Medical Innovation Bill [HL]

Lord Kirkwood of Kirkhope Excerpts

Friday 24th October 2014 Lords Chamber

[Lord O’Donnell (CB)]

My Lords, like the noble Lord, Lord Giddens, I am not a medic. I rise to speak because I think that this issue creates all sorts of problems and challenges in which my experience in public policy and economics can help. To me, what determines innovation is essentially economic. Economists have studied for a long time precisely how you get innovation in systems. I will not lecture noble Lords on the medical side. It is important that we operate with our heads, not our hearts, in this, so you will not get any emotional stories for me; I will be boringly analytical. I think that this is an issue about evidence-based policy.

We know that markets will not solve the issues that the noble Lord, Lord Saatchi, raises in the Bill. The incentive structures are such that the pharma companies will go for those areas where they can sell large amounts of drugs. Rare cases will be problems. One issue I have as someone who cares enormously about evidence-based policy—I gave a lecture at the Royal Statistical Society earlier this week on this, when I went on at length, which I will not repeat—is how you generate the right amount of data to handle this problem. I received a briefing from the BMA which said that there was no evidence to support such things. Of course there was no evidence; that is the whole point. We have to find ways to generate evidence.

I strongly support the Bill. In that, I am with Sir Michael Rawlins, president of the Royal Society of Medicine and former head of NICE, who knows about the analysis, so I take the medic side as given. I am very pleased that the noble Lord, Lord Saatchi, has accepted the safeguards. If you believe, as I do, that the really important part of this is the generating of evidence, we need something in the Bill to state that we will record evidence and register it correctly. That makes a lot of sense, but as a good former civil servant, I look forward to hearing the Minister’s reply and hope that he will reassure me that there is an equivalent way to do that. If that is true and is as solid, I will accept that; but in its absence, we need to make sure that we learn, that we get every innovation documented so that we build up the evidence base. That is what this is about—innovating safely and successfully.

[Lord Kirkwood of Kirkhope (LD)]

My Lords, I am pleased to follow the noble Lord, Lord O’Donnell, whose experience in the area of public policy is well known. I have come late to consideration of the Bill. Regrettably, I could not make the debate at Second Reading. My interest in the subject was generated by a four-year period on the General Medical Council, which ended at the end of 2012. I was deeply sceptical about the Bill when I first read that the noble Lord, Lord Saatchi, was proposing it. However, I pay tribute to those colleagues who have thought about the amendments and presented them. I am not a medical doctor; I trained as a pharmacist; but this has been a very good, easily understood, high-quality debate about the issues. I pay tribute to the noble Lord, Lord Saatchi, because he has obviously been listening very carefully. He may even win my support, subject to one or two points that I will raise in a moment.

As a former business manager, I am prepared to accept the Saatchi-Keogh package, as it were, but I would not want to take a final decision on some of the other important amendments. I might support some of them on Report, but I do not think that this morning is a good time to do anything other than take a step forward with the amendments of the noble Lord, Lord Saatchi, with the help of Bruce Keogh. That would be in the best interests of the consideration of the Bill. I warmly accept the noble Lord’s change of heart, if that is not too strong a way to put it. The Bill is much better dealt with in this House than along the Corridor, because I have been along the Corridor and I know what happens there. This is a much better context in which to get the Bill as good as it can be before we send it there. I recognise that that was a big decision for him.

I would be much happier to vote for this package in its entirety if the noble Lord paid attention to five amendments. I have listened to the careful way in which they were presented this morning. The Turnberg Amendments 15 and 19 are very important for me, and the noble Lord, Lord O’Donnell, made an important case. If we do not capture the benefits, the Bill is not worth having. At the top of my Christmas list of five amendments are Amendments 15 and 19. Given the tone of the debate in the House, the noble Lord, Lord Saatchi, may reflect that if he does not concede something in that direction he will find it difficult to persuade me that the Bill is worth having at all. Second on my list is Amendment 10, tabled by the noble Lord, Lord Pannick, because I think reasonableness and proportionality are necessary in the Bill. The noble Lord made a concise and compelling case. The noble Lord, Lord Saatchi, dismissed it rather lightly, so I ask him to think again about Amendment 10. Amendment 17 concerns restrictions. I am very nervous about the Bill being applied to mental health, and I corroborate and underscore comments made by other colleagues. Lastly, Amendment 22, in the name of the noble Lord, Lord Winston, would make it absolutely clear that there is no duty to innovate. That may seem irrelevant but it is important for the protection of doctors—and I say that as a former member of the General Medical Council.

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[Lord Turnberg]

My Lords, I am very pleased to see Amendment 29 in the name of the noble Lord, Lord Saatchi. I support it because it allows doctors to continue to rely on the current common-law arrangements based on the Bolam principle and on a body of reasonable medical opinion. It means, however, that there are now three options open to an innovating doctor. He or she can engage in a research clinical trial in which ethics committee approval has been given, the patient has given consent and all the regulatory approvals have been given, he or she can rely on the Bolam principle and take all the precautions that that entails or he or she can go through the processes outlined in this Bill in the belief that this will somehow avoid the fear of litigation under the common law. I just wonder whether that might lead to a little confusion and lead doctors simply to use and rely on the current common-law principle. However, I am happy for this amendment to be approved. I see that it would be a useful amendment to the Bill because it gives the doctors the opportunity to use what they always have done.

