Today we are focusing on the Innovative Licensing and Access Pathway (ILAP).
What is the ILAP?
The ILAP is a new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access. It aims to accelerate the time to market, facilitating patient access to medicines. Horizon scanning and regulatory science aim to ensure the pathway is at the forefront of cutting-edge developments and has the framework to develop evidence-based practice as new technologies and methods emerge.
What types of medicines does it include?
- new chemical entities
- biological medicines
- new indications
- repurposed medicines
Who is the ILAP open to and what does it involve?
Available to both commercial and non-commercial developers of medicines (UK based and or global), the ILAP comprises of:
- an Innovation Passport designation
- a Target Development Profile (TDP)
- access to a toolkit to support all stages of the design, development and approvals process for applicants
- opportunities for enhanced regulatory and other stakeholder input
Which partners are involved in the ILAP?
Permanent partners:
- The Medicines and Healthcare products Regulatory Agency (MHRA)
- National Institute for Health and Care Excellence (NICE)
- Scottish Medicines Consortium (SMC)
Supporting partners:
NHS England and NHS Improvement
Health Research Authority (HRA)
National Institute for Health Research (NIHR)
How does the Innovation Passport work?
The Innovation Passport application is the first step in the ILAP. It is the mandated entry point to the ILAP and is open to developers at the pre-clinical trial stage through to the mid-development programme point. The passport includes a broad and inclusive definition of innovation and both new and repurposed medicines are within scope. This designation is linked to a portfolio of activities through the creation of a product-specific Target Development Profile. The evidence required for a product to fulfil the criteria will depend on where in the development pathway the product is and can be based on non-clinical data. The Innovation Passport does not replace the Promising Innovative Medicine (PIM) Designation of the EAMS and you can apply for both initiatives. You must submit an Innovation Passport application for each separate medicinal product (different active substances). However, a single Innovation Passport can cover multiple indications for the same medicine (active substance).
What are the criteria for the passport?
There are 3 categories which make up the criteria for the Innovation Passport:
Criteria 1: Details of the condition, patient or public health area:
- the condition is life-threatening or seriously debilitating
- there is a significant patient or public health need
Criteria 2: The medicinal product fulfils one or more of a specific area:
a) innovation – such as an advanced therapy medicinal product (ATMP) or new chemical or biological entity or novel drug device combination
b) clinically significant new indication for an approved medicine
c) rare disease and/or other special populations such as neonates and children, elderly and pregnant women
d) development aligning with the objectives for UK public health priorities such as the Chief Medical Officer, Department of Health and Social Care (DHSC) or Life Sciences Sector Deal (including those in Devolved Administrations, where appropriate)
Criteria 3: the medicinal product has the potential to offer benefits to patients
You must provide a summary of how patients are likely to benefit from the product or indication coming to market.
Link to Innovation Passport application form.
When can you enter the pathway?
The ILAP enables multiple entry points depending on:
- the stage of development of the product
- the data available
- the ambition of the applicant to engage with UK stakeholders
- the applicant’s appetite for new innovative ways of working
Therefore, the pathway will allow entry very early, based on non-clinical data, where all the tools described below might be options, as well as catering for products with mid-development ‘global’ dossiers. However, to maximise the benefits, applicants are encouraged to apply early in the development of their products. Products that are towards the end of their development programme are generally not suitable for the ILAP unless there are one or more indications still under active investigation.
The ILAP does not replace the Early Access to Medicines Scheme (EAMS), which remains an important flexibility for earlier patient access towards the end of the development programme in areas of unmet medical need and where major advantage over existing therapies can be demonstrated. The ILAP is broader in scope and is open to all innovative products.
What is the Target Development Profile (TDP)?
A product-specific team of experts will help define the target development profile (TDP) based on your product’s characteristics. The TDP will:
- define key regulatory and development features
- identify potential pitfalls
- create a road map for delivering early patient access
What will the TDP include?
It is anticipated that the TDP will be a living document, updated along the development programme timelines and milestones as new knowledge is generated.
The TDP will include details about how to work with other UK stakeholders for coordinated and efficient evidence generation and evaluation and address commercial and managed access considerations.
Need more information?
Contact innovationpassport@mhra.gov.uk and TDP@mhra.gov.uk
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If you would like to discuss how Fusion Pharma can support you with ILAP, please email us at hello@fusion-pharma-limited.com or phone us on +44 (0) 203 1379 799.