Baroness Jolly
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Medical Innovation Bill [HL]
Baroness Jolly Excerpts(9 years, 11 months ago)
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Baroness Garden of Frognal
My Lords, I thank my noble and learned friend for his suggestion. I think that the noble Lord, Lord Winston, suggested moving Amendment 13 into the group which begins with Amendment 5 but leaving Amendments 11 and 12 in this group. If we proceed on that basis, then, as my noble and learned friend said, when Amendments 11 and 12 are called, he will have the opportunity to speak.
Baroness Jolly (LD)
My Lords, this group of amendments relates to the scope of the Bill. As noble Lords are aware, the Bill relates to a decision by a doctor to depart from the existing range of accepted medical treatments for a condition. I make it clear that the Bill applies not to research but only to decisions relating to individual patient treatment. My noble friend Lord Saatchi and the Government listened to concerns expressed in Committee that the conditions of the Bill might add to the requirements under which researchers operate. Amendment 8 in the name of my noble friend Lord Saatchi responds to these concerns, clarifying that the Bill does not apply to treatment carried out for the purpose of research. As such, Amendment 9 removes the existing provision on research, which is no longer necessary.
My noble friend Lord Saatchi and the Government listened to concerns expressed in Committee and at the round-table event hosted by my noble friend on 11 November that cosmetic treatment may be subject to less scrutiny than other treatments. Peers were therefore reluctant that the Bill should apply to this area of practice. Amendment 10 ensures that the Bill does not apply to treatment which is carried out solely for cosmetic purposes. Beyond this, the Government do not consider it necessary to exclude certain treatments or conditions from the Bill.
Amendment 1 from the noble Lord, Lord Winston, seeks to clarify that a doctor would not have to rely on the Bill where time or place did not allow the required consultation. The Government do not view this as a necessary amendment as the Bill already makes it clear that there is no requirement to innovate. If a doctor chooses to innovate, it is for that innovating doctor to decide whether to rely on the protection of the Bill and therefore to take the steps set out under the Bill. Clause 2, as amended in Committee, ensures that the common law test of clinical negligence is not affected by the Bill.
My noble and learned friend Lord Mackay of Clashfern suggested that Amendment 1 would be a helpful clarification to the Bill. Amendment 14 in the name of my noble friend Lord Saatchi will clarify that the Bill does not limit the circumstances in which the common law may be relied upon, and it expressly gives emergency treatment as an example. Amendment 1 is not necessary and could create confusion for doctors in determining exactly when the Bill applies. The amendment might also suggest that it is only in these limited circumstances that the Bill would not apply, whereas it is intended that doctors can choose whether to rely on the Bill, and it provides an option for them to demonstrate that they have acted responsibly. Amendment 14 proposed by my noble friend Lord Saatchi clarifies the point, confirming that the Bill does not limit the circumstances in which the common law may be relied upon, giving emergency treatment as one such example.
I want to pick up a point raised by my noble friend Lord Colwyn concerning placing GPs in a position where they are asked to innovate but are not able to do so. The Bill requires a doctor, in making a decision to innovate, to consider any opinions or requests expressed by, or in relation to, the patient in order to ensure that the decision to do so is taken responsibly. The clause in question does not confer any additional rights on patients to demand innovative treatment. However, it is crucial that, when making a decision to innovate, a doctor considers the view of that patient. As such, I hope that noble Lords will throw their support behind Amendment 14 put forward by my noble friend Lord Saatchi.
A further clarification is provided by my noble friend’s Amendment 15. In Committee, the noble and learned Lord, Lord Woolf, argued that the Bill does not offer an alternative defence to that under common law; rather, it is supplementary. The Government agree with that interpretation and also that the Bill’s current wording is not sufficiently clear on this point. Amendment 15 clarifies that a decision to innovate in accordance with the Bill does not prevent a doctor also relying on the existing common law defence under Bolam, and it would be a valuable addition to the Bill.
Amendments 11 and 12 seek to extend the application of the Bill to dentists as well as doctors. The Bill applies only to doctors, as it responds to concerns that doctors have raised concerning the fear of litigation. The Bill is aimed at reassuring doctors who feel unable to innovate due to concerns about litigation. The Department of Health’s consultation on the Medical Innovation Bill revealed that some doctors find the threat of litigation to be a block to innovation, although this view was not universally held. The consultation did not reveal the same demand for the Bill from dentists. If the Bill passes, we will consider its impact and will continue to listen to the concerns of all healthcare professionals.
Amendment 12 also seeks to limit the application of the Bill to practitioners or health workers who are registered by the GMC or to dentists who are registered by the General Dental Council. The Government consider this amendment to be unnecessary as the Bill’s scope is already limited to doctors, who are defined under the Bill as registered medical practitioners. All registered medical practitioners are registered with the GMC.
