New Innovative Licensing and Access Pathway (ILAP) launched

On 30 January 2025, the new ILAP was launched by the Medicines and Healthcare products Regulatory Agency (MHRA), the Health Technology Appraisal Bodies (the All Wales Therapeutics and Toxicology Centre (AWTTC), the National Institute for Health and Care Excellence (NICE), the Scottish Medicines Consortium (SMC)) and the NHS.  

Below is an attempt to lay out the guidance in a in an easy to understand manner. Note that the MHRA guidance has not been reproduced here in its entirety. You can use this blog post as a starting point to learn about the new ILAP and then refer to the actual guidance on the MHRA website to reinforce your understanding. Links to all the guidance pages on the IKAP are also provided at the end of this post.

About the ILAP pathway

The new ILAP will bring a number of key improvements compared to the original pathway, including: 

  • Involving the NHS as a core partner, focused on operational planning and system preparedness for the introduction of innovative new medicines into the NHS for the benefit of patients. 
  • Better quality bespoke services through more selective entry and dialogue between the ILAP partner organisations and the developers. 
  • Predictable delivery timelines enabling developers to plan more effectively and engage with ILAP more productively.  
  • Early interaction with patients and the NHS to facilitate smoother routes for routine access and system-wide adoption. 
  • A single point of contact provided for each product. 
  • Future proofing to help accelerate access to transformational products by including support for drug-device combinations. 

The ILAP partners will be taking an iterative approach, allowing the pathway to be refined, adapted and improved over time in response to an evolving life sciences landscape, and patient and stakeholder feedback.  

The ambition of this new pathway is to support the rapid development of transformative medicines that can be introduced into the NHS to address unmet clinical needs for patients and healthcare professionals at the earliest opportunity, without compromising on standards of safety, quality, and effectiveness. 

What is the ILAP expected to enable?

The ILAP should enable:  

  • More efficient and joined up progress through the UK medicines development landscape to facilitate the most appropriate route for rapid access (removing inefficiencies and costs associated with independent interactions) with enhanced ability for parallel evaluation of data by multiple organisations, as well as data sharing.  
  • Prevention of unnecessary delays to patients accessing innovative and transformative medicines and supports navigation of the UK regulatory and HTA processes. 
  • Early and ongoing interaction with the MHRA, HTA bodies and the NHS to enhance understanding and access to the different elements of the UK access pathway. 
  • More predictable timelines, enabling developers to plan more effectively. 
  • Early interactions with patients and the NHS to facilitate smoother routes for routine access and system-wide adoption.  
  • Priority access to regulatory and HTA services. 
  • De-risking of the product development pipeline – helping companies succeed by offering earlier insights into regulatory, HTA and NHS access requirements. 
Access to a single integrated platform

The ILAP will provide developers with access to a single integrated platform for sustained working between the developer, the regulator, the UK Health Technology Assessment (HTA) bodies and the National Health Service (NHS).  

What will products that enter the ILAP benefit from?

Products that enter the ILAP will benefit from joined-up, system-wide guidance and support from the early stages of clinical development.

It will facilitate a life-cycle approach for product development by harnessing the power of collaboration between the MHRA, NHS, HTA bodies and patients to reduce the time to patient access for transformative medicines. 

Who are the partners in the ILAP?

The ILAP is a UK-wide initiative, comprising the following partners: 

Supporting partners include: 

  • Department of Health and Social Care (DHSC) 
  • Department of Health Northern Ireland 
  • National Institute for Health Research (NIHR
  • Office for Life Sciences (OLS) 
  • Scottish Government 
  • Welsh Government
Which developers is the ILAP open to and when will the pathway open to new applications?

Entry to the ILAP is open to both commercial or non-commercial developers (UK based or global) and will open to new applications in March 2025

Which products are in scope of the ILAP?

The ILAP is open to products at the stage of clinical development where the human safety pharmacology has been preliminarily characterised and there is evidence of safe use in humans and confirmatory trials have not yet started.

  • This is the stage of development in which the ILAP can offer the most benefit.
  • Entry onto the ILAP will be for products that are considered to meet the ILAP eligibility and selection criteria based on the information provided by the developer.  

