National Institute for Health and Care Excellence (Miscellaneous Amendments) Regulations 2018
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Baroness Thornton (Lab)
I thank my noble friend for bringing this matter to the Floor of the House and for leading this short discussion. I too have many questions for the Minister but many of the questions that I would have asked have already been asked by my noble friend and the noble Baroness, Lady Jolly. It seems that our concerns are very similar. I agree with the noble Baroness, Lady Jolly, that when I read through the notes accompanying this regulation, it seemed puzzling that the consultation had produced a majority against this process, and I too was not completely convinced by the Government’s justification. That must lead to something which we can probably call cuts and wanting to save money. To want to save money with an organisation which is so integral to our NHS infrastructure and so important to ensuring the efficacy and cost benefit of and access to medicines and procedures is not a sensible way to proceed.
Some of my other questions centre around a concern about the impact that these charges will have on the jewel in the crown that is the UK-based science industry, particularly at a time when there is already such uncertainty with the dual impact of Brexit and these charges. It seems that the additional costs for a market may diminish the UK’s attractiveness for life science businesses, which has already been mentioned, and may also mean that NHS patients get access to new therapies later than those in other countries across Europe, which my noble friend also alluded to. Has there been an assessment of the impact of these charges on the UK bioindustry and its attractiveness to the international life science community, and of the UK as a location to research, develop and launch innovative medicines?
What will be the impact on patients? The UK BioIndustry Association has stated its concerns that the charges for technology appraisals could either prohibit or delay patient access to medicines in England. This could result in inequalities across the UK, as medicines may be available in Wales and Scotland, where charges for technology appraisals have not been introduced, before receiving approval for use on the NHS in England. That might disproportionately affect patients with very rare conditions, and therefore might also undermine the UK rare disease strategy to ensure equity of access across all four nations of the UK. Have the Government considered not only the financial impact but the potential impact on patient health? Do the Government have a strategy in place to mitigate delays in patient access to medicines that may come from these charges?
I join the noble Baroness, Lady Jolly, in asking whether there will be a review of the impact of this proposal, when that will take place, and when we will learn about the impact of this proposal on NICE and the NHS infrastructure. That will be important. We need to review this, because I fear that it may be a wrong decision.
The Parliamentary Under-Secretary of State, Department of Health and Social Care (Baroness Blackwood of North Oxford) (Con)
I thank all noble Lords who have contributed and congratulate the noble Lord, Lord Hunt, on securing this debate. It is an important subject and it is right that we take time to consider it. I know that he takes a keen interest in NICE’s work from his previous role as the first Minister with responsibility for NICE, and it is a privilege to have taken on his mantle some years later.
This year marks a significant milestone for NICE, as it celebrates its 20th anniversary, during which time it has transformed the way in which decisions are made in the health and care system. I echo the comments made by the noble Baroness, Lady Thornton, who referred to NICE as a jewel in the crown of the UK life sciences ecosystem. She is absolutely right that we must ensure that we not only protect it but promote its success. Since its inception, NICE has played a vital role, not only in securing maximum value from health spending but in ensuring that patients are able to benefit from rapid access to effective new drugs and other treatments. The noble Lord, Lord Hunt, hit the nail on the head when he said that that balancing act in the health system is so challenging.
Of course, the NHS is required to fund the treatments recommended through NICE’s technology appraisals and HST evaluation programmes, so that they can be provided if a patient’s doctor says that they are clinically appropriate for the patient. Over the past 20 years, more than 80% of NICE’s recommendations have supported use of the technology assessed, meaning that many thousands of patients have benefited from rapid access to effective new treatments. A less-frequently reported statistic is that 75% of HST applications have also gone through, which is encouraging.
Recent IQVIA research has just been published which showed that, despite some of the frustrations we have with update and access—which is something we are working hard on—the UK is in fact one of the fastest countries in Europe to get products through its regulatory system. We can be very proud of that, and must protect it.
I know that your Lordships will agree not only that it is extremely important that we have a system such as NICE in place to ensure the NHS spends its money in the most effective way possible, but also that it is critical that NICE operates on a sustainable footing so that it continues to be responsive to developments in the life sciences sector, to which noble Lords all referred.
To date, as has been mentioned, NICE’s TA and HST programmes have been funded through government resources but, as is common with government bodies, it is right that NICE considers how to operate to the utmost efficiency, and that those who stand to benefit from services contribute.
This is standard procedure and a standard model for many organisations and ALBs such as NICE. It is standard for the MHRA, the HTA, the CQC and for HTAs in other countries, so we are not operating an unusual procedure here, as the noble Lord, Lord Hunt, mentioned. I was grateful for his support for the charging model.
However, recognising the need for sustainability must be balanced with the imperative to encourage innovation, and the Government and NICE believe that the most appropriate and sustainable model for NICE’s TA programmes in future is for it to levy a proportionate charge on companies that benefit directly from its recommendations. This goes right back to a recommendation of the triennial review of NICE in 2015, so long-term work has been going on in this area. Recognising the importance of getting it right, the Government consulted on the draft regulations. That consultation has been referred to by noble Lords. At that point, as part of those proposals, the Government proposed the 25% discount for small companies. The consultation also sought views on a proposal to enable NICE to recruit appeal panel members engaged in the provision of healthcare in the health services across the UK instead of just England. This has not been mentioned and I know is widely supported, but I just wanted to point out that fact, which we are very pleased about.
As was raised by the noble Baronesses, Lady Thornton and Lady Jolly, there were 78 responses to the consultation, around half of which represented views from the life sciences industry, including pharma companies, industry representatives, consultancies and medtech companies. Other responses came from patient groups, NHS organisations and individuals. Although, as has been said, the majority of respondents—62%—disagreed with the specifics of the proposal to charge companies for making recommendations, the analysis showed that just over half of respondents agreed that life sciences companies should contribute to the cost of developing NICE recommendations, which is why further work was done to develop the charging proposal but refine it.
Respondents also supported, by 59%, a mechanism for reducing the impact on small companies, but felt that the proposed 25% discount did not go far enough. Other more specific concerns were raised about the potential impact on patient access to new treatments, in particular for rare diseases, the impact on NICE’s independence, and the analysis contained in the impact assessment.
The SLSC also picked up on issues in its report, and I will address some of those in response to points raised by the noble Baronesses, Lady Thornton and Lady Jolly. The Government considered the issues raised in the consultation very carefully and carried out further analysis to feed into the final impact assessment. We concluded that it was appropriate to make two main changes to the policy in light of the consultation responses. These particularly dealt with concerns about the design of the charging with respect to SMEs. I know that noble Lords are well aware of those concerns.
There is an increased discount for small companies of 75%, to minimise barriers to the participation of small companies wishing to bring forward new products. I realise that many feel that that did not go far enough but, to address that concern, it also included the new power to enable the Secretary of State to direct NICE in specific cases to calculate charges on what it considers to be the appropriate commercial basis. This provides more flexibility for amending charges, should that be required in future, subject to consultation with stakeholders. For example, we may see different types of innovation, including devices or digital products going through TA programmes, and this provides flexibility for the Secretary of State to direct NICE to propose charges at a level appropriate to those markets. I think that responds to the point raised by the noble Lord, Lord Hunt.