Amendment 6 in the name of the noble Lord, Lord Winston, seeks to define the meaning of innovation under the Bill. Over the course of the debates on this Bill, a number of suggestions have been brought forward on how to approach this issue. Drafting a positive definition of innovation is a difficult task. This is revealed by the addition in this amendment of paragraph (e) relating to the application of a monitoring device or biosensor, which has been absent from prior definitions. It is crucial that the definition of innovation under the Bill is future-proof and clear for both doctors and patients.
The Bill defines innovation as a situation where a doctor decides to depart 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. Here I pick up three points, one being from the noble Lord, Lord Colwyn. I was asked about upholding the advice given by NICE and whether the Bill would allow doctors to go against NICE guidelines. The Bill does not impact on the existing legal obligation for NHS commissioners to provide funding for drugs that have been recommended in NICE technology appraisals. However, it will remain for doctors to decide on the most clinically appropriate treatment for their patients, whether or not they are innovating under the Bill.
Lord Kirkwood of Kirkhope (LD)
My noble friend has helpfully explained the Government’s position regarding the new amendments tabled by the noble Lord, Lord Saatchi. I support his amendments. What I am unclear about is whether any special provision has been made for the risks of mental health which were raised in Committee. Does the department believe that the Saatchi clutch of amendments gives sufficient protection for patients receiving innovative treatment who suffer from mental illness?
Baroness Jolly
My Lords, I am waiting for confirmation from the Box on the mental health issue. If the noble Lord will be patient, I believe something is coming. The answer is no, but under a special provision doctors can choose. I hope that is clear to the noble Lord.
Lord Saatchi (Con)
My Lords, in speaking to Amendment 1, in the name of the noble Lord, Lord Winston, I will speak also to his Amendments 6, 11, 12 and—I am advised—13, and my own Amendments 8, 9, 14, and 15.
Before I start, I will take a moment to echo what the noble and learned Lord, Lord Woolf, said. He described the discussions about the Bill at all its stages as being your Lordships’ House at its best. I so agree. I said in the debate in the Moses Room last week in the name of the noble Lord, Lord Kakkar, that the experience of watching your Lordships’ House debate and discuss the Bill is, as far as I am concerned, a tremendous privilege to be able to hear the greatest legal and medical minds in the country at work.
I thank the noble Lord, Lord Turnberg, for saying that there had been a constructive process of listening to Peers’ views as expressed in Committee. I am also grateful for the view expressed by the noble Baroness, Lady Wheeler, that the Bill team and the Department of Health have behaved constructively since Committee. I have really been only a witness to the toing and froing between Peers whose views were expressed in Committee and the Department of Health through our own Bill team. It will not come as any surprise to your Lordships that this has been a really admirable process of the officials and the legislation department in the Department of Health listening carefully and trying to respond, and I certainly have appreciated that hugely. I know your Lordships will agree. I also thank my noble friend the Minister for her clarification of the Government’s position on many of these amendments.
Amendment 1, in the name of the noble Lord, Lord Winston, would have the effect of disapplying the Bill in emergency cases. I believe and I am strongly advised that it is already clear from the terms of the Bill that doctors will be able to rely on the existing application of the Bolam test in cases where, for whatever reason, they are not able to follow the recording and other procedures set out in the Bill. Amendment 14 and the other amendments in my name have been kindly prepared by the Department of Health. Amendment 14 makes it expressly clear that emergency cases are an example of situations in which it would not be practicable for a doctor to follow the procedures set out in the Bill. Perhaps the noble Lord, Lord Winston, might agree with me that my Amendment 14 deals with the case that concerns him—emergencies—and that it does so in a clear fashion, even clearer perhaps than his Amendment 1. It also has the advantage of being less prescriptive because of the nature of the situations in which the provisions of the Bill might not apply, leaving a doctor to rely on the existing Bolam test. For that reason, I hope that the noble Lord will support my Amendment 14 and therefore not feel the need to press his Amendment 1.
Amendment 6, in the name of the noble Lord, Lord Winston, would define “innovation”. As the noble Lord said, this point was discussed in Committee. My noble and learned friend Lord Mackay of Clashfern expressed his view then, which he has repeated today, that the concept of innovation has a natural meaning in the context of the Bill and that we might do more harm than good by attempting to give it a statutory definition. That is a view with which I, as a non-lawyer, respectfully agree. In particular, I would express the fear to the noble Lord, Lord Winston, that a number of the building blocks of the definition attempted in his Amendment 6 raise more questions than they answer; for example, in paragraph (b), the question of what amounts to an “appropriate clinical trial” could give rise to considerable confusion. It is also worth saying that on 16 January 2013 he himself pointed out—and he should be in good position to know—that,
“one of the issues with true innovation is that serendipity is extremely important”.—[Official Report, 16/1/13; col. 761.]
