Accelerating Access to Transformative Medicines: The UK’s ILAP

1. What is the ILAP

The Innovative Licensing and Access Pathway (ILAP) is a UK initiative led by the Medicines and Healthcare products Regulatory Agency (MHRA), designed to accelerate the time it takes for transformative new medicines and drug-device combinations to reach patients within the National Health Service (NHS). It provides a single integrated platform for sustained collaborative working between developers, regulators, health technology assessment (HTA) bodies and the NHS.
Source: Innovative Licensing and Access Pathway (ILAP) - GOV.UK

Unique in the world, ILAP is the only end-to-end access pathway where a developer can work collaboratively with the national health system, regulators and HTA bodies from the earliest stages of clinical development, enabling a system-wide approach to product development and access.
Source: Innovative Licensing and Access Pathway (ILAP) - GOV.UK

2. Goals and purpose

The ILAP aims to:

• Reduce timelines for research, regulatory approval, HTA evaluation and adoption into standard care.
• Provide coordinated support across regulatory, clinical and health system stakeholders.
• Align evidential requirements so developers can plan and generate data efficiently.
• Facilitate earlier engagement with NHS stakeholders and patients to support adoption and system readiness.
  Source: Innovative Licensing and Access Pathway (ILAP) - GOV.UK

3. Entry into the ILAP: Innovation Passport

The first step for a product to join the ILAP is applying for an Innovation Passport. This designation is awarded to developers whose products meet defined eligibility and selection criteria, which typically include:

• A therapeutic aim and evidence of safe use in humans, and
• Clinical development where confirmatory trials have not yet started.
  Source: Innovative Licensing and Access Pathway (ILAP) application guidance - GOV.UK

Once an Innovation Passport is granted, the developer works with ILAP partners to create a Target Development Profile (TDP) — a collaborative roadmap outlining key evidence generation and regulatory milestones throughout development.
Source: Innovative Licensing and Access Pathway (ILAP) - GOV.UK

4. Collaboration and services offered

The ILAP brings together multiple partners, including:

• MHRA – the UK medicines regulator
• NHS – ensuring healthcare system readiness and adoption
• HTA bodies, such as NICE (National Institute for Health and Care Excellence), SMC (Scottish Medicines Consortium) and AWTTC (All Wales Therapeutics and Toxicology Centre)
  Source: Innovative Licensing and Access Pathway (ILAP) - GOV.UK

Collaboration through the ILAP includes early and ongoing interactions with stakeholders, priority access to regulatory and HTA processes, and coordinated guidance to support the generation of evidence needed for licensing and adoption.
Source: Innovative Licensing and Access Pathway (ILAP) - GOV.UK

5. Benefits for developers

Developers participating in the ILAP can benefit from:

• Faster timelines, by aligning regulatory and HTA activities in parallel.
• De-risked development, via early insights into evidence requirements.
• Improved predictability, through coordinated planning and regular engagement.
• Early patient and NHS involvement, enhancing the likelihood of successful adoption into clinical practice.
  Source: Innovative Licensing and Access Pathway (ILAP) - GOV.UK

6. Scope of eligible products

The ILAP is open to both commercial and non-commercial developers (UK based or global) of transformative medicines and drug-device combinations with a therapeutic goal, provided preliminary human safety data exist and confirmatory trials are not yet initiated.
Source: Innovative Licensing and Access Pathway (ILAP) - GOV.UK

7. Real-world uptake

Since the refreshed ILAP launched in 2025, several investigational products have been awarded Innovation Passports and enrolled in the pathway, demonstrating the real-world application of this collaborative model to accelerate access for promising therapies, including those for rare or unmet medical needs.
Source: The new Innovative Licensing and Access Pathway welcomes first investigational products

Summary: The ILAP represents a world-leading, integrated, end-to-end pathway that aligns regulators, HTA bodies, healthcare providers and developers to accelerate the journey from innovation to patient access, especially for transformative therapies addressing significant unmet medical needs.
Source: Innovative Licensing and Access Pathway (ILAP) - GOV.UK