Medicines in the scope of the ILAP include:  

  • Novel products: no other product exists in clinical practice that uses the same mechanism of action such as a first in class molecule  
  • New chemical or biological entities 
  • Products which feature new or a novel modification of existing technologies 
  • Approved medicines being developed in a clinically significant new indication 

Drug-device combinations in the scope of the ILAP include: 

  • Novel drug-device combination products with a therapeutic aim, regulated under the Human Medicines Regulations 2012 
Which products are not in scope of the ILAP?

Medicines and drug-device combinations with a diagnostic aim, as well as immunisations for the prevention of infection or disease are not within the scope of the ILAP. 

Will a separate ILAP application be required for each individual product and each specified indication?

Yes, a separate ILAP application is required for each individual product and each specified indication. There may however be limited exceptional circumstances where this is not necessary.   

About the Innovation Passport

The Innovation Passport application is the first step in the ILAP and the mandatory entry point. Products that meet all of the eligibility criteria and which best meet the selection criteria, will be awarded an Innovation Passport.  The developer will then proceed to work with a team of specialists from across the ILAP partners to develop a Target Development Profile (TDP) based on the product’s specific development needs.  

Does the Innovation passport replace other accelerated access routes?

No, the Innovation Passport does not replace the [promising innovative medicine (PIM) designation of the Early Access to Medicine Scheme (EAMS) or other accelerated access routes such as Project Orbis. Applications are permitted for other initiatives. 

What are the eligibility criteria for the Innovation Passport?

Applications will be considered from any commercial or non-commercial developer (UK based or global) that can fulfil all the following eligibility criteria: 

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

The product must:   

a) Contain any substance or combination of substances presented as having properties of treating disease in human beings; or  

b) Contain any substance or combination of substances that may be used by or administered to human beings with a view to restoring, correcting or modifying a physiological function by exerting a pharmacological, immunological or metabolic action.  

The substance(s) within any drug-device combination (DDC) must have more than an ancillary effect and the DDC product must be regulated under The Human Medicines Regulation 2012 (The Human Medicines Regulations 2012) to be considered eligible for the ILAP.

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

  • Vaccine products that are intended for prophylactic purposes are not in scope for the ILAP (e.g., see vaccine definition in The Human Medicines Regulations Act 2012). Instead, these types of products are under the remit of the JCVI (Joint Committee on Vaccination and Immunisation).
  • Any therapeutic vaccines intended to treat existing disease (e.g., cancer immunotherapies, often referred to as cancer vaccines) are eligible for the ILAP.

3. The applicant must be a legal entity with the rights to market the product in the UK. 

The applicant must be:

  • a company
  • organisation or
  • sole trader

that has legal rights and responsibilities and has rights to the Product or under Product Intellectual Property Rights, for

  • developing
  • manufacturing
  • commercialising
  • marketing
  • promoting
  • distributing
  • selling
  • offering for sale
  • importing, or otherwise exploiting the Product in the UK.   

For the avoidance of doubt this includes, but is not limited to,

  • private companies,
  • public limited companies,
  • limited liability partnerships,
  • community interest companies,
  • sole traders,
  • Higher Education Institutions,
  • NHS organisations and
  • charities

This list is not exhaustive.

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

Clinical trials must be underway with initial safety pharmacology data available, but clinical trials to confirm safety and efficacy to provide definitive evidence for a Market Authorisation Application (MAA) in the UK have not yet started.

  • Products that have had their Clinical Trial Authorisation (CTA) approval, but initial safety data is not yet available will not be eligible.
  • Where an unlicensed product has been administered to humans outside of clinical trials e.g. ‘specials’, the safety data collected may be considered as evidence to support an application to the ILAP.
  • In cases where the First in Human (FIH) clinical trial is intended to be the confirmatory trial, such as for rare diseases where a comprehensive MAA data package is particularly challenging to provide, the product may also be considered eligible for the ILAP.
  • In this scenario, the initial safety data from the FIH must be available and submitted as part of the ILAP application.

5. There must be an intention to obtain regulatory authorisation to market the health product in the UK and a commitment to meeting UK Health Technology Assessment (HTA) bodies’ evidential standards to demonstrate cost-effectiveness.  

Once clinical development has finished, there must be an intention to market the product on the UK market and commitment to meeting UK HTA bodies evidential standards.

