UK patients enabled access to transformative new medicines in shortest time possible via new, integrated Innovative Licensing and Access Pathway
Source: gov.uk (2025-01-30)

It is the only example globally of an end-to-end access pathway, where a medicine developer can work collaboratively with the national health system, the regulator, and health technology assessment bodies from the early stages of clinical development.

Full details have been published today of the refreshed UK-wide Innovative Licensing and Access Pathway (ILAP), that will offer a clearer, more streamlined and integrated process for developers to help get transformative new medicines to patients in the National Health Service (NHS) in the shortest time possible.

The new ILAP has been 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.

It is the only example globally of an end-to-end access pathway, where a medicine developer can work collaboratively with the national health system, the regulator, and health technology assessment bodies from the early stages of clinical development. The ILAP was first launched (https://www.gov.uk/government/news/the-mhra-innovative-licensing-and-access-pathway-is-open-for-business) in January 2021 to offer developers of promising new medicines a single platform to collaborate with the MHRA and the UK Health Technology Assessment (HTA) bodies to accelerate the time taken for innovative medicines to get to patients.

The UK life sciences ecosystem within which the ILAP sits has since evolved. In response to feedback from stakeholders and the recommendations of the Pro-innovation Regulation of Technologies Review, ILAP partners have worked together to refresh the pathway.

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.

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.

Dr June Raine, MHRA Chief Executive said:

“It is exciting now to share the full details of the refreshed ILAP, which will help to get transformative medicines to the NHS more quickly.

“This new ILAP is clearer, more streamlined and joined up than its predecessor, making the UK a more attractive place to develop and launch innovative products and, most importantly, helping to get transformative medicines to the patients who need them in the shortest possible time.

“This is a great example of how collaboration with our healthcare partners, industry and patients can help us refine and refresh our services and deliver world-leading services for the benefit of public health.”

Fiona Bride, NHS England’s Interim Chief Commercial Officer and Director of Medicines Value and Access, said:

“NHS England is delighted to be a core partner in the new Innovative Licensing and Access Pathway, which will accelerate cutting-edge medicines into the hands of frontline NHS clinicians for the benefit of their patients.

“We are committed to collaborating with the pharmaceutical industry and other healthcare system partners to take the opportunity this world-first end-to-end medicines pathway creates, strengthening the UK’s position as a leader in medical innovation.”

Professor James Coulson, AWTTC Clinical Director said:

“AWTTC are delighted to continue its collaboration with our ILAP partners and look forward to working together on the refreshed pathway.

“ILAP has the potential to deliver timely, effective, and innovative medicines to our patients. We will continue to work collaboratively with our partners to ensure these goals are achieved.”

Dr Sam Roberts, Chief Executive of NICE said:

“The launch of this revised offer marks a significant milestone for the Innovative Licensing and Access Pathway (ILAP).

“As an organisation committed to getting the best care to people fast, we welcome any initiative that helps developers get transformative medicines into the NHS. The collaboration between partner organisations, industry and patients has really helped shape this new offer, and so we look forward to continuing this close working and delivering the ambitions of the ILAP.”

Dr Scott Muir, SMC Chair said:

“SMC is pleased to be an active participant in the ILAP, representing the NHS in Scotland.

“We will continue to work together with our ILAP partners to enable clinically and cost effective, new and innovative medicines to reach patients more quickly.”

Dr Richard Torbett the CEO from ABPI said:

“The ABPI is pleased to see the launch of the new ILAP offer which we hope will result in the delivery of rapid integration of the most innovative new medicines, through a synergised path from regulation, HTA and subsequent NHS adoption.

“The principles that underpin ILAP have broader application for a strong UK life sciences ecosystem. The ABPI stands ready to support the development of measurable markers of success and to actively contribute to the plans to evolve the pathway in the future.”

To be eligible for the ILAP, applicants must submit medicines that have not yet entered their confirmatory trial, which will give more opportunity to benefit from the support offered within the pathway.

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.

Further information about the ILAP and how to apply can be found on the MHRA website (https://www.gov.uk/government/publications/innovative-licensing-and-access-pathway-ilap).

Notes to editors

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

The All Wales Therapeutics and Toxicology Centre (AWTTC) (http://www.awttc.org/) (on behalf of NHS Health boards and Trusts in Wales)

The Medicines and Healthcare products Regulatory Agency (MHRA) (https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency)

National Institute for Health and Care Excellence (NICE) (https://www.nice.org.uk/)

NHS England (https://www.england.nhs.uk/)

Scottish Medicines Consortium (SMC) (https://www.scottishmedicines.org.uk/) (on behalf of NHS boards in Scotland)

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