Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what his Department's planned timescale is for making the (a) Certifications, (b) Continuous Benefit Risk Assessment integrating Real World Evidence, (c) Enhanced Patient Engagement and (d) Novel Methodology and Innovative Clinical Trial Design tools available for Innovation Passport holders.

The Innovative Licensing and Access Pathway (ILAP) was launched in January 2021, and has seen strong interest from both small and large companies in a variety of therapeutic settings. Companies who successfully gain an Innovation Passport designation are able to apply for the next step which is the Target Development Profile (TDP).

The TDP interaction provides an opportunity for platform discussions with the ILAP partners on the Company’s development programme and the resulting roadmap may make reference and or recommendation for use of one or more of the tools of the ILAP toolkit. Time scales for the delivery of these tools is subject to agreement with the ILAP partners, the stage of development of the product and availability of partner resources.