Intended Declaration: Restart of the Innovative Licensing and Access Methodology
The Innovative Licensing and Access Pathway (ILAP) is a groundbreaking initiative launched by the UK government, aimed at speeding up the development, regulatory approval, and adoption of transformative new medicines within the National Health Service (NHS). This new pathway facilitates earlier patient access to innovative treatments by streamlining collaboration and decision-making among drug developers, the Medