On 30 January 2025, the UK Government announced the re-launch of the Innovative Licensing and Access Pathway (“ILAP”) for medicines.

The ILAP is an “end-to-end” access pathway offering a unique opportunity for a medicine’s developer to engage with: (i) the UK’s medicines regulator – the Medicines and Healthcare products Regulatory Agency (“MHRA”); (ii) England’s HTA body – the National Institute for Health and Care Excellence (“NICE”); and (iii) and the National Health Service (“NHS”) (together the “ILAP Partners”).  By providing medicines developers with joined-up, co-ordinated and tailored guidance from the ILAP Partners, from the early stages of clinical development, the ILAP scheme hopes to accelerate the time to market for innovative and transformative medicines and drug-device combinations.

The ILAP first launched in 2021 but paused for review in November 2024.

Feedback on the first version of ILAP, which welcomed 166 successful applicants, was that the “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.” (see MHRA’s Statement of policy intent, 6 November 2024). 

The new ILAP seeks to address these concerns, including through:

1. Offering a more bespoke pathway through closer dialogue between stakeholders and more selective entry criteria;
2. A simpler pathway with more predictable timelines;
3. Involving the NHS as a core ILAP Partner; and
4. Expanding the scheme to drug-device combinations.

From a practical perspective, these innovations may also help to alleviate resource and capacity constraints with regulatory authorities.

This is very much a process of evolution rather than revolution.  The core concepts in the new ILAP remain fundamentally the same as under the old scheme.

The first application window for the ILAP opens on 31 March 2025 and closes on 3 July 2025.

Why Apply for the ILAP?

The ILAP’s core aim is to facilitate early-stage collaboration between developers and the ILAP Partners.  To that end, the ILAP offers access to a range of services geared towards providing developers with joined-up, system-wide guidance and support from the ILAP Partners.

Successful applicants – developers with products that meet all of the eligibility criteria, and which best meet the selection criteria – will be awarded an Innovation Passport.

Innovation Passport holders will be offered a meeting with the ILAP Partners to develop a Target Development Profile (“TDP”).  The TDP will outline a product’s critical regulatory and developmental aspects, providing a roadmap for regulatory approval and market access.

After an Innovation Passport holder has developed its TDP, they will have access to a range of services delivered by the ILAP Partners, including exclusive access to:

• The ILAP Joint Scientific Advice service, which facilitates a joint discussion with the MHRA and NICE’s health technology assessment (“HTA”) agencies to provide advice on the evidence generation plans for a product from a regulatory and HTA perspective.

• The ILAP Access Forum, which is delivered by NICE in partnership with the NHS in England, Scotland and Wales.  This service aims to provide expert feedback from across the healthcare system, including from clinical, patient groups, HTA, and NHS experts, to support the development of the developer’s market access strategy.

Innovation Passport holders will also have priority access to certain services offered by the ILAP Partners: MHRA scientific advice and pre-submission meetings; certain NICE advice services; the National Institute for Health and Care Research (“NIHR’s”) Research Delivery Network, which provides support and advice on study development and delivery; and the MHRA’s and NIHR’s Clinical Practice Research Datalink – “a real-world research service supporting retrospective and prospective public health and clinical studies.”

Who is Eligible to Apply?

Novel medicines (e.g., those with a new mechanism of action or a new chemical/biological entity), novel drug-device combinations, new or novel modifications of existing technologies, or approved medicines being developed in a clinically significant new indication are all within the scope of the ILAP. 

Applications will be considered from any commercial or non-commercial developer (UK based or global) (see ILAP application guidance).

Applicants must meet the following eligibility criteria:

• The product must be a medicine or drug-device combination product with a therapeutic aim.

• The product must not be an immunization for the prevention of infection and/or disease. 

• The applicant must be a legal entity with the right to market the product in the UK. 

• The product must be at the stage of clinical development where the human safety pharmacology has been preliminarily characterized, there is evidence of safe use in humans, and confirmatory trials have not yet started.

Once clinical development has finished, the applicant must intend to market the product in the UK (i.e., obtain regulatory approval in the UK) and commit to meeting UK HTA evidential standards to demonstrate cost-effectiveness.  Further, the applicant must commit to developing a TDP and conducting feasibility for opening clinical trial sites in the UK.

Applications that meet the eligibility criteria will be assessed against the following three selection criteria:

• Criterion 1: the intended indication of the product is life-threatening and/or seriously debilitating and there is a significant unmet clinical need.

• Criterion 2: the product must be innovative; it is novel, or it is an approved medicine being developed in a clinically significant new indication.

• Criterion 3: the product will provide benefit to patients and/or the wider healthcare system.

How can Applicants Apply?

Prospective applicants must submit the Innovation Passport application form via the ILAP registration portal.  The ILAP registration portal and application form will be available when the first application window for the ILAP opens on 31 March 2025

An Innovation Passport fee of £3,624 is payable, which is not refundable if the application is not successful (note other fees are payable for the TDP and ILAP services).

Next Steps

The UK Government’s re-launch of ILAP indicates its commitment to delivering access to innovative and transformative medicines by making the UK a more attractive place to develop and launch medicines.  Other UK developments expected to boost innovation include the launch of the UK’s international reliance scheme (see our update here) and new point of care manufacturing regulations.

Covington will continue to follow developments and provide further updates. 

If you would like to discuss the latest developments and what they may mean for your company’s operations, please contact our specialist UK and EU teams: Grant Castle, Marie Doyle-Rossi and Raj Gathani.