Medical Innovation Bill [HL]

Debate between Baroness Jolly and Lord Saatchi

Friday 12th December 2014 Lords Chamber

[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—

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[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.

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[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.