Medical Innovation Bill [HL]

Lord Mackay of Clashfern Excerpts

Friday 12th December 2014 Lords Chamber

[Lord Giddens (Lab)]

I support Amendments 1 and 6 —the latter because I speak as someone who has spent much of his life studying innovation. I recognise that the backdrop to this Bill is the massive acceleration of innovation in some core areas of medicine, so the point is to try to bridge the gap between that and the time taken to test medicines. However, I will comment especially on Amendment 1, even though I cannot hope to match the rhetorical power of my noble friend Lord Winston.

I have stressed several times in the debate the crucial importance of looking for possible unintended or even perverse consequences that the Bill could have. Amendment 1 is very worth while for this reason. It would certainly be a perverse outcome of the Bill if it had the effect of inhibiting or slowing down emergency measures where they need to be taken, and I hope therefore that the noble Lord, Lord Saatchi, might be prepared to accept both the amendments, which seem to me to add strength to the Bill.

[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.

--- Later in debate ---

[Lord Winston]

It is very kind of the Front Bench to offer that possibility. If I were to degroup an amendment, I would degroup the stem cell one and put it with Amendment 5, as it would fit better with patient safety. One of my difficulties is that the groupings are slightly odd in terms of the relevance of the different aspects of my amendments.

[Lord Mackay of Clashfern]

My understanding of the groupings system is that those who have views on the amendments should take the opportunity to speak when the relevant group is first dealt with, but it does not preclude a noble Lord who has tabled an amendment speaking when the amendment is called in the ordinary course of events. As your Lordships know, following a debate an amendment is often called as being not moved, but the person who tabled the amendment has the option to move it at that point. Therefore, in that sense there are two opportunities to speak. However, in order to try to make the procedure as economical as possible, the general idea of the groupings system is to enable a group of amendments to be considered as a whole on the basis that, rightly or wrongly, such consideration is facilitated in that way.

[Baroness Gardner of Parkes]

Perhaps I may raise a point. When you table an amendment, you are usually sent a draft list of the groupings. You are asked whether you are happy with that or whether you want your amendment to be grouped separately. I wonder why that has not happened in this case.

--- Later in debate ---

[Baroness O'Neill of Bengarve (CB)]

My Lords, I am not certain whether the noble Lord, Lord Turnberg, makes things easier by suggesting in Amendment 3 that one should move from views to support, for two reasons. One is that we have a later amendment that refers to views and the recording of them. The other is that I would have thought it would be important to record the spectrum of views concerned, not just the support—the negative views as well as the positive. So I have my doubts about Amendment 3.

[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.

--- Later in debate ---

[Baroness Masham of Ilton]

My Lords, I support the amendment, as do many organisations. They say that it is essential that provision is made for collecting and sharing data to ensure that information, both on beneficial and harmful effects of treatment, is captured for the benefit and subsequent use of patients. We should be much better at collecting data than we are at present. This is important for research, but also for safeguarding patients. I hope that the amendment will be accepted.

[Lord Mackay of Clashfern]

My Lords, one of the purposes of the amendment, as I understand it, is as the noble Baroness has said: to record the results of an innovative treatment for the benefit of succeeding generations. If innovative treatment has been successful in a particular case, the details of that case are required to make sure of the extent to which the results might be expected to follow in another case. I regard it as important that that should happen. I understand—no doubt this will be explained later—that there are possibilities of voluntary registration systems being set up. The Government may be able to help us on that, but I regard it as essential, if the Bill is to achieve its purpose, that the innovations, particularly if they are successful, are not kept secret. If they are unsuccessful it is also wise to warn people off later attempts.

[Lord Turnberg]

My Lords, the purpose of the amendment is to ensure that all attempts at innovation are recorded, not simply those that are successful. A voluntary register might allow those who have some mishap with their innovation not to register. The whole point of having a more than voluntary register is important. I am very supportive of the amendment.

--- Later in debate ---

[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.