Medical Innovation Bill [HL]
Lord Saatchi Excerpts(9 years, 11 months ago)
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Baroness Jolly
My Lords, I am waiting for confirmation from the Box on the mental health issue. If the noble Lord will be patient, I believe something is coming. The answer is no, but under a special provision doctors can choose. I hope that is clear to the noble Lord.
Lord Saatchi (Con)
My Lords, in speaking to Amendment 1, in the name of the noble Lord, Lord Winston, I will speak also to his Amendments 6, 11, 12 and—I am advised—13, and my own Amendments 8, 9, 14, and 15.
Before I start, I will take a moment to echo what the noble and learned Lord, Lord Woolf, said. He described the discussions about the Bill at all its stages as being your Lordships’ House at its best. I so agree. I said in the debate in the Moses Room last week in the name of the noble Lord, Lord Kakkar, that the experience of watching your Lordships’ House debate and discuss the Bill is, as far as I am concerned, a tremendous privilege to be able to hear the greatest legal and medical minds in the country at work.
I thank the noble Lord, Lord Turnberg, for saying that there had been a constructive process of listening to Peers’ views as expressed in Committee. I am also grateful for the view expressed by the noble Baroness, Lady Wheeler, that the Bill team and the Department of Health have behaved constructively since Committee. I have really been only a witness to the toing and froing between Peers whose views were expressed in Committee and the Department of Health through our own Bill team. It will not come as any surprise to your Lordships that this has been a really admirable process of the officials and the legislation department in the Department of Health listening carefully and trying to respond, and I certainly have appreciated that hugely. I know your Lordships will agree. I also thank my noble friend the Minister for her clarification of the Government’s position on many of these amendments.
Amendment 1, in the name of the noble Lord, Lord Winston, would have the effect of disapplying the Bill in emergency cases. I believe and I am strongly advised that it is already clear from the terms of the Bill that doctors will be able to rely on the existing application of the Bolam test in cases where, for whatever reason, they are not able to follow the recording and other procedures set out in the Bill. Amendment 14 and the other amendments in my name have been kindly prepared by the Department of Health. Amendment 14 makes it expressly clear that emergency cases are an example of situations in which it would not be practicable for a doctor to follow the procedures set out in the Bill. Perhaps the noble Lord, Lord Winston, might agree with me that my Amendment 14 deals with the case that concerns him—emergencies—and that it does so in a clear fashion, even clearer perhaps than his Amendment 1. It also has the advantage of being less prescriptive because of the nature of the situations in which the provisions of the Bill might not apply, leaving a doctor to rely on the existing Bolam test. For that reason, I hope that the noble Lord will support my Amendment 14 and therefore not feel the need to press his Amendment 1.
Amendment 6, in the name of the noble Lord, Lord Winston, would define “innovation”. As the noble Lord said, this point was discussed in Committee. My noble and learned friend Lord Mackay of Clashfern expressed his view then, which he has repeated today, that the concept of innovation has a natural meaning in the context of the Bill and that we might do more harm than good by attempting to give it a statutory definition. That is a view with which I, as a non-lawyer, respectfully agree. In particular, I would express the fear to the noble Lord, Lord Winston, that a number of the building blocks of the definition attempted in his Amendment 6 raise more questions than they answer; for example, in paragraph (b), the question of what amounts to an “appropriate clinical trial” could give rise to considerable confusion. It is also worth saying that on 16 January 2013 he himself pointed out—and he should be in good position to know—that,
“one of the issues with true innovation is that serendipity is extremely important”.—[Official Report, 16/1/13; col. 761.]
Obviously that is true and it is certainly very hard to define.
I hope I have shown that we are open to making changes to improve the Bill wherever noble Lords or others have shown that it requires refinement. As I said, there has been a great deal of positive response to the comments and thoughts that we have received. I am not convinced that an addition of the kind proposed by the noble Lord could be welcomed in that way. I am sorry to say that but I hope that he will not feel the need to press Amendment 6.
I turn to Amendments 8 and 9. It has always been the intention of the Bill to make no change in the law relating to research. Clause 1(5) was included for that purpose. Concerns were expressed in Committee and in discussions since then that the point is not understood with the necessary clarity by all readers of the Bill and that it needs to be made even clearer. My Amendments 8 and 9 have been kindly prepared by the Department of Health for the purpose of putting the point beyond any possible doubt.
Amendment 10 relates to cosmetic surgery. In Committee, suggestions were made that the Bill should be confined expressly to the principal kinds of cases at which it is aimed; namely, relatively rare terminal cancers and other terminal conditions. In the discussions since Committee to which I referred earlier, attempts to define the intended scope of the Bill have proved unsuccessful in finding a formula that answers more questions than it raises. Much of the concern, however, has centred on the potential use of the Bill in relation to cosmetic surgery. It was suggested by Peers that it could at least be made clear that it is not the purpose of the Bill to apply to that. My Amendment 10 accordingly excludes cosmetic surgery from the Bill. However, cosmetic surgery can of course be crucial to life or quality of life, as in the case of severe burns, for example. Doctors wishing to innovate in such cases will be able to rely on the existing common-law Bolam test.