6. The applicant must commit to working with the ILAP partners to create a Target Development Profile (TDP). 

When a product enters the ILAP, a meeting with a team of cross partner experts to develop a product specific Target Development Profile (TDP) will be arranged.

  • The TDP will define regulatory and access touchpoints across the product development.
  • This is a prerequisite for ongoing support and access to the service on offer via the ILAP.
  • Developers with products in the ILAP will have their product withdrawn from the pathway if they do not commit to the creation of a TDP.

7. The applicant must commit to conducting feasibility to opening clinical trial sites in the UK. 

The UK Government is committed to supporting placement of clinical trials in the UK.

  • Successful applicants will be expected to demonstrate commitment to conducting feasibility for opening one or more clinical trial sites in the UK for the product on the ILAP.
  • Additional support will be on offer to facilitate site identification and feasibility.
  • Where this has not already been conducted, failure to undertake this may result in the product being withdrawn from the pathway.
Selection criteria for applicants who meet the eligibility criteria

Applications who meet the eligibility criteria will be assessed against the selection criteria by all the ILAP partners. 

  • In addition, opinions will be sought from lay person representatives, known as Lay Members.
  • This input will be used to inform the decision-making process.
  • To facilitate this, applicants will be asked to include a plain English summary that clearly explains how their product meets the selection criteria. 
  • This assessment will be completed based on the information provided in the application form.   
  • The Innovation Passport will be awarded to products which are considered to demonstrate compelling evidence against all three of the selection criteria. 

The evidence provided in the application will be considered against the following selection criteria: 

Criterion 1: The specific indication is life-threatening and/or seriously debilitating and there is a significant unmet clinical need 

The application must provide sufficient evidence to demonstrate the extent to which the indication impacts a patient’s life and represents a clinical unmet need. The product will be considered in the context of the available NHS standard of care treatment(s) for the specified indication. It should demonstrate that the product meets both of the following: 

  • The indication is life threatening and/or seriously debilitating despite current NHS standard of care.   
  • Must address a significant unmet clinical need, which means that there is no satisfactory method of prevention or treatment for the indication that has regulatory approval or, even if such a method exists, the medicinal product concerned will be of major therapeutic advantage to those affected.  
  • Products being developed for the treatment or management of rare diseases are encouraged.  
  • Alignment to health system priorities will be taken into consideration.   
Criterion 2: The product is innovative 

The application must provide sufficient evidence demonstrating the extent of the product’s level of innovation and impact, in the context of the current treatment paradigms, as well as the wider scientific and technological landscape.

The application must provide evidence to demonstrate that the product meets one of the following: 

  • It is novel. No other product exists in clinical practice that uses the same mechanism of action such as a first in class molecule, a new chemical or biological entity, a novel drug device combination, new or a novel modification of existing technologies.   
  • It is an approved medicine being developed in a clinically significant new indication.   
Criterion 3: The product has the potential to offer a step change in management of the indication 

The application should provide evidence to demonstrate the product’s potential to deliver benefits to patients and/or the wider healthcare system.

Sufficient evidence must be provided to demonstrate that the product meets one or more of the following: 

  • Clear and justified claimed benefits demonstrating the potential to substantially improve patient health outcomes   
  • Offers the potential of a cure where none currently exists.  
  • Has the potential to substantially reduce care-related costs without negatively impacting the outcomes of patients.  

The claimed potential benefits and magnitude of impact should be contextualised against the existing NHS standard of care treatment(s) for the indication.

  • Therefore, it is essential to detail how the product offers improvements or advancements in comparison. 
  • All claims made should be substantiated by robust, scientific reasoning and evidence.
  • The evidence required for a product to meet the criterion will vary based on its stage in the development pathway and may include data generated during the product’s development or from the broader scientific literature. 
The Innovation Passport application process

The Innovation Passport application is the first step in the ILAP and the mandatory entry point.

  • Products that meet all of the eligibility criteria and which best meet the selection criteria, will be awarded an Innovation Passport. 
  • The developer will then proceed to work with a team of specialists from across the ILAP partners to develop a Target Development Profile (TDP) based on the product’s specific development needs.  

