Medical Innovation Bill [HL]

Baroness Finlay of Llandaff Excerpts

Friday 24th October 2014 Lords Chamber

[Lord Giddens (Lab)]

My Lords, I am neither a medical specialist nor a lawyer and it is pretty near impossible to follow a speech such as that given by my noble friend Lord Winston. However, I am a sociologist and we deal in unintended, or what we often call perverse, consequences. Therefore, to me it is highly important that this Bill, which itself is an innovation, covers the question of whether perverse consequences could arise and whether the Bill could therefore end up subverting some of its own intentions.

With this in mind, I ask the noble Lord, Lord Saatchi, to think again about Amendments 13, 15 and 17 and perhaps to be a bit less dismissive of them than he was in his speech, because I think they would enrich the Bill. A clinical ethics committee would be a more robust way of affirming decisions than the existing way in the Bill. Amendment 13 spells out procedure to be followed. More importantly, it also insists that written records are kept. Critics say that it would add to the bureaucracy but there is no reason why such a committee could not be quite small and have a limited brief.

I regard Amendment 17 as very important. It is crucial that if it becomes law the Bill applies to very specific and limited circumstances. Especially important in my view, and I again speak as a lay person with no direct expertise, are the clauses limiting the legislation to drug treatments and excluding surgery and conditions involving acute trauma. It is important to spell these things out and I do not think they in any way undermine the Bill. They could contribute to what I think should be a key concern of noble Lords to close any avenues to perverse consequences that could arise, especially with legislation dealing with vulnerable people. We all know the issues here are twofold—what do you do about reckless doctors and how do you make sure that vulnerable patients are not exploited? The more loopholes we can close, the better for the progress of the Bill.

[Baroness Finlay of Llandaff (CB)]

My Lords, I have added my name to Amendment 15 and I hope that the Minister will give it due consideration. It is really important that the process laid out in the Bill is recorded in the patient’s clinical record. That is the one way that you can verify that things have been done properly. It is also important that there is notification to the central register, as referred to by the noble Lord, Lord Saatchi.

I also hope that the Minister will be able to give due consideration to the situations already mentioned by the noble Lord, Lord Winston, and others. It is very important that we do not make it more complicated than it is already for clinicians to be able to treat patients as they feel appropriate. It is also important that patients have the appropriate safeguards in place. While quite a lot will go into guidance, there is merit in having emergency treatment actually in the Bill as a situation where the Bill would not apply and that treatment in the best interests of the patient in an emergency can proceed by whichever means appear to be best at the time.

[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.

--- Later in debate ---

[Baroness Butler-Sloss (CB)]

My Lords, I strongly support the Bill as it is drafted. I am relieved that the noble Lord, Lord Saatchi, produced a short Bill; I hope that the House does not think that it was a bad idea to suggest that a short Bill might be more attractive than a longer one. For that reason I am not at all happy about the various amendments that were in the first part of our discussions today.

I do have reservations about the words in brackets in Clause 1(1), and I take the view that the noble Lord, Lord Pannick, is probably right to say that they should be excluded.

[Baroness Finlay of Llandaff]

My Lords, I added my name to the amendment deleting “reckless” because I felt quite strongly that it detracted from the overall intention of the Bill. This is not about reckless innovation; it certainly must deter irresponsible innovation, but it is about encouraging responsible innovation. I also added my name to Amendment 3, on treatment for the “relevant conditions”, because many of these patients who are seriously ill will have multiple co-morbidities and may have many things happening to them. This Bill is aimed, as far as I have understood, at the principal condition—the condition for which patients are often desperate for some innovative treatment. It should not inadvertently allow lots of other strange things to be presented to patients to cope with many of the other co-morbidities that they may have.

My feeling about that comes particularly from my own specialty, which the House knows is palliative medicine, where we see time and again patients who are very emotionally vulnerable, psychologically fragile and potentially in despair, so they are unable to make sense of what is going on. In that state, they are quite vulnerable to people presenting all kinds of strange treatments with false claims. I will give a specific example from my own practice. We came across a group of patients on a ward who all had small crystals by their bed, and we discovered that a member of staff strongly believed that holding on to these crystals would shrink the patients’ cancers. The evidence for it was absolutely zilch; I think that the patients had paid to have the crystals given to them. That type of so-called experimentation is completely outside the scope of the Bill—and must be outside its scope. That is why it struck me that the wording about the relevant medical condition should feature in the Bill, because of the potential for exploitation otherwise.

