Medical Innovation Bill [HL]

Lord Turnberg Excerpts

Friday 24th October 2014 Lords Chamber

Moved by

[Lord Turnberg]

1: Before Clause 1, insert the following new Clause—
“Provision of advice by registered medical practitioner
(1) This Act applies only to decisions made by a registered medical practitioner to advise a patient for whom he has assumed a professional responsibility for the provision of advice with regard to the choice of treatment for—
(a) a cancer which in the reasonable opinion of the practitioner is affecting the patient and is likely to cause the patient’s death without the provision of effective treatment;(b) such other conditions as may be prescribed by regulations made by the Secretary of State.(2) A condition to which this Act applies is referred to as a “relevant condition”.”

[Lord Turnberg (Lab)]

My Lords, this is a rather omnibus group of amendments. I will do my best to try to speak to all of those to which my name is attached as well as to serve the others.

I should say at the outset that in setting out my amendments my purpose is to try to make sure that any Act that comes out is both sufficiently safe for patients and practicable so that the innovative practice that everyone wants to see is achievable. However, I would hate to see the opening up of a bureaucratic and legal nightmare that Sir Robert Francis tells me he still has problems with.

I would also like to correct a couple of possible misapprehensions. The first of these is that I want in some way to inhibit innovation in medical practice. I find that particularly galling when I have spent much of my life in clinical practice trying to introduce innovations. In my own field of gastroenterology I constantly tried novel treatments for Crohn’s disease, for example, and, indeed, published in journals the results of the research that I carried out. I say as an aside that at that time I did not feel the need for a Bill of this sort to allow me to innovate when I already had ethics committees’ approval and the informed consent of my patients. I fear that I am not alone in wondering whether the Bill is necessary. When Action against Medical Accidents, for example, and a number of important medical bodies express doubts about the need for it, one begins to wonder. I will not reiterate the Second Reading arguments as I want to concentrate on trying to make the Bill workable. However, I reiterate that innovation has been part of my very being and I still want to do everything that I can to encourage it.

The other misapprehension seems to be that there have been no advances in the treatment of cancer since the Middle Ages. That is patently not the case for many cancers—for example breast cancer, where there have been remarkable improvements, and in the leukaemias, where many, especially in children, have been cured. Now we see remarkable possibilities emerging for melanomas and a number of other carcinomas. However, it is certainly the case that no major advances have been made in the treatment of some cancers of the pancreas or the ovary, for example. That is terribly sad but true. It is also true, however, that no one anywhere has come up with a breakthrough for any of them—not in the USA, Japan, Oxford, Cambridge or anywhere—despite enormous effort by many researchers across the world. I declare my interest as a trustee of the charity Ovarian Cancer Action. We support a fascinating range of research into potential cures and keep a very careful eye on any advances in the field through our international band of distinguished researchers and advisers, who are often mainly based in the USA, so the idea that someone somewhere has a wonder cure that we have not heard about seems somewhat remote. I fear that we may have some way to go to find a cure but we at the charity have heard recently of some fascinating research in Oxford that we are supporting. However, we have some way to go.

I have tabled these amendments as I fear that the Bill’s wording leaves open to too great a degree the potential for harm by unorthodox, unregulated practitioners. Amendment 1 seeks to make it clear that we are talking about registered medical practitioners and that for the moment we should limit the innovative treatments to patients with cancers that are likely to kill them. The idea here is that this would narrow the field of endeavour a little and give time to consider whether, after the Act is in operation and has been shown to be valuable, it could be expanded and consideration be given by the Secretary of State, taking advice from reputable sources, as to whether other conditions should be included. After all, cancers are among the most high-profile cases where patients are constantly seeking new and better treatments and are willing to try almost anything.

It is under those circumstances that my Amendment 7 is absolutely critical, as it is for precisely these vulnerable people, desperate to try anything, that we have to have in place processes and mechanisms to protect them from unethical practitioners who may take advantage of their vulnerability. We have to face the fact that there are practitioners out there using all sorts of weird and wonderful treatments that have no basis whatever. So, in Amendment 7, I set out in some detail the conditions under which a doctor may prescribe such an innovative treatment. He or she should be the doctor with responsibility for that particular patient’s care. He should have reached,

“an honest and responsible opinion”,

that it will be more effective than orthodox treatment and that it is in the patient’s best interests. He should make sure that other doctors looking after that patient who have an interest in that patient will agree with him and he should have the agreement of another expert in the field. He should have not just consulted that person but obtained their agreement—not just to take account of that person’s views, as in Amendment 12 of the noble Lord, Lord Saatchi—and it should all be put down in writing in the patient’s record. I like the way in which Amendment 14, tabled by the noble Baroness, Lady Masham, sets out the requirement for patient consent, and hope that that can be incorporated. I hope that the noble Lord, Lord Saatchi, will agree that this will make his Bill a safer Bill and that he will accept this amendment or something very like it.

