Our role in the Innovative Licensing and Access Pathway
The Innovative Licensing and Access Pathway (ILAP) is a unique initiative which works with medicine developers early on to help get new medicines to patients faster.
The ILAP works with medicine developers early on to help get new medicines to patients faster. It does this by:
providing specific guidance and support during drug development
making better use of existing regulatory processes
using knowledge gained during development to streamline evidence requirements
helping healthcare systems prepare for new medicines.
Partners
The ILAP is delivered in partnership by:
the All Wales Therapeutics and Toxicology Centre
the Medicines and Healthcare products Regulatory Agency (MHRA)
NICE
the Scottish Medicines Consortium, part of Healthcare Improvement Scotland.
Who the ILAP is for
The ILAP is open to both commercial and non-commercial developers of medicines (UK based and/or global). This includes:
new chemical entities
biological medicines
new indications
repurposed medicines.
The benefits
The ILAP helps developers to engage with key stakeholders early and often in the journey from development to patient access.
Successful applicants will get:
an Innovation Passport designation
access to a Target Development Profile (TDP)
access to a support toolkit.
Our role in the ILAP
NICE has a key role in this work.
we're part of the steering group and make joint decisions about awarding innovation passports
we're actively involved in TDP meetings and the development of TDP roadmaps
and we work collaboratively with the other ILAP partners to continuously develop and improve the initiative.
Several of our established programmes provide sound foundations for the delivery of the ILAP, including:
our commercial and managed access infrastructure
our role in the Cancer Drugs Fund and Innovative Medicines Fund
our involvement in the Research to access pathway for investigational drugs for COVID-19 (RAPID C-19), a multi-agency initiative.
Being part of the ILAP gives us a great opportunity to build on this valuable work.
The HTA access forum
The HTA access forum supports developers in England, Scotland and Wales in bringing innovative medicines to market.
The access forum is based on our well-established NICE Advice system engagement meeting (previously safe harbour process). But it will also give joined-up feedback from system stakeholders in England, Scotland and Wales, including NICE, the Scottish Medicines Consortium and the All Wales Therapeutics and Toxicology Centre.
The tool aims to help developers understand:
where the new medicine may potentially fit in the care pathway
the service delivery implications of introducing the new medicine into the NHS
any high level health technology assessment challenges
how processes will apply in practice
commercial options and suitability of approaches to support the new medicines value proposition and minimise the financial burden on the NHS.
This is a not-for-profit service, but we will charge a fee to cover our costs.
Find out more
You can find out more about the ILAP on the GOV.UK website.
Email [email protected] for queries about the Innovation Passport.
Contact [email protected] if you'd like to find out more about the TDP.