have committed to issuing an annual ministerial Statement on the operation of the reciprocal healthcare arrangements. The noble Baroness, Lady Wheeler, asked what this ministerial Statement would include. I am afraid that I cannot comment on that, because it is subject to any arrangements we enter into with the countries concerned. The Statement will be published as soon as is practical at the end of each financial year. It will include, but will not be limited to, reporting on the expenditure and income of reciprocal arrangements as a whole. This could include aggregated expenditure and income for the year, as well as country-by-country sums of expenditure and income. It could also provide an overview of the operation of arrangements, identifying areas of successful operation. I hope that that allays the fears that the noble Baroness, Lady Finlay, expressed. The types of reciprocal agreement entered into will determine the content of the Statement, as I said. However, I am happy to meet the noble Baroness to discuss these details further.

I hope that the noble Baroness, Lady Wheeler, and my noble friend Lord Dundee feel reassured on our commitment to ensuring that there are sufficient and appropriate checks and balances in place on reciprocal healthcare agreements and agree that it is not necessary to set out in the Bill detailed provisions on reporting. In any case, as I said, the frequency and detailed content of a financial report should and could only be determined once reciprocal healthcare agreements have been made. Currently, the UK and other EU member states are able to collect data and report both nationally as well as at EU level, as provided for in the relevant EU regulations.

The department is currently working to ensure that UK nationals can continue to access healthcare in the EU in the same way as they do now, either through an agreement at EU level or through agreements with relevant member states. In either case, we will have to agree how eligibility is evidenced, the way that and frequency with which information is exchanged and the reimbursement mechanisms that will govern these new agreements. Each of these could differ from country to country. Such agreements will have to take into account the operational possibilities and limitations of each contracting party to ensure the smooth operation of reciprocal healthcare arrangements. This should include how NHS trusts in the UK can evidence eligibility for the treatment of non-UK citizens in the most efficient and least burdensome manner. Once these administrative details are known, the Government will be able to confidently speak to the specific measures that can be reported for each country. It is therefore unnecessary to set out detailed reporting provisions in the Bill for aspects that are subject to negotiations.

It must not be forgotten, however, that regardless of the specifics of any arrangements entered into, as with all departmental expenditure, reciprocal healthcare costs are and will continue to be authorised by the Treasury supply process and included in the department’s annual estimates, as well as being included in the annual resource accounts, which, as I said, are audited by the Comptroller and Auditor-General.

The noble Baroness, Lady Finlay, raised this issue, and it was raised earlier this evening. Let me be very clear that we do not need new front-line NHS processes to charge visitors and tourists from the EU, either directly or via reciprocal healthcare arrangements. We already have processes in place for non-EU visitors. After exit day, instead of identifying EU visitors for the purposes of EHIC claims, they will be identified for the purposes of whether they are chargeable directly or covered by a reciprocal healthcare arrangement, in the same way as non-EU visitors are currently identified. They will then be charged as appropriate.

I will end by saying this. As well as the auditing that will be done by the Auditor-General, as I have mentioned, the Government have committed to lay before the House an annual ministerial Statement, which will provide an additional check and balance on the Government’s reciprocal healthcare arrangements. I hope that I have a given sufficient assurances to noble Lords, and that the noble Baroness will feel able to withdraw the amendment.

[Baroness Finlay of Llandaff]

Can the noble Baroness confirm whether she is absolutely confident that the current systems in place to pick up those coming from abroad who should not be treated on the NHS and who should be charged for their care are 100% effective? How many of those systems are not effective? I am concerned that, with a potentially increased number of people coming into the system, any system that is already not functioning well will just fall over unless more people are put in to administer it.

[Baroness Manzoor]

My Lords, no one can ever be 100% confident, but we are putting in place robust charging mechanisms. Each trust has an accountable person to look at how charging is working. We are working very closely with NHS organisations to ensure that, where charging needs to take place, it is done effectively and efficiently.

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Clearly, some of this is covered by the guarantee that I have just referred to, which is extremely helpful. But the other worry is that trusts may, frankly, turn a blind eye if they are suddenly deluged with very large quantities of people under the threat of a no-deal Brexit. I look forward to the Minister’s response and I beg to move.

[Baroness Finlay of Llandaff]

I should declare my interest as a past president of the BMA and a current BMA member, because I would like to refer to its brief on this. The BMA has indeed highlighted the potential problem, as the noble Baroness, Lady Brinton, set out, of having 27 reciprocal arrangements all containing different terms. This will inevitably put pressure on front-line NHS staff, who will be expected to be familiar with and administer these different arrangements.

There is an additional problem that the association has highlighted, however: if the 190,000 UK state pensioners who are signed up to the S1 scheme and living in the EU need to return to the UK to receive care, health services will face drastically increased demands and costs. The Nuffield Trust has calculated that if those individuals return to the UK for treatment, that could incur additional costs to health services of between £500 million and £1 billion per annum, and require an additional 900 hospital beds and 1,600 nurses to meet demand. That is quite apart from the additional medical and allied healthcare professional staff, and all the clerical and managerial staff. The potential pressure on services, which are already stretched to bursting point, cannot be ignored.

As the noble Baroness, Lady Brinton, said, the difficulty is in how the money is recouped, where it goes and who can use it, as well as in accounting for it. While we are talking about cost recovery, I shall pick up on general practitioners. It is difficult to know where that money goes and to whom it is reported. If it is the clinical commissioning group, would it be expected to bill the person, who may well have disappeared from the UK by the time any such processes go through? Receptionists are not familiar with billing. The complexity of administering a multiple arrangement scheme cannot be ignored.

My final question goes back to one I have raised previously about the devolved Administrations. Given that there are now different healthcare systems in the four countries of the UK, each administered and managed slightly differently, what discussions have the Government had to date about recouping costs both as they stand and in the event of a large influx of pensioners currently living and receiving treatment abroad?

[Baroness Thornton (Lab)]

My Lords, I knew that the noble Baroness, Lady Brinton, would make a very thorough job of moving this amendment, so I was not just being lazy but was making sure that the Committee got the best person to introduce it. The noble Baroness mentioned the BMA’s brief, to which I shall refer. While the amendment refers to NHS trusts, any funding incurred by primary care providers in administration of the new healthcare arrangements should also be met. As a member of a CCG, I think that probably means CCGs. That is quite important.

