Select Committee on Science and Technology Minutes of Evidence


Examination of Witnesses (Questions 460 - 479)

WEDNESDAY 21 JULY 2004

MS ANGELA MCNAB, MS TRISH DAVIES, MR CHARLES LISTER AND DR CHRIS O'TOOLE

  Q460  Chairman: Do you record near misses and incidents as a safety procedure which operates across the business?

  Ms McNab: Since the Alert process came in, all clinics have to report every adverse incident that occurs, including near misses, and they have to report them to us within 24 hours.

  Q461  Dr Harris: For the general public whom you serve, do you, following suitable anonymisation, publish them?

  Ms Davies: Indeed. We publish a report every six months. We are just about to issue the first one—because this is a relatively new process that we have put into place.

  Q462  Chairman: Is it ever used in evidence to de-licence a clinic? Or are you inhibited from getting the data because you may have to de-licence a clinic for too many near misses? Is that a factor: if there are six near misses, that is as bad as an incident?

  Ms McNab: There is not a recipe or a calculation of that kind.

  Q463  Chairman: Do you think there should be?

  Ms Davies: I do not think it would be appropriate to classify all near misses as exactly the same, or all incidents as exactly the same, actually. There are different types of incident. They have different weights attached to them. There is a big difference, for example, between nearly pressing the wrong programme on a freezer and mis-labelling gametes. There is a huge difference, so I think to lump them all in together and say, "If you've got more than three strikes you are out," would be grossly unfair. But I think we have to remember here that there is a real balance to be struck between encouraging clinics to be open and to tell us when things go wrong, so that we learn from those and we make sure we have proper systems in place that prevent that happening somewhere else . . . . We are never going to get rid of human error. We will never, ever, ever get rid of human error.

  Q464  Chairman: I would not want to tell you because I might be de-licensed for a near miss.

  Ms McNab: Exactly. That is the dilemma.

  Q465  Chairman: How do you get round that?

  Ms McNab: When we talk about publishing the reports, we have to balance the need to put information properly and accurately into the wider domain so that we can learn from it and so that people do not think things are being kept secret, and on the other hand not having things all over the front page of one of the newspapers every other week, dramatising things so that clinics just think, "Okay, we will not tell you." We have to get a balance between those two things. I feel passionately that we have to work with the clinics and the professional bodies to find a system that does encourage open reporting, without blaming people for what might actually be a near miss, a minor system problem, that by flagging it up we can do something about and protect the wider world.

  Q466  Dr Harris: Coming back to the Toft report and continuing with the Toft report, it was highly critical of the HFEA in various areas. Why do you think HEFA has fallen into such disrepair that such a strong report was needed to correct it?

  Ms McNab: There were clearly a number of difficulties with the inspection regime—and I have to put my hands up to that. I think, largely, the authority had served this area extremely well in the first ten years that it had been running, but clearly there were some resource issues, and Professor Toft himself draws attention to those. The number of treatments had doubled in the first two years, the complexity of the treatment systems we were working with had really significantly increased, and the funding had not increased. In addition to that, there had been difficulties with perhaps reviewing the way that inspection was being carried out (standing back and thinking what an appropriate safe system would be) and clearly there was a need for more openness—and I put my hands up to that. So there were some weaknesses in the system, some of which were down to resources and some of which were needing to have a more modern understanding of regulation. I am absolutely convinced we have made the vast majority of changes that Professor Toft himself recommended. We have gone further in some stages. I think the system we have now is much stronger, much more robust, and considerably more open.

  Q467  Dr Turner: These nine adverse incidents that happened in the past, were they each the subject of independent investigation? Were the results of that investigation published? How confident are you that those nine adverse incidents were the only ones that actually happened?

  Ms McNab: Let me take those points in order. When Professor Toft approached me when I first came into post, he asked me whether I could find information about whether there had ever been incidents in the past of this nature, of this particular type he was looking at around labelling and identification, and, if so, how many. It was very difficult getting hold of the information. The systems that were in place at the time, for the first ten years or nine years of the Authority, did not make it easy to retrieve that information, so it meant going back through a number of records to find out whether such events had occurred. By going through that exhaustive process, I did identify a small number. I cannot recall whether it was seven or nine, but I am happy to correct that later if the Committee would like me to. It was certainly less than 10, a small number, over a 10 year period. In each case they had been reported to the Authority by the clinic concerned or identified upon inspection. They had been investigated, therefore, by the regulatory staff and the information presented to a Licence Committee; so there had not been an external review, as there had been with the situation Professor Toft was commissioned to look at. The report had been made to a Licence Committee. They had clearly then followed up with the clinic whether the appropriate changes had been made to make sure that such things could not happen again, whether they were satisfied about the safe running of the clinic, and it was a private matter on the licensing history of the clinic. That changed when we instituted the Alert system, when we said that any event that was reported to us, once appropriately anonymised to encourage open reporting, would be circulated right across the whole of the UK, so that we did not have a situation where a clinic has a problem, they realise there is a potential for human error causing a problem, they tell us and we do not tell anybody else: "Gosh there is this potential and let's all do something to make sure it cannot happen again." Now, we do have that system, so that we do not keep any of these events localised and the learning therefore not shared.

