The Long-term Sustainability of the NHS and Adult Social Care
Lord Saatchi Excerpts(6 years, 7 months ago)
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Lord Saatchi (Con)
My Lords, the noble Baroness, Lady Finlay, says that this report is a thank you gift to the NHS on its great anniversary. Perhaps my words could be a thank you to the noble Lord, Lord Patel, and his distinguished committee. I hope that this report and debate will be another proof, if any were needed, that your Lordships’ House can change the course of history.
To that end, I will start with what the committee says in recommendation 24, on what it calls “the uptake of innovation” in the NHS. It says that there is no credible strategy. My noble friend the Minister will recall the passage through Parliament of the Bill that became the Access to Medical Treatments (Innovation) Act 2016, in which I had the privilege of playing a part, together with many other noble Lords here today. The Minister may recall that Section 2 of that Act confers a power on the Secretary of State to, in effect, use subordinate legislation to establish a database about the process and results of innovative medical treatments in the NHS.
Noble Lords will share my concern that, more than two years since that Act achieved cross-party support and received Royal Assent, not only has the database not been established but the section itself has not even been brought into force by commencement regulations under Section 4. So far as I have been able to establish in correspondence with the Minister’s department, he has no definite plans to commence this section, to make the regulations or to establish the database.
As was noted in the two standing-ovation debates of the noble Baroness, Lady Jowell, in both Houses, data that can direct and fashion the future of medical treatment is absolutely crucial, and it was the clear will of Parliament, in enacting Section 2, that innovative treatment data would be used for that purpose. When the Minister replies to the debate I very much hope that he will give a firm assurance about the commencement of Section 2 of the 2016 Act and for the timetable for the making of regulations under it and the establishment of the new database.
My noble friend the Minister will note that my advice from parliamentary counsel is that two years should have been more than sufficient to enable the necessary pre-commencement consultations to be carried out. Although the courts will not force the exercise of a commencement power, given the other work being done on data in the NHS this could well be a situation—I am told—that engages the Fire Brigades Union case rules and the Court of Appeal judgment in that case, with which my noble friend will be familiar. I am sure that he will be anxious to give us a sufficiently clear assurance about his commencement plans to avoid any suggestion that it may become necessary to apply those rules.
The committee’s report considers the organisational structure of the NHS, and here to help us we have the official government response, which other noble Lords have spoken about. When I first read it, I thought it was a spoof—not written by my noble friend the Minister but by someone auditioning for the next series of “Yes Minister.” We learn that the STPs are working closely within the BCF, as are the GDEs. Meanwhile, the ACC and the AAC are developing the AAP in the TB, ITT and ITP programmes. The ACPs and the SCPs are also giving the AHPs the opportunity to work alongside the FFs to implement the ALBs following the NDG. Some say that these acronyms are harmless enough and just bureaucracy-speak. However, to make a serious point, as the Governor of the Bank of England said, such acronyms in the banking world—CDIs, CDOs, CDSs, SPVs et cetera—brought the world to its knees. Let us make sure that these acronyms do not bring the NHS to its knees.
I will come to the main point. Looking at the main conclusion of this outstanding report, the noble Lord, Lord Patel, and his committee want to see two separate things. They want a long-term approach; they also want a bipartisan, cross-party approach. The committee is nothing if not ambitious, but in those two ambitious aims it has a great friend—if I may say so, a powerful friend—that shares its conclusions. The Centre for Policy Studies, of which I am the chairman, has published two pamphlets on the subject of this report and debate. The first sets out why a royal commission on the NHS is now required—because, in the words once used when royal commissions were more fashionable, the NHS is,
“an issue of great national importance in which the tribal warfare between the parties is an impediment to the national interest”.
That is much as the committee said. The CPS has also published the proposed remit for such a royal commission.
This came about because the researchers at the CPS, in their inquiries throughout the medical profession, Whitehall and Parliament, et cetera, found that there was no agreement on anything to do with the NHS—not on whether there is a problem with it; nor on whether, if there is a problem, that is the problem; nor what is the solution might be if that is the problem. The first of the many people to whom the CPS spoke said, “It’s the money, it’s the cuts—that’s the problem”. The next person said, “It’s not the money, it’s the organisation”. The third said, “It’s not the money and it’s not the organisation, it’s the culture that’s the problem”. The CPS published 69 of these alternative facts to portray the level of disagreement.
I will come to a happy ending now. Thanks to the gift granted to me to see ahead—I am looking at the right reverend Prelate for confirmation—I can bring your Lordships joyous news towards the end of this debate. On 5 July, it will be a beautiful summer’s day for a great state occasion to celebrate the NHS, and the Prime Minister will confirm that she has been to Buckingham Palace to see the Queen. Addressing the nation on the steps outside No. 10, she will explain her decision to appoint a royal commission on the NHS. I will finish in one minute. Her reason will not be A&E waiting times, cancer mortality rates or anything to do with that. It will be because the trend in the NHS now contradicts her inaugural speech on the steps of No. 10, which was about attempting to remove injustice, inequality and unfairness.
A system in the NHS in which it is possible for people to be told, “If you have the money, the doctor will see you now; if you are poor, go to the back of the queue”, which means one law for the rich and one for the poor, is the ultimate injustice. This is something that the Prime Minister cannot accept, and therefore she will capture the mood of the country about the NHS by saying, as she has just said about the EU, “Let’s just get on with it”. She will say, “I’m not prepared to go on kicking the can down the road”, and that she wants a long-term view. She will agree with the noble Lord, Lord Patel, and his committee, and with the Centre for Policy Studies. She will want a cross-party approach to give us back our pride in the glory of the NHS. As she turns off the light on her bedside table—which I can also see ahead—the Prime Minister will say, “I will do it. If not me, who? If not now, when?”.
Access to Medical Treatments (Innovation) Bill
Lord Saatchi Excerpts(8 years, 9 months ago)
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Lord Saatchi (Con)
My Lords, I beg to move that this Bill be now read a second time. These days, the parliamentarians in another place are often an abused minority who receive very little praise. What they usually get is offhand criticism from people who question their motives and behaviour. However, to those who have eyes to see and ears to hear, the Hansard reports on the well-mannered and illuminating debates on this Bill in another place bear witness to the fact that the place is occupied overwhelmingly by intelligent and responsible people, honestly striving by their own best light to pursue the aims for which the place stands. I would like to thank, in particular, the MP for Daventry, who kindly invited me to bring this Bill before your Lordships today, and I thank noble Lords for the interest, commitment and time that they have given the Bill and its predecessor.
In the House of Commons, I observed many hours of thoughtful and painstaking line-by-line scrutiny of the Bill. I draw the attention of the House to the definite intent in the House of Commons for a cross-party, non-partisan, non-tribal approach. That is a great credit to Chris Heaton-Harris, who searched for consensus throughout the successful passage of this Bill through the House of Commons. I ask noble Lords to consider, for example, the Conservative Member for Bury St Edmunds, Jo Churchill, who is herself a courageous double survivor of cancer. She spoke with real passion and authority on the power of research and data, and on why we need urgently to develop this new landscape to support the speedier adoption of medicines. Noble Lords should also consider the Labour Member for Torfaen, Nick Thomas-Symonds, who generously agreed to include in this Bill some of the provisions of his own widely supported Bill in another place, which was intended to promote the greater use of off-label and repurposed medicines. They may also consider the SNP Member for Central Ayrshire, Dr Philippa Whitford, a greatly respected medical specialist who has also played an important role in bringing the Bill to this point today.
I would also like to acknowledge the late Les Halpin. He founded Empower: Access to Medicine with a passion that his death should not be in vain and might inspire and motivate others to accelerate innovative medicines being brought to patients. The campaign that was started for him continues to grow and build support for the programme that we are discussing today.
Finally, I pay special tribute to the Life Sciences Minister in another place, George Freeman, whose sincerity and consistency in pursuit of the programme at the centre of the Bill is plain for all to see. As he said:
“I have been determined to work with Back Benchers to reach a solution that the House and the Government could support”.—[Official Report, Commons, 29/1/16; col. 593.]
He explained at the end of Third Reading that:
“It is wonderful to see MPs from all mainstream parties … in support of a measure that offers real benefits for patients and front-line clinicians, without undermining the latter’s clinical sovereignty over patients. It is about giving them information, so that they can make the exquisite clinical judgment we all want them to make. I … commend the Bill to the House and … congratulate all those involved, and I am delighted to have done my bit to help strike a blow for joined-up government”.—[Official Report, Commons, 29/1/16; col. 598.]
The MPs whom I have mentioned, and others who spoke in earlier debates in another place, did, as the Life Sciences Minister concluded, bring us to a much better place with a Bill that commands and deserves respect and support.
I thank the officials in the Department of Health. Many noble Lords will have seen the excellent Explanatory Notes on the Bill and the professional guidance note, also prepared by the department. The officials I have worked with throughout the passage of the Bill and its predecessor are true exponents of the Northcote-Trevelyan ethic of public service.
I will give the briefest of brief histories. The Medical Innovation Bill was passed by your Lordships’ House on 23 January 2015. The general election interrupted its progress in another place. In the new Parliament, it was taken up by Chris Heaton-Harris, who I am delighted to see is at the Bar, with government support as this Access to Medical Treatments (Innovation) Bill and passed by the House of Commons on 29 January 2016.
The UK Chief Medical Officer and the medical director of the NHS both confirmed to the Secretary of State that the clinical negligence provisions in the predecessor Medical Innovation Bill, as your Lordships had decided, were safe. But anxiety continued about possible unintended consequences, and it was concluded by all that it was best to focus on the strongest, agreed part of the Bill—the database. From the beginning, the aim has been to move forward a culture of innovation, and all agree that the existence of the database of information, sharing knowledge of best practice, could help achieve that, with popular support in the medical and scientific community.
The Bill gives the Secretary of State the power to make regulations conferring functions on the Health & Social Care Information Centre—the HSCIC—which is the body that develops and puts into place databases such as the one we are discussing in connection with the establishment, maintenance and operation of the database for innovative medical treatments. Clause 2 of the Bill provides a regulation-making power for the establishment of this database by the HSCIC. Conferring this function on the HSCIC is in keeping, I understand, with its existing powers under the Health and Social Care Act 2012, which included the establishment and operation of systems to collect or analyse health and social care information. The HSCIC is, I believe, well equipped to handle information of this type, including ensuring the necessary safeguards are in place. It is intended that information relating to innovative medical treatments and the outcomes of those treatments carried out by doctors in England will be passed to the HSCIC through existing national data flows by using national coding structures derived from patient notes. The information will be presented in a consistent way.