Health: Pancreatic Cancer Treatment

Baroness Finlay of Llandaff Excerpts

Wednesday 19th December 2018 Lords Chamber

[Lord O’Shaughnessy]

I agree with my noble friend and am grateful to her for raising this topic. The truth is that outcomes of pancreatic cancer are very poor, and have not improved, as she said. We are determined to change that through a number of routes. The Prime Minister has committed herself and the Government to improving early diagnosis of cancer, so that more cancers are caught earlier, which will be critical for those often caught at a late stage, such as pancreatic cancer. The faster diagnostic standard that I mentioned will help, as will a series of rapid diagnostic centres that have been rolled out around the country. I take the point that we need to do a lot more, and the NHS long-term plan gives us an opportunity to do that.

[Baroness Finlay of Llandaff (CB)]

Can the Minister inform the House how access to treatment will be rapid, given that many people with pancreatic cancer need highly specialised techniques, such as a celiac plexus block from integrated specialist services, but who are currently at the mercy of random commissioning by clinical commissioning groups, or even for the gaps to be filled by different charities? I declare an interest as a vice-president of Hospice UK and of Marie Curie.

[Lord O’Shaughnessy]

I am grateful to the noble Baroness for that question. Obviously, rapid diagnosis is important, but she is quite right that it needs to progress to treatment. The main way we are trying to address that issue is to increase the cancer workforce at every level—nurses, radiologists, endoscopists, oncological doctors, and others. Unless there are the staff to carry out those procedures, we will not get the outcomes that we want.

Mental Capacity (Amendment) Bill [HL]

Baroness Finlay of Llandaff Excerpts

3rd reading (Hansard): House of Lords
Tuesday 11th December 2018 Lords Chamber

[Baroness Jolly (LD)]

My Lords, I welcome the amendment and declare my interests as set out in the register.

I too would like to talk about the application to adults with learning disabilities, autism or dementia who also have a mental health diagnosis, and I would also like to talk about what other noble Lords have mentioned—the interface between the Mental Health Act and the Mental Capacity Act. As the Minister will have seen, Sir Simon’s review redraws the dividing line between when a person should be detained under the Mental Health Act and when they might fall under the Mental Capacity Act.

Given that the proposed new dividing line is “objection” —in other words, those not objecting fall under the Mental Capacity Act—the role of the advocate in articulating the wishes of the individual becomes paramount in ensuring that the individual is treated under the appropriate legislation. With that in mind, I have a couple of questions for the Minister. Does he agree that advocates will need to receive sufficient support and training to understand this new dividing line, as and when it comes into being? Can he also clarify who will be responsible for ensuring that the training takes place and from whose budget the funding for it will come?

[Baroness Finlay of Llandaff (CB)]

My Lords, I am most grateful to the Government for adopting the principle of the amendment that we put forward on Report and for recognising its importance. I am glad to see that this will be in pre-authorisation reviews and to hear the assurances that it will act as a trigger for all types of reviews and will be put into the Bill when it goes to the other place.

I also recognise that the Minister has touched on staff induction, which will need to include training on liberty protection safeguards and cover when the review should trigger further action. However, I seek a categoric assurance from the Minister that the code of practice will state that staff will have the full protection of whistleblower legislation whenever they raise a concern, even if, for whatever reason, it does not proceed to initiating a review. I was grateful that during our meetings the Minister openly discussed the possibility of vexatious triggers, although I estimate that these would be very few and that triggers for reviews would involve legitimate concerns about a person’s welfare.

I also seek assurance that in its inspections the Care Quality Commission will be asked specifically to check that all staff know that they can request a review to be triggered and that they know that they will be protected. In addition, the responsible body, whenever asked to undertake a review, will need to keep a register of all such requests so that an emerging pattern of several requests coming from an institution will trigger a more major review into the type of care provided for everyone there.

One of the difficulties I anticipate arising at the interface between the Mental Health Act and the Mental Capacity Act is over the principle of objection. Among this cohort of people, objection may not be active; it may be passive. Sitting quietly, being withdrawn and being unhappy should be enough objection for people to consider whether the person should have been placed somewhere different or whether the conditions of their liberty protection safeguards should be altered. I have the impression that the type of objection envisaged in the Mental Health Act review was much more active than this type of passive objection, which could be interpreted as consent.

The other worrying aspect relating to this Bill and to the entire mental health review is the acute shortage of accommodation for people, both in the short and long terms. There is a shortage of suitable accommodation for people in crisis and of long-term accommodation that can meet people’s needs. Some are therefore accommodated in places not really adequate for their needs, but there seems to be no other option.

I repeat my gratitude to the Minister for having listened and brought forward this government amendment, and for all the other amendments that have gone into the Bill and brought about substantive changes. I look forward to hearing those reassurances in his response.

[Baroness Watkins of Tavistock (CB)]

My Lords, I concur with what other noble Lords have said and ask the Government to take one more look at the remaining conflict of interest relating to independent hospitals. It appears they will be able to employ their own AMCPs and, as the responsible body, authorise the deprivation of liberty of people in the hospital. This could pose a huge conflict of interest. The team has taken a great deal of trouble to remove this in the care home setting, and it seems it would be relatively straightforward to do so for independent hospitals. I fully support the amendments outlined today.

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[Baroness Barker]

My Lords, I do not want to detain the House but I have one or two important things to say. First, the House owes a debt of gratitude to the ministerial team for their work in getting us to this point. The noble Lord, Lord O’Shaughnessy, should take a great deal of the credit for enabling all the things he listed as achievements of the House, going forward. Obviously, the Bill leaves us in a much better state than when it arrived.

There was one contribution by a Member of your Lordships’ House that we have not acknowledged but should: that of the noble Baroness, Lady Browning. She has not been able to take part in many of our debates but she made an important contribution when she stood up and said that the Bournewood gap still exists. For all our work, it does, and it will continue to exist until such time as we sit down and really consider mental health and mental capacity legislation, including who makes the decisions about who comes under what piece of law. Until we sort out that gap, people will still be deprived of their liberty. We can call it by a different name, but they will be.

I will ask the Minister to reflect on one thing. Nobody came to this legislation believing that DoLS had to be preserved. Everybody knew that it was wrong. Everybody understands that we need to make greater and better use of the limited professional resources for overseeing the lives of people detained for one reason or another. We should listen to the noble Baroness, Lady Browning, and reflect on what else Parliament may have to do over the next five, six or seven years to make sure that the gap is addressed once and for all so that people are not wrongfully detained.

