Select Committee on Science and Technology Minutes of Evidence

Examination of Witnesses (Questions 520 - 539)



  Q520  Mr McWalter: You have issued 150 licences. How many of those have been withdrawn? You have a licence. Now you are inspected and this inspector is looking at all sorts of things, presumably quite a lot of the time including perhaps training but that does not seem to be very clear, and now you have arrived at the situation where you think these guys are not hacking it. How many times does that happen?

  Dr O'Toole: To my knowledge, it has not happened very often. I think there have been about two. However, I can supply the Committee with the exact figures where a licence may not have been renewed because the work was not progressing as it should have been or something like that.

  Ms Davies: Are you talking about licences in general or just research licences?

  Q521  Mr McWalter: If I had 150 students and only two failures and both of those had withdrawn voluntarily, they might view my assessment techniques as perhaps rather less than harsh. If this general feeling in the community is that on the whole once you have the licence you are unlikely to be subject to really intensive scrutiny, including for instance it would appear that since patient safety is rather entirely dependent upon the actual things that laboratory technicians do, we do not seem to have an agreed training protocol for that so it becomes a bit easier for people, once they have a licence, to keep it. The sharpness of the evaluation seems to be a bit of an issue.

  Ms Davies: I agree with you that the sharpness of the evaluation is very important. The Authority has a range of powers it can use before it goes to the extent of revoking a licence and refusing renewal. It can impose conditions and it does and has done. It can suspend activities. There is a range of ways in which it can limit the functioning of a centre. It can refuse to agree to a new person responsible and not accept them as being suitable for that role. There is a variety of ways in which it can impose sanctions on a centre without going to the step of revoking a licence, but it has revoked licences in the past on several occasions.

  Q522  Mr McWalter: Are you qualified to judge whether research in human embryonic stem cells is justified or not?

  Dr O'Toole: Parliament extended the purpose for which we could issue a research licence that included the use of embryos for detecting and treatment of serious disease.

  Q523  Mr McWalter: I asked whether you were qualified. If you go into a lab and this guy says, "This might help with Parkinson's disease", are you qualified to say, "Hang on. These cells are being taken for too long a term"?

  Dr O'Toole: We have expert scientific inspectors and that is one of the reasons we go out for peer review. Depending on the application, we can extend our peer reviews or approach different peer reviewers to tailor for each application. If it was for a particular disease, we might go out for a clinical opinion for that.

  Q524  Mr McWalter: The Newcastle Fertility Centre has argued that there should be a clear, biological distinction between a nucleus and a pronucleus in the law. That is one of the potential changes because they are worried about mitochondrial disease for unborn children from nuclear systems. Do you recognise that as a problem? Do you think that something should be done about that?

  Dr O'Toole: With the review of the Act, it was one of the issues that was raised by the House of Lords Select Committee, the treatment of mitochondrial disorders.

  Q525  Mr McWalter: They did not raise the issue about the distinction between nuclear and pronuclear.

  Dr O'Toole: No. If we think that any research that involves pronuclear rather than nuclear is outside the Act, we would alert the Secretary of State for Health, as is our duty to do so. It is then up to Parliament to make that decision whether they want it brought into the remit of the Act.

  Ms Davies: We are currently taking legal advice on this.

  Q526  Mr McWalter: You do recognise the problem?

  Ms Davies: Yes.

  Q527  Dr Turner: In your decision making process, how do you weigh social and clinical research in making your decisions? How do you incorporate social and clinical research?

  Ms McNab: Are you talking about licensing decisions?

  Q528  Dr Turner: Yes.

  Ms Davies: The Licence Committees have a mixture of members. In terms of research, there is always a lay majority and a lay chair. They will have an ethicist, a scientist and lay people on the Research Licensing committee and they will take a view. Watching Licence Committees operate—and they meet every fortnight so I have a good opportunity to do that—the committees take their responsibilities extremely seriously. They consider the applications in front of them very carefully indeed and they also have very careful legal advice as to the issues that the Act requires them to take account of. They do that systematically.

  Q529  Dr Turner: Can you say what in practice drives the decisions? How much weight do clinical members who are essentially regulating their fellow clinicians have, or public opinion? Which holds the balance?

  Ms Davies: I do not think either holds the balance. The committees when they operate take account of public opinion and clinical advice, but they also look at other issues that may be before them and they form a view on the evidence before them. I do not get any sense at all that they are making their decisions based on external pressures.

  Q530  Dr Turner: How do you evaluate the ethics of a decision?

  Ms Davies: Fortunately, I do not have to do that. That is what the licence committees have to do but it is a very difficult job. It is a very weighty job which Parliament has given the Authority members to do.

  Dr O'Toole: With research, we ask for local research ethics approval before it comes to the Authority because they are the ones who will have looked at the information etc., for local patients. Therefore, they are the best placed to say whether they think the research or the patient information etc., is adequate for their patients. That is why we insist on having that before we even consider a licence application for research.

  Q531  Dr Turner: I was going to ask you about how you interact with local research ethics committees, but coming back to the role of public opinion, do you not think it is particularly important in making the ethical distinctions in the decision making, especially given that as an Authority you are essentially a servant of the public?