I cannot remember such unanimity and intensity of feeling on any clause in any Bill in your Lordships’ House as there was when we discussed this database during proceedings on the original Medical Innovation Bill. It followed an initiative from the University of Oxford that was designed to encourage the creation of such a database. It is why the noble Lord, Lord Kakkar, said at Second Reading of that Bill that,
“this is a vitally important Bill … I hope that it will also drive forward a positive culture of putting innovation at the heart of all clinical thinking ”.—[Official Report, 24/10/14; col. 875.]
And it is why the noble Lord, Lord O’Donnell, arguing that we needed evidence-based medicine, said that:
“Of course there was no evidence; that is the whole point. We have to find ways to generate evidence”.—[Official Report, 24/10/14; col. 878.]
So he strongly supported the Bill. It is also why the noble Lord, Lord Giddens, who is not here today because he has an infection said at Third Reading:
“Science is a collective enterprise. It depends on the accumulation of evidence. It is crucial that that be recognised … as part of the advancement of scientific progress more generally”.—[Official Report, 23/1/15; col. 1583.]
The noble Lord, Lord Giddens, has written to me today saying:
“The radical nature of innovation in medicine today exists because of the overlap of supercomputers, genetics and global data sources”.
That is why he strongly supports this Bill. The noble Baroness, Lady Masham, who has been involved throughout this process, said that,
“it is essential that provision is made for collecting and sharing data to ensure that information, both on beneficial and harmful effects of treatment, is captured for the benefit and subsequent use of patients”.—[Official Report, 12/12/14; col. 2061.]
It is why my noble and learned friend Lord Mackay, who also cannot be here today, said:
“If innovative treatment has been successful in a particular case, the details of that case are required to make sure of the extent to which the results might be expected to follow in another case. I regard it as important that that should happen”.—[Official Report, 12/12/14; col. 2061.]
I pay particular tribute to the noble Lord, Lord Hunt of Kings Heath, who took forward in the consideration at Third Reading of the original Medical Innovation Bill the Oxford initiative. He deserves great credit for the fact that we are where we are. The noble Lord, Lord Kakkar, also thanking the noble Lord, said, with the approval of the whole House, that the database would,
“allow colleagues to understand what has been achieved and not achieved … and it will ensure that through transparency we have the best opportunity to ensure the greatest patient protection … The measure enjoys substantial support and will be a vital contribution to this long journey with regard to innovation”.—[Official Report, 23/1/2015; cols 1582-83.]
The Minister for Life Sciences in the Commons took forward the debate from that point, and another place passed a money resolution on 3 November 2015 to provide funds for the creation of this database. The Minister set that firmly in the context of the new field of personalised or precision medicine, in which he said that this country is leading the field. The Minister launched the accelerated access review to look at how we can better integrate and speed up our landscape for the adoption of innovative medicines using informational genomics and informatics so that NICE and NHS England have more freedom to target particular treatments at the right patients. The interim report on the accelerated access review will arrive shortly, and I am sure that my noble friend the Minister will say something about how this Bill fits into the landscape of that wide review.
I am not going to take much time describing the current position in terms of the maintenance of data, but perhaps only to say this. There were attempts throughout the 20th century to maintain registers and records, as that is of course a requirement of those who treat patients. However, owing to the expense of maintenance, then often carried out by hand, the limited information available, which relied on data sheets completed by clinicians in addition to their routine workload, meant that there were always practical difficulties. For example, the most recent figure available for the total number of registers used by the medical professions is from 2002. Back then, the Department of Health commissioned a report into disease registers in support of the White Paper, Saving Lives: Our Healthier Nation. The report found at that stage that there were more than 200 disease registers in existence in England and stated that they would not be surprised if there were more than 400 specific registers. That rendered the situation on data collection at best confusing and at worst made finding evidence and navigating through the data almost impossible.
I believe that my noble friend the Minister will say that the database set out in the Bill will provide clarity to the vast web of registries’ information and data that already exist and help clinicians find evidence for innovative treatments simply and quickly. This is now very important because, as we read every day, research has come on in leaps and bounds, meaning that a huge number of new treatments are coming into the NHS and innovative ideas are everywhere. I know also that my noble friend will want to confirm that patient safety and confidentiality are the Government’s priorities to ensure patient trust and confidence, and I know that this is of particular importance to the noble Baroness, Lady Masham, and indeed to all noble Lords.
There is a growing movement of patients, charities and campaigners who want us to accelerate access to innovative medicines. The Minister has described seeing many demonstrations outside his office in Whitehall which are, as he puts it, demonstrations asking for progress in access to drugs not to be slowed down but to be speeded up. He has also said that he has taken part in more debates on the subject of access to innovative drugs than on any other subject in his brief. I am sure that my noble friend the Minister will respond to the request in another place made by the opposition Front Bench spokesman, Heidi Alexander, the Member for Lewisham East, to take very seriously the design of the database and the process of consultation. I know that my noble friend will want to give an undertaking to engage closely with the medical profession and all who take an interest in the Bill to put the patient’s voice at its centre as the Government put the detailed proposals together. He has a close relationship with the Association of Medical Research Charities. He will want to repeat the offer made by the Minister in the House of Commons for it to come to the top table and help to shape this landscape for the faster adoption of innovative medicines. Indeed, by putting the patient’s voice and experience—in many cases best expressed by the great research charities—at the heart of this, we can move forward in empowering patients and accelerating innovation.
I do not need to add any more about the purpose of the Bill, only to say that I know my noble friend will want to ensure that, through the process of creating this database, we explore mechanisms for ensuring that NICE can look at evidence and develop evidence-based guidance on off-label medicines so that doctors are aware of which drugs are being used in an off-label indication. I hope that my noble friend will also confirm that, after discussions, NICE is now looking at ways to collect evidence on repurposed medicines. It is looking at taking evidence and how it could use, through its existing evidence review process, evidence on repurposed medicines specifically. That would be a helpful reassurance.
I say to your Lordships what you are all well aware of: the world of drug discovery is changing profoundly, as the noble Lord, Lord Giddens, said. The transformational power of genomics and informatics creates a wholly new opportunity to discover new medicines and to target them at individual patients more quickly, and to discover repurposed uses of existing drugs in a way that we have not been able to previously. The 100,000 Genomes Project, which the Government have initiated and funded, has already begun to identify existing drugs that have uses and indications that were not hitherto known. The pace at which new drugs are being developed and discovered is increasing, as one of the leaders of oncology said this week, at what he called a supersonic pace—a great testament to the creativity of the medical profession. In time, with the Government’s extensive consultation in the medical profession, the model that emerges of this database could supplant the expensive and time-consuming manual surveys currently used for cancer mapping.
I end with this. It is striking to me, and I hope to all your Lordships, that it is 50 years since President Nixon declared America’s war on cancer. Seven Presidents later, in his State of the Union address to Congress two weeks ago, the current US President put all US federal agencies at the disposal of the US Administration’s attempt at what he called a “moonshot” in cancer. He declared that information and data sharing would be at its scientific heart. The next day, the US President told schoolchildren in Baton Rouge, Louisiana, that cancer would be cured in not his lifetime but in theirs. He said that America would be the country that cures cancer. I hope that the Bill will help a little to make it British scientists who make Britain achieve the greatest of great moments in medical history and that your Lordships will join the House of Commons in taking this first step. I beg to move.
Lord Saatchi
My Lords, I thank all noble Lords who have spoken in this debate and earlier debates. As last time, I hope that all noble Lords who have been involved in this Bill and the predecessor Bill take pride in the ability of your Lordships’ House and, as it perhaps surprisingly turned out in the House of Commons, of both Houses of Parliament to avoid tribal party warfare and work together, at least in this area of health. That is a remarkable achievement of which both Houses of Parliament and all of us can feel very proud.
I shall try to reflect the tone of what my noble friend the Minister said. This is a modest step, authorising the Secretary of State to instruct one of the key bodies in the NHS to start to work with medical professionals—the royal colleges, the charities, the patient groups—in assembling this database, which everyone wants. I hope that your Lordships’ House will allow me to ask it to give the Bill a Second Reading.
Medical Innovation Bill [HL]
Lord Saatchi Excerpts(9 years, 10 months ago)
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The Parliamentary Under-Secretary of State, Department of Health (Earl Howe) (Con)
My Lords, my interpretation of the amendment moved by the noble Lord, Lord Winston, is that it aims to ensure that in obtaining the views of one or more appropriately qualified doctors, a doctor is carrying out a test equivalent to the Bolam test. I recognise that these words are carefully chosen, and I listened closely to what the noble Lord, Lord Winston, said. However, I do not believe that the language of the amendment accurately reflects the requirement of the Bolam test.
To go a bit further, I am concerned that the amendment would create more confusion than clarity for both doctors and the courts. In particular, how would a court determine what is meant by the phrase “command the respect of”? It certainly does not mean agreement. If Noble Lords want an illustration of the difference, I deeply respect the noble Lord, Lord Winston, but, as in this case, I do not always agree with him.
Like my noble friend Lady Gardner, I question what might count as,
“a representative body of responsible medical opinion”.
Again, this wording is not in the Bolam test. The Bolam test sets out that a doctor is not negligent if their decision is accepted as proper by a responsible body of medical opinion. Bolam accepts that a doctor is not negligent merely because there is a body that would take a contrary view. Therefore, the courts recognise that there is not necessarily a representative body of medical opinion. The wording of the amendment would be open to interpretation by the courts.
I recognise that the noble Lord’s aim in tabling this amendment is thoroughly worthy and is to ensure the protection of patients. I assure him that the existing provisions in the Bill seek to achieve that same aim. Therefore, the Government do not consider the amendment moved by the noble Lord, Lord Winston, necessary. The Bill’s provisions boil down to one key test: a test of responsibility. Clause 1(2) states:
“It is not negligent for a doctor to depart from the existing range of accepted medical treatments for a condition if the decision to do so is taken responsibly”.
This objective test of responsibility ensures that the decision about whether a doctor has been negligent is based on the same premise as the existing Bolam test: has this doctor acted responsibly? Patient safety is an integral part of this test. Clause 1(3) makes clear that the risks of any innovative treatment must be considered, so if the treatment was likely to compromise patient safety unacceptably, it is highly unlikely that it would be considered a responsible decision when later judged in court. Furthermore, the Bill does not require doctors simply to obtain the views of experts in the field; it requires a doctor to take full account of those views in a responsible way. As such, a doctor could not simply listen to, or note, the views of colleagues and then proceed to disregard those with which he or she disagrees. A doctor can fully expect a court to scrutinise closely how they have taken account of those views and consider whether they had acted on the views in a responsible way.
