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Branded Medicines (NHS)

Volume 589: debated on Thursday 4 December 2014

I beg to move,

That this House has considered availability and pricing of branded medicines on the NHS.

I am most grateful to the Backbench Business Committee for providing this opportunity to raise an issue of continuing importance to Members and their constituents. The debate will be short, but I am sure that we will be able to put it on the record that there are areas of concern. The two Front-Bench teams will, I am sure, be keen not only to respond now but to take some of these matters forward in the future as the Minister and his colleagues have sought to do over the past couple of years.

Colleagues from the previous debate must not feel that they have trespassed too much on to our debate. Listening to the contributions, it was amply clear that it was important for Members to be able to represent their constituencies. I know that all colleagues are very happy that they had the chance to do that.

Let me set the scene. Over the many years that I have been engaged with health matters, one of the most persistent sources of frustration has occurred when our constituents have not been able to access the medicines that they need through the national health service. That can happen because of a lack of data, and the National Institute for Health and Care Excellence will not appraise such a drug at that point because it determines that it is not cost-effective and is not therefore approved for NHS use, or because local commissioning decisions are incorporated in a local formulary.

Since its inception, NICE has created a more consistent national basis for decisions on access to medicines, but the application of what is essentially an arbitrary cost-effectiveness threshold still means that patients can be denied access to some new drugs. That has been exacerbated by the chronic slowness of uptake of some new medicines across the NHS, because of a clinical conservatism—new drug treatments are viewed as an extra cost rather than an opportunity to improve outcomes—or a general bureaucratic lack of responsiveness to patients.

That is deeply ironic as the UK is among the leading countries for drug discovery. We may represent only 3% of the international pharmaceuticals market, but we have been responsible in this country for 10% of new drug development, including such major innovations as monoclonal antibodies, which were first invented in my own constituency at the Laboratory of Molecular Biology.

As a coalition Government, we commit resources to world-leading research. Ministers have rightly sought both early access to new medicines and continuing support for research and innovation, but we continue to face institutional and cultural resistance. One of my objectives over recent years was to tackle that issue. I wanted to assure patients that, through the NHS, they could access the best and latest medicines and treatments. We wanted the NHS to adopt new innovation and technologies and to move away from a system in which the drug companies set a price that NICE and the NHS appraise and reject, leaving patients unable to access the medicines that their clinicians believe are best for them.

Instead, we should have a system that puts the patient at the heart of the service. If a clinician believes that a medicine is the right one for their patient, they should be able to prescribe it and the NHS and the pharmaceutical company should settle on a fair price, reflecting the value of that drug and a fair return to the costs involved in drug development.

One of the things my right hon. Friend will know probably better than anyone from his role as Secretary of State for Health and something that is not well understood by my constituents is that the NHS is one of the most exciting clients for anybody selling drugs and has the most efficient buy-in capability. Why does that not seem to come across to our patients and constituents, and what about medicines that used to work but now are not available? Will he cover that in his speech?

On the latter point, no, but drugs that move beyond patent become generically available to the NHS. On the former point, my hon. Friend is absolutely right. I often found this issue frustrating. The best way for drug companies to get their new medicines adopted internationally is to introduce them successfully into the NHS. As we move to a more systematic patient record system, the introduction of new treatments and medicines through the NHS will provide the strongest possible database of outcomes anywhere in the world, because of the character and scale of the NHS. So he makes a really important point.

The principle behind securing patient access to new medicines lay behind the proposal for a value-based structure of drug pricing. It was my intention that come the introduction of the new pharmaceutical price regulation scheme, which was to be negotiated for January 2014, a transition to a new price-setting mechanism would also be in place. As the House will recall, in the interim, we introduced the cancer drugs fund because patients in the UK had significantly worse access to new cancer medicines than patients in other countries. That contributed to our poor relative cancer survival rates, and we were determined that it should stop and that the lack of access to new cancer medicines should be tackled while a longer-term solution was developed.

In 2010, therefore, we introduced the CDF to meet that specific need over a defined period and within a defined budget. The achievement of the CDF has been vital. More than 60,000 patients have accessed the cancer drugs they need through the CDF over the past four years. I am immensely proud of that fact. However, the fund is not, and was never intended to be, a permanent solution. Over time, more cancer drugs will be introduced, and if we carry on like this, an increasing number will not be available other than through the fund. Some drugs, such as cetuximab, Avastin and abiraterone, have already been substantially provided through the CDF. If this continues, while other drugs are added, it will greatly increase the cost.

