Medical Innovation Bill [HL]

Baroness O'Neill of Bengarve Excerpts

Friday 24th October 2014 Lords Chamber

The noble Lord, Lord Saatchi, has got me half way along the road. I hope that we will take no action today other than to accept the package of Keogh-Saatchi provisions. I am happy to do that but I warn the noble Lord, if that is the right verb, that some of us might be waiting for him on Report if he does not give a little more thought to some of the important issues raised by colleagues today.

[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.

--- Later in debate ---

[Baroness Wheeler]

My Lords, I am pleased that Amendment 28 has been grouped with the amendment of my noble friend Lord Winston and the noble Lord, Lord Pannick, as we have considerable sympathy with their attempts to define innovation. I understand that it is a probing amendment. We consider that the Bill would benefit from a clearer understanding of what we mean by innovation and indeed of some of the exclusions that would apply that were referenced in the earlier comments on Amendment 19. I am grateful to my noble friend Lord Giddens. His perspective on that was helpful. I look forward to the response on that.

Amendment 28 is also a probing amendment and underlines that medical innovation and the adoption of new treatments require the whole NHS to make both research and innovation its business. The Secretary of State, the NHS regulators and all the key NHS bodies have a clear responsibility and the authority that they need; they need to use it. We have had many debates in this House that recognise the scale and pace of innovation taking place across the NHS and the frustrating barriers that prevent innovative treatments being adopted.

The noble Lord, Lord Saatchi, considers that doctors’ fear of medical litigation or disciplinary proceedings is a key factor that,

“reinforces a culture of fear and defensive medicine in the NHS”.

Whether medical litigation evidence supports that or not, we need to keep emphasising that it is just one of a number of barriers that have to be overcome. I know that the noble Lord recognises this as the context for his Bill. As Sir Robert Francis QC puts it:

“The real obstacles to responsible innovation are not to be found in the Bolam test but in the minefield of regulation and bureaucratic inertia which doctors presumably have to surmount, not to mention the reluctance to fund innovative treatment”.

The contribution of the noble Lord, Lord Blencathra, underlines that we are far too slow in this country to introduce new treatments.

The Health Research Authority is still yet to make a real impact on speeding up the painfully slow, complex and bureaucratic process of getting innovation in care and treatment adopted in the NHS. There is huge frustration across the NHS that existing pathways and mechanisms are not being fully used, such as the single portal of entry and single application procedures for clinical trials. NHS trusts’ slow implementation of the UK life sciences strategy, Innovation, Health and Wealth, and the very low level of awareness and action that they have taken on that strategy are continuing causes for concern.

Most important too is the role of Health Education England in ensuring that innovation and research are incorporated into the education and training of key medical and other health staff. The excellent vision report from the Association of Medical Research Charities, which my noble friend Lord Turnberg takes every opportunity to raise and endorse, showed the huge challenges we face in building support among doctors and patients for participating in research that leads to innovation.

As research and innovation go hand in hand, we were keen to include reference to research and innovation in our amendment, but I hear what has been said by the noble Lord, Lord Saatchi, and the Minister on this. I note that the Medical Defence Union, while now supporting the changes the noble Lord, Lord Saatchi, has made to the Bill, also makes the point about the importance of research being included because that is where most innovation takes place. It is concerned on this issue because it feels that many doctors are likely to be uncertain about whether the Bill would apply to innovation they are contemplating. This may hold up a proposed treatment or procedure while they check the position. In most cases, the Bill will not apply. Even where innovation arises out of a research project, doctors are likely to want to ensure that information gathered in treating the patient contributes to overall research in that area, and the MDU is concerned that the wording of the Bill may prevent that. I would be grateful for comments on this point from either the noble Lord, Lord Saatchi, or the Minister.

Our amendment seeks to place the Bill in the context of the duty of the Secretary of State and the key bodies of the NHS to support responsible innovation in medical treatment and makes it clear that that is the overall purpose of the Bill. I would welcome a response from the noble Lord, Lord Saatchi, on whether, despite his desire to keep the Bill short, he considers that a clear definition of the core concept of innovation, as the noble Lord, Lord Pannick, said, could be incorporated into the Bill as a reference to its overarching purpose. I would also appreciate the Minister’s comments on this.

[Baroness O'Neill of Bengarve]

My Lords, before the noble Earl responds, I would like to know whether other noble Lords think that this attempted definition of “innovation” does not perhaps inadvertently classify some entirely traditional medical treatments as innovations simply because they have been around for much longer than randomised clinical trials with equivalent clinical validation, and there will be no published evidence of their risks and benefits in peer-reviewed medical journals. I have in mind such homely treatments as prescribing the drinking of a lot of water, taking the waters or dietary advice. Many such things seem to be medical treatments but have probably not been documented in the journals.