My Lords, as this is my first contribution on Report, I declare my interests as a member of the GMC board and president of GS1, the British Fluoridation Society, the HCA and HCSA.
I welcome what the Minister said about research and its importance, and some of the tensions between practical work as a clinician and the crucial importance of clinicians engaged in research. The amendments that he introduced are very welcome, but like the noble Baroness, Lady McIntosh, I am disappointed that he has not brought similar amendments forward in relation to NICE. One suspects that it is something to do with money; he thinks that giving away amendments on research is cost-free, whereas there might be a resource implication when it comes to NICE. That is a pity.
The noble Baroness has talked about a postcode lottery in this country on the outcome of NICE judgments, but we also have a European postcode lottery. The fact is that NHS patients have much less access to modern new medicines and devices than those in many other countries. Stats that I have seen on medicines suggest that, for every hundred European patients who can access new medicines in the first year they are available, just 15 UK patients have the same access. We know that even when NICE has given its blessing to new medicines and treatments, take-up in the NHS still lags behind that in other countries.
I think that the noble Baroness, Lady McIntosh, and I were somewhat puzzled by the ministerial response in Committee in this area. We know that the NHS uses all sorts of rationing devices to prevent those new medicines and devices being allocated generally throughout the NHS, notwithstanding what NICE has to say—that is why I support the noble Baroness’s amendments. Essentially, my two amendments seek to build on the principles that she has referred to.
Amendment 171 relates to three issues which I think remain from Committee. The first relates to the links between licensing and reimbursement processes. Happily, the MHRA has established two new licensing pathways, ILAP— the Innovative Licensing and Access Pathway—and Project Orbis, for cancer medicines. This is very welcome; it is designed to speed up access.
However, the challenge with faster licensing decisions is that NHS reimbursement decisions need to speed up too, otherwise medicines can be placed on the market but cannot be made available to patients on the NHS. To its credit, the MHRA has designed this into ILAP, because NICE is directly involved in ILAP, and licensing and reimbursement decisions can be joined up. However, in respect of Project Orbis, there has been no such effort. Late last year, breast cancer patients faced the worrying situation where a drug, Trodelvy, which offered them hope, was licensed through Orbis but was not then available on the NHS. My amendment would therefore ensure that NICE acted to issue guidance on Project Orbis medicines as close to licensing as possible, as it does for ILAP.
Secondly, the amendment would clarify that NICE alone is responsible for determining its methods, as an independent body should be. In its recent methods and processes review, it concluded that
“there is an evidence-based case for changing the reference-case discount rate to 1.5% for costs and health effects. However, because of the wider policy and fiscal implications and interdependencies that are beyond the reach of this review, no change to the reference-case discount rate”
could be made. It further stated:
“Reducing the discount rate will make most technologies appear to be more cost effective.”
We are therefore in a situation where NICE wants to make a change to its methods, which would result in more medicines being made available to patients but is being stopped from doing so. That is not acceptable. NICE should be free to determine its methods, including the discount rate.
The final effect of the amendment would be to clarify the role that the current voluntary scheme, VPAS, and the statutory scheme play in reimbursement decisions. These schemes essentially cap the NHS’s expenditure on drugs, meaning the exposure of the taxpayer to spending on drugs is limited. The problem is that the health service then adds a whole host of other mechanisms to restrict access to medicines as well. My own view is that once we have VPAS and the statutory scheme in place, we do not need those other mechanisms.
Amendment 178 builds on this. I have already referred to the Project Orbis scheme. It has great potential, but unfortunately, as Gilead has pointed out, there is a lack of alignment across the system between government, the MHRA, NICE and NHS
England, which has an impact on timelines for approval. This is particularly concerning in light of moves by other countries such as France to legislate to enable early access to innovative therapies prior to a cost-effectiveness assessment, with any difference in the final agreed price rebated by the company. We need an integrated access and funding pathway for medicines licensed by Orbis, prior to NICE approval, modelled on the French system, whereby companies rebate any difference in price following the decision by NICE.
The final point I will make is that we also need to deal with NICE capacity issues. In January 2022, NICE highlighted in its board papers that approximately 20 evaluations were paused in 2021-22 due to capacity constraints because of vacancies. This is despite increased industry fees paid for health technology assessments. While NICE’s vacancy rate has reduced, the same board papers note that:
“Organisational capacity continues to be the key risk for NICE ... strategy, and gaps in hard to fill specialist roles in a competitive global market.”
I would like the Minister to respond to this.
More generally, I hope that the Minister can give us some assurance that he and other Ministers recognise that all these initiatives to speed up access, excellent though they are, will come to very little unless they can sort out the NHS side of things and get rid of some of these rationing mechanisms which have been put in place.