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.
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.
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.
Baroness Finlay of Llandaff
My Lords, I added my name to the amendment deleting “reckless” because I felt quite strongly that it detracted from the overall intention of the Bill. This is not about reckless innovation; it certainly must deter irresponsible innovation, but it is about encouraging responsible innovation. I also added my name to Amendment 3, on treatment for the “relevant conditions”, because many of these patients who are seriously ill will have multiple co-morbidities and may have many things happening to them. This Bill is aimed, as far as I have understood, at the principal condition—the condition for which patients are often desperate for some innovative treatment. It should not inadvertently allow lots of other strange things to be presented to patients to cope with many of the other co-morbidities that they may have.
My feeling about that comes particularly from my own specialty, which the House knows is palliative medicine, where we see time and again patients who are very emotionally vulnerable, psychologically fragile and potentially in despair, so they are unable to make sense of what is going on. In that state, they are quite vulnerable to people presenting all kinds of strange treatments with false claims. I will give a specific example from my own practice. We came across a group of patients on a ward who all had small crystals by their bed, and we discovered that a member of staff strongly believed that holding on to these crystals would shrink the patients’ cancers. The evidence for it was absolutely zilch; I think that the patients had paid to have the crystals given to them. That type of so-called experimentation is completely outside the scope of the Bill—and must be outside its scope. That is why it struck me that the wording about the relevant medical condition should feature in the Bill, because of the potential for exploitation otherwise.
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.
Baroness Butler-Sloss
It seems to me that if one is going to have Amendment 6, instead of saying that it “means”, it should say that it “includes”. That would then leave open everything else that might come in as medical innovation.
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.
Baroness Wheeler
My Lords, we have had a very authoritative and detailed contribution on the issues raised by Amendment 29 from the noble Lord, Lord Saatchi. Opinion among noble Lords and indeed the stakeholder medical and patients’ organisations is still divided on: first, whether a change to the law is required or whether the existing law and professional ethics arrangements will allow responsible innovation; and secondly, whether the potential two options/processes—or three as my noble friend now makes it clear will be available if the Bill becomes law—will improve and speed up the administering of innovative treatments or will cause considerable confusion among doctors about which system they should use, lead to more bureaucracy and deter them from embarking on the course?
As we said earlier, we welcome the attempts of the noble Lord, Lord Saatchi, to ensure that with this amendment the Bill does not affect the common-law Bolam test. On the overall Bill he has led a powerful campaign and is reported to have won the support of patients responding to the consultation and the publicity from Cancer Research UK, Marie Curie Cancer Care and other patient organisations. I was pleased that the noble Baroness, Lady Masham, raised a number of questions from Marie Curie about palliative care and the use of drugs arising from issues in the Bill, and I was grateful for the Minister’s very helpful response.
The General Medical Council has now given its support to the amended Bill and the Medical Defence Union has said that the amendments cover the main objections to the previous Bill. However, we have to acknowledge that some key stakeholders maintain that the Bill is not necessary because the existing law already ensures protection for doctors to innovate, and the current law and ethical guidance from the General Medical Council are clear. The Royal College of Surgeons still has strong reservations about the Bill, particularly about it applying to surgery, as we have heard. The Medical Protection Society still believes that it confuses rather than clarifies the law. The Association of Personal Injury Lawyers says that the amendments make a confusing Bill even vaguer. The BMA still strongly questions the necessity and desirability of clarifying or changing the law. Action Against Medical Accidents, one of the leading patient organisations, still says that the Bill is fraught with unintended and dangerous consequences and will create a more bureaucratic system. Sir Robert Francis QC, while considering that the amendments have produced an improvement in safeguards over what was originally proposed, has said that serious problems remain. In particular, he is concerned, as my noble friend Lord Turnberg pointed out earlier, that the Bolam amendment, while restoring a level of safeguard, also has the disadvantage of restating Bolam in different language, leading to a real risk of confusion. His question is: why not just stick to Bolam? I would be grateful for the noble Lord’s comments on that.
Will the noble Lord, Lord Saatchi, and the Minister tell the Committee whether they consider that the amended Bill now meets Dr Dan Poulter’s key test that I referred to earlier; namely, of not placing an undue bureaucratic burden on the NHS or not exposing doctors to a risk of additional liabilities?
I welcome the response of the noble Lord, Lord Saatchi, on the question of convening a round table, which I think will be a very helpful way of going forward. Obviously, it will never be possible to satisfy everybody’s concerns but, if the Bill is to be further supported, what steps will be taken by the Government to engage with stakeholder concerns?
Earl Howe
My Lords, the Government support these two amendments, which ensure that the Bolam test will remain unaffected by the Bill. In practice, this will mean that it is for the innovating doctor to decide whether to take the steps set out under the Bill or to rely on the existing Bolam test. In other words, there would be no requirement for doctors to follow the Bill when innovating.
