Medical Innovation Bill [HL]

Lord Pannick Excerpts

Friday 24th October 2014 Lords Chamber

To what I am sure will be the great relief of noble Lords, I think that I have come to the end of this group of amendments.

[Lord Pannick (CB)]

My Lords, I have tabled a number of amendments in this group and I thank the noble Lord, Lord Saatchi, for his helpful responses to them. The purpose of my amendments is to ensure the protection of vulnerable and often desperate patients and their families. Amendment 10 seeks to introduce a test of reasonableness and proportionality. The noble Lord, Lord Saatchi, said in his comments that reasonableness and proportionality are central to the objectives of the Bill. Perhaps I may explain my concern.

The Bill uses the concept of “responsible” innovation. Clause 1(3), along with Amendment 12 in the name of the noble Lord, Lord Saatchi, which he has rightly described as crucial, would define responsible innovation by reference to process; that is, obtaining and taking account of the views of others, considering the risks and benefits, and securing transparency. My concern is that this is insufficient because it says nothing about the substantive content of the decision of the doctor to innovate. Amendment 10, which has the support of the noble Lords, Lord Winston and Lord Turnberg, would provide that innovation is lawful only if it is “reasonable and proportionate” in a substantive sense. It must be reasonable in the sense that the course of innovative treatment should be based on a reasoned decision, that in the light of some evidence the treatment has some prospect of success, and proportionate in the sense that in the patient’s case and taking into account the existing available treatments, the innovative treatment is not likely to cause pain and suffering that is unjustified by the prospects of success. Plainly, this is going to depend, and will necessarily depend, on the circumstances of the individual case.

At Second Reading, the noble and learned Lord, Lord Mackay of Clashfern, who I am pleased to see is in his place, said at col. 1457 that in the context of innovation, it is very difficult to see how you can assess the “reasonableness” of treatment. With respect, I do not accept that. You assess the reasonableness of an innovative treatment in a substantive sense by asking whether there is some evidence to suggest that the treatment will or may have a positive result. I think that reasonableness and proportionality are as important in the context of terminal illness as they are in any other context. Unreasonable and disproportionate medical treatment can cause pain and suffering and it can of course blight the remaining time that patients have with their families.

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Moved by

[Lord Pannick]

2: Clause 1, page 1, line 2, after “encourage” insert “reasonable and”

[Lord Pannick]

My Lords, Amendment 2 refers again to the concept of “reasonable” innovative treatment. I will be very brief on this. First, I am reassured by the comments just made by the Minister that as a matter of law, “responsible” and “reasonable” in this context have the same meaning. Secondly, I am persuaded by the noble Baroness, Lady O’Neill of Bengarve, that we do not also need a criterion of proportionality in this context.

Thirdly and finally, the noble and learned Lord, Lord Mackay of Clashfern, pointed out that in this context of innovation there is of course by definition a limited amount of information already available. That is why innovation is required. My concern is that to justify the innovative treatment, especially if it causes further pain and suffering, it needs to be based on some evidence or at least on a rational judgment that there are some prospects of success. I should also mention Amendment 4, which would leave out the concept of “reckless” treatment. I note that the noble Lord, Lord Saatchi, has added his name to a similar amendment: Amendment 5. I beg to move.

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[Lord Saatchi]

My Lords, I thank my noble friend the Minister for what he said. I think that there is a consensus on Amendment 5 in my name, that of the noble Lord, Lord Turnberg, and that of the noble Baroness, Lady Finlay, to remove the word “reckless”. I think that we are agreed on that. My noble friend dealt with the point under Amendment 3 from the noble Baroness and the noble Lord. We understand the wish to exclude certain treatments and types of surgery, and perhaps that is something that we can discuss between now and Report.

I share the Minister’s wish to accept Amendment 4 from the noble Lord, Lord Pannick, which removes the reference to deterring quackery from the purpose clause. We are agreed on the view that, if the noble Lord, Lord Pannick, believes that it is important to confine the purpose clause to the positive, we should not insist on the inclusion of both limbs—positive and negative—since as a matter of law the negative flows naturally from the positive in any event. If the noble Lord, Lord Pannick, presses that amendment, I shall support it.

[Lord Pannick]

I beg leave to withdraw the amendment.

Amendment 2 withdrawn.

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Moved by

[Lord Pannick]

4: Clause 1, page 1, line 3, leave out “(and accordingly to deter reckless irresponsible innovation)”

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[Lord Giddens]

My Lords, the noble Lord, Lord Saatchi, knows that I support the thrust of the Bill but there are issues around some of these amendments that the noble Lord might at least listen to.

As I have mentioned previously, one of the core things about this legislation, given its sensitive nature, is that we have to comb through it all the time for possible perverse consequences. At the risk of sounding like sociology 101, unintended consequences are different from perverse consequences. Unintended consequences can be good or bad; perverse consequences undermine good intentions and reach the opposite result of what an individual needs to achieve. For example, strong rent controls were introduced in New York City to help poor people; in fact, they adversely affected them because they could not find places to live. The noble Lord says that the Bill is crystal clear in its intent, but that is not enough because there is a massive difference between intent and consequence. I therefore feel that as a general principle we should comb through the whole Bill to try to spot possible perverse consequences.

On the whole, with the reservations that have been noted, I support Amendment 6 because it might help to block off some of those reservations. We surely must know what innovation actually means in the context of clinical practice. Without such specification, one can see that various perverse consequences could occur. What would happen, for example, if a doctor was accused in court of failing to innovate because he or she did not try some eccentric form of treatment that was available? One could block off that perverse consequence by specifying, in the way that Amendment 6 tries to do, what actually counts as innovation.

I feel strongly that as the Bill proceeds through Parliament we must tighten every loophole that could lead to a situation in which, to some degree, the Bill undermines what it is actually supposed to achieve—helping vulnerable patients in a situation in which they are often desperate by bringing innovations to them that they would not have had available before. However, I fear that some of those things could happen if one was not aware of the minefield of perverse consequences. If we do not examine it all carefully, there could be consequences that, to some degree, undermine the purest of intentions with which the legislation is introduced.

[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.