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My Lords, I thank the Minister for that unusually brief reply. I welcome the creative steps that the department has taken to ensure that MS sufferers are able to benefit from proper treatments. But does not the so-called risk-sharing arrangement currently being negotiated demonstrate how embarrassed the department is by NICE's actions and the fact that it has been thwarted by the very body which it set up in the first place? Does this demonstrate a new willingness on the part of the Government to take direct political responsibility for the rationing of these treatments?
My Lords, we set up NICE to deal with the problem of postcode prescribing whereby drugs were available in one, but not a neighbouring, health authority. We asked NICE to provide advice and guidance to the NHS on which drugs and treatments were clinically and cost effective. Beta interferon is still going through NICE's processes. The final appraisal was determined some weeks ago and is the subject of an appeal. We do not know the outcome of that appeal. But as part of the final appraisal NICE recommended that the department discuss with manufacturers the possibility of securing supplies to the NHS on terms that could be regarded as cost-effective. In its current discussions with manufacturers the department is following NICE's own recommendation.
My Lords, does the Minister accept that the Association of British Neurologists—I declare an interest as a past president—the MS Society and patients who suffer from multiple sclerosis regard the provisional agreement between the Department of Health and the drug manufacturers as a major step forward that is greatly welcomed? Can the Minister tell the House who is to pay for these drugs which are very expensive? Will the cost fall upon health trusts and authorities? As part of an evaluation exercise, would it not be proper to charge some of it to the Government's R&D initiative?
My Lords, it is far too early to say what the outcome of the discussions with the manufacturers will be. The department is in the process of negotiation. It is right that in general the cost of NICE's judgments should be met by the NHS as part of its normal expenditure processes. That is how we shall continue in future.
My Lords, those are factors which NICE can take into account. Most people who have looked at NICE consider that in the two years or so that it has been in operation it has been extremely thorough in reviewing the best available evidence in relation to efficacy and cost-effectiveness. The whole point of establishing NICE was to have independent guidance. I believe that NICE has undertaken its work with great care and thoroughness.
My Lords, I am grateful to my noble friend. As part of the evaluation process NICE fully consults and liaises with patient and carer groups, as is right. Next year NICE will also establish what is described as a citizens' council. That will not advise NICE on specific evaluations but the general process by which it undertakes its work.
My Lords, the way in which NICE decisions are dealt with in Wales is a matter for the National Assembly for Wales. As far as concern the Government and their relations with the NHS in England, we believe it is right that the impact of these decisions should be funded at local level by NHS authorities out of their general allocations. Noble Lords will be aware that, in the light of the Chancellor's announcement last week, the NHS budget for this year and next will allow for considerable growth. It is surely right that out of that growth money for NICE judgments, alongside many other developments in the health service, should be provided at local level.
My Lords, I cannot give an answer to the noble Lord for two reasons. First, the National Institute for Clinical Excellence is still considering the guidance that eventually will be given to the health service. It would not be proper for me to comment on the specifics until the institute has published that guidance. Secondly, we are still holding discussions with the manufacturers. Because of that, I cannot provide the responses that the noble Lord seeks.
My Lords, how strongly are the Government, along with the governments of Europe, exerting their undoubted power to screw the manufacturers down on the price? From his reply, it appears that this is a new approach. Does the Minister agree that the practice of driving down the price of these drugs should be widespread throughout Europe in order to secure the cheapest form of support for MS sufferers and to lower the cost of their medication?
My Lords, I do not see the situation in that light. We are following the recommendations made by NICE by discussing with the manufacturers whether it would be possible to obtain supplies in a cost-effective manner. The noble Lord developed his question to consider the profitability of the pharmaceutical industry in this country and in Europe. I should say to the noble Lord that the pharmaceutical industry is one of the most important elements of Britain's business sector. For example, it is responsible for 23 per cent of all commercial R&D undertaken in this country. It is also responsible for making a huge positive contribution towards the balance of trade. The pharmaceutical price regulation scheme negotiations, which set the parameters within which prices are set and profits made in this country, allow for value for money but also recognise the enormous research and development contribution made by the industry. I believe that we have struck the right balance in this area.
My Lords, as I responded earlier, such factors are considered by NICE, but judgments about cost-effectiveness are based very much on reviewing the results of clinical work and providing robust advice to the NHS based on the best-known clinical research being undertaken throughout the world.
My Lords, I am not prepared to go into further detail because we are in the middle of our negotiations and discussions with the industry. However, what I can say to the noble Lord is that in pursuing those discussions, in no way do we wish to undermine the integrity of the PPRS process. As I pointed out, we regard that process as an excellent means of achieving a proper balance between recognition of the research and development contribution made by the research-based drug industry in this country and ensuring value for money for the National Health Service.
No, my Lords, I cannot respond specifically to the noble Earl because such matters are for NICE to consider in order to develop its own methodology and hence to offer advice. I cannot answer also because the work being undertaken by NICE in relation to beta interferon is still under way. Of course many factors have to be taken into account by NICE; that is for the institute to do. As I said, it is for NICE to set the methodology, not the Government.