Mr Kevin Barron (Rother Valley, Labour)

There is uncertainty about what research will not take place if the Bill as it stands becomes law. The hon. Member for Sutton and Cheam (Mr. Burstow), who is not in Committee at present, referred last week to a briefing from the Medical Research Council and the Wellcome Trust, which were concerned that the research provision would inadvertently restrict certain categories of research that are of importance to adults who lack the capacity to consent. The briefing gives an example, saying that the provisions

''may restrict certain types of research on the side-effects of medicines used to treat people with mental disorders. This is illustrated by the following example. The drug clozapine is an important anti-psychotic drug the use of which has been restricted because it adversely affects the production of white blood cells. This side effect is not a 'condition' which is 'attributable' to the 'impairment of, or disturbance in the functioning of, the mind or brain'.''

Those three points are related directly to subsection (2)(b). The briefing continues:

''Rather, it is a 'condition' which is probably attributable to an inappropriate immune response triggered by the drug.''

Their concern is that

''If the term 'connected with' is interpreted narrowly, research on the side-effects of this drug would not be permitted under the Bill. This could have serious implications for patients who suffer from schizophrenia or other mental disorders who stand to benefit from this type of research.''

The hon. Member for Sutton and Cheam spoke about the use in subsection (5)(a) of the word ''risk'', and the phrase ''in a significant way'' used in subsection (5)(b)(i). He said that the Medical Research Council was concerned about that. The example that I have cited clearly outlines the council's fears that a strict interpretation of the term ''connected with'' could narrow the scope for research.

I have been contacted by the British Medical Association, which has been negotiating with the Department of Health on the drafting of the Bill. The BMA is worried about non-therapeutic procedures, saying in its briefing note:

''The provision to include non-therapeutic procedures that will benefit other third parties was originally included in the Law Commission 1995 report into Mental Incapacity . . . It mentioned that any order made by the Secretary of State must stipulate

whether the procedure requires the prior approval of the court; or alternatively a certificate from an independent medical practitioner.

The Mental Capacity Bill does not tackle the question of minimally invasive interventions that are not directly in the best interests of the incapacitated person, but are not harmful and provide a significant benefit for third parties. There are two particular instances in which this would occur.''

I shall read out the two examples. I do not expect the Minister of State, Department of Health, my hon. Friend the Member for Doncaster, Central (Ms Winterton), to give detailed responses to them now, but if she could do so in future it might benefit members of the Committee and medical professionals who work in such areas.

The BMA first has in mind

''testing for blood borne diseases following a needlestick injury to a health professional where there are good reasons to think that the patient may have a condition, such as HIV, for which prophylactic treatment is available. As the Bill is currently drafted, it would be illegal to take a blood sample for testing. In circumstances where an individual is unconscious and unlikely to regain consciousness in the short term, a doctor who has received a needlestick injury cannot make an informed decision about ongoing . . . treatment if a test cannot be undertaken to determine the patient's infection status.''

In its guidance on serious communicable diseases, the General Medical Council, of which I am a lay member, makes it clear that

''taking a blood sample for testing in such circumstances may leave the doctor open to criminal charges and that testing an existing sample, without consent, may also be challenged in the courts or before the GMC.''

The doctor might end up being subjected to the fitness to practice procedures if he did that. The BMA

''would like the Bill to address this circumstance to allow doctors to take steps to protect their own health and the health of other health professionals where those incidents occur.''

Secondly, the BMA is

''very pleased to note that provision is to be made in the Human Tissue Bill for Regulations to allow genetic testing of a sample from incapacitated adults for limited purposes other than their own medical benefit. There are circumstances where information obtained from DNA analysis will be of huge benefit to other family members and we hope that this will be covered by Regulations. As the Bill stands, however, there is no provision for samples to be taken for that purpose. It is not clear that taking blood for genetic testing for the benefit of a relative would satisfy the 'best interests' tests as a matter of law. In discussing this issue the Human Genetics Commission said ' . . . the position of the adult without capacity remains unsatisfactory. The lack of any specific legal authority means that, whether or not such an intervention is lawful remains open to doubt.' The BMA would like to see this issue clarified in the Mental Capacity Bill.''

I do not think that we will clarify the issue this morning, but I say to my hon. Friend that people working in the profession need to have those two issues clarified, particularly the consequences of a needlestick injury to a health professional. Although that may be outwith the aims of the clause, we ought to clarify the issue at some point both for professionals and for patients—obviously, patients need to know what might happen to them in certain circumstances.

I do not want to trawl over the issue any more. I recognise that it is difficult to respond to the picking out here and there of words such as ''risk''. The Bill is drafted by parliamentary lawyers, who have made their best guess as to how we should proceed, but

questions have been raised by outside organisations and professions and we ought to try to answer them as best we can during the passage of the Bill.

Mr Tim Boswell (Shadow Minister, Home Affairs; Daventry, Conservative)

I am grateful to the right hon. Member for Rother Valley (Mr. Barron) for raising these issues, which he does both of his own cognisance and on behalf of the GMC. The issues he raises go to the heart of concerns expressed in earlier debates, which I do not need to rehearse.