My Amendment 15 also proposes, first, that all the considerations that have gone into reaching the decision to innovate, together with the type and nature of the innovation, should be recorded in the patient’s record and, secondly, that the results of such innovation should be available in some public format. Here I have suggested that it should be available within six months. I am not wedded to that time limit, only to the principle that others should be able to learn from someone else’s innovations. I know that the noble Lord, Lord Saatchi, has the agreement of Oxford University that it will act as a repository for this information. However, as I understand it, there is no compulsion on behalf of the innovating doctor to report to Oxford. We need something in the Bill that makes it not just desirable but essential. My Amendment 19 also makes that point clear.

Amendments 21 and 32 refer to research. Here I want to make the Bill absolutely clear that those engaged in research involving clinical trials will not be subject to even further stringent requirements than they already labour under. After all, these innovative treatments which we are all so desperately seeking are entirely dependent on high-quality research in clinical trials. However, there is a fear out there in the Association of Medical Research Charities—in which I express my interest as scientific adviser—the Medical Research Council, the Wellcome Trust and so on, that the stringent requirements under which researchers operate, involving clinical governance, research ethics committees, informed consent by patients and so on, will be added to by the conditions set out in the Bill. No one, least of all the noble Lord, Lord Saatchi, I suspect, wants his Bill to act as a further deterrent to clinical trials of new treatments. I therefore hope that he will find these amendments helpful.

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We have heard in today’s important debate that noble Lords want dialogue and discussion with the noble Lord, Lord Saatchi, and indeed he has said that himself. Is he prepared to consider hosting a round-table discussion with all those Peers who have an interest in the matters before us today? That would be a very helpful way forward.

[Lord Turnberg]

My Lords, I hope that I am not out of order in responding to some of the comments from the noble Lord, Lord Saatchi, about my amendments. I am grateful to him for his comments and I listened with care to what he had to say. I am also impressed by the noble Lords, Lord Cormack and Lord Kirkwood, and indeed the noble and learned Lord, Lord Mackay, that further discussions may be possible before Report, which I would very much welcome.

On Amendment 1, I note that the noble Lord, Lord Saatchi, is not very keen on the idea of limiting the scope of the Bill at the moment to cancer, but my point here was to start with that and expand cautiously in the light of experience. I note that the noble Lord, Lord Kirkwood, also urged some caution in the way in which we introduce the Bill. The amendment also impacts on Amendment 17, whose lists of exclusions, if we went along the line of limiting the Bill to cancers, would not be quite so necessary.

My Amendment 7 and Amendment 12 from the noble Lord, Lord Saatchi, overlap to a considerable extent, and I am grateful for that. The main difference is that his concentrates largely on taking account of the views of another expert, while mine suggests that we should obtain the agreement of at least one other expert, which should be recorded in the note. I think that that strengthens his amendment, and I hope he will think about that rather carefully.

On Amendment 15, a number of other noble Lords have referred to the need to have any innovations recorded in some form of register but also in the patient’s records. I listened carefully to whether the noble Lord, Lord Saatchi, had accepted the idea that the record should be in the notes as well, and I hope he will accept that too.

Amendments 21 and 32 talk about research. I am pleased that the noble Lord agrees with the principle that this Bill should not interfere with research; I do not think that anyone feels that it should. However, there are many in the research world who are concerned that the Bill might have that unexpected consequence. Something in the Bill along the lines that would exclude the possibility would therefore be extremely helpful.

Similarly with Amendment 24, which talks about emergency care, it is true that the Bill may not cover emergency care, but there are people involved in accident and emergency departments who are concerned that the Bill may somehow, in some way, inhibit them. It would be a shame if the impression left by the Bill inhibited that sort of emergency innovative practice, hence the reason to have something in the Bill.

I do not intend to divide the Committee today on any of these amendments, and I am very grateful for the informed debate on many of them. I hope we will have a chance to come back to at least some of them on Report.

