The MHRA has announced its intention to relaunch the Innovative Licensing and Access Pathway (ILAP) in March 2025. 

The new-look ILAP will bring together the MHRA, health technology assessment bodies and the NHS to accelerate the availability of transformative new medicines and, for the first time, medicine device-combinations to patients.  The refreshed pathway will open for applications in March 2025, with detailed information, including new eligibility and selection criteria, benefits packages, and application guidance, to be released in January 2025.

Background 

Since its initial launch in January 2021, the ILAP has awarded 166 Innovation Passports. However, feedback indicated the original pathway’s offer was not clear enough, the entry criteria were too permissive, leading to sustainability issues, and there was a lack of direct NHS involvement. The relaunch aims to address those challenges by providing a more compelling offer to medicine manufacturers and ensuring timely patient benefit.

Key Improvements

The new ILAP, announced in a statement of policy intent, will provide a single integrated platform for collaboration between developers, the MHRA, UK Health Technology Assessment (HTA) bodies, and the NHS to help speed up pre-market processes.

The MHRA state that key improvements in the new ILAP will include:

  • Better collaboration: The ILAP will have more focused entry criteria and more frequent dialogue between ILAP partners and developers, ensuring it targets medicines that provide a significant step-change in care and address unmet needs within the NHS.
  • NHS involvement: The NHS will be directly involved as a core partner, focusing on operational planning and system preparedness for the introduction of new medicines.
  • Streamlined Processes: The ILAP will offer a simpler roadmap and more predictable timelines, enabling developers to plan more effectively.
  • Exclusive Access to Joint Scientific Advice: The ILAP will maintain exclusive access to Joint Scientific Advice (JSA) and Access Forums, which span regulatory, HTA, and healthcare system expertise across England, Scotland, and Wales.
  • Prioritised Scheduling: The ILAP will have prioritised scheduling for JSA, Access Forums, MHRA scientific advice, pre-submission meetings, and access to the Clinical Practice Research Datalink (CPRD).
  • Drug-device combinations: The ILAP will be broadened to include medicine-device combinations.

The MHRA and the other ILAP partners will engage with industry to finalise the details for the pathway. 

This article was written by Nick Lee and Rory Trust.