“Refreshed” UK-wide Innovative Licensing and Access Pathway (ILAP) Applications Now Open

Commercial and pre-commercial developers of potentially transformative medicines or drug-device combination products can now utilize a unique accelerated regulatory pathway in the UK. Article authored by Marie Manley and Victoria Kerr.

The Innovative Licensing and Access Pathway (ILAP) is a post-Brexit accelerated assessment procedure that was first launched by the UK regulator Medicines and Healthcare products Regulatory Agency (MHRA) in January 2021. It aims to accelerate patient access to transformative new medicines and drug-device combinations by facilitating a streamlined, collaborative approach between developers, regulators, the National Health Service (NHS), and health technology assessment (HTA) bodies from early stages of clinical development. ILAP was hailed by the UK medicines regulator as “the only example globally of an end-to-end access pathway, where a medicine developer can work collaboratively with the national health system, the regulator, and health technology assessment bodies from the early stages of clinical development.”

On March 31, 2025, the MHRA announced that applications are now open for the “refreshed” UK-wide ILAP. This means that starting yesterday, pharmaceutical companies fulfilling all eligibility criteria may apply for an “Innovation Passport” that will enable their pharmaceutical products to benefit from this unique regulatory pathway. The refreshed ILAP aims to accelerate patient access to new medicines by integrating regulatory and HTA procedures and to streamline collaboration between medicine developers and the national health systems.

The MHRA also updated its ILAP application guidance detailing eligibility requirements, selection criteria, and how to apply for an Innovation Passport. An ILAP refresh webinar and ILAP registration portal video demonstration are now available on the MHRA website to assist applicants (see here).

ILAP is open to both commercial and pre-commercial developers (UK based or global) of potentially transformative medicines or drug-device combination products that have a therapeutic aim and evidence of safe use in humans; confirmatory trials have not yet started. Applicants will have to demonstrate that they fulfill the eligibility criteria, one of which is to be an intention to obtain regulatory authorization to market the health product in the UK and a commitment to meeting UK HTA bodies’ evidential standards to demonstrate cost-effectiveness.

Since the launch of ILAP in 2021, over 160 Innovation Passports have been awarded. However, the industry has raised several concerns regarding ILAP, namely that ILAP’s “offer was not clear enough, the entry criteria were overly permissive leading to the pathway becoming unsustainable, and there was a lack of direct NHS involvement to support timely adoption of ILAP products.”

In January 2025, in response to feedback and recommendations by stakeholders, the MHRA “refreshed” ILAP by making the following key improvements:

• Involving the NHS as a core partner, focused on operational planning and system preparedness for the introduction of innovative new medicines into the NHS for the benefit of patients.
• Better quality bespoke services through more selective entry and dialogue between the ILAP partner organizations and the developers.
• Predictable delivery timelines enabling developers to plan more effectively and engage with ILAP more productively.
• Early interaction with patients and the NHS to facilitate smoother routes for routine access and system-wide adoption.
• A single point of contact provided for each product.
• Future proofing to help accelerate access to transformational products by including support for drug-device combinations.

It is hoped that the refreshed ILAP will expedite the access of transformative medicines for the NHS to address unmet clinical needs for patients and healthcare professionals at the earliest opportunity, without compromising on standards of safety, quality, and effectiveness. Although not binding on the regulatory bodies (i.e., MHRA, NICE, and pricing authorities), ILAP provides a unique opportunity to engage with all the key regulatory players and hopefully to secure an accelerated access to patients in the UK.

While it remains uncertain whether all industry concerns will be fully addressed in practice, the recent enhancements to ILAP represent a marked effort by the MHRA to encourage investment and facilitate market access for innovative medicines in the UK and goes in hand with other regulatory accelerated access routes, such as Project Orbis, which can be applied for together with the ILAP procedure.

This post is as of the posting date stated above. Sidley Austin LLP assumes no duty to update this post or post about any subsequent developments having a bearing on this post.