Select Committee on Science and Technology Minutes of Evidence

Examination of Witnesses (Questions 600-615)



Baroness of Finlay of Llandaff

  600. Could you just try to put this quite simply for me? How could the UK system be simplified to be closer to the US system, which sounds as though it is more streamlined?
  (Dr Chatfield) It is not an issue about the UK system, it is an issue about the European system, in terms of the existing agencies and the way they work. Although we have a centralised procedure, for a biotech product we could not just take it through the UK procedure; in terms of regulatory approval it has to go through the centralised procedure. So in order to be able to simplify, in the end it needs better understanding, better coming together, better harmonisation of immunisation regimens for instance in different territories. That is the way you could end up simplifying the procedure.

  601. How much dialogue is there within Europe between people like yourselves?
  (Dr Chatfield) We spend quite a bit of time talking to different regulatory agencies within Europe. You have to introduce the national agencies fairly early on to what you are doing in terms of a product development concept in order to overcome some of the issues you alluded to. You do not want to leave it until you have your registration package together and have done all your pivotal clinical studies then to find that this package may not be acceptable in one of the territories and you need to go back and carry out further work. You need to understand those things early on.

  602. I meant people like yourselves as a group who are doing the research and production. How much of a united voice is there coming from there into all the European regulatory bodies that this has to be made simpler?
  (Dr Chatfield) There is quite a bit of pressure from different groups, particularly from the European vaccine manufacturers' group as well.
  (Mr Kingston) The position from the industry's point of view is a clear one. For us EU harmony in schedules and licence procedures is good because that means we can bring vaccines and make them available faster. We will perpetually say the more harmonisation we get in schedules and requirements, the better. That is the principle we work to, but in practice you do find in the limit one country will just be dropped from the procedure because they are preventing a licence being granted in the other nine or ten.

Lord Lewis of Newnham

  603. How many of these licences do you have to go for? How many countries are involved in this? How disparate is this particular problem?
  (Dr Chatfield) There should be one licence for all the territories. That is not the issue. There are certain variations on what might be acceptable in some territories rather than others, related to immunisation schedules which you have to make sure you understand early on in the licensing procedure.

  604. How many territories would that involve in the worst scenario?
  (Dr Chatfield) The number of members of the European Community; 15 now and 25 next year.

  605. Is there no attempt within Europe to give you what you are asking for, within the European Union itself, Brussels?
  (Dr Miller) There is the European Medicines Evaluation Agency for biotech products. That has a central registration process. There are guidelines about GMP, about avoidance of BSE agents, which apply across Europe. It is not quite as bleak and as fragmented as my colleagues have made out. The arguments around it being easier if everybody were harmonised onto the same immunisation schedule, have been debated inside out and upside down. That is not going to happen, simply because epidemiology differs quite markedly between countries, the way the health services are organised in different countries means that the opportunities for vaccination are going to present at different ages. It is a Utopia which will not happen unless we have a Federated States of Europe and we all do everything all the same. The solutions have been for the manufacturers to look at extremes of the schedules which are available in the European Union and that seems to me a perfectly reasonable solution. You always get idiosyncratic countries with one medical assessor who has a particular view. Unfortunately that is a reality of life.
  (Dr Chatfield) What we are saying is that as part of the process, we have to understand what those idiosyncrasies are in terms of how we design our clinical programmes.

Lord Lewisham of Newnham: May I declare an interest? The fact that you are having to go to DEFRA for GM does not worry me in the slightest. I should be very worried if you could get a GM product onto the market without having to go to DEFRA. They have set up a process and a protocol which is absolutely essential if you want to get the public at large to accept GM products.

Lord Rea

  606. What is progress in Britain? How much work is going on in developing vaccines for malaria and TB, leaving aside HIV as perhaps the main killer in the world at the moment.
  (Mr Kingston) I shall answer that in my company capacity for GlaxoSmithKline, if I may, because I cannot speak for all the other companies' development programmes. Those three diseases are clearly disease areas which would bring an enormous health benefit to the developing world. We do have programmes to develop vaccines for all three of them: HIV, malaria and TB. HIV is probably at the earliest stage, because technically it is so hard. Those programmes are managed as part of a large corporation's corporate and social responsibility bit of the business. The funding would not be at high price levels and it would be arranged through UNICEF or through the Bill and Melinda Gates Foundation or GAVI or these people. There is an active desire and programmes in place to try to get research breakthroughs on those three disease areas for the developing world.

