Full details have been published of the refreshed UK-wide Innovative Licensing and Access Pathway (ILAP), that will offer a clearer, more streamlined and integrated process for developers to help get transformative new medicines to patients in the NHS in the shortest time possible.

The new ILAP has been launched by the MHRA, the Health Technology Appraisal Bodies (the All Wales Therapeutics and Toxicology Centre, NICE, SMC) and the NHS.

It is 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.   The ILAP was first launched in January 2021 to offer developers of promising new medicines a single platform to collaborate with the MHRA and the UK HTA bodies to accelerate the time taken for innovative medicines to get to patients.

The UK life sciences ecosystem within which the ILAP sits has since evolved. In response to feedback from stakeholders and the recommendations of the Pro-innovation Regulation of Technologies Review, ILAP partners have worked together to refresh the pathway.

The ambition of this new pathway is to support the rapid development of transformative medicines that can be introduced into 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.

The new ILAP will bring a number of key improvements compared to the original pathway, including:

• 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 organisations 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.
• Futureproofing to help accelerate access to transformational products by including support for drug-device combinations.

The ILAP partners will be taking an iterative approach, allowing the pathway to be refined, adapted and improved over time in response to an evolving life sciences landscape, and patient and stakeholder feedback.

Further information about the ILAP and how to apply can be found on the MHRA website.