Cancer Task Force

Lord Woolf Excerpts

Tuesday 20th October 2020 Lords Chamber

[Lord Bethell (Con)]

My Lords, I completely and utterly agree with my noble friend.

[Lord Woolf (CB) [V]]

I am pleased to hear of the arrangements made for treating the backlog of patients suffering from cancer. However, that is not the only backlog that exists; other conditions require urgent attention. I disclose the position of my 24 year-old grandson, who is studying for a doctorate in epidemiology. He was born with a condition which meant that, at a very early age, he had to be fitted with a pacemaker. Unfortunately, when changing his pacemaker, the wiring was found to have become embedded in his heart. It was therefore decided to leave the wiring in that position and to fit a second pacemaker. Towards the end of last year, his health deteriorated. He was eventually admitted to the Brompton hospital, and by that time was in a very serious condition. Fortunately, after five weeks in an induced coma, his condition dramatically improved and he should make a full recovery. However, it was touch and go. I make no criticism of anyone, but it is important that it is not only cancer that is regarded as important; other patients should also be regarded as important.

Medicines and Medical Devices Bill

Lord Woolf Excerpts

Committee stage & Committee: 1st sitting (Hansard) & Committee: 1st sitting (Hansard): House of Lords
Monday 19th October 2020 Grand Committee

[Lord Woolf (CB) [V]]

I am most grateful to the noble Lord, Lord Lansley, for setting out the position we are in with such clarity. I will add just a few words to explain my involvement. It has already been pointed out that not many of my legal friends who I would expect to be concerned about this are present in Committee today. I am sure that the ones who one thinks of are busily engaged in the Chamber over a different piece of legislation which is causing them greater concern than the proposal here, although I believe that they would not disagree with my comments.

In this House, we naturally think as parliamentarians and are concerned about our process of scrutinising legislation, but bad legislation all too frequently ends up not being disputed in this House. That is not the end of the matter, however: the difficulties it creates then have subsequently to be sorted out, which is frequently done by judicial review in the courts. What the noble Lord, Lord Lansley, has said so well is very relevant to judicial review, and that is an area where I feel that, just as the doctors can comment about this Bill with a certain background of knowledge, I should refer to my entries in the register, which, at least with regard to judicial review, are quite important.

If the courts are to provide scrutiny at a later stage, they must know the purpose of the legislation. That is why what the noble Lord, Lord Lansley, has already said is so important. With blank cheques, the danger is that they can be used for all sorts of purposes. I have been trying, under the leadership of the noble Lord, to ensure that the blank cheques given by this legislation are as restricted as they can practically be, bearing in mind the situation in which we find ourselves.

I agree with what the noble Lord said about the amendments with regard to the present proposals. On the one hand, there is the proposal put forward by the Government; on the other is the proposal that the noble Lord, Lord Lansley, and I have suggested might be appropriate. My view, for the reason he indicated, is that our proposal is better, but, above all, I am attracted by the fact that what the Government are proposing is much better than what was there before. On that basis, with a degree of reluctance, I would be capable of being persuaded that we should accept what the Government offer, whereas I am quite satisfied that we should not have accepted what was there before.

Leaving the matter in that way, I hope that the further discussion which will no doubt take place will enable agreement to be reached on an amendment which achieves what is needed for the purposes I have indicated.

[Lord Hunt of Kings Heath (Lab)]

My Lords, I am glad that the Minister said that he was listening, and his amendments are important, particularly the one that makes the principle of the health and safety of the public the key consideration when making regulations under the parts of the Bill relating to human medicines and medical devices. He will be aware that concern was expressed by patient groups, in particular, about the Bill as originally drafted and the implication of the attractiveness provision. That concern takes us back to our first debate on “whither regulation in future”.

If we are not going to be aligned to the European Medicines Agency and are to plough it alone, the UK pharma industry will be at a huge disadvantage unless the Government offer an incentive. It may be a bung—the debate about state aid is very relevant to that—or much faster regulation. Otherwise, it is very difficult to see why the industry would continue to invest in R&D in this country. Its position could be as vulnerable as is the motor car industry as a result of the bumbling ineptitude of the Government in their Brexit so-called negotiation.

It is not far-fetched, it is a legitimate question to ask what on earth the Government really want from medicines and medical devices regulation. They may have issued all sorts of draft regulations, but we are clueless about what they are actually seeking to do. The MHRA is clearly not allowed to talk to anybody about this. I remember when the MHRA would talk to politicians and debate these things. It has clearly been given an instruction not to talk to anyone. We are absolutely clueless about the future direction of regulation. None the less, the amendments are clearly helpful, and no doubt we will consider them between Committee and Report.

