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Medical Innovation Bill [HL]

Volume 758: debated on Friday 23 January 2015

Third Reading

Clause 1: Responsible innovation

Amendment 1

Moved by

1: Clause 1, page 1, line 10, at end insert “(for the purpose of ensuring that the proposed treatment would command the respect of a representative body of responsible medical opinion, having regard to the needs of patient safety).”

My Lords, I shall not detain the House for great length. The amendment in my name and that of the noble Lord, Lord Saatchi, addresses patient safety, an issue which is dear to this Government. One of the concerns expressed again and again throughout the Second Reading and Committee stages of this Bill, and subsequently, has been that some patients might in desperation, for various reasons, seek treatment which is innovative but not properly regulated or properly justified. Particularly in the private sector, patients might be tempted to go into treatments which seem attractive but perhaps are overadvertised as sensible. In the end, they may be more futile than more recognised treatments that may carry known side-effects or perhaps be more frightening. I think that that is the case for cancer in particular.

This amendment is designed to make sure that any treatment given under this Bill would get broad support from responsible medical practitioners. There would be an onus, not only on the person doing the treatment, but on the person responsible for advising that the treatment was reasonable to the operator, the medical practitioner concerned. This would fall within that area. Essentially, there would be a legal onus, a responsibility, for that adviser to give advice which was regarded as serious and acceptable to a broad body of medical opinion in that field. That is the essence of this amendment, which we have discussed.

I am delighted that the noble Lord, Lord Saatchi, has agreed to put his name to this amendment. It is helpful. I hope that it will not prevent people participating in trials, particularly in cancer medicine. I also hope that it will make sure that private medicine is carried out responsibly. We all have reservations about this Bill but it covers most of the issues about which we have been concerned. I am concerned about reproductive medicine because I fear that that is now in a burgeoning private area. It worries me still that quite a lot of reproductive medicine done in the private sector is not properly validated and that patients are paying very heavily for it. Beyond that, broadly speaking, this is the amendment that I would like to see on the statute book. I therefore beg to move.

My Lords, I am slightly concerned about the wording of the amendment because I would not want it to become a way of dragging things on forever. How do you decide what is,

“a representative body of responsible medical opinion”?

To lay people such as myself, there seem to be heaps of medical bodies and I wonder how that would be determined. I would be interested to be satisfied on those points. The speech of the noble Lord, Lord Winston, was clear that he does not intend the amendment to represent any of those matters, but I would like someone who is more of an expert on the wording of these things to assure me that it would not be only a preventative technique.

My Lords, I declare my interest as professor of surgery at University College London and as a member of the General Medical Council, although I do not speak for the council in this Chamber.

I thank the noble Lords, Lord Winston and Lord Saatchi, for having tabled this important amendment. It goes to the heart of good medical practice, of course, always to innovate—but always to innovate, first and foremost, with absolute regard to patient safety. The fact that the amendment will now appear in the Bill will provide absolute clarity on what is required to discharge that patient safety responsibility with regard to innovation, as described in the Bill, which is vitally important. I strongly support the amendment. Once again I thank the noble Lord, Lord Winston, for his contributions in the passage of the Bill and, in particular, for tabling this important amendment.

My Lords, I, too, welcome the amendment. It will further emphasise that, in order to be lawful, medical innovation must be responsible. The criterion of responsibility has been the essence of the law on this subject since the judgment of Mr Justice McNair in the Bolam case in 1957, when he said that a doctor,

“is not guilty of negligence if he has acted in accordance with a practice accepted as proper by a responsible body of medical men skilled in that particular art”.

That may provide some reassurance to the noble Baroness, Lady Gardner of Parkes, that the courts will easily understand what is involved in the amendment.

The amendment will reassure many of those concerned about patient safety. The words will further confirm what I understood to be the Minister’s statement in Committee that the Bill is not intended to alter the substance of the Bolam test but to provide a practical means by which innovative doctors can take steps in advance of carrying out the treatment.

