Lamb , Harris , George , Mulholland, and Burstow quiz Johnson on Access to Medicines

6.31.00pm GMT Wed 5th Nov 2008

Prof Mike Richards

• [Nov 04]: Norman Lamb*: I . . join hon. Members in thanking Professor Mike Richards for his work in producing the report.

The statement-albeit it a remarkable U-turn, albeit that it comes after pressure of a threatened judicial review and albeit that the Government seem to be fudging or drawing a distinction between what is proposed and the principle of top-ups-is none the less a welcome step. It is a complex area. There are understandable anxieties about the implications of moving in the direction outlined, but the bottom line is that we cannot justify a cruel and pernicious system that threatens to withdraw NHS care if a patient chooses to follow a clinician's advice in paying for a drug that is not available under the NHS. However, allowing top-ups must go hand in hand with reforms to ensure that access under the NHS is available to drugs that are routinely accessible in Europe but are not currently available in this country.

On proposals to extend access, the Secretary of State's ambition is to achieve draft or final guidance within six months, but he will only achieve that for all drugs by 2010. Surely if it is only draft guidance within six months, there could be a further long delay in producing the final guidance. Why will it take so long to get to the six-month point, given that there is already a much faster system in Scotland? I know that the process there is different, but it usually ends up achieving the same verdict as we do in England only it does so much quicker. That the system is taking so long results in a great sense of unfairness in England.

The Secretary of State said nothing about the need to reform the requirement of ministerial referral. Surely we should scrap that and allow NICE to make its own decisions. Surely, also, we should ensure that there is complete transparency of the modelling that NICE undertakes in reaching its decisions.

The Secretary of State referred to the need for more flexibility in the evaluation of high-cost drugs. Will he consider widening the factors that NICE takes into account-the impact on carers and the potential to get an individual back to work-in assessing whether a drug is cost-effective? There is a key question for him: under the reforms, which drugs that have been rejected does he expect will become available? What analysis has he undertaken of that? He must have done some. Will appraisals be reopened on drugs that have recently been rejected by NICE? He said that the current rules would come to an end with immediate effect, but at the same time he announced a consultation on how those new rules will apply. What will happen in the meantime?

The right hon. Gentleman said that treatment must be in a separate facility, but is that not inconsistent with good quality patient care and patient safety? Will he address that specific concern?

With regard to the importance of local transparency in the decision-making process by primary care trusts, when will the Secretary of State announce those core principles, and will they take into account social factors-family circumstances-in determining whether a drug should be available?

The statement contained nothing about the absolute importance of independent advice to patients on whether it is right to pay for an additional drug. It also said nothing about the potential need to regulate any market that might develop in dealing with very vulnerable people at a critical stage in their life. Finally, the right hon. Gentleman said nothing about addressing the potential conflict of interest for clinicians and the NHS in making these difficult judgments. Will he address those concerns as well in his response?

Alan Johnson (Secretary of State, Department of Health; Kingston upon Hull West & Hessle, Labour): I thank the hon. Gentleman for his welcome for the statement. He says that it is a remarkable U-turn, but this guidance has been around for many years. We can track it back to the early '80s, under the Thatcher Government, and it was there before that. [Interruption.] He says from a sedentary position that it is a U-turn from what I said, but I said that if we allowed NHS care and private care to be given together-I talked about an episode of treatment, to introduce a new variation into all the descriptions, back in December last year-that could be the end of the founding principles of the NHS. It could be, and Mike Richards has accepted that it could be, which is why separate care is an important part of his proposals. [Interruption.] Everyone in the House apart from those on the Conservative Front Bench understands that Mike Richards' terms of reference were to defend the principles of the NHS, and that combining private and NHS care would be the route to an insurance-based system and the end of a taxpayer-funded system.

The hon. Gentleman said that the proposal would have to go hand in hand with greater availability. That is what Mike Richards recognised, and that is why a large part of my statement was concerned with that. The hon. Gentleman asked the reason for the delay in NICE's appraisal of the drugs. I understand that it is due to the tail in the system. We committed ourselves to a more rapid appraisal a year ago in our cancer strategy, and as new drugs come in we can move quickly, but the old drugs are still being appraised under the old system. It will take us some time to work our way through the backlog, but NICE has already announced that it is increasing the number of appraisal teams and standing committees and starting more appraisals earlier, so I think that the time scale is realistic.

The hon. Gentleman mentioned ministerial referral, which was also mentioned by the hon. Member for South Cambridgeshire. We are not handing the whole process over to NICE and taking politicians out of it completely, but once a drug has been referred to NICE, the process becomes a NICE process, independently run. NICE also has an enormous role in the earlier process of selecting drugs to be referred. It is responsible for the consideration panels of experts before the matter is sent to the referral oversight group, which consists of clinicians. The ministerial sign-off for which my right hon. Friend the Minister of State is responsible is a very short part of that process.

Mark Simmonds (Shadow Minister, Health; Boston & Skegness, Conservative): It takes 12 months.