[Baroness Finlay of Llandaff]

My Lords, I will very briefly add my thanks to the Minister, the noble Baroness, Lady Stedman-Scott, and the Bill team, for listening. I also thank everyone from outside who brought their own experience, either individually or as part of a professional group, a voluntary sector group or the care home sector. I thank personally those in the Welsh Government who arranged meetings for me and also brought expertise, coming from a different health service framework. That was important because this legislation must apply across England and Wales. So I add my thanks to others.

[Baroness Thornton]

My Lords, I hope this is the final remark. This is indeed the place where, as the noble Baroness, Lady Murphy, said, we all say how wonderful we are; and I think we probably are. The Minister has set the homework that the Commons needs to undertake to get this Bill into even better shape; it needs to consider length of renewal periods, the interface with Simon Wessely’s review, the role of IMCAs, remaining conflicts of interest, impact assessments and implementation, and indeed, the issue of the definition of deprivation of liberty, which the Minister has undertaken to tackle. It also needs to discuss money, budgets and so on, as we have not done so during the passage of the Bill.

I have a few thanks to add to those of other noble Lords. First, I thank the organisations that have given us so much support during the passage of the Bill. If noble Lords cast their minds back to the summer, we were thrown into this Bill at very short notice, as were those organisations. I thank Mencap, VoiceAbility, Mind, the National Autistic Society, the Alzheimer’s Society and the Relatives and Residents Association. I must also mention Lucy Series at Cardiff University, who provided some fantastic briefing.

I thank colleagues from across the House who put things on hold over the last few months to respond to the challenge of this Bill. Indeed, the noble Baroness, Lady Jolly, and I were exchanging emails while we were on holiday at the end of the summer. I thank the Minister and the Bill team for their work. I thank the Minister for listening and for always being available. If I am honest, I think that members of the Bill team might have been on a bit of a learning curve about how to deal with legislation in the Lords, but they eventually seemed to get it. We are much nicer here when it comes to dealing with Bills—but Bills are hard work for everybody involved. Finally, I thank my own team. In the Chamber I thank my noble friends Lord Hunt, Lord Touhig and Lady Wheeler, as well as my noble friend Lord Cashman for his support in the early days. Outside the Chamber I thank Molly Critchley and Bernadette Daly, who have been absolutely brilliant. We will meet our Commons team tomorrow to talk about what we think they need to do.

Health: Cancer

Baroness Finlay of Llandaff Excerpts

Thursday 29th November 2018 Lords Chamber

[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.

[Baroness Finlay of Llandaff (CB)]

My Lords, what is the Government’s estimate of the funding needed for better radiological equipment; to train radiographers to be able to report, given the shortage of radiologists; to develop AI, given that the diagnosis of malignant melanoma using AI has been shown to be as accurate as diagnosis by a dermatologist; and to invest in pathology services? Without quantifying the amount and making sure that NHS England and CCGs sign up to these things, I worry that our diagnostic facilities will never catch up with those of other countries.

[Lord O'Shaughnessy]

The noble Baroness pinpoints some really important issues that we need to deal with. The good news is that the number of radiographers has increased by 3,500 in the last eight years, but of course we need to do more and the cancer workforce plan includes plans to recruit more specialists. Greater investment in equipment is taking place, the Prime Minister has announced investment in specialist cancer centres, and the first proton beam therapy centres in this country have now opened. Finally, AI has extraordinary benefits. It is now able to diagnose some tumours better than most expert specialists. We have made some commitments in this area through the expansion of digital pathology and radiology, and we will be doing more.

Mental Capacity (Amendment) Bill [HL]

Baroness Finlay of Llandaff Excerpts

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

[Baroness Finlay of Llandaff (CB)]

My Lords, Amendments 49, 85 and 87, which are in my name, complement Amendment 29—which, like others, I strongly support. Information to the family and those who care deeply about the welfare of the person is the cared-for person’s safeguard against exploitation or bad care or simply having their needs ignored. It is paramount that families have a role to play in the care planning of their relatives, not least by giving them the option to stay fully informed and to object to the proposed plans if they are unsatisfied.

When an assessment happens at one point it is easy to collate all the information, get it signed off and then forget that every day until the scheduled review is a day to be lived by the cared-for person. If the conditions laid out in the authorisation are not adhered to, if the person is not empowered as much as possible to be both mentally and physically active, gradual inactivity and a slipping decline set in.

The care itself is important. Certainly, quality of care will vary between care homes and within them, but monitoring the care plan is central to ensuring that the cared-for person’s dignity is maintained. Their quality of life depends on how they are treated day in, day out, as well as whether they receive care in a way that enhances their personal dignity or, shamefully, they are treated as though they are of less worth. It is therefore imperative to ensure that the cared-for person is placed at the heart of the LPS authorisation process, which is why I want all those consulted in the initial process, as laid out in paragraph 17(2), to be able to access easily the care and support plan. Being able to apply for it is not enough; many people may not even know that they are able to apply to look at it. Relatives will notice if the care plan states that something is not happening and question why.

The care plan and authorisation record must be available to the cared-for person, enabling them to keep track of what is supposed to be happening. For those with fluctuating capacity or less severe impairments, the sense of control and empowerment that this would give is completely in line with the ethos of the Mental Capacity Act. Where the cared-for person cannot monitor their care plan, they can still know, even in their short-term memory, whether they are getting what they should get. Those with specific responsibilities for the cared-for person’s welfare—such as the nominated representative, the donee of the lasting power of attorney for health and welfare or the court-appointed deputy—must have both the authorisation statement and the accompanying care plan.

The care plan must also be provided to the care team in the cared-for person’s place of residence, because where such a place is supported living, I am concerned that those who provide support and are not on a professional register may find that they are not given all the details. I strongly support Amendment 29, introduced so clearly by my noble friend Lady Watkins. People must know what their rights are and what will happen. This will not be costly; it will be far less costly than the court cases that are likely to come if the requirement to provide information about all aspects of the process and plan is not in the Bill.

