Medical Innovation Bill [HL]

Lord Woolf Excerpts

Friday 12th December 2014 Lords Chamber

[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.