I welcome the Government’s commitment to the CDF through to 2016—it is needed while the pricing of drugs to the NHS is tackled—but that extension cannot continue indefinitely. I therefore call on the Government to reinvigorate the drive to a value-based assessment of new drug pricing and to incorporate that into the PPRS, so that while the Government and the NHS have control of the budget, the NHS can make all licensed new medicines available through the NHS. In addition, it would incentivise innovation in the pharmaceutical industry and result in a fair return to industry on the cost of drug discovery.

The CDF has been necessary and successful, but it was intended only as a bridge to a better scheme across the whole NHS. It cannot bear the weight that will fall on it if we do not reform the system for the pricing of medicines more generally. If we can see our way to that reform, the prospect of de-listing new or existing medicines to the CDF can be deferred. However, reform of drug pricing has not been progressed as it should have been, or as we hoped it would be.

The new PPRS did not incorporate a value-based assessment of the pricing of medicines payable by the NHS. It gave the Treasury a good deal, securing a real-terms reduction in the drugs budget, but a reduction via a rebate is not transparent to the NHS. Drug companies setting their own price for new medicines will continue to set prices that conflict with NICE cost-effectiveness thresholds.

Members might have noted that, yesterday, Roche won an appeal against NICE’s final appraisal of Kadcyla, a drug used to treat HER2-positive breast cancer. Roche won on the basis that NICE should have taken account of the PPRS but did not do so. It argued that as a budget control mechanism, the PPRS, through its rebate, could be argued to offset the relatively high cost of a medicine on introduction. Roche won the appeal, but I have to say that the NICE appraisal might none the less remain unchanged.

The rebate is not predictable; nor is it attributable to any particular drug. It goes to the Treasury, not to the NHS. So, in practice, any NHS purchaser of a high-cost medicine must fully absorb the cost, and the opportunity cost, that paying a high price implies. This case highlights the theoretical link between a NICE appraisal and the PPRS, and it demonstrates how the PPRS does not in practical terms serve to resolve the dilemma of how to introduce high-cost medicines in the NHS.

The PPRS deal showed how much the pharmaceutical industry in this country was willing to offer for a guaranteed rate of return and the ability to set prices at introduction here in the UK, which can then act as a reference price for a quarter of the drugs market across the globe. The current PPRS of course benefits the shareholders and the boards of the big pharmaceutical companies, which are able to maintain high prices throughout a quarter of the world on the back of high prices in the UK, even for those drugs that offer limited clinical benefit. The other beneficiaries are those in the Government who are able to plan spending on drugs a little bit better than they were before. The losers, unquestionably, are patients, who continue to be denied access to the drugs that their doctors think they need.

This is not the kind of price regulation we should have in future. Price should reflect the value of new medicines. A new drug that offers little or no benefit relative to the best available alternative for treatment should secure only a small price differential. New drugs that tackle unmet need or substantially reduce the burden of disease should enjoy a correspondingly substantial price premium. By such a means, we would incentivise innovation and drug development, particularly in relation to major unmet targets. We could also build a premium into pricing in areas in which drug development was most needed, such as early-stage dementia, new antibiotics or the treatment for some cancers, such as pancreatic and ovarian cancer.

The benefits of a value-based pricing system were set out in an OECD study six years ago. But the study recognised—as, subsequently, did we—that the principle had yet to be given practical effect. A year ago, the Minister responsible, Earl Howe, said that value-based assessment would be taken forward and that it would be brought in late this year. That is not happening. NICE was given the task of developing value-based assessment last year, but in September this year, it appeared to have put that on the back burner. That is just not good enough.

Without value-based assessment, NICE will continue to apply an arbitrary threshold to a measurement of the benefits of drugs which takes into account only the quality-adjusted life year gain—the QALY—and end-of-life addition, not the broader societal benefits or the need to promote drugs targeted at key areas of therapeutic need and to promote innovation.

We must look to the value beyond the QALY. We must ask NICE to design a clearer methodology for value, but not just through add-ons to its existing methodology. It should recognise the burden of disease in extending life and the importance of greater clinical and patient engagement. In developing realistic pricing, it could draw on the real-world mature outcomes data for drug use that the cancer drugs fund has given us. It must also draw on the work done by charities and by Sanofi to examine ways in which patient engagement with NICE could be supported. Qualitative judgment of innovation and patient benefits must form a part of this broader assessment, as well as the quantitative data relating to the QALY.

