Medical Innovation Bill [HL]

Baroness Wheeler Excerpts

Friday 12th December 2014 Lords Chamber

[Lord Mackay of Clashfern (Con)]

My Lords, as far as Amendment 1 is concerned, I think that the later amendment tabled by my noble friend Lord Saatchi has the same effect. Amendment 1 is very clear on the matter, and I think that it has been the law that emergency treatments are dealt with in a way that is suitable for the emergency. Accordingly, something of this sort in the Bill is an improvement.

I find Amendment 6 more difficult. As I said in Committee, “innovation” is an ordinary word in the English language, so to try to list all possible innovations seems to suggest a foreknowledge of what innovations may be introduced in the future. It requires unnecessary precision. As I said, “innovation” is a reasonably simple word and it is easy for a practitioner to carry it in their head. I venture to think that Amendment 6 would be somewhat more difficult to carry in your head. I have read it, of course, but I would find it quite difficult to repeat it now without reading it, so I will not attempt that test.

On the later amendments, it seems to me that emergency medicine is certainly not intended to be dealt with by the Bill. It is obviously intended to deal with a deliberate decision to administer a treatment into which has gone a degree of consultation and prior thought. I am therefore entirely of the view that innovation ought not to be covered by it. In so far as my noble friend Lord Saatchi’s amendment does not do that already, Amendment 1 is very acceptable so far as I am concerned.

[Baroness Wheeler (Lab)]

My Lords, as this is the first contribution from the Front Bench to the discussion of today’s amendments, perhaps I may again place on the record our support for the key principles and intent of the Bill. As we stress, Labour has always strongly supported efforts to bring innovative treatments to patients faster, and we underline the need for a major effort by government to address the barriers and bureaucracy that prevent progress being made and ensure that innovations are rapidly transcribed into practice. The noble Lord, Lord Kakkar, recently held a short debate in the Moses Room on the impact of innovation and research strategies on health improvement. It provided an excellent overview of the key issues, the progress being made, and the problems still to be addressed. We are keen to ensure that the Bill of the noble Lord, Lord Saatchi, is seen in the context of this wider, bigger picture. I know that the noble Lord accepts that his Bill will be one measure in the broader landscape of what needs to be done.

Along with my noble friend Lord Turnberg, I am also grateful to the noble Lord for the efforts he has made to address the issues and concerns raised by noble Lords across the House. In Committee we underlined our broad support for the changes—the “Sir Bruce Keogh amendments”, as they are now known—which have been made to ensure patient safety and safeguarding. We also found the round-table discussions for Peers that were organised by the noble Lord following our suggestions in Committee very valuable and useful. Again, we are broadly supportive of the new amendments he has brought forward today, which are the result of the discussions, on emergency care, on the recording of key information in the notes of the patient receiving the treatment, on excluding cosmetic surgery from the scope of the Bill, and on ensuring the preservation of the existing law about clinical trials and other forms of research.

My noble friend Lord Winston continues to express strong concerns about the Bill, and his amendments are designed to add further safeguards and limitations on the scope. He fully reflects the continuing concerns that have been voiced by a number of key stakeholders and doctors, including the BMA and the Medical Practitioners’ Union, which have issued further detailed briefs warning against the possible consequences of the Bill. At my noble friend’s instigation, I have read carefully Tuesday’s Adjournment debate in the House of Commons on patient safety and medical innovation, and in particular the contributions from Dr Sarah Wollaston MP, who expressed the strong criticisms we have heard from the noble Lord and the Bill’s critics, and the contribution from the Minister for Life Sciences, George Freeman. I thought that Dr Wollaston’s contribution well reflected the issues and concerns we have heard in this House—but also that the Minister presented a pretty balanced response as to where we are today in terms of the safeguards and workability of the Bill.