[Lord Winston]

Does my noble friend agree that one of his amendments tends to limit the Bill almost entirely to cancer treatment? There is a problem even there, however, because, as the noble Baroness, Lady O’Neill, said, surgery is an important part of cancer treatment. It is absolutely certain—I am not a cancer surgeon but I have watched many cancer operations, and perhaps other surgeons in the Chamber will support me on this—that cancer surgery is often the most innovative surgery, and you cannot possibly take a decision with the sorts of permissions that are usually required beforehand, because you do not know exactly what you are going to encounter. There is a problem there with the structure of the Bill as it presently stands.

[Lord Turnberg]

I accept entirely what my noble friend has said. The surgical aspects of the Bill are quite tricky.

[The Parliamentary Under-Secretary of State, Department of Health (Earl Howe) (Con)]

My Lords, this large group of amendments, all in their own separate ways, seek to ensure that patients are protected against negligent or irresponsible treatment. As we have heard, these amendments take many different approaches in seeking to achieve essentially the same goal. The Government are absolutely committed to safeguarding patients. That is why my right honourable friend the Secretary of State for Health asked Sir Bruce Keogh, the medical director of NHS England, to work with the medical profession to devise a package of amendments that would make this Bill safe for both patients and doctors. Like my noble friends Lord Kirkwood and Lord Cormack, I take this opportunity to commend my noble friend Lord Saatchi for listening to concerns and agreeing to table the amendments recommended by Sir Bruce Keogh in full.

I now address the amendments themselves. On Amendments 1, 7, 17 and 33, the Government do not feel that there is anything to be gained by restricting the scope of the Bill in the way proposed. To set out specific medical treatments or circumstances that would or would not be covered by the Bill would make it complicated for doctors to follow and less flexible to individual patients’ circumstances. That was well exemplified by the exchange that we have just heard. This might limit the Bill’s usefulness to patients and doctors alike. I say to the noble Lord, Lord Turnberg, that there is no question of the Bill applying to unregulated practitioners: it applies to doctors. In answer to the noble Baroness, Lady Wheeler, about what constitutes an appropriately qualified doctor, we believe that to define the required level of experience and expertise would create an overly burdensome requirement on doctors looking to innovate responsibly. A requirement that a doctor is appropriately qualified provides a sufficient safeguard to patients. New Clause 1(3)(b) requires the doctor to take full account of the views of an appropriately qualified doctor in a way in which a responsible doctor would be expected to do.

The provisions in Amendment 7 outlining the process that a doctor must follow to reach a responsible decision are largely addressed by my noble friend Lord Saatchi’s Amendment 12. The provisions in Amendment 7 which require doctors to consult a specified range of other doctors are too restrictive and would make the Bill complicated for doctors to follow. My noble friend’s amendment for doctors to take full account in a responsible way of the views of one or more appropriately qualified doctors in relation to the treatment is less burdensome and is a better equivalent to the existing law.

The noble Lord, Lord Pannick, raised concern that a responsible decision under the Bill is defined as relating to the process rather than the substance of the decision. I listened very carefully to that point. The steps that a doctor has to take under new Clause 1(3) include taking account of substantive factors as well as process. This includes taking full account in a responsible way of the views of one or more other doctors about the proposed treatment. In addition, the doctor must consider the risks and benefits of the proposed treatment as compared to other treatments and to not carrying out any treatments at all. This strays outside the realm of process.

The Government’s view is that it is not necessary in this Bill to require doctors to record their innovation in medical records as set out in Amendments 7 and 15. The General Medical Council’s Good Medical Practice guidance already sets out requirements on doctors to record their work clearly in clinical records, including clinical decisions made and discussions with patients. On Amendment 19 and the related Amendment 34, the Government believe that requiring doctors to record the results of innovative treatments in order to demonstrate that they have not been negligent is not the right approach. This is too bureaucratic and risks deterring doctors from innovating. As regards the idea put forward by the noble Lord, Lord Winston, that there should be some sort of oversight by a clinical or research ethics committee, that would add a very significant level of bureaucracy. Considering the time it would probably take to receive a response, it would act as a barrier to innovation. As the noble Lord knows, research ethics committees are specialists in considering research proposals and would not necessarily be qualified to comment on innovative clinical practice. They do not necessarily have universal coverage and they would not necessarily have the requisite knowledge to advise doctors on very specialised innovative new practices.

However, I have heard the legitimate concerns of noble Lords today, and I commit on behalf of the Government to explore this issue further and constructively with the relevant professional bodies. It will clearly be helpful to understand, should this Bill become law, what might be useful in terms of record keeping and reporting in relation to medical innovation. Furthermore, I commit to ensuring that any guidance that may be appropriate is developed and made available in a timely manner. I hope the intention to issue guidance will be of help to my noble friend Lord Kirkwood.