Amendment 11 in the name of the noble Lord, Lord Winston, would include dentists within the Bill’s definition of “doctor”, therefore bringing them within the scope of the Bill. The Bill is aimed at an issue on which I am aware there is a need for action: to protect health professionals from the fear of litigation or disciplinary action in relation to innovation, but neither I nor, I think, the Minister has received evidence from dentists or dentists’ patients to suggest that a similar problem arises in their context. Therefore, I do not see the need to include dental treatment in the Bill. If the noble Lord has evidence that there is a problem in the dental sector of a similar nature to the problem that I and many others have identified in the medical sector, I would be very happy to discuss that with him. In the mean time, I hope that, hearing that, he will not press his Amendment 11.
While we are speaking about a niche—perhaps that is not the appropriate term—part of the medical world, it might be interesting to refer to what the Royal College of Ophthalmologists says in a press statement on the use of a particular drug in the treatment of eyes, a drug that one would more normally use in the treatment of cancer. It states:
“Without unequivocal GMC and NICE support, ophthalmologists are understandably concerned that they may be assuming unacceptable personal liability by using an unlicensed drug when a licensed alternative exists … Consequently, patients may not be getting treatment when they need it and not getting the best results”.
Amendment 12 in the name of the noble Lord, Lord Winston, relates to the exclusion of non-registered doctors. It would prevent a non-registered doctor from relying on the provisions of the Bill. At the round-table discussion that the noble Baroness, Lady Wheeler, suggested and that we arranged after Committee—it was requested by the noble Baroness and a number of other noble Lords—the difficulty of designing helpful exclusions was carefully discussed. The exclusions suggested by the noble Lord in his Amendment 12 were discussed and difficulties of a technical nature were suggested. There might be difficulties, for example, in relation to our European Union obligations in respect of practitioners from overseas. Despite that, this is an issue with which I have sympathy for the reasons set out by the noble Lord, and I would welcome an opportunity to discuss with him whether some way could be found of achieving his objective and meeting any technical difficulties of the kind that I described.
I have been authorised by my noble friend Lord Ribeiro, who is unfortunately unable to be here today, to make a statement on his behalf about this question of registration of doctors. He says:
“I am keen to make a distinction between regulated health practice which requires surgeons to hold a licence and unregulated practices where botox and other injectables and implants are performed by unlicensed and unregulated practitioners, many of whom may not be doctors … It is important that this Bill is not seen as a charter for those in unregulated medical practice, like the cosmetic surgery industry, whose sole purpose is the enhancement of a normal appearance through the use of injectables and other materials. Surgeons who are licensed and regulated and undertake cosmetic surgery can continue to rely on the Bolam test … I make the latter point because”,
as the Bill has identified,
“reconstructive surgery is used following burns, congenital defects and as part of the restoration of limbs and the body after ablative surgery, but still perceived by some as cosmetic surgery. That is why the British Association of Plastic Surgery (BAPS) changed its name to”,
the British Association of Plastic, Reconstructive and Aesthetic Surgeons, the BAPRAS. I hope that those comments from the noble Lord, Lord Ribeiro, will help the noble Lord, Lord Winston. In the mean time, I hope that he will decide not to press his Amendment 12.
I turn to Amendment 13, which I have been advised to speak on. The amendment, in the name of the noble Lord, Lord Winston, would have the effect of disapplying the Bill—
Lord Hunt of Kings Heath (Lab)
My Lords, I thought that it had been agreed that Amendment 13 would be grouped with Amendment 5, so the noble Lord needs to respond to it then.
Lord Saatchi
I am sure that that will be done. I will return to Amendment 13 when I respond to a later group.
Amendment 14 relates to the preservation of the Bolam test, an extremely important point. The amendment is in my name and deals with the fact that concern was expressed in Committee about whether in emergency situations, as we discussed earlier, doctors will realise that they are not expected to follow the procedures set out in the Bill—the point made by the noble Lord, Lord Winston. Amendment 14 accordingly introduces a reference to “emergency” and makes it expressly clear that a doctor treating an emergency can and should rely on the existing law. The amendment would achieve this by giving emergencies as an express example of a situation in which the existing common-law Bolam test would apply and a doctor might not engage in the procedures of this Bill.
Amendment 15, again in my name, is a most important amendment in relation to the preservation of the general Bolam test. It deals with the principle that the Bill does not force doctors or require them to rely on its procedures, and they can simply rely on the existing Bolam test in all cases. It recasts the proposition to meet concerns expressed as to whether the intention of existing Clause 2(2)(a) was sufficiently clear. I shall return to Amendment 13 on a later group.