I would, however, like to ask the Minister about Amendment 2 and its relevance to Northern Ireland. I understand that, exceptionally, it will be moved in Grand Committee because legislative consent takes three months to get through, which impacts on the Bill’s process. I understand that, but, as Parts 1 and 2 of the Bill affect Northern Ireland, does that similarly affect any amendment to Part 1 or 2 passed on Report? What is then the impact on Northern Ireland legislation?

Overall, however, most of the amendments are a constructive improvement, but we will obviously consider them further between now and Report.

Medicines and Medical Devices Bill

Lord Woolf Excerpts

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

[Lord Woolf (CB) [V]]

My Lords, I begin by referring to the entries in the register regarding my legal career.

When I first read the Bill, I appreciated immediately that its powers of delegation to legislate by regulation were extraordinarily broad. I do not think anyone has disputed that. The Government have done no more than say how its breadth will assist them. They have not yet dealt with the concerns that are naturally being expressed by committees of this House, and by others, about the lack of anything more than a skeletal framework for the Bill.

In that connection, I noted with interest that the noble Lord, Lord Lansley, made the point that what was needed was to make the Bill a framework Bill, which it currently is not. If his plea were accepted by Ministers, as I believe it should be, there would be a power to make sure that the regulatory power, though undesirable—especially on criminal matters—is at least capable of being controlled. What the Government actually then do in exercising the delegated powers can be tested against the framework—indeed, it can be tested by the courts. This would enable the proper disciplining of any misuse of the regulatory powers provided by the delegated legislation.

If the Minister is in listening mode, as he said, I ask him to bear the wise remarks of the noble Lord, Lord Lansley, very much in mind. It may be thought that giving powers like this is harmless. It is not. We do not know who will exercise the powers, why, and with what result, because that cannot be supervised in the way that a Bill could be. However, at least it helps.

I suggest that another thing that would help would be a sensible sunset clause. It has been suggested that the difficulty with a sunset clause is the timespan that would inevitably be involved before it would come into operation. I suggest that that matters not. The advantage of a sunset clause in this case is that those who are exercising the delegated powers will know that what they have done will come under scrutiny again within a set limit. It would be really helpful to the effectiveness of the Bill if a sunset clause of that sort were there.

Having said that, there are many things that have been said in the course of the debate today that I agree with. The first, of course, is what the noble Baroness, Lady Cumberlege, had to say in her report. I strongly endorse the support that she has already received. There are particular difficulties with harvesting paths, referred to by my noble and learned friend Lady Butler-Sloss and others. Again, I exercise my support. We must make this Bill better than it is now.

Covid-19

Lord Woolf Excerpts

Thursday 23rd April 2020 Lords Chamber

[Lord Bethell]

I am very grateful for my noble friend’s helpful update, but I remind him that these arrangements are conducted by local authorities. The question that he asks is best answered by those local authorities.

[Lord Woolf (CB)]

I thank the noble Baroness for her consideration. I am afraid that at a critical moment my microphone turned itself off. It is back on now. The Minister rightly referred to hero volunteers. He will be pleased to hear that those volunteers include members of the staff of this House, such as my part-time secretary, who has volunteered. That is worth noting, as are the many others who I am sure are in the same position.

[Lord Bethell]

I thank the noble and learned Lord. Will he please express my and the Government’s profound thanks to his secretary for their contribution? I hope it is proving to be rewarding to him or her personally and impactful to the causes in which he or she serves.

Mental Health of Children and Young Adults

Lord Woolf Excerpts

Thursday 16th May 2019 Lords Chamber

[Lord Woolf (CB)]

My Lords, like previous speakers, I thank the noble Baroness, Lady Royall, for obtaining this debate, and I congratulate her on a remarkable speech in opening it. It was of a standard which has so far been maintained by the other speakers.

I have one thing in common with the noble Baroness, Lady McIntosh, in that I, too, am not an expert on this matter. However, I am speaking in this debate largely because of the interest I have gained as a result of a member of my family being autistic. I have seen at first hand, although not as a parent, the problems that autism can cause for families. Here, I acknowledge that the noble Lord, Lord Farmer, is undoubtedly right in saying that if you have a good family background, the problem can be more proportionate than it would otherwise be. Even for the best of families, where the parents are deeply devoted to an autistic child, the problems of having that child can be immense because things do not work as well as they should.

I draw attention to my interests in the register, and point out that as a judge, or a person who spends his working life largely judging, you become very much involved with prisons. At one time I was president of the Prison Reform Trust—I believe I am still technically president. I see the noble Lord, Lord Bragg, who helped me very much when I was chair. He is nodding his head. The fact is that you need to go around prisons to see what the consequence can be of young people not getting the assistance that we know they need. The sad thing is that the majority of youngsters you meet there have a mental health problem of one sort or another, and sometimes dyslexia. I would not say that that was a mental health problem but it is one that, like an earlier speaker, I suffered from myself at one time, so I am very conscious of the difficulties that it can create.