It is that requirement which ensures that the Bill is the nearest equivalent to that of the Bolam test. I fear that the amendment of the noble Lord, Lord Winston, despite its best intentions, would not add to the operative provisions of the Bill but would only risk creating confusion as to the language of the existing Bolam test. It is not just that the Government consider this amendment unnecessary—which we do—but that we also have serious concerns about whether the language of the amendment will create confusion for doctors and, indeed, the courts.
Lord Saatchi (Con)
I thank noble Lords who have addressed this amendment. I happily added my name to the amendment of the noble Lord, Lord Winston, because I believe that it provides helpful additional clarity for Peers and those outside the House about the intention and effect of the Bill.
Your Lordships will be aware that on a number of occasions I have tried to stress that the intention and effect of Clauses 1(3)(a) and (b) are not, as my noble friend was just saying, that a doctor can just ignore the views of anyone who disagrees with the proposed treatment or that he or she can choose to consult only those who are known to agree. I agree with my noble friend that Clause 1(3)(a) and (b) contain a legal duty to obtain views and take proper account of them, and that that is a serious and effective threshold. However, I wonder whether I may encourage my noble friend to share with me the observation that a number of noble Lords, including the noble Lords, Lord Winston and Lord Turnberg, were anxious to see this set out more expressly in the Bill in language that at least resembles, if not copies completely, the wording of the Bolam test, as described by the noble Lord, Lord Pannick. I believe that the amendment of the noble Lord, Lord Winston, does that in a manner that will not change the substantive policy of the Bill, as already agreed by your Lordships, but will perhaps give greater clarity about the intention for those Peers and others who want to see this language expressed in the Bill in the closest approximation possible to the existing Bolam test, which is what we are all trying to preserve.
As your Lordships know, the Bill is all about giving greater clarity and certainty to patients and doctors at the point of treatment, and not forcing them to wait for the unpredictable outcome of possible litigation or disciplinary proceedings. I can only welcome any amendment designed to enhance clarity and certainty about the effect of the Bill itself. I am therefore very happy to support it.
Lord Winston
My Lords, as this is probably the last opportunity I will have during the passage of the Bill, I thank the noble Lord, Lord Saatchi, who has behaved with extreme courtesy throughout the debate on this Bill. We do not entirely agree, but I think we have come to respect each other’s point of view and we are in total agreement about this issue.
I was surprised that the noble Baroness, Lady Gardner, raised this concern, because a representative body of medical opinion is exactly what courts ask me to give and to be mindful of. I am very grateful to the noble Lord, Lord Pannick, for his quotation, which is of course now on record, because on the number of times that I have been an expert witness in court, that is exactly what my Silk, in taking evidence from me, has required me to recognise—whether I am doing something that is recognised by a responsible body of medical opinion. That is a phrase which is firmly in our minds and was therefore firmly in my mind when I set this amendment down.
I therefore really am disappointed with the response from the noble Earl, Lord Howe, on behalf of the Government. If the Government really want to protect patient safety—I have no doubt about their absolute commitment to that—this would be a very good way of doing that. It seems to me that there is a risk of mavericks operating without that control. This is a very shocking issue. We do have desperate patients seeking all sorts of treatments, sometimes at the end of life but often perhaps because they are infertile— which is hardly at the end of life—and they will go through anything that they think might be of benefit, even though it is not proven. That is innovative treatment and sometimes it is possible that for various reasons that innovative treatment might work; sometimes, purely biology works and random effects happen. The amendment is designed to deal with that issue.
I do not think it would be appropriate to divide the House. I am grateful to see so many of your Lordships here late on a Friday afternoon, which is a great credit to this House and something we should be proud of. I am sure that the noble Lord, Lord Saatchi, is grateful as well. However, I feel that this is something that will need to be teased out. If the Bill now proceeds to another place, I very much hope that some consideration will be given to the patient safety aspect. Of course, it is really in the Government’s interests, particularly at the moment, when we are increasingly concerned, understandably, about our health service, which we all want to see survive and prosper. For the moment, I will withdraw the amendment.
Earl Howe
I will reply very briefly, with apologies to noble Lords for speaking so often. I have been troubled by the fact that if we were to build this amendment into the Bill, it would apply to those innovative treatments covered by my noble friend’s process and not to other innovative treatments. It would seem inherently odd if we did not have a database that captured all innovative treatments—so, again, we need to consider that, and the noble Lord, Lord Hunt, referred to that issue himself.
On the second point made by the noble and learned Lord, my concern is that—going back to the previous amendment we were discussing—there was a mismatch of wording that does not quite conform to the Bolam test. However, I will consider what he said carefully and come back to him, if I may.
Lord Saatchi
My Lords, I am so grateful to all noble Lords who have spoken on this amendment. I will not in any way detain your Lordships by reciting again what has been brilliantly and articulately expressed by other noble Lords. I will say only one thing about this amendment, which is to pay tribute to Oxford University, whose original concept it was—I refer to Professors Alastair Buchan and Stephen Kennedy at Oxford—that a database should be created to record the results, positive and negative, of innovation under the Bill. The reasons were, as expressed by noble Lords today, to advance scientific knowledge, as the noble Lords, Lord Giddens and Lord Winston, said, and to protect patients with full disclosure and full transparency.
A number of individuals and organisations have told me that any doubts that they had about the utility of the Bill would be removed by the emergence from it of this new and exciting initiative in data collection and sharing. This database will, I hope, be a significant—perhaps enormously significant—development in the field of medical practice. I am confident that my noble friend and the officials in the Department of Health will be able to devise a suitable system, in collaboration with the medical profession and the regulatory bodies, which will achieve what is wanted here.
I will end by saying that I do not remember ever seeing your Lordships’ House in full agreement, on all sides of the House, on one amendment. We have not just had that once, on Report, but have had an exhibition of exactly the same unanimity and strength of feeling again. I very much hope that my noble friend the Minister will not consider voting against the amendment should it be put, but will, as he said, take forward the Government’s commitment to ensure that the register happens and is put in place, and that he will be able to encourage the noble Lord, Lord Hunt, and all the rest of us here that that will happen.
Lord Hunt of Kings Heath
My Lords, it has been a very good debate; I am sorry that it has happened so late in the day. I, too, echo the words of the noble and learned Lord, Lord Woolf, in paying tribute to the noble Earl, who has been extremely helpful during the passage of the Bill. Of course, I am well aware that Sir Bruce Keogh, medical director of the NHS, has himself been extremely helpful in assisting with the drafting of some of the clauses in the Bill.
I will make three or four points. First, the noble Lord, Lord Ribeiro, was very helpful in giving us a practical example of why a register was necessary. The register that he referred to was a voluntary one and was used by most surgeons, but of course not by all. My contention is that, in the specific circumstances of the use of the Bill, we need greater reassurance by having a mandatory register. The noble Lord was concerned in essence that a mandatory register would be a disproportionate requirement, and that in so being it would discourage doctors from using the provisions in the Bill. I disagree with that. All of us have received, at every stage of the Bill, extensive letters from just about all the medical bodies you could think of, all of which have expressed some concerns about the provisions of the Bill. They recognise that the noble Lord has moved a very long way and in a very helpful way, but they remain concerned. My view is that the kind of amendments being proposed today would go a very long way to reassuring those bodies. In the end, the more that those bodies are reassured, the more likely it is that they would provide the advice that would allow their members to consider use of the provisions in this Bill.
We have had a very interesting debate, with contributions from the noble and learned Lords, Lord Woolf and Lord Brown, and the noble Lord, Lord Pannick, on the provisions of the Bill and their relationship to the Bolam test. I make it clear that my amendment refers only to the provisions of this Bill. At Report, my amendment was criticised by the Government because they thought that in its wording it might go wider than the Bill, which is why I have rewritten the amendment to make it clear that it provides only for the Bill. It may well be that, as the noble and learned Lord, Lord Brown, suggested, we should discuss the use of a register in relation to all innovation. However, that is not today’s argument. I believe that we are justified in seeking a specific requirement in relation to the use of this Bill because of its special provisions and, in particular, because of concerns raised by many responsible medical bodies.
On the question of the GMC, I agree with the noble Lord, Lord Saatchi, that it is not beyond the bounds of possibility that the Department of Health and the GMC can come to a sensible outcome within the confines of my amendment. In the end, it may well be that, in the circumstances to which my noble friend Lord Winston has referred, whereby rogue doctors use this legislation inappropriately, it should fall to a fitness to practise committee.
In the end, as the Minister said, we need to engage with the medical community. Many of us have been engaged with it for a long time and we have come under great criticism for seeking to help the Bill. Most of the letters that we received from very responsible medical bodies have asked your Lordships’ House to make sure that the Bill does not proceed. We have tried to be as fair to them as to the noble Lord, Lord Saatchi, and it is through these kinds of amendments that the Bill can go to the other place considerably enhanced. For that reason, I move the amendment.
Lord Saatchi
My Lords, I shall not delay the House, as it is late, but I want to express my enormous gratitude to my noble friend the Minister and to his team at the Department of Health, who have been unfailingly courteous and professional in the most admirable way. One hears that this is a scrutinising House and that it is its particular skill to look in detail, line by line, at legislation in a careful way. I do not know of a case in which that has been better demonstrated than in this Bill, and I take my hat off to your Lordships’ House. I beg to move.
NHS: Health Improvements
Lord Saatchi Excerpts(10 years ago)
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Lord Saatchi (Con)
My Lords, every year my respect and affection for your Lordships’ House grows. That is largely because of occasions such as this, expertly secured for us tonight by the noble Lord, Lord Kakkar, when your Lordships can hear the voices of great leaders and pioneers in medical science.
I should like to pay a tribute to my noble friend the Minister and his team at the Department of Health for the work that he has undertaken with the Chief Medical Officer and the NHS medical director to take forward an agenda of innovation and to try to advance in the NHS a culture of innovation, as the noble Lord, Lord Kakkar, described it. I also thank the noble Baroness, Lady Wheeler, for the interest that she has taken in the innovation agenda and her scholarship, which I appreciate enormously.
