Select Committee on Health Minutes of Evidence

Examination of Witnesses (Questions 774 - 779)



  Q774  Chairman: Colleagues, good morning. Can I welcome you all to this session of the Committee and welcome our witnesses. Can I thank you for your co-operation and for your evidence to us; we are most grateful. Can I ask you briefly each to introduce yourselves to the Committee.

Dr Raine: Good morning. I am Dr June Raine. I am the Director of the Post-Licensing Division at the Medicines and Healthcare products Regulatory Agency and my responsibilities include all the issues that relate to medicines once they are authorised for use on the market.

  Professor Sir Alasdair Breckenridge: I am Alasdair Breckenridge, I am the Chairman of the Board of the MHRA.

  Professor Woods: Good morning. I am Kent Woods and I am the Chief Executive of the MHRA.

  Q775  Chairman: Can I begin by asking you this, Sir Alasdair: you have been around for quite a long time in this whole area and obviously you have got some pretty detailed knowledge of many of the issues that we have been addressing during this inquiry. We are now towards the end of the inquiry and I have no doubt you will have been following some of the sessions and some of the evidence that we have had. What is our view, from your background, of the key issues that perhaps have been picked up in this inquiry in relation to the medicines regulatory system?

  Professor Sir Alasdair Breckenridge: I think one of the impressions that I have gained is that a lot of the discussions which have taken place have referred to what happened many years ago in the old Medicines Control Agency and the one thing that I would like to stress is that since the MHRA came into being in April 2003, there have been many, many changes in the way in which the organisation works, partly because this is the aim of the organisation itself and partly because the climate in which medicines regulation takes place has changed totally.

  Q776  Chairman: So what you are saying is that some of the evidence that we have had is outdated? Could you give examples in particular where you feel that the situation is being inappropriately represented?

  Professor Sir Alasdair Breckenridge: Well, it is not misrepresented, but there was quite a lot of discussion about how the Agency did not release information, for example, on human albumen and on some of the other issues in the early 1990s. Well, we have changed that now and there are two big things which we are actually changing. One is the transparency under which we work and secondly is the communication skills which we have put into being, and there are some very important examples which I am sure we will be coming back to in terms of transparency. For example, you are aware of the report which the Agency published on the SSRIs at the end of last year and the other report which we put into the press in May 2003. Well, as part of that, we published all the evidence, published and hitherto unpublished, on which the Agency made its decision. Now, people may look at that evidence and disagree with it, but at least they have the evidence on which we made our decision, so that is the kind of thing which we are determined to do now and we are doing.

  Q777  Chairman: I think that was a good example which will probably be picked up by one of my colleagues later on, but in terms of the future, do you see, from the evidence that we have picked up, any particular key areas where you perhaps would suggest there is a need for change?

  Professor Sir Alasdair Breckenridge: I think that the other area that I would pick up is that of the education of the public in terms of risk and benefit. A lot of the discussions which have taken place in the Select Committee have been about the safety of medicines and relatively little about this concept of risk and benefit. When we change a licence, we do not do this purely based on a safety profile of a drug. If we did this, there would be no anti-cancer drugs available and there would be no anti-HIV drugs because the adverse reactions to them are huge. They have got to be balanced against the benefits which these drugs have and the one thing which I would like to see you concentrating on, with all respect, is this concept of risk and benefit. We are going to be communicating that very strongly with our new communications set-up, but I would like to see that as one important aspect coming through from this Committee.

  Q778  Chairman: You had in 2003 a report from the NAO which was somewhat critical about your external profile. We have got a rough idea of the main findings. Now, in terms of the way you suggest that the information we have received perhaps is a little dated from some of the witnesses that we have had and some of the representations we have received, in relation to those findings what steps have been taken to address them and perhaps what further steps might you take in the light of some of the issues that we have picked up?

  Professor Sir Alasdair Breckenridge: The main thing which the Agency did when it received this report is that we commissioned a report on our communications strategy and this reported to us in June 2004 and there were many recommendations from that report which we took up. The main two which we have acted on are the two I have mentioned already, firstly, setting up communications, and this is absolutely critical for an agency like ours. In the past, the old Medicines Control Agency and Medical Devices Agency, working in a different time, did not see this as one of their main purposes. Now it is quite clear, and we are determined, that this is one of ours. The second one is the issue of increased transparency and I have already mentioned the example of SSRIs. The other thing which we have done is that as of the middle of this year, when we give a licence, we will be issuing what we call a "United Kingdom public assessment report" which will give data of all the clinical trials on which we made our decision, so the public will be able to see again the evidence on which a drug has been licensed. The third part of the transparency move which we have made is that we have reviewed the yellow card system. This was done independently and we might be coming back to that later, but in fact as of this week we have published on our website all the adverse reactions to every licensed drug and this is accessible to everyone, suitably "anonymised". Therefore, we have taken concrete steps with respect to transparency, communication, and the other question which was raised by the National Audit Office was the question of interests and we have moved on that both with respect to the staff and with respect to the committee structure, and we can deal with that. The final one which I would mention is that we have increased greatly the patient voice in medicines regulation. We have been conscious for a long time that regulation was too inward-looking, not involving the public enough, and we can discuss again in some detail how we are actually increasing the patient voice in regulation.

  Q779  Chairman: So taking account of the views we have had expressed about your external profile as an organisation, how would you describe it now?

  Professor Sir Alasdair Breckenridge: We are moving very quickly from the time when we started business in April 2003 and if someone who worked in the Agency even in the early part of the 2000s came back and looked at the work that we are doing now, they would find huge changes.

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