Select Committee on Science and Technology Minutes of Evidence

Examination of Witnesses (Questions 500 - 519)



  Q500  Dr Harris: The implication of your earlier answer was that the Whitakers were turned down on the basis of factors that now may have changed, which were public opinion and two years of data on safety.

  Ms McNab: Any policy which is set or reviewed is based on those principles that I have outlined. They include the legal principles, the medical, the scientific and ethical evidence and any information that is available about public opinion. That is the evidence that would have been considered when a new, controversial technique such as PGD with or without HLA was first considered by the Authority and that is the information that will be considered today in a review.

  Q501  Dr Harris: My understanding was the Whitakers were turned down on legal grounds; it was outside the powers of the HFEA under the HFE Act to license that activity. Has the law changed?

  Ms McNab: My understanding is that when this technique was first considered and an application was first received, there was a limited amount of evidence regarding the long term safety and the outcomes from this particular procedure. The balanced view at that time was that, in the case of the Whitakers where there was no potential benefit to the embryo being created, it was considered not to be for the welfare of the child to allow this procedure to go ahead.

  Q502  Dr Harris: You have had a legal opinion to that effect?

  Ms McNab: The weight of the evidence at that time was a lack of information about the safety of this procedure. Clearly, it is an invasive technique one is carrying out when you are carrying out a PGD or an HLA on an embryo. There is a biopsy involved. Therefore, one needs to consider what is the evidence about long term safety to the embryo being created. What are the potential psychological implications of a child being created in order to save the life of another, a whole range of information about the wellbeing of the embryo that is being created. My understanding is that at that stage, at this very early time when this new technique became available, there was very little evidence and therefore a precautionary approach. It was the view of the Authority at that time that, from the point of view of the welfare of the child, because in the Whitakers' case there was not a benefit to the embryo being selected, this could not be justified.

  Q503  Dr Harris: What you are saying is that there is not some legal opinion there in the files that has not been published by the HFEA that says you cannot do this. I do not disagree with your analysis. I understand where you are coming from in respect of the lack of benefit and potential risk to the embryo but you are saying that all this is in the public domain and there is no secret legal opinion.

  Ms McNab: As I have said, the evidence that will be presented to the Authority this afternoon will be presented on the web, along with the minutes. That will not be a secret at all.

  Q504  Chairman: Safety is one of the issues. Would you say that there is new data on safety?

  Ms McNab: We have two years' experience that we did not have when the first applications of this kind were received by the Authority. This is a situation which is bound to happen again and again. A new technique becomes available, something novel, something that looks as if it has huge benefits potentially. An application is made to the Authority. There will be two decisions to be made. One will be about the overall policy regarding such a new technique and one will be about granting a licence to an individual clinic to carry out that process or not for the individual couple. I have to draw that distinction because it is important that you know that even in an overall policy about a particular application you still need to have an application from a clinic to carry that out for a particular couple. This is always going to be a dilemma when a new technique comes to us and there is limited data. We have to be very aware of the risks as well as the benefits and we may at times have to be precautionary. That is why it is right that we are flexible when we review these things.

  Q505  Dr Harris: When you made your decision on the Hashmi case, it was different for reasons we understand. You were criticised by this Committee in the report for potentially exceeding your powers. Was that a factor underlying your decision in the Whitaker case and, if not, in the view of this Parliamentary Select Committee, why not?

  Ms McNab: I am very happy to look at the information from the committees and from the Authority at the time in order to clarify this, if I in any way do not give you the factually correct position. My recollection is that the difference between the two cases was fundamentally based on the welfare of the child and a concern for the ethical principles underpinning selecting an embryo where there is no benefit to the embryo itself. That is my understanding of the fundamental principle that separated the two decisions. You are absolutely right to draw attention to the fact that questions were asked about the legal powers and whether this was a treatment that fell within the jurisdiction of the Authority. That was a challenge from outside. If you recall, we were challenged by an outside organisation. That did go through the courts and our powers were fundamentally confirmed in this area, so to that extent in the intervening period those court cases have taken place. I am quite sure that, as part of the context that is presented to the Authority today, they will be reminded of that. My own recollection of the initial decision between the Hashmis and the Whitakers is that it was based on ethical and welfare of the child issues regarding the benefit to the embryo and the risks and benefits of the procedure itself, given that there might be no benefit to the embryo in one case and there would be in another case. It was not a legal issue.

  Q506  Chairman: If there is new safety data for the implementation of this now, how will that input into your guidelines on serious disease? There would have to be implications for that too, would there not, in terms of your guidelines? They would have to change too. Will that be examined today?