Perhaps your Lordships share with me and many others in the medical world a sense of anticipation at the appointment of George Freeman as the Minister for Innovation in another place. It is often said of politicians that they will say anything to be elected. In the case of George Freeman, it really is the case that here is a man for whom the pursuit of genomics, the Cancer Drugs Fund, early access to medicine, more transparency and more disclosure have been his life’s work. It is rather a marvellous moment now that he has become a Minister, as I hope noble Lords agree.
I am a late arrival in the world of medical innovation. I will borrow the family credo of the former Leader of your Lordships’ House, Lord Salisbury—“late but in earnest”. I am certainly late and I am certainly in earnest. I will tell you why. Perhaps I am reflecting something that was said by my noble friend Lord Selsdon early in his remarks. To me, the medical innovators are true heroes. Isaiah Berlin addressed his considerable mind to the question of whether such persons as heroes can ever really be said to exist. He defined a hero as an individual who, acting alone or almost single-handed, makes what seems highly improbable in fact happen. It means a flat refusal to accept the status quo—a determined conviction that an individual can change the world by an act of will.
By Berlin’s definition, we have before us two examples of such people. The first is the noble Lord, Lord Kakkar, himself, whose Thrombosis Research Institute is dedicated to the study of a disease which is responsible for 95% of fatal heart attacks and 92% of fatal strokes. His institute, of which Prince Philip is the royal patron, aims to develop novel therapies to prevent long-term disablement and early death. Secondly, we have the noble Lord, Lord Turnberg. The noble Lord recently brought together at his alma mater, the Royal College of Physicians, two of the great medical innovation institutions in the world. He hosted the launch, by the Memorial Sloan Kettering hospital in New York and the Weizmann Institute in Tel Aviv, of a visionary collaboration, combining the long-standing track records of both institutions for breakthrough science. This new partnership unites Weizmann’s basis scientists with MSK’s clinical practitioners—a combination long considered impossible between two completely opposite cultures—to try to speed up the process “from bench to bedside”.
These noble Lords inspired me, so here is a question: what inspired them? Perhaps it was the night of Saturday 25 May 1940 when something took place, at the Dunn School at Oxford, which the New York Times called,
“perhaps the most exciting tale of science since the apple dropped on Newton’s head”.
Until then, there had apparently been many ways to measure a human body in distress: pulse rate, blood pressure, blood sugar, body weight, white cell count, red cell count and so on. Then one man decided to concentrate on only one measure: body temperature. I have here the lab notes of Dr Florey that night, and I thank one of today’s other great innovators, Professor Alistair Buchan, the Dean of Medical Sciences at Oxford, for letting me see them.
At 11 am, Florey injected eight white mice with virulent streptococci, known to be fatal to a mouse of average weight. At noon, mice 1 and 2 were given an injection of 5 millilitres of penicillin solution. Mice 3 and 4 received injections of 10 millilitres. The other four were controls and received none. Further injections of penicillin followed through the day. As this great event unfolded, just before midnight Florey wrote in the lab notebook that all four mice with penicillin were apparently well, but the controls were certainly not. He wrote that one mouse got up and staggered about for a few seconds, then fell down, twitched once or twice and was dead. Others were “seedy”. His colleague, Heatley, made a cross sign in red ink to mark the death. By 1.30 am on 26 May, the four protected mice had napped and awoken, but two more controls had died, noted by two more red crosses. At 3.28 am, Heatley noticed that the last control moved about drunkenly. With each respiration it lifted its head and opened its mouth widely. Respiration became slower, the animal twitched and died.
One of the mice that received a single shot of penicillin lived two days, the other six. Of those that received five shots, one lived 13 days, the other indefinitely. What no one realised at the time is how little penicillin it actually took to save the mice that received it. However late the hour, the result was clear and its implications so breathtaking that Heatley was overcome with “relief, joy, happiness”. He got on his bicycle and began his ride home, the first light of day already in the sky. He had, as he later wrote,
“just witnessed the world change”.
At 11 am on Sunday 26 May, Florey, Chain and Heatley returned to the lab for a pre-arranged meeting. “It looks quite promising”, Florey said, although even he could not maintain that sober view for long. In the end he said, “It looks like a miracle”.
Here is a real miracle. At exactly the same time that morning—26 May 1940—a miracle of another sort took place, to rescue hundreds of thousands of British, French and Belgian soldiers, trapped in northern France along the coast by Dunkirk. Dr Florey became Sir Howard Florey and the winner of the Nobel Prize for Medicine. We conclude from this that God works in mysterious ways.
Medical Innovation Bill [HL]
Lord Saatchi Excerpts(10 years, 1 month ago)
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Lord Saatchi (Con)
My Lords, I am grateful to the noble Lord, Lord Turnberg, for opening this Committee. I am greatly respectful of all he has said. In speaking to his Amendment 1, I will speak also to Amendments 8, 9, 11, 12, 16, 20, 25, 26 and 27 in my name; Amendments 7, 15, 19, 21, 24, 32 and 33 in the name of the noble Lord; Amendment 10 in the name of the noble Lord, Lord Pannick; Amendments 13, 17, 22 and 30 in the name of the noble Lord, Lord Winston; and Amendments 14, 18 and 34 in the name of the noble Baroness, Lady Masham.
In winding up the Second Reading debate—at which I was grateful, as I am today, for so many of your Lordships’ attendance, and for all that was said; it was an excellent debate—I gave an undertaking that there would be an opportunity to consider whatever amendments were suggested as a result of the study by the NHS medical director, Sir Bruce Keogh, commissioned by the Secretary of State. I suggested that it might be possible to leave those amendments to be considered in the House of Commons, but a number of your Lordships made it clear to me that there was a desire to consider these important matters in this House so that we can, I hope, send the Bill to the other place in a form that represents the consensus not just of myself and the Government but of all noble Lords who have taken such a helpful and serious interest in the Bill.
I and the Government have listened to these representations. I can testify to the seriousness with which the Government have paid attention to all that has been said. I have witnessed it with my own eyes. I am very grateful to my noble friend the Chief Whip for facilitating the Committee for the purpose of considering the amendments which were settled by Sir Bruce Keogh and which stand in my name. I hope that after today it will be possible for the Bill to make swift progress into the House of Commons so that it has a reasonable chance of becoming law before the general election. There will of course be an opportunity for the issues considered in this House, and perhaps others as well, to be considered in a Public Bill Committee in another place.
I do not propose to give a lengthy, detailed description of each amendment in the group; I have been warned not to attempt a Second Reading speech of any kind. To some extent the amendments are self-explanatory—they build on the safeguarding themes already in the Bill on introduction—but let me give a brief introduction to the purpose and effect of the amendments, which are now known as the Keogh amendments. I will do my best to answer any questions noble Lords have.
The key amendment that addresses the safeguards in the Bill is Amendment 12, which replaces Clause 1(3) of the Bill. The most significant features of the new list of safeguards are as follows. First, proposed new Clause 1(3)(a) requires the doctor to,
“obtain the views of one or more appropriately qualified doctors in relation to the proposed treatment”.
I suggest that that must be read with Amendment 16, which inserts proposed new Clause 1(4) into the Bill, to the effect that,
“a doctor is appropriately qualified if he or she has appropriate expertise and experience in dealing with patients with the condition in question”.
Proposed new subsection (3)(b) requires a doctor to take full account of those views in a way that a responsible doctor would be expected to do. That ensures that a doctor cannot ignore views or give them minimum weight unless there are reasonable grounds for doing so. The proposed new clause provides a critical safeguard in ensuring that there is expert peer review of the doctor’s proposal and that the doctor acts responsibly in taking account of that view. We have all been concerned to ensure that the Bill cannot be seen as giving comfort to quacks or cowboys. This provision will hopefully give additional comfort to the noble Lord, Lord Turnberg, and to other noble Lords that the Bill does not do so, and, as I said at Second Reading, that it provides a statutory benchmark of good practice that will act as an effective deterrent to quacks and charlatans.
Proposed new subsection (3)(d) requires the doctor to consider a number of factors relating to the proposed treatment, including a requirement to consider,
“the risks and benefits that are, or can reasonably be expected to be, associated with the proposed treatment”,
other accepted treatment,
“and not carrying out any of those treatments”.
The proposed new subsection no longer requires a doctor to notify their responsible officer about the proposed treatment. The responsible officer may not have expertise relating to the condition in question and it may be difficult for a doctor to notify them in advance in all cases.
These replacement provisions are not designed to alter the fundamental purpose of the Bill as I explained it on Second Reading, which is simply to bring forward the Bolam test to the point of treatment, so that doctors can be reassured in advance that they are innovating in a manner that the law will regard and uphold as responsible. They would not have to wait or speculate about the possibility of litigation or disciplinary proceedings before finding out whether their action is considered reasonable. By giving certainty we help doctors to innovate with confidence. We help the thousands of patients who wish to benefit from innovative treatment and do not wish the doctor to be scared off or institutionally discouraged by the mere possibility of later litigation.
A number of the amendments proposed by Sir Bruce Keogh are designed to emphasise or clarify aspects of the Bill, rather than to change its legal effect. I shall therefore mention them only briefly. Amendment 8 amends Clause 1(2) to emphasise that the protection offered by the Bill applies to the doctor’s departure from the existing range of accepted treatments for a condition, not just to his decision to do so. Amendment 9 emphasises that the Bill applies only to medical treatment. Amendment 11 amends Clause 1(2) to provide that a doctor’s departure from the existing range of accepted medical treatments for a condition is not negligent where the decision to depart is taken responsibly. This applies an objective test of responsibility to the doctor’s decision and prevents a doctor who acts irresponsibly from relying on the Bill. Amendments 20, 25, 26 and 27 are minor and consequential.
Amendment 1 would limit the Bill to terminal cancer and other conditions prescribed by the Government. I have considerable sympathy with this. As your Lordships are aware, the Bill is aimed in particular at the horror of cancer and terminal or extreme conditions. However, the principle is a general one: that doctors and patients are entitled to clarity and certainty at the point of treatment. That is its main aim and purpose. I understand completely that some Peers dislike the idea of the Bill being used for cosmetic surgery, for example. I would certainly consider an amendment later—subject to the views of the Minister, who I am sure will speak to this—either in the Lords or the Commons, to exclude cosmetic surgery if the House feels that that is important. That might well be possible, subject to discussion with the noble Lord, Lord Turnberg, and with the agreement of Sir Bruce Keogh and the Secretary of State. In the mean time, I ask the noble Lord not to press the amendment.