I congratulate Ministers for pushing the NHS to promote innovation. We had our report in December 2011 and more recently Ministers have launched the early access to medicine scheme. The Under-Secretary of State for Health, my hon. Friend the Member for Mid Norfolk (George Freeman), has been right not only to support that and the Medical Innovation Bill but to launch a review of how innovation processes can be enhanced in the NHS.

How perverse would it be if, at the same time, licensed and effective medicines were not approved or available through the NHS? In recent months, a number of drugs have not been approved by NICE, such as Kadcyla, Alimta for lung cancer and abiraterone for prostate cancer prior to chemotherapy. Several of those cases demonstrate the problem of paying for new personalised medicines, but we cannot see the difficult process of introducing new drugs being made even worse by the de-listing of drugs by the cancer drugs fund.

I hope that in response to the debate Ministers will tell NICE to reinvigorate and make progress on the work on value-based assessment, while developing a new methodology in the way that I have described. The Government should work with industry to develop the pharmaceutical price regulation scheme, so that pharmaceutical companies can, within the overall framework, continue to set the price of their medicines at introduction but accept that the NHS should receive a rebate if, and to the extent that, a value-based assessment shows a lower price. That would lead to drug-specific rebates that could then be incorporated within the overall rebate for budget control purposes. In my view, such a system must be in place by 2016, so that the cancer drugs fund can be maintained between now and then and can be the bridge that it was intended to be, while having a realistic time-limited remit.

Only by pushing forward with such measures can we expect in future to offer doctors in the NHS the assurance that they can access the medicines and treatments they think best for their patients and give patients the confidence that the NHS, as a comprehensive free service, is able and willing to provide whatever treatment is in their best interests. I am grateful for the time and attention of the House.

Time is short, so I shall keep my remarks brief, but it is a shame to truncate such an important debate on a matter that touches many lives.

The availability of medicines in our national health service affects millions of families throughout the country and with that in mind I must thank the right hon. Member for South Cambridgeshire (Mr Lansley) and congratulate him on securing the debate. I also thank the Backbench Business Committee for ensuring that the debate was heard. I know that the right hon. Gentleman tried to make progress on these issues when he was Health Secretary and I am sure that he is frustrated by the lack of progress in more recent years. In addition, I am sure that he will be amazed and potentially aghast when he hears that I agree with a great deal of what he said.

As I say, this is an important issue affecting millions of patients who rely on these drugs everyday. Members on both sides of the House want to see progress on improving access and ensuring that more people get the drugs they need. The issue was brought into sharp focus recently when, in September, NICE announced that it was not going ahead with its proposed value-based assessment reforms. That this was in part due to a lack of consensus in stakeholder consultation submissions to the proposals serves to highlight how complex an issue it is. We all accept that.

There are clear problems with access to medicines, as demonstrated clearly by recent publications from the Office of Health Economics and the Association of the British Pharmaceutical Industry. I want to make a number of points from those publications in my speech. There are issues, too, about the proposed changes to the cancer drugs fund, which have been highlighted by the concerns of charities such as Breast Cancer Care, that I shall come to later. None of them will be a surprise to the Minister.

A vital tool in improving access to treatments is the pharmaceutical price regulation scheme, the latest iteration of which came into effect this year. Some questions need answering about it. In 2010, the Conservative manifesto included a commitment to increasing access to drugs. The commitment was echoed and bolted down in the coalition agreement, which stated:

“We will reform NICE and move to a system of value-based pricing”.

As we have heard and discussed, value-based pricing was meant to be introduced in January this year when the drug pricing agreement between the Government and pharmaceutical industry expired, but despite the comments in the coalition agreement, when the new drug pricing agreement, the 2014 pharmaceutical price regulation scheme, was published in November 2013 it contained no plans either to introduce value-based pricing in 2014 or on the promised reform of NICE’s processes towards evaluating how treatments would be made available on the NHS.

When proposals were finally brought forward this year, they included not value-based pricing but value-based assessment, which is altogether different. The plans would have included two new modifiers entitled “burden of illness” and “wider societal impact”. The burden of illness modifier would have replaced the current end-of-life criterion. The burden of illness criterion that would have been introduced is already largely counted in the current quality-adjusted life-year measures. There are also wide-ranging issues with the other suggestions, so it was no surprise that, after lengthy consultation, NICE confirmed that the plans to introduce the changes had unfortunately been shelved. What this means in practice, though, is that the Government have failed to deliver on a key commitment, the fulfilment of which many people were looking forward to. I should be grateful if the Minister would reflect on progress to date.