Like the noble Lord, Lord Winston, I am less confident than the noble Lord, Lord Saatchi, that this Bill will have much, if any, beneficial effect. I am doubtful that the fear of litigation deters responsible innovation, but I have been reassured by the amendments that the Bill will certainly do no harm. I thank the noble Lord, Lord Saatchi, for the responsible manner in which he has responded to concerns about the Bill by welcoming amendments of this sort. I also thank Mr Daniel Greenberg, a former parliamentary draftsman, now an expert consultant, for the assistance that he has provided to many noble Lords, including myself, on the issues raised.

I hope my memory is not at fault when I recall that I have attended all the previous stages of this Bill but deliberately not spoken because I preferred as a lay man to listen to what the medical experts were saying. We have had considerable testimony from them in the previous stages which has helped us make progress. I thank the noble Lord, Lord Saatchi, again. I know it has been done before but it is important to record our thanks for his introduction of this extremely interesting legislation, which will be very useful and important to humanity in the future—although it is difficult at this early stage to tell exactly how it will develop and the noble Lord, Lord Pannick, is right in expressing certain reservations about it.

We all have experience of the sufferings of friends and families in cancer cases and the Bill, not only in a moving way but in a scientifically respectable way, makes progress in widening the ability of medical experts, operating under the strict safeguards that have been agreed in the previous stages, to make sure that people can be helped more than the already marvellous help that doctors give within the existing framework. I am glad to support the amendment.

My Lords, I, too, welcome the amendment and thank my noble friend for his efforts. I also thank the noble Lord, Lord Saatchi, for the way in which he has been prepared to listen and to support amendments which we see as improving the Bill. This amendment goes a long way to meeting some of the concerns expressed by medical bodies about what might be described as unintended consequences arising from the Bill.

I do not agree with the noble Baroness, Lady Gardner, that this amendment could be seen as delaying action. I think it is rather the reverse. Having this provision and the need to act within it would give confidence to doctors. I think the definition of,

“a representative body of respectable medical opinion”,

is a question of you know what it is when you see it. I would have thought that doctors would have no doubts about to which responsible body they should turn.

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.

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.

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.

Amendment 1 withdrawn.

Amendment 2

Moved by

2: Clause 1, page 1, line 24, at end insert—

“comply with any professional requirements as to registration of the treatment under the provisions of this Act with a scheme for capturing the results of innovative treatment (including positive and negative results and information about small-scale treatments and patients’ experiences),”

My Lords, throughout the passage of the Bill the noble Lord, Lord Saatchi, has been enormously helpful to the House in responding to concerns and in his willingness to accept constructive changes to the Bill. I am most grateful to him for adding his name to my amendment.

We had a useful discussion in Committee and on Report about the establishment of a register that could record uses of the Act. This would be immensely helpful to clinicians, regulators and doctors—and, indeed, patients. It would reassure those who have concerns about the implications of the Act. It would enable use of the Act to be tracked. I argue that it would also help spread good practice. It would inform legislators about further changes to the law that might be required in the light of practical uses of the Act.

On Report, I received considerable support around the House. The noble Lord, Lord Kakkar, is here today. He probably will not mind me quoting from what he said—that,

“the register needs to be obligatory, in which all innovation and the outcome of that innovation is properly reported. It would do much to ensure the development of an enhanced culture of innovation, but also, fundamentally, to provide very important protections”.

On Report, the noble Baroness, Lady Jolly, opposed the amendment on four grounds. First, she argued:

“Requiring doctors to record the results of innovative treatments in order to demonstrate that they have not been negligent … would impose requirements … additional to those in the existing law”,


“may risk deterring doctors from innovating”.

Secondly, she argued that my amendment,

“would widen the scope of the Bill to cover all innovation. This Private Member’s Bill is not the right vehicle to make provision that would relate to all innovation”.