  Ms McNab: It is very important that we distinguish between the different sorts of decisions that the Authority makes. There are licensing decisions about whether or not a centre should have a treatment licence, is fit to do so and meets the requirements; and likewise whether a centre can carry out research, whether it meets the requirements. That decision making is based absolutely upon what is in the Act. The clear criteria set out in the Act are the criteria that the licence committees are assessing a centre against. Clearly, when it is a treatment centre, they are looking at the standards that are set out in the code of practice and guidance. The ethical principles have been determined by Parliament. There is much more weighing up of social research, the different public viewpoints, the different values, alongside other evidence such as legal, medical and scientific evidence when you come to the policy decisions. That is a completely different section of the decision making. There is a danger that we may be blurring the two types of decision making. Charles, who heads up the policy division, will be able to talk to you much more about the policy decision making and how research is balanced there.

  Q532  Dr Turner: Your licensing decisions follow from your policy decisions so you cannot tease them apart?

  Ms McNab: I categorically can say that the licensing of research projects decisions is fundamentally made against the Act and, yes, ethics committees of course to make sure that the ethical considerations are taken into account around how the research is being conducted, how the information is presented and how consent is gained. Of course, that is absolutely fundamental. The criteria about the research project itself and whether or not it should be permitted are fundamentally against what is in the Act. Chris and Trish sit on far more of these committees than I do so they are the ones to tell the stories of those but those are the distinctions that are absolutely extricated, pulled apart and examined in minute detail.

  Q533  Dr Turner: You had a working group with the MRC on research in assisted reproduction two years ago. Has the MRC funded any research as a result? When do you expect the working group to report?

  Ms McNab: I believe what you are talking about is the concern that we have around follow-up studies of a whole range of assisted reproduction technologies. There has been a working group with the MRC. We very much sought the MRC's view, particularly around what the priorities for research might be. Obviously there is a whole range of different technologies and techniques used in assisted reproduction and we felt it was very important that there was some joint consideration of where the priorities would be for long term follow-up studies to take place. We are not a research institution, as the Committee will be aware. We do not have research funding. We are not set up in that way to commission our own research. That working party has been meeting and they have looked at a whole range of issues. We expect a report fairly shortly.

  Q534  Dr Turner: One of your duties is to keep a register. Has any work on the contents of this register been undertaken? Has there been any analysis of the register and does it have a useful research function? You must have a vast accumulation of data, no doubt.

  Ms McNab: The work that has been undertaken has been limited because, as you may well be aware, there have been some difficulties with the IT system or the register system itself, the technology, if you like, where all the information is kept. When I joined the Authority, there had been a difficulty that had been identified and one of the major tasks for the Authority in the last couple of years has been to put in place a new register of information on screening and the treatments that are provided. That work, I am glad to say, is absolutely on target. We now have a new register up and running. We are going through a task of going back and validating all the old information that was held in the previous register where there was a problem. That is going to take us still a little more time but we are on target to do that. So far, the analysis that we have managed to do is very much providing information for the European data set which we give every year and also the information that goes into our patient guide which gives, for example, some indication about what the average outcomes are and the types of treatment provided, the age groups that are focused on. In terms of follow-up, particularly to answer your question about that, this is an area where we would very much welcome your advice to government for a review of the Act. The legal advice that we have is that the confidentiality requirements in the Act prevent us from, for example, linking our register with other disease based registers so that, for long term follow-up investigations, say if we wanted to link with the cancer register, we cannot do that. We are bound by the confidentiality requirements within the Act and that is frustrating to us and obviously to researchers.

  Q535  Dr Turner: That is a problem we have encountered with the cancer register in the past. Both of these need to relate to the normal NHS medical records. Are you satisfied with that relationship? Does any data fall down the cracks? Do you get patients who will be treated by other doctors who are unaware of things which could be important to them had they access to your original records and register?

  Ms McNab: I will go back and check on this and it may be I have misunderstood your question, but I am not aware that there is a problem with information getting lost. What I am aware of is that, because of the confidentiality which is so strict, the sharing of information and aggregating so that you can see whether there is a greater incidence of something or another and being able to do that through the electronic records in the NHS, would be terribly valuable. At the moment, the restrictions in the Act prevent us doing that and this is something that we would very much like to see change when the review of the Act takes place. We think that would be terribly helpful.

  Q536  Chairman: It says here, "We are keen to work collaboratively with other regulators to avoid over and under regulation." Tell me quickly, please, what that means. What have you done about it?

  Ms Davies: We have had two meetings with the Healthcare Commission which as you know only came into existence at the beginning of April. We have begun to map out the kind of information gathering that they are doing as opposed to what we are doing and we are beginning to look at where the overlaps might be and how we can begin to streamline that so that one or other of us collects it.

  Q537  Chairman: Why not just shovel it on to them? CHAI, for example, is another organisation that looks at your clinics.

  Ms Davies: Our powers are very different from CHAI. We cannot at the moment delegate our inspection powers. They can delegate their inspection powers to us. We are looking at whether we can, at least as a preliminary, do some joint inspections to begin to see how well it would work for one or other of us to start taking on some of their functions.

  Q538  Chairman: Are you going to merge with the Human Tissue Authority?

  Ms Davies: That is for Parliament to decide.

  Q539  Chairman: Have you had talks with them or will you have talks with them when they are set up? Is that the plan?

  Ms Davies: The Human Tissue Authority, I understand, has not yet been brought into existence so it is currently still in draft legislation.

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