Lord Winston
My Lords, I apologise for my infelicity in getting the groupings wrong. I am very grateful to the Front Bench for making their proposal, which is very helpful.
I realise that I have been in your Lordships’ House since 1995 and this is the first time that I have ever proposed amendments at a Report stage. I should have learnt by now how to handle a Report stage, but I have to admit that, due partly to inexperience and partly to lack of attention to your Lordships during other Report stages of different Bills, I do not. Be that as it may, I shall not go on for long.
I was pleased to hear a degree of support for my Amendment 1, about emergencies, because I think that that approach is necessary. If the noble Lord, Lord Saatchi, is prepared to talk to me about that and see what we might do perhaps at Third Reading, I would be very happy to see how we might get more effective wording for some of these ambiguous areas in the Bill.
I am disappointed that we are not defining “innovation”. That is important because, clearly, these are issues which doctors will need to consider. It is clear from a large number of responses from doctors that there is very considerable confusion about the Bill. What is extraordinary is the number of bodies that show this confusion and say how right doctors are to be confused. Although the Royal College of Ophthalmologists is apparently worried about a particular drug—I bow to the knowledge of the noble Lord, Lord Saatchi, about this; I did not know that it was—the list of concerned bodies includes the Academy of Medical Sciences, of which I have the honour to be a fellow, the Academy for Healthcare Science, the Medical Research Council, the Wellcome Trust, the British Medical Association, the Royal College of Physicians, of which I am also a fellow and therefore I have an interest, the Royal College of General Practitioners, the Royal College of Radiologists, the Royal College of Psychiatrists, the Royal College of Surgeons of Edinburgh and, to some extent, the Royal College of Surgeons of England, the Association of Medical Research Charities, Action Against Medical Accidents, the Medical Defence Union and the Medical Protection Society. I know that it has been suggested, rather irrationally, that somehow the lawyers want to leave things as they are so that they can make more money but, in fact, the Medical Defence Union and the Medical Protection Society are most involved in litigation and they clearly want a reduction in litigation, which is why they are not in favour of the Bill.
Also concerned about the Bill are the British Pharmacological Society, the NHS Health Research Authority and the NHS Litigation Authority—I checked its website this morning to confirm that—Healthwatch and, rather importantly, Cancer Research UK, which raises about £700 million a year for the treatment of cancer in this country. Also concerned are the Motor Neurone Disease Association and, to some extent, the National Institute for Health and Care Excellence. They are mostly concerned about the confusion to doctors, but some would go further than that. They say that the Bill is unnecessary and, as I shall seek to explain, may endanger patient safety.
The reason why I tabled the two amendments about medical practitioners is that it is fair to say that, in future, the National Health Service will have to rely more and more on people who are graduates other than medical graduates. Therefore, the Bill should recognise that they will sometimes need to innovate. It may be worth clarifying their position at this stage.
For the moment, I will not divide the House on Amendment 1, but I would very much value further discussion with the noble Lord, Lord Saatchi.
Lord Winston
I personally think that that is very important. That is why I tabled the amendment, because I wanted discussion on the issue—in particular, for health visitors and more senior nurses, whose position means that they often have to be innovative. The real issue here concerns midwives, because midwives—particularly district midwives, when they do not have a medical practitioner with them—are often presented with horrendous situations where they have to act innovatively. We hear from the Department of Health that it would like to extend home delivery. That may be a very good thing—I do not know; although I am a qualified obstetrician, I have concerns about that—but if that extension happens, as seems likely given that the health service is strapped for income, it is important to consider other health professionals who may be confronted with those problems. At the moment, the Bill does not do that, and I think that that will cause problems in future.
Lord Saatchi
My Lords, on behalf of our team and, I am sure, that of my noble friend and the Department of Health, I greatly welcome and would appreciate the opportunity to discuss the points that he has made between now and Third Reading.
Baroness Jolly
My Lords, to put a definition of an abstract term such as “responsible” in the Bill would be quite a considerable challenge. I think that the Government have covered the issue through the first clause.
Lord Saatchi
My Lords, in speaking to Amendment 2 in the name of the noble Lord, Lord Winston, I will also speak to Amendment 3 in the name of the noble Lord, Lord Turnberg, to my Amendment 7, and to Amendment 13 in the name of the noble Lord, Lord Winston. I am therefore starting with Amendment 2.
To say that it was touching to hear what the noble Lord, Lord Winston, said, would be a considerable understatement. We share the experience of witnessing a terrible event. However, I know that he will share with me the view that, although we have that experience in common, it has not led to an agreement between the two of us about the merit of the Bill, for which I am very sorry. I hope that, in the course of the wide-ranging discussions that he has happily said that we will have before Third Reading, we can arrive at a happy synthesis—perhaps above all for the reason of the two stories that we have to tell. We have a great deal in common.
