Statement of policy intent: relaunch of the Innovative Licensing and Access Pathway
Published 6 November 2024
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The Innovative Licensing and Access Pathway (ILAP) is entering a new era with a refreshed offer to applicants. The ILAP is focussed on getting the most transformative new medicines to patients in the National Health Service (NHS) more quickly.
The ILAP is a unique initiative which aims to accelerate the time to patient care for transformative medicines and medicine-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 National Health Service (NHS).
The new ILAP will continue to target timely patient benefit, take forward lessons learnt from ILAP to date and respond to the needs of our fast-paced life sciences sector by providing a more compelling offer of support to the medicine developer. This will include more focused entry criteria and an extension of the partnership to directly involve the NHS.
1. Purpose of this statement of policy intent
This statement sets out the plans for the new ILAP for innovative medicines in England, Scotland and Wales. The ILAP aims to accelerate the time to patient care for transformative new medicines, facilitating patient access. It is a pre-market pathway that harnesses the collective expertise of the regulatory and health technology assessment systems and NHS bodies with the aim of supporting medicines from an early stage through to patient access more quickly.
The ILAP partnership is now preparing to relaunch its offer in response to the evolving needs of our fast-paced life sciences ecosystem and having been substantially reworked since the pathway’s launch back in 2021. The new ILAP will open to applications in March 2025, with full details of the pathway to be published in January 2025.
2. Background
The ILAP first launched in January 2021 to offer an integrated pre-market pathway awarding an Innovation Passport for promising medicines across England, Scotland and Wales. The pathway has seen an unprecedented number of applications and 166 Innovation Passports have been awarded since it was launched.
The UK life sciences ecosystem within which the ILAP sits has evolved, with new regulatory initiatives such as the international recognition procedure.
We want to build on the successes, learnings and feedback from the first iteration of the ILAP to develop a more sustainable and impactful pathway that delivers benefits for medicine developers and patients in the NHS.
The feedback from stakeholders on the first version of the ILAP has been that the offer was not clear enough, the entry criteria were overly permissive leading to the pathway becoming unsustainable, and there was a lack of direct NHS involvement to support timely adoption of ILAP products.
The ILAP partner organisations have worked together to address the previous challenges and to clearly position the ILAP as the pathway in England, Scotland and Wales for transformative medicines that meet NHS unmet needs and require coordinated system support to take time out of the path to patient access. We can now share our intention to launch the new ILAP with new entry criteria and a more compelling offer.
3. What the new ILAP will offer
When relaunched, the ILAP will be the only end-to-end access pathway where the developer can work collaboratively with the UK’s national health system, the regulator, and health technology assessment bodies from the early stages of clinical development. The new ILAP offer will streamline important product development activities to reduce the time to patient access for transformative new medicines. We will do this by providing a single integrated platform for sustained collaborative working between the developer, the Regulator (MHRA), UK Health Technology Assessment (HTA) bodies and the NHS. We will maintain exclusive access to ILAP Joint Scientific Advice and Access Forums which uniquely span regulatory, HTA and healthcare system expertise from across England, Scotland and Wales.
The ILAP will focus on medicines that have not yet entered their confirmatory trial, which will give more opportunity to benefit from the support offered within the pathway. Some of the key improvements that the new ILAP will bring compared to the existing pathway are:
- Better quality bespoke service through more selective entry and dialogue between the ILAP partner organisations and the developers.
- Simpler roadmap and more predictable timelines, enabling developers to plan more effectively.
- The NHS will be involved as a core partner and will bring a focus on operational planning and system preparedness for the introduction of innovative new medicines into the NHS for the benefit of patients.
- Prioritised scheduling of the ILAP Joint Scientific Advice (JSA), the ILAP Access Forums, the MHRA scientific advice and pre-submission meetings and access to Clinical Practice Research Datalink (CPRD).
- The ILAP will be future-proofed to accelerate access for transformational products by broadening to drug-device combinations.
The initial step for Innovation Passport holders, known as the Target Development Profile (TDP), will include a simpler ‘roadmap’ to help developers entering ILAP to more effectively navigate the support on offer and meet evidential requirements. The refreshed ILAP pathway will introduce more selective entry criteria to ensure that the focus remains on an identifiable cohort of potentially transformative medicines, which provide a step-change in care while also addressing unmet needs in the NHS.
4. Ongoing activities and timelines
The intention is to provide further information on the new ILAP in January 2025, with full details of the new pathway, including the new eligibility and selection criteria, the new benefits package on offer within the ILAP and the guidance documents for applications, being available by then. The new ILAP will launch and be open to applications in March 2025. The current ILAP will only be accepting applications received up until 20 November 2024 in order to allow system partners and medicine developers to transition to the new pathway.
The ILAP partner organisations will continue to engage with industry on the detailed plans for the evolved ILAP, through trade associations. Plans for patient and public involvement in the new ILAP are in development to ensure the patient voice is embedded in a meaningful way throughout the pathway.
5. Enquiries
If you have general queries about this announcement, contact us on: innovationpassport@mhra.gov.uk
The statement has been prepared jointly by MHRA, NICE, SMC, AWTTC and NHS partners.