Medical Innovation Bill [HL]

Lord Mackay of Clashfern Excerpts

Friday 27th June 2014 Lords Chamber

[Lord Mackay of Clashfern (Con)]

My Lords, I shall attempt to stick to the advisory limit. This is an extremely important Bill which, as has been said, has generated a lot of opposition and very many pages of debate. I am greatly obliged to Leigh Day solicitors for presenting me with a large file on the Bill. Of course, the flow of such material has continued up to the last minute. I want briefly to summarise the Bill as I see it because I believe that it provides the best possible protection in relation to medical innovation that could be devised. You just have to look at the Bill in this way.

Clause 1(4) states:

“(4) Nothing in this section—

(a) permits a doctor to administer treatment for the purposes of research or for any purpose other than the best interests of the patient”.

This is the centre of the Bill. If you innovate, you will depart from the existing practice. The law as I understand it in respect of medical and other professional people is that, in treating their clients or patients, they have to use the reasonable care that is expected of a person of that skill. That is the fundamental rule. Other ancillaries have been developed such as the Bolam principle, which says that if there is a body of medical opinion that is responsible and relevant, that is evidence that the doctor in question has in fact exercised reasonable care. The question is this: if there is no such body, how do you exercise reasonable care?

The Bill sets out a procedure by which that can be done. It analyses the process of coming to a decision that reasonable care has been taken in the circumstances of an innovation. It sets out that this must be done by a process which is accountable, transparent and allows for full consideration of all the relevant matters. I personally do not find it easy to suggest an improvement to that particular formula. The Bill sets out in some detail the process which must be followed in order to achieve that overall objective. The first requirement is,

“consultation with appropriately qualified colleagues, including any relevant multi-disciplinary team”.

That implies consultation. I have read some opinions which suggest that it could be ignored without any consequences whatever. You can ask someone’s opinion, and if it goes against what you want to do, you just ignore it and carry on. That is not my understanding of the term “consultation” as it is used in the law. Consultation means that you have regard to the opinion. In a case where a doctor is challenged, this will have to be set out. If, for example, Dr A says, “This is very dangerous”, the defendant doctor will have to give a good reason why he thinks that that statement is not correct. That is the first stage, and of course consultation would include looking at the relevant literature on the subject.

The second requirement is,

“notification in advance to the doctor’s responsible officer”,

which is in accordance with the statutory provisions covering medical responsibility. The third requirement is,

“consideration of any opinions or requests expressed by or on behalf of the patient”.

That would include the patient’s consent, which is absolutely essential for any treatment by a doctor. It must be full consent that is given after a full explanation of the risks involved in the treatment. The fourth requirement is,

“obtaining any consents required by law”,

which, as I say, includes the consent of the patient himself or herself. The last requirement is,

“consideration of all matters that appear to the doctor to be reasonably necessary to be considered in order to reach a clinical judgment, including assessment and comparison of the actual or probable risks and consequences of different treatments”.

That is a very full assessment. As I say, I have received quite a body of literature but I have not seen any that actually formulates the way to achieve a result of reasonable care in the situation of an innovation. How do you do it if there is no body of opinion already in favour of it? How do you justify your decision as taking reasonable care? In my judgment, most of the literature that has come in from a great number of bodies, including all the professional bodies, is based on a failure to give full effect to the provisions of the Bill.

I declare an interest as an honorary fellow of three of the medical royal colleges. I am also a member of Cancer Research UK, and I join my noble friend in paying tribute to the work of the charities, particularly Cancer Research UK in its research function. I also had some experience of this area of the law when I was in private practice but, of course, as your Lordships will understand, that is rather a long time ago. I support the Bill heartily and I have seen very little in the way of suggested improvements to this line of thought.