All these notes are about patient safety. I would like to reassure the House that at a certain crucial moment—probably the crucial moment in the legislative journey of this Bill—the Secretary of State for Health called a meeting in his office of all the great representative bodies and all the great figures in the medical world. I know that he will not mind me saying this. There was a discussion and views were sought by the Secretary of State, after which he said, as an accurate summary of the meeting, that he thought that there was a consensus to move forward with the Bill. However, he said that he wanted reassurance that the safeguards in the Bill in relation to patient safety were adequate. He said that he had decided therefore to formally ask the NHS medical director, Sir Bruce Keogh, to formally advise the Secretary of State on that one question. As we know, this resulted in Sir Bruce widely consulting and producing what are now famously known as the Keogh amendments, as the noble Baroness, Lady Wheeler, said, which were passed in my name in Committee. Therefore, I would like to reassure the House that the Government have taken the greatest possible interest, even at the cost of significant delay to the passage of the Bill, to be sure that the clauses reflected that concern and those concerns expressed in this group about patient safety.
I come to Amendment 2, in the name of the noble Lord, Lord Winston, which would disapply the Bill to cases where the body of responsible medical opinion considers that the innovation proposed is likely to compromise patient safety. As I have just said, everyone—not least of all the Government—want to ensure that patient safety is paramount. I am confident that the Bill already makes that clear in a number of ways, which my noble friend the Minister recited, including in the safeguards added in response to the concerns expressed by the Keogh amendments. Perhaps the noble Lord would allow me to say that the formula suggested in the amendment does not bring an additional clarity to the Bill, for the reasons given by my noble friend the Minister. When there is a requirement to take account of the views of appropriately qualified and experienced colleagues, it means that when there is a general consensus against the proposed innovation, on safety grounds or otherwise, the doctor would not be safe in relying on the Bill to innovate. Nor would I want a doctor to be able to rely on the Bill in those circumstances. My fear is that in attempting to add clarity on the point, the noble Lord might be introducing a number of concepts that could add a high degree of uncertainty, particularly in relation to what amounts to sufficient consensus for the purpose of his new provision, and what amounts to a serious or trivial compromise of patient safety. For those reasons, I hope that the noble Lord will accept that the point at which his amendment is very sensibly aimed is already covered by the terms of the Bill and that perhaps he might agree that his amendment could cause some uncertainty on that point. Therefore, he may agree with me that he will not want to press Amendment 2.
Amendment 3 deals with the question of “views” versus “support”. I would like to reflect in these comments, perhaps in a more long-winded way, on what my noble and learned friend Lord Mackay said, and on what the noble Baroness, Lady O’Neill, said on this subject, on the use of the words “views” versus the words “support”. We have heard that the amendment proposed by the noble Lord, Lord Turnberg, would replace the requirement to obtain the “views” of “appropriately qualified” colleagues with the requirement to obtain their “support”, which sounds perfectly straightforward. However, in Committee there were suggestions that the requirement to consult colleagues should become a requirement to obtain their formal approval. We all thought very hard about whether we could meet those suggestions; several senior doctors were consulted on the point and it was discussed at a round-table event suggested by the noble Baroness, Lady Wheeler, last month, which we arranged following Committee. At that meeting and elsewhere, a number of doctors expressed concern about giving formal approval to another doctor’s proposed course of treatment without knowing the full history and other circumstances, while they were clear that they would be relaxed about expressing a view, orally or in writing, of the soundness of a doctor’s proposal as described to them. Senior lawyers also consulted were concerned, as my noble friend the Minister said, about a possible new form of legal liability for doctors giving approval. We certainly would not want that, for just the reasons that she gave. That is why my Amendment 7 would require doctors to record views expressed by colleagues in the patients’ notes, in the hope of introducing the necessary formality, transparency and accountability, while avoiding the problems that doctors and lawyers have expressed in relation to introducing a requirement for formal approval of colleagues.
Baroness Jolly
My Lords, Amendment 4 of the noble Baroness, Lady Masham, supported by the noble Baronesses, Lady Gale and Lady Wheeler, seeks to require doctors to explain the steps they have taken under the Bill, including the views they have obtained from other doctors, as part of the process of obtaining consent from the patient.
The noble Baroness inquired whether the Bill should specify the need to obtain informed consent in the light of the aims, processes and risks involved in untested treatments. The Bill requires that doctors obtain any consents required by law when taking a decision to depart from the existing range of accepted medical treatments for a condition. The Bill does not change the law of consent, whereby a patient must still provide an informed and voluntary consent to any treatment offered to them. This would include the need to ensure that patients have sufficient understanding of the treatments being provided. Nor does the Bill change the law of consent in relation to children and people who lack capacity, whereby any treatment provided to them by a doctor must be in their best interests.
The Government are reluctant to set out in the Bill the factors that are needed to meet the existing law of consent. To do so might imply that the requirements listed in the Bill are all that are needed to obtain consent under the existing law. We think that a more sensible approach is to make clear that all the existing requirements under the law of consent will continue to apply to doctors who act under this Bill.