  Ms McNab: The evidence that will be presented to the Authority today will cover all of those areas. It will not only look at outcomes and any information that there is on safety, but obviously that will be a key bit of the information that is presented. The principles that we need to apply within this policy are one of the areas that the Authority will be considering.

  Chairman: I can see sparks flying when it is all decided.

  Q507  Mr McWalter: In the evidence we had in July 2002, some people of distinction told us that the HFEA were inefficient, lacking specialist knowledge; you were a slow and reactive body. This is to do with licensing. Were those the bad old days and has it all changed?

  Ms Davies: Of course. Since I joined the Authority, I have certainly been made aware of a lot of improvements that have been put in place, but the pace of change is, if anything, even more rapid at the moment. If you look at any recent cases we have been dealing with, you will find the correspondence is dealt with a lot more efficiently. We have certainly been streamlining the licensing process. We have made a lot of improvements in terms of legal support. We have three teams of committee members in place so that we have no problem now setting up committees which I think has been a problem in the past. We have just appointed a committee secretary to service those licences which has not been the case in the past. We will be able to turn around the correspondence. We are streamlining the whole process of generating licences electronically and there are some fairly complex conditions that have to be attached to licences. All of that adds up to a much more efficient and effective licensing process. That is what is going on in terms of managing the Authority end of it. In terms of the inspection end of it, we are booking our renewal licences well in advance now and centres have a lot of notice. We are piloting some new inspection protocols to make sure that the evidence we are looking at and gathering is much more standardised than it has been in the past. We have modernised our inspection process. We have changed our inspection reports. We have given them the plain English once over. We want to make them much more accessible to the public. We are turning them round now within our performance indicator of four weeks after the inspection and we are doing that regularly. I think all those add up to quite a lot of improvements, but there is still more to do and we are still looking at ways in which we can improve even on those figures.

  Q508  Mr McWalter: I know you have not been there very long but does it not surprise you that you have had to make so many improvements? How the heck did it reach the stage that the HFEA was falling down on the job in the first place?

  Ms Davies: I did not get the impression when I joined the organisation that it was falling down on the job at all. What is refreshing is that the organisation is very much prepared to look at the way it is operating and continuously make improvements. I do not say for one moment that the things we are looking at now and the improvements we are putting in place will be the end of it. We will go back and talk to clinics and centres and get information from them. One of the most pleasing things for me about our recent improvements is the fact that we have just put on line, on our website, a patient feedback questionnaire. We want to improve our engagement of patients on inspections. I am sure that has been an issue for some time and fortunately we have the resources now to put that into practice. Not only are we using paper copies being given out on the inspections themselves; we have direct access for patients to feed back to us on line which will help us gather together and focus the inspections that we are going to be carrying out.

  Q509  Mr McWalter: You must understand that it would be a slight source of worry to us that the organisation reached a stage where it had extensive evidence that there were many problems. The previous chief executive was dismissed and yet we are talking to somebody who says, "Well, no, it was not too bad really". If that is the judgment of someone who is now in post, namely you, and you feel pretty untroubled by what has happened in the past, I am worried that if there are major defects still now you might not be the person to spot them and correct them.

  Ms Davies: I am not sure—and I apologise if I did—that I did say I was untroubled about what happened in the past.

  Q510  Mr McWalter: You said it was not falling down on the job.

  Ms Davies: From the review five years ago and certainly from prior to Professor Toft's report, there were clearly a lot of issues that needed attention in the Authority. Over the last year or so, a lot of improvements have been put in place and we are building on those and capitalising on the extra resources that we have to do so.

  Q511  Mr McWalter: We have some evidence that there are continuing problems post the Toft report. Would that surprise you?

  Ms Davies: I am happy to take any criticism that you might have received in front of this Committee and to act on it. Clinics are usually inspected once a year so there is obviously a time lag between instituting improvements and a centre being on the receiving end of those improvements. Some of these will take several months to work through into the next round of inspections for some centres.

  Q512  Mr McWalter: Some of the problems we have relate to the quality and professionalism of inspectors and the question of accreditation. I would be interested in your views on whether you feel there is a lot of work still ongoing on that and indeed, for instance, whether you have thought of having full time inspectors and whether there are any other matters that relate to those expressions of concern that we have had.