Alan Johnson (Secretary of State, Department of Health; Kingston upon Hull West & Hessle, Labour): It does not take 12 months. Here is £13 billion of taxpayers' money, and once again the Conservatives want to remove Government completely from the process and allow a giant unelected quango to deal with it.

Norman Lamb referred to the consultation that NICE has undertaken. NICE has said that the new procedures will apply while its consultation takes place. Those new procedures start today. I believe that members of NICE are the best people to say which drugs are likely to come through the process, and I believe that NICE will reappraise drugs through the process as well if they are referred.

The core principles put forward by the PCTs should be ready early in January.

• . . Evan Harris (Shadow Minister (Science), Innovation, Universities and Skills; Oxford West & Abingdon, Liberal Democrat): Does the Secretary of State accept that there are lots of unanswered questions? For example, how does he deal with the situation of an NHS consultant referring and recommending a private treatment given by himself in an NHS pay bed with the income going to that trust? How does he deal with the problem faced by someone who responds to a private treatment that keeps them alive but then runs out of money and finds that the drug is not allowed on the NHS because it worked for only a few people? Surely that treatment should then become payable by the NHS. Does he accept that more work needs to be done on those questions?

Alan Johnson (Secretary of State, Department of Health; Kingston upon Hull West & Hessle, Labour): I accept that, as does Mike Richards. He has done a thorough piece of work in a short space of time; he needed to do so, given the urgency that the public attach to this. He says in his recommendations that measures need to be in place to prevent what the hon. Gentleman described. I think that the ethos and the integrity of doctors, their contract, the fact that they are not allowed to raise the issue of private drugs-it must be raised by the patient, rather than by the practitioner-and perhaps some other measures that we could introduce would resolve those problems. If we stick to the current system, what the hon. Gentleman describes could happen just as well, except that tied on to it would be this withdrawal of NHS treatment.

• . . Andrew George (St Ives, Liberal Democrat): Can the Secretary of State reassure me that the NHS will use its procurement muscle when negotiating, especially in regard to what he described as the new and more flexible pricing arrangements, which will enable "drug companies to supply drugs to the NHS at lower initial prices, with the option of higher prices if value is proven at a later date." Will that be a one-way street? In other words, if the value is not proven, or if more drugs are purchased than anticipated, will the price go down?

Alan Johnson (Secretary of State, Department of Health; Kingston upon Hull West & Hessle, Labour): That is a question for NICE in deciding how to operate the system. Currently, drugs companies come in with a price at the beginning and cannot alter it, but under a value-based system they could come in with a lower price and then argue for a higher price later.

Andrew George (St Ives, Liberal Democrat): But can it go down?

Alan Johnson (Secretary of State, Department of Health; Kingston upon Hull West & Hessle, Labour): I shall take advice from NICE on that, but I doubt it. The whole point is to have a voluntary, rigorous agreement. Drug companies have agreed to a 5 per cent. reduction in drug prices with a further 2 per cent. reduction in prospect. It is a great tribute to them that they have entered negotiations and that they are proceeding so successfully. I reassure the hon. Gentleman that a robust negotiating system will be put in place, but at the end of the day it is up to drugs companies to seek to make a drug available and to put it through the NICE process. It must be voluntary. We cannot proceed otherwise.

• . . Greg Mulholland (Shadow Minister, Health; Leeds North West, Liberal Democrat): I commend this positive step and remind the House of the heroic Jane Tomlinson, who did so much for charity but could not access the drugs that she needed.

May I ask the Secretary of State a practical question about the ever-changing medicines available for people who are terminally ill? NICE often takes time to make decisions and decisions on what the NHS will fund often change, so will the Secretary of State say whether, if someone starts to pay for treatment straight away-clearly, if they medically need to do so, they should-they will get their treatment refunded, if, at the end of the process, it is recommended that the NHS should fund it?

Alan Johnson (Secretary of State, Department of Health; Kingston upon Hull West & Hessle, Labour): The decisions do not apply retrospectively. A NICE decision applies from the time at which it takes effect. In terms of the additional care that we are talking about, when NHS care is withdrawn from a patient in those circumstances that comes into effect immediately.

• . . Paul Burstow (Chief Whip, Whips (Commons); Sutton & Cheam, Liberal Democrat): Speedier NICE appraisal decisions are essential but they are not sufficient. We also need more transparency and accountability in NICE decisions. In the light of the Law Lords' decision to refuse permission to NICE to go to appeal on the dementia drug case decision, will the Secretary of State now put it beyond doubt that he expects NICE to place all the models it uses in respect of decisions on appraisals into the public domain?

Alan Johnson (Secretary of State, Department of Health; Kingston upon Hull West & Hessle, Labour): That is an issue for NICE. It needs to comply with the court judgment. This is not the end of the story about NICE, as I hope to make fresh announcements early in the new year. Perhaps we will return to the subject then.

• (Shadow Secretary of State for Health, Health; North Norfolk, Liberal Democrat)