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Clause 5
Prohibition of activities without consent etc.
Dr. Murrison: I beg to move amendment No. 22, in
clause 5, page 5, line 18, after 'does', insert
'or causes to be done'.
The purpose behind the amendment is fairly clear to anybody who has read the various briefing notes with which medical research organisations—particularly pathologists—have regaled us. They are concerned about the apparently unfair onus that will be placed upon them—given that they are most unlikely to be actively involved in obtaining consent—rather than on clinicians, who would be actively involved. Therefore, there is some fear among the organisations that represent pathologists and medical researchers that they will be unduly affected by the Bill. The focus is very much on them, and not on clinicians, who are really in the front line of the gaining of consent.
Much of the concern has to do with the slightly ambiguous language in the Bill. The Under-Secretary has explained that much of it will be fleshed out in codes of practice, but as we have discussed before, that will not give a great deal of comfort to those organisations that represent pathologists and medical researchers. Indeed, in clause 5(1) we have the words ''reasonably believes''. The word reasonably is something that we could argue about, and no doubt lawyers will argue about it at great length and cost in the law courts. It is that sort of ambiguity that worries many of the organisations to which I have referred, and those concerns are well founded.
It is important for organisations such as the BioIndustry Association and others that have corresponded with us that the focus is shifted slightly away from them, and on to those who are involved with the garnering of informed consent—in practice, that tends to mean clinicians. All that the insertion of ''causes to be done'' will do is shift that burden slightly closer to the clinician who is involved with the patient. I think that that is a reasonable small addition to the
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Bill, and will address some of the concerns of the likes of the BioIndustry Association and those organisations representing workers in medical research and in pathology. I hope that the Under-Secretary will consider accepting that amendment and keeping those organisations happy.
Dr. Ladyman: Again, I understand what the hon. Gentleman is getting at, and it bears repeating that we greatly respect the work that pathologists and others do, and we recognise the difficulties that they face and the worries that they have in this regard. I hope that I am able to clarify that our belief that the existing wording of the Bill is an adequate protection for them. It makes it clear that a reasonable belief that consent had been obtained would be a perfectly good defence were anyone to face sanctions under the legislation. If they were being asked to do something when they knew that consent had not been obtained, the criminal liability in the Human Organ Transplants Act 1989 would be a perfectly legitimate reason for them to refuse to do it. Both of those purposes are covered.
We also believe that were someone required by another person to do something that went against the provisions of the 1989 Act, the Bill would cover it. That person would in effect be committing a criminal activity. For example, if a supervisor in a laboratory required his PhD students to carry out work knowing that consent had not been properly obtained, the supervisor would face the criminal sanction. We believe that the wording in the Act is sufficient to guarantee protection for people in such circumstances.
Dr. Murrison: I think the Under-Secretary has answered my principal concern, but just for clarification I would like to exemplify my concerns. A clinician on a ward has a patient, on whom he wants a pathologist to undertake an examination. The clinician says to the pathologist, ''Consent has been gained.'' The pathologist takes that in good faith, and his defence would be that he reasonably believed that consent had been gained. Where would the blame lie if that consent had not been obtained, and who would be in the frame?
Dr. Ladyman: The pathologist would have a good defence by claiming that he had reasonable belief that consent had been obtained. It is my view that in those circumstances the clinician—especially if he were aware that consent had not been obtained when he gave that guidance—would be liable. I shall certainly undertake to reflect further on that point before Report, but those points are covered by the wording in the 1989 Act, and the Bill will sufficiently cover the hon. Gentleman's points. On that basis, I hope that he is prepared to withdraw the amendment.
Dr. Murrison: Given the Under-Secretary's assurances and the fact that he will think about the matter, I beg to ask leave to withdraw the amendment.
Amendment, by leave, withdrawn.
Mr. Lansley: I beg to move amendment No. 138, in
clause 5, page 6, line 7, leave out '12' and insert '3'.
The Chairman: With this it will be convenient to discuss the following:
Amendment No. 139, in
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Amendment No. 140, in
clause 5, page 6, line 11, leave out '3 years' and insert '12 months'.