Amendment 87 deals with what to do in the event of a dispute. It requires an AMCP to be appointed to explore the reasons for the dispute and assess the situation independently. If agreement cannot be reached, independent mediation must be sought before resorting to the adversarial processes of going to court. A group of family law solicitors has been working for over a year to develop a system of mediation to be used before a court proceeding in the Court of Protection. This type of dispute, where everyone agrees that a solution must be found in the interests of the cared-for person, lends itself well to mediation; it would be swifter, cost less than any court action and be far less traumatic for all concerned. If the principle of dealing with dispute is not in the Bill, can the Minister reassure the House that it will be dealt with in the code of practice?

Before I finish, I urge the Minister to recognise the strength of feeling about people needing to be given information about their rights. If he will not accept these amendments, will he agree to bring the lead amendment in this group back as a government amendment at Third Reading? Requiring adequate information-giving must be in the Bill; it cannot be left to the code of practice, nor deferred to the Commons stages. This is one of the most essential planks in ensuring that the care that should be given is given.

[Baroness Wheeler (Lab)]

My Lords, we on these Benches strongly support the key amendments in this group. Amendment 29, to which my noble friend Lady Thornton added her name, would ensure that the responsible body has a duty to make sure that the cared-for person or the person representing them in an advocacy, professional or other capacity fully understands the rights of the cared-for person for whom deprivation of liberty is proposed, and the rights to challenge. Those rights also include specifically the rights to an independent and professional assessment, to a review of the LPS arrangements, to advocacy and support and to be able to challenge the LPS authorisation in court.

The noble Baroness, Lady Watkins, made a strong case for rights to information to be on the face of the Bill, ably following on from the interventions of the noble Baroness, Lady Hollins, during its previous stages. She spoke on the importance of this issue, particularly in respect to people with learning difficulties, and the need, wherever possible, to take steps to increase the cared-for person’s capacity to understand what is happening to them and to have as much involvement as possible to help them determine their wishes and feelings.

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[Lord O’Shaughnessy]

On the noble Baroness’s first point, of course there is nothing to stop us setting out anything in the code of practice. The concern would be whether there would be a clash between what was set out in the Bill and what was set out in the code of practice or in Article 5. That is one of our concerns and it is for that and other reasons that unfortunately we are not able to support that amendment.

[Baroness Finlay of Llandaff]

Does the noble Lord agree that one of the differences here between Article 5 rights normally and this group of people is that these are people who lack capacity to make their own decision, which is why they are being deprived of their liberty? They are particularly vulnerable and unable to speak up for themselves and depend on others. Therefore, if we have something in the Bill—and it may be that the wording in Amendment 29 is not right—brought back by the Government at Third Reading, we would know that there is an explicit right to information to be given to people when they lack capacity, as well as giving it to people when you have done everything to confirm that they have capacity for it.

[Lord O’Shaughnessy]

I recognise the point that the noble Baroness is making. As I said, our belief is that the rights that currently exist, and are in no way amended or reduced as a result of the Bill, provide what she is asking for. Unfortunately, I am not able to give a commitment that we will be able to return to this issue at Third Reading.

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Moved by

[Baroness Finlay of Llandaff]

33: Schedule 1, page 10, leave out lines 14 to 16

[Baroness Finlay of Llandaff]

My Lords, I am most grateful to the Government for having changed the role of the care home manager. All the changes in the Government’s amendments have been welcomed. Almost all of my amendments in this group have fallen away, but I seek reassurance from the Minister that the authorisation process will include inspection of the proposals and conditions as set down in the care and support plan. This is because the necessary and proportionate test can be understood only in the context of the way that the care will be provided and how it will meet the wishes and feelings, as well as important information gleaned from the consultation process. The helpful diagram that was attached to the Minister’s letter of 15 November shows the factors, but I am unclear how they will be contextualised for the authorising body without the authorising body having access to a copy of the care and support plan. It is for that reason that I decided to speak to this group of amendments. I hope the Minister will be able to give me reassurance. This is about the process whereby the authorising body will know that it has accurate information that will affect the day-to-day care of the person. I beg to move.

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[Baroness Finlay of Llandaff]

I am most grateful to the Minister for that clear reassurance. I reiterate our gratitude that the Government decided to change the role of the care home manager, making most of the amendments in this group redundant. Therefore, I beg leave to withdraw the amendment.

Amendment 33 withdrawn.

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Moved by

[Baroness Finlay of Llandaff]

35: Schedule 1, page 10, line 32, at end insert—
“12A The responsible body may not authorise arrangements if an Approved Mental Capacity Professional has concluded that the arrangements should not be authorised.”

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[Baroness Finlay of Llandaff]

My Lords, Amendment 35 is a failsafe mechanism that will save a great deal of court time in the future and make it clear where the process has halted if things go awry. The failsafe is that an approved mental capacity professional—AMCP—can veto authorisation if the AMCP has grounds to object. However, it is important that the AMCP cannot authorise arrangements. In other words, the default position is to preserve liberty and not to impose restrictions on a person without a very sound reason. It is important that we are explicit about the extent of the AMCP’s powers, whether on the face of the Bill or in subsequent regulation, as we will need to be more prescriptive about these powers in the statutory code of practice than we have been to date, for the sound reason of flexibility and the independence of the AMCP.

The reason I tabled the amendment and feel it should be in the Bill is that there is a risk that local authorities facing financial stringencies might be inclined to authorise arrangements that are less costly, thereby revealing an inherent conflict of interest where a local authority is funding a person’s care. We have had many debates about conflicts of interest in relation to care homes but we must remember that in a whole-health and social care system which is under financial pressure, all kinds of little conflicts and pressures can creep in.

The other amendments in this group specify the different criteria whereby an approved mental capacity professional must conduct the review. I am not going to go through each line of these amendments—they are quite self-explanatory—but they show the importance of that degree of independence before taking the major step of imposing restrictions on somebody’s liberty and conditions under the new liberty protection safeguards process. I beg to move.

[Baroness Barker]

My Lords, I will speak briefly to Amendment 77 in my name, which was drawn up because of the experience of many relatives. I make particular reference to the case of Stephen Neary, where relatives had to deal with local authorities which were telling them wrongfully what their position was in law. A great deal of responsibility was put on to the relatives to oversee the right interpretation of the law. This amendment seeks to ensure that, where they are acting in the best interests of someone who is cared for, relatives would be able to meet an AMCP and trigger their involvement. In our earlier discussions, there was an underlying sense on the Government Benches that the involvement of professionals can often be an unwelcome intrusion into families. In fact, many of them do not find that at all. Many find that the first occasion when they come into contact with a professional is the point at which all sorts of information and understanding becomes available to them in support of their loved ones.

