Human Fertilisation and Embryology Bill [Lords]

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Dr. Harris: I am grateful to the Minister for her exposition on the amendments, which I followed on a track changes document—I think that that is the only way to do it. First, in response to a point made by the hon. Member for Norwich, North, I am a little confused. I had a meeting with Alison Murdoch last night, who is a clinician in Newcastle. I am sure that he would have been entitled to attend had I known that he was around and interested.
Dr. Gibson: Sorry.
Dr. Harris: I did not think that it was illegitimate to meet a clinician—
Dr. Gibson: What a cheek!
Dr. Harris: And to ask her to e-mail me—[Interruption.]
The Chairman: Order.
Dr. Harris: I did not think that it was unreasonable to meet someone and ask them to e-mail me a couple of points because the meeting was coming to an end, and then to raise them in Committee. That is entirely appropriate. In respect of the hon. Gentleman’s point earlier, I checked with Newcastle about the mitochondrial DNA and I checked my e-mail. I understand that that was sent to all members of the Committee. I merely quoted from a document sent to all members of the Committee about the research on mitochondria and IV-derived gametes.
Dr. Gibson: That may be so, but in my conversation with them I made it clear that I had not seen that document. They may have sent it, and these things happen now and again. The hon. Gentleman is in a difficult position if it is seen that he may be a lobbyist, rather than a full member of the Committee. I will be watching carefully throughout our proceedings to see whether the individual views of scientists or others are available to all hon. Member, in terms of the whole context of what they have given to him.
Dr. Harris: I object to that. If the hon. Gentleman used the term lobbyist as a smear, I object to it, and I object to the assertion that when I and, for that matter, Lord Patel and Lord Turnberg meet any scientist to express concerns about the Bill, we are somehow not doing our job. It is reasonable to do that and we have been diverted in a peculiar way, Mr. Hood. I am happy to hand the hon. Gentleman a copy of the e-mail that was sent to me by Alison Murdoch last night.
The Chairman: Order. I am sure that the hon. Gentleman will get back to the debate.
Dr. Harris: I am keen to do so, but I thought it was right to defend the normal activities of Opposition Members. For 10 years I have been meeting people who are concerned about legislation, and I will continue to do so despite the hon. Gentleman’s admonitions.
I want to make two points on the Government’s provisions. Am I correct in understanding that amendment No. 45 does two things, which are brought together in one amendment because proposed new (h) follows on from proposed new paragraph (g)? New paragraph (g) is an important amendment because it makes it clear that the disclosure that would not be permitted is where any individual can be identified from the information, rather than a disclosure whereby no individual to whom the information relates could be identified. That is a separate and helpful amendment, and proposed new paragraph (h) is much more in keeping with the rest of the amendments. They are simply brought together by a good fortune of drafting, that (h) follows (g).
I understand the Minister’s specific point about getting general consent at the beginning. I think that the problem is merely one of interpretation by the HFEA, and what she said will be helpful. In normal clinical practice, information is not divulged without consent; it is divulged with implied consent. When people see a GP they do not have to sign anything to say, “You have my permission to send the information on to a consultant”, because when someone seeks a referral from a GP, it is implied that that information will be transmitted. When the medical or surgical team want to write to GPs to explain that someone is in hospital and has received treatment, that is not done without consent, because it is implied.
Dawn Primarolo: I hope that the hon. Gentleman forgives me, but I forgot to cover that point. I absolutely accept what he says about data protection and general confidentiality, but I remind him that the EU tissues and cell directive sets standards of safety and quality for human tissue intended for human application, which includes areas that we are discussing, and goes further than the Data Protection Act. When I alluded to other legislation that would impinge on confidentiality, I had not meant to be more specific than that. It explains why there is a higher hurdle.
11.30 am
Dr. Harris: The Minister has no need to apologise, because I assumed that that was what she meant, and I was going to raise that in my points at the beginning. I thought, given what she had said previously, that I would not raise it in advance. I have a question about it, so it is useful that she has raised it.
Coming back to what I was saying, there is implied consent; treatment is not done without consent. Because of the nature of this treatment, and because of the complication of identifying donor information, there needs to be a process. Otherwise relying on implied consent can lead people to fall into traps of not knowing where the division goes. I understand the reason why there is a need for an explicit or written consent. Consent is a process, and written consent is a sign that there has been a process and it is useful. However, there is a problem with interpretation by the HFEA, because clinicians tell me—I believe that this is on the record in the House of Lords debates as well—that they are required, or feel that they are required, by the HFEA, whether in their code of practice, in their inspection system or by some other means, to get a consent form filled in for every visit, every procedure and every test, even when the general consent form has been filled in at the beginning.
There may be scope here not for legislation, but for it to be made clear to the authority, which may feel that it is doing its job and playing safe, that the requirements of the tissues and cells directive, 2004/23 EC, particularly article 14, can be met by a written general consent at the beginning, and that specific consent is unnecessary as long as patients are made aware that they can at any point change the terms of that consent. That should be straightforward to do, and specific requests can be made for certain information not to be provided. I think that requiring a form each time is unnecessary.
I am hoping that the Minister can assure me that the extra requirements created by the directive would not prevent a general consent at the beginning as long as the patient knows that.
Dawn Primarolo: I am happy to confirm that to the hon. Gentleman. When we were discussing consent at the beginning of our proceedings, we noted that discussions are taking place between the Department and the HFEA, and the HFEA is considering the whole question of consent, the exceptions, and how it is provided. That point might have been raised by the hon. Gentleman. Some of the things that he is saying now would need to be clarified within that discussion. The HFEA would need to take forward those discussions and the support and advice given to clinics.