Obviously that is true and it is certainly very hard to define.
I hope I have shown that we are open to making changes to improve the Bill wherever noble Lords or others have shown that it requires refinement. As I said, there has been a great deal of positive response to the comments and thoughts that we have received. I am not convinced that an addition of the kind proposed by the noble Lord could be welcomed in that way. I am sorry to say that but I hope that he will not feel the need to press Amendment 6.
I turn to Amendments 8 and 9. It has always been the intention of the Bill to make no change in the law relating to research. Clause 1(5) was included for that purpose. Concerns were expressed in Committee and in discussions since then that the point is not understood with the necessary clarity by all readers of the Bill and that it needs to be made even clearer. My Amendments 8 and 9 have been kindly prepared by the Department of Health for the purpose of putting the point beyond any possible doubt.
Amendment 10 relates to cosmetic surgery. In Committee, suggestions were made that the Bill should be confined expressly to the principal kinds of cases at which it is aimed; namely, relatively rare terminal cancers and other terminal conditions. In the discussions since Committee to which I referred earlier, attempts to define the intended scope of the Bill have proved unsuccessful in finding a formula that answers more questions than it raises. Much of the concern, however, has centred on the potential use of the Bill in relation to cosmetic surgery. It was suggested by Peers that it could at least be made clear that it is not the purpose of the Bill to apply to that. My Amendment 10 accordingly excludes cosmetic surgery from the Bill. However, cosmetic surgery can of course be crucial to life or quality of life, as in the case of severe burns, for example. Doctors wishing to innovate in such cases will be able to rely on the existing common-law Bolam test.
Amendment 11 in the name of the noble Lord, Lord Winston, would include dentists within the Bill’s definition of “doctor”, therefore bringing them within the scope of the Bill. The Bill is aimed at an issue on which I am aware there is a need for action: to protect health professionals from the fear of litigation or disciplinary action in relation to innovation, but neither I nor, I think, the Minister has received evidence from dentists or dentists’ patients to suggest that a similar problem arises in their context. Therefore, I do not see the need to include dental treatment in the Bill. If the noble Lord has evidence that there is a problem in the dental sector of a similar nature to the problem that I and many others have identified in the medical sector, I would be very happy to discuss that with him. In the mean time, I hope that, hearing that, he will not press his Amendment 11.
While we are speaking about a niche—perhaps that is not the appropriate term—part of the medical world, it might be interesting to refer to what the Royal College of Ophthalmologists says in a press statement on the use of a particular drug in the treatment of eyes, a drug that one would more normally use in the treatment of cancer. It states:
“Without unequivocal GMC and NICE support, ophthalmologists are understandably concerned that they may be assuming unacceptable personal liability by using an unlicensed drug when a licensed alternative exists … Consequently, patients may not be getting treatment when they need it and not getting the best results”.
Amendment 12 in the name of the noble Lord, Lord Winston, relates to the exclusion of non-registered doctors. It would prevent a non-registered doctor from relying on the provisions of the Bill. At the round-table discussion that the noble Baroness, Lady Wheeler, suggested and that we arranged after Committee—it was requested by the noble Baroness and a number of other noble Lords—the difficulty of designing helpful exclusions was carefully discussed. The exclusions suggested by the noble Lord in his Amendment 12 were discussed and difficulties of a technical nature were suggested. There might be difficulties, for example, in relation to our European Union obligations in respect of practitioners from overseas. Despite that, this is an issue with which I have sympathy for the reasons set out by the noble Lord, and I would welcome an opportunity to discuss with him whether some way could be found of achieving his objective and meeting any technical difficulties of the kind that I described.
I have been authorised by my noble friend Lord Ribeiro, who is unfortunately unable to be here today, to make a statement on his behalf about this question of registration of doctors. He says:
“I am keen to make a distinction between regulated health practice which requires surgeons to hold a licence and unregulated practices where botox and other injectables and implants are performed by unlicensed and unregulated practitioners, many of whom may not be doctors … It is important that this Bill is not seen as a charter for those in unregulated medical practice, like the cosmetic surgery industry, whose sole purpose is the enhancement of a normal appearance through the use of injectables and other materials. Surgeons who are licensed and regulated and undertake cosmetic surgery can continue to rely on the Bolam test … I make the latter point because”,
as the Bill has identified,
“reconstructive surgery is used following burns, congenital defects and as part of the restoration of limbs and the body after ablative surgery, but still perceived by some as cosmetic surgery. That is why the British Association of Plastic Surgery (BAPS) changed its name to”,
the British Association of Plastic, Reconstructive and Aesthetic Surgeons, the BAPRAS. I hope that those comments from the noble Lord, Lord Ribeiro, will help the noble Lord, Lord Winston. In the mean time, I hope that he will decide not to press his Amendment 12.