Although I am not seeking to press this amendment today, I hope that the Minister might think about it and, if he is disposed to do so, make some supportive statements.

[Lord O'Shaughnessy]

I am grateful to the noble Baronesses for tabling these important amendments. It is critical to get right the role of approved mental capacity professionals and when they should review cases under the liberty protection safeguards system. AMCPs will be a vital part of the system. They will be qualified, knowledgeable and experienced professionals. It is intended that they will act independently, both of the care provider and the responsible body, and that they will make a determination on proposed arrangements after meeting the person and reviewing relevant information.

Amendment 35, tabled by the noble Baroness, Lady Finlay, explicitly prevents the responsible body overriding a determination of the AMCP. The responsible body is responsible for approving the authorisation, but an AMCP is required to complete the pre-authorisation review if it is reasonable to believe that the person objects to the arrangements. The AMCP can also conduct the pre-authorisation review in other cases. Where an AMCP conducts the pre-authorisation review they will determine whether the authorisation conditions are met.

The critical issue here is the consequences of the AMCP determining that the authorisation conditions have not been met. We are absolutely clear that the responsible body should follow the AMCP’s determination, and indeed any responsible body that did not do so would be taking on a significant legal risk. The responsible body might believe that it has a good reason to disagree with the AMCP’s assessment, but in that case the proper course of action would be to discuss this with the AMCP. If the responsible body then tried to override the AMCP’s decision, we would expect the AMCP to raise concerns—first, with the responsible body itself. If the local authority is the responsible body, the concern can be escalated to the Local Government Ombudsman, and if a CCG is the responsible body, it can be escalated to the regional director of commissioning in NHS England. Concerns regarding NHS organisations and independent hospitals can also be raised directly with the CQC in England or Health Inspectorate Wales. Therefore, I hope that noble Lords are reassured that mechanisms are in place to stop any unjustified behaviour on behalf of responsible bodies.

Amendment 77, tabled by the noble Baronesses, Lady Barker, Lady Finlay and Lady Jolly, makes explicit that a pre-authorisation review must also be conducted by an approved mental capacity professional if relatives or those with a genuine relationship to the person object to the arrangements, if there is restriction on contact, if the care home manager or responsible body considers the case to be exceptional, or if the arrangements are for mental disorder or the arrangements include covert medication.

The Government agree that families and carers play an important role in liberty protection safeguards. As the people who know the cared-for person best, they will often know what the person’s wishes and feelings are and whether they do, or would, object to what is being proposed. The Bill already states that a pre-authorisation review must be completed by an AMCP if there is a reasonable belief that a person objects to residing in or receiving care and treatment at a particular place. We are clear that an objection raised by someone with an interest in the cared-for person’s welfare can also give rise to a reasonable belief that the person objects, and this will be confirmed and clarified in the code.

We all agree that deprivation of liberty is a serious matter, especially when accompanied by measures such as high levels of restriction, covert medication and restrictions on contact. Such measures should be put in place only following a best-interests meeting and in some cases will require a court application. This is confirmed in the current MCA code of practice and will continue to be a key aspect of the new code.

I agree that in some circumstances such cases should be considered by an approved mental capacity professional. The Bill expressly allows for a pre-authorisation review to be completed by an AMCP in other cases, as is clear from paragraph 19(1). However, although the Bill is clear about how the lodging of an objection will lead to a review by an AMCP, I have heard clearly from noble Lords and stakeholders that there is a concern about referring appropriate cases to an AMCP. I hope that noble Lords will be glad to hear that I have been persuaded that we need to clarify on the face of the Bill that other cases can be referred to an AMCP.

In the previous day on Report, I stated that we would revisit, in the Commons, the issue of referral to AMCPs, specifically regarding those in independent hospitals. I can now confirm we will be looking at this issue more widely, including the specific concerns raised in the debate and in the amendment, as part of our considerations for government amendments in the other place. I look forward to working with all noble Lords to make sure that we get this right.

I turn briefly to Amendment 46 in the names of the noble Baronesses, Lady Thornton and Lady Barker. The amendment would mean that in care home cases the statement to the responsible body must indicate whether any person interested in the person’s welfare is satisfied that the person does or does not object. I understand that the intention here is to create a mechanism for those with an interest to be able to raise objections. I have already said that the Bill specifies that the statement must reflect any consultation that has been completed with those with an interest in the cared-for person’s welfare, and our later amendments will also make it explicit that that includes the person themselves under the “duty to consult” government amendments. The IMCA and the appropriate person will also have a role in reflecting these concerns.

To conclude this group of amendments, Amendment 104 states that a review is triggered if a person with an interest in the cared-for person’s welfare has raised concerns. As I said, that will be the case. Amendment 109 would change the Bill to reflect the effects of Amendments 34 and 104.

I hope that in answering points raised on these important issues, I have been able to give two kinds of reassurance. The first is that the process of triggering a review will be clearly set out. The Bill as it stands, as well as amendments that we are making, will mean that anybody with an interest in a person’s welfare will be able to trigger a review and that will lead to a consideration by an AMCP. Secondly, in the rare cases where there is a dispute between an AMCP and a responsible body, there will be avenues to escalate such a disagreement to mediation and resolution.

Furthermore, we are determined to get the role of the AMCP right. We think it is necessary to go beyond specifying that those in independent hospitals can see an AMCP and to think of other cases as well, and we are intending to bring forward amendments at the Commons stages of the Bill. I hope that that provides the reassurance that the noble Baronesses are looking for and that the noble Baroness, Lady Finlay, will be prepared to withdraw her amendment.

[Baroness Finlay of Llandaff]

I think I can speak on behalf of all noble Baronesses who had their names on these amendments. We are most grateful to the Government for listening and find all that the Minister said in his speech in response to this group of amendments reassuring and positive. We look forward to working with the Government as these new criteria evolve. I beg leave to withdraw the amendment.

Amendment 35 withdrawn.

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[Baroness Barker]

My Lords, Amendments 61 and 67 return to two issues that I and the noble Baroness, Lady Finlay, raised at earlier stages in our debates.

