The current version of the Innovative Licensing and Access Pathway (ILAP) was first launched by the UK government in January 2021, shortly after the Brexit transition period came to an end. Its aim was to be a new, accelerated route to bring innovative medicines to the UK market, through facilitating a streamlined and efficient collaboration between developers, regulators, the UK Health Technology Assessment (HTA) bodies and the NHS, and facilitating enhanced patient access to medicines.

While ILAP has received an unprecedented number of applicants, with 166 Innovation Passports having been awarded since its launch, there have also been criticisms, including delays in considering applications and limited coordination with the NHS and HTA bodies, which slows the adoption of ILAP products. The Medicines and Healthcare products Regulatory Authority (MHRA) is therefore relaunching a renewed version of the scheme to “refine and refresh” the process.

It is hoped that the improvements will make for a quicker and more effective path for transformative medicines to be adopted into the UK market, reducing time to patient access and making the UK a more desirable market to launch innovative products.

Current version of ILAP

Under the current version of ILAP, applicants must fulfil certain criteria to receive an Innovation Passport, which allows both commercial and non-commercial companies  developing transformative medicines (whether based in the UK or internationally) to draw upon the collective expertise of stakeholders and create a target development profile (TDP). The TDP is intended to be a living document, setting out key regulatory and development milestones and creating a product specific roadmap. Under the current version, eligible products can be at very early stages of development or at mid-level development stages. That said, applicants are encouraged to apply as early as possible to maximise the benefits of using the resources available through the ILAP, with the intention of expediting product development and integration of medicines into the UK market.

The relaunched ILAP

The relaunched version of ILAP is intended to utilise a “simpler roadmap” for TDPs and provide “more predictable timelines” to allow effective planning for developers and a more streamlined process from start to finish. The aim is to achieve this through the introduction of a single integrated platform, allowing for “sustained collaborative working” between the developer, the MHRA, HTA bodies and the NHS, while prioritising scheduling of the ILAP Joint Scientific Advice and Access Forums and providing access to Clinical Practice Research Datalink (CPRD). It is also promised that the NHS will have a more direct involvement in the pathway as a core partner. This increased involvement will bring attention to “operational planning and system preparedness” for the delivery of new medicines directly into the NHS that have come through the ILAP.

Furthermore, following relaunch, services will be more bespoke and targeted, with the aim of the pathway being more tailored to suit each developer’s (and their product’s) individual and specific needs. This will be assisted through improved dialogue between developers and ILAP stakeholders.

In order to ensure the ILAP is focused on a cohort of developers producing transformative medicines with considerable potential, the entry criteria will become more selective. The new criteria is yet to be published; however, the MHRA’s recent statement confirms that ILAP will focus on medicines that have not yet entered their confirmatory trial, narrowing its scope. That said, to bring ILAP up to date with the developing life sciences sector, product scope will be broadened to include drug-device combinations, as well as medicines. 

Next steps

The current ILAP remained open to new applications up until 20 November 2024.

The current intention is for the new ILAP to be launched and opened to applications in March 2025. Further guidance and information on the new ILAP is anticipated in January 2025, including  the new eligibility and selection criteria and the new benefits package on offer within the ILAP.