Clause 31 - Requirements for approval
Mental Capacity Bill
9:30 am
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.