I turn to Amendment 7, to which the noble Lord, Lord Turnberg, gave great importance. I believe that it is similar to my amendments in the sense that they both replace the existing conditions for the operation of the defence to negligence under the Bill with an alternative set of conditions. I understand that the noble Lord is trying to find a set of conditions that limit the opportunity for the Bill to be misused by quacks. As I have said, my amendments, proposed by Sir Bruce Keogh and the Secretary of State following consultation, have the same purpose. I hope that the noble Lord, Lord Turnberg, will therefore feel that those amendments address the fundamental concerns addressed by Amendment 7 and that he may feel able not to press it.
Amendment 10 inserts a reference to reasonableness and proportionality in the conditions for application of the test under the Bill. I agree that reasonableness and proportionality are key requirements of that test. I believe they are already provided for in the Bill as drafted and in the amendments standing in my name. In the interests of preserving a single coherent package of amendments as prepared by Sir Bruce Keogh, and on the understanding that reasonableness and proportionality are inherent to that package, I hope that the proposers will feel able not to press the amendment.
Amendment 13, in the name of the noble Lord, Lord Winston, is similar to my amendments in the group in that it replaces the existing conditions for the operation of the defence to negligence under the Bill with an alternative set. I understand that the noble Lord is trying to find a set of conditions that limit the opportunity for the Bill to be misused. My amendments were proposed by Sir Bruce Keogh and the Secretary of State for exactly the same purpose. I hope that the noble Lord will feel that those amendments address the fundamental concern of his amendment and that he will feel able not to press it.
I absolutely understand the aim of the noble Baroness, Lady Masham, in Amendment 14, which is to amplify the existing set of patient safeguards in the Bill. I hope that the noble Baroness will accept that the package of safeguards prepared in consultation with the profession by Sir Bruce Keogh and set out in my amendments deal with the concerns reflected in her amendment. I welcome the opportunity to discuss these issues with the noble Baroness in more detail. In the mean time, I hope that she will feel able not to press Amendment 14.
Amendment 15, in the name of the noble Lord, Lord Turnberg, would require the results of innovation carried out in reliance on the Bill to be registered or recorded. This is a most important amendment and I can certainly assure the House that I have great sympathy with its aim—it has been our aim from the beginning. I explained at Second Reading that we strongly believe that the Bill should be used to generate useful data about innovation. We agree completely with what the noble Lord, Lord Turnberg, said: if the Bill were successful in its aims and encouraged innovation, what would be the point if no record of the innovations was kept in an open, transparent and fully disclosable way to show that the claims that we make—that the Bill will advance scientific knowledge—were true.
Earl Howe
Personally, no, I do not—although my noble friend may choose to address that point. I believe that what initially motivated my noble friend to introduce the Bill was a perception on his part that there are doctors out there who are afraid to innovate, and perhaps afraid to innovate even on the spur of the moment, for fear of being litigated against. If that situation were to apply, that doctor could regard the Bill as a useful way forward. I do not think that that poses any confusion, because my noble friend is proposing to bring the Bolam test forward, as he has clearly explained, so that the essence of the principle that the courts look at would apply in whichever course the doctor chose to take.
The noble Baroness, Lady Wheeler, made a point about conflict of interest. The Bill makes it clear that the doctor will be protected from a successful claim in negligence only where they have reached a responsible decision. That includes a requirement to consult with one or more appropriately qualified doctors. In choosing which doctors would be most appropriate to consult, a doctor would need to be confident that their views would enable him or her to reach a responsible decision in order to benefit from the protection offered by the Bill. Just to make the point absolutely clear, I say that the Bill does not change the law of consent in relation to children or people who lack capacity, whereby any treatment provided to them by a doctor must be in their best interests.
Amendment 10 would add a requirement on doctors to act in manner that is reasonable and proportionate. My noble friend Lord Saatchi’s Amendment 11 would ensure that a doctor must be acting responsibly in an objective sense when making a decision to depart from the existing range of accepted medical treatments for a condition. Under the law of negligence, “reasonable” and “responsible” have the same meaning. Therefore, the Government’s view is that Amendment 10 is unnecessary.
Amendment 24 would clarify that doctors would not have to follow the steps of the Bill in an emergency. My noble friend Lord Saatchi’s Amendment 29 ensures that it is for the innovating doctor to decide whether to take the steps set out in the Bill or to rely on the existing Bolam test, as I have just explained. There is no requirement to follow the Bill.
My noble friend’s package of amendments ensures that the Bill comes as close as possible to achieving the policy intent of bringing forward the Bolam test to before treatment is carried out. The amendments would do this in a non-bureaucratic way by avoiding the creation of new approval structures or alteration of the remit of existing groups such as multidisciplinary teams. They provide a critical safeguard in ensuring that there is both expert peer review of the doctor’s proposal and that the doctor acts responsibly. The Bill would not provide any protection to a doctor who carried out an operation or procedure negligently. The Government would not support any Bill that sought to prevent patients who receive negligent treatment from seeking compensation or which sought to remove the requirement of doctors to behave responsibility and in the best interests of their patient.
I will turn briefly to the questions put to me by my noble friend Lord Kirkwood. First, he asked me whether the Bill would apply to pharmacists who dispense medicines. The Bill applies to a decision by a doctor to innovate, which would include a decision to prescribe an innovative medicine. The Bill does not impact on the reliability of a pharmacist who provides a patient with a medicine in accordance with a doctor’s prescription.
My noble friend also asked whether the Bill would apply in Scotland. It would apply in England and Wales but not Scotland or Northern Ireland. Medical negligence law is within the legislative competence of Northern Ireland and Scotland, but not Wales. He also asked me whether there is a conflict between the Bill and the common law. Under both the Bill and the common law a doctor will not be negligent if they have acted responsibly. The Bill, so far as possible, brings forward the common-law Bolam test, as I have explained, to before the doctor offers treatment. There is therefore no conflict between the requirements under the Bill and the common law. The Bill simply offers doctors a way to demonstrate and be confident before providing treatment that they have acted responsibly and thus not negligently.
As regards the cost of implementing the Bill, which my noble friend also asked me about, my reply to him at this stage is that there is not sufficient evidence for us to arrive at a cost figure. The impact of the Bill is by its very nature hard to predict.
I hope that noble Lords will accept my noble friend’s package of amendments in this group—that is to say, Amendments 8, 9, 11, 12, 16, 20, 25, 26 and 27. It is the Government’s view, based on medical and legal advice, that together these amendments do all that is necessary to protect patients, while freeing doctors to innovate responsibly without undue bureaucratic burden.
Lord Saatchi
My Lords, I thank all noble Lords who have spoken on this group, which was initiated by the noble Lord, Lord Turnberg. Many interesting points have been made on ethics, law, science and medicine. I am sure that we will all agree that the Minister has dealt with them all admirably. He certainly put the points better than I could have myself, and I hope that he has covered most of what was said.
What can I add to what my noble friend has said? I do not want to descend into anecdotage, but if any noble Lord sensed a reluctance on my part in relation to these amendments, perhaps this will help. I was taught the importance of what the noble and learned Lord, Lord Mackay, and the noble Baroness, Lady O’Neill, said as regards trying to maintain the simplicity of the Bill in an exchange with the noble and learned Baroness, Lady Butler-Sloss. At an early stage Daniel Greenberg, the Parliamentary Counsel, who has been the draftsman of the Bill throughout, showed her the first or second draft and said, in effect, “What do you think?”. She replied, “Make it shorter”.
Over the course of the last two years we have tried very hard to keep the Bill in a state which I think the noble and learned Baroness and the noble and learned Lord, Lord Mackay, would approve of. I learnt from her that the courts want to have an Act of Parliament that is absolutely crystal clear in its intent, so that there is no doubt and confusion at all in the mind of the court about what Parliament intended with this or that clause, phrase or wording. We have tried very hard to do that. I reassure your Lordships that if that has in any way given the appearance of reluctance on my part, I am deeply apologetic.
I would certainly welcome following up the suggestion of the noble Baroness, Lady Wheeler, and those of many other noble Lords. The noble Lord, Lord Kirkwood, had an excellent wish list of following up Committee today—with your Lordships’ approval—with discussion between now and Report to see where we can get to. I am trying only to deliver to the noble and learned Baroness, Lady Butler-Sloss, and her fellow judges in the courts, an Act of Parliament that is simple, completely straightforward and totally clear, and which does what it is supposed to: provide clarity and certainty at the point of treatment both to the doctor and the patient. As noble Lords can see, I am resisting the enormous temptation to revert to a Second Reading speech, so I will now sit down, after a long group of amendments, so that we can go on to the next group.
Lord Saatchi
My Lords, I think that the Minister has answered this point, and I do not know what I can add. The Bill at the moment focuses on “responsible” and “irresponsible”, and it is very pleasing to hear that the noble Lord, Lord Pannick, might accept that the Bill concentrates on that distinction, and that to introduce a reference to “reasonableness” or “proportionality” might risk causing confusion. Therefore, perhaps this is a topic on which he can satisfy himself in the discussions that follow Committee.
Lord Turnberg
My Lords, I strongly support Amendment 2 in the name of the noble Lord, Lord Pannick, for inserting the word “reasonable” for all the cogent reasons that he has given. Amendment 3 follows on from my earlier Amendment 1, which defines “relevant condition” and does not need further discussion here. I am very pleased to see that we have the agreement of the noble Lord, Lord Saatchi, that the word “reckless” will disappear from the Bill.
Earl Howe
My Lords, this group of amendments seeks to alter the purpose clause of the Bill. Under the law of negligence, the words “reasonable” and “responsible” have the same meaning, as the noble Lord, Lord Pannick, reminded us. As such, the addition of “reasonable” is not necessary and risks creating confusion. Existing clinical negligence law commonly refers to a responsible body of professional opinion. The addition of “reasonable” may suggest that the test under this Bill differs from the existing Bolam test.
The noble Lord, Lord Pannick, asked me whether the Bill required a rational judgment of success. Proposed new subsection (3)(d) in Amendment 12 requires the doctor to consider a number of factors in relation to the proposed treatment. This includes a requirement to consider,
“the risks and benefits that are, or can reasonably be expected to be, associated with the proposed treatment”,
other accepted treatments, or,
“not carrying out any of those treatments”.
In weighing this up, the doctor must apply an objective standard as to what could reasonably be expected in relation to those treatments. This provides a further safeguard for patients in ensuring that a doctor may not offer an innovative treatment in accordance with the Bill unless he has acted in an objectively responsible way. I hope that that helps the noble Lord, Lord Pannick.