Access to medicines is key because the UK is lagging behind other countries. From analysis of more than 60 medicines launched in the UK, the Office of Health Economics found that people living in the UK are less likely to have access to a new medicine for the first five years after its launch than people living in other countries. That shows clearly that reform is vital.

Does the hon. Gentleman agree that one of the real problems is that some of these treatments, such as abiraterone, are not available in Wales but are available in England? That is leading to people leaving Wales and taking up residence in England in order to get that treatment.

I am grateful for the question. Without doubt, there are issues that need to be addressed on both sides of the border.

One major part of the issues that we are discussing today is the pharmaceutical price regulation scheme, which caps the expenditure of the NHS on branded medicines. It has existed since the 1950s. It is an excellent scheme in principle but must work properly in practice. Given that there has been essentially no parliamentary debate on the PPRS, I should be grateful if the Minister would explain a bit more how the new agreement is intended to work in practice.

As I understand it, if the NHS exceeds the agreed expenditure, as the right hon. Member for South Cambridgeshire said, the money is rebated back to the Treasury. But given that the outgoing moneys will presumably be taken from clinical commissioning group prescription budgets, can the Minster explain how the CCG in question will actually feel the benefit of the PPRS? If the rebate stays in the centre, rather than being reimbursed to CCGs, how will the PPRS work as a tool with which to increase access to treatments? Has the Minister considered how the rebate might be better used for incentivising improvements in access? What can be done to speed up drug accessibility and reduce the duplication by CCGs of work already undertaken by NICE? That is clogging up the system and slowing down access to new medicines.

The Minister will be aware that at Health questions last week I raised some of the genuine concerns of patients, such as Clive Stone in the Prime Minister’s constituency, and charities, such as Breast Cancer Care, about the cancer drugs fund. As the Minister knows, the overspend in the cancer drugs fund last year and the way in which it operates has led to its being under considerable pressure, and many in the industry believe it to be unsustainable. The former Health Secretary has been absolutely clear that it was always intended to be a bridge, and I welcome his candour on that.

The issue with any new medicines, which I know NHS England is now looking at, is how to balance clinical benefit and cost-effectiveness. None of us would pretend that that is an easy task, but it is clear that it needs to be done in a much clearer and more transparent way than is currently proposed, and I should be grateful if the Minister would set out how patients will be involved in the evaluation of drugs and represented in that process at the meeting of the cancer drugs fund clinical panel later this month.

One way to improve access to medicines would have been to back the Off-patent Drugs Bill that was before this House only a few weeks ago. That would have improved access to many drugs for many people but, as the Minister is aware—he was speaking opposite me at the time—the Government refused to support it. Will the Minister again take the time to explain why the Government opposed that piece of legislation, which originated from one of their own Members? It was certainly supported by Labour Members. The innovative medicines review has the potential to do real good in this area. I should be grateful if the Minister would speak to that, too, in some detail in the time available for his speech.

I realise that time is short, so I will draw my remarks to a close. We all want to see improvements to access and we are all desperate—I use the word in its accurate sense—for progress on this, so will the Minister set out what action he will take over the next few months and what progress he realistically expects to make before the election?

It is a pleasure to respond to this debate and to follow the hon. Member for Copeland (Mr Reed) and my right hon. Friend the Member for South Cambridgeshire (Mr Lansley). It is a shame that there are not more Members present, because I know that the debate has been warmly welcomed across the House. I congratulate the Backbench Business Committee on granting it and my right hon. Friend on securing it.

I would like to take this opportunity to pay tribute to my right hon. Friend for all his work in this field, both as the Member for South Cambridgeshire—I do not think there is a constituency that more represents this cluster—and as the former Secretary of State for Health, because he led many of the initiatives that he spoke about so eloquently this afternoon. He is as well placed as anybody to describe the evolution of policy in that space, and it is my great privilege, as the first Minister for life sciences, to inherit that baton of leadership.

I also want to acknowledge the very helpful comments and questions from my hon. Friend the Member for North Herefordshire (Bill Wiggin) on whether there is more of an opportunity for the NHS to become more of a partner in the development of novel medicines. He is absolutely right, and I will come to that in a moment. He also raised the question of off-label drugs, as did the hon. Member for Copeland, and I will also address that shortly. The hon. Gentleman also requested an update on progress in this field and some detail on the review of innovative medicines that I announced two weeks ago. I am grateful for his support for that and for his recognition of NICE’s work on value-based assessment.