I turn to Amendment 13, which I have been advised to speak on. The amendment, in the name of the noble Lord, Lord Winston, would have the effect of disapplying the Bill—
Baroness Wheeler
This is a very important group dealing with patient safety. I shall briefly intervene in support of my noble friend Lord Turnberg’s Amendment 3, which refers to seeking the support of the appropriately qualified doctor rather than his or her views, and to support Amendment 7 from the noble Lord, Lord Saatchi, on recording the treatment and consultation on the patient’s notes.
Our firm preference was for the Bill to specify the need for the written consent of the appropriately qualified doctor, but we have heard senior medical doctors’ concerns about giving formal written consent to another doctor’s proposed course of treatment for the patient without knowing their full history and other circumstances.
As my noble friend Lord Turnberg said, there is something of an irony in a Bill designed to address doctors’ fears of litigation running the risk of opening up the fear of litigation from the supporting doctor. We consider “support” to be preferable to the doctor’s “views” and I hope that the noble Lord, Lord Saatchi, can respond positively to this as a way of reassuring patients and their carers and relatives and enhancing patient safety.
My noble friend Lord Winston’s Amendment 2 seeks additional safeguards for patient safety by reference to excluding treatment where a,
“body of responsible medical opinion”,
considers that the treatment is likely seriously or unreasonably to compromise patient safety. He has raised some very important issues here, particularly in response to cancer treatment, and I look forward to hearing from the noble Lord, Lord Saatchi, or the Minister.
The clarification the noble Lord, Lord Saatchi, provides in Amendment 7 concerning the issues to be recorded in the patient’s notes provides welcome safeguards. It does not include the full range of issues, covered under Clause 1(3), which noble Lords have been concerned to see recorded in the patient’s notes, but it goes some way to providing the greater transparency and accountability that we all wish to see, particularly in recording the doctor’s decision to depart from the existing range of accepted medical treatments for the patient’s condition and the explanation of the proposed treatment.
Finally, we have considerable sympathy with Amendment 13 for the reasons ably put forward by my noble friends Lord Winston and Lord Turnberg, and I look forward to hearing from the noble Lord, Lord Saatchi, or the Minister on this issue.
Baroness Jolly
My Lords, I shall start my remarks by addressing Amendment 13. This amendment seeks to exclude from the Bill treatments that involve the insertion or injection of cells, tissues or other biologically derived material into the body of a patient. The Government do not consider this amendment to be necessary. The use of human tissue and cells is a heavily regulated area of practice. It is regulated by the Human Tissue Authority, the Human Fertilisation and Embryology Authority and the Medicines and Healthcare products Regulatory Agency. As part of making a responsible decision to innovate, the Bill requires that a doctor must consider not only the risks and benefits of the proposed treatment but how they would compare with other treatments and with not carrying out any treatment. This requirement provides a robust objective test of whether an innovative treatment should be used.
Clause 1(5) makes clear that the requirements in the law relating to best interests continue to apply in that nothing in the Bill permits a doctor to carry out treatment for any purpose other than the best interests of the patient. Further to this, the amended Bill requires doctors to act responsibly, including taking full account, in a responsible way, of the views of other appropriately qualified doctors. This 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 review. Clause 1(3)(c) requires that doctors obtain any consents required by law when taking a decision to depart from the existing range of accepted medical treatments for a condition.
The Bill provides safeguards for patients while ensuring that doctors can use their clinical judgment and be flexible to individual patients’ circumstances.
I now move to Amendments 2, 3 and 7. It is essential that any legislation is safe for patients. That is why the Government are pleased that the package of amendments devised with advice from Sir Bruce Keogh, the medical director of NHS England, to make the Bill safe for patients was accepted in Committee in this House on 24 October. The noble Lord, Lord Winston, has tabled an amendment that seeks to ensure that a doctor cannot rely on the Bill where a body of responsible medical opinion considers the treatment to compromise patient safety. He referred to the recent debate in the other place where my honourable friend George Freeman, the Minister, asserted that the Government are dedicated to patient safety and evidence-based medicine. I should like to reassure noble Lords that the Bill does not remove any of the current safeguards in place to protect patient safety. If the innovative treatment was considered likely to compromise patient safety, it is extremely unlikely that it would be considered a responsible decision under the Bill when later judged in court. A doctor who innovated in such circumstances is highly likely to be aware that his or her decision would not be considered responsible.
