Medical Innovation Bill [HL]

Lord Forsyth of Drumlean Excerpts

Friday 12th December 2014 Lords Chamber

[Baroness Jolly]

My Lords, Amendment 5, moved by the noble Lord, Lord Hunt, and supported by the noble Baronesses, Lady Wheeler and Lady Masham, and the noble Lord, Lord Turnberg, seeks to require the registration of innovations that are carried out under the Bill as part of the steps that a doctor should follow when taking a responsible decision to innovate. The Government have listened carefully to the concerns expressed by noble Lords and several key stakeholders, including the Royal College of Physicians, with regard to the collection of data resulting from innovation. We agree that it is vital that doctors are able to share learning about innovation that results from the Bill. However, we do not think that a requirement to record the results of innovative treatments should be included on the face of the Bill. Requiring doctors to record the results of innovative treatments in order to demonstrate that they have not been negligent, as Amendment 5 would require, would impose requirements that go beyond the current Bolam test of negligence. We are reluctant to impose requirements additional to those in the existing law as this may risk deterring doctors from innovating.

A stand-alone clause that would require doctors to register the results of innovative treatment would widen the scope of the Bill to cover all innovation. This Private Member’s Bill is not the right vehicle to make provision that would relate to all innovation. Broadening its scope in this way risks the Bill becoming the receptacle for a host of measures on innovation that are unrelated to the subject of clinical negligence. What is more, such an amendment may lead to confusion as doctors associate the Bill with clinical negligence and may therefore wrongly assume that the recording of innovation is tied in with the test of clinical negligence under the Bill. This additional burden may dissuade a doctor from innovating. It would be unclear to those doctors who choose not to innovate under the Bill whether they would be required to register the details of their innovation on the registry or whether the provision applies only to those innovating under the Bill. If the provision applied only to those innovating under the Bill, this would create an anomalous position for those acting under the Bill. More importantly, the act of putting something into legislation does not guarantee that doctors will adhere to it. We need to focus on incentivising doctors to use the registry and make such a registry work for their needs. It would be unwise to put something into legislation that does not work for doctors and that they would therefore not be able to adhere to.

I am sorry, but I have lost my place.

[Lord Forsyth of Drumlean (Con)]

I am trying to be helpful to my noble friend while she finds her place. I have been listening to her words, but surely from the point of view of the intention of the Bill, which is to encourage innovation so that people can benefit from it, it is rather extraordinary to argue that there should not be some record of success or failure.

[Baroness Jolly]

My noble friend is right. The Government are suggesting that there should be a registry because it would make no sense not to record innovations. It could otherwise not be replicated. The Government’s preferred approach is to set up a registry but not to put that on the face of the Bill.

In Committee, my noble friend Lord Howe committed on behalf of the Government to explore constructively what might be useful in terms of record-keeping and reporting in relation to medical innovation. The Government have begun engaging with partners in the health system to discuss how to achieve this goal and will continue to do so as the Bill progresses. This mechanism should be developed with a sufficiently light touch so that clinicians see it as being facilitative of good practice rather than burdensomely bureaucratic. It is also important to consider the efficiency of the data-collection mechanism and how it can be developed in the most cost-effective way.

In response to my noble friend Lord Cormack, once we have a Bill, the Government will work closely with the professional bodies and all other organisations to help the health system and patients understand and prepare for the changes to the law made by the Bill, including producing any guidance that might be helpful.

--- Later in debate ---

[Lord Saatchi]

I am going to put my notes to one side, probably to the horror of parliamentary counsel. On this amendment I find myself in complete agreement with every word that has been said by every Peer who has spoken on the subject. The reason is that it has been my fundamental position on the Bill from the beginning that, without a register that records both positive and negative results of innovation, it is very hard to explain to a man from Mars what the point of the Bill is. The Bill is designed to move science forward. If it does not do that, I can only say that I do not know quite what it does. That is its purpose.

I do not speak as an expert on the subject, but at least I can read. The standard text on the subject of science and scientific discovery was written by Professor Popper some years ago—noble Lords will all be familiar with it. In it, he describes the logic of scientific discovery as “reputation by application”. If no record is kept of a case in which a hypothesis has been refuted, then science will not advance in the way that the logic of scientific discovery requires. Therefore, it is, in the words of my noble and learned friend Lord Mackay of Clashfern, absolutely essential that there is a register that records both the successful and the unsuccessful results of innovation. In that way, science will advance and the wonderful result will be, as is the purpose of the Bill, to speed up the discovery of cures for horrific diseases.

I also want to reflect on what my noble friend Lord Cormack said. It has been pointed out to me that the work on the Bill will really only start on the day it receives Royal Assent. My noble friend the Minister and the Department of Health will have to hold some kind of conference and undertake some kind of educational programme with the royal colleges in order to achieve the purpose of the Bill, which, as described by the Chief Medical Officer of the United Kingdom, is a culture change. It is designed to change the culture slightly towards innovation and to provide doctors with a relief from the fear of litigation that some doctors have. None of those things will be possible or logical without the register.

I remind your Lordships that Oxford University has offered to maintain the register. It regards it, as I do and as we all do, as an essential part of the Bill. Therefore, it is reassuring to hear from the Minister today that the Government are not saying that the register is something that they are going to review or consider, or that it is something that they regard as perhaps having a benefit. The Minister has said today, for all of us to hear, that the Government commit to the creation of a register that does exactly what Members of your Lordships’ House have said. I am satisfied by what my noble friend the Minister has said because she has said flat-out in Hansard that the Government intend this register to be created—by Oxford, NICE, the Government themselves or whomever—and that the Government intend to bring the relevant people together during the passage of the Bill through the House of Commons in order to resolve the question of how and by whom that register is going to be compiled. I have certainly heard the Minister say that the Government are committed to the register. That is very reassuring to me.

[Lord Forsyth of Drumlean]

Will my noble friend deal with the issue of compulsion? You can create a register, but it might be a voluntary register, not a compulsory one.

[Lord Saatchi]

That is an important point and many have made it. The discussion that has to be had is whether this can be achieved by regulation, as I think my noble friend the Minister believes, or by GMC guidance. It is possible that there are other ways to achieve what is in effect compulsion without putting it in the statute.