At the moment I am a member of the Joint Committee on Human Rights. Under the able chairmanship of Harriet Harman, the committee is taking an in-depth look at the people we are talking about today. The report will not be available until the summer but it is probably good for the House to know about the sort of evidence that has been presented to us. The adviser to the committee and our clerk from the Lords have kindly helped me to, I hope, tread on the right side of making revelations about what the committee is considering without prematurely disclosing some of our evidence.

From the evidence that we have received, there is no doubt that there are still substantial problems in this area for those directly involved. Evidence from parents and people who work in this area indicates the sort of problems that occur. My belief is that, unfortunately, although there has been the progress that previous speakers have mentioned, it has been nothing like as great as it could have been if the efficiency with which the help was provided had been greater. People caught up in the situation of doing what is right for a child who has problems of this sort find that they are pulled in different directions, and that they do not get the sympathetic hearing they would expect to receive. It is very disturbing that this should be the situation.

There is also the fact that, all too often, instances of separation and restraint occur because the children, if they receive help, are in institutions that cannot care for them. I accept that there are huge difficulties in managing the complex issues in custodial settings, but surely we can manage to ensure that our system works in a way that is compatible with the real needs of the people seeking help.

I notice that my time is running out, so I shall sit down.

Healthcare (International Arrangements) Bill

Lord Woolf Excerpts

Report stage (Hansard): House of Lords
Tuesday 12th March 2019 Lords Chamber

[Baroness Thornton]

I listened very carefully to the Minister and I am not convinced, partly because the regulations under Clause 2(2) are very helpful. They give the Government everything they need to take forward the negotiations on reciprocal healthcare, and as the Minister herself said, we have put the regulations in place to help with a no-deal situation, which I hope will not occur. But the noble and learned Lords, Lord Hope and Lord Judge, made the point that those words are, while dangerous might be an exaggeration, certainly not appropriate.

[Lord Woolf (CB)]

Does the noble Baroness agree that, with “for example”, you may not be extending the jurisdiction of the regulations but actually limiting their range? That is what the Minister was seeking to tell us in her eloquent description of her case. If you say “for example, cows”, you have the example of animals that fall within the range of cows. Without that phrase, some cases would not apply to cows.

[Baroness Thornton]

I hate to disagree with the noble and learned Lord, Lord Woolf, but the words “for example” expand the list rather than decrease it. That is the point of this amendment. Given the huge weight of regulations that we are dealing with in this House, if something is not included in that list, I am sure that that can be remedied. We are getting very good at remedying those situations. We on these Benches think—and other noble Lords have certainly agreed—that “for example” expands the range and that is not necessary or appropriate, so I beg to move and wish to test the opinion of the House.

Mental Capacity (Amendment) Bill [HL]

Lord Woolf Excerpts

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

[Lord Woolf (CB)]

My Lords, I am very grateful for the expectation about my contribution to this debate, which the noble Baroness, Lady Tyler, just referred to. I am only too conscious that I shall disappoint her, but I will do my best.

First, I must disclose an interest. I have a relative whom the Bill may affect. I am also a member of the Joint Committee on Human Rights. The noble Baroness, Lady Tyler, was quite right in everything she said about the committee’s report, which has something useful to say in connection to this. I hope the Minister will agree with that. I see him nodding his head and telling me that it is so.

I shall focus on the second amendment proposed by the committee, which supplements the one moved by the noble Baroness, Lady Tyler. It is designed to limit the unintended harm caused as a consequence of the Cheshire West case, which is not easy. That harm takes two forms: first, it has resulted in a huge increase in the number of people who will be caught by the Bill; secondly, it means that people who do not need the precise benefits normally available to those in their position are dragged into that protection to their disadvantage.

I shall try to describe the persons concerned. They are people who have problems that would fall within the context of the Bill, but are residing, possibly in their home or some other institution, somewhere where they are perfectly content and well looked-after. There is no problem in their case. I do not think it necessary to expand the burdens on the Treasury caused by people in their condition by including them, unless it can be shown that there is a real necessity. Although the language of the amendment proposed by the committee, to which I am speaking, is complex, if one reads it carefully it does not give rise to any difficulties, but it could have the ameliorating effects to which I have referred. For those reasons and those the noble Baroness has given, I commend this amendment.