My noble friend’s Amendment 11 seeks to ensure that a doctor must be acting responsibly in an objective sense when deciding to depart from the existing range of accepted medical treatments.
On Amendment 3, the Government do not feel that there is anything to be gained by restricting the scope of the Bill in this way. To set out specific medical treatments or circumstances that would or would not be covered by the Bill would make the Bill complicated for doctors to follow and less flexible to individual patients’ circumstances. This might limit the Bill’s usefulness to patients and doctors alike.
On Amendments 4 and 5, the Government support the amendment to remove the reference to deterring “reckless irresponsible innovation” from the purpose clause. Recklessness has a very specific meaning in criminal law, and the term is out of place in a Bill about the law of negligence. Furthermore, the substantive provisions of the Bill focus on how a doctor can demonstrate that he has acted responsibly. This amendment therefore ensures that the purpose clause better reflects the focus of the Bill. I hope that noble Lords will accept Amendment 4, which brings clarity to the purpose of the Bill.
Lord Saatchi
My Lords, I thank my noble friend the Minister for what he said. I think that there is a consensus on Amendment 5 in my name, that of the noble Lord, Lord Turnberg, and that of the noble Baroness, Lady Finlay, to remove the word “reckless”. I think that we are agreed on that. My noble friend dealt with the point under Amendment 3 from the noble Baroness and the noble Lord. We understand the wish to exclude certain treatments and types of surgery, and perhaps that is something that we can discuss between now and Report.
I share the Minister’s wish to accept Amendment 4 from the noble Lord, Lord Pannick, which removes the reference to deterring quackery from the purpose clause. We are agreed on the view that, if the noble Lord, Lord Pannick, believes that it is important to confine the purpose clause to the positive, we should not insist on the inclusion of both limbs—positive and negative—since as a matter of law the negative flows naturally from the positive in any event. If the noble Lord, Lord Pannick, presses that amendment, I shall support it.
Earl Howe
This group of amendments seeks to define innovation and the scope of the Bill. This is a uniquely difficult task as innovation is, in essence, about constant improvement, change and progression. It is essential that in the act of defining we do not inadvertently limit responsible innovation. I ask the Committee to take on board the point neatly made by my noble and learned friend Lord Mackay.
Amendment 8 to Clause 1(2) in the name of my noble friend Lord Saatchi limits the scope of the Bill to situations where a doctor departs from,
“the existing range of accepted”,
medical treatments for a condition. This will be well understood by doctors, who are best placed to know whether they are following accepted treatments. This amendment also ensures that the Bill applies only to medical treatment.
A further provision, Clause 1(4)(a), ensures that the Bill applies not to research but only to the care of individuals. This exclusion of research is sufficient to achieve the same effect as Amendment 6 in the name of the noble Lord, Lord Winston. I hope that that clarifies that point for the noble Baroness, Lady Wheeler.
The Bill’s definition of innovation allows for situations in which doctors choose to carry out no treatment in the best interests of the patient. The definition of innovation in medical treatment proposed by the noble Lord, Lord Winston, would exclude that. I hope that that point, if no other, will give him pause when he decides what to do with Amendment 6.
There is another basic point to make here. Defining innovation on the face of the Bill would restrict the application of the Bill and could risk uncertainty for doctors as to whether the protection offered by the Bill would extend to the treatment that they are proposing. It is important that the scope of the Bill is clear to the medical profession.
Moving on to Amendment 28, the Government do not believe this to be necessary. The Government are already fully committed to promoting innovation which can save and improve lives. The Committee may be aware that NHS England has a full programme of initiatives to unblock innovation and disseminate the benefits to the NHS and beyond—something that the Government fully support. These include Innovation Connect, a programme to help innovators in the health service and industry to realise their ideas, embed them into clinical practice and exploit new opportunities in international markets, NHS innovation challenge prizes to encourage, recognise and reward front-line innovation and drive the spread and adoption of these innovations across the NHS, and the NICE Implementation Collaborative, which supports work streams by providing essential support to overcome identified barriers to innovation. Those are just some examples.
My noble friend Lord Blencathra asked in particular about off-label treatments. Without repeating the answer that I gave earlier to the noble Baroness, Lady Masham, on a similar issue, the Bill sets out a series of steps which doctors can choose to take when innovating to give them confidence that they have acted responsibly and with the intention of reducing the risk to doctors of successful claims of clinical negligence. With that threat diminished, the intended effect is that doctors will be confident to innovate appropriately and responsibly. That applies in full measure to off-label treatments. I would say as an aside that the cancer drugs fund, which has enabled access to a number of novel medicines, including off-label treatments, has benefited more than 55,000 patients since September 2010. So the decision on whether to prescribe unlicensed or off-label medicines will remain a matter for the doctor or prescriber who has clinical responsibility for the patient’s care, taking into account their individual clinical circumstances.
In response to the noble Baroness, Lady Masham, about funding, I should make the simple point that the Bill does not add any extra funding for drugs. Funding may be a consideration in certain circumstances, but the Bill does not affect the situation one way or the other.
I hope that noble Lords will take into account the Government’s view that innovation is best defined as a departure from the standard range of existing medical treatments, and that on reflection the Committee will not accept Amendments 6 and 28.
Lord Saatchi
My Lords, as we have just heard, Amendment 6 attempts to make a definition of “innovation”. I myself think that that is quite difficult to do, even though the noble Lords, Lord Pannick and Lord Winston, made it clear that they are trying to provide a definition in order to assist the purposes of the Bill. I find it difficult to do for the reasons given by my noble and learned friend Lord Mackay. The word is clear and the Minister has just defined it even more clearly, which is that innovation is a departure from the standard procedure. I am advised that that definition of the concept is sufficiently clear for doctors, patients and the courts to be able to judge in the light of the circumstances of each case. I am told that the proposed definition also refers to some procedures, so that the legislation may become outdated at some point.
The main point in plain English is that the noble Lord, Lord Winston, himself described innovation elsewhere as being serendipitous; in other words, the term has in it the concept that what is about to happen is unheard of and unknown, and therefore it is a true innovation because it has not been conceived of. It is quite difficult to make a definition, but perhaps that is something we can talk about with the noble Baroness, Lady Wheeler, when we meet before the Report stage.
I wish I could say something more encouraging to the noble Baroness, Lady Masham, about funding. Many people have said to me over the course of the long journey of this Bill that, “This is all very well, but what we actually need is more money. If we had more money, we could have more innovation for every disease”. I really do not know whether that is true because there are completely different views about it. However, the one thing that is certain is that this Bill, as my noble friend the Minister said, does not do anything to increase the UK GDP, nor does it increase the percentage of UK GDP that is spent on health, nor does it increase the percentage of UK health spending that is spent on innovation. As my noble friend has just said, it has no impact on what the noble Baroness is interested in hearing, which is on the subject of funding. It is completely neutral.
I will come to Amendment 28 in a moment. Perhaps at this point I could say that it is wonderful to hear my noble friend Lord Blencathra speak because we are hearing the true voice of the patient, as I understand it. We all say that what we do in this House and in the Department of Health is putting patients first. If that is what we are doing, your Lordships have just heard the true voice of the patient and nobody has ever expressed it better.
Lord Saatchi
Lord Saatchi
Lord Saatchi
“( ) For the purposes of subsection (3)(a), a doctor is appropriately qualified if he or she has appropriate expertise and experience in dealing with patients with the condition in question.”
Lord Saatchi
Lord Saatchi
Lord Saatchi
My Lords, in moving Amendment 23 I will speak also to Amendment 29 in my name.
Amendment 23 is a paving amendment. The substantive amendment in this group is Amendment 29, which inserts a new clause into the Bill after Clause 1, expanding the existing provision that states that the Bolam test is unaffected by the Bill. It is for the innovating doctor to decide whether to take the steps set out in the Bill or to rely on the Bolam test as at present. The new clause also includes express provision that doctors are not negligent merely because they have not followed the Bill. I beg to move.
Lord Turnberg
My Lords, I am very pleased to see Amendment 29 in the name of the noble Lord, Lord Saatchi. I support it because it allows doctors to continue to rely on the current common-law arrangements based on the Bolam principle and on a body of reasonable medical opinion. It means, however, that there are now three options open to an innovating doctor. He or she can engage in a research clinical trial in which ethics committee approval has been given, the patient has given consent and all the regulatory approvals have been given, he or she can rely on the Bolam principle and take all the precautions that that entails or he or she can go through the processes outlined in this Bill in the belief that this will somehow avoid the fear of litigation under the common law. I just wonder whether that might lead to a little confusion and lead doctors simply to use and rely on the current common-law principle. However, I am happy for this amendment to be approved. I see that it would be a useful amendment to the Bill because it gives the doctors the opportunity to use what they always have done.
Lord Winston
Both the Royal College of Surgeons of Edinburgh, of which I am a fellow, and the Royal College of Surgeons in London, absolutely support the idea that surgery should be excluded from the Bill for this very reason: they consider that there might be situations where the courts become unnecessarily involved. That involves extra expenses to the health service because of our current concern with litigation. As the noble Earl well knows, in obstetrics, for example, litigation already accounts for a huge proportion of the expenses devoted to maternal care. There are considerable knock-on effects where litigation may be started because of lack of clarity. It is possible that I am being stupid—I recognise that I am not nearly as intelligent as the noble and learned Lord, Lord Woolf—and I will have to go away to think about this, but there seems to me to be a misconstruction here which is puzzling and, I think, worrying.
Lord Saatchi
I hope that this may help my noble friend Lord Kirkwood. What we have just heard from the former Lord Chief Justice and the Minister is completely clear to me. I will try to explain it in this way: if the doctor feels completely confident that the innovation he is about to attempt will be approved when the Bolam test is applied in a subsequent trial, he will go forward with his innovation. If a trial then takes place, he either will or will not be proved right when the test is applied—that is, if he departed from standard procedure and decided to do it on the basis of his confidence that the Bolam test would make him innocent of negligence.
However, as we all know—this is fundamental to the Bill—if the doctor is obliged to speculate in advance about what might or might not happen in a trial, that raises a very high degree of uncertainty. If it is possible for a doctor to move the Bolam test forward and comply with it in advance, which is what would happen as a result of the Bill becoming an Act of Parliament, that would enable the doctor to move forward with an innovation without the fear that a subsequent trial will find him guilty. I therefore say to my noble friend Lord Kirkwood that what we have here in simple, plain language, is that the Bill is giving the doctor an option if he wants to be certain before he goes ahead with an innovation. It is not a requirement that he does that. If he is confident of the result of a subsequent application of the Bolam test, he does not need the Bill at all. It is a fundamental benefit of the Bill that it gives that option, which I think is a very simple one.