Applicants are strongly encouraged to review the eligibility and selection criteria and application form, prior to applying for an Innovation Passport.  

  • To apply, applicants will be required to complete the Innovation Passport application form and submit this through the ILAP registration portal. 
  • Please note the ILAP registration portal and application form will be available on the 31 March 2025. The ILAP webpage will be updated with a link to the portal on 31 March 2025. 
  • The application will be initially reviewed by the MHRA ILAP team to confirm eligibility.
  • Following the eligibility review of the application, the ILAP partners (AWTTC, MHRA, NICE, NHS England and SMC) and Lay Members, will jointly consider the application.
  • An Innovation Passport will be awarded to products which are considered to demonstrate compelling evidence against all three of the selection criteria.  
  • The ILAP application and assessment process operates in quarterly cycles.
  • Each application round is open for three months, with new rounds of applications and assessment running concurrently over time.  
  • Applicants will be informed of the outcome of their application by the end of the review period.  
What are the fees to apply for an innovation passport?

Innovation Passport fee: £3,624  

Please note that:

  • the Innovation Passport fee is not refundable if the application is not successful. 
  • the MHRA updates its fees on a regular basis.
  • Changes to the MHRA’s fees will be implemented in April 2025 and therefore fees quoted may be subject to change. 
What are the services available to support developers in the ILAP?

Included are core services which all innovation passport holders will have access to. This includes the Target Development Profile (TDP), as well as optional support that may be recommended to help maximise opportunities for accelerating a product’s journey through clinical development, access and uptake.  

About the Target Development Profile (TDP) for all Innovation Passport Holders

The TDP establishes a collaborative platform to review a product’s development, aiming to streamline, align and coordinate evidence generation and evaluation, whilst identifying key implementation and service delivery issues.

  • It will outline critical regulatory and developmental aspects, identifying potential challenges, and providing a roadmap for delivering early access for patients.
  • It is expected that the TDP roadmap is a living document, updated along the development programme timelines and milestones as new knowledge is generated.

At the point of confirmation on entry onto the ILAP, developers will be offered a meeting with the ILAP partners to develop a TDP.

  • The TDP is accessible following confirmation of the Innovation Passport. Developers must commit to collaborating with the ILAP partners to create a TDP within 6 months after receiving the Innovation Passport. 
  • This will enable developers to meet with a team consisting of all the ILAP partners, to define the TDP based on the product’s development needs.   
  • The TDP establishes a collaborative platform for the ILAP partners to review a product’s development, aiming to streamline, align and coordinate evidence generation and evaluation, whilst identifying key implementation and service delivery issues.
  • The TDP will outline a product’s critical regulatory and developmental aspects, identifying potential challenges, and providing a roadmap for delivering early access for patients.  
  • It is expected that the TDP roadmap is a living document, updated along the development programme timelines and milestones as new knowledge is generated. 
  • The TDP roadmap provides a pathway for facilitating a regulatory and access ready approach to medicines development.
  • It will indicate which ILAP services are considered important for the advancement of the product through to regulatory approval and patient access and identify key areas for future engagement. 

Regular interactions

The Innovation Passport holder will be appointed a dedicated point of contact to coordinate all support provided through the ILAP and can support with access to the various services on offer.  

Fees: Target Development Profile

Initial Target Development Profile (TDP) fee: £4,451 

How can the ILAP services be accessed?

The ILAP services can be accessed by Innovation Passport holders after receiving a Target Development Profile (TDP).

The services are intended to drive efficiencies in the product’s development programme, supporting data generation, evidence requirements and market access.  

The ILAP will undergo an interactive and iterative process of improvement with more services added in the future.  

Developers will receive information on how to access these services after receiving their TDP. 

Please note that the MHRA updates its fees on a regular basis. Changes to the MHRA’s fees will be implemented in April 2025 and therefore fees quoted may be subject to change.   

Other Services

These include:

Prioritised Access to Key Services  

Exclusive to the ILAP 

Entry into the ILAP grants Innovation Passport holders access to ILAP specific services. These enable interactions between Innovation Passport holders and all relevant ILAP partners and patients as part of the unique system wide approach at key points in the product lifecycle. These are: 

  • The ILAP Joint Scientific Advice (JSA) 
  • The ILAP Access Forum  
Priority Scheduling Pass 
AboutWhich services benefit from the Priority scheduling Pass?Fees
Entry into the ILAP grants Innovation Passport holders a Priority Scheduling Pass.