[Baroness Finlay of Llandaff (CB)]

My Lords, I should like to comment on these amendments. Before I do that, I thank the Minister on behalf of everyone for listening, as well as for his willingness to meet Peers and to move on the things that had caused enormous concern to many of us.

I have a couple of concerns regarding these amendments. I commend the noble Baroness, Lady Tyler, and the noble and learned Lord, Lord Woolf, for trying to get us back to a definition. I completely agree that if we do not have a definition, the matter will go to court and we will end up back in a circle that we do not want to be in. The problem I see is the non-negligible period, which will be really difficult to define. If somebody is in a confined space for even 10 minutes or a quarter of an hour, that could be absolutely terrifying for them and completely unjustifiable. We have a difficulty in trying to use time as a measure, but I understand why it is there as well.

In his amendment, the noble and learned Lord, Lord Woolf, certainly includes the principle of consent, which means that there should be information that the person has capacity and that their care and treatment are voluntary. I was a little worried, however, that his proposed new paragraph 2(1B)(d) in the amendment, which would require two clinicians to confirm in writing, rather ran counter to the principles set out in Part 1 of the Mental Capacity Act itself, Section 1(2) of which states:

“A person must be assumed to have capacity unless it is established that he lacks capacity”.


It almost turns itself on its head if you must have somebody to verify that they have capacity.

I note that in his letter to us, the Minister stressed the importance of supporting liberty as much as possible and valid consent wherever possible. Would the Minister be prepared to say that we can work on this between now and Third Reading? If we can reach a definition that seems right by then, we will have done the whole community a great service.

[Lord O’Shaughnessy]

My Lords, I am more than happy to do so. I express my gratitude to the noble Baroness, Lady Tyler, and the noble and learned Lord, Lord Woolf, for tabling their amendments and for precipitating this incredibly important debate. As has been set out, Amendment 2, moved by the noble Baroness, Lady Tyler, states that the liberty protection safeguards apply only to,

“arrangements which give rise to the deprivation of the cared-for person’s liberty”,

when,

“the cared-for person is subject to confinement in a particular place for a not negligible period of time … and … the cared-for person has not given valid consent”.

The amendment explains that someone is confined when they are,

“prevented from removing himself or herself permanently … and … the dominant reason for the deprivation of liberty is the continuous supervision and control of the cared-for person, and not treatment for their underlying condition”.

Amendment 4, tabled by the noble and learned Lord, Lord Woolf, also states that a deprivation of liberty for the purposes of liberty protection safeguards is where,

“the cared-for person is subject to confinement in a particular place for a not negligible period of time … and … the cared-for person has not given valid consent to their confinement”.

The amendment goes on to define “valid consent”, stating in particular that valid consent has been given when,

“the cared-for person is capable of expressing their wishes and feelings … has expressed their persistent contentment with their care and treatment arrangements … there is no coercion involved in the implementation of the … arrangements”,

and it is,

“confirmed in writing by two professionals, one of whom must not be involved in the implementation of the cared-for person’s … arrangements”.

The intention behind the amendments is to create a statutory definition of the deprivation of liberty, as has been discussed. I note that the amendments were influenced by the work of the Joint Committee on Human Rights, which I both applaud and welcome. We are aware, and the Law Commission’s consultation confirmed, that there is real confusion on the ground over the application of the so-called acid test and determining whether a person has been deprived of their liberty. In some cases, that has led to blanket referrals and applications for authorisations being made where there may be no deprivation of liberty at all.

As the noble Baroness, Lady Thornton, pointed out, I promised to think about this issue and we have given it a great deal of thought. Like other noble Lords, we have reached the conclusion that deprivation of liberty should be clarified in statute. However, we want to get the definition right and make sure that it is compatible with Article 5 of the ECHR. I agree that the aims of the amendments are laudable. As I said, the Government support providing clarity in the Bill. However, as I am sure all noble Lords appreciate, this is a complex and technical issue, and we have to make sure that any amendment is compliant with Article 5.

The noble Baroness, Lady Thornton, pointed out one particular concern around the use of the term “not negligible … time”. The point I want to make is much more technical, but it serves to introduce how difficult this issue is. I hope noble Lords will bear with me as I explain it; it is incredibly important. We believe that the amendments tabled by the noble Baroness, Lady Tyler, and the noble and learned Lord, Lord Woolf, would not have the intended effect of defining deprivation of liberty, but would instead limit the application of liberty protection safeguards to those who fall within the respective definitions.