[Lord Kirkwood of Kirkhope]

Perhaps I may expand on the point I made on the first group of amendments. I am grateful for the comment from the Minister, which I understood as far as it went. I agree with what the noble Lord, Lord Turnberg, has just said. This changes how the regulator approaches a complaint, as far as I can see. It would not change the way that the regulator decides whether there is a case to answer but it seems that this clause—which I think I welcome—gives the doctor an option of which defence he uses against the allegations in front of him.

As I know from previous experience, the General Medical Council has very clear, long-established systems for determining how complaints are lodged and how fitness-to-practise procedures are put in hand. It is very carefully controlled. Do I understand that the proposed new clause in Amendment 29 would merely—if I can put it that way—give the doctor against whom the complaint was alleged the choice of one of these channels of defence in relation to any complaint made against him by the regulator? I am still not clear as to whether I understand this properly. I think I am in favour of this amendment but I am not too sure. If anybody can help me understand it better, I will be really pleased.

[Baroness Wheeler]

My Lords, we have had a very authoritative and detailed contribution on the issues raised by Amendment 29 from the noble Lord, Lord Saatchi. Opinion among noble Lords and indeed the stakeholder medical and patients’ organisations is still divided on: first, whether a change to the law is required or whether the existing law and professional ethics arrangements will allow responsible innovation; and secondly, whether the potential two options/processes—or three as my noble friend now makes it clear will be available if the Bill becomes law—will improve and speed up the administering of innovative treatments or will cause considerable confusion among doctors about which system they should use, lead to more bureaucracy and deter them from embarking on the course?

As we said earlier, we welcome the attempts of the noble Lord, Lord Saatchi, to ensure that with this amendment the Bill does not affect the common-law Bolam test. On the overall Bill he has led a powerful campaign and is reported to have won the support of patients responding to the consultation and the publicity from Cancer Research UK, Marie Curie Cancer Care and other patient organisations. I was pleased that the noble Baroness, Lady Masham, raised a number of questions from Marie Curie about palliative care and the use of drugs arising from issues in the Bill, and I was grateful for the Minister’s very helpful response.

The General Medical Council has now given its support to the amended Bill and the Medical Defence Union has said that the amendments cover the main objections to the previous Bill. However, we have to acknowledge that some key stakeholders maintain that the Bill is not necessary because the existing law already ensures protection for doctors to innovate, and the current law and ethical guidance from the General Medical Council are clear. The Royal College of Surgeons still has strong reservations about the Bill, particularly about it applying to surgery, as we have heard. The Medical Protection Society still believes that it confuses rather than clarifies the law. The Association of Personal Injury Lawyers says that the amendments make a confusing Bill even vaguer. The BMA still strongly questions the necessity and desirability of clarifying or changing the law. Action Against Medical Accidents, one of the leading patient organisations, still says that the Bill is fraught with unintended and dangerous consequences and will create a more bureaucratic system. Sir Robert Francis QC, while considering that the amendments have produced an improvement in safeguards over what was originally proposed, has said that serious problems remain. In particular, he is concerned, as my noble friend Lord Turnberg pointed out earlier, that the Bolam amendment, while restoring a level of safeguard, also has the disadvantage of restating Bolam in different language, leading to a real risk of confusion. His question is: why not just stick to Bolam? I would be grateful for the noble Lord’s comments on that.

Will the noble Lord, Lord Saatchi, and the Minister tell the Committee whether they consider that the amended Bill now meets Dr Dan Poulter’s key test that I referred to earlier; namely, of not placing an undue bureaucratic burden on the NHS or not exposing doctors to a risk of additional liabilities?

I welcome the response of the noble Lord, Lord Saatchi, on the question of convening a round table, which I think will be a very helpful way of going forward. Obviously, it will never be possible to satisfy everybody’s concerns but, if the Bill is to be further supported, what steps will be taken by the Government to engage with stakeholder concerns?

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[Lord Saatchi]

My Lords, I also speak to Amendments 37 and 38 in my name and Amendment 36 in the name of the noble Lord, Lord Turnberg. Amendments 35, 37 and 38 amend Clause 2 of the Bill on commencement and provide for the Bill to be brought into force by the Secretary of State. I am content with this change proposed by my noble friend, on the basis that it will allow time for the Department of Health and professional bodies to produce any guidance that may be helpful. Amendment 36 would stop the Bill coming into force on Royal Assent and would allow the Government to control commencement. The amendment has essentially the same effect as my amendment and I hope that the noble Lord, Lord Turnberg, will be content not to press it. I beg to move.

[Lord Kirkwood of Kirkhope]

Not to prolong events, I support Amendment 35, which I think is sensible. It is necessary to make sure that steps are taken so that practitioners are fully advised and informed in England and Wales about the provisions in the Bill. I assume that the answer to my question is yes, but can I have an assurance that the regulators have the full Section 60 power that they would need to implement this? If there is any doubt about the regulators not having complete legal cover, will the department make sure that any Section 60 provisions for those powers are put in place before these statutory instruments are brought forward, to avoid any confusion?

[Lord Turnberg]

My Amendment 36 has a similar effect to that of Amendment 35. Mine seems somewhat simpler, but I am quite happy to bow to Amendment 35 in the name of the noble Lord, Lord Saatchi.