The noble Lord, Lord Winston, raised a couple of points. One was about quack doctors and the other was about stem cell injection. The Bill does not remove any safeguards for patients. There is no escape for negligent doctors under the Bill. They still need to demonstrate that they have acted responsibly. Nothing in the Bill allows doctors to bypass any processes and requirements set by their trust in relation to undertaking innovative treatments in the NHS. This would include ensuring that the commissioners would fund any treatment if it is to be provided within the NHS. Individual innovation is incredibly important, but it is not a substitute for medical research, which usually tests the efficacy of treatments in a systematic way. Successful individual innovations are likely to lead to systematic research projects as evidence builds around a particular speciality. As part of their professional development, doctors should contribute to research as well as look for innovative ways to treat their patients. Noble Lords will be pleased to note that we will emphasise the importance of research in accompanying guidance to doctors on the use of the Bill.
On stem cell injection damaging patient safety, there is no reason for the Bill to damage patient safety. The decision to innovate under the Bill has to be responsible and the doctor would be negligent if he did not innovate responsibly. The Bill gives no extra leeway in respect of stem cell injection, as he suggested. Any decision to inject stem cells would have to comply with all existing safeguards and be responsible. The alarming examples given by the noble Lord are extremely unlikely to have been responsible. Quack treatments would simply not pass the hurdles of responsible decisions required by the Bill.
The amended Bill requires doctors to act responsibly, taking full account of the views of other appropriately qualified doctors. This 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 review. Clause 1(3)(c) requires that doctors obtain any consents required by law when taking a decision to depart from the existing range of accepted medical treatments for a condition.
Lord Avebury (LD)
My Lords, I wonder whether a doctor who is asked by a patient about alternative therapies is obliged to tell the patient that these treatments have not been approved and that he does not recommend that the patient use them. Many patients, when they are desperate, will go for those alternative therapies even if that means paying for them themselves. I would therefore like an assurance that the doctor would dissuade the patient from taking that course of action.
Baroness Jolly
I am sorry; I do not have a note on that here, but I will write to the noble Lord and place a copy in the Library.
Amendment 7, in the name of the noble Lord, Lord Saatchi, adds to the steps that a doctor must take for the purposes of evidencing a responsible decision to innovate. The amendment requires doctors to record in the patient’s notes details relating to the views they have obtained from one or more appropriately qualified doctors, their decision to innovate and the proposed treatment.
As noble Lords may be aware, the NHS constitution is clear that patients have the right to access their own health records. The Government have gone further, setting the clear expectation in the first two mandates to the NHS that by 2015, everybody who wishes to get online access to their own health records, which are held by their GP, will be able to do so. Furthermore, we would fully expect doctors to have an honest and open conversation with their patients about treatment decisions. The GMC’s guidance Consent: Patients and Doctors Making Decisions Together sets out a model for a constructive dialogue between doctors and patients about treatment options.
I can now answer my noble friend’s question about complementary and alternative medicine and whether doctors who practise those forms of medicine will be able to experiment with untested procedures under the Bill. Under both the existing common law and the Bill the doctor needs to show that they have acted responsibly when deciding to offer a patient innovative treatment in order not to be negligent. Doctors are able to offer patients innovative, complementary and alternative medicine under the current law. If the innovative treatment were a medical treatment provided by a doctor, they could seek to take the steps under the Bill to evidence that they had acted responsibly in so doing. The amendments made to the Bill in Committee apply an objective test of responsibility to the doctor’s decision to innovate and would prevent a doctor who acts irresponsibly from relying on the Bill. The guidance is clear that doctors should set out in an honest and open way what is known and not known about the benefits and risks of innovative treatment and why it is being proposed.
I therefore hope that noble Lords will join me in accepting Amendment 7 from this group, which is a welcome amendment that requires doctors to record the details of innovative treatment in patients’ records.
Lord Avebury
My Lords, my question was whether the doctor has a positive obligation to say to the patient who asks about an alternative therapy that it is not approved by medical opinion, and that they should positively advise the patient not to go in for these alternative or complementary therapies, knowing that they are unable to help patients.
Baroness Jolly
Perhaps I can help my noble friend. The Bill is about the doctor making a decision about treatments for patients that are innovative and untested. If a doctor has a conversation with a patient about something that is complementary or alternative, that is a slightly different situation, and not the sort of situation that the Bill addresses.
Lord Davies of Stamford (Lab)
Before the noble Baroness sits down, the word “responsible” has played a key part in the debates on the Bill, and she has used that term herself about a dozen times this morning. Do the Government consider that Clause 1(3) adequately defines that word; or, otherwise, that the word “responsible” in a medical context is adequately defined in the existing jurisprudence—which it may be; I am not a lawyer and am not familiar with that jurisprudence? Or do the Government think that the Bill might gain from a specific definition of “responsible” at some point in the Bill?