This enables products with an Innovation Passport to be prioritised in the ILAP partners work schedule.

Priority scheduling enables timely interactions between Innovation Passport holders and the ILAP partners, supporting efficient product development by delivering essential services at optimal points in the product lifecycle, precisely when they are most needed.

The scheduling pass is complemented by the TDP, which recommends use of specific services at critical points, along the product’s development path.
The following services benefit from the priority scheduling pass: 
MHRA Scientific Advice   
MHRA pre-submission meetings  
Clinical Practice Research Datalink (CPRD)  
NICE Advice services for example the health economic model advice service (excluding NICE technology appraisal/Highly Specialised Technologies evaluation) 
• At Scottish Medicines Consortium (SMC), prioritisation for evaluation and potential eligibility for interim acceptance 
National Institute for Health and Care Research (NIHR) Study Support Service  
Standard fees apply. There are no extra costs associated with priority scheduling. 
Clinical development 

The ILAP offers a range of services designed to streamline and accelerate the products progress during the clinical development stages. This will support developers to generate the required evidence in the most efficient way, for the provision of adequate data for benefit–risk assessment at the time of Marketing Authorisation Application (MAA) and Health Technology Assessment (HTA). 

About the ILAP Joint Scientific Advice  How it can helpHow it works 
The ILAP Joint Scientific Advice service is only available for products on the ILAP and is designed to provide advice on the evidence generation plans for a product from a regulatory and HTA perspective.  
The service is delivered by NICE in partnership with AWTTC, the MHRA and the SMC.
Having a joint discussion with the MHRA and HTA agencies will help develop a more efficient and relevant evidence generation strategy, which could potentially reduce delays and barriers in the product development, regulatory assessment and market access journeys. 

The ILAP Joint Scientific Advice can be used to provide advice in the following areas: 
• Prospective clinical trial/clinical investigation and novel trial design plans, including advice on study population and subgroups, comparators, endpoints, and patient reported outcomes. 
• Real world evidence generation plans, including use of relevant patient registries for data collection. 
• Health economic plans, including advice on economic modelling approach and relevant data input. 

The ILAP Joint Scientific Advice cannot be used to: 
• design trial protocols or economic models, 
• endorse proposals, 
• discuss how to price a product, or 
• provide an early evaluation of the product 
The developer creates a briefing book with key questions and shares their draft protocols and evidence with us, and we set up and facilitate the advice meeting. The advice meeting is a confidential meeting for up to 3 hours, usually delivered virtually. It includes company representatives, ILAP partner representatives (MHRA, NICE, SMC, AWTTC), and external experts, which may include clinicians, patients, HTA and academic experts as appropriate. The developer will also receive two comprehensive advice reports detailing the discussion and recommended actions. 

The developer will benefit from signed confidentiality agreements, sharing of relevant declarations of interests for those involved, and assurance that the advice provided is non-binding on any party. 

This service is not part of formal HTA guidance processes, although it will help prepare for the regulatory and HTA evaluations. 

Read more information on NICE Advice service
A fee estimate range can be provided during the TDP meeting; however, as a bespoke service, exact pricing will be determined by the specific needs of the develope
Clinical Trial Delivery 

Innovation Passport holders will, via the NIHR Research Delivery Network (RDN), have access to England’s national research delivery infrastructure, reducing the time and effort needed to plan, place, set-up and deliver clinical trials. Through the RDN, companies can access opportunities for delivering studies across the breadth of England. The RDN currently supports studies in every NHS Trust in England and approximately 56% of GP practices, as well as organisations in other community and residential settings. 

