Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, whether any (a) vaccines and (b) alternative preventative treatments for recurrent urinary tract infections are (i) currently under review by UK regulatory bodies and (ii) expected to enter the UK market.

The Medicines and Healthcare Products Regulatory Agency (MHRA) is an executive agency of the Department and regulates medicine, medical devices, and blood components for transfusion in the United Kingdom, with responsibility for ensuring medicines meet appropriate standards of safety, quality, and efficacy.

At present there are no pending vaccines or new medicines awaiting market authorisation for urinary tract infections by the MHRA. The MHRA is ready to support companies that are looking to introduce new medicines to the United Kingdom market, offering regulatory and scientific advice to help companies at any stage of the product development process. The MHRA has established procedures in place to review any applications we receive to evaluate the benefit risk of a product. The exact timeframe will depend on the type of submission the company makes.

The National Institute for Health and Care Excellence (NICE) evaluates new licensed medicines, to determine whether they represent a clinically effective and cost-effective use of National Health Service resources. NICE aims to publish guidance on new medicines as close as possible to the date that the drug receives its marketing authorisation from the MHRA.

The MHRA and NICE have launched an aligned pathway for the assessment of medicines enabling access for patients three to six months earlier for those medicines using this route.