Medical Innovation Bill [HL]

Lord Colwyn Excerpts

Friday 12th December 2014 Lords Chamber

Those are the amendments that I wish to speak to at the moment. I will leave them for the consideration of the House. I beg to move.

[Lord Colwyn (Con)]

My Lords, I support the amendment in the name of the noble Lord, Lord Winston, providing for a number of medical treatments to be excluded from the Bill. As I said at Second Reading, I have always encouraged innovation and I listened to the examples given by the noble Lord in Committee and to the response from my noble friend the Minister, who said:

“To set out specific medical treatments or circumstances that would or would not be covered by the Bill would make it complicated for doctors to follow and less flexible to individual patients’ circumstances”.—[Official Report, 24/10/14; col. 886.]

I take the opposite view. Not to state clearly on the face of the Bill where its provisions do not extend would make innovative practice much more complicated for doctors and, I believe, be a risk to patient safety. Surely, if this House is to give its approval to a Bill where both the title and stated aim are to encourage more of something that is already being done on the front line of the medical profession, and furthermore where it actually stands to impact on current good medical practice, then there needs to be maximum clarity about where and when the Bill actually applies. On Report, it falls to the House to ensure that the Bill has clarity. We must do so to limit the potential risks created by my noble friend Lord Saatchi’s Bill and prevent it from extending into areas of treatment where it could pose a risk to the patient.

In Committee, the noble Lord, Lord Winston, gave an example of responsible innovation, describing the treatment of a young woman with a life-threatening ectopic pregnancy. From this example, as with many others, we see how potentially dangerous it would be for the Bill to extend into emergency care, operative surgery, delivery during childbirth and so forth. These areas of treatment must be excluded from the Bill. Where a doctor is in theatre and required to act quickly in a rapidly deteriorating situation, which we all know is a frequent scenario, a Bill such as this, which has the best of intentions, should not have the remotest potential to confuse that doctor about their responsibility, namely, to use their professional judgment and act quickly in the best interests of the patient.

My Lords, a recurring theme in this debate, for good reason, is that current law allows doctors acting responsibly to innovate. The Medical Protection Society, a body that remains opposed to this Bill, notes that, currently, a slight departure from NICE guidance—guidance that has been held to be the established method by which doctors gauge what procedures and drugs are standard—is done on the basis of a doctor’s professional judgment. Common law, rooted in the Bolam and the Bolitho tests for standards of care, underpins that judgment. Yet I believe that the MPS is right to say that the Bill, without greater clarity, would add,

“unnecessary bureaucracy to current good medical practice”,

creating more hurdles to treatment than there are at present. This is why the amendment is so important.

To cover briefly the exclusion of primary care from the Bill, as I understand it, the definition of an “appropriately qualified doctor” is flexible enough for it to be possible to cover treatment in a wide range of settings, including primary care. If the Bill was to reach treatment given in a primary care setting, then there are a number of concerns. In Clause 1 there is a requirement for the doctor to,

“obtain the views of one or more appropriately qualified doctors in relation to the proposed treatment”.

There has been much debate about how effective this is as a safeguard, but in a primary care setting the risk of this requirement being open to interpretation is particularly high. Take an independent general practitioner seeking to perform an innovative treatment through the process outlined in the Bill: who would be the appropriately qualified doctor? Would it be another independent practitioner known to be in agreement? Why would a general practitioner, seeking to innovate irresponsibly, seek the advice of someone they know to be in disagreement?

While such a practitioner is absolutely in the minority of GPs, primary care must explicitly feature in the Bill as one of those areas of medical treatment excluded. Not to do so, I believe, has the potential to risk patient safety. Clinical governance in primary care looks very different to what can be seen in hospitals; GP practices tend to work in greater isolation. The concern among many in the medical community, such as the MPS, which has about 20,000 GP members, cannot be ignored. Its concern is that the Bill is placing primary care doctors in a position where treatment is demanded of them that their decision-making structures do not support them to carry out. It all comes back down to the danger of doctors being falsely reassured, and of patients being led to believe, incorrectly, that their doctor is somehow in a position to perform an innovative treatment for their condition because of the Bill.

I remain unconvinced that legislation is necessary. Continued parliamentary scrutiny is certainly needed and I give the amendment my full support as an important step towards bringing much greater clarity to the Bill and to protecting patients.

[Lord Turnberg (Lab)]

My Lords, I am pleased that many of the amendments that I and others proposed in Committee have now appeared in one form or another in the amendments before us. I presume that they are acceptable to the noble Lord, Lord Saatchi—many are in his name—and to the Government. May I also say how much I appreciated Daniel Greenberg’s efforts in trying to draft acceptable wording in many of the amendments?

There was considerable correspondence in the media after Committee stage and quite a bit of opposition voiced by the 100 oncologists who wrote to the Times expressing their concern. This was followed by a robust response by the noble Lord, Lord Saatchi, in which he accused them of being reactionary, failing to accept innovations and not wanting to move with the times. Considering that these doctors are among the most forward-looking and innovative researchers in cancer treatment, that was somewhat unfortunate and inappropriate. Their worries, and those of the BMA, the Medical Defence Union, the Medical Protection Society, the BioIndustry Association and the Academy of Medical Sciences, were about whether the Bill was really necessary, suggesting that the barriers to innovation—of which there are many—do not include a fear of litigation. Perhaps more importantly, they were worried about its safety.

These amendments go some way to help on the safety issues, even if they do not make it a necessary Bill—I will not go into that today. In this group, I am glad to see in Amendments 8 and 9 in the name of the noble Lord, Lord Saatchi, that attention has been paid to the need to clarify that the Bill will not interfere with any research or clinical trials. I am very supportive of that. There was a worry that research might be inhibited by the Bill. There is now provision in Amendment 14 to ensure that the Bill will not cut across the need to innovate in an emergency.

Amendment 1 in the name of my noble friend Lord Winston achieves a similar intent and expands on it. His amendment is excellent because it points out how it is important, in an emergency, to be able to innovate without going through this process. I believe that the clarity my noble friend Lord Winston seeks in Amendment 6 by defining “innovation” is very helpful. I hope that the noble Lord, Lord Saatchi, will see it as a helpful clarification and accept it.

Amendment 15 seems to suggest that a doctor will not be legally liable if he or she does not innovate. If it says that then I am strongly in favour of it. I hope that it does. However, there are a number of other issues that require further work. I will raise those points for clarification in a later group. They are concerned with increasing the safety of the Bill.