Medical Innovation Bill [HL]

Baroness Gardner of Parkes Excerpts

Friday 24th October 2014 Lords Chamber

[Lord Kakkar (CB)]

My Lords, I declare an interest as Professor of Surgery at University College in London and as a member of the General Medical Council. I welcome the interventions of my senior clinical colleagues, the noble Lords, Lord Turnberg and Lord Winston. They have helped us to understand that, although it is hard, this is a vitally important Bill to drive forward the practicalities of innovation in clinical practice. I hope that it will also drive forward a positive culture of putting innovation at the heart of all clinical thinking. However, there must be safeguards to ensure the protection of vulnerable patients. A number of amendments in this grouping try to address that issue. When this Bill was first made available for public comment some years ago, I was initially anxious about the fact that there were insufficient safeguards. The approach that I wished to adopt was one that I know has been considered but has been also dismissed. I have, however, become reassured by the process under the supervision of the Medical Director of the NHS, Sir Bruce Keogh. He has consulted widely among the profession and I believe that the amendments in the name of the noble Lord, Lord Saatchi, particularly Amendments 12 and 16, bring us to a place where appropriate safeguards have now been introduced. I hope that they will be judged sufficient to provide the protection that all responsible and reasonable clinical practitioners would want in a Bill of this nature.

There are two other amendments being considered in this group that I believe to be vital, Amendments 15 and 19, dealing with the registration and reporting of the results of innovation. There is no doubt that if this Bill is to achieve what it hopes to, the innovations that are provided as a result of having this provision available to us in clinical practice must be reported widely and be available for other clinical practitioners to consider. I know that, at this stage, the view is that other mechanisms are available that provide the opportunity for that reporting to be made, but I wonder whether the Minister might consider during the further passage of the Bill how very powerful a provision of the kind suggested in the two amendments would be in securing the greatest benefit for the largest number of patients.

Another question to have been raised on this group of amendments is that of being certain that the Bill does not apply to situations of emergency care and does not in any way interfere with the mechanisms available for ethical and appropriate clinical research. A strong research governance structure supported by strong legislation is available in our country, and this Bill should not be seen to impinge on that in any way. I am reassured by the noble Lord, Lord Saatchi, saying that the Bill does not relate to the conduct of research and should not be confused as doing so, nor does it in any way interfere with what are, as the noble Lord, Lord Winston, said, acute and deeply stressful decisions that have to be taken in the situation of providing emergency care. I hope that the Minister will be able to reassure us that other legislation, guidance and mechanisms exist to ensure that the Bill does not impinge on those two areas.

[Baroness Gardner of Parkes (Con)]

My Lords, I strongly support the Bill and hope that we will be able to reach agreement on important points today. It is essential that patients should feel safe, so all the safeguards being put forward are welcome, but patients also want to feel hope. When I think of Les Halpin, referred to by the noble Baroness, Lady Masham, I recall his rapid deterioration with motor neurone disease. When he first launched the idea of doing something, it was hard to detect that there was anything wrong with him. Within no time at all, it seemed—but probably it was about a year—he could not stand; he was in a wheelchair; and he had to have his head supported. It was unbelievable. What he wanted, not only for himself but for others, was hope.

The noble Baroness, Lady Masham, referred to Ebola, where they are trying things, irrespective of whether they know they are right, and in many cases they are probably working. It is hard to know. When I was chair of the hospital that has the Ebola clinic here in the UK, we had a case and the man recovered. In those days, there was no treatment other than just isolation and patients relying on their own strength to pull through. The noble Lord, Lord Winston, related a story about an ectopic pregnancy. It was interesting to see there how there was a conflict between two highly qualified medical practitioners. If he had not bravely taken that action, irrespective of any action that might be taken against him, that woman would not have survived. We do not want to make the procedure so enormously complicated that, by the time you have the result, it is too late for the person that you are aiming to help. On the other hand, I think that everyone agrees that the recording of the information, referred to by the noble Lord, Lord Turnberg, in speaking to his amendments, is essential. Unless it is recorded and open for use by everyone, it might help one individual, but no one will know what happens and how to help any others afterwards on a wide scale.

I think that everything that can be said on this Bill today will be said. I remember at Second Reading that the noble Lord, Lord Winston, was worried about people being sued for failure to innovate. I feel that that is only a remote prospect and should not be worried about too much. If all the safeguards are put in place, I believe that that will not happen. I strongly support the Bill and hope that the Minister will assure us that we will be able to proceed with it.

--- Later in debate ---

[Lord Saatchi]

I hope that this may help my noble friend Lord Kirkwood. What we have just heard from the former Lord Chief Justice and the Minister is completely clear to me. I will try to explain it in this way: if the doctor feels completely confident that the innovation he is about to attempt will be approved when the Bolam test is applied in a subsequent trial, he will go forward with his innovation. If a trial then takes place, he either will or will not be proved right when the test is applied—that is, if he departed from standard procedure and decided to do it on the basis of his confidence that the Bolam test would make him innocent of negligence.

However, as we all know—this is fundamental to the Bill—if the doctor is obliged to speculate in advance about what might or might not happen in a trial, that raises a very high degree of uncertainty. If it is possible for a doctor to move the Bolam test forward and comply with it in advance, which is what would happen as a result of the Bill becoming an Act of Parliament, that would enable the doctor to move forward with an innovation without the fear that a subsequent trial will find him guilty. I therefore say to my noble friend Lord Kirkwood that what we have here in simple, plain language, is that the Bill is giving the doctor an option if he wants to be certain before he goes ahead with an innovation. It is not a requirement that he does that. If he is confident of the result of a subsequent application of the Bolam test, he does not need the Bill at all. It is a fundamental benefit of the Bill that it gives that option, which I think is a very simple one.

[Baroness Gardner of Parkes]

Can I seek some clarification? I wonder whether anyone could make clear for the Committee whether, if the doctor says that he does not want to do the innovative treatment, there is a defence in court on the grounds that he thought that it would be unwise or unsatisfactory. I say this because everyone seems concerned about the effect of not doing something innovatory.

[Earl Howe]

I can reassure my noble friend on that score that a doctor’s clinical judgment not to go ahead with something innovative would be something that the doctor would be able to cite in court, if necessary, as being the most reasonable course to take in the circumstances.