Introduction
The Innovative Licensing and Access Pathway (ILAP) is changing to bring transformative medicines to NHS patients faster. Relaunching in March 2025, the updated pathway aims to accelerate approval for innovative medicines, featuring streamlined processes, selective entry criteria, and stronger collaboration with the NHS to address unmet needs. By focusing on early-stage clinical development, ILAP aims to reduce time to market while supporting developers with guidance and integrated access to regulatory and healthcare systems. This refreshed approach aims to create a clearer pathway for innovative medicines.
This article provides an overview of the changes to the innovative licensing and access pathway in the lead-up to the relaunch going live.
Highlights
- What is ILAP?
- ILAP collaborators
- Why has the MHRA relaunched ILAP?
- When will the relaunch of ILAP come into force?
- What does the ILAP relaunch include?
What is ILAP?
The Innovative Licensing and Access Pathway is an MHRA initiative originally launched in 2021 that accelerates marketing authorisation in the UK and provides additional support to medicine developers throughout the process. ILAP is open to commercial and non-commercial organisations developing new chemical and biological products, as well as those applying for new indications for repurposed medicines.
ILAP collaborators
As a collaborative initiative, medicine developers are offered guidance from other prominent organisations including the Health Technology Authority (HTA) body NICE (National Institute for Health and Care Excellence); NHS England; the National Institute for Health and Care Research (NIHR), and the Health Research Authority (HRA).
Why has the MHRA relaunched ILAP?
The relaunch of ILAP focuses on “getting the most transformative new medicines to patients in the National Health Service (NHS) more quickly”.1
Essentially, the scheme has shifted focus to utilise the collaboration between the MHRA, the HTA and the NHS in a single integrated platform to bring new medicines to patients in the UK faster.
Two noticeable changes to ILAP include:
- Selective entry criteria, and
- extending the collaboration to include the NHS as a partner.
The MHRA cites the ‘evolving needs’ of the ‘fast-paced’ life sciences sector as the reason behind the relaunch.1 Feedback to the MHRA from stakeholders also attributed to the relaunch, expressing a lack of clarity regarding what ILAP offered, liberal entry criteria leading to process unsustainability, and a lack of NHS involvement, which affected the practical application of ILAP.
When will the relaunch of ILAP come into force?
Applications can be submitted from March 2025 and the MHRA ceased acceptance of current applications on the 20th of November 2024.1 The MHRA will publish full details on the new pathway in January 2025.1 We can expect information on:
- The new eligibility and selection criteria,
- the new benefits, and
- the new application guidance documents
What does the ILAP relaunch include?
Medicine developers can now collaborate with the NHS, the MHRA and the HTAs in early-stage clinical development. To improve medicinal product development, the MHRA will implement one platform with integration between the medicine developer, the MHRA, the NHS and HTA organisations. Additionally, the relaunch of ILAP will focus on medicinal products that haven’t yet reached the pivotal clinical trial stage to better support medicine developers within the ILAP pathway at early-stage development.
Improvements include:1
Summary
The relaunch of ILAP aims to accelerate patient access to transformative medicines in the NHS by fostering collaboration among developers, the MHRA, health technology assessment bodies, and the NHS. Relaunching in March 2025, the updated ILAP will include selective entry criteria, a streamlined roadmap, and direct NHS involvement to support operational planning. Focused on early-stage clinical development, the pathway will prioritise transformative medicines addressing unmet NHS needs and reduce timelines through integrated support and enhanced Joint Scientific Advice forums.
How Somerville Development Partners can help
We can advise you on how to approach and apply for ILAP. This will enable you to get the greatest return on your resources and have the greatest likelihood of being accepted into the ILAP pathway.