For our part, we have sought to work constructively with the noble Lord, Lord Saatchi, and other noble Lords to improve the Bill and to make it workable and safe for patients. The round-table discussions particularly focused on the outstanding areas of our concerns which we are discussing today. First, there is the issue of obtaining written consent from the appropriately qualified doctor in relation to the proposed treatment, which will come up in the next group. Secondly, we seek to ensure that the Bill does not impact on or affect the existing law on clinical trials and other forms of research. We are satisfied that Amendments 8 and 9, tabled by the noble Lord, Lord Saatchi, have the effect of reinforcing this in the Bill.

Thirdly, we desire to see a definition of “innovation” in the Bill and we have sympathy for the arguments that key areas need to be excluded from its scope, as again set out in the amendment retabled by my noble friend Lord Winston. The Department of Health has argued strongly that any definition of innovation would need to be the subject of a widespread, cross-government consultation that should include the devolved Governments. We have made a dignified retreat on our particular amendment and we accept the difficulties that would be involved at this stage in the progress of the Bill. However, my noble friend Lord Winston has made a strong case for defining innovation in respect of medical treatments and the use of drugs, and I look forward to the responses of the Minister and the noble Lord, Lord Saatchi. Like my noble friend Lord Turnberg, we think that a form of words based on that would provide a useful clarification.

On exclusions, the briefing on the amendment of the noble Lord, Lord Saatchi, states that he has considered attempting to define the extent and scope of the Bill, but has found it impossible to do so in a way that answers more questions than it raises. However, Amendment 10 does provide the important exclusion of cosmetic surgery that was sought by noble Lords across the House, and we welcome this. At the round table there was discussion about the possibility of the scope of the Bill referring to the regulated branches of medicine to distinguish the areas it covers. My noble friend Lord Winston makes this point in Amendment 12 in relation to excluding practitioners and health workers who are not registered with the General Medical Council or the General Dental Council.

Fourthly, I turn to the very important issue of emergency situations in the treatment of patients, which is a strong area of concern for noble Lords across the House, including my noble friends Lord Turnberg and Lord Winston, and the noble Lord, Lord Kakkar. Amendments 14 and 15 tabled by the noble Lord, Lord Saatchi, address this by providing a reference to emergencies as an example of a situation in which the existing common law Bolam test would apply and a doctor might not engage in the procedures of the Bill. But if there is further clarification in respect of the issues raised by my noble friend Lord Winston, we would be grateful for that. Amendment 1 raises other issues in respect of emergency care, and again I look forward to hearing from the noble Lord, Lord Saatchi, and the Minister in response.

As I have said, we have worked constructively with the noble Lord, Lord Saatchi, to make the Bill safe and workable, and we believe that the amendments that were made in Committee—and that we hope will be made today—will make it a better Bill. It has strong support, but we know that key stakeholders still have major concerns. There needs to be strong commitment from the noble Lord, Lord Saatchi, and the Government to address these issues and ensure that there is full consultation on the regulations, guidance and codes that will enforce its implementation. The registration of innovative treatments will be crucial, and this will be picked up by my noble friend Lord Hunt under our amendment later.

Finally, I remind the House of the four key tests of what the Bill will achieve, which were set out to the House of Commons by the Health Minister, Dr Daniel Poulter. He said that the Bill must,

“ensure it does not … put patients at risk … deter good and responsible innovation … place an undue bureaucratic burden on the National Health Service; or … expose doctors to a risk of additional liabilities”.—[Official Report, Commons, 21/7/14; col. 999W.]

Again, I would be pleased to hear from the noble Lord, Lord Saatchi, and the Minister as to whether they consider that the Bill in its amended form will achieve this.

[Lord Woolf (CB)]

My Lords, I hope that I will be forgiven for not speaking before the noble Baroness, Lady Wheeler, addressed the House. Unfortunately, she responded more quickly than me in getting to her feet; thus, we have this order. The progress of the Bill has been a remarkable example of this House at its very best. The Bill has been very carefully scrutinised by people who have immense knowledge of the areas covered in the Bill. That does not mean that anything said by a particular Member of the House with undoubted expertise in this area is necessarily right in this matter. As is the case with many Bills, sometimes more than one profession can be involved. I suggest that this is an example where two professions, which in the past have been guilty at times of excessive conservatism, are involved and have been loud in some of the things that they have had to say. The other profession of which I am thinking is my own; lawyers are not always celebrated for their innovative approach. They have improved from the situation of not so long ago. They are more ready to accept change—indeed, they have been forced to accept it—than they willingly would have done in the early days when I was practising.