My right hon. Friend the Member for South Cambridgeshire set out eloquently, and incredibly helpfully for the House, the challenge we face and the evolution of policy in this area. He talked fluently about the challenge facing the Government, and indeed all mature western democracies, with an ageing population, a demographic time bomb and the rise of chronic diseases. As the Chancellor reminded us in yesterday’s autumn statement, we inherited a very serious structural deficit in the public finances and huge pressure on our budgets. We have to balance the requirement to spend our drugs budget as effectively as we can for patient benefit, but in a way that supports our leadership in medical research for the benefit of patients. That goes to the heart of my mission as the new Minister for life sciences: how do we embrace science, research and innovation so that we spend every health pound more effectively? It is about embracing precision medicines, cutting out waste and ensuring that we deliver maximum health benefit for patients through our health budget, but in a way that attracts inward investment to our economy to equip us better to pay for the modern medicines that we will all need.

My right hon. Friend highlighted that NICE has led the world in health economics on the 20th century model, which is really based on an averaging of health economic benefits, as he explained, and that is under increasing pressure from some of the breakthroughs in science that are bringing us a new generation of stratified and personalised—in some cases, literally—medicines, which do not fit well with the model of averaged, whole-population health economic assessments.

My right hon. Friend made the point fluently that it is ironic that we are a leading centre for research, but unless we also become a leading centre for adopting these new medicines, we will struggle to retain that. We set that out very clearly three years ago in the life sciences strategy. The Prime Minister was very clear about that. We do not believe that we can rest on our laurels simply as a 20th economy with a strong pharmaceutical footprint; in the 21st century we have to use all our resources, including our NHS, to accelerate the discovery of new medicines and their adoption into the system.

I wish the Minister every success in that mission and offer the fulsome support of the Opposition in ensuring its success, but does he agree—I do not wish to divert him too much—that critical to that success is that Britain remains in the European Union?

I thank the hon. Gentleman for that warm support for this mission. We are ambitious for this country in life sciences research, and ambitious for Europe too. One of the things I am exercised by is the danger of the European Union putting in place a regulatory framework that does not support 21st-century leadership in regenerative medicine, in stem cells, and in the use of data. In the new year, I will lead a delegation to the European Commission to highlight the fact that this new landscape requires a new regulatory framework. I very much hope that we can persuade the European Union to embrace that so that Britain can lead in a Europe that leads in a global sector.

My right hon. Friend talked about institutional and cultural barriers to rapid adoption of new medicines and the need for a new system. I strongly agree with the tenor of his thinking. It must be a system in which we put patients right at the heart of the assessment of need and in which clinicians are empowered and supported to make decisions based on what their patient needs. The new model of 21st-century research and medicine is about accelerating a much more patient-centred model of research, not just so that we design drugs around patients and their genetics and data, but so that the patient voice is stronger in the allocation of resources. That is a challenging but important agenda that we need to embrace.

My right hon. Friend reminded us that this formed a lot of the thinking behind the original concept of value-based pricing and the need for us to move towards a new mechanism for reimbursing innovations on the basis of the impact that they have in populations. I strongly support all that. He highlighted the cancer drugs fund—a really important measure that seeks to make sure that, in cancer, the therapeutic area that has most challenged the traditional method of health economics, we do not allow patients to suffer from lack of access given the increasing stratification of new drugs that do not fit well with the NICE model. I pay tribute to his leadership on this. I am very proud that we have managed to increase the funding of the cancer drugs fund at a very difficult time for the public finances, with another £160 million this year bringing the total to £280 million. More than 60,000 patients have benefited from that.

My right hon. Friend is right, however, to signal that the cancer drugs fund is, in essence, a stop-gap mechanism to make sure that we are able to update the systems, protocols and procedures within NICE for adopting and procuring innovative medicines. We do not intend to have a specific fund for every therapeutic area or, indeed, additional assessment measures within NHS England on top of those already faced by the industry through NICE. It is crucial that we use this window of opportunity to put in place the new system to adapt NICE’s mechanisms and procedures to the new landscape. That is precisely what the review that I announced a couple of weeks ago is about.