Amendments 12, 14, 18 and 21 seek to ensure that consent is sought and that proper consideration is given to the views of the patient. My noble friend Lord Saatchi’s Amendment 12 ensures that to fall within the Bill a doctor must obtain any consents required by law. This amendment also ensures sufficient protection for the views of the patient. Furthermore under the existing law of consent patients already have the right to information about the testing and treatment options available to them.

The noble Baroness, Lady Masham, posed questions about drugs. She asked me whether the NHS would pay for unapproved drugs or whether the patient would have to do so. It is worth noting that nothing in the Bill allows doctors to bypass any processes or requirements set by the trust that they are working for. This would include ensuring that the trust would fund any treatment if it were to be provided within the National Health Service. She was fearful that this could result in a two-tier health system in which a patient would be required to pay for innovative treatment. The Bill does nothing to alter funding arrangements for accessing innovative treatments within the NHS, as I have said. That will be governed by whatever rules apply in the trust concerned. However, the Bill also does not change the ability of patients to pay for private medical treatment, as they are able to do now.

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As regards emergency situations, as I have said, the Bill does not need to be used in all situations. The existing law remains. That route can be used where the doctor does not want to follow the Bill, or where it is not appropriate to do so. That, indeed, could include an emergency.

[Lord Turnberg]

I am sorry to interrupt the Minister’s flow. Does he not think that that is confusing for doctors in an emergency situation, wondering which route to take and about the options at that stage, rather than just getting on with the job?

[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.

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[Lord Turnberg]

My Lords, I am very grateful to the noble Lord, Lord Saatchi, and to the Minister for their comments and their acceptance of many of the points that we made in these amendments and in Amendment 1. I commented earlier on many of the points that have been made. I am somewhat disappointed that the Minister does not like the idea of ensuring that agreement in writing is put into the patient’s record—I thought that that would be quite a useful thing to have. However, perhaps we can talk about that at a later date. Meanwhile, I beg leave to withdraw my amendment.

Amendment 1 withdrawn.

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[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.

[Baroness Butler-Sloss (CB)]

My Lords, I strongly support the Bill as it is drafted. I am relieved that the noble Lord, Lord Saatchi, produced a short Bill; I hope that the House does not think that it was a bad idea to suggest that a short Bill might be more attractive than a longer one. For that reason I am not at all happy about the various amendments that were in the first part of our discussions today.

I do have reservations about the words in brackets in Clause 1(1), and I take the view that the noble Lord, Lord Pannick, is probably right to say that they should be excluded.

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[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 Kirkwood of Kirkhope]

Perhaps I may expand on the point I made on the first group of amendments. I am grateful for the comment from the Minister, which I understood as far as it went. I agree with what the noble Lord, Lord Turnberg, has just said. This changes how the regulator approaches a complaint, as far as I can see. It would not change the way that the regulator decides whether there is a case to answer but it seems that this clause—which I think I welcome—gives the doctor an option of which defence he uses against the allegations in front of him.

As I know from previous experience, the General Medical Council has very clear, long-established systems for determining how complaints are lodged and how fitness-to-practise procedures are put in hand. It is very carefully controlled. Do I understand that the proposed new clause in Amendment 29 would merely—if I can put it that way—give the doctor against whom the complaint was alleged the choice of one of these channels of defence in relation to any complaint made against him by the regulator? I am still not clear as to whether I understand this properly. I think I am in favour of this amendment but I am not too sure. If anybody can help me understand it better, I will be really pleased.

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Moved by

[Lord Turnberg]

31: After Clause 1, insert the following new Clause—
“Code of practice
(1) The Secretary of State may issue one or more codes of practice in connection with—
(a) the process to be undertaken by a doctor before giving advice under this Act;(b) the form in which the agreement required under section 1(2)(d) is to be recorded;(c) the factors which the doctor should take into account in deciding to offer advice under this Act;(d) requirements for making and keeping records required by the Act;(e) such other matters relating to the operation of the Act as the Secretary of State thinks fit.(2) Before issuing a code under this section, the Secretary of State shall consult such persons as he thinks appropriate.”

[Lord Turnberg]

As we have heard, my Lords, there is a degree of uncertainty surrounding certain aspects of the Bill that we have been trying to clarify. It is on that account that I have tabled Amendment 31, which sets out the need for a code of practice in which the Secretary of State describes in somewhat more detail what the Bill is about and how it should be enacted. I hope that it will be helpful to have that in the Bill.