Mr. Lansley: We turn to the question of associated penalties. I am sure that Committee members will be aware of the concerns that have been raised about the introduction of penalties and the views expressed in certain places that they seem harsh. I was aware that the consultation contemplated the introduction of penalties, and although there were divergent views as to the appropriate severity of those penalties, there was broadly a consensus that enforcement and penalties were required.
When I read the Bill, I was slightly surprised at the severity of penalties because I had anticipated that they would be in line with the existing penalties under the Human Organ Transplants Act 1989. I do not necessarily seek to substitute my view for the Government's, but the amendment is in line with the 1989 Act. The penalties in the clause are substantially in excess of that, and at the time of consultation the Government's consultation document stated that they were not aware of any concerns about the suitability of the provisions relating to penalties.
I was surprised at the general application of the penalties to a range of offences, many of which are similar to those that related to commercial dealings in human material in the past. We are talking about an offence of similar severity, so why has there been a shift?
From the point of view of those who are affected by the legislation, and to whom such penalties might be applied, imprisonment seems to me a sufficiently severe penalty in itself. A fine at level 5 might be exactly the same as the standard statutory maximum—it is certainly not far off it. The provision for 12 months' imprisonment on summary conviction, or three years on indictment, seems excessive. I would be interested to hear the reasoning behind the Government's decision to increase the penalties.
Dr. Ladyman: As always, these things are judgment calls. The hon. Gentleman has clearly spoken to some people who think that the penalties are too severe; I assure him that we have spoken to people who do not think that they are severe enough. We have come to a judgment. We can debate its merits, but it is our judgment.
We hope that the penalties in the clause will never have to be imposed, or will be imposed only rarely. We hope that the legislation is clear enough and that the willingness of clinicians and researchers to co-operate with it will be such that it will never be necessary to bring any cases to trial. If a case does come to trial, we think that we have the judgment right. We consulted the Home Office on the appropriate level of penalties for the offences. There is provision for penalties to vary depending on the seriousness of the offence and whether it is dealt with on summary conviction or on indictment. No person may be prosecuted for an offence under the clause without the consent of the
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Director of Public Prosecutions. Subsections (1) and (4) also make it clear that it will be a defence if a person ''reasonably believes'' that he has consent, or that the activity that he is undertaking does not require consent.
I made those points when we debated the previous amendment. May I correct something that I said in that debate? In the example that the hon. Member for Westbury gave, I think I said that the clinician would be liable under the Bill. It is my understanding, in fact, that neither the clinician nor the pathologist would be liable in those circumstances. The clinician is not carrying out a licensable activity, and so the penalties would not be imposed on him or her. I hope that I have clarified that.
Dr. Murrison: Oh!
Dr. Ladyman: I can tell from the hon. Gentleman's furrowed brow and his exclamation that the Opposition are probably already writing amendments for consideration on Report.
Dr. Murrison: That is quite something. My word! I asked who would be in the frame, because when something goes wrong, people naturally want a culprit—
Mr. Lansley: Ours is rather a good amendment.
Dr. Murrison: Indeed. I wonder whether, in the light of the information from the Under-Secretary's civil servants, he will retrospectively consider the amendment that I withdrew.
Dr. Ladyman: I understand the hon. Gentleman's concerns. We probably all need to think about the clause before Report. My understanding is that if somebody were deliberately flouting the proposed legislation, there would be penalties that could be used. However, we certainly need to reflect on these matters. The hon. Gentleman is right to say that in such circumstances somebody should be held responsible. We must ensure that that is covered in the Bill. I believe that it is, but if it turns out not be, he can rest assured that we will address that.
Amendment No. 139 would change the wording of the clause so that instead of referring to the ''statutory maximum'' it referred to
''level 5 on the standard scale''.
That would have no effect, because both amounts would be £5,000. Since the offence is triable either way, the correct term to use when the offence is tried summarily is the ''statutory maximum''. It is only for summary offences that the standard scale is used. I hope that, with that explanation, the hon. Gentleman will withdraw his amendment.
4.15 pm
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