To make an obvious but important statement, the Bill sets out provisions for research and is designed to provide some boundaries beyond which that research should not take place. In fairness, and remembering earlier discussions about research ethics committees and so on, and the oaths taken and personal moral judgments made by members of the medical profession, I ought to say that there are, of course, limits on the process. We have discussed the inappropriateness of, among other things, carrying out research that has no connection with the person involved or their condition but has to do with something completely other, or research that is likely to cause them serious pain or distress. Both are ruled out, and so they should be—that is not the issue.

The right hon. Gentleman is right to raise the issues and say, with great respect to the Minister, that we probably will not resolve them today. Further reflections and discussions, and perhaps deliberations in another place, will be required before they are hammered out. He is right to raise them in relation to acts that are connected with the condition but not actually the condition itself—I have some sympathy with his points on that—and in relation to research that is not demonstrably for the benefit of the patient. I touched on that earlier.

Interestingly, the word ''benefit'', which is drawn from parallel Scottish legislation, as the right hon. Member for Coatbridge and Chryston (Mr. Clarke) reminds the Committee, is introduced at this point in the Bill but does not appear elsewhere. I said the other day—it remains my view—that there is concern about the overall application of the best interests principle in clause 1 to this clause. One has to stretch the principle, which has to be very elastic, to encompass all situations now. We have to think long and hard about whether we need to set boundaries.

Subsection (4)(a) talks about

''the potential to benefit P without imposing . . . a burden that is disproportionate''.

That is a reasonable test, which is why I did not seek to exclude it through my amendment. However, it is made clear in subsection (5) that that test in subsection (4)(b) would be different. Research that passed that test would not be a subset of something that might benefit P—in fact, it is implied that it would not benefit P. In effect, subsection (5) states that if such a test will not benefit P, we have to make sure that it will not damage P. That brings me on to what I have called neutral acts—acts that do not help the person who has lost mental capacity, but are somehow related to their condition and might benefit a class of people in the

future. That employs a wide interpretation of the best interests clause. We need to watch carefully and establish whether we need to tie the matter down further, either with language, or, as the right hon. Gentleman suggested, with an independent umpire who could rule on behalf of the court if necessary. That would be a reasonable test.

The right hon. Gentleman also raised the issue of blood tests. I am not clear about whether a blood sample or part of one taken for one purpose in connection with the treatment of the person, P, could be diverted to another purpose. Will the Minister clarify that?

Mrs Angela Browning (Tiverton & Honiton, Conservative)

My hon. Friend might be aware that a year or so ago, with the assistance of the Home Office, I helped to introduce a new rule on the taking of blood samples when, for example, somebody enters casualty unconscious but might be the perpetrator of a fatal road accident as a result of drink-driving. I had many discussions with the BMA ethics committee in the run-up, and we eventually got a solution. It seemed unfair that somebody could go into the mortuary of a hospital having been the victim of a drink-driver, whereas the drink-driver could go into casualty with all the protections that have been mentioned.

Mr Tim Boswell (Shadow Minister, Home Affairs; Daventry, Conservative)

I am grateful to my hon. Friend for reminding the Committee of that. Such areas are very difficult to negotiate. We should not demonise the medical profession, but nor should we give it carte blanche. The Committee is picking its way through. I hope that the Minister will reflect on what has been said and on what others may wish to add this morning. We can then hammer out something with which we can all be happy.

Ms Rosie Winterton (Minister of State, Department of Health; Doncaster Central, Labour)

I begin by welcoming you to the Committee, Mr. Hurst. I am looking forward to serving under your chairmanship.

The purpose of clause 31 is to define what kind of research involving people who lack capacity to consent can be approved. Subsection (2) sets out the first requirement: that

''research must be connected with a condition which—

(a) affects P, and

(b) is attributable to the impairment of, or disturbance in the . . . mind''.

My right hon. Friend the Member for Rother Valley made an important point about the grey area surrounding the word ''attributable'' in the clause. He pointed out that we might have not covered absolutely what research might be done into causes. We have noticed that that needs clarification and I assure him that I will consider whether we need to clarify that issue further.

The hon. Member for Daventry (Mr. Boswell) made a point about best interests and the scope for research. The best interests test will apply to acts done or decisions made for or on behalf of P, and the application of that to research is difficult. I

acknowledge that to define what might be in general best interests is more difficult—for example, in research projects it will not always be possible to prove that something will be of direct benefit to P, because then it would be a treatment rather than research.

The hon. Gentleman asked about whether blood taken for one purpose could be diverted to another. That touches on some of the points that we have made about whether research would be unduly invasive. Clearly, if blood samples are being taken for one purpose, such as diabetes testing, a research ethics committee might give the go-ahead for those samples to be used, or for a little extra blood to be taken, for a research purpose. However, if conducting the research meant that hourly blood samples had to be taken, a research ethics committee might feel that that was unduly invasive. The Human Tissue Bill, particularly schedule 2, covers some of the issues about samples taken for one purpose being used for another where there are public health issues.

My right hon. Friend was right to raise the point about needlestick injury, and it is important that we look at that. Some of that is covered by clauses 4, 5 and 6, and some of it may cross over with the Human Tissue Bill.

Question put and agreed to.

Clause 31 ordered to stand part of the Bill.