I have been criticised in letters I have received in a way in which I perhaps am not accustomed for my involvement in the Bill sponsored by the noble Lord, Lord Saatchi. Those who have asked me to identify cases by name and reference so that they can analyse the cases and show how they do not help any particular argument might be relieved to hear me say that if they want to know where I come from, I wrote a little book called The Pursuit of Justice. I focused on the medical profession at that time because I found that its conservatism was interfering with the pursuit of justice. As far as victims were concerned, one of the most difficult areas of litigation in this country was clinical negligence cases.

Both sides in those cases were put into great difficulty because of that conservatism. On one side were the patients who often wanted the doctors to say sorry. On the other side were the doctors who felt that they could not say sorry because if they did they would be admitting liability for negligence. So the two never met—and that, I am afraid, can happen.

I listened very carefully to the graphic examples given by the noble Lord, Lord Winston, of where he thought that the Bill could be a problem. In his first example, he said that there was a difference of opinion between his anaesthetist, who did not think that an unusual and innovative form of intervention was appropriate, and the noble Lord, who thought that it was appropriate in the circumstances. Happily, he took the initiative and acted in an innovative way. But if one pauses and thinks about what would have been the position under the Bill as it is at present, would it have made the situation more difficult or would it have alleviated the situation? I suggest it is quite clear that it would have done neither.

--- Later in debate ---

[Lord Mackay of Clashfern]

My Lords, I think that we would all take the view that the last thing we want to do in any sort of legislation is endanger patient safety. However, I suggest that the honourable Honor Smith was not acting under my noble friend Lord Saatchi’s Bill; she was acting, I take it, under the law that existed at that time. Therefore, even in the best regulated circles, with no provision for innovation, something can happen. No doubt the lady thought that she was doing the right thing when she did it, but it turned out ultimately that that was not so.

With regard to the Bill, the ultimate test of the defence is whether it is in the best interests of the patient. In taking account of views from qualified people in the area, that is an important factor. It is necessary that a doctor who is going to use this treatment should be able to satisfy the court that, in the light of the available evidence at the time when the decision was taken, this decision was in the best interests of the patient. Therefore, endangering a patient strikes me as something that is already covered quite clearly by that requirement. The mention of danger must be an important aspect of the best interests of the patient, surely.

On Amendment 2 from the noble Lord, Lord Winston, he talks about the body of medical opinion. The cases that I know of talk about “a” body; lawyers certainly do not often agree one with another and I think that sometimes doctors do not agree either. Someone therefore has to make a choice from time to time.

It is perfectly clear that we all want to prevent patients from being put in danger. I have seen and listened to the programmes by the noble Lord, Lord Winston, about the injection of stem cells into people for money in different parts of the world without the promised success ensuing from that. I am sure that there is a danger in that area. Indeed, there are dangers in many areas. However, the problem for the doctor—and I am glad in a way that this responsibility is not the kind of responsibility that one has to carry generally in other professions—is that it is the life of the patient that may well be in question. Therefore, in taking an innovative step it is essential that the views which are available in relation to the matter and which are reasonably readily available to the doctor making the decision to use the treatment are taken fully into account. That is what this Bill is trying to do.

The Bill is set out as providing for responsible innovation. One of the fundamental elements of responsibility must be the patient’s safety. While I entirely agree with the view that that is an important issue, I believe that the Bill safeguards that so far as possible. The experience to which the noble Lord, Lord Walton, referred is an example of what can happen. On the other hand, you cannot make certain; nothing is infallible. I believe that from that point of view this is as good as we can achieve.

[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.