Section 64(5) of the Mental Capacity Act defines “deprivation of liberty” as having the same meaning as in Article 5. The definitions in the amendments would not change this. Deprivations of liberty that fall outside those definitions would still be deprivations of liberty under Article 5, and would still need to be authorised in accordance with Article 5. However, because the liberty protection safeguards would not apply, authorisation would instead need to be sought in the Court of Protection, which, as we know, can be a cumbersome and distressing process for persons and their families, and would have significant cost implications for public bodies and the court system

Furthermore, the amendment tabled by the noble and learned Lord, Lord Woolf, although closely resembling the proposal put forward by the JCHR, also seeks to determine what valid consent would mean, and we are worried that that would not work in the way intended, because the definition is very broad. Its consequence could be that a significant number of people currently subject to DoLS authorisation would be caught by the definition and excluded from the liberty protection safeguard system, and tens of thousands of people might need to seek authorisation from the Court of Protection. Again, I do not believe that anyone would want to see that outcome. I notice that the noble and learned Lord is shaking his head, so clearly there is some disagreement on this point. I use it, however, to illustrate that there is a concern that we get this right.

[Lord Woolf]

I was shaking my head because I do not want to see what the Minister suggested might be a consequence.

[Lord O’Shaughnessy]

I will come to that. I am using that technical point to illustrate that there are concerns with the amendments as laid. We recognise the importance of this issue and the strength of feeling on it in the House. As I have said, I see merit in the argument for having this defined in statute, and I am sympathetic to that point of view. I can therefore give noble Lords some assurance, and confirm today not only that we are working on this matter, but that we intend to bring forward an amendment in the Commons to give effect to a definition. We want to work with all noble Lords and other stakeholders, and of course the JCHR, to ensure that we can table an effective amendment that achieves our shared aims and gains the level of consensus that we all want to achieve, and that we shall be able to lay it and have it agreed during the Commons stages of the Bill. I hope that in providing that commitment, I have been able to reassure noble Lords of the strength of our intentions. We absolutely want to do this, and we want to get it right. I still think it will take a bit more time, but I know that, working together, we can achieve that.

Mental Capacity (Amendment) Bill [HL]

Lord Woolf Excerpts

Committee: 1st sitting (Hansard): House of Lords
Wednesday 5th September 2018 Lords Chamber

[Baroness Murphy]

I really struggle to understand where these gaps might fall. For example, these people who have brain damage, which gives rise to a mental disorder, or people who have transient episodes of epilepsy, which might lead to some fugue state—would they not also be included in mental disorder, under the definition suggested by the noble Baroness, Lady Tyler? I cannot see where these gaps might arise. Have they been identified by psychiatrists? If we look through the Diagnostic and Statistical Manual of Mental Disorders, or the International Classification of Diseases, if you prefer, I cannot understand where these gaps might arise.

[Lord Woolf (CB)]

If the real purpose is to ensure protection under the Human Rights Act for those we are concerned about, has the Minister considered whether that might not be achieved merely by stating that the category of people we are looking at should have the benefit of the relevant section of the Human Rights Act? When I say the Human Rights Act, I mean the convention.

[Baroness Barker]

The Human Rights Act was in force when the Mental Capacity Act was being debated. During the passage of that Act we considered very carefully what language we should use. Is the Minister saying that we got that wrong, and have there been cases of people who have fallen into the gap? If so, how many are there, and can he give the evidence by which the Government arrived at the conclusion they have now?

--- Later in debate ---

[Lord O’Shaughnessy]

I am glad that we have had a subsequent opportunity to discuss this. I would like once again to restate that I personally, and government Ministers, officials and others, do not find this comfortable language. I know that the noble Baroness, Lady Watkins, did not mean it this way, but this is absolutely not a case of trying to take us back to the 1950s. In proceeding with this legislation, we have to make sure that people who currently get protection do not lose it. I know that we all agree that we do not want that to happen. If you like, that is the goal; the law is the means, if I may say so to the noble and learned Lord, Lord Woolf. The key is making sure that we have the terminology that will reflect that we do not want people falling through the gap. It is perfectly reasonable to ask, “What is the nature of this gap?”

The Court of Appeal in G v E said that a gap would arise. Our understanding and advice from lawyers is that current case law indicates that there might be individuals—I do not have specific details of the kind of conditions from which those people might be suffering. It is worth pointing out that the Court of Protection also uses the term “unsound mind” at the moment. It is a term that is clearly operable in a legal context but which has become inoperable in a medical context. That is the challenge we face and which we have explored in this discussion and at Second Reading.

We have given this very careful consideration. We need to be incredibly conscious of not creating that gap. However, I also understand that noble Lords would like to see more evidence of two things. First, there is the reality of the gap: who, what kinds of people and what situations? That is a perfectly reasonable thing to ask. Secondly, has there been further exploration of alternatives to what we all agree is an outmoded and regrettable phrase? I am absolutely prepared to commit to do that between now and Report, because I share noble Lords’ intentions that we should make sure both that we move with the times and that we do not remove protections from people currently entitled to them, or who would have been entitled to them, in the future. On that basis, I hope the noble Baroness might be prepared to move on from her starter for 10 and withdraw the amendment.