  Ms Davies: One of the recommendations of Professor Toft that we are still putting in place is the whole business of appraising our inspectors and retraining them. We did a big recruitment drive at the end of last year and we put the inspectors that we recruited then through a two day training process and selection process, at the end of which we had a lot of confidence in their ability to handle inspections in a consistent way and in accordance with our protocols. We are commissioning another piece of work with existing inspectors to put them through that same process so that we can ensure consistency. The fact that we have introduced new protocols will help in that respect. We will expect them to fill in the details of the questions we are asking in a standardised way. You can never eliminate some kind of human variation and variability, but we are putting in as many measures as possible to do that. With regard to your question about full time inspectors, we have tried to recruit so far a clinical inspector without success but we are looking at that again. We are about to advertise for a full time scientific inspector. I think it is healthy to have a mixture of full time inspectors with expertise and the ability to call on expertise from the field when we need it. It is a very specialised field and I think we will always be in a situation where we need a certain amount of expertise that we cannot necessarily maintain in house.

  Q513  Mr McWalter: It is worrying though, is it not? If you are looking for people in very senior posts to hopefully give you specialist expertise that currently you lack and yet you are still appointing inspectors, it looks as if the claim about lack of specialist knowledge may still have a certain amount of sting to it and it might mean, for instance, that people offer themselves as inspectors to you and they may not be assessed as adequately as they would be had you more senior people in post.

  Ms Davies: We have about 80 inspectors on our books and between them they have an enormous range of expertise which gives us the ability to draw in the teams we want for each inspection. Within my own staff, there is a lot of expertise in terms of scientific background and those staff are full time. They chair the inspections. Their job is to ensure that the team operates with a degree of consistency and to pull together and write up a report. We have the mechanisms in place at the moment. I go back to my earlier point about always wanting to improve.

  Q514  Mr McWalter: You have awarded 150 research licences since 1991. How many of those have been for staff training?

  Ms Davies: I am not aware that we license for staff training.

  Q515  Mr McWalter: You license for staff training in connection with the other eight functions for which you will need licensing and training has to be part of that, does it not?

  Ms Davies: In terms of the competence of the centre to carry out their research?

  Q516  Mr McWalter: Yes. If you are enabling knowledge to be developed in terms of serious disease or something, will not training play a role in your evaluation?

  Ms Davies: In our evaluation of the applications, yes. We do carry out extremely thorough evaluations.

  Dr O'Toole: The fundamental part of giving a research licence is that the use of a human embryo has to be absolutely necessary for one of the purposes set down in the Act. 16 of our current projects are towards improving fertility, looking at for example non-invasive biochemical marker to evaluate embryos so that we can move towards putting back a single, good quality embryo that has the best chance of implanting, which hopefully will reduce the multiple birth rate. Prior to a licence being granted, it has to have external ethics approval. We send it out to peer review and part of that is to ask whether the use of human embryos is necessary, whether it meets the criteria of the purposes set down in the Act. We also insist on seeing patient information and consent forms because fundamentally it is the patient that has to consent to the use of their embryos in research and they have to do so in an informed way that will not impact on their own treatments. We look at all of this as part of the inspection of research and the information that we ask for before it is submitted to a research licence committee to make the ultimate decision on whether the licence should be granted.

  Q517  Mr McWalter: Obviously if you go along to a research institute and you are looking to evaluate whether they should be licensed or not, you are in part going to be looking at the extent to which they are or are not competent to train the people who work there to be able to carry out the tasks within the purview of the Act. I would have thought that should be a very clear indicator.

  Dr O'Toole: Absolutely. Some of our projects for looking at pre-implantation genetic diagnosis is to look to see if they can improve the texts or extend the text to look for more genes as detection for other serious diseases. Obviously part of it as well is to improve the technique of removing the single cell from the embryo, which is done under a research licence to begin with before we allow that person to perform an embryo biopsy as part and parcel of clinical practice. Obviously staff have to be competent before we allow them to use these quite invasive techniques in clinical practice.

  Q518  Mr McWalter: You have a training protocol, standard operating procedures and technicians and so on and that is all part of your inspection regime, is it?

  Dr O'Toole: In terms of the research inspections, we have in house staff that chair the inspections and we will take along with us an appropriate scientific inspector.

  Q519  Mr McWalter: That is sharp to me. Would you be surprised to hear that some people have told us that on the whole clinics do not have much to worry about really when an inspection happens and, on the whole, it is pretty easy to meet the requirements of the HFEA?

  Dr O'Toole: Say a centre wants to carry out research either for the first time or in another project. We are in constant dialogue with that clinic. We will go and see them or invite them to meet with us. There is an awful lot of dialogue before we get to the full application coming in and before the inspection so hopefully the inspection has been met before we get there.

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