  Q468  Mr Key: I would like to turn to your powers under the Act. It has been put to us that you exceed your remit, that, in the words of one witness, you are "altering statutory boundaries". Do you think you are?

  Ms McNab: No, I do not think we are. I think we meet very well the principles that are set out in the original Act. As I have said, and as the authority has made public, we think that now is the time for a review of the Act. We are very pleased about that. We think there are some areas where debate in Parliament and further consideration is absolutely appropriate. But, as confirmed by the courts, whenever decisions that we have made have been taken to the courts, I believe we have utilised those well and we have worked within those powers responsibly.

  Q469  Mr Key: Are you talking about schedule 1, paragraph 2 of the Act, which gives you a general power to perform certain functions, that bit which you use to justify your campaigning, your comments on court rulings and so on? That is the bit, is it, that you use?

  Ms McNab: Yes.

  Q470  Mr Key: Do you think you should be a policy-making body? Because effectively you are trying to change policy, are you not?

  Ms McNab: I think there has to be a balance between being able to respond fairly swiftly, through an organisation such as the HFEA, to new advances that are made in the field that we regulate, and particularly being able to consider some of the individual situations that come to us where we are very much at the boundaries of new science. I think the balance is between having an organisation that can respond appropriately, based on the legal, medical, scientific and ethical evidence, and, on the other hand, absolutely appropriately standing back and looking at some of the wide ethical issues and ensuring that those are debated in Parliament and that those principles are set by Parliament. I think we work very well within the statute that we have and I think we make those decisions in a measured, evidence-based way.

  Q471  Mr Key: Under schedule 1, paragraph 2, which gives you the power to do anything which is calculated to facilitate the discharge of its functions, it does not give you any power to do anything new. It has been put to us that you are in fact extending the powers which are given to you under the act; for example, encouraging research, which is not in the act.

  Ms McNab: I think it is appropriate in our regulation of research that we are not obstructive. By ensuring public confidence and ensuring the safety of research and ensuring that research is carried out to the criteria within the Act, that we facilitate good research, and therefore improving patient safety and treatment services.

  Q472  Mr Key: You have had a Legal Adviser since 2003. What difference has that made?

  Ms McNab: Our Legal Adviser is now absolutely on hand to be able to advise every single Licence Committee. I would say the greatest difference which that has made is in the support to Licence Committees. Previously Licence Committees clearly could access legal advice, but, because we did not have our own in-house Legal Adviser, I think there were sometimes delays in accessing advice. I think the on-going potential for legal support was not as well put forward as it could have been.

  Q473  Mr Key: Has your Legal Adviser ever advised you that you are acting outside your statutory remit?

  Ms McNab: The Legal Adviser, particularly when we are looking at individual clinical issues, will remind us of the boundaries of our statute regularly.

  Q474  Mr Key: But that is not what I asked. Has the Legal Adviser ever told you that you are acting outside your remit?

  Ms McNab: No. They have told me what the remit is, what the boundaries are, and therefore we have made sure that we have not overstepped them.

  Q475  Mr Key: Has the Department of Health ever had any discussions with you about your remit and possibly exceeding it?

  Ms McNab: We have regular ongoing discussions with the Department of Health about our remit, but I do not recall ever being told that I was overstepping my remit. And when we have taken decisions that have been controversial or where people may have been concerned about those areas, the courts have confirmed that what we have done has been appropriate, within our powers.

  Q476  Mr Key: Do you think it is appropriate that the HFEA should campaign for changes in the law on ethical or, indeed, social grounds?

  Ms McNab: I think it is appropriate that the HFEA can draw to people's attention where there may be inconsistencies or where there may be a need for society and Parliament to review certain areas. I think that is appropriate.

  Q477  Mr Key: We have been told by a former member of the HFEA that you have on occasions acted ultra vires. Do you reject that?

  Ms McNab: It is not my recollection whilst I have been at the Authority but I am happy to go back and check any specific issues which you draw to my attention.

  Q478  Mr Key: Would you please do that and let us know. Thank you very much. Do you have staff, senior staff, who have the same level of expertise in social justice issues, for example, as in legal terms? I mean, do you have ethicists and other staff who can advise you on that?

  Ms McNab: The decision-making, of course, rests with the Authority itself and not with the executive staff. We have to remember the split between the executive and the non-executive side of the organisation. We have staff who certainly have good experience in working with ethics but we have an ethicist on the Authority. The Ethics and Law Committee is where the first consideration of ethical issues will take place and advice will then be placed before the Authority. I am quite content, particularly with the increase in resources that we have been given, that we have been able to draw in the skills and the expertise that we need.

  Q479  Mr Key: Is it becoming increasingly difficult to interpret the Act in the light of new technologies in science?

  Ms McNab: Yes, I think that is true. That is one of the reasons why we have said that we welcome your discussions in this area and your advice to government and we welcome the possibility for a review. Science has moved on enormously in 13 years and it is absolutely time to revisit some of those areas, particularly around issues such as the selection of characteristics and some of the areas that the new technologies pose to us.


 
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