OBJECTIVES: The UK’s ILAP program aims to expedite access to medical products by streamlining evidence requirements and regulatory and access pathways. The entry-point to ILAP is the Innovation Passport, which can be awarded at different stages during the product development. Our objective was to characterize products which were awarded ILAP Innovation Passports since the program’s inception in 2021.

METHODS: English-language records, including published peer-reviewed articles, grey literature and news reports, and websites of the MHRA, EMA, FDA, Project Orbis, and drug manufacturers, were reviewed. For each medical product, target indication, clinical trials, regulatory status, and designations were collected.

RESULTS: We identified public records for 40 medical products which were awarded ILAP Innovation Passports in 2021 (n=28, 70%) and the first half of 2022 (n=12, 30%). The most common target indications were oncology (n=17, 43%), followed by psychiatry (n=4, 10%). The FDA and EMA granted orphan drug designations to 18 and 13 products, respectively. Five therapies had FDA Breakthrough Therapy Designation, while four had EMA PRIME status. Most products were in the mid-stages of clinical development and were in Phase 2 and 3 clinical trials (n=10, 25% each). FDA and/or EMA-approved medicines represented 20% of awardees. Among these, 10 therapies received approvals through Project Orbis. Products in pre-clinical development represented only 15% (n=6) of publicly disclosed awardees.

CONCLUSIONS: ILAP is a promising program with the potential to create efficiencies in medical product development, regulatory appraisal, and reimbursement. As ILAP is confidential, limited public information is available on awardees, particularly those in early clinical development. As such, we were only able to identify a subset of the 44 Innovation Passports awarded in 2021 (n=28, 64%). The lack of transparency and limited public records of ILAP experience present a challenge to researchers and manufacturers considering application and should be reassessed during the early stages of the program.