In order to give patients quicker access to cutting-edge treatments and therapies, the UK government introduced a pathway in 2021 called “Innovative Licensing and Access Pathway” (ILAP). By offering a flexible, streamlined approach to licensing and regulatory processes, the pathway is intended to support the development of new medications, medical devices, and diagnostics.
In this blog post, you will learn more about:
- what ILAP entails,
- Innovation Passport applications,
- Collaborative Partners in evaluating novel treatments,
- Eligibility requirements for the ILAP Pathway,
- and GMP Compliance Team support for Innovation.
Do you want to bring a new, innovative product to market? Then read on quickly.
What is ILAP?
The Innovative Licensing and Access Pathway aims to accelerate the time taken for an innovative product to reach the market, facilitating widespread adoption of new medicines including new chemical entities, biological medicines, new indications, and repurposed medicines.
The ILAP pathway was created in response to comments made by patients, medical professionals, and industry stakeholders who stressed the need for quicker access to cutting-edge treatments. The pathway will concentrate on therapies for serious and life-threatening conditions where there is a significant unmet need and where the benefits may outweigh the risks.
The pathway consists of first obtaining an Innovation Passport which then provides access to developing a product-specific Target Development Profile (TDP) with MHRA and their partners.
Overview of Innovation Passport applications
The top three therapeutic areas of interest right now are oncology, neurology, and respiratory, but applications have been received for both novel and well-established pharmaceuticals for both common and rare diseases.
Numerous pharmaceutical companies, including small and mid-sized businesses, have submitted applications. The statistics below provide an indication of how often the ILAP pathway is used for novel medicines as of January 2023.
- Total applications received (cumulative): 164
- Numbers of Innovation Passports awarded: 108
- Numbers of Innovation Passports not awarded: 12
- Applications in process: 35
- Applications withdrawn: 9
Collaborative Partners in evaluating novel treatments
The Medicines and Healthcare products Regulatory Agency (MHRA) will be able to collaborate with organisations developing novel treatments under the ILAP pathway to create a customized licensing and access plan. This calls for early consultation with the MHRA in order to decide on the best regulatory pathway to market, which may include the possibility of accelerated review and licensing.
The ILAP pathway will also include cooperation with the National Institute for Health and Care Excellence (NICE) to guarantee that novel treatments are evaluated and assessed for their clinical and financial viability. NICE also helps facilitate engagement between life science companies and the healthcare system, enabling the National Health Service (NHS) to adopt drugs, devices, and diagnostics quickly. This will make it easier to make sure that patients can access treatments and that the healthcare system gets value for its money.
Other permanent collaborative partners include the All Wales Therapeutics and Toxicology Centre (AWTTC) and Scottish Medicines Consortium (SMC). These partners and the MHRA collaborate with the single aim of providing a single integrated platform for sustained collaborative working which will reduce the time to market for new innovative medicines and ensure that patients have timely access to a wide range of medicines including advanced therapy medicinal products (ATMPs), medicines for rare diseases and repurposed medicines.
Eligibility requirements for the ILAP Pathway
Innovation Passport application
Applicants must first submit an Innovation Passport application, which is a necessary requirement, in order to be qualified for the Innovative Licensing and Access Pathway (ILAP) pathway. Developers can use this entry point from the pre-clinical stage through to the end phase of product development. The passport has a broad definition of innovation that encompasses both novel and repurposed medications.
Target Development Profile (TDP)
A portfolio of initiatives with the goal of providing early patient access is connected to the Innovation Passport. This is accomplished by developing a product-specific Target Development Profile (TDP), which outlines the key regulatory and development features, points out potential stumbling blocks, and is made in collaboration with a team of subject-matter experts. The TDP should be updated as new knowledge is developed and significant milestones are reached.
The significance of the innovation to patient need and public health, as well as whether the innovation relates to a seriously disabling or life-threatening condition, are just a few of the requirements that the applicant must satisfy in order to receive a favourable decision on their Innovation Passport application. Only those with an Innovation Passport designation are eligible to access the TDP, and applicants can find the Innovation Passport application form on the MHRA submissions portal.
Innovation Passport entry criteria
In order to become eligible for the innovation passport the applicant must meet one of the 3 entry criteria:
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 fulfills one or more of a specific area
- an innovative medicine such as an advanced therapy medicinal product or new chemical or biological entity or novel drug-device combination
- medicines being developed in clinically significant indication for an approved medicine
- medicines for a rare disease and/or special populations
- development which aligns with the objective of UK public health priorities
Criteria 3: the medicinal product has the potential to offer benefits to patients
The applicant should submit their TDP application using the TDP submission form, which is also available on the MHRA submission portal, after receiving a favourable response for their Innovation Passport application.
Rapid Clinical Trial Dossier Pre-Assessment service
Innovation passport holders with an agreed TDP also have access to the Rapid Clinical Trial Dossier Pre-Assessment service, which provides expert MHRA feedback on their clinical trial authorisation (CTA) application dossier prior to being formally submitted to the agency. This service will help the applicant reduce the likelihood of receiving ‘Grounds for Non-acceptance’ being issued for the trial following submission.
ILAP HTA Access tool
One of the ways ILAP pathway also promotes an optimised route to market is through the ILAP HTA Access tool. The tool is delivered by the collaboration partners NICE Office for Market Access (OMA), SMC, AWTTC providing a common view on areas such as
- new technologies which may potentially fit the care pathway,
- the implication of delivering the technology into the NHS,
- an opinion on the potentially high-level HTA challenges,
- clarification on how processes will apply in practise and commercial options,
- and an opinion on the suitability of approaches to support your value proposition and minimise the financial impact on the NHS.
The use of this tool will enable you to work with Health Technology Assessment bodies, NHS representatives, and clinical experts (where appropriate) from England, Scotland, and Wales.
GMP Compliance Team support for Innovation
The GMP compliance team is involved in inspections of new and innovative manufacturing facilities. The MHRA inspectorate is also involved in ILAP assessments, where GMP aspects or compliance readiness inspections are being conducted.
The inspectorate supports the assessors within the Clinical Investigations & Trials division to evaluate any manufacturing license impact or GMP concerns, as well as supporting Scientific Advisory Meetings. The aim of the inspectorate is to enable new approaches to innovation where possible and play a role to help patients access safe and effective, new and novel treatment
In conclusion, the Innovative Licensing and Access Pathway is a promising development that has the potential to completely alter the process by which novel treatments are created and introduced to the UK market.
The pathway has been created to give businesses access to a flexible and streamlined licensing and regulatory process while also ensuring that patients can access the newest and most cutting-edge treatments. There are also other early access schemes such as the Early Access to Medicines Scheme (EAMS) and Project Orbis.
It will be interesting to watch how the ILAP pathway and other schemes aiming to enable innovation evolve over the next few years as it represents a significant advancement for the UK’s life sciences industry.
Need advice or support?
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