Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what steps his Department is taking to increase the speed of the (a) development and (b) approval of effective HIV vaccines.

The Department is committed to maximising the United Kingdom’s potential to lead the world in clinical research, with the aim of ensuring that all patients, including those with human immunodeficiency virus (HIV), have access to cutting-edge clinical trials and innovative, lifesaving treatments.

The Department is working closely with the National Health Service, industry, academia, research regulators and charities to make clinical research in the UK more efficient, more competitive and more accessible. We expect these efforts to attract more commercial investment in clinical research and yield a broad and diverse portfolio of clinical trials in the UK, including clinical trials for HIV patients.

The Medicines and Healthcare products Regulatory Agency (MHRA) is ready to assess any market authorisation applications for HIV vaccines against high standards of quality, safety and efficacy. A standard assessment would take up to 210 days to complete.

The MHRA has several routes to support access to innovative medicines for patients with conditions with unmet need. One such route for doing so is the Early Access to Medicines Scheme (EAMS), and the entry for the scheme is a Promising Innovative Medicine (PIM) Designation. If a PIM Designation was awarded, the application would then continue under the EAMS, where it would be assessed for an EAMS Scientific Opinion, which if awarded would need to be renewed annually. Further information is available at the following link:

https://www.gov.uk/guidance/apply-for-the-early-access-to-medicines-scheme-eams

Another route is the Innovative Licensing and Access Pathway (ILAP), which is focused on getting the most transformative new medicines to patients in the UK health system more quickly. The ILAP is the only end-to-end access pathway in the world where the developer can work collaboratively with the national health system, the regulator, and Health Technology Assessment bodies. Further information is available at the following link:

https://www.gov.uk/government/publications/innovative-licensing-and-access-pathway-ilap