Clause 1 - Authorisation of activities for scheduled purposes
Human Tissue Bill
9:10 am
Dr Richard Taylor (Wyre Forest, Independent)
I, too, crave your indulgence and guidance, Mrs. Adams, as I am new to the job.
Amendment No. 34 stands in my name and that of the hon. Member for Oxford, West and Abingdon (Dr. Harris). I echo the remarks that have been made: this could work out as a cosy sort of Committee, because there is so much agreement on ending up with the right Bill.
There is universal support for the aims of the Bill. The concerns that I have picked up from those who have written to me are largely about its wording. The Royal College of Pathologists states:
''The tortuous wording of the Bill may cause much confusion about what is lawful. It fails to provide the clarity in the law that is one of its stated prime objectives.''
The Pathological Society of Great Britain and Ireland states:
''Even with the Explanatory Notes, the drafting of this Bill is opaque and difficult to understand as presently drafted.''
That is why the amendments press for more clarity.
Consent in the Bill, as I read it, covers very adequately the matter of consent from the appropriate person, which is obviously very important. The Alder Hey disaster, to which we all look back, occurred not only because there was inadequate consent from the right person, but because the details of the consent were hopelessly inadequate. I look back to years of practice in hospital medicine before the Alder Hey disaster, when hospitals were judged on the post mortem rate—the number that they could perform—to justify their training status. That led to a perfunctory application for permission for post mortems; the junior doctors to whom the job was deputed felt that they had to get a yes from the relatives. That in turn led to inadequate practice in obtaining consent.
Amendment No. 34 would clarify ''appropriate consent'' by requiring consent from the appropriate person and detail of the consent needed for different functions. That is vital, and it should be at the beginning of the Bill and give force of law to the use of adequate consent forms, for both post mortems and operations, that specify generically to what the person is giving consent.
On Second Reading, the Minister said:
''The Bill gives statutory effect to the current requirement for consent.''
It is an example of the opacity of the Bill's wording that I am not sure from where she gets that, and I would be grateful for confirmation. The Royal College of Pathologists writes that
''the main weakness of the current version of the Bill is the failure to compel those who remove human tissue from living patients to seek appropriate consent sufficient to cover its subsequent uses.''
Pathologists are worried. They do not request consent; clinicians do that. Therefore, we have the anomalous position of pathologists carrying out an examination and bearing any penalty, which may include a prison sentence, if the consent obtained by someone else is inadequate.
A paediatric pathologist wrote to the Royal College of Pathologists:
''My prediction, based on experience from autopsy practice in recent years, is that pathologists will attempt to 'play safe', and fail to take specimens for microscopy, let alone subject these to a rigorous investigation, because the hazards of reaching an unreliable diagnosis (patient complaint, civil proceedings, GMC referral) are less than the hazards of inadvertently using a specimen for something that contravenes the Human Tissue Act''.
The BioIndustry Association picks up on that point:
''It should be noted that penalising only those who perform an activity that requires consent without penalising those who have stated wrongly that appropriate consent has been obtained for such an activity seems unfair''.
Unless the Minister can explain that that is already covered, the Bill must be amended to contain enough detail to force the use of adequate consent forms that can be passed to the pathologist, who will then know what consent has been given. Indeed, again on Second Reading, the Minister said that
''obtaining consent will reflect current good practice and need not be onerous''.—[Official Report, 15 January 2004; Vol. 416, c. 991.]
Amendments Nos. 35 to 47 would alter the Bill to be consistent with provisions in amendment No. 34. A new clause is also necessary in addition to clauses 2 and 3, which address appropriate consent from the person who gives it. New clause 1 attempts to address the appropriateness of consent for the intended purpose. It also separates consent when the person concerned is dead from consent from a living person. The Royal College of Pathologists believes that
''A clear distinction should be made between tissue removed after death (which has considerable emotional importance in terms of bodily integrity) and tissue removed from living patients as part of a consented therapeutic or investigative procedure (which is regarded by most patients as 'waste').''
Proposed new subsection (2) aims to enforce the use of a post mortem consent form, as is used now, which will cover those points. In my NHS trust, the standard form contains a separate section headed ''Medical research and education'', which allows the person who is asked for consent to describe to what they are consenting in the way of research and education, and to opt out. Proposed new subsection (3) covers the ability of the living patient to give consent to the removal of spare tissue during an operation.
I ask the Committee to consider amendment No. 34 and its consequential amendments, and new clause 1.