Our role in the Innovative Licensing and Access Pathway (ILAP)

The Innovative Licensing and Access Pathway (ILAP) aims to streamline patient access to safe, financially sustainable and innovative medicines.

It's delivered in partnership by:

  • the All Wales Therapeutics and Toxicology Centre
  • the Medicines and Healthcare products Regulatory Agency
  • 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 is a key strategic partner in this work.

  • We are 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:

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 (previouslty 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.

Further information

You can find out more about the ILAP on the GOV.UK website.

Email innovationpassport@mhra.gov.uk for queries about the Innovation Passport.

Contact TDP@mhra.gov.uk if you'd like to find out more about the TDP.