UK enhances ILAP to accelerate access to innovative medicines

The UK has unveiled an enhanced Innovative Licensing and Access Pathway (ILAP) to accelerate the delivery of transformative medicines to NHS patients.

This updated pathway is the result of a collaboration between the Medicines and Healthcare products Regulatory Agency (MHRA), Health Technology Assessment (HTA) bodies—including the All Wales Therapeutics and Toxicology Centre (AWTTC), the National Institute for Health and Care Excellence (NICE), and the Scottish Medicines Consortium (SMC)—along with the NHS.

Launched initially in January 2021, ILAP provided a framework for developers to engage with the MHRA and UK HTA bodies to bring innovative medicines to market more quickly.

The latest enhancements to the pathway are in response to feedback from stakeholders and recommendations from the Pro-innovation Regulation of Technologies Review.

Overall, the improved ILAP offers a more integrated end-to-end process, enabling medicine developers to work closely with regulators, the NHS, and HTA bodies from the early stages of clinical development.

NHS collaboration and early patient engagement

A key enhancement to the pathway is the active involvement of the NHS, which will now play a direct role in operational planning and system preparedness. This is designed to ensure that innovative medicines can be swiftly and effectively integrated into NHS services.

The pathway also prioritises early engagement with patients and the NHS to streamline adoption and routine access. By addressing potential barriers to implementation at an early stage, the initiative aims to accelerate the transition from regulatory approval to widespread patient availability.

“This new ILAP is clearer, more streamlined and joined up than its predecessor, making the UK a more attractive place to develop and launch innovative products and, most importantly, helping to get transformative medicines to the patients who need them in the shortest possible time,” Dr June Raine, MHRA Chief Executive explained.

Key improvements in the ILAP

• More selective entry and bespoke support – The pathway now applies stricter entry criteria to prioritise only the most transformative medicines that address unmet clinical needs. This ensures that tailored support and engagement can be provided to developers.
• Clearer timelines for medicine development – Developers will benefit from predictable timelines, allowing for more efficient planning and engagement with the regulatory process
• Support for drug-device combinations – Recognising the growing importance of drug-device combination products, the ILAP now includes support for these innovations, ensuring the pathway remains future-proof.
The pathway is open to commercial and non-commercial developers, both within the UK and internationally, who are working on transformative medicines or drug-device combination products. Eligible products must have a therapeutic aim and some evidence of safe use in humans, though confirmatory trials do not necessarily need to have started.

Benefits for developers

Developers entering the ILAP will gain access to a more streamlined regulatory process with:
• Faster progression – A more efficient route through the UK’s medicines development landscape, reducing unnecessary delays and costs.
• Ongoing interaction with regulators and NHS bodies – Continuous engagement with the MHRA, HTA bodies, and NHS, ensuring a clear understanding of regulatory and access pathways.
• Priority access to regulatory and HTA services – Faster scheduling of key services, including regulatory assessments and HTA evaluations, helping to speed up approval and adoption.

By strengthening collaboration between regulators, the NHS, HTA bodies, and medicine developers, the enhanced ILAP aims to accelerate access to innovative treatments while ensuring a robust and efficient approval process. The pathway represents a significant step towards ensuring that groundbreaking medicines reach NHS patients as swiftly as possible.