Thirdly—and quite remarkably—she said that,

“the act of putting something into legislation does not guarantee that doctors will adhere to it”.

Fourthly, she said that she would support a voluntary register,

“but it should be such that doctors would not dream of not recording on the register”.—[Official Report, 12/12/14; cols. 2062-63.]

My response is simply: let us put it beyond doubt by making registration mandatory.

On the question of the amendment going wider than the Bill, I have changed my amendment to make it clear that it relates only to this Bill—or Act, as it will become. On whether having to comply with this provision would dissuade doctors from innovating, I simply do not accept that. I would worry about doctors who were dissuaded because of the need to record an innovation in the register. I would have thought it created the conditions in which doctors would feel more confident in taking innovative action. On the suggestion that doctors will not adhere to the legislation, I simply do not accept that and ask what possible evidence there can be of it.

I do not think it is unreasonable to say that every use of the Act should be captured and available, to check on patient safety from the point of view of regulation but also for the purposes of research. I beg to move.

My Lords, I am very pleased to support this amendment, to which I have added my name. Within the rare disease community, there is significant unmet medical need, and research and innovation are seen as the means through which new therapies for currently untreatable conditions will be developed. For this to make a difference to patients, the barriers to medical research and the adaption and integration of research and innovation into the NHS need to be addressed. Therefore, it is vital to ensure that registries are created to enable the collection and exploitation of real-world patient data and to promote the sharing of research findings and best practice.

The Royal College of Pathologists says that, unfortunately, this Bill, allowing the results of new tests and treatments to go unrecorded, will hinder its work and medical science more widely. Without the mandatory recording of results of such treatments, unexpected adverse outcomes and irresponsible activity will be harder to detect and prevent.

All results of innovative treatments should be centrally recorded, reported and publicly accessible. This must include both positive and negative outcomes and feedback from patients. Without the mandatory recording of results, the public benefits of medical innovation will not be achieved and the advantages to future patients will be lost.

I am pleased that the noble Lord, Lord Saatchi, is supporting this amendment. I hope that the Government will, too. I would like to ask whether patients from both the NHS and the private sector are covered by the Bill. In my view, all patients who wish it should be able to benefit from innovation as long as it is fully explained to them and is felt to be as safe as possible.

There are many splendid trusts which support medical research. I hope that if this Bill becomes an Act they may find it possible to help fund the register.

My Lords, I remind noble Lords of my interests, stated earlier, as professor of surgery at University College and as a member of the GMC, but I do not speak for the council in this Chamber.

I thank the noble Lord, Lord Hunt of Kings Heath, for once again bringing this issue to your Lordships’ House. It is critically important, and probably one of its most vital elements is that there is the opportunity for registration of innovative interventions and therapies.

Clearly, providing transparency and the opportunity for sharing the outcomes of such innovations rapidly and broadly across clinical communities in this country and internationally is of so much importance. It will allow colleagues to understand what has been achieved and not achieved; it will allow those with other ideas to build on knowledge gained from experience to date; and it will ensure that through transparency we have the best opportunity to ensure the greatest patient protection. I am very grateful to the noble Lord, Lord Saatchi, for having considered this issue carefully and having come to the place where he has put his name to the amendment and supports it. I hope that Her Majesty’s Government will be able to consider this issue. The measure enjoys substantial support and will be a vital contribution to this long journey with regard to innovation, ensuring that we can do the best for patients as rapidly as possible without undermining the very best practice and the ability to share knowledge, and ultimately ensuring that this Bill enhances patient safety.

My Lords, I strongly support this amendment and hope the Government will take it seriously because we are talking here about not innovation but scientific innovation. Science is a collective enterprise. It depends on the accumulation of evidence. It is crucial that that be recognised formally somewhere in the Bill, with this embodied as part of the advancement of scientific progress more generally.