[Lord Woolf]

In the list of people whose help the Minister is going to seek, may I suggest that parliamentary counsel be invited to consider whether it is possible, through the use of language in the Bill, to ensure that there is no gap?

[Baroness Tyler of Enfield]

I am grateful to the Minister for his response, particularly the last bit, which I found a tiny bit more reassuring. I thank everyone who has contributed. It has been an excellent short debate and we have benefited hugely from highly distinguished medical and legal expertise.

I understand that the Minister may have concerns around risks and gaps, but we need—and he has agreed to bring forward—examples and evidence of what these gaps and risks are and why they could not be dealt with by language that is perhaps slightly different from that which I proposed. There is a huge opportunity to be seized here. I have made it very clear that the wording I propose may well not be quite right. I am sure that others could come up with better wording that meets the Minister’s concerns, which I understand are legitimate. I am grateful that he said he will think further and come back with further evidence. I should like to put down a marker that I will wish to return to this on Report.

--- Later in debate ---

[Baroness Thornton]

I have added my name to the amendment tabled by the noble Baroness, Lady Jolly, precisely because I thought we needed to have this discussion. That was exactly right. I would hate to choose between the two amendments, but this sets out when deprivation of liberty occurs:

“Arrangements that give rise to a deprivation of … liberty”,


are when the cared-for person is placed,

“under continuous supervision and control”,

they are “not free to leave” and the responsible body believes that it is in the cared-for person’s “best interests”. That is worth putting on the face of the Bill if at all possible.

The Joint Committee on Human Rights made a strong argument in favour of a statutory definition. I read its report and it seems absolutely right that that is what we should do. I would be interested to hear what one of the lawyers in our midst might have to say about this: whether they think that it would be a useful thing to do and whether the stabs we have made at it so far are helpful. We are interested in this discussion but we realise that this is the beginning of the discussion rather than something that may be appropriate right now.

When listening to the noble Baroness, Lady Finlay, talking about her amendment, it occurred to me that this is one of those occasions when technology is important. When you have an emergency admission, you need to be able to input the name of the person into a PalmPilot, which will tell you whether a DoLS is already in place and whether a do not resuscitate order has been made. Recently I have had experience of exactly this situation with a family member. Because the information was not readily available in an emergency, we ended up where we did not want to be. I just add that to the debate because I know that the Minister and his boss are very interested in technology and its uses in the health service. This is another of those occasions where it might be useful.

[Lord Woolf]

Perhaps I may respond by giving one lawyer’s view on the matter referred to by the noble Baroness, Lady Thornton. I should put on the record that I am a member of the Joint Committee on Human Rights and therefore was a party to the report, and of course I support it.

When the opportunity arises to deal with a situation where it is clear that a decision of the Supreme Court has had consequences which may never have been anticipated, it would sometimes be helpful if the judges had the opportunity to look at the matter again. If the sort of steps so ably advocated by the noble Baroness, Lady Murphy, were taken, I would suggest that serious consideration should be given to them as they could have a beneficial effect from the pragmatic point of view as well as on the point of principle.

I am sorry, but I ought to have added that I have a relative who could be affected by this legislation, and I declare that.

[Lord O’Shaughnessy]

I am grateful to all noble Lords who have spoken to their amendments, which have produced this discussion on the application of the liberty protection safeguards. Indeed, the noble Baroness, Lady Murphy, said that this goes to the heart of why we are here in the first place. I know that she has long-standing concerns about the DoLS system both in its application and the scenarios where it may or may not be appropriate, to whom it should best be applied and so on. I know that that is what has motivated her attempt in this amendment. She and others, including the noble Baroness, Lady Thornton, have said that this is the start of a process.

The first amendment in the name of the noble Baroness addresses the circumstances in which the authorisations could be given in a care home or supported accommodation environment, and people deprived of their liberty as interpreted in the Cheshire West case. As the noble and learned Lord, Lord Woolf, pointed out as a member of the committee, the Joint Committee on Human Rights has recommended introducing a statutory definition of the deprivation of liberty in its report The Right to Freedom and Safety: Reform of the Deprivation of Liberty Safeguards. I can tell him and all noble Lords that we are considering its findings closely. Many noble Lords have expressed a desire, whether in the form set out in the amendments in this group or otherwise, to explore the possibility of including a statutory definition in the Bill. Following this discussion, that is something I should like to consider further. It is worth stating, however, that there are risks in doing so because it means that to change a definition requires primary legislation. Noble Lords are much more knowledgeable about and aware of those risks than I am, but nevertheless it is something that warrants further consideration.