Amendment 61 pertains to what happens when the circumstances or condition of a person deprived of their liberty change. As we have said on previous occasions, that may be someone with dementia whose condition deteriorates or, as in the cases cited by the noble Baroness, Lady Finlay, it could be someone with a brain injury whose condition improves and who regains some of their capacity. It is the intention under the Bill that deprivations of liberty will last considerably longer than under current circumstances.

I seek an assurance that there is an ongoing duty on care home managers and those responsible for arranging and carrying out assessments to revisit people whose conditions are likely to change to ensure that their detention is still the least restrictive option.

In Amendment 67, I use the word “conditions” in a completely different sense. As has been said, under DoLS people carrying out assessments and authorisations have the right to say that it would be in order to detain someone and deprive them of their liberty provided that certain conditions are met. The noble Baroness, Lady Finlay, has given us memorable examples of what those conditions might be. However, in truth, the most common condition concerns medication and reviews of medication.

The Government have consistently said that the Bill does not alter that—and that, as ever, the matter will be dealt with in the code of practice—but I am simply asking for a statement from the Minister setting out the legal force by which it will be possible in future for those who are responsible for depriving people of their liberty to do so on the basis of conditions which must be met. The importance of those conditions— particularly when we talk about DoLS in the community —is that they can make something a least restrictive option and therefore admissible.

It is for that reason that I have returned to these two amendments today, and I beg to move.

[Baroness Finlay of Llandaff]

I have added my name to Amendment 61 because it is important that we recognise that no one has a crystal ball—we cannot predict what is going to happen. Even people we think might be seriously impaired, as the noble Baroness, Lady Barker, said, can sometimes improve and it can be quite unexpected.

It is inconceivable that the course of a person’s illness will match the timetable of annual reviews—that is not the way bodies behave when they have an impairment; if someone does not improve within an expected time frame, they must be reassessed. Otherwise, there is a real possibility that they will languish with inappropriate restrictions on their liberty when such restrictions are no longer necessary or proportionate. In fact, in the case of medication reviews, they may have become inappropriate because they may be on medication that is unnecessarily a sedative.

Of course, those who deteriorate will also need phased authorisations and reviews. Without the Government laying out explicitly this degree of uncertainty in the timeframe and the fact that wherever there is expected to be uncertainty, it should be specified, I fear that there will be pressure to define the amendment’s principle by going to court. We will then end up with a court precedent that is not necessarily applicable to a lot of people, but which they will get caught up in anyway. We will end up with a risk-averse response. I hope the Government will be able to accept, if not the actual wording of the amendment, the principle that the timeliness and the timeframe need to be specified wherever possible to avoid that confusion.

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[Lord O’Shaughnessy]

My Lords, before introducing these amendments, I thank the noble Baroness, Lady Barker, for accepting my explanation on the previous group. I am conscious that we need to explain this in more detail, but I am grateful to all noble Lords and to the noble Baroness, Lady Thornton, for not pushing this point. This is something that we can clarify to get to a better system.

The amendments in this group are clearly central to the Bill, because they are all about putting the cared-for person at the centre of the new liberty protection safeguards. Noble Lords have been at pains to highlight a concern that the cared-for person is not listed explicitly as a person to consult. That has clearly always been our intention, but it is nevertheless quite right that that should be explicit in the Bill.

Amendment 71 clarifies that the cared-for person must be consulted as part of the consultation under new paragraph 17. Amendment 63 sets out that the person’s wishes and feelings must be considered as part of the determination that the arrangements are necessary and proportionate. Amendments 110 and 111 update other parts of the Bill to reflect the new explicit consultation requirement and to make some other minor drafting changes.

The consultation required by the Bill is important in establishing the cared-for person’s wishes and feelings, and identifying objections to the arrangements. It is also an important way of involving the person and their families in the process, and making sure that the liberty protection safeguards authorisation is something that happens not just to them, but with them. It has always been our position that the person should be consulted, but it is quite right that we set this out explicitly. Through these amendments we have also been explicit that the person’s wishes and feelings must be considered as part of the necessary and proportionate determination.

Briefly, Amendment 68, tabled by the noble Baronesses, Lady Finlay and Lady Jolly, would also ensure that this point is considered. I hope they will feel that the Government’s amendments have dealt with their issues and that they will feel happy not to press their amendments.

[Baroness Finlay of Llandaff]

I am looking to the noble Baroness, Lady Jolly, because I am sure she will agree with me. I am grateful and happily give way to the government amendment, which does what we wanted to do. We will not do anything with our amendment. I thank the Minister for his clarifications.

[Lord O’Shaughnessy]

I thank the noble Baroness for her agreement. I beg to move.

--- Later in debate ---

Moved by

[Baroness Finlay of Llandaff]

76: Schedule 1, page 13, line 15, at end insert “, or
(c) there is dispute between the responsible body and the registered health or social care professional who has carried out the review under paragraph 20.”

[Baroness Finlay of Llandaff]

My Lords, I declare an interest. Some years ago I was involved in helping the police prosecute people who were responsible for care but who were delivering terrible abuse in what was then termed an EMI home. A care assistant, encouraged and supported by her friend who worked on the domestic side, thought, “This wouldn’t be good enough for one of my relatives”. As we explored the cases, families in their statements commented on all they had noticed but said they did not feel able to raise concerns, let alone complain. They feared that their relative in the home would be victimised if they said anything or raised any questions. It was case records that revealed repetitive patterns of entry that gave the clues to support the statements that relatives gave to the police and provided evidence against those abusing these people, which led to a successful prosecution. The Minister has already said that the triggers for an AMCP review will be expanded. We look forward to working with him and officials on this. That should cover Amendment 76 when there is a dispute. Amendment 74 has, of course, fallen through pre-emption.

I shall focus on Amendment 76A, because it supports the whistleblower and ensures an independent review. Without that, we will fail those who need protection and leave whistleblowers with no option other than to stay silent and say nothing—or, if they can pluck up the courage, go to the CQC or the police, with all the disruption, expense and risk of losing their job that that involves. It would also mean a delay in alerting when things are not as they should be. The other amendments in this group concern other ways of triggering a professional expert review. I know that we have legislation designed to protect whistleblowers, but for domestics—cleaning and kitchen staff—and care assistants, who are often those who spend most face-to-face time with people, who need the job and may not be able to find alternative employment where they live, it takes enormous courage to say that things are not right. Sadly, it is more courage than many people can pluck up.