My right hon. Friend made a number of comments about the pharmaceutical price regulation scheme. His overall message that price should reflect the value of new medicines and that we should, as far as we can, pay on results, paying a premium to innovations that have particularly high impacts and patient benefits. I suggest that that should apply equally to med tech as to pharmaceuticals. That is part of what was originally conceived of in the value-based pricing proposals that he brought forward. I agree with all that, and I think it is the direction of travel. In a moment, I will explain how the review and the work we are pursuing in the Department of Health is intended to pick up that thinking and drive it forward.

I welcome my right hon. Friend’s reference to the importance of new methodologies. I have discussed this with NICE. He will not be surprised to hear, as it is an organisation that is constantly looking to update its procedures, that it is actively looking at these challenges and welcomed my review as creating a forum for it to share things with industry and charities. I particularly welcomed his mentioning the role of charities. Increasingly, we will see charities as sponsors of drugs alongside big pharma and small companies. As he said, the system is very heavily geared around big pharma as the main developer of new drugs, but that is increasingly not the case. We need a policy and reimbursement landscape that reflects the needs of not-for-profit and smaller company sponsors.

Clinical validation of whether an innovative drug or device is going to work in patients is key, and I know that that is the most valuable moment of all for organisations, because I used to work with them. We should not forget that there is also value in the developers of an innovation being told that it will not work in patients. The “slow no” is the death knell for so many innovative companies and charities. We should look to embrace a model in which we can add value by helping the developers of innovations not to pursue those that will not work well and to target those that can be channelled towards those patients who will benefit most.

I hear loud and clear my right hon. Friend’s call for us to urge NICE to develop a more value-based assessment and to explore all mechanisms in the PPRS for innovative medicines. I am very happy to agree with those two things and take up the challenge to support them. I agree with my right hon. Friend’s analysis that we have a window of opportunity in which it is important that we set out a new framework so that, beyond the cancer drugs fund, NICE is able to provide a holistic, comprehensive model for assessing the new range of medicines that come on stream, and that we do not have to set up additional funds for different types of medicines with additional burdens of assessment both within and outside NICE. That is precisely what the review I have announced is about and I will deal with some of those specific points.

My right hon. Friend made an excellent speech that captured and set the scene and the challenge we face. I will summarise in my own words the problem. We are moving from a 20th-century model of drug discovery and pharmaceutical innovation whereby typically a new drug takes 10 to 15 years to come to market and costs $1 billion to $1.5 billion. It follows a linear process that starts with deep university biological research and then, if we are lucky, it gets spun out into a company or licensed and sent to industry. If we are lucky, it will then get financed through various stages and taken through phases 1, 2, 3 and 4 of trials, with hugely costly international studies. Then it is approved as safe by the Medicines and Healthcare products Regulatory Agency or the European Agency for the Evaluation of Medicinal Products. Then it is approved by NICE as being of suitable cost-benefit for recommended use in the NHS, and then it has to be taken up by clinicians in the service.

The truth is that that model is not working well enough for anyone, but most importantly, as my right hon. Friend has pointed out, it is not working for patients. It is coming under pressure for a series of reasons, partly because the industry is struggling with the time cost of a 10 to 15-year development pipeline, leaving it with innovations it needs premium pricing for to justify the huge sunk costs at a time when we are facing a demographic time bomb. Given the rising cost of disease, we need to get maximum value out of every pound. We cannot afford to pay premium prices for every new innovation, so we need a new model.

The great challenge that that represents is also a great opportunity for this country, because the new model will be about designing innovations around particular patient groups. Yesterday, we believed that what we thought were blockbuster diseases required blockbuster drugs, but today, the more we know about disease, patient data and genomics, the more we know that certain patients respond to the same disease—and, indeed, the same drug—in different ways. If we can use that insight with industrial partners, a new generation of treatments can be designed around patient groups and introduced to them dramatically earlier, which is a completely new value proposition, principally for patients, but also for the NHS. That will allow us to become something of a partner in innovation and unlock the basis of a new model of reimbursement.

I do not pretend that that is easy, or we would be able to do it overnight. We will certainly not be able to do it by Christmas, by the election or even within a year or two. It might involve a 10-year programme of deep and long-term change, but we are definitely committed to embracing it and to laying a policy foundation for it.

I want to say something about the PPRS, because it plays a very important role in this landscape. We negotiated and agreed this important deal with the industry. It contains mechanisms for supporting innovative medicines, not least the exclusion for small companies—those with a turnover of less than £5 million—and the exclusion of new medicines brought on stream from January this year. The review we have announced—

Motion lapsed (Standing Order No. 9(3)).