I am grateful to my noble friend for his amendment and for raising the issue of reporting requirements and how that relates to the responsibilities of NICE.
Under the current PPRS, the Department of Health regularly publishes information relating to the operation of the voluntary scheme. For a future statutory scheme, as my noble friend is aware, the illustrative regulations, which we have published alongside the Bill to assist in scrutinising the provisions, already include regulations for both the statutory scheme, in Regulation 32, and the information regulations, in Regulation 14, for an annual review of the regulations and a requirement to publish our report of each review. Our illustrative regulations require an annual review to,
“set out the objectives intended to be achieved … assess the extent to which these objectives are achieved; and … assess whether those objectives remain appropriate”.
These requirements will be tested through the consultation on the regulations and we will of course take account of those views.
I assure my noble friend that that review would take into account the duties under Section 266(4), which currently are,
“the need for medicinal products to be available for the health service on reasonable terms, and … the costs of research and development”.
Of course, subject to further consideration of the Bill, there may be further duties. I accept that reporting is an important principle but setting out the requirements in primary legislation is too restrictive. Over time, it is to be expected that both the statutory scheme and the information requirements will be amended through their respective regulations to reflect changing circumstances. It is essential that the review and reporting arrangements be able to be similarly flexed, so that they remain appropriate to the schemes in operation. My noble friend has suggested that we report every time there is a new voluntary or statutory scheme. I believe the annual reviews as set out in the illustrative regulations would provide more frequent review than the amendment proposes, at least for the statutory scheme.
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Secondly, my noble friend has proposed that we would cover the impact of a price control scheme for the duties of NICE under Section 233 of the Health and Social Care Act 2012. In Committee, we discussed reporting requirements at length and in particular whether it would be appropriate for any report or review to address matters relating to the NHS duty to promote innovation. As I set out at the time, this would
not be appropriate. Similarly, it would not be appropriate to address the duties that have been put on NICE through reports relating to the operation of the Bill, which is ultimately about controlling the cost of medicines and medical supplies.
The Health and Social Care Act 2012 puts duties on NICE in relation to its functions, including a duty to have regard to the broad balance between the benefits and costs of the provision of health services or of social care, and a duty to have regard to the desirability of promoting innovation. The Government’s priority is to make sure that we get the best possible results for all NHS patients with the resources we have, which means using taxpayers’ money responsibly and getting good value for money. NICE will continue to make its valuations on that basis and look at how best to promote access to effective medicines, through its recommendations and guidance to the NHS.
In developing its guidance, NICE of course takes account of all health-related costs and benefits, including benefits to carers. As I am sure my noble friend will recall, in 2014 NICE considered changes to its methods to capture better the wider costs and benefits to society of new drugs and treatments, known as value-based pricing. During the consultation some significant concerns were raised—for example, about the potential implications for products that offer limited life extension without associated gains in quality of life for those with terminal illnesses. The consultation highlighted a significant diversity of responses, demonstrating that this is a complex issue.
It is critical that stakeholders continue to have confidence in NICE’s work. I agree with NICE that these issues require careful consideration before making changes to the way it assesses medicines. That is one of the reasons why I do not believe it appropriate for the reporting and reviewing structure of the schemes that could result from the Bill to incorporate the duties of NICE. The statutory scheme has no link to the duties that the 2012 Act places on NICE.
I hope I have been able to address the issues that my noble friend has raised. I know he is a passionate proponent of the importance of value-based pricing, and look forward to continuing to work with him to see how those considerations could be included not only in future NICE assessments but in the operation of any pricing control Bill. On that basis, I ask him to withdraw his amendment.