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 ensure that the MHRA’s Innovative Licensing and Access Pathway (ILAP) procedure meets the needs of small and medium sized companies.

The Innovation Passport application is the initial stage of the Innovative Licensing and Access Pathway (ILAP), which open to developers at an early stages. This aims to be attractive to small and medium-sized enterprises (SME) where the clinical trial stage has not yet been reached. Since 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) has engaged with SMEs with expertise and platform discussions from the ILAP partners at the Target Development Profile. The MHRA continues to monitor the proportion of applications received from SMEs to ensure that ILAP remains attractive and relevant to all developers of innovative medicines.