Baroness Jolly
My Lords, to put a definition of an abstract term such as “responsible” in the Bill would be quite a considerable challenge. I think that the Government have covered the issue through the first clause.
Lord Saatchi
My Lords, in speaking to Amendment 2 in the name of the noble Lord, Lord Winston, I will also speak to Amendment 3 in the name of the noble Lord, Lord Turnberg, to my Amendment 7, and to Amendment 13 in the name of the noble Lord, Lord Winston. I am therefore starting with Amendment 2.
To say that it was touching to hear what the noble Lord, Lord Winston, said, would be a considerable understatement. We share the experience of witnessing a terrible event. However, I know that he will share with me the view that, although we have that experience in common, it has not led to an agreement between the two of us about the merit of the Bill, for which I am very sorry. I hope that, in the course of the wide-ranging discussions that he has happily said that we will have before Third Reading, we can arrive at a happy synthesis—perhaps above all for the reason of the two stories that we have to tell. We have a great deal in common.
All these notes are about patient safety. I would like to reassure the House that at a certain crucial moment—probably the crucial moment in the legislative journey of this Bill—the Secretary of State for Health called a meeting in his office of all the great representative bodies and all the great figures in the medical world. I know that he will not mind me saying this. There was a discussion and views were sought by the Secretary of State, after which he said, as an accurate summary of the meeting, that he thought that there was a consensus to move forward with the Bill. However, he said that he wanted reassurance that the safeguards in the Bill in relation to patient safety were adequate. He said that he had decided therefore to formally ask the NHS medical director, Sir Bruce Keogh, to formally advise the Secretary of State on that one question. As we know, this resulted in Sir Bruce widely consulting and producing what are now famously known as the Keogh amendments, as the noble Baroness, Lady Wheeler, said, which were passed in my name in Committee. Therefore, I would like to reassure the House that the Government have taken the greatest possible interest, even at the cost of significant delay to the passage of the Bill, to be sure that the clauses reflected that concern and those concerns expressed in this group about patient safety.
I come to Amendment 2, in the name of the noble Lord, Lord Winston, which would disapply the Bill to cases where the body of responsible medical opinion considers that the innovation proposed is likely to compromise patient safety. As I have just said, everyone—not least of all the Government—want to ensure that patient safety is paramount. I am confident that the Bill already makes that clear in a number of ways, which my noble friend the Minister recited, including in the safeguards added in response to the concerns expressed by the Keogh amendments. Perhaps the noble Lord would allow me to say that the formula suggested in the amendment does not bring an additional clarity to the Bill, for the reasons given by my noble friend the Minister. When there is a requirement to take account of the views of appropriately qualified and experienced colleagues, it means that when there is a general consensus against the proposed innovation, on safety grounds or otherwise, the doctor would not be safe in relying on the Bill to innovate. Nor would I want a doctor to be able to rely on the Bill in those circumstances. My fear is that in attempting to add clarity on the point, the noble Lord might be introducing a number of concepts that could add a high degree of uncertainty, particularly in relation to what amounts to sufficient consensus for the purpose of his new provision, and what amounts to a serious or trivial compromise of patient safety. For those reasons, I hope that the noble Lord will accept that the point at which his amendment is very sensibly aimed is already covered by the terms of the Bill and that perhaps he might agree that his amendment could cause some uncertainty on that point. Therefore, he may agree with me that he will not want to press Amendment 2.
Amendment 3 deals with the question of “views” versus “support”. I would like to reflect in these comments, perhaps in a more long-winded way, on what my noble and learned friend Lord Mackay said, and on what the noble Baroness, Lady O’Neill, said on this subject, on the use of the words “views” versus the words “support”. We have heard that the amendment proposed by the noble Lord, Lord Turnberg, would replace the requirement to obtain the “views” of “appropriately qualified” colleagues with the requirement to obtain their “support”, which sounds perfectly straightforward. However, in Committee there were suggestions that the requirement to consult colleagues should become a requirement to obtain their formal approval. We all thought very hard about whether we could meet those suggestions; several senior doctors were consulted on the point and it was discussed at a round-table event suggested by the noble Baroness, Lady Wheeler, last month, which we arranged following Committee. At that meeting and elsewhere, a number of doctors expressed concern about giving formal approval to another doctor’s proposed course of treatment without knowing the full history and other circumstances, while they were clear that they would be relaxed about expressing a view, orally or in writing, of the soundness of a doctor’s proposal as described to them. Senior lawyers also consulted were concerned, as my noble friend the Minister said, about a possible new form of legal liability for doctors giving approval. We certainly would not want that, for just the reasons that she gave. That is why my Amendment 7 would require doctors to record views expressed by colleagues in the patients’ notes, in the hope of introducing the necessary formality, transparency and accountability, while avoiding the problems that doctors and lawyers have expressed in relation to introducing a requirement for formal approval of colleagues.
