§ Lord Clement-Jones asked Her Majesty's Government:
Whether the Department of Health's current discussions with pharmaceutical companies regarding beta interferon and glatiramer acetate represent a loss of confidence in the National Institute for Clinical Excellence.
§ The Parliamentary Under-Secretary of State, Department of Health (Lord Hunt of Kings Heath)My Lords, no.
§ Lord Clement-JonesMy 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?
§ Lord Hunt of Kings HeathMy 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 he regarded as cost-effective. In its current discussions with manufacturers the department is following NICE's own recommendation.
§ Lord Walton of DetchantMy 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? 828 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?
§ Lord Hunt of Kings HeathMy 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.
§ Lord Roberts of ConwyMy Lords, is the noble Lord satisfied that NICE can take full account of the social and economic costs of the diseases that these drugs are meant to alleviate?
§ Lord Hunt of Kings HeathMy 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.
§ Lord Corbett of Castle ValeMy Lords, perhaps I may congratulate the Minister on taking forward NICE's proposals to conduct clinical trials with beta interferon. In future will the Minister try as far as possible to include patients in the evaluation of drugs which NICE is considering?
§ Lord Hunt of Kings HeathMy 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.
§ Lord RixMy Lords, I have before me a report that Edwina Hart, AM, Minister for Finance in the National Assembly for Wales, has already set aside £1.7 million a year to assist with the funding of the proposed scheme. If that is correct, why is funding not available to other parts of the United Kingdom?
§ Lord Hunt of Kings HeathMy 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 829 growth money for NICE judgments, alongside many other developments in the health service, should be provided at local level.
§ Lord EltonMy Lords, is the Minister able to tell the House how soon beta interferon in particular will be available to all patients in the NHS suffering from relapsing and remitting MS, and is there any prospect of it being available to those who suffer from progressive MS?
§ Lord Hunt of Kings HeathMy 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.
§ Lord Mackie of BenshieMy 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?
§ Lord Hunt of Kings HeathMy 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.
§ Baroness Masham of IltonMy Lords, as well as considering how to stop deterioration which leads to further disability, what value does NICE attribute to the quality of life of disabled people when assessing drug treatments?
§ Lord Hunt of Kings HeathMy Lords, as I responded earlier, such factors are considered by NICE, but judgments about cost-effectiveness are 830 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.
§ Lord NasebyMy Lords, is the Minister able to confirm that the negotiations will be held within the parameters of the existing PPRS?
§ Lord Hunt of Kings HeathMy 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.
§ Earl HoweMy Lords, can the Minister tell the House whether, in reaching its determination on this matter, or indeed on others, NICE has operated to a benchmark; namely, a cost of £30,000 per quality-adjusted life year? If that is the case, can the Minister tell the House who set that benchmark?
§ Lord Hunt of Kings HeathNo, 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.