In addition, the Government do not consider this amendment to be necessary as Amendment 7 of the noble Lord, Lord Saatchi, will ensure that the steps the doctor has taken in following the Bill are recorded in an accountable and transparent way. I hope that noble Lords will take into account the Government’s view that it is best to rely on the existing law of consent, and not accept Amendment 4.
Lord Saatchi
My Lords, this amendment in the names of the noble Baronesses, Lady Masham, Lady Gale and Lady Wheeler, would add a proposition to the provision that requires innovating doctors to ensure that they obtain all the necessary consents required by law. The amendment would add a qualification to ensure that the patient’s consent must, in particular, have been based on a process in the course of which the innovating doctor explains to the patient what steps the doctor has taken to comply with the reasonableness, transparency and accountability requirements of Clause 1. The doctor must explain the steps taken generally, and in particular must tell the patient what views have been sought from the doctor’s colleagues and what those views were.
I do not claim for this Bill the status of our great poetry, usually best defined as the only possible words in the only possible order. I can quite see why the noble Baronesses think that this specific requirement would add clarity and certainty without changing the essence of what the Bill already requires. Although I think that what the noble Baroness proposes would already be a necessary part of any reasonable reliance on Clause 1(1), I can absolutely appreciate—we have spoken about this, obviously—why she thinks that express provision on this point would help readers to understand how the Bill is intended to work. However, my noble friend the Minister has explained why the Government do not consider this amendment necessary, and will therefore not invite the House to support it.
I hope that the noble Baroness will consider the relevance to this amendment of my Amendment 7, which seeks to do exactly what she is describing. Therefore, although I have considerable sympathy with the intentions behind this amendment, I know that she will appreciate that I am bound to follow the lead of my noble friend the Minister on this matter. However, I hope she will feel reassured by the fact that her amendment has enabled both the Minister and myself to place on record that our understanding of how Clause 1 would be applied in practice is absolutely in accordance with the noble Baroness’s own understanding, as set out in her amendment, of how it ought to work.
Baroness Butler-Sloss (CB)
But it is permitted for noble Lords to ask the Minister a question before she technically sits down. I should just like to reiterate what has already been said: it seems to me that making the register compulsory ought to be on the face of the Bill.
Lord Saatchi
I am going to put my notes to one side, probably to the horror of parliamentary counsel. On this amendment I find myself in complete agreement with every word that has been said by every Peer who has spoken on the subject. The reason is that it has been my fundamental position on the Bill from the beginning that, without a register that records both positive and negative results of innovation, it is very hard to explain to a man from Mars what the point of the Bill is. The Bill is designed to move science forward. If it does not do that, I can only say that I do not know quite what it does. That is its purpose.
I do not speak as an expert on the subject, but at least I can read. The standard text on the subject of science and scientific discovery was written by Professor Popper some years ago—noble Lords will all be familiar with it. In it, he describes the logic of scientific discovery as “reputation by application”. If no record is kept of a case in which a hypothesis has been refuted, then science will not advance in the way that the logic of scientific discovery requires. Therefore, it is, in the words of my noble and learned friend Lord Mackay of Clashfern, absolutely essential that there is a register that records both the successful and the unsuccessful results of innovation. In that way, science will advance and the wonderful result will be, as is the purpose of the Bill, to speed up the discovery of cures for horrific diseases.
I also want to reflect on what my noble friend Lord Cormack said. It has been pointed out to me that the work on the Bill will really only start on the day it receives Royal Assent. My noble friend the Minister and the Department of Health will have to hold some kind of conference and undertake some kind of educational programme with the royal colleges in order to achieve the purpose of the Bill, which, as described by the Chief Medical Officer of the United Kingdom, is a culture change. It is designed to change the culture slightly towards innovation and to provide doctors with a relief from the fear of litigation that some doctors have. None of those things will be possible or logical without the register.
I remind your Lordships that Oxford University has offered to maintain the register. It regards it, as I do and as we all do, as an essential part of the Bill. Therefore, it is reassuring to hear from the Minister today that the Government are not saying that the register is something that they are going to review or consider, or that it is something that they regard as perhaps having a benefit. The Minister has said today, for all of us to hear, that the Government commit to the creation of a register that does exactly what Members of your Lordships’ House have said. I am satisfied by what my noble friend the Minister has said because she has said flat-out in Hansard that the Government intend this register to be created—by Oxford, NICE, the Government themselves or whomever—and that the Government intend to bring the relevant people together during the passage of the Bill through the House of Commons in order to resolve the question of how and by whom that register is going to be compiled. I have certainly heard the Minister say that the Government are committed to the register. That is very reassuring to me.
Lord Forsyth of Drumlean
Will my noble friend deal with the issue of compulsion? You can create a register, but it might be a voluntary register, not a compulsory one.