I am also sympathetic to the sentiment expressed by the noble Baroness, Lady Murphy, about the state involving itself unnecessarily in family and private life while also being mindful of making sure, as we all are, that individuals are not denied the safeguards they need and that we are complying with our obligations under Article 5 of the ECHR. The effect of her amendment would be to limit the circumstances in which arrangements giving rise to deprivation of liberty in a care home or in supported accommodation can be authorised under the liberty protection safeguards, but of course that would mean that such arrangements would still have to be authorised by the Court of Protection. We have already discussed how that can be burdensome and expensive for families. It is for that reason that domestic arrangements were included in the deprivation of liberty safeguards. Given that, while in general I would like to have a further discussion around definitions, there is a problem with the definition that the noble Baroness has provided because of its application in that case.

Medical Innovation Bill [HL]

Lord Woolf Excerpts

Friday 23rd January 2015 Lords Chamber

[Earl Howe]

Perhaps I may deal briefly with the question posed by the noble Baroness, Lady Masham, who asked whether the Bill would apply to patients receiving private treatment. The answer is yes. Any departure from the accepted range of medical treatments for a condition, whether that patient be receiving NHS or private treatment, would be covered under the Bill.

The amendment of the noble Lord, Lord Hunt, would change the test of negligence under the Bill. If accepted—and assuming that the appropriate professional requirements were created—the amendment would require a doctor to comply with any professional requirements as to registration of the treatment; that is, to register the treatment with a scheme for the purposes of taking a responsible decision to depart from the existing range of accepted medical treatments for a condition. In other words, registering details and results of an innovative treatment on a data-capturing scheme would form part of the steps that a doctor has to take under the Bill.

[Lord Woolf (CB)]

I hope the Minister will forgive me for saying that I do not think he is right in saying that the amendment would in any way change the standard. It is only adding a requirement to keep records. That does not change the standard of care which is required. It puts on the doctor an obligation to do something in addition, but I suggest with respect that it does not change the standard.

[Earl Howe]

I am grateful to the noble and learned Lord. Obviously, I must take account of his expert view, but the fear that I was about to articulate is that if you require a doctor to register the details and results of whatever innovative treatment he or she may have administered on some kind of data-capturing scheme in the way suggested by the noble Lord, Lord Hunt, that would constitute part of the requirement for the doctor to demonstrate that he or she has acted responsibly, and thus not negligently. Therefore, if the amendment were accepted, the result could be that a failure to record would be part of the picture when deciding whether a doctor had acted negligently.

If that point is accepted—I expect the noble Lord, Lord Pannick, to take me to task on it—my submission is that that would be a disproportionate requirement.

--- Later in debate ---

[Lord Woolf]

There are provisions as to machinery and provisions that deal with standards of care. I think that this is a machinery requirement. You could not sue the doctor because he had not reported something. It is something that the law requires but I do not think it is intended that this should be enforced by criminal sanctions. There is certainly no specific provision of that sort.

However, it would exclude the ability to take advantage of Clause 1. You have to do Clause 1 in a way that complies with the Act, and the requirement that is now being inserted says that if you are going to do so, you have to do this. The implication is that if you do not do it, you will not get the benefit of Clause 1. This does not mean that the doctor is going to be liable for negligence just because he has not signed the register. As the noble Lord, Lord Pannick, has made clear and those who have taken part in the debate so far have emphasised, the common-law position remains the same. This is an additional mechanism to allow innovation. I therefore suggest that a machinery provision does not do anything else than act on a requirement that you have to go through if you want to take advantage of the Bill.

[Earl Howe]

My Lords, I have been in the House long enough to know that when the noble and learned Lord, Lord Woolf, opines on something, it is a matter that all noble Lords would do well to listen to, and I am grateful to him. I agree that the amendment does not change the standard of care, we are agreed on that, but our concern is that a court might look at the requirements under the Act—and this is one of the requirements—as part of the picture that it would form as to whether or not the doctor had acted responsibly. It is merely part of the picture.

If we are agreed on that, and I hope that we are, it does not seem sensible to me that we should impose requirements in the Bill additional to those under the existing law, as that could risk deterring doctors from innovating under the Bill. Let us not forget that a doctor does not have to follow the Bill if he or she does not want to; they can simply rely on the Bolam test later on if they are challenged. Do we want to deter doctors in the form of a test or requirement that obliges them to go further than they would otherwise go? If they were deterred by that, it would defeat the whole object of the Bill and result in less benefit to patients, so I worry about that.