[Lord Hunt of Kings Heath (Lab)]

My Lords, this has been a fascinating debate, both in Committee and at Second Reading. We are all very grateful to the noble Lord, Lord Saatchi, for listening carefully and bringing the amendments that he has today, and for agreeing to a roundtable discussion between Committee and Report, which is a very constructive response to some of the issues that have been raised.

I say at once that I am absolutely with the noble Lord on the need to encourage innovation in our NHS, but the more that I have listened to the debate, the more convinced I am that it is not so much a question of the law but more one of actual practice within our NHS. I am afraid that we have to face up to the fact that there is a culture of regulatory processes and funding procedures that often get in the way of introducing innovation. For me, the Act that the Bill will become will be a signal to the NHS.

The noble Lord, Lord Blencathra, raised some interesting points about some of the problems that we have at the moment. He talked about off-label medicines. The Minister responded by saying that the Government are committed to innovation and gave a number of examples, which were welcome, but the point that I would put to him is that we now have a situation where NICE produces technology appraisals of new innovative procedures and drugs that clinical commissioning groups are essentially breaking the law by not implementing. He knows that they are under a requirement to fund the use of those procedures and medicines within three months of the technology appraisal being issued, yet we know from research by patient groups that the actual implementation is patchy. We could do an awful lot in relation to innovation if we insisted that people locally did what they were required to do.

My second point relates to the drug budget, an issue that the noble Lord raised. A few months ago the Government concluded an extremely interesting agreement with the branded drug companies, so that for five years the cost of branded drugs in England, apart from modest rises in inflation, will be fully met by the pharmaceutical industry. This is a very good agreement and one that I very much welcome. We still hear people in the NHS saying that they cannot afford the new drugs, yet the industry has promised to pay back any increase in the cost of those drugs over what they are paying now plus a modest increase in inflation. Here is a wonderful opportunity at last for the NHS to move quickly in widely adopting new medicines, but somewhere in the system someone is stopping it. I have read the NHS England five-year plan and it says nothing about the introduction of innovative new medicines.

I am sorry that this is a little outside the noble Lord’s Bill and I hope that he will forgive me, but this is about innovation. I am genuinely puzzled, and we will come back to this point, about why the Government did not rush to insist that the NHS took advantage of the agreement. In fact very few people in the NHS know about the agreement. My concern is that the rebates that the drug industry is going to give will be used for other purposes, which would be a very big mistake.

I hope that the Minister will agree to the amendment; I strongly advise him to do so, or at least to consider it. It is clear from the speeches that have been made that there is some confusion about the circumstances in which the noble Lord’s provisions are going to be made. Earlier in our debates, the noble Earl essentially said that doctors would have a choice when it came to whether, in relation to a given medical treatment, they would use this Bill’s provisions or rely on the traditional approach, the Bolam test. The noble and learned Lord, Lord Woolf, said that they are not alternatives and, in the circumstances raised by one noble Lord where there was not time to get the advice of the clinicians that is provided for in the noble Lord’s Bill, you would rely on the Bolam test. I am only a lay person, but I suspect that there is a risk of doctors not catching the nuance of that distinction. It is clear from the various letters that we have had from many of the medical bodies that there is some concern about this. I know that the noble Lord will speak and I strongly endorse his amendment on the regulation-making power, but I strongly advise the Government to agree to issuing guidance to the medical profession in this regard. There is a danger of some confusion and such guidance would be useful. If the noble Lord is not able to accept this amendment today, perhaps he will give it some further consideration.

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[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.

Amendment 31 withdrawn.

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[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 Turnberg]

My Amendment 36 has a similar effect to that of Amendment 35. Mine seems somewhat simpler, but I am quite happy to bow to Amendment 35 in the name of the noble Lord, Lord Saatchi.

[Earl Howe]

My Lords, this group of amendments addresses how the Bill would come into force. My noble friend Lord Saatchi’s Amendment 35 would ensure that the Bill came into force in accordance with regulations made by the Secretary of State rather than on Royal Assent as under the Bill as introduced. This would allow the Government and the medical profession time to prepare for the changes to the law made by the Bill—for example, to produce any guidance that might be helpful. This amendment also enables transitional and saving provision to be made if necessary. My noble friend’s Amendment 35 achieves the same objective as Amendment 36, which the Government therefore do not consider necessary.

The Government also support minor technical Amendments 37 and 38, which clarify that the section in question comes into force on the day on which the Act is passed. I urge noble Lords to accept Amendments 35, 37 and 38, which would ensure a smooth commencement of the Bill, and I hope that my noble friend Lord Kirkwood will allow me to write to him on the question that he posed a minute ago.