Lord Saatchi
That is an important point and many have made it. The discussion that has to be had is whether this can be achieved by regulation, as I think my noble friend the Minister believes, or by GMC guidance. It is possible that there are other ways to achieve what is in effect compulsion without putting it in the statute.
Lord Ryder of Wensum (Con)
Will my noble friend accept that there are precedents in other Private Members’ Bills going back several years for such registers being set up?
Lord Saatchi
“( ) The steps that must be taken by virtue of subsection (3)(e) include the recording in the patient’s notes of details relating to—
(a) the views obtained under subsection (3)(a),(b) the doctor’s decision to depart from the existing range of accepted medical treatments for the patient’s condition, and(c) the proposed treatment.”
Lord Saatchi
(b) is to be read as limiting the circumstances in which any such rule of the common law may be relied on (including, for example, where emergency treatment is required).”
Medical Innovation Bill [HL]
Lord Saatchi Excerpts(10 years, 4 months ago)
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Lord Saatchi (Con)
My Lords, what a privilege it is to address your Lordships’ House with so many distinguished Peers and noble and learned Lords in their places today. I thank the usual channels for arranging the time for the debate, and my noble friend the Minister. The Medical Innovation Bill can be regarded as one of the many initiatives being taken in his innovation agenda to advance medical science, along with early access to medicines, the cancer fund, the genomics project et cetera.
I congratulate the Minister’s department for a model consultation on the Bill. A full-scale public consultation of this kind is an enormous undertaking and it has carried it out brilliantly. I understand that the public service ethos not only exists but is alive and well in our top civil servants, and is nurtured by them in the true spirit of Northcote-Trevelyan. In particular I thank the director of legal services in the Treasury Solicitor’s Department, Isabel Letwin; the head of legislation, Ian Dodge; his deputy, Peter Howitt; Jenny Harper; and Jenny Munday.
Advice has been received from over 20,000 doctors, patients, charities, the Royal Colleges and many other medical and legal organisations. I thank them all. I should say that the noble Lords, Lord Patel and Lord Kakkar, who cannot be here today, have asked me to express their strong support for the Bill.
It is hard to overpraise the distinguished former parliamentary counsel, Daniel Greenberg—the draftsman of the Bill—and Dominic Nutt and Liz Scarff, who have managed parliamentary and media liaison. My warmest thanks are due to Debbie Binner, whose daughter Chloe died of cancer aged 18; Alex Smith, whose son Harrison suffers from cruel Duchenne disease; Mavis Nye, a lung cancer victim; and the hundreds of other families whose stories have all been part of the Bill from the outset.
The Medical Innovation Bill has been on a long, winding and sometimes bumpy road, as it should. My noble friend Lord Strathclyde, who was the Leader of our House, says it should be hard to change the law. There are many hurdles, even for Governments. So it should be and so it is. Whatever happens to the Bill now, I have made lifelong friends in the medical and legal worlds, from whom I have learnt so much and to whom I am so grateful.
I will start by laying out the parliamentary status of the Bill. It was originally introduced in your Lordships’ House at the end of 2012. In October 2013 Michael Ellis, the Member of Parliament for Northampton North, introduced the Bill in another place. In November 2013 the Secretary of State for Health expressed the Government’s intention to bring forward early legislation, subject to the public consultation, which closed in April this year. On 1 May the Secretary of State asked Sir Bruce Keogh, the medical director of the NHS, to advise on the safeguards in the Bill. I am sure that the Minister will bring us up to date. I am greatly encouraged by what I have heard about Sir Bruce’s work.
The government Chief Whip advises that, if no amendments are tabled in your Lordships’ House, the Bill will go to another place before the Summer Recess. Amendments can then be laid there in Public Bill Committee. Then, all being well, the Bill will go to Her Majesty for Royal Assent in February 2015 and become an Act of Parliament before the next general election.
I turn to the Bill. In our House a précis is a form of good manners. The best summary I can give you of what this Bill is about comes from Professor Norman Williams, the President of the Royal College of Surgeons, who sums it up in six words:
“Protect the patient: nurture the innovator”.
That is exactly what the Bill does. I will explain.
“The sentence of this Court is that you be taken from hence to the place of execution and that each of you there will be hanged by the neck until you be dead. And may Almighty God have mercy on your souls”.
So wrote Charles Dickens, 150 years ago. It sounds medieval—barbaric even—does it not? Yet much the same can be heard in every cancer ward in every NHS hospital every hour of every day, with only one difference. In Dickens, the condemned were sentenced to death by a court of law. I am not aware that the cancer dead or the victims of any other terrible disease are guilty of any crime. Death by hanging, by firing squad, by electric chair—no human being has ever devised a more brutal execution than death by cancer. Perhaps only the Benches of the right reverend Prelates can advise us on the vexing theological question of why bad things happen to good people.
