Health Technology Assessment Charges — House of Commons, 2018-12-04
Topic: Health
Anne Marie Morris (Conservative, Centre-right): I rise to speak about health technology assessment charges in England. I am sad to see that there is not more interest in this debate, even at this very interesting early hour of the morning The Government are proposing to charge for technology appraisals undertaken by the National Institute for Health and Care Excellence. The House should understand that for a drug to be fully marketed, it has to go through three stages: it is required to be licensed, to go through NICE and then to go through the formulary. Licensing enables the drug to be certified as doing, in effect, what it says on the tin. The NICE process ensures that it offers good value for money and is something the NHS is prepared to make generally available. The formulary is all about endeavouring to ensure that the drug is available locally It is not common in other markets for technology appraisals to be charged for. It is not unheard of, as I am sure the Minister will tell me, but in the grand scheme of things, these pharmaceutical companies or life sciences businesses have already put billions of pounds into these particular drugs. As hon. Members will appreciate, there is quite a high failure rate at the first stage for licensing, but by and large, those that get to NICE are fit for purpose and are good value for money, and most of them are eventually passed Given the billions that the drug companies have already spent, to ask them to pay for this approval process, which is for the benefit of the NHS, seems a little churlish. Hon. Members may ask, given that the amount to be raised will be £10 million—with the cost for a single technology appraisal at £126,000 and a highly specialised appraisal of the same amount—whether this really matters. The answer is yes, it does. This is not a comment on NICE. NICE is incredibly well respected. It is a global leader in what it does. It makes very high-quality decisions, and it is absolutely clear that if we want to ensure something is fit for purpose and safe, NICE is where we want to go. Indeed, we need more NICE, not less NICE: we need more drugs to be available to patients The trouble with what is being proposed is that, while there is undoubtedly a need to look at the cost issues, it sends the wrong message, and that wrong measure will be far more damaging and costly to UK plc and to patients than the £10 million. The balance of risk between the taxpayer and the life sciences or pharmaceutical companies will change, albeit ever so slightly, but that message says that this is not something that we, UK plc, should be incentivising. That is wrong: it goes against the life sciences industrial strategy and against any recognition of the competition out there There is huge competition. The United Kingdom has some of the best brains in the world, but increasingly, because of the challenge of getting the drugs to market, competitors are looking at incubating in the UK, where we have the expertise, but when marketing and taking a drug to a competitive position, going to the USA or Japan, and failing that, Germany or France. What might seem a small figure is sending out the message, "Don’t invest here" Following Brexit, that is absolutely the wrong message. The sector could—and should—be a real source of this country’s growth post Brexit. It needs to grow: it can and must grow. We must send a strong message that we want people and businesses to invest in the UK to develop the medicines that we need and, most importantly, to ensure that the UK citizen has the best access to the best drugs in the world We then have to examine the NHS’s duties when it considers approvals for drugs. It has at least four duties. The first is to provide equal access to NHS facilities, irrespective of cost. The second is to promote research. The third is to take account of research and development costs when making decisions. The final duty is the family test to ensure that its actions respect the impact on the whole family of approving or not approving a drug The challenge with equal access is that the unmet need is for often expensive therapies and pharmaceuticals for very small patient groups. Increasingly, those new therapies are being developed by start-ups—new companies that focus on one particular disease area. Doubtless the Minister will say, "What if those small companies were offered a reduced rate, cut by 25%?" Frankly, that is the proverbial drop in the ocean. The negative message is still there. I am sure that the Minister will remind me that those small companies can phase payment. The problem is that that is front-loaded. The Minister will then no doubt say that there is the potential—as, when and if NICE decides not to proceed—of reimbursement. However, by that stage, most of the money—the equivalent of the £126,000—will have already been spent. It is a nice idea, but it does not work in practice The NHS has committed to promoting research, but as I have already mentioned, there is huge competition from America, Japan, Germany, France and many others. Not only will those who incubate here go to those countries to commercialise, develop and market that product, but in those countries, it is quicker, cheaper and easier to get to market. We are talking about businesses—those are business decisions—so why would they not do that? Sadly, we are no longer the first choice of place to commercialise, then sell and market drugs. We are often the second, third and even fourth choice. We cannot afford to lose pharmaceutical companies and investment. Compared with that, the £10 million the Government are looking to gain is a drop in the ocean. Post Brexit, we must do everything we can, in the interests of patients and our life sciences industry, to support our companies and ensure that they can continue to grow We must look at taking into account R&D costs. They are going up, not down. It is not clear from the regulations how many times the fee has to be paid, because there are several parts to those processes and there are also appeals processes. The other peculiar part of the way in which this has been shaped is that the charge applies only to medicines. It does not apply to medical devices and diagnostics, so it does not apply across all the possible cures that go through NICE. Are the pharmaceutical companies supposed to pick up the costs for medical devices and diagnostics, too? That does not seem right or fair. Finally, there is the family test. The family will obviously be impacted by what happens to a member of it. If one member is suffering from something very acute, very rare and very debilitating, that will have a huge impact on the family members and the carers of that individual. The win in sorting this out is much greater than just that individual I propose to the Minister that none of the tests, to which the NHS has committed, has been met. Clearly, I would be with the Minister and the Government in saying that costs are an issue, but that is not the answer. Clearly we must look at ways of finding the money to produce more for less, but there are many other ways of doing that. Let us look instead at removing bureaucracy, improving efficiency and avoiding the duplication we see because of the three-part process of getting drugs licensed so they do what they say on the tin, going through the NICE process to see whether the Government and the NHS are prepared to ensure that they are readily available and, finally, going through the formulary process I submit that what we need to do is look at licensing, the NICE process, baseline commissioning and formulary decisions in the round. Let us look across those processes and cut out the duplication which other countries have achieved so successfully. I submit that we should not, in the best interests of patients and the country particularly post Brexit, introduce the regulations in April next year. We should look again at the broader issue and at all the processes in the round, and instead make this part of the NICE methodology review, which is due next year. Let us consult on efficiency and effectiveness, not just cost reduction We want more drugs assessed, not fewer. We want it done faster. We want it to be more efficient. We want it to be more effective and we want to make sure that UK patients get the benefit of lifesaving medicines more quickly than others. We need to strengthen the life sciences sector. We need to encourage investment in the UK. I say to the Minister, "Do not introduce the regulations. Think again."