Baroness Gardner of Parkes
Can I seek some clarification? I wonder whether anyone could make clear for the Committee whether, if the doctor says that he does not want to do the innovative treatment, there is a defence in court on the grounds that he thought that it would be unwise or unsatisfactory. I say this because everyone seems concerned about the effect of not doing something innovatory.
Lord Saatchi
Lord Saatchi
“Effect on existing law
(1) Nothing in section 1 affects any rule of the common law to the effect that a departure from the existing range of accepted medical treatments for a condition is not negligent if supported by a responsible body of medical opinion.
(2) Accordingly—
(a) where a doctor departs from the existing range of accepted medical treatments for a condition, it is for the doctor to decide whether to do so in accordance with section 1 or in reliance on any rule of the common law referred to in subsection (1);(b) a departure from the existing range of accepted medical treatments for a condition is not negligent merely because the decision to depart from that range of treatments was taken otherwise than in accordance with section 1.”
Earl Howe
My Lords, the Government’s view is that it is not necessary to include in the Bill a provision for the Secretary of State to issue codes of practice about the Bill, but I hope that I can reassure the noble Lord, Lord Hunt, on the last point that he made. If the Bill is passed, the Government will work closely with the professional bodies, including the General Medical Council, to help doctors to prepare for the changes to the law. This will include producing any guidance that may be helpful.
I listened carefully to the points that the noble Lord made about the adoption of innovative treatments in the National Health Service. He knows from his experience as a Minister that this issue has been with us for quite a long time. We have silos of innovation and forward-thinking practice throughout the health service. The challenge has been to spread that innovative behaviour more widely and for the diffusion of innovative treatments to become second nature to the health service. It is a cultural issue.
The noble Lord is right to say that in many cases the non-adoption of NICE-approved drugs is a particular feature in parts of the NHS. That is exactly why the document Innovation, Health and Wealth was published some time ago. It is why we now have the NICE implementation collaborative, which is designed to bring together the key players in the system to ensure that NICE-approved medicines are adopted. There is the innovation score card, which helps in this regard. The academic health science networks are there to shine a spotlight on promising new innovative devices and medicines and to spread them at pace and scale throughout the health service. The early access to medicines scheme is another example of where we are trying to give patients access to innovative treatments, even before they have been licensed.
There is on occasion a good reason why a NICE-approved medicine may not be adopted by a particular trust. That is quite simply that for a given condition there are many alternative treatments, many of which have been endorsed by NICE. The Government cannot mandate clinical decision-making by individual doctors. Where there is a choice between one and another NICE-approved medicine available to a doctor, it is open to the doctor to make that choice. Nevertheless, the noble Lord’s basic point is well made and I hope that he will accept that the Government are taking a number of measures in conjunction with NHS England to ameliorate the situation.
I hope that, with the remarks that I made earlier about producing guidance, the noble Lord will be reassured and the noble Lord, Lord Turnberg, will not press his amendment.
Lord Saatchi
My Lords, perhaps we could add this point to the discussions that we are going to have before Report. My noble friend the Minister expresses a modest view of what the Government should and should not do and wants to leave it to the regulatory bodies to make this happen.
I refer once again to anecdote. The noble Lord, Lord Turnberg, said to me at an early stage in this process, in which he has been a great inspiration, “What are you going to do after the Bill becomes law?”. I said, “I am going to go on a very long vacation”. He said, “Oh no you’re not”. I said, “Why not?”. He said, “Your work is only just beginning”. His point, and he speaks as an expert, is that a culture change is contained in this Bill. “Culture change” is a phrase that my noble friend just used, and it was used by Dame Sally Davies, the Chief Medical Officer, many months ago. A culture change is being sought, but it will not happen overnight. It will follow, exactly as the noble Lord, Lord Hunt, says, a great deal of education and discussion in the medical profession.
Not to go on, but the noble Lord, Lord Turnberg, said that this will fall largely not just on the regulatory bodies, such as the GMC and NICE, but on the royal colleges. They will have to be involved in the process of educating people about what this means. This is the beginning of the process and I am rather with my noble friend in not wanting to have the Government set out the rules. I hope that that is acceptable to the noble Lord, Lord Hunt.
Lord Turnberg
My Lords, I am slightly reassured by the noble Earl’s comments that the Government’s intention is to produce some guidance with help from the relevant bodies. I am sorry that he does not think it necessary to have that in the Bill. I wonder why not. He has not explained why the amendment should not be there, because it sets out the need for such a code of practice. Meanwhile, however, I beg leave to withdraw the amendment.
Lord Saatchi
“(1A) Sections 1 and (Effect on existing law) come into force on such day or days as the Secretary of State may by regulations made by statutory instrument appoint.
(1B) Regulations under subsection (1A) may—
(a) appoint different days for different purposes;(b) make transitional or saving provision.”
Lord Saatchi
My Lords, I also speak to Amendments 37 and 38 in my name and Amendment 36 in the name of the noble Lord, Lord Turnberg. Amendments 35, 37 and 38 amend Clause 2 of the Bill on commencement and provide for the Bill to be brought into force by the Secretary of State. I am content with this change proposed by my noble friend, on the basis that it will allow time for the Department of Health and professional bodies to produce any guidance that may be helpful. Amendment 36 would stop the Bill coming into force on Royal Assent and would allow the Government to control commencement. The amendment has essentially the same effect as my amendment and I hope that the noble Lord, Lord Turnberg, will be content not to press it. I beg to move.
Lord Kirkwood of Kirkhope
Not to prolong events, I support Amendment 35, which I think is sensible. It is necessary to make sure that steps are taken so that practitioners are fully advised and informed in England and Wales about the provisions in the Bill. I assume that the answer to my question is yes, but can I have an assurance that the regulators have the full Section 60 power that they would need to implement this? If there is any doubt about the regulators not having complete legal cover, will the department make sure that any Section 60 provisions for those powers are put in place before these statutory instruments are brought forward, to avoid any confusion?
Lord Saatchi
Medical Litigation: Impact on Medical Innovation
Lord Saatchi Excerpts(11 years, 5 months ago)
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Lord Saatchi
To ask Her Majesty’s Government what assessment they have made of the impact of medical litigation on medical innovation.
The Parliamentary Under-Secretary of State, Department of Health (Earl Howe)
My Lords, it is the Department of Health’s view that no assessment is required as no changes are needed to the law or medical guidance in this area. The current system allows for doctors to initiate novel treatments provided that they are evidence-based, in the best interests of the patient, and with patient consent. While the law does not seek to block innovation, it does require new forms of treatment to be rigorously tested before being introduced.
Lord Saatchi
My Lords, would my noble friend allow me to share the latest figures with your Lordships’ House? The number of lawsuits filed against the NHS last year was double the level of four years ago. Last year the payout of claims against the NHS was £1.2 billion. The current Treasury provision for likely payouts in the future for litigation against the NHS is now over £19 billion. Against that backdrop, is there not a danger that the growing fear of medical litigation leads to a growing bias against medical innovation? Will my noble friend consider the warnings of judges about the tendency of current law to inhibit medical progress? For example—
Lord Saatchi
I will shorten what I was going to say. Will my noble friend consider the warnings of judges, including that of the noble and learned Baroness, Lady Butler-Sloss, that under current law no innovative work—such as the use of penicillin, or performing heart transplant surgery—would ever be attempted?
Earl Howe
My Lords, naturally I share my noble friend’s concern about the level of litigation in the NHS. Having said that, I have seen no evidence that a particularly large or indeed significant element of that bill relates to medical innovation. We need to reflect that all treatments in routine use in the NHS today began as innovative treatments. We continue to support the introduction of new and innovative treatments in the NHS. I think that, if anything, doctors have more concerns about being reported to the General Medical Council than they do about being sued.
NHS: Association of Medical Research Charities Report
Lord Saatchi Excerpts(11 years, 5 months ago)
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Lord Saatchi
My Lords, I join other noble Lords in congratulating the AMRC on the report and the noble Lord, Lord Turnberg, on bringing it to our attention. I share with the noble Lord the view that grief is not a disqualification from rational thought. I particularly congratulate Sharmila Nebhrajani, the chief executive of the AMRC. Reading this report, she reminds me of Adlai Stevenson’s striking description of President Kennedy: an idealist without illusions.
She is certainly a realist to say that,
“we still have quite a way to go if we are to get close to the government’s goal of every clinician a researcher and every willing patient a research participant”.
In saying that, the AMRC is reflecting the Prime Minister’s speech on life science in December 2011. He speaks about 34 Nobel prizes in medicine in the context of the global race in which, he says,
“we must ensure that the UK stays ahead … to keep pace with what’s happening we’ve got to change quite radically … the way we innovate”.
As has been said, the Prime Minister sees the NHS as an amazing asset to innovation because it has,
“a huge wealth of information all consented to, all anonymous—and that is helping them find new answers”.
The Prime Minister concludes that,
“the end result will be that every willing patient is a research patient; that every time you use the NHS you’re playing a part in the fight against disease”.
He reflects the view of his life science adviser, George Freeman, who also in a recent article wants to see every willing patient a research patient.
Unfortunately, the shared vision of the Prime Minister and the AMRC is about to hit a roadblock because, as T S Eliot put it:
“Between the idea And the reality … Falls the shadow”.
In this case, the irresistible force of their idea, their dream, will soon meet an immovable object, which is the law. Current law obliges the doctor to follow the status quo, even though he or she knows that it leads only to poor life quality followed by death. This is why all cancer deaths are wasted lives. Science learns nothing from those thousands of deaths—scientific knowledge does not advance by one centimetre—because current law requires that the deceased receive only the standard procedure, the endless repetition of a failed experiment. The pre-eminence in law of the standard procedure is a barrier to progress in curing cancer.
I had better close with this. There is not time to take your Lordships through the case law that I have here but I will summarise it like this. Under present law, any deviation by a doctor from the standard procedure is likely to result in a verdict of guilt for medical negligence. Current law defines medical negligence as deviation from standard procedure. However, as innovation is deviation, non-deviation is non-innovation. That is why there is no cure for cancer. That is why the AMRC vision of every clinician a researcher cannot be realised without a change in the law.
