Medical Innovation Bill [HL]

Lord Mackay of Clashfern Excerpts

Friday 24th October 2014 Lords Chamber

[Baroness O’Neill of Bengarve (CB)]

My Lords, I am sorry to say that I am another non-medic. Indeed, I am a philosopher by trade and training but I would like to make three points. First, I was puzzled at Second Reading and again this morning by a certain divergence of vision among those of our medical colleagues with surgical experience and those who are not surgeons. It seems that, on the whole, those with surgical experience are quite happy with current legislation. They feel that they must innovate and that the non-standard anatomy, which I have learnt that we all enjoy, means that they cannot go in there with a rule book and just stick to it. I have not heard quite the same uniformity from our clinical colleagues who are non-surgeons. I hope that we could be a bit clearer about whether surgical procedures should be in here at all.

Secondly, the question of unintended consequences has already been raised by the noble Lord, Lord Giddens, and others. Some quite process-heavy amendments have been proposed which deserve rather more picking apart than they have already received. We do not wish to put in so much process that we successfully stifle the very innovation that it is the purpose of the Bill to achieve. I hope that we can come back to those amendments.

Finally, and with trepidation as I am standing right behind the noble Lord, Lord Pannick I say that, there is a bit of a difference between reasonableness and proportionality. They tend to come as twins. I am entirely in favour of reasonableness but proportionality suggests that you have at the back of your mind enough data to say what is proportionate and what is not. I fear that introducing requirements for proportionality may actually wreck the possibility of innovation in areas where part of the objective is to obtain the data, because they are not yet there. I would have thought that from a patient’s point of view it is reasonable to go for a treatment for which there are not yet complete data, and therefore no judgment of proportionality can be made, but which nevertheless is reasonable because the other options are dire.

[Lord Mackay of Clashfern (Con)]

My Lords, I had not intended to take much part this morning but, my name having been mentioned, I am stimulated to respond. The Bill is about innovation. Therefore, if a doctor is attacked for some failure in respect of innovation, the ordinary rules of defence that are presently available do not seem appropriate. Our colleagues who are excellent innovators have managed to avoid the necessity for litigation as a result of their innovations. However, if by any chance any of them were challenged, how would they go about their defence?

I make this basic point in answer to my colleague the noble Lord, Lord Pannick. He quoted what I said at Second Reading. It will not surprise your Lordships if I happen to hold still to what I said then. The point is that when there is an innovation, there is not much material on which to judge whether it is reasonable or proportionate. If there were in the existing practice, it would not be an innovation. The problem is therefore that the ordinary formulations of reasonable and proportionate with which lawyers are very familiar—I am enough of a lawyer to be familiar with them—are not really appropriate. I believe that the test which my noble friend Lord Saatchi’s Bill originally had, and which is preserved among all the innovations that have taken place since, is in Clause 1(4)(a):

“Nothing in this section … permits a doctor to administer treatment for the purposes of research or for any purpose other than the best interests of the patient”.

That is a simple test which the doctor must face at the time of innovation and, so far as I am concerned, elaboration with the familiar legal phrases that are very dear to lawyers is a mistake. I therefore adhere to what I said at Second Reading.

I should perhaps say that I am not entirely without experience in this area for when I was in practice in Scotland, which is now a long time ago, I did quite a lot of work in the Medical and Dental Defence Union of Scotland area. My very first appearance as a counsel in this House was in respect of a doctor’s negligence. My experience was over quite a long period; it may not have been very good but it was certainly extensive. I very much support the Bill and hope that we need not get around to voting on it today. There is plenty of scope for discussion about these matters and a good deal of substance in many of the amendments. We should discuss them further and, if necessary, have votes on Report.

[Baroness Wheeler (Lab)]

My Lords, on behalf of these Benches I welcome the commencement of the Committee stage of the Bill. At Second Reading we underlined the necessity for close scrutiny by this House, and we are pleased that the opportunity has been presented to us. In that debate there was both strong support for and strong reservations about the Bill, with many questions and issues to be addressed. We have moved on since then, but despite acknowledged progress made on safeguards for staff and patients contained in the amendments from the noble Lord, Lord Saatchi, there remain crucial reservations and concerns from key parts of the medical profession and from patients’ organisations, as we continue to discuss today.

We commend the work that the noble Lord has undertaken on the Bill, and feel that the changes on patient and staff safety signify improvements to it. It is reassuring that his proposed amendments have the backing of Sir Bruce Keogh, the NHS medical director, and the Government, and that the common-law Bolam test would remain unaffected by the Bill. The noble Lord, Lord Saatchi, knows that there is strong support for the principles and the intent of what he is trying to achieve. Labour has always strongly supported efforts to put innovation at the heart of the NHS and to bring innovative treatments to patients faster.

