Select Committee on Science and Technology Minutes of Evidence

Examination of Witnesses (Questions 480 - 499)



  Q480  Chairman: Animal/human hybrid cells.

  Ms McNab: Indeed.

  Q481  Chairman: Do you have a view on that in the HFEA?

  Ms McNab: I do not particularly have a view, because my job is to serve the Authority. My job is to give them the advice and the evidence that they need in order to form a view.

  Q482  Mr Key: Would the view of the HFEA be determined by the methods of the Authority coming to a decision?

  Ms McNab: Clearly that is where the decision-making lies within the organisation.

  Q483  Mr Key: What is the quorum of the Authority? How many members must be present in order to make a decision which is in effect a change of policy?

  Ms McNab: I will have to check that I have my facts right on this, but my understanding is that it is two-thirds and that there has to be a lay majority.

  Q484  Mr Key: How good are the members of the authority at turning up? Because obviously a decision might be quite different if the ethicist on the Authority is not there one day.

  Ms McNab: I think the first thing to say about that is that we have an incredibly committed and conscientious Authority and our attendance is extremely good. The second thing to say is that, if there were a particular issue that required specific expertise, we would defer that issue if we were aware that members with that expertise, who would be particularly wanting to contribute or if it was important to have their contribution, were not going to be there. The Chair is particularly aware of this situation. We would not allow a meeting to take place where a crucial decision was taking place without the appropriate expertise.

  Q485  Mr Key: Would you be willing to send us a list of the attendances at the Authority's meetings.

  Ms McNab: Absolutely.

  Q486  Mr Key: Over the past year.

  Ms McNab: Absolutely. I would have no problem with that at all.

  Q487  Mr Key: Thank you very much. Each Code of Practice when it is coming out, the new edition, has been longer than the last Code of Practice. In other words, there is a regulatory burden which of course falls on clinics. I wondered if you have any method of making an impact assessment on the work of the clinics in order to comply with your regulations.

  Ms McNab: I think, to some extent, it is inevitable that, as the science becomes so much more complex, the guidance or the detailed information that we provide to clinics on how they can properly meet the standards also becomes more detailed or more complex. As I said earlier, I think it is absolutely right that we continue to look at the balance between proper safe regulation and not being a burden. I am fully aware of the need for us to stand back. In fact, I think it is very important in the next couple of years, with the Tissue Directive, that we look at what are the appropriate methodologies for regulation. I do not make an apology for increased length if it means that we are addressing some of the new complexities out of the developments that are taking place. I think it would be much worse to say not enough and for people to be left in a chasm of misunderstanding. Regulatory impact assessments are carried out with every new bit of guidance that we give. I can give you a really good example here: Through our Alert system, we became aware that there were a small number of problems arising with dewars, where gametes are stored. We investigated therefore whether we should change the standards, the guidance that we gave to clinics about this issue, because it is clearly very important. If people have, for example, had cancer and have stored gametes so that they can have a family later on, the last thing they want to find is that those have been made vulnerable because of a problem with the equipment. We looked at this and we carried out a regulatory impact assessment, as we do with any change of that kind: Looking across the board at all the clinics, what will this mean for clinics if we impose some greater standard to protect individuals' future potential for a family? Then we put through a policy change. That is a really good example of how the Alert system works well, how we can react fairly quickly, but not impulsively, without consulting and looking at the impact of what we do.

  Q488  Mr Key: Have you discussed the problem of regulatory and financial impact upon clinics and which they dislike most: the regulations or the prospect of very substantial fee increases?

  Ms McNab: I have not given it to them as a choice in that way: which do you like least, being inspected or potentially having to pay more in fees, so I cannot tell you which one they would choose. I have to say that we now seek feedback from every clinic and after every inspection so we certainly get comments about the quality of the inspections, whether or not they were burdensome, whether or not they were consistent and any comments that they want to make. We have also done a survey of all clinics asking similar questions just recently. Largely, clinics appreciate the inspection and regulation that goes on because it is in their interests not to have rogue clinics operating, not to have poor standards operating. They clearly want the profession to be a quality profession that everybody has confidence in and they support regulation very strongly. They also see that through good regulation you can ensure that services are protected.

  Q489  Mr Key: Why do you carry out public consultations?

  Ms McNab: In order to take account of the public view on particular matters.

  Q490  Mr Key: If your duty is to interpret the statutes, is it really appropriate for you to do that?

  Ms McNab: I think it is absolutely appropriate and I was very pleased to see in the BMA's own response that they agree that not necessarily purely relying on public opinion but taking account of public views is very important indeed.

  Q491  Mr Key: Do most of the views come from one particular lobby group one way or the other or are they generally representative of the public, do you think?

  Ms McNab: I do not want to mislead the Committee in any way. I suspect that it depends largely on the topic that we are consulting upon. I suspect that there will be some topics where there will be a lot of interest from a particular community and maybe not so much interest from others. I suspect that for other issues such as sex selection there will be a wide ranging interest across a whole range of groups. If the Committee would like me to look at the last few consultations that we have had and give you a balance of the types of reply we have had from different sectors, I would be very happy to do that. I do not have those facts in my head, I am afraid. My apologies.

  Mr Key: That would be very helpful.

  Q492  Chairman: Is it your bet that today the Authority will make a decision on the situation which has been heavily trailed on the family in Northern Ireland?

  Ms McNab: The policy regarding PGD and HLA, as we have said, has been under review and the evidence regarding that review is being presented to the Authority today.

  Q493  Chairman: You are making a judgment on a particular case that has been heavily trailed through the media.

  Ms McNab: No, we are definitely not doing that. We are reviewing the overall policy and information is going to the Authority today.

  Q494  Dr Harris: Will a decision be made today? Is that your expectation? Is there a question to be decided today?

  Ms McNab: The policy is being reviewed and the Authority will wish to look at that policy as it exists and consider the evidence put before it to see whether it is now timely to change that policy. I cannot anticipate whether or not the Authority will do that and I cannot absolutely guarantee that that will happen today because the Authority must make its own mind up when it sees the evidence presented before it.

  Q495  Dr Harris: Is it scientific evidence or has there been a legal development? What has changed since the Whitakers were turned down?

  Ms McNab: What has changed in the area of PGD and HLA is that there is now two years' more data across the world of carrying out these kind of techniques. Therefore, there is information regarding outcomes, safety, and about the data, not just in this country because a relatively small number of these procedures are carried out worldwide, but there is collectively two years' worth of experience and in addition any update on the views of the public and on the wellbeing of the children.

  Q496  Chairman: As members of the public, will we see that evidence as presented to you?

  Ms McNab: Absolutely.

  Q497  Chairman: Will it be in The Times?

  Ms McNab: The minutes of all our meetings go onto the web.

  Q498  Chairman: Including the evidence?

  Ms McNab: Including a summary of the evidence, indeed.

  Q499  Dr Harris: I am still confused. I am not clear about this. You did not mention in your reasons why the policy might change legal advice or legal changes. You said public opinion, which you have already caveated as not being critical, scientific work and the safety of the procedure.

  Ms McNab: Forgive me if I misled you. Whenever any policy review is carried out, it will look at the legal, the ethical, the medical, the scientific evidence that there is and it will take account of public opinion. Those are the principles that underpin all policy, whether it is new policy or policy review, and those are the areas of evidence that will be presented this afternoon to the Authority.

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