Either way, those condemned by cancer suffer a worse fate than the worst mass murderer. While they await execution, they are tortured. For them, hair loss is the good news. Less good news is that their treatment regime—the drugs and the cycles of their administration, and the surgical procedures—are often 40 years old. They create the same symptoms as the disease: nausea, diarrhoea, vomiting and fatigue. A beautiful woman’s legs turn into elephant’s legs; her arms begin to make a heroin addict’s arms look attractive; and her bosoms turn into raisins. That is before the bad news: the discovery that standard cancer treatment does such damage to the immune system that the cancer patient is quite likely to die from fatal infections such as MRSA, E. coli and so on—like Mrs Goodrum, aged 46 and a mother of five, who died a few weeks ago of septicaemia during her chemotherapy.
In my visit with my honourable friend Michael Ellis to the NHS hospice in Northampton, the wonderful volunteers explained to me that 80% of the patients in their hospices are cancer patients. Average life expectancy is six weeks. If they leave the hospice, it is two weeks. It would take quite a few of the biggest JCBs of my noble friend Lord Bamford to dig the mass grave for the 165,000 British cancer dead this year—the same as last year and the same as next year. With current UK mortality rates, this looks like reliable repeat business for gravediggers—and for grave-robbers, too. For them, it is quite easy. After Hamlet and Laertes leave Ophelia’s grave, they jump into it with a claim against her doctor for failure to diagnose her suicidal tendencies, and another against the river authority for failure to put out adequate warning notices to swimmers.
The law cannot cure cancer—Parliament’s power, though awesome, is not sufficient. Only science can do that. However, the law does have the power to change the culture. Let us consider its impact on attitudes to race, drink-driving, homosexuality and smoking in public places. No amount of exhortation or guidance from on high could have achieved what the law has done. This law change will not cure cancer but it will encourage the man or woman who will.
All cancer deaths are wasted lives. Scientific knowledge does not advance by one centimetre as a result of all these deaths, because the current law requires that the deceased receive only a standard procedure—the endless repetition of a failed experiment. In this way, the current law is a barrier to progress in curing cancer. It defines medical negligence as deviation from standard procedure. In other words, any deviation from standard procedure by a doctor could currently result in a verdict of guilt for medical negligence. However, as innovation is deviation, non-deviation is non-innovation. Sticking to the status quo—I am looking anxiously at the noble Lord, Lord Giddens—does not meet Professor Popper’s The Logic of Scientific Discovery: refutation by application. If there is no application, there is no refutation and no science. This is at least one reason why there is no cure for cancer.
As a result of this change in the law, medical practitioners will be encouraged rather than discouraged to seek improvement to the standard procedure. This Bill achieves that in a safe and responsible way. I shall not make any attempt to describe the legal status of the Bill—certainly not in front of a former Lord Chancellor and a former Lord Chief Justice. I shall simply say that the Bill achieves its aim—safe and responsible innovation—in a simple way. It moves the Bolam “responsible persons” test from after the event to before the event. The result is that doctors are not obliged to speculate in advance about what might happen in a subsequent trial, and they can move forward with confidence, safe in the support of a responsible body of medical persons—in other words, the Bolam test brought forward. This crucial time change removes any uncertainty and ambivalence about what is or is not lawful medical innovation.
If I may, I shall take a few minutes to try to deal with one question. It sounds quite logical, yet noble Lords will all be aware that some have objected to the Bill, and I think that I should try to address some of the objections from serious people. The Bill has touched a nerve. For some, it has been painful. Some doctors have asked, “Is this Bill saying that we are not innovating?”. Some medical negligence lawyers have asked, “Is this Bill saying that we are responsible for the fact that there is no cure for cancer?”. No, my Lords, this Bill is not a criticism of anyone—by anybody. Nobody is doing anything wrong. Everyone is doing their best, by their own best lights, to serve the community. However, the fact remains that there is no cure for cancer.
Your Lordships may have heard it said that the Bill is unnecessary because, as I said, innovation is taking place now. Of course it is, and I take my hat off to those who are working flat out to achieve the innovations that have taken place, but to be in favour of innovation is not to say that there is no innovation; it is just saying that we need more of it. On that, we can all agree.
Your Lordships may have heard it said that the Bill is unnecessary because there is no fear of litigation. The Medical Defence Union has protested strongly that no doctor has ever asked it for advice about litigation risk. Yet the MDU is an insurance company for doctors. It receives millions of pounds of insurance premiums from doctors to insure them against—yes—medical negligence claims. But at the same time it says that doctors have no fear of such claims. That does not make much sense, does it? Perhaps the MDU runs the risk of appearing too clever by half.
In the real world, the culture of medical litigation grows and grows, and I cannot spare your Lordships the statistics. Last year, we, the taxpayer, paid out £1.2 billion to meet negligence claims against the NHS. That figure has doubled in five years. According to the Treasury, we the people have a further liability for a staggering £24 billion—another sum that has doubled in five years. Are we to assume that doctors have never heard of all this litigation? Fortunately, the Government are not so deaf. The NHS Litigation Authority has been formed to deal with this tidal wave of litigation. It has, according to its report,
“an extensive risk management programme ... Most healthcare organisations are regularly assessed against the NHSLA Risk Management Standards”.