The amendment from the noble Lord, Lord Hunt, specifies that the use of a scheme be enforced through professional requirements. We have sought advice from the GMC about whether professional requirements in the form of guidance might be a suitable route to enforce the sharing of learning from innovation. The GMC has been clear that it is very happy to consider anything it can do to be helpful. However, from those initial conversations, it seems that this may not in fact be an effective route. The GMC’s statutory power is to provide advice. Doctors must be prepared to justify their decisions and actions against the standards set out in its guidance.

Serious or persistent failure to follow the guidance would put a doctor’s registration at risk. So on the one hand, were we to go down this route, a doctor who failed only once to use a data registry might not face any consequences; that would be okay for the doctor. However, this would not address noble Lords’ concerns that the results of each and every innovative treatment, whether or not successful, should be recorded. On the other hand, if a doctor persistently failed to use the data registry, this could result in fitness to practise proceedings being brought against him or her for not having recorded information on an online database designed to foster the sharing of learning from innovation. Should a doctor’s fitness to practise be called in question simply on those grounds, that really does not seem a proportionate response.

For the reasons that I have outlined today—namely, the difficulty of relying on professional requirements and the link, which I hope noble Lords will accept, to the test of clinical negligence—the Government would not be able to support this amendment.

--- Later in debate ---

[Baroness Gardner of Parkes]

Before the noble Earl sits down, from the outset we have been very clear that this was to be recorded. Everyone has wanted someone reputable to come forward and say that they were going to record it. To see that this will possibly now not happen is just unbelievable because what is the benefit, unless people in the future can benefit from it and it is accurately recorded? I am sorry to say that I cannot accept the view that this amendment should not be accepted by the Government.

[Lord Woolf]

My Lords, before the noble Earl sits down for the last time, I am very conscious of the kind things said by the Minister about my interventions, and I can assure him that I hold his approach to all matters of this sort in equally high esteem, if not higher. He is a lesson to us all in the care with which he approaches these matters.

Just before we leave the subject, I want to draw attention to the words,

“comply with any professional requirements as to registration”.

That is a very important limitation in the amendment because—as I understand it; I did not have anything to do with the drafting—it presupposes that there should be professional requirements. Surely we can rely on the medical profession to put in sensible requirements.

[Lord Winston]

Before the noble Earl sits down—although I do notice that he has managed to take his seat on the Front Bench—I would argue that of course it is not research; we accept that completely. But it is science within the meaning of the Latin word, which has the notion of knowledge, and of course it is wrong for us to exclude knowledge being dispersed and promulgated. Of course, the Medical Innovation Bill hopes to do this, and that is the point of supporting it. Otherwise, I fear that the Bill when enacted will be almost useless. This has been an issue of great concern and was the cause of correspondence this week from many different medical sources. I hope that the Government will consider that very carefully.

Medical Innovation Bill [HL]

Lord Woolf Excerpts

Friday 24th October 2014 Lords Chamber

[Lord Woolf (CB)]

My Lords, before the Minister replies, perhaps I could just make a comment. I have resisted getting involved in the various excellent speeches that have been made so far. While I am on my feet, I make it clear that I strongly support the noble and learned Lord, Lord Mackay. There is a danger in looking at these as alternatives. If the matter comes before the court—of course, one hopes that it will not—the court’s approach would be to say that there is nothing in the Bill, because of the amendment we are now considering, which prevents the Bolam test being relied upon as it is today, without the Bill.

On the other hand, if the situation is one that enables the Bill to be relied on, that is another matter that the person can rely on. In some situations, such as a state of emergency, it may not be possible to rely on the Bill, but that does not prejudice the doctor involved in any way, because the Bill leaves the Bolam test intact. It is supplementing the Bolam test, and the importance of the fact that it is supplementing it is apparent in the fact that it states that if the doctor can comply with the Bill, he knows that he is safe and does not have to wait until the Bolam test has been applied to find out whether he is in danger. I think that that is understood. Does the Minister agree with my approach, which is that these are not alternatives?

[Earl Howe]

I completely agree with the noble and learned Lord’s analysis of the situation. I hope that that has been helpful to the noble Lord, Lord Winston. Earlier, the noble Lord cited an example where a doctor was confronted by an emergency requiring innovative practice. Whether the doctor was acting responsibly or not, and the consequences, will depend on a number of factors. It will depend on the extent to which the doctor is confident in his or her judgment, based on experience in previous clinical practice and can, if necessary, show to a court that what he or she did was responsible and, at least in intent, in the best interests of the patient.

The noble Lord asked whether there was a risk of a doctor being found to be irresponsible in some emergency situations where innovative treatment is practised. Yes, there would be a risk if the process outlined in the Bill were not followed—but that situation obtains today.