After Second Reading, the Minister for Health, Dr Daniel Poulter, responding to a Parliamentary Question in the Commons from Labour on the progress of the Bill, acknowledged the Government’s support for the principles of the Bill but emphasised that the amendments were necessary,

“to 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”.

These four key tests are what we should keep firmly in focus today, and I hope that the noble Lord, Lord Saatchi, and the Minister will address whether they consider that the tests have been met in the revised Bill in their responses to the issues that have been raised today.

I will limit myself to speaking on just some amendments in this group. Like other noble Lords, I look forward to hearing from the noble Lord, Lord Saatchi, and the Minister on the key issues raised by the many experts in this field who have spoken today. On patient safety, as I have stressed, we welcome the efforts made by the noble Lord, Lord Saatchi, in his amendments to address widespread concerns that the overall Bill would encourage reckless rather than responsible innovation and put patients at risk. We support the new emphasis on reasonable and responsible innovation contained in amendments in the next group, as well as the reference in Amendment 10 in this group from the noble Lord, Lord Pannick, and my noble friends Lord Turnberg and Lord Winston, to the doctor needing to act in a manner that is both reasonable and proportionate. The new provisions in Amendments 8 and 9 are important because we recognise that they are designed to provide that a doctor’s departure from the existing range of accepted medical treatment for a condition is not negligent where the decision to depart is taken responsibly.

We also welcome the deletion of the references in the previous Bill to the doctor’s responsible officer and appropriately qualified colleagues in respect of the staff to be consulted about the proposed treatment. These caused much confusion among both supporters and people with concerns about the Bill, and the new reference in Amendment 16 to the need to obtain the views of one or more appropriately qualified doctors in relation to the proposed treatment is clearer—although it is a critical area that will also need to be developed under guidelines, codes and/or regulations. It needs to be clear who is an appropriate qualified doctor. The new definition of a doctor being,

“appropriately qualified if he or she has appropriate expertise and experience in dealing with patients with the condition in question”,

is also an improvement to the Bill, although the question of the independence of the doctor whose opinion is being sought is a critical one.

My noble friend Lord Turnberg addressed this earlier with much force under Amendment 7. Key stakeholders have stressed that requiring the doctor to have regard to the opinions of other professionals responsible for patients’ care, together with the requirement for written consent to be sought from at least one other doctor who is independent of the responsible doctor, would be a welcome step in providing more clarity to the process.

There is an extremely worrying potential for conflict of interest here—for example, in the supporting doctor’s involvement in the development of the drug or treatment in question—and clear guidelines and rules of engagement will be essential. Sir Robert Francis QC points to the problem that arises from the choice of the appropriate qualified doctor to consult resting entirely with the doctor wanting to offer a new treatment. He or she is free to choose someone in his own partnership or laboratory, or someone with a commercial interest in promoting or selling the treatment. It is less than clear who is the final judge of whether the individual is appropriately qualified. There is also concern among a number of stakeholder groups that pharmaceutical companies could put undue pressure on doctors to try out potentially dangerous treatments, and this concern will also need to be addressed.

Concerns remain that the involvement and consent of patients to untested innovative treatments are not more explicitly in the Bill. Amendment 14 from the noble Baroness, Lady Masham, addresses this issue by specifying the need to obtain informed consent in light of the aims, processes and risks. I look forward to hearing further from the noble Lord, Lord Saatchi, on how he considers the Bill can address this, as this point has been raised by a number of noble Lords in the debate.

--- Later in debate ---

[Lord Pannick]

My Lords, I added my name to Amendment 6 because I agree with the noble Lord, Lord Winston, that it would improve the Bill to provide a definition of the core concept of innovation. As the object of the Bill is to provide greater clarity for medical practitioners, it is surely perverse not to include any definition of that core concept in the Bill. No doubt Amendment 6 needs improvement, perhaps for the reasons given by my noble friend Lord Kakkar, but I could not be persuaded that it is beyond the very considerable skills of the draftsman of the Bill, Daniel Greenberg, to provide a definition of innovation.

[Lord Mackay of Clashfern]

My Lords, the word “innovation” is a straightforward word in the English language. I am not sure that clarity is necessarily brought by multiplying it by how many in this amendment. Apart from anything else, one of the possibilities of innovation is for a doctor to say, “The standard treatment for this is a particular course of operation and chemotherapy. My belief is that that would not ultimately save you; it would subject you to a lot of pain and suffering and so on. The best thing, as far as I am concerned, is that you should not have any further treatment”. I am not sure whether that comes under the definition in Amendment 6, but if we want simplicity, we should go for perfectly clear English words. “Innovation” is one of them.