My Lords, I support this amendment. I was surprised that the Government took a line similar to my own on the previous amendment because I was greatly reassured by what noble Lords said on that point. In this case, and right from the start of the passage of the Bill, we have all believed it essential to fully record what happens. The whole aim of this has been not only to give hope to people via an innovative treatment but also to have research that will benefit other people in future. No one has for a minute queried the need for recording the cases and results. I would be amazed and shocked if the Government denied that today.

My Lords, many noble Lords will remember the disasters that occasioned the introduction of laparoscopic cholecystectomy in the 1990s. Quite a few patients suffered as a result of the innovation of our surgeons playing with a new instrument, new tools and a new operation. At the time, I was secretary of the Association of Surgeons of Great Britain and Ireland. In recognising the problems, we introduced a voluntary register of all surgeons undertaking the procedure and got a very good response. Admittedly, it was not compulsory and not every surgeon introduced their data to it, but the net effect was that when we analysed our data we were able to identify where many of the problems lay. That led to further research and proper control trials in the procedure. We were able to turn to that from an innovation used by a succession of surgeons as and when they felt necessary, without any good evidence on how best to use it. On that basis, and mindful of the benefits that we saw in the 1990s, I would very much support some form of register to ensure that, if an innovation is introduced, we have the information, can go back and refer to it again, learn from the mistakes and improve the outcome.

My Lords, briefly, I support the amendment of my noble friend Lord Hunt of Kings Heath as well. I was reminded by the noble Lord, Lord Ribeiro, of laparoscopic surgery. Of course, we gynaecologists were doing that 20 years before the noble Lord was and we did not have as many deaths. Having said that, what the surgeons did with laparoscopic surgery and recording those events was really important in bringing down the complication rate and the haemorrhages that occurred. That is a very good example and the noble Lord is to be thanked for bringing it to the House. It is exactly what would be covered here.

I would be astonished if the Government seriously opposed this amendment. I was very unconvinced by the noble Baroness, Lady Jolly, in the previous stages of the Bill. She did not seem to take on board exactly what we were trying to say about the need for keeping proper records, which is important in all sorts of ways. If you keep a record and it is done under this Bill then you are effectively legally protected. For that reason if no other that would be important, but in any case we have to build up the knowledge of our experience. We do that automatically in the laboratory. Every single thing we do in the laboratory, whether negative or positive, we record in our laboratory books. If we do not, we are not doing good science or science useful to the public. Here in innovative medicine, we are—whether we like it or not—doing a form of science because we are exploring our knowledge about what a treatment means. That is what science means. I urge the Government to support the amendment. I feel very strongly about this. If the Government were reluctant to support it and my noble friend Lord Hunt were to divide the House, I would certainly join him.

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

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

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

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

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

I understand the noble Earl’s concern that if there is an obligation to report the results, that might have an effect on the common law Bolam test, but surely it would not, because of the contents of Clause 2(1), which states:

“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”.

I therefore understand that under the Bill—the noble Earl can tell me whether I am right or wrong—the doctor has two means of defending himself or herself. One is the Bolam test at common law; the other is to take advantage of the procedures of the Bill. If one of the procedures of the Bill is a duty to report, that does not affect the general Bolam test under Clause 2(1).

My Lords, I take the point made by the noble Lord, Lord Pannick. My point was not that the amendment would alter the effect of Clause 2(1). It would not have an effect on the common law, but it would create a more burdensome test under the Bill. That is troublesome to me, because to do that would in itself impose requirements which go beyond the current Bolam test of negligence. It would mean that the test of clinical negligence was more burdensome under the Bill than under the common law.

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

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

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

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

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

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

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

I am not a medical specialist but I have followed this all the way through. What kind of structure would the Minister envisage being put in place if there is not a formal requirement of this sort? If you do not have some kind of system of dealing with the data produced, the whole thing becomes an erratic exercise and therefore does not contribute to the overall fund of medical knowledge.

