Innovative Licensing and Access Pathway

SMC is a full partner within the Innovative Licensing and Access Pathway (ILAP), aiming to enable access to transformative clinically and cost-effective medicines in the shortest time possible.

Overview
ILAP is a unique initiative which aims to accelerate the time to patient care for transformative new medicines and drug-device combinations, facilitating patient access by providing a single integrated platform for sustained collaborative working between the developer, the Regulator (MHRA), the UK Health Technology Assessment (HTA) bodies and the NHS, as well as patients.   

ILAP is the only end-to-end access pathway in the world, where the developer can work collaboratively with the national health system, the Regulator, and HTA bodies. By engaging with medicine developers from early stages of clinical development with tailored guidance and support, the ILAP aims to facilitate accelerated access through better use of established regulatory and procedural services, facilitated by knowledge gained throughout development to enhance and align evidential requirements, including health system preparedness. It is intended to:  

  • Provide a complementary pathway that gives developers coordinated and collaborative support, to enable a system-wide approach for product development and access to the UK market. 
  • Apply to an identifiable cohort of potentially transformative technologies that address unmet needs. 
  • Reduce the end-to-end timeline for product research and development, regulatory approval, HTA and timely adoption of new technologies to benefit patients, the health systems and the broader economy. 

ILAP is open to both commercial and non-commercial developers (UK based or global) of potentially transformative medicines or drug-device combination products that have a therapeutic aim and there is evidence of safe use in humans, but confirmatory trials have not yet started.  

Application guidance and further information is available here: Innovative Licensing and Access Pathway (ILAP) - GOV.UK