Medical Innovation Bill [HL]

Lord Saatchi Excerpts

Friday 24th October 2014 Lords Chamber

Finally in this group, Amendment 33 brings up the point that regulations made under the Act should be exercisable by statutory instruments. We may return to this later in our debates on some other relevant amendments. I hope that the noble Lord, Lord Saatchi, will recognise that in raising my amendments my intention is to support him as strongly as I can in making innovation in medicine an important part of practice that is safe and practicable, and I hope that he will find these amendments helpful. I beg to move.

[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.

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[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.

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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.

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[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.

[Lord Pannick]

I beg leave to withdraw the amendment.

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[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.

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Moved by

[Lord Saatchi]

8: Clause 1, page 1, line 4, leave out “to decide”

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Moved by

[Lord Saatchi]

11: Clause 1, page 1, line 5, leave out from “decision” to end of line 7 and insert “to do so is taken responsibly.”

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Moved by

[Lord Saatchi]

16: Clause 1, page 1, line 18, at end insert—
“( ) 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.”

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Moved by

[Lord Saatchi]

20: Clause 1, page 1, line 20, leave out “administer” and insert “carry out”

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Moved by

[Lord Saatchi]

23: Clause 1, page 1, line 22, leave out paragraph (b)

[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.

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[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.

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Moved by

[Lord Saatchi]

25: Clause 1, page 1, line 25, leave out “section” and insert “Act”

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Moved by

[Lord Saatchi]

29: After Clause 1, insert the following new Clause—
“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.”

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[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.

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Moved by

[Lord Saatchi]

35: Clause 2, page 2, line 9, at end insert—
“(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.”

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[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?

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Moved by

[Lord Saatchi]

37: Clause 2, page 2, line 10, leave out “Act” and insert “section”