We do not want patients to be treated like mice but, on the other hand, we want bold scientific innovation, which alone can bring a cure for cancer. It is well known that in politics, when a man says, as I say now to the noble Lord, Lord Turnberg, “I agree in principle with this report”, it usually means, “I intend to do nothing about it in practice”. On the contrary, I say to the noble Lord, Lord Turnberg, that not only do I intend to do something about it in practice, I intend to devote my entire life to ensuring that the dream of the Prime Minister and the AMRC comes true.
Health: Cancer
Lord Saatchi Excerpts(11 years, 7 months ago)
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Lord Saatchi
To ask Her Majesty’s Government in what proportion of deaths recorded as caused by cancer is the actual cause of death the treatment of cancer.
The Parliamentary Under-Secretary of State, Department of Health (Earl Howe)
The Office for National Statistics publishes national cancer mortality data annually. Data are collected where cancer has been recorded as the cause of death, but not on treatment for cancer as the cause of death. I therefore regret that I am unable to provide this information.
Lord Saatchi
My Lords, I thank my noble friend for that reply. The point of this Question is that there is no answer to it. Since I tabled the Question, I have received an estimate from within the medical profession that last year 15,000 people in Britain were killed by cancer treatment rather than by cancer. We do not know whether 1% or 100% of patients die as result of the treatment; what we do know is that cancer drugs do such damage to the immune system that the patient is helpless to resist fatal infections such as MRSA, E. coli or septicaemia. Does my noble friend agree, as I think he has, that the official statistics for the UK cannot distinguish between cancer death and treatment for cancer death? Is this not because the ONS, under WHO guidelines, records only the single underlying cause of death? In other words, it does not record the sequence of causation, sometimes known as the sequence of conditions, that led to the death. This is supposed to be the era of big data. Will my noble friend review the limitations of cancer mortality statistics in order to assist scientists and doctors to have the information to move forward innovation towards a cure for cancer?
Earl Howe
My Lords, I agree that it is important to have more information on the effect of cancer treatments on mortality. New data collections which will provide more detail in this area are under way. The systemic anti-cancer therapy dataset will enable better information to be collected about deaths after the delivery of chemotherapy, and the cancer outcomes and services data set will provide information in respect of death after surgical treatment. However, it is important to make one point here: it can be hard to identify the precise cause or sequence of progression of factors resulting in death, particularly for those with end-stage cancer or who are particularly frail and are experiencing physical deterioration. I do not think that it can ever be a precise science.
Health: Medical Innovation
Lord Saatchi Excerpts(11 years, 11 months ago)
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Lord Saatchi
To ask Her Majesty’s Government what steps it proposes to take to encourage best practice in medical innovation.
Lord Saatchi
My Lords, I express my gratitude to the usual channels for allowing the time for this debate. I have introduced the Medical Innovation Bill into your Lordships’ House. I will not be covering the details of that Bill in this debate; Second Reading will follow at some point in the year and we can discuss them then. However, this debate may illuminate the context of the Bill and give your Lordships’ House an opportunity to consider the whole complex question of what best practice is in innovation, particularly the application of research and knowledge to patient treatment.
In opening this debate among the judicial and medical experts in your Lordships’ House who have devoted a lifetime to this subject—compared to my own brutally short experience—a certain humility is appropriate. It will be my privilege to hear many noble Lords who are among the great innovators of our time. I particularly thank my noble friend and his team at the Department of Health for their wisdom; Dame Sally Davies, the Chief Medical Officer, for her viewpoint; the Secretary of State himself for making improved survival rates his key priority for healthcare; and the many patient groups, academics and practitioners who have contributed their thinking.
The Prime Minister himself has encouraged British medical innovation in the context of the global race, and the document on diffusion of innovation in the NHS by my noble friend, himself Minister for innovation, is, if he will allow me to say so, a model of agenda-setting by a government department.
Buoyed up by Bertrand Russell’s view that simplification is not always obfuscation and often serves to crystallise the issues, I will attempt first a simple description of the need, and then a specific suggestion of what steps your Lordships may consider to meet that need. I will concentrate on the most emotive word in the English language—cancer—and hope to draw wider conclusions from this area. To express the need, I am helped by an unexpected source, the Father of the House in another place. In his tribute to Her Majesty the Queen on the occasion of her Diamond Jubilee, he used a striking phrase:
“There is nothing more inspiriting in the whole world than a beautiful woman”.—[Official Report, 07/3/12; col. 852.]
I can amend that. There is no more distressing thing in the whole world than a beautiful woman being reduced to a sparrow.
Unfortunately, here is the status quo. A woman is told that her tests are “normal” and to come back in 12 months. She is removed from her home 12 months later and cut and drilled until she loses half her body weight. Wires and tubes are attached to her throat, nose, stomach and vagina. Drugs are given to her that cause nausea, vomiting, diarrhoea and fatigue. They open the path for fatal infections to enter the woman’s body and reduce her body’s defences against such infection. The woman is left for dead, and sooner or later the woman dies. The “process”, as it is called, involves scenes that would not be permitted in a Hollywood horror movie.
I hope that that is a fair description of the need for medical innovation. The screening techniques for such a cancer are inadequate; no reliable early detection method is available, and even if it was, it would improve the overall survival statistics but not the date of death. The treatment regimes, when provided—that is, the drugs, the cycles of their administration and the surgical procedures—are 40 years old. They are also ineffective; cancer quickly develops resistance. Not surprisingly, the survival rate for such cancers is the same as it was 40 years ago—in other words, nought; and the mortality rate is the same as it was 40 years ago—that is, 100%.
This disease is relentless, remorseless and merciless. Its treatment is medieval, degrading and ineffective. Why are we so forsaken? It is said that cancer is so complex that it is beyond the judgment and understanding of the human mind to comprehend its variables. Therefore, through ignorance, we kill people unnecessarily.
If that is true, it is not through lack of trying. Scholars in cancer have long sought general rules about the world as robust as the laws of physics and to verify statements, propositions and putative facts by the results of empirical studies. Unfortunately, it has not worked out quite like that. Instead, we find the stubborn fact that, after 2000 years of human progress, cancer is still outside Newton’s universe where physical laws govern reality.
In the natural sciences, even though, as Popper says, the closest approach to proof is just a succession of unsuccessful attempts at falsification, we can nevertheless make statements in the natural sciences, perhaps without finality but with a certain degree of probability. If I drop these papers, they will fall to the ground. Tomorrow the sun will rise. In cancer, though, the record seems to show that once we express opinions or beliefs or attempt to offer explanations, descriptions or predictions, then error, doubt and uncertainty come to the fore. In cancer you hear it said that, “Every case is different” and, “There is always hope”. Such well meaning sentiments are not science. There is no hope that if I drop my papers they will not fall. These statements are meant to bring cheer to the desperate, but instead the effect is the opposite. They bring despair—the dread revelation that cancer is a realm in which science has yet to achieve sovereignty.
In the end, all attempts to place cancer medicine within the canons of scientific objectivity have failed. There remains an irremediable tentativeness about the logically perplexing question of what is the cause or cure for cancer. Cancer science has not yet found its Newton. Why? There is a powerful deterrent to innovation at the heart of the current system. Economists would call it a systemic failure. Current law is a barrier to progress in curing cancer. Under present law, any deviation by a doctor from standard procedure is likely to result in a verdict of guilt for medical negligence. Current law defines medical negligence as deviation from standard procedure. As innovation is deviation, though, non-deviation is non-innovation. In this way, the fear of litigation for medical negligence is a roadblock to innovation in cancer treatment. The present pre-eminence in law of the standard procedure provides no inducement to progress. The self-interest of medical practitioners, as defined, for example, in doctors’ insurance policies, means that innovation—that is, deviation—is a form of self-harm.
In Clark v MacLennan, an important test case in 1983, the significance of departing from an approved mode of practice was treated by the trial judge, J Pain, as having the effect of reversing the burden of proof, so that once the plaintiff established a deviation the defendant had to disprove an inference of negligence. I quote Crawford v Board of Governors of Charing Cross Hospital, 1953:
“The practitioner who treads the well-worn path will usually be safer, as far as concerns legal liability, than the one who adopts a newly discovered method of treatment”.
In the standard Butterworth text on medical negligence, the authors Nathan and Barrowclough expressed in 1957 the following view, still applicable today, concerning deviation from accepted modes of practice and the ethics of new treatment research and experimentation:
“Medical men cannot be permitted to experiment on patients (Slater v Baker and Stapleton) (1767) ... On the other hand the courts will not press this proposition to a point where it stifles initiative and discourages advances in techniques … a line must be drawn between the reckless experimentation with a new and comparatively untried remedy or technique, and the utilization of a new advance which carries with it unforeseen dangers and difficulties”.
I hope that we can agree with Lord Diplock, who was looking for a better balance to be struck between therapeutic innovation and therapeutic conservatism. He warned of the dangers of so-called defensive medicine:
“Those members of the public who seek medical or surgical aid would be badly served by the adoption of any legal principle that would confine the doctor to some long-established, well-tried method of treatment only, although its past record of success might be small, if he wanted to be confident that he would not run the risk of being held liable in negligence simply because he tried some more modern treatment, and by some unavoidable mischance it failed to heal but did some harm to the patient. This would encourage ‘defensive medicine’”—
that is his phrase—
“with a vengeance”.
I am looking carefully at the time and will therefore bring these remarks to a close. Your Lordships will agree that optimal care is evidence-based care. Evidence-based medicine is therefore standard procedure for the protection of patients. However, as your Lordships are well aware, cancer is the least evidence-based disease of all. There is great uncertainty: either the evidence does not exist or, if it does, it is not clear what it means. Innovation is therefore more appropriate in cancer treatment and the consequences of not innovating are greater—poor life quality, followed by death.
I shall end with this. What can your Lordships’ House do—that is the point of this debate—to encourage the drive towards medical innovation, on which my noble friend has made such a great contribution? The advance of science depends upon the free competition of thought and thus upon freedom; that must come to an end if freedom is destroyed. Are the intellectual problems of cancer insoluble? I do not think so. What is more inspiring, apart from a beautiful woman, than the quest by scientists to explain the world; to find satisfactory explanatory theories—simple theories—and to test them? One of them will cure cancer. We should rise to our feet to applaud the great cancer doctors and scientists, many of them in this House, who are striving by their own best lights to serve the community. Let us erect statues in their honour or build bridges in their name, or parks, or avenues, or airports. Let us encourage them, not frighten them.