Source · Select Committees · Health and Social Care Committee
Recommendation 11
11
Accepted in Part
Require DHSC and NHS England to submit plan for regulatory readiness and resourcing.
Recommendation
The Department of Health and Social Care and NHS England must lay before Parliament a plan for how they intend to ensure all relevant regulatory and delivery systems are ready to assess and deliver these new innovations to patients. As part of that plan, the JCVI and the MHRA must be adequately resourced and supported, focusing on modelling capability at the JCVI and, at the MHRA, on recruiting and retaining expertise relevant to new innovations, especially in personalised health. (Paragraph 42) 16 Prevention in health and social care: vaccination
Government Response Summary
The government describes existing regulatory processes and monitoring for new medicines, detailing how it supports JCVI's modelling capabilities and allocates £10 million over two years to MHRA for accelerating innovative medicine delivery, but does not commit to laying a formal plan before Parliament as requested.
Government Response
Accepted in Part
HM Government
Accepted in Part
The regulatory and delivery processes for the introduction of new medicines, including novel vaccines, is outlined in Annex A, for which partner organisations own planning responsibility. In the Department’s sponsorship capacity, DHSC continues to monitor partners’ role in supporting the introduction of such medicines. The Department recognises the key role of UKHSA in providing secretariat, modelling and health economics capacity support for JCVI as captured in the Department’s strategic remit letter to UKHSA7 and UKHSA’s 3-year strategic plan8. The UK system for reviewing new immunisation products for potential programmes is effective and responsive. It is grounded in scientific review of evidence and allows for a fast response to outbreaks, and to new products being developed. The JCVI membership is comprised of experts in a wide range of relevant fields and their combined expertise ensures robust and timely review of new and emerging evidence in the field. If it is needed, the JCVI can recruit members with specific skills and expertise to its sub-committees. These sub-committees then report to the main committee. JCVI reviews modelling work to assess a potential vaccination programme’s cost-effectiveness and impact. Where necessary, second opinion modelling may also be sought. Various modelling groups have supported the JCVI including UKHSA modellers and academic groups. DHSC also commissions second-opinion modelling to support the work of the JCVI via the Mathematical & Economic Modelling for Vaccination and Immunisation Evaluation (MEMVIE) project. The Department is working closely with the JCVI and UKHSA to support resources being available to support outbreak response, as with the London polio response, and regular improvement of all extant immunisation programmes, as with the recent changes to Shingles and HPV programmes. This support includes funding for external modelling contracts as well as internal resource allocation. At Spring Budget, the Chancellor announced a total of £10 million over the next two years for MHRA to help bring innovative new medicines and medical technologies to UK patients more quickly. The funding will be used to accelerate routes for bringing innovative medical products developed in the UK onto the market, as well as the those made and approved by other trusted regulatory partners globally.