The amendments clarify that, separate to the existing Bolam test which is applied by the courts, the Bill provides doctors with an alternative option for showing that they are acting or have acted responsibly. Furthermore, subsection (2)(b) of the proposed new clause provides that doctors are not negligent, and thus will not be judged adversely if their actions are later challenged, merely because they have not followed the Bill.
My noble friend Lord Kirkwood asked how the proposed new clause affects how a regulator approaches a complaint or fitness-to-practise procedures. This Bill addresses clinical negligence law and how the courts will assess these cases, not how the regulators will process fitness-to-practise cases.
The noble Baroness, Lady Wheeler, asked whether the Bill was necessary. The Department of Health’s consultation on the Bill revealed that some doctors find the threat of litigation to be a block to innovation, although this view was not universally held. The Bill is aimed at reassuring those doctors who feel unable to innovate due to concerns about litigation. There will also be many doctors who are not afraid to innovate and for whom litigation is not a material concern. Those doctors can continue to act as they have done previously and rely on the existing law of clinical negligence, or, as I have explained, they may choose to take advantage of the Bill instead.
I hope that noble Lords will accept these two amendments, which give flexibility and choice to doctors who want to innovate.
Lord Winston
There is something troubling me here. Let us say that somebody in an emergency or other situation does not have a chance to go through the required tests stipulated by the Bill, consulting other individuals who may be confident about or more experienced in that position. I still do not understand in the context of what the Minister has just said where that individual stands in innovating without those permissions. Is that still part of the Bill? How does that work? Is there a risk of that person being irresponsible in view of his not fulfilling what is required in the Bill when he is innovating?
Lord Woolf (CB)
My Lords, before the Minister replies, perhaps I could just make a comment. I have resisted getting involved in the various excellent speeches that have been made so far. While I am on my feet, I make it clear that I strongly support the noble and learned Lord, Lord Mackay. There is a danger in looking at these as alternatives. If the matter comes before the court—of course, one hopes that it will not—the court’s approach would be to say that there is nothing in the Bill, because of the amendment we are now considering, which prevents the Bolam test being relied upon as it is today, without the Bill.
On the other hand, if the situation is one that enables the Bill to be relied on, that is another matter that the person can rely on. In some situations, such as a state of emergency, it may not be possible to rely on the Bill, but that does not prejudice the doctor involved in any way, because the Bill leaves the Bolam test intact. It is supplementing the Bolam test, and the importance of the fact that it is supplementing it is apparent in the fact that it states that if the doctor can comply with the Bill, he knows that he is safe and does not have to wait until the Bolam test has been applied to find out whether he is in danger. I think that that is understood. Does the Minister agree with my approach, which is that these are not alternatives?
Earl Howe
I completely agree with the noble and learned Lord’s analysis of the situation. I hope that that has been helpful to the noble Lord, Lord Winston. Earlier, the noble Lord cited an example where a doctor was confronted by an emergency requiring innovative practice. Whether the doctor was acting responsibly or not, and the consequences, will depend on a number of factors. It will depend on the extent to which the doctor is confident in his or her judgment, based on experience in previous clinical practice and can, if necessary, show to a court that what he or she did was responsible and, at least in intent, in the best interests of the patient.
The noble Lord asked whether there was a risk of a doctor being found to be irresponsible in some emergency situations where innovative treatment is practised. Yes, there would be a risk if the process outlined in the Bill were not followed—but that situation obtains today.
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.
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.
Earl Howe
I can reassure my noble friend on that score that a doctor’s clinical judgment not to go ahead with something innovative would be something that the doctor would be able to cite in court, if necessary, as being the most reasonable course to take in the circumstances.
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 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.
Baroness Finlay of Llandaff
My Lords, I will be brief; this will probably turn out to be a probing amendment. We have an interesting situation in Wales because health and healthcare provision is completely devolved. The experience of patients under the Welsh NHS falls completely within the legislative competence of the Assembly. However, if I am right, this relates to the law of negligence, and the Ministry of Justice does not have any devolved functions. The concern expressed to me within Wales has been about the use of resources and the possibility of practitioners being answerable as regards legislation that covers England and Wales, when the provision of healthcare is something for which they are answerable to the National Assembly. I tabled this amendment with a view to seeking clarification over that.
Sadly, we have had experience of extremely strange medical practices sometimes being put forward in the past. The Assembly is particularly concerned that, with its move toward prudent healthcare, which is a whole policy direction for NHS Wales, the Bill should not inadvertently cut across the principles of prudent healthcare, the first of which is, of course, to do no harm. I tabled the amendment with that in mind.
Earl Howe
My Lords, this amendment seeks to ensure the Bill would not apply in Wales unless a legislative consent Motion had been passed. The operative provisions of the Bill relate entirely to modifying the law of tort, which is a reserved matter. The Bill can fairly and realistically be classified as relating to a non-devolved subject, and therefore not within the competence of the National Assembly for Wales. The Government cannot accept this amendment, and I urge noble Lords to resist it.
Baroness Finlay of Llandaff
I am grateful to the Minister for the clarification. I expected that answer, but it is important to have it on the record. I beg leave to withdraw the amendment.