About the NIHR Study Support Service Fees
Innovation Passport holders get ready access to the support on offer through the NIHR
Study Support Service, providing access across the RDN to: 
• Support study-wide planning activities such as identifying extra trial sites including Patient Identification Centres (PICs) and the new Site Scoping Tool. 
• Clinical advice, such as assessment of study deliverability in the UK, recommendations of recruitment methods and pathways, study design considerations. 
• Research delivery advice – advising on the most efficient recruitment strategies and recruitment settings you may not have considered in the original protocol. This includes setting-specific delivery advice, regional care pathways, NHS support services, investigators, capabilities and exploring digital recruitment methods. 
• Opportunity to discuss site or trial delivery issues affecting study delivery, with support to overcome barriers or delivery challenges 

his also provides access to the Sponsor Engagement Tool, to provide a more efficient and effective way for sponsors to provide regular assessments of study progress and ensure the data that the Network holds is up-to-date. This will result in improved data quality and accuracy which can be used to improve study planning and placement to make best use of the research system’s capacity and capability. 
There are no fees for this service. 
Active National Delivery 
About Active National DeliveryFees
Innovation Passport holders who are seeking to undertake commercial clinical trials in the UK will have access to the new Active National Delivery Service offered by the NIHR RDN when it is launched later in 2025.  

Sponsors will benefit from bespoke services, including: 
• Enhanced centralised support and easy access to the flexible resource provided by the NIHR RDN Agile Research Delivery Team, who are staff based in Regional Research Delivery Networks (RRDNs) across England. They are skilled, multi-disciplinary teams who can work flexibly across a variety of different locations to support research delivery.  
• Access to the NIHR Patient Engagement in Clinical Development Service to help you ensure your clinical trials are participant-friendly, enabling direct engagement with patients, members of the public, and carers to improve the design and delivery of your research. This also helps meet growing regulatory requirements and industry-wide codes of conduct, while working within your internal company guidelines. 
• The RDN will also be able to link you into the Commercial Research Delivery Centres (CRDCs) across the UK, which are bespoke facilities to deliver later phase trials for the for the life sciences industry.  

Innovation Passport holders will be able to access support and advice from the NIHR RDN to guide holders through study development and delivery to meet the evidential requirements for transit through regulatory and HTA processes. The nature and extent of this support will be further explored as part of the piloting of Active National Delivery. 

Further details on the Active National Delivery service, including the full range of options that will be made available through the future service, will be published later in 2025. 
This service will be on offer for commercial clinical trials on a fee-for service basis. As a bespoke service, exact pricing will be determined by the specific needs. 
Clinical Practice Research Datalink  
About Clinical Practice Research Datalink  How it can helpFees
Products in the ILAP will get prioritised access to services from the Clinical Practice Research Datalink (CPRD), which is the pre-eminent UK real-world research service supporting retrospective and prospective public health studies and interventional research. CPRD collects pseudonymised patient data from a network of General Practices across the UK. This primary care data is linked to a range of other health-related data to provide an anonymous, longitudinal, representative UK population health dataset. CPRD can improve the efficiency of clinical studies delivery through innovative data-driven approaches and offers a range of data and services to support developers throughout the product development lifecycle. This includes access to: 
• High quality longitudinal data on 60 million patients, many with over 20 years of follow-up 
• A potential pool of over 18 million currently registered patients, enabling speedy recruitment into phase 3 clinical trials through the CPRD SPRINT (Speedy Patient Recruitment INto Trials) service, which is tailored to support organisations rapidly recruit patients, through near real-time centralised searches of UK-wide electronic health records. 
• Research services based on real world data which can be used to support regulatory and Health Technology Assessment submissions, including: 
• Providing a longitudinal and representative UK perspective of the current epidemiological landscape for patient cohorts 
• Delivering external control arms for both single- and multi-arm trials, using retrospectively and/or prospectively collected data to assess the internal and/or external validity and provide context to trial results. 
• Post authorisation safety, efficacy and utilisation data and services due to the high-quality data collected on primary and secondary care resource utilisation, and clinical outcomes of efficacy and safety in the real world. 
Find out more about CPRD 
Find out more about CPRD fees
Market Access 

The ILAP offers a range of services designed to streamline and accelerate the product’s progress during the licensing and HTA stages. It supports developers to determine the most appropriate licensing route and information needed to enable first-right-time applications, as well as maximising opportunities to benefit from time saved through parallel assessments between the MHRA and the NICE.  

About The ILAP Access ForumHow it can helpHow it worksFees
The ILAP Access Forum is an exclusive offer to the Innovation Passport holders and aims to promote understanding of the market access approaches that will optimise the route to patient access. 

