Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what assessment his Department has made of the potential impact of the Part IX medical devices process on (a) supplier confidence and (b) future investment in the UK medical devices market; and what steps he is taking to (a) improve and (b) reduce the time taken for that process.

As part of our development work on Part IX of the Drug Tariff reforms, we have undertaken detailed assessment of the impacts on the market and suppliers. We have worked closely with industry and the joint Department and Industry Drug Tarff Committee to ensure we understand the likely impact. The reforms are designed to support innovation while also addressing unwarranted price variation for similar products. The new enhanced assessment process will allow comparison between products based on their merits, which will increase transparency and competition and, by extension, patient choice. This approach is intended to encourage new innovative products and small and medium-sized businesses to enter the market. Suppliers may also, for the first time, apply to list products temporarily for up to two years to allow them to generate evidence to support a longer-term listing. Through temporary listings, the Department is ensuring early National Health Service access to innovative products, providing a clear and transparent route to market.

To improve the listing process, we are introducing a robust assessment framework for products, including independent clinical advisory panels supported by patient representatives. An updated application form is being introduced to streamline the process, and the NHS Business Services Authority is recruiting additional resources for renewals. We are engaging with industry throughout the process, with opportunities to collaborate on any changes during the post-action review after each category is reviewed. This review will enable us to understand if the new process operates in the way that is expected and to make any adjustments as needed. It will also review process steps to ensure its as optimal for industry as possible.