My Lords, my Amendment 124 concerns NICE’s current review of its methods and processes as part of the agreement of the voluntary scheme for branded medicines pricing and access—commonly known as the VPAS. I will also speak to Amendment 85 in the name of the noble Lord, Lord Lansley, because he made some important points in his opening remarks.
I have a particular interest in NICE. Under Frank Dobson, I was the first Minister and worked closely with it for the first few years. It was established because of concern that effective new treatments, including medicines and devices, were not getting to NHS patients. This is a continuing problem. At the beginning, we put an additional sum into baseline budgets to cover the estimated cost of technology appraisals.
I have to say that pharmaceutical companies were obviously reluctant to embrace NICE, but so was the NHS. As early as December 2001, I was responsible for a funding direction to the NHS—the original one, referred to by the noble Lord, Lord Lansley—which required NHS bodies to implement their technology appraisals, because research showed that they were not doing so. They had been given the money, although it was not identified but put into baseline budgets, which is an interesting point.
The funding directions have been modified a few times since then and, to an extent, have reduced the impact. But the fact is that the NHS remains a reluctant partner—and you can add that to the unprecedented level of rationing taking place locally. There is a tendency, even when NICE has approved drugs or a technology appraisal, and even when the funding direction applies, for local mechanisms to be used to restrict access by patients. I have already referred to clinical commissioning groups: they are informed by regional medicines optimisation committees. Essentially, these are rationing committees designed to legitimise decisions by CCGs to ration treatments. I come back to this point: why do we tolerate NHS patients missing out on medicines and devices that are available to most patients in most European countries?
We come to the NICE review. I am a great admirer of NICE, which has done a fantastic job and has some brilliant people. It works with some fantastic universities, and we are world leaders in this field. However, I hope that the methods review will lead to tangible change and that we will get a fair and effective assessment of the true value of innovative medicines.
We are clearly at a crossroads: exiting the EU represents a significant threat to the attractiveness of the UK for pharma and devices companies. What factors do companies take into account? Clearly, the strength of our life sciences sector is one of them. Secondly, there is the regulatory system, which we are discussing in Grand Committee. Thirdly, there is the ability to launch medicines and technologies quickly into a market, getting medicines to patients who need them quickly. These are clearly part of the equation for any company, and pharmaceutical companies tend to be global, to all intents and purposes. The risk is that we will start to lose our reputation as a leader at the cutting edge of medical science. My hope is that NICE’s approach to appraising value must take into account the strategic benefits of the NHS remaining at the forefront of medical innovation.
I shall give an example of where NICE’s current rules rule against this. Gene therapy is a prime example of a medical technology that the UK should embrace, but a procedure called discount rate, used by NICE to adjust for future costs and health benefits when valuing treatments, discriminates against one-time therapies that offer potential long-term health benefits over many years, such as gene therapies. NICE almost always uses the 3.5% rate but can apply a lower 1.5% rate for therapies that offer longer-term health benefits. I understand that it chooses to do that only on exceptionally rare occasions. Post the new 2019 voluntary scheme, negotiated to deliver a triple win for patients, government and industry, we now see NHS England doing bespoke commercial agreements, which of course significantly undervalue innovation.
There is always a tension, but the tension is that the main interest of NHS England is to pare down drug costs. The impact that that has is that, for all the brave words about innovation, it simply does not play out in the field. I was very interested in what the noble Lord, Lord Lansley, had to say. There is a HealthTech Connect portal, but I am told that not a single innovation submitted via that portal was adopted by NHS Supply Chain during the first year of operation, March 2019 to April 2020. Are we to assume that none of the submissions meets the criteria in terms of evidence, efficiency or satisfying unmet needs, or are they simply being thwarted by a process that raises the bar to unrealistic levels?
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This is a very worrying debate. We know that the UK has so much to offer. With our universities and the centres that the noble Lord, Lord Lansley, talked about being established in Cambridge, we know that we have a huge amount to offer. The Department of Health, as the department concerned with life sciences, understands that but, as the overseer of the NHS, it does not understand it, because it will not discuss or embrace issues around funding.
We are having great difficult in tempting the Minister to respond to these more general issues rather than the specifics in the Bill, but this is a genuine and heartfelt plea to do something to change the dynamic. I hope that, as we go through Committee, we may persuade the Minister to respond some more to these pressing issues. At stake is one of our best industries, and we really need to protect it.