Unpacking market access challenges and addressing these upfront through early engagement with system stakeholders from England, Scotland and Wales is a key enabler for achieving timely patient access. 

This service, which is delivered by NICE in partnership with the AWTTC, SMC, and NHS England (NHSE) aims to provide a joined-up view from system stakeholders in the UK on themes such as: 
• Where the new technology may potentially fit in the care pathway in order to contextualise the value proposition. This is particularly important in situations where the current care pathway is complex or undefined, or in situations where the clinical trial was not conducted in the UK. 
• Service delivery implications of introducing the technology into the NHS, including any commissioning considerations, testing requirements, infrastructural changes, and other implementation activities necessary to facilitate the use of the technology once it receives a positive reimbursement decision.
• High level HTA challenges. This could include helping developers to navigate the different HTA routes for each nation where applicable and understanding the implications of the processes and methods for the technology. It is also an opportunity to understand how to best engage with the HTA agencies and to optimise a HTA submission strategy. (In-depth technical questions on evidence generation should be addressed via the Joint Scientific Advice service). 
• Clarification on how different life sciences initiatives/ processes will apply in practice. As the healthcare landscape continues to evolve rapidly, it can be difficult to navigate current and new processes / initiatives and what these could mean for a developer’s technology in practice. 
• How commercial processes are likely to apply.
Engaging early in the planning process means that feedback from system stakeholders across the UK can be built into a developer’s ongoing market access strategy. Acting on this feedback will help to develop the right approaches to optimise the route to patient access. 

This service is particularly useful for products that need careful management into the system. It is most suitable for products that may involve complex HTA and commercial challenges, radical changes to an established care pathway, and significant changes to service delivery, infrastructure, training and workforce. The service is not a mechanism for making HTA routing decisions, challenging existing decisions made by the HTA guidance programmes or challenging national policies.  
Market access challenges are systematically ‘unpacked’ through preparatory discussions to understand the developers needs and the market access insights they are looking for. 

The MHRA develop the scope of the meeting and work with the developer to finalise the structure, content and attendance. 

AWTTC, NHSE NICE and SMC identify and bring together the most appropriate people in the healthcare systems in England, Scotland and Wales for developers to engage with to gain insight for ongoing market access planning. This may include stakeholders such as clinical, patient groups, HTA, and NHS experts where appropriate. 

Engagement meetings are facilitated and conducted in a safe harbour environment. This ensures confidential, free-flowing, peer-to-peer discussions, which can act as the basis for ongoing engagement with system stakeholders. 

Developers’ will benefit from signed confidentiality agreements (for people not already covered by their system contracts), sharing of relevant declarations of interests for those involved, and assurance that discussions are non-attributable, non-binding and non-transmissible. 

This service is not part of formal HTA guidance processes. It provides expert feedback to support development of the optimal market access approach. 

Read more information on NICE Advice service
 A fee estimate range can be provided during the TDP meeting; however, as a bespoke service, exact pricing will be determined by the specific needs. 
Health System Adoption 
About Health System Adoption Fees
The ILAP will offer a range of support to engage with NHS partners (including NHSE and parties representing NHS organisations in Scotland and Wales) from the early stages of clinical development to inform operational planning and system preparedness for the potential introduction of medicines into standard patient care across the UK.  

NHS partners will provide a range of services based on an underlying assumption that products with an Innovation Passport will achieve a market authorisation and have a reasonable potential to achieve a subsequent positive HTA determination. This will include: 
• Providing advice and guidance to understand the available routes to NHS access. 
• Facilitating engagement with appropriate clinical and commissioning expertise to identify any potential barriers to future adoption and uptake. 
• Supporting the development of a UK-wide adoption strategy.  
• Monitoring and evaluating the uptake of ILAP products across the NHS to understand variation in adoption.  

Further details on the services available to support health system adoption, including the full scope of the adoption strategy that will be made available, will be published later in 2025. 
There are no fees for this service
Source:

UK patients enabled access to transformative new medicines in shortest time possible via new, integrated Innovative Licensing and Access Pathway -MHRA

Innovative Licensing and Access Pathway (ILAP) – MHRA

ILAP application guidance – MHRA

What’s on offer in the ILAP -MHRA