A Guardian report, published on Friday, cites examples of “terrible indignity and neglect” in for-profit care homes across the country. Whistleblowers have risked their jobs and livelihoods to report cases of,

“inappropriate and disproportionate use of physical restraint”,

on residents with autism, and carers failing to manage medicine safely. In this article, Eileen Chubb, founder of Compassion in Care—a charity that campaigns on behalf of whistleblowers for better levels of care—was quoted as saying:

“We have seen first hand the appalling consequences of poor care … company after company making millions whilst on the frontline vulnerable people are left without the basics to sustain life”.


Carers who break the silence surrounding abuse, such as the whistleblowers at the home cited, deserve protection.

Even if a care home is a good home and receives a good rating from a CQC inspection, relatives may visit only intermittently and may not be aware that the care that they think is being given to their relative just is not happening for them. They will not be aware of the minute-to-minute, hour-to-hour aspect of a person’s care. It is the staff there for hours on end who can benchmark that care. They may realise that the person has become increasingly withdrawn and increasingly less communicative, and perhaps cries at night and seems very unhappy. The staff must confidently be able to ask for a review without prejudice.

This amendment will play an important role in giving protection both for residents and for those who call for a review. It calls for a review because it is far less threatening for somebody who has a concern to be able to ask for an independent review from an AMCP who can come in and assess what is going on—they do not feel that they need the body of evidence to make an accusation of malpractice. That is why this should be in the Bill, even if all the other ways of triggering a review are consigned to the code of practice. I feel quite strongly that when staff feel that something is not right and want to say so but their seniors are not recognising it, they must have the ability to protect the cared-for person, because the cared-for person is so vulnerable. I beg to move.

[Baroness Thornton]

My Lords, right from the beginning of this Bill—at Second Reading and in Committee—concerns have been expressed across the House about how the interests of the cared-for person can be ensured through the process of using the AMCP when that person is at their most vulnerable and may not be articulate at all. The noble Baroness, Lady Finlay, articulated exactly what we are saying. Amendment 76A, in my name and those of the noble Baroness, Lady Barker, and the right reverend Prelate the Bishop of Oxford, is an essential fail-safe that we believe needs to be in the Bill.

Like the Minister, we have sought across the House to prioritise the issues that we thought were most important for the cared-for person. I think we have come through rather well in improving this Bill together, and mostly without having to resort to Divisions. I hope that the Minister will accept Amendment 76A, because it is certainly in line with the aspirations that he has expressed to the House about safeguarding the cared-for person. If he is not prepared to do that, certainly on these Benches we hope that the noble Baroness, Lady Finlay, will seek the opinion and support of the House, because it is certainly there.

--- Later in debate ---

[Baroness Finlay of Llandaff]

I am most grateful to the Minister for realising the seriousness of this issue and that our current whistleblowing policies are inadequate. I do not share his concern about vexatious reporting because if you got such reporting from a staff member, it would be pretty obvious pretty quickly. The review would have happened and if one person is better protected, it is far safer than many people being inadequately protected. I accept that my drafting—I am grateful to the Public Bill Office—may not be perfect and because the Minister will come back to this at Third Reading, we will have a meeting and then be able to bring back an amendment.

[Baroness Thornton]

May I seek clarification from the Minister? He said that he would come back to Amendment 76A. Is this about Amendment 76 or Amendment 76A?

[Lord O'Shaughnessy]

It is Amendment 76A.

[Baroness Finlay of Llandaff]

I am grateful to the noble Baroness, Lady Thornton, for clarifying on the record that we are talking about Amendment 76A. With the caveat that the meeting will include all of us who have been involved in and feel so concerned about this matter, I will withdraw the amendment, knowing that we will bring something back at Third Reading in this House and not leave it to the code of practice or the Commons. I beg leave to withdraw the amendment.

Amendment 76 withdrawn.

--- Later in debate ---

[Baroness Finlay of Llandaff]

My Lords, I support the amendment. I would like to put an illustrative example before the House, although I know this is Report so I will be very brief. I heard recently about someone who had sustained a head injury, living in a place where he received care, who got very aggressive whenever people suggested that he should attend to his own personal hygiene or tidy up. Any type of reasoning or persuasion completely failed. The solution was not to restrict what he did at all but rather just to walk in, put a vacuum cleaner in the room and go out again. He seemed to then go into an automatic mode of vacuuming, cleaning up, tidying up and then washing, and everything was sorted, including his personal hygiene.

I mention that because it is important for us to realise, when we are thinking of restrictive options, that sometimes you need to be imaginative to find the least restrictive option for people. Letting people out a certain amount can be far more effective than being so risk-averse that you limit what they can do.

[Baroness Thornton]

Yet again, the noble Baroness, Lady Finlay, brings us a helpful example. I put my name to the amendment and we support it. It is part of a suite of amendments about keeping the cared-for person as far as possible empowered to make their own decisions, which must be intrinsic to the Bill. The amendment would ensure that the least restrictive method is always used.

--- Later in debate ---

[Lord O'Shaughnessy]

I am grateful to the noble Baroness for moving the amendment. Obviously, it is worth having an opportunity to restate that we clearly agree with her that it is necessary that anybody with an interest in a cared-for person’s welfare is able to trigger a reasonable request or, indeed, an objection on their behalf that constitutes a reasonable belief. That is something that we have discussed in terms of people who are supportive, such as family members, appropriate persons, IMCAs, and so on. Clearly, we have agreed to talk further about the role of whistleblowers and staff members.

I can reassure the noble Baroness that what she is asking for is already contained in numerous places in the Bill. The amendment deals specifically with paragraph 31(3)(b) of Schedule AA1. It is implicit in the description,

“person with an interest in the arrangements”,

that that includes people who have an interest in the cared-for person’s welfare. That is the purpose of the Bill. As I have made clear, any objection from someone who has an interest in the person’s welfare constitutes a reasonable belief, as set out elsewhere in the Bill. I am grateful for the opportunity to return to this issue and hope that I have reassured the noble Baroness that this is absolutely included in the definition.

[Baroness Finlay of Llandaff]

Before the Minister sits down, will he confirm that “interests” does not include the interests of the care home manager, where it may be a cheaper option, and that the interests of the cared-for person are definitely at the centre of the clause as written? I want to be absolutely sure that it cannot be misinterpreted in the future to mean “interests” in a much broader sense than the interests of the cared-for person.