[Earl Howe]

My Lords, this group of amendments seeks to alter the purpose clause of the Bill. Under the law of negligence, the words “reasonable” and “responsible” have the same meaning, as the noble Lord, Lord Pannick, reminded us. As such, the addition of “reasonable” is not necessary and risks creating confusion. Existing clinical negligence law commonly refers to a responsible body of professional opinion. The addition of “reasonable” may suggest that the test under this Bill differs from the existing Bolam test.

The noble Lord, Lord Pannick, asked me whether the Bill required a rational judgment of success. Proposed new subsection (3)(d) in Amendment 12 requires the doctor to consider a number of factors in relation to the proposed treatment. This includes a requirement to consider,

“the risks and benefits that are, or can reasonably be expected to be, associated with the proposed treatment”,

other accepted treatments, or,

“not carrying out any of those treatments”.

In weighing this up, the doctor must apply an objective standard as to what could reasonably be expected in relation to those treatments. This provides a further safeguard for patients in ensuring that a doctor may not offer an innovative treatment in accordance with the Bill unless he has acted in an objectively responsible way. I hope that that helps the noble Lord, Lord Pannick.

My noble friend’s Amendment 11 seeks to ensure that a doctor must be acting responsibly in an objective sense when deciding to depart from the existing range of accepted medical treatments.

On Amendment 3, the Government do not feel that there is anything to be gained by restricting the scope of the Bill in this way. To set out specific medical treatments or circumstances that would or would not be covered by the Bill would make the Bill complicated for doctors to follow and less flexible to individual patients’ circumstances. This might limit the Bill’s usefulness to patients and doctors alike.

On Amendments 4 and 5, the Government support the amendment to remove the reference to deterring “reckless irresponsible innovation” from the purpose clause. Recklessness has a very specific meaning in criminal law, and the term is out of place in a Bill about the law of negligence. Furthermore, the substantive provisions of the Bill focus on how a doctor can demonstrate that he has acted responsibly. This amendment therefore ensures that the purpose clause better reflects the focus of the Bill. I hope that noble Lords will accept Amendment 4, which brings clarity to the purpose of the Bill.

--- Later in debate ---

Moved by

[Baroness Finlay of Llandaff]

39: Clause 2, page 2, line 11, at end insert “but shall only come into force in Wales following legislative consent from the Assembly”

[Baroness Finlay of Llandaff]

My Lords, I will be brief; this will probably turn out to be a probing amendment. We have an interesting situation in Wales because health and healthcare provision is completely devolved. The experience of patients under the Welsh NHS falls completely within the legislative competence of the Assembly. However, if I am right, this relates to the law of negligence, and the Ministry of Justice does not have any devolved functions. The concern expressed to me within Wales has been about the use of resources and the possibility of practitioners being answerable as regards legislation that covers England and Wales, when the provision of healthcare is something for which they are answerable to the National Assembly. I tabled this amendment with a view to seeking clarification over that.

Sadly, we have had experience of extremely strange medical practices sometimes being put forward in the past. The Assembly is particularly concerned that, with its move toward prudent healthcare, which is a whole policy direction for NHS Wales, the Bill should not inadvertently cut across the principles of prudent healthcare, the first of which is, of course, to do no harm. I tabled the amendment with that in mind.

[Earl Howe]

My Lords, this amendment seeks to ensure the Bill would not apply in Wales unless a legislative consent Motion had been passed. The operative provisions of the Bill relate entirely to modifying the law of tort, which is a reserved matter. The Bill can fairly and realistically be classified as relating to a non-devolved subject, and therefore not within the competence of the National Assembly for Wales. The Government cannot accept this amendment, and I urge noble Lords to resist it.

[Baroness Finlay of Llandaff]

I am grateful to the Minister for the clarification. I expected that answer, but it is important to have it on the record. I beg leave to withdraw the amendment.

Amendment 39 withdrawn.