The 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 Regulatorregulator (MHRA), the UK Healthhealth Technologytechnology Assessmentassessment (HTA) bodies and the National Health Service (NHS), as well as patients.   

The ILAP is the only end-to-end access pathway in the world,world where the developer can work collaboratively with the national health system, the Regulator,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:  

• Provideprovide 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. market
• Applyapply to an identifiable cohort of potentially transformative technologies that address unmet needs. needs
• Reducereduce 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. economy

The 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.  

The ILAP enables:  

• Moremore efficient and joined up progress through the UK medicines development landscape to facilitate the most appropriate route for rapid access (removing inefficiencies and costs associated with independent interactions) with enhanced ability for parallel evaluation of data by multiple organisations, as well as data sharing.  sharing
• Preventionprevention of unnecessary delays to patients accessing innovative and transformative medicines and supports navigation of the UK regulatory and HTA processes. processes
• Earlyearly and ongoing interaction with the MHRA, HTA bodies and the NHS to enhance understanding and access to the different elements of the UK access pathway. pathway
• Moremore predictable timelines, enabling developers to plan more effectively. effectively 
• Earlyearly interactions with patients and the NHS to facilitate smoother routes for routine access and system-wide adoption.  adoption
• Prioritypriority access to regulatory and HTA services. services
• De-riskingde-risking of the product development pipeline – helping companies succeed by offering earlier insights into regulatory, HTA and NHS access requirements.  requirements

The Innovation Passport application is the first step in the ILAP and the mandatory entry point. Products that meet all of the eligibility criteria and which best meet the selection criteria, will be awarded an Innovation Passport. Passport. The The developer will then proceed to work with a team of specialists from across the ILAP partners to develop a Targettarget Developmentdevelopment Profileprofile (TDP) based on the product’s specific development needs.  

The TDP establishes a collaborative platform to review a product’s development, aiming to streamline, align and coordinate evidence generation and evaluation, whilstwhile identifying key implementation and service delivery issues. It will outline critical regulatory and developmental aspects, identifying potential challenges, and providing a roadmap for delivering early access for patients. ItWe isexpect expected that the TDP roadmap isto be a living document, updated along the development programme timelines and milestones as new knowledge is generated. 

A dedicated point of contact will be assigned to coordinate all support provided through the ILAP. 

Summary of what’s on offer and how the ILAP can help with:  

• Prioritisedprioritised Accessaccess to Keykey Servicesservices 
• Clinicalclinical Developmentdevelopment
• Clinicalclinical Trialtrial Deliverydelivery
• Marketmarket Accessaccess  
• Healthhealth Systemsystem Adoptionadoption

See the guidance above for information on how to apply, including determining whether a medicine or drug-device combination is eligible for the ILAP.

Partners 

The ILAP is delivered by the ILAP partners who are: partners: 

• The All Wales Therapeutics and Toxicology Centre (AWTTC) (on behalf of Health Boards and NHS Trusts in Wales) 
• The Medicines and Healthcare products Regulatory Agency (MHRA) 
• National Institute for Health and Care Excellence (NICE) 
• NHS England (NHSE) 
• Scottish Medicines Consortium (SMC) (on behalf of NHS boards in Scotland) 

Supporting partners include:  

• Department of Health and Social Care (DHSC) 
• Health Research Authority (HRA) 
• National Institute for Health Research (NIHR) 
• Office for Life Sciences (OLS) 
• Scottish Government 
• Welsh Government 
• Department of Health Northern Ireland  

Governance 

It is important that the activities and decisions of the ILAP partners are managed and coordinated effectively. To ensure effective governance and that patient involvement remains integral to how the pathway operates, a tri-level governance structure is in operation consisting of: of the: 

• The ILAP Delivery Group 
• The ILAP Management Board 
• The ILAP Sponsor Board 

These are supported by Advisoryadvisory functions, representing the life sciences sector and patients.

Contact 

For further information on any of the specific services, please contact innovationpassport@mhra.gov.uk.