[Lord O'Shaughnessy]

That is a very valid question. We have tried to deal with the conflict issues in other amendments. It is absolutely not the intention that that ought to be misused for the purpose referred to by the noble Baroness. I will need to get specific clarification about the implications of this, but I can reassure her that that is not the intention of it. If it needs to be clarified in a letter to noble Lords and, subsequently, in a code of practice then that is what we will do.

Organ Donation (Deemed Consent) Bill

Baroness Finlay of Llandaff Excerpts

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

[Baroness Finlay of Llandaff (CB)]

My Lords, I congratulate the noble Lord, Lord Hunt of Kings Heath, on bringing this important Bill to this House. It will bring organ donation legislation in England in line with that of Wales and Scotland for the benefit of all. I should declare that I was involved in the early stages of consultation in Wales, and I introduced the Kidney Transplant Bill in 2008 for presumed consent to donate one kidney, provided there was no evidence either from a central registry or from the dead patient’s relatives that he or she had opted out of being a potential donor. My Bill did not progress but I continued to have an involvement in the developments in Wales.

Many years ago, I conducted a study of bereaved parents and was struck by the comfort that donation gave them after their terrible, tragic loss. Some regretted not being asked about transplant donation and one regretted having declined.

Laws send social messages. When we were considering such legislation in Wales, we undertook very widespread consultation and carefully considered the pros and cons. I hope that England can now learn from our experience, because all the planning and consultation was essential to the success of the legislation when it came into force.

I want to cover how we went about it, the results of our process overall and things that I hope the Minister and the team will implement to take this forward. I am grateful to Professor Vivienne Harpwood from Cardiff University school of law for giving me the latest data. She has worked on this issue for years. I also pay tribute to the noble Baroness, Lady Randerson, whom I would like to call a friend—she is indeed a friend—for the important role she has played in Wales.

A tremendous amount of careful thought and planning contributed to the success of the legislation: there was very careful consideration of the ethical issues; we studied the outcome of similar legislation in other countries and consulted with many sections of society, including faith groups and ethnic minority groups to help us understand their sensitivities, respect their views and address their concerns; and numerous meetings and consultations took place. Although the Human Transplantation (Wales) Act obtained Royal Assent on 10 September 2013, the system did not begin to operate until December 2015 to allow adequate time for people to absorb and understand essential information about the new law.

As we had decided to introduce a “soft” opt-out system, we realised that it was necessary to have a large-scale information/education process, during which families were encouraged to discuss their wishes and people were urged to make their views about organ donation known to their relatives. Every household in Wales received carefully designed bilingual written information on more than one occasion, and there was an extensive media campaign, roadshows in supermarkets and other places, and a national countdown clock. This campaign informed people clearly that they could either opt in or opt out of the organ donor register, or do nothing if they did not object but wished their family to decide. A 20-second TV advert urged, “Talk about your organ donation decision or someone else may speak for you”. It was very powerful.

By 2017, over half the adult population in Wales had talked with family about their wishes. The widespread publicity about the benefits of organ donation helped people understand the gift of life, and we saw an early rise in the number of organs donated and transplanted. We also invested in training specialist nurses in organ donation. As the noble Lord, Lord Hunt, stressed, these nurses are key to the legislation working well. They sensitively explore the family’s recall of those conversations and their feelings.

It is essential that the bereaved family are able to express their views and know that they will be respected, as the Bill before us ensures. There must never be pressure on families. They are being asked to consider donation when they are numb at the sudden loss of the person they love—their child, spouse, fiancée, partner, brother, sister or a parent. Their grief at that time is overwhelming, and they live for the rest of their lives with the events of that tragic day. They remember every word of the conversations they had, second by second. That is why a soft opt-out, as in this Bill and in Wales, is so important.

Remembering donors and thanking families with national events, such as the Order of St John services of thanksgiving, are important to recognise that they have given the gift of life. In my own family, the service honoured the man who died, bringing enormous comfort to all the bereaved, including his children.

Three and a half years after we implemented our legislation in Wales, we now have the highest combined donation rate in the UK of 80.5% after brain stem or circulatory death. Currently, England runs at 66.2%, Scotland at 63.6% and Northern Ireland at 66.7%. Donation after brain stem death now has consent rates in Wales of 88.2%, as opposed to those in England at 73.3%. Donation after circulatory death consent has also risen in Wales to 68%, compared with 59.8% in England. These figures are better than we were expecting when the legislation was going through the Assembly, and the accompanying publicity campaign might account in part for this latest good news and, importantly, that we have not had the problems or backlash predicted.

There has been a steady increase in Wales. On 1 December 2016—the first anniversary of the implementation of the new legislation—the figures indicated that 39 organs were transplanted from patients whose consent was deemed. Welsh Government reports published on the same day were accompanied by positive statements by both the First Minister and the Cabinet Secretary for Health. By February 2018, 39% of the Welsh population had opted in to donate.

When you speak to people from donor families, you realise how glad people are to have been able to transform the lives of complete strangers, despite having faced the overwhelming tragedy of losing a loved one. You realise how important the recognition of their gift is, through these services of thanksgiving and so on, as they go forward in their own lives.

I seek two reassurances from those taking this forward. The first is that the public education campaign will be as thorough and carefully planned as ours in Wales. The second is that it will be accompanied by enough intensive care beds and specialist nurses in organ donation. Families must never feel hurried, and there can be a need to maintain hydration and oxygenation while waiting for the transplant to be set up. Even those waiting for a transplant always keep the phone by them, anxiously waiting for that call to the operating theatre, but it can take some time to get there. I am grateful for the assurance given in the letter from the Minister and the noble Lord, Lord Hunt, that preferential donation, which I argued hard for in 2009, will not be jeopardised. Where a family member is awaiting transplant, and the tissue is compatible, relatives must be able to ask for that specific organ to go to that person, while other organs go unconditionally to others waiting.

On a solemn note, I hope with this Bill we will see an end to transplant tourism, where desperately poor people sell an organ—nearly always a kidney—or, even worse, organs are harvested from executed prisoners. We should follow Italy, Spain, Israel and Taiwan in legislating to confront this abhorrent human rights issue, but that is for another day.

The Bill before us today is incredibly important. It can help the 5,000-plus people waiting for a transplant to join the 50,000 now living thanks to organ donation. It is truly the gift of life, and it deserves a smooth passage.