I would not disagree with the noble Lord at all. I was about to say that on Report, my noble friend Lady Jolly suggested that there should be a registry and made a commitment to that effect. I would like to clarify that the Government are committed to exploring what may be useful in the data registry. The key here is to establish what could be workable and beneficial. The Government have heard a range of views on the topic of a data registry from those who argue, as many of your Lordships do, that this is essential to the Bill to others, including eminent clinicians, who argue that informal methods of sharing learning are more effective and that a compulsory registry would be overly burdensome.

With thanks to the contribution of your Lordships, the Government have started this conversation and are committed to continued engagement with relevant bodies. Any method of learning that should develop from the Bill must surely work for doctors to be of benefit to patients and the wider medical community. That is no simple task. It is crucial that any mechanism to encourage learning should be developed with a sufficiently light touch so that clinicians see it as facilitative of good practice, rather than burdensome and bureaucratic. It is also important to consider the costs of a method of learning and how this can be encouraged in the most cost-effective way. While I do not take issue with the end-point which noble Lords want to reach, I really believe that it is wise for us to remain open to all possibilities, rather than committing in legislation to an approach which may discourage doctors from innovating under the Bill and therefore not be of benefit to patients in the longer term.

This is a beguiling amendment and I understand the motivation behind it but I hope that noble Lords will join me in questioning the wisdom of having such an amendment in the Bill and accept instead our preferred approach: to continue to discuss this issue with relevant parties as the Bill progresses and, should the Bill pass, to engage with the medical community as to the best way to ensure that innovation can be translated into learning.

Before the Minister sits down, to do research surely one needs data to see what benefits patients because these are new procedures that we are talking about.

I would just say that the Bill is not to do with research but with innovative treatment, which is rather different. There is no question of the noble Lord, Lord Saatchi, promoting another form of clinical trial so while I accept the principle that the gathering of data is a very good idea, we must be clear that this is not for clinical research.

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

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

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

“comply with any professional requirements as to registration”.

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

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

Of course the Government will consider this carefully. Let me make it clear that I do not want to sound negative about the idea of data gathering. I am the first to recognise that that could be a major advantage of the procedures that my noble friend Lord Saatchi is encouraging within the scope of the Bill. I would not dispute that for a moment. My concern is that to build a further requirement into the test of negligence would be the wrong course to take, because that is how this amendment is framed.

Also, what would be the benefit if we do not engage fully with the medical community to make sure that doctors are able to use any registry that might be created easily and simply? If it does not work for doctors, there will be no benefit—so I think that we need to take longer over this. It is not a case of kicking it into the long grass, but in the time available we have not been able to come up with a precise solution, despite our best endeavours in our discussions with the GMC.

My Lords, before the Minister finally sits down, does he agree that it would be desirable that any professional requirements of registration should deal not only with innovation,

“under the provisions of this Act”,

but also with innovation that may well be outside the provisions of this Bill but are covered by Bolam and expressly contemplated in Clause 2(1): namely,

“a departure from the existing range of accepted medical treatments”.

That, too, needs to be recorded and registered because it may point the way ahead. As matters stand, that is not within the compass of the proposed amendment to Clause 1.

Perhaps I may further ask the Minister whether he agrees with me that the real purpose of this Bill is to carry Bolam a stage further. Bolam applies if a proposed innovation is,

“a departure from the existing range of accepted medical treatments”,

and is,

“supported by a responsible body of medical opinion”.

Clause 1 of the Bill, as was made plain by the first proposed amendment, deals with a situation where,

“a departure from the existing range of accepted medical treatments”,

may not actually be supported by, but has the respect of,

“a responsible body of medical opinion”.

In other words, the,

“responsible body of medical opinion”,

may not support it, but, taking that into account and having regard to patient safety, none the less respects it and therefore implicitly allows it to go forward as a responsible treatment. That is outside Bolam but within the compass of the Bill.

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.

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.

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.

Amendment 2 agreed.


Moved by

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.

Bill passed and sent to the Commons.

House adjourned at 3.23 pm.