UK's refreshed Innovative Licensing and Access Pathway (ILAP) provides a more integrated approach to patient access

The updated ILAP streamlines collaboration, accelerates access to transformative medicines, and enhances regulatory and NHS integration.

The UK’s Innovative Licensing and Access Pathway (ILAP) has been updated to provide a clearer, more streamlined, and integrated approach to supporting access to transformative medicines for patients in the NHS. The pathway, launched by the Medicines and Healthcare products Regulatory Agency (MHRA) in collaboration with key health technology assessment (HTA) bodies and the NHS, is a unique initiative that enables medicine developers to work with the UK healthcare system, regulators, and HTA bodies from the earliest stages of clinical development.

What is ILAP?

The ILAP accelerates access to transformative medicines and drug–device combinations, providing a single platform for collaboration between developers, the MHRA, UK HTA bodies, and the NHS. It is the only end-to-end access pathway globally, enabling early engagement with regulatory and healthcare bodies to streamline development. It is designed to:

• Provide coordinated support to developers, enabling a system-wide approach to product development and access to the UK market.
• Identify and support potentially transformative technologies that address unmet medical needs.
• Reduce the time required for product research, regulatory approval, HTA, and NHS adoption to benefit patients and the healthcare system.
• ILAP is open to both commercial and non-commercial developers, whether UK-based or international, who have a potentially transformative medicine or drug–device combination that has demonstrated safe use in humans but has not yet entered confirmatory trials.

Key enhancements to ILAP

The updated ILAP introduces several improvements, including:

• Increased NHS involvement: The NHS is now a core partner, ensuring better operational planning and system readiness for integrating new medicines.
• Selective entry and tailored services: More targeted engagement between ILAP partner organizations and developers to enhance service quality.
• Predictable delivery timelines: Enabling developers to plan more effectively and optimize engagement with ILAP.
• Early patient and NHS engagement: Facilitating smoother adoption of innovative medicines across the healthcare system.
• Single point of contact for each product: Streamlining communication for greater coordination.
• Support for drug–device combinations: Adapting ILAP to support the integration of new medical technologies.

Dr June Raine, Chief Executive of the MHRA, stated:

“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.”

ILAP will be continuously updated based on stakeholder feedback and changes in life sciences. Open to global developers of medicines not yet in confirmatory trials, applications will open in March 2025.

A collaborative approach to innovation

ILAP’s success relies on collaboration between key regulatory and healthcare bodies. The initiative is led by the MHRA, NHS England, the National Institute for Health and Care Excellence (NICE), the Scottish Medicines Consortium (SMC), and the All Wales Therapeutics and Toxicology Centre (AWTTC), with support from the Department of Health and Social Care, the Office for Life Sciences, and other government agencies.

Fiona Bride, NHS England’s Interim Chief Commercial Officer, noted:

“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.”

Similarly, NICE’s Chief Executive, Dr Sam Roberts, commented:

“As an organization committed to getting the best care to people fast, we welcome any initiative that helps developers get transformative medicines into the NHS.”

Prioritized access and early engagement

ILAP’s relaunch improves collaboration between health technology developers and key healthcare bodies, streamlining regulatory guidance and accelerating patient access to treatments.

Products awarded an Innovation Passport, the first step in ILAP, benefit from preferential scheduling and early engagement with key stakeholders. Innovation Passport holders receive a priority scheduling pass, granting access to MHRA scientific advice, NICE Advice services, and priority for SMC evaluation.

ILAP also provides joint scientific advice, involving the MHRA, NICE, SMC, and AWTTC, offering guidance on clinical trial design, real-world evidence generation, and health economic plans. This includes structured meetings with ILAP partners and external experts, such as clinicians, patients, HTA, and academic professionals.

Facilitating market access

The ILAP Access Forum, coordinated by NICE in collaboration with AWTTC, SMC, and NHS England, helps developers understand where new technologies might fit into the UK healthcare system. Neil Grubert, Independent Global Market Access Consultant, describes it as a key service for products that, “involve complex HTA and commercial challenges, radical changes to care pathways, service delivery, infrastructure, or workforce.”

Additionally, ILAP supports health system adoption by guiding developers on NHS access routes, identifying potential barriers, developing a UK-wide adoption strategy, and monitoring uptake across the NHS.

A future-ready model

ILAP aligns with the MHRA’s strategy to enhance service efficiency and innovation. The MHRA’s 2024/25 business plan prioritizes improved access to new technologies and regulatory processes, including IT systems like SafetyConnect and RegulatoryConnect to enhance communication and responsiveness.

The updated ILAP supports the UK in maintaining regulatory standards while introducing new medical innovations. Raine stated:

“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 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.”