Dr. Harris: That is good news indeed. The Government amendments are an improvement on the existing situation. Using the Minister’s words today—I hope that I have got this right—a general, specific consent at the beginning does not have to be augmented, although it can be resiled from at any point by a patient; they must have the right to change their mind in respect of future disclosures or for new treatments.
Dawn Primarolo: Just to put a qualification in there: of course, that should be within the limitations of the 1990 Act. It is about identifying and non-identifying information about the donor. For example, the identifying information cannot be made available until the child reaches 18; that cannot be the case, and nobody can vary that.
Dr. Harris: I completely accept that, and I have had no representations from clinicians questioning the need for such clear separation. They understood that part of being licensed was to understand the sensitivity of that. I welcome the fact that there are ongoing discussions and note that the Government amendments are an improvement. It should be possible to reduce the pressure. The criminal offence worries clinicians, and perhaps they are also playing safe. If the HFEA could make it clear that if they fulfil certain requirements—particularly for patients who give the general consent at the beginning that is not retracted at some point—it should be reasonable.
The only other point to bear in mind is that there is a continuing concern about the differentiation between licensed and non-licensed individuals, licensed and non-licensed treatments, licensed clinics and non-licensed premises. Some of that is inevitable. We cannot have a licence and say that there should not be a difference. The fact that one has to have a licence is because there is a difference, and that creates a difference. The Minister should have a discussion with the HFEA—I emphasise that for the columns of Hansard—about making sure that there is not what seems to be an unfair burden on someone doing normal work who happens to be licensed, or on someone doing work that could take place in an unlicensed place, but who happens to have a licence because they do other work. If it can be shown that they are not unfairly at risk, or facing unfair or unreasonable burdens, people will welcome the progress made, both in the legislation and in our debates.
Mark Simmonds: I thank the Minister for her response to my amendments and for her explanation of the Government amendments.
I accept what the Minister says about amendment No. 37. The list is clearly comprehensive and well thought through. It is correct that if there are to be regulations, or there is a necessity for them, they are subject to the affirmative procedure so that they have to be discussed in Parliament. Everyone on the Committee wants to see the Bill, when it becomes an Act, to last effectively at least as long as its predecessor, the 1990 Act. That is the whole purpose, so regulations can keep up to date with scientific advances as the years go by.
On amendment No. 38, again I thank the Minister. I understand what she says. It is right that there is general consent at the beginning of treatment, within the limitations of the Act, but she seemed to suggest that there was an ability for conditional consent—for information to be passed on. Her example was if the GP might be a family member. Is the Minister saying that exclusions can be specified on the consent form about whom is not able to receive that information, or, as I suspected originally, will there be generic consent?
On the implied consent argument and the exchange that has just taken place between the Minister and the hon. Member for Oxford, West and Abingdon, it is quite right that there is a higher hurdle when we are talking about such issues, as well as about human tissues. I am pleased that there are ongoing discussions with the HFEA and licensed premises, because I am concerned, like the hon. Member for Oxford, West and Abingdon, about the potential to put unreasonable bureaucratic burdens on licensed premises. I hope that those ongoing discussions will facilitate such a situation not occurring.
With regard to the Government amendments, I have one question for the Minister relating to amendment No. 54, which I am not clear about. Proposed new subsection (3) of that amendment reads:
“Consent in respect of a person who has not attained the age of 18 years”—
referred to in the amendment as “C”—
“may be C, in a case where C is competent to deal with the issue of consent”.
If I read that correctly, that implies that someone below the age of 18 could give consent. How young could that person be to give consent? Would they have to be above the age of 16 but below 18? Could they be 12? Could they be eight? There does not seem to be any clarification elsewhere in the Bill or anywhere in the group of amendments.
Dawn Primarolo: The hon. Member for Boston and Skegness asked about consent. What I described as general consent is the position that all the consent works from for disclosure of information. The patient is able to put exceptions into that. If the hon. Gentleman recalls the exchange between myself and my right hon. Friend the Member for Coatbridge, Chryston and Bellshill in last Thursday’s sitting, my right hon. Friend said that he might be prepared to give consent for certain types of research, but that he would want to make exceptions in other areas. We were talking about cases in which the donor was deceased. However, that starts from a general consent in which patients have the option to put in exceptions.
Although we are talking about general consent, patients should have the ability to make explicit exceptions to their consent for the disclosure of that information if those exceptions are not overridden by any of the other exceptions. It would be much too complex to have the two consents working in different ways against different principles. I understand that matters would proceed in very much the same way, but it is crucial that the HFEA examines the issue very carefully when it takes on new considerations of consent. There will clearly be active discussion of those particular considerations with stakeholders and the individuals and organisations that have made representations on this part of the Bill. I hope that I have made clear how the process will operate.
The other question that the hon. Member for Boston and Skegness asked was how old a person needed to be for the purposes of consent. The system does not work on the basis of age, but on whether an individual has sufficient understanding of the implications of the decision. That is obviously a fine judgment that needs to be made. I do not think that we can take that away from clinicians because individuals vary in their understanding. That is why there is not a specific age. I do not think that that is at odds with how we test competency elsewhere. Everybody has to be satisfied that an individual understands the implications.
The hon. Member for Oxford, West and Abingdon asked me a question about Government amendment No. 45, and I think that I answered it. The amendment specifically ensures that the provisions cannot be used to require the HFEA to disclose identifying information about donors for which specific provision is made elsewhere in the 1990 Act and the Bill. The amendment is constraining in that it reflects the wish to keep the measure very tight to the specific purpose. It was a result of clarification and tidying up following the very extensive debate on these measures that was held in another place.
I think that I have answered all of the questions that I was asked. If I have not, the hon. Gentleman needs to say now. I hope that the Committee will support the Government amendments, which I shall move formally at the appropriate time.
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