Select Committee on Science and Technology Minutes of Evidence

Examination of Witnesses (Questions 540 - 557)



  Q540  Dr Iddon: Some people have said to us that you are regulating things that are now routine medical procedures. Do you think those could be transferred to the General Medical Council for controlling and inspection—IVF, for example, and infertility treatment?

  Ms Davies: I am not sure that the creation of life is a routine medical procedure. I think that is a bit different from any other medical procedure. As the Act stands, Parliament has thought this is a very special area and needs regulating separately. One of the ways in which we are trying to streamline our licensing and inspection process is, where say new techniques have come in and we have been looking at them very closely, like ICSI, and we have required centres to give us a lot of information, we have gone out and inspected how competent their staff are. Now that that has become much more of a routine procedure, the Authority has now agreed that we do not have to do that any more. We can put the responsibility back to the clinic to ensure that their staff are competent and just give us the data so that we can periodically check that that is the case.

  Q541  Dr Iddon: Can I make sure that you are giving us the view of the HFEA, your committee, rather than the executive opinion on what I have just said about routine medical procedures being transferred out of your control into GMC control? Is this something you have discussed as medical procedures become much more routine that are now under your control? Has that been discussed, the transfer to the General Medical Council?

  Ms McNab: I do not think it would be appropriate for it to transfer to the GMC whose focus of interest would be slightly different. We have a memorandum of understanding with them so we are very clear about what our areas of responsibility are. We have to remember that, when you look back at the alerts that we have had and the incidents that have occurred, they have largely occurred during the course of routine, day to day, ordinary activities, not the new technologies. Therefore, I think that demonstrates that continued, strong regulation in this area is what is required.

  Q542  Dr Iddon: You have told us you are in the process of appointing a full time scientific inspector.

  Ms Davies: Recruiting.

  Q543  Dr Iddon: You plan to employ a clinical inspector to carry out a proportion of inspections consistently to monitor the performance of external inspectors. Is that person in post now?

  Ms Davies: No. We have not been successful in our first couple of attempts to recruit a clinician so we are having another go at it.

  Q544  Dr Iddon: Is that going to be a continuing trend towards more in house inspectors to bring about the consistency we discussed with Professor Toft earlier, which would diminish the number of external instructors?

  Ms Davies: What we will want to do is evaluate the impact of having in house inspectors. Clearly, if we feel that that is beneficial and the most effective way to proceed, we can expand on that and divert resources from one set of staff to another.

  Q545  Dr Iddon: Do you think there are conflicts of interest when clinicians are responsible for making judgments about their competitors?

  Ms Davies: The whole issue of conflict of interest is dealt with extremely scrupulously both by Licence Committees and by inspection teams. For example, I am aware of one team which got to an inspection—and we do screen for conflicts of interest before we put the teams together—and the clinician recognised that he had trained with one of the clinicians on site. It was agreed that he should depart and we got somebody else in at very short notice to carry on the work. We are very careful about that.

  Q546  Dr Iddon: Are inspectors expected to declare interests of that kind as part of your procedures?

  Ms Davies: Yes.

  Q547  Chairman: Will the EU Tissue Directive cause more work for inspectors?

  Ms Davies: We understand that we are likely to be the Competent Authority in terms of the gametes and embryos that we regulate. It will be more work for us. In terms of the centres, I think there will be particularly challenging standards for them to meet. That will involve them in a certain amount of extra work but the whole idea behind the Tissue Directive of having mandatory quality assurance systems is a really good one and it is something that we want to move towards having a much stronger focus on.

  Q548  Dr Iddon: What is it about assisted conception that requires it to be regulated in the same way today as it was in 1990?

  Ms Davies: What we have said and what the Authority feels is that there is scope for some changes in the legislation. Your review and the review of the Act are welcome. Assisted conception does need regulating but it may need some changes in the way it is regulated.

  Q549  Dr Harris: I want to ask a policy question around the welfare of the child. It is a difficult area. You have now recommended that this be looked at—indeed, in particular, the need for a father provision within that being looked at again by Parliament—and that was a recent suggestion by your chairman. Do you think that is timely or overdue, given that we have had the Human Rights Act protecting the rights of people not to be discriminated against somewhat longer than we have had the recommendation from the chair of the HFEA that this needs to be looked at?

  Mr Lister: It is very timely and, as well as the Human Rights Act, we also have the civil partnership legislation as well.

