Clause 1 - Authorisation of activities for scheduled purposes
Human Tissue Bill
9:30 am
Dr Evan Harris (Oxford West and Abingdon, Liberal Democrat)
I am grateful to the hon. Gentleman for making that point, particularly in regard to clause 23. I will be interested to hear the Minister's response.
The remit of the Human Tissue Authority is set out in clause 11, which is written in more general terms. However, it would be useful to know whether the Minister believed that the remit of the Human Tissue Authority and what it will cover in the code of practice would be sufficient to cover the question of consent without relying on the Secretary of State to make a post hoc amendment to the legislation.
So far, the Government have not proposed to put the issue of consent, as understood in clinical practice, on a statutory footing, and I understand the reasons for that. Nevertheless, the point that we are making in the group of amendments still stands. There is a danger either that people will be put at risk or that people will feel that they are at risk. There is an exemption in relation to the penalty clauses for those who are carrying out activities in good faith—believing that there was consent—but any area of doubt may cause people to leave the field of such work, or to choose not to go into that area, or to minimise the number of procedures they carry out on such material. One can understand their fears, given the incidents that occurred after the Alder Hey scandal. There is a strong argument for clarifying that area in a Bill that is otherwise not very clear.
The hon. Member for Wyre Forest chose, when seeking to explain the reasons for a paving amendment that mentions
''consent for the appropriate purpose''
to single out education research. That is important, because that area is the one in which there might be the most doubt. If the Government are setting out a series of purposes and uses in schedule 1, it might be more appropriate for the discussion to focus on ensuring that the consent is specific, where appropriate, to each of the purposes set out in schedule 1, rather than singling out education research. The hon. Gentleman and I tabled similar new clauses, but with that difference, in the hope that both would be selected and that we could have this discussion.
New clause 2(2) states:
''Where the person concerned has died, consent appropriate for the intended purpose shall specify whether or not consent is given for each of the purposes specified in Part 1 of Schedule 1.''
There is an argument that that might have read simply schedule 1 or part 2. As will become clear when we discuss the next group of amendments, there is an argument that no distinction should be made between material from the dead and the living in respect of the activities set out in part 2, and that those activities would normally be covered by the consent for removal for the purposes in part 1 of schedule 1, as they are for dealing with live material. That is why I drafted the proposed new clause in that way.
However, if the Government are not minded to agree that consent for part 2 purposes should be included in consent for removal of tissue for the purposes set out in part 1, part 2 will be more important in clarifying that consent is available. The
part 2 activities listed in the schedule are those in which it would be more likely to be assumed that consent had been given by virtue of the consent that had been provided to obtain the material and carry out some of the other activities. Clinical audit,
''education or training which is incidental to medical diagnosis or treatment''
and quality assurance, are part of the everyday work on almost every sample—from both the living and the dead—that comes through a pathology laboratory. If the Government require specific consent for part 2 purposes, there is a stronger argument that those purposes should be specified in any consent, and that that should be made clear in the primary legislation.
In cases in which the person concerned is alive, and in which the Government concede in clause 1 that specific consent is not required for the purposes listed in part 2, the purpose of new clause 2 is to establish whether consent has been given for paragraphs 1 and 3 to 8. Determining the cause of death would not be an appropriate purpose for which to seek consent from a living person prior to an operation, for obvious reasons. One might argue that anatomical examination might be included in that list but, as is made clear in clause 56, that can take place on a part of the body removed from a person who is alive.
I hope that I have set out the reason why we are seeking to table the amendments, and in a way additional to the points made by the hon. Member for Wyre Forest. I look forward to hearing the Minister's response to the point. I understand, from the helpful conversation that I had with someone in her team, the problem that the Government foresee, among others, around this sort of new clause. It would require those seeking consent to go into whether consent was required for all the other purposes, particularly part 1 purposes, when it might be obvious that it would be inappropriate. It is clear that there will be a restricted purpose and it is not worth going through all the other purposes to get the person giving consent to tick all the boxes.
That is not necessarily as strong an argument as it might be, because we need to ensure that in the consent process there is more openness about these issues. It would benefit society if people having operations were not protected from the things that happen in pathology labs; otherwise, we will continue to have this air of ignorance and mystery. It is relatively straightforward sensitively to explain—in written form, supplemented or substituted by verbal explanation where appropriate—the sort of purposes for which material might be used, and the sort of purposes for which the health service and the scientific community might find it helpful to use, and to seek that consent in explicit terms.
There is a worry about forcing or encouraging doctors and patients or relatives to go through some of these purposes, but that is exactly—even in a tick-box sort of way—the sort of position we need to be moving towards if we are going to make these sorts of things more explicit. I hope I am not pre-empting or
misrepresenting some of the arguments the Minister will use, but I thought I should get my rebuttal in first, to save time.