Baroness Jolly
My Lords, Amendment 4 of the noble Baroness, Lady Masham, supported by the noble Baronesses, Lady Gale and Lady Wheeler, seeks to require doctors to explain the steps they have taken under the Bill, including the views they have obtained from other doctors, as part of the process of obtaining consent from the patient.
The noble Baroness inquired whether the Bill should specify the need to obtain informed consent in the light of the aims, processes and risks involved in untested treatments. The Bill requires that doctors obtain any consents required by law when taking a decision to depart from the existing range of accepted medical treatments for a condition. The Bill does not change the law of consent, whereby a patient must still provide an informed and voluntary consent to any treatment offered to them. This would include the need to ensure that patients have sufficient understanding of the treatments being provided. Nor does the Bill change the law of consent in relation to children and people who lack capacity, whereby any treatment provided to them by a doctor must be in their best interests.
The Government are reluctant to set out in the Bill the factors that are needed to meet the existing law of consent. To do so might imply that the requirements listed in the Bill are all that are needed to obtain consent under the existing law. We think that a more sensible approach is to make clear that all the existing requirements under the law of consent will continue to apply to doctors who act under this Bill.
In addition, the Government do not consider this amendment to be necessary as Amendment 7 of the noble Lord, Lord Saatchi, will ensure that the steps the doctor has taken in following the Bill are recorded in an accountable and transparent way. I hope that noble Lords will take into account the Government’s view that it is best to rely on the existing law of consent, and not accept Amendment 4.
Lord Saatchi
My Lords, this amendment in the names of the noble Baronesses, Lady Masham, Lady Gale and Lady Wheeler, would add a proposition to the provision that requires innovating doctors to ensure that they obtain all the necessary consents required by law. The amendment would add a qualification to ensure that the patient’s consent must, in particular, have been based on a process in the course of which the innovating doctor explains to the patient what steps the doctor has taken to comply with the reasonableness, transparency and accountability requirements of Clause 1. The doctor must explain the steps taken generally, and in particular must tell the patient what views have been sought from the doctor’s colleagues and what those views were.
I do not claim for this Bill the status of our great poetry, usually best defined as the only possible words in the only possible order. I can quite see why the noble Baronesses think that this specific requirement would add clarity and certainty without changing the essence of what the Bill already requires. Although I think that what the noble Baroness proposes would already be a necessary part of any reasonable reliance on Clause 1(1), I can absolutely appreciate—we have spoken about this, obviously—why she thinks that express provision on this point would help readers to understand how the Bill is intended to work. However, my noble friend the Minister has explained why the Government do not consider this amendment necessary, and will therefore not invite the House to support it.
I hope that the noble Baroness will consider the relevance to this amendment of my Amendment 7, which seeks to do exactly what she is describing. Therefore, although I have considerable sympathy with the intentions behind this amendment, I know that she will appreciate that I am bound to follow the lead of my noble friend the Minister on this matter. However, I hope she will feel reassured by the fact that her amendment has enabled both the Minister and myself to place on record that our understanding of how Clause 1 would be applied in practice is absolutely in accordance with the noble Baroness’s own understanding, as set out in her amendment, of how it ought to work.
Lord Winston
My Lords, as far as patient safety is concerned, it is clear that there is a need to keep a record so that other patients do not receive a misguided innovative treatment following an unsuccessful one. That is very important.
Baroness Jolly
My Lords, Amendment 5, moved by the noble Lord, Lord Hunt, and supported by the noble Baronesses, Lady Wheeler and Lady Masham, and the noble Lord, Lord Turnberg, seeks to require the registration of innovations that are carried out under the Bill as part of the steps that a doctor should follow when taking a responsible decision to innovate. The Government have listened carefully to the concerns expressed by noble Lords and several key stakeholders, including the Royal College of Physicians, with regard to the collection of data resulting from innovation. We agree that it is vital that doctors are able to share learning about innovation that results from the Bill. However, we do not think that a requirement to record the results of innovative treatments should be included on the face of the Bill. Requiring doctors to record the results of innovative treatments in order to demonstrate that they have not been negligent, as Amendment 5 would require, would impose requirements that go beyond the current Bolam test of negligence. We are reluctant to impose requirements additional to those in the existing law as this may risk deterring doctors from innovating.