  607. How does funding research for TB and malaria compare with funding for research on other vaccines?
  (Mr Kingston) At this stage, because we are not into the final scale of clinical trials, it is comparable. Again speaking from a GlaxoSmithKline company perspective, of the £150-£200 million annual spend, the vast majority is in late stage clinical trials on products which, all being well, will be on the market next year, the year after, the year after that. Until we get to the phase 3 trials, a lot less actual expenditure is required in relative terms and the money is there.

Lord Turnberg

  608. Is much work going on into vaccine development for non-infective diseases, cancers and the like?
  (Dr Chatfield) Yes, there is a lot of work going on in that area, particularly in some of the smaller biotech companies, but it is at a fairly early stage in terms of where it is going. One or two UK companies are involved in that.

  609. Are any of the big pharma companies involved?
  (Mr Kingston) There is one particular example on which two companies are very actively working and my company is one of them. It is a vaccine against human papilloma virus, which is an established precursor of cervical cancer. And hepatitis B vaccine will protect against a disease that will ultimately lead to cancer of the liver. In terms of therapeutic vaccines as cures for cancer, again there is some interest but it tends to be in the big companies, as far as I am aware, at the pre proof of principle stage.


  610. The Gates Foundation has put a lot of funding for vaccine production in many of the important areas but this is for a limited time. Who is going to pick up that sort of assistance on vaccine development when the Gates money comes to an end?
  (Mr Kingston) I do not have a specific answer to that.

  611. Who should? Let me put it that way.
  (Mr Kingston) The Gates Foundation money and the way they have used it to work with the supplying companies has clearly shown how many millions of doses can be administered to people who would benefit from them. Those vaccines are generally supplied at something very close to the cost of goods, so it is a very tiny cost compared with what would be charged in a developed country. Who should fund when the Gates money runs out? I do not know. Companies themselves clearly have corporate social responsibility programmes where drugs are donated against specific diseases in specific territories. UNICEF and the European Union will doubtless keep having their funding programmes in place. It is not an easy question but the positive way of looking at it is that we have now seen what can be done and hopefully before the Gates money does run out, a longer-term solution will be identified.
  (Dr Chatfield) I do not think I have much to add to that, but maybe we will have to end up with more government consortia being able to pick up on that funding.

  612. We are nearly at the end of our session but two points, one for Dr Miller. Will the Public Health Laboratory Service functions with regard to vaccines continue with the HPA?
  (Dr Miller) Certainly the intention is not only that they should continue but they should flourish within the Health Protection Agency. In the period of transition, particularly with the return of some PHLS laboratories to NHS management and the general reorganisation which is happening within the NHS with the formation of the strategic health authorities and PCTs, we are concerned that short term there may be an interruption of the high quality surveillance data that we have. The potential of having CCDCs as part of the Health Protection Agency and widening the remit should mean that it becomes better eventually, but we do see some risks in the short term during this period of change, upheaval and struggling to identify routes, responsibilities and accountabilities and keeping information channels flowing.

  613. Thank you; that is good news. Could we ask Mr Kingston to send us some information, especially the list of vaccines you said are being over-produced, which are not being taken up? Could you let us have a list of those and also any possible costings which might be associated with those? I am aware that it takes funding to development and the costings, which might be rather hidden in way, for not using them, the loss.
  (Mr Kingston) Understood.

Lord Oxburgh

  614. The question is whether they were too expensive for the various authorities to use them.
  (Dr Miller) It is a bit more complicated. In the case of varicella for instance, there are risks associated with the use of the vaccine, longer term risks, which need to be thoroughly looked at in epidemiological data. It is not just a question of not spending the money, it is thoroughly evaluating how best to use them, the most efficient way and the most cost effective way.

Baroness Finlay of Llandaff

  615. It may also be useful to have an idea of some of the future developments as well, to give us an idea how broad you see future developments. You have spoken of HPV and a little bit about some of the trials which are going on, but some of the other agents which are on the stocks which we might see emerging in five or 10 years would give us a feel of the background research which has not yet come through into the clinical arena.
  (Dr Chatfield) Yes; certainly.

Chairman: Thank you all very much indeed for coming along. We have covered a wide field and it has been most interesting. If there are any additional points you feel we have not touched on and should have touched on, please let us know in writing. You will receive a transcript of this morning's session and you will have the opportunity to correct any factual errors. Again, let me thank you very much and we look forward to hearing from you, Mr Kingston, in response to our request. Thank you.

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