Are we to believe that no hospital trust has ever heard of these legal risk management assessments? Of course not, particularly as only this week the Secretary of State has asked Sir Robert Francis to review what Sir Robert calls the “culture of fear” in the NHS. That, of course, is why Professor Sir Michael Rawlins, president of the Royal Society of Medicine, says, flat out, that,
“departing from what is regarded as ‘established practice’ or ‘the standard of care’ leaves a doctor open to legal action for negligence”.
The noble and learned Lord the former Lord Chief Justice, who I am pleased to see in his place and who will speak later, agrees. He said:
“At the moment, the doctor’s hands are tied—by concerns about professional reputation and potential negligence claims. That needs to change”.
Some have still objected that if more innovation is needed, the right place for it to be is in clinical trials. Sir Austin Bradford Hill, the forefather of the RCT—the randomised control trial—writes:
“Any belief that the control trial is the only way”—
to study therapeutic efficacy—
“would mean not only the pendulum had swung too far but that it had come right off its hook”.
This is why the Regius Professor of Medicine at Oxford, Professor Sir John Bell, said:
“There will be no cure for cancer until real doctors with real patients in real hospitals can attempt an innovation”.
The Secretary of State for Health said:
“We must create a climate where clinical pioneers have the freedom to make breakthroughs in treatment”.
The Prime Minister said that his vision of the NHS is:
“Every clinician a researcher, every willing patient a research patient”.
Can we safely put aside the objection that this Bill is unnecessary? The objection, however, that we must consider most seriously is that in its attempt to open the door to more innovation the Bill opens the door to quacks, crooks, cowboys and charlatans. No one wants that and so I greatly welcome the Secretary of State’s invitation to Sir Bruce Keogh to consider the oversight mechanism in the Bill. I am greatly encouraged by his thoughts. My noble friend will say more about that later, I am sure.
As well as that, there has been another important new result from the consultation which I should like to announce to your Lordships. Oxford University has come forward to say that it will maintain a public register of innovations that take place under the Bill. This Oxford initiative achieves two aims simultaneously: to advance scientific progress through the dissemination of knowledge to the global medical community; and full public disclosure and transparency to deter recklessness. Sunlight is the best disinfectant.
The Bill has exposed a fault line in the medical legal profession. Some say the law does not block innovation; others say it does. Some say there is no fear of litigation; others say there is. Some say they can innovate now; others say they cannot. We have here proof of one thing beyond doubt. After all the words, blogs, letters, interviews, tweets and articles that have been written about the Medical Innovation Bill, there is one definite, irrefutable conclusion. As the noble Lord, Lord Kakkar, says:
“There is an ambiguity in the way that the current law may be interpreted”—
and, therefore, uncertainty about what constitutes a safe path to lawful innovation. A lack of clarity demands a clarification.
Cancer is the number one cause of the untimely death of British citizens. Who among us can accept the counsel of patience and delay? Scientists want this Bill, the Prime Minister wants this Bill, the Secretary of State wants this Bill—and, last but not least, patients in their thousands want this Bill. Unless the phrase “putting patients first” is a mere platitude, let us listen to them. They ask a simple, despairing question: “Can anything more be done? Is there anything else we can do?”. They have tried every form of prayer to beat cancer. The Almighty cannot do this job for us. He wants us to do it for ourselves. With your Lordships’ help, that is what we will do. I beg to move.
Lord Saatchi
My Lords, I thank all noble Lords who have spoken today. As my noble friend the Minister said, it has been a remarkable privilege to address, and to hear, your Lordships. There may have been moments when it did not sound like it but I think that your Lordships’ House is unanimous in that we want to encourage more innovation but we want it to happen safely.
In that context, I now give an undertaking before the whole House regarding what the Secretary of State has put in motion to deal with the safeguards in the Bill to achieve the dual aim of more innovation, safely. The Secretary of State asked the medical director of the NHS, Sir Bruce Keogh, to examine that, and he has done so with great care and diligence. I believe that the result of his work will be, as my noble friend summarised briefly, that the Government will themselves propose amendments to the Bill in the Public Bill Committee in the House of Commons. I hope that that may be an appropriate point for other amendments to be tabled, following the Government’s example in the Public Bill Committee in the House of Commons.
I give the House this undertaking. I and Michael Ellis, the MP for Northampton North, who will propose the Bill in the House of Commons, undertake here and now to adopt the government amendments that my noble friend and the Department of Health will put forward and to take them forward in our name in the House of Commons.
I thank all noble Lords very much indeed. It is indeed a privilege to have addressed your Lordships and I now ask the House to give the Bill a Second Reading.