  Q550  Dr Harris: The fact that there may be hundreds of people who have been discriminated against since the Human Rights Act—and of course those rights existed with the European Convention of Human Rights—and clinics you regulate have been saying, "Go away, you are gay" you think has been acceptable until very recently?

  Mr Lister: I am not aware of how many such cases there have been.

  Dr O'Toole: There are probably very few. Most clinics that have a criterion that restricts who they will treat and say they do not treat single women etc., would normally refer them on to a clinic that will treat them.

  Q551  Dr Harris: Do you know how many clinics discriminate in a way that is questionable in law? Do you know how many people have been humiliated in that way by being told, "We are not going to treat you"?

  Ms McNab: I cannot give you that number but I am very happy to come back to you with the number. I do not have the absolute number of those clinics that say they are uncomfortable about treating single women or single sex couples. There is a small number of clinics who say they are not comfortable about doing that and they do not offer that therefore as a service.

  Q552  Dr Harris: It is not just that they are not comfortable; they are not going to do it.

  Ms McNab: They have taken the decision that they do not feel comfortable with it. I can give you the numbers. There is also a large number of clinics that treat single women and that make it very clear that they treat single women and lesbian couples. The fundamental issues here around the welfare of the child are twofold. One is that it seems absolutely right that reproductive freedom on the one hand should be balanced with the welfare of children being created on the other hand, and it is right that clinics absolutely according to the Act consider the welfare of children to be born. The more important issue that you are alluding to here is: is it still right that there are specific questions asked about the child's need for a father when that appears to be perhaps inconsistent with other areas of legislation such as the civil partnership scheme and human rights.

  Q553  Dr Harris: And inconsistent—you have raised this yourself—with the evidence from social research suggesting that there is no detrimental effect on the welfare of the child, which is the only context for this need for a father provision.

  Ms McNab: We would welcome your advice to government and we would welcome this area being discussed again in Parliament.

  Q554  Dr Harris: Do you think you should have proactively sought to question in law, through a judicial review of the decision of a clinic, to help clarify the situation whether that was lawful; or do you think it is okay to be relatively laid back and say, "The law may be being broken, but we will wait for someone to have the courage and the ability to parade themselves publicly and take a judicial review themselves"?

  Ms McNab: I am happy to be corrected on this one but I absolutely believe that that would be outwith my powers. I absolutely believe that the Authority is there to implement the Act as it stands and to ensure that clinics meet the requirements of the Act. It is not for us to judicially review what is essentially in the Act. I think that the earlier question about do I believe I exceeded my powers would apply if we had tried to do that, but we are very grateful for your advice on this particular issue to government.

  Q555  Chairman: For long term issues you will end up just regulating the market, will you not? You will be looking at clinics, looking at their books and making sure that they do not cheat and so on. Is that not how this whole thing will end up for you as an organisation?

  Ms McNab: That is absolutely not my expectation. My expectation is that the fundamental improvements that we have put in place to ensure that patient safety is guaranteed and that patients are at the heart of regulation will continue. I am sorry we have not had time this morning, for example, to talk about our patient feedback process and the fact that patients' own views and experiences are incorporated into inspections and the judgments that we make. That is the direction that I would very much see regulation continuing in. We will have more of a patient voice and more methodology around the way that we carry out our inspections, to ensure that we get this balance between the burden or the bureaucracy, if you like, but also the absolutely strong, fundamental assurance about standards. We have more to do on that. I am sure we will improve on that.

  Q556  Chairman: Tell me how patient safety is compromised with the current processes. You are saying you need to do more. How are they compromised?

  Ms McNab: I do not believe that they are compromised but with the Tissue Directive and new technologies constantly appearing we have to continue to look at the standards that are set and the way that we regulate. Another year's worth of data from our alert system will, for example, give us a lot more information about where are the real risk areas; how can the technologies such as bar coding or electronic tagging and those kinds of developments play a part in ensuring patient safety. I do not pretend for a minute that we have all the answers to that, as we do not have in other areas of medical care, but I do think we will gather a lot more information now that we have those systems correctly in place and we will be able to act upon them.

  Q557  Chairman: Thank you very much indeed for coming along and subjecting us to your knowledge and enthusiasm. We wish you well and we look forward to a full investigation, a full report and the government reacting.

  Ms McNab: Thank you. We will come back to you wish the issues that we promised.

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