A stand-alone clause that would require doctors to register the results of innovative treatment would widen the scope of the Bill to cover all innovation. This Private Member’s Bill is not the right vehicle to make provision that would relate to all innovation. Broadening its scope in this way risks the Bill becoming the receptacle for a host of measures on innovation that are unrelated to the subject of clinical negligence. What is more, such an amendment may lead to confusion as doctors associate the Bill with clinical negligence and may therefore wrongly assume that the recording of innovation is tied in with the test of clinical negligence under the Bill. This additional burden may dissuade a doctor from innovating. It would be unclear to those doctors who choose not to innovate under the Bill whether they would be required to register the details of their innovation on the registry or whether the provision applies only to those innovating under the Bill. If the provision applied only to those innovating under the Bill, this would create an anomalous position for those acting under the Bill. More importantly, the act of putting something into legislation does not guarantee that doctors will adhere to it. We need to focus on incentivising doctors to use the registry and make such a registry work for their needs. It would be unwise to put something into legislation that does not work for doctors and that they would therefore not be able to adhere to.
I am sorry, but I have lost my place.
Lord Forsyth of Drumlean (Con)
I am trying to be helpful to my noble friend while she finds her place. I have been listening to her words, but surely from the point of view of the intention of the Bill, which is to encourage innovation so that people can benefit from it, it is rather extraordinary to argue that there should not be some record of success or failure.
Baroness Jolly
My noble friend is right. The Government are suggesting that there should be a registry because it would make no sense not to record innovations. It could otherwise not be replicated. The Government’s preferred approach is to set up a registry but not to put that on the face of the Bill.
In Committee, my noble friend Lord Howe committed on behalf of the Government to explore constructively what might be useful in terms of record-keeping and reporting in relation to medical innovation. The Government have begun engaging with partners in the health system to discuss how to achieve this goal and will continue to do so as the Bill progresses. This mechanism should be developed with a sufficiently light touch so that clinicians see it as being facilitative of good practice rather than burdensomely bureaucratic. It is also important to consider the efficiency of the data-collection mechanism and how it can be developed in the most cost-effective way.
In response to my noble friend Lord Cormack, once we have a Bill, the Government will work closely with the professional bodies and all other organisations to help the health system and patients understand and prepare for the changes to the law made by the Bill, including producing any guidance that might be helpful.
Lord O'Donnell (CB)
As a strong supporter of this Bill, I back the idea that we must learn from the innovation. To be honest, I worry not about the successes but about the failures not being recorded. Therefore, I am grateful that a register will be set up. However, will it be compulsory? If it is not, that would not meet the requirements.
Baroness Jolly
At the moment, it is not the intention that it should be compulsory, but it should be such that doctors would not dream of not recording on the register. In that way innovation is spread but failures are disseminated, if that makes sense.
Lord Cormack
The noble Lord has made a very important point. My noble friend clearly is very sympathetic. At Third Reading there will be an opportunity for a suitable amendment. It would reassure people throughout the House and, more important, throughout the country if there were such an amendment.
Baroness Jolly
As I have said, the Government are very sympathetic to the idea of a registry. On Monday, I have a meeting with the noble Earl, Lord Howe, when I shall pass the views of the House to him. Third Reading will be in the new year.
Baroness Masham of Ilton
My Lords, surely patients have a right to know what works and what does not work and surely the noble Lord, Lord Saatchi, wants his Bill to be positive rather than negative.
Baroness Jolly
I have said that the Government are very supportive of a registry. Of course, patients would want to know what does and does not work, as would all doctors. I have said that I will take this issue back and discuss it with the noble Earl, Lord Howe.
Baroness O'Neill of Bengarve
My Lords, in so doing, it would be valuable if the Minister could go back to the central theme of today’s debate, which is patient safety, not the protection of doctors from clinical negligence claims. If we are focused on patient safety, any failure to collect valuable information, whether positive or negative, would compromise patient safety—not perhaps the safety of that individual patient at that moment but patient safety generally. The collection of data here is of fundamental importance. I cannot see the reasons why it should not be compulsory.
Lord Mackay of Clashfern
Do I understand that the position that the Government are taking is a technical one on the scope of this Private Member’s Bill and that it would be improper in a Private Member’s Bill to set up a register that would go beyond the scope of this Bill as to the innovations that it covers? The idea is to set up a register that would be wider in its scope than the mere innovations that take place under this Bill, assuming that it becomes an Act. Is that the difficulty?
Baroness Jolly
I thank my noble and learned friend for helping me out. I thought that I said at the onset that this was felt by the Government to be outside the scope of the Private Member’s Bill. But they are very sympathetic to the idea and have already started to have conversations. The noble Baroness, Lady O’Neill, talked about safety and, as the noble Lord, Lord Davies, said, responsibility is another thing. The Government see it as the responsibility of doctors to enter on to the registry. In the mean time, I ask the noble Lord to consider withdrawing his amendment.
Baroness Warnock (CB)
Surely it is important that this register should be compulsory. The obvious point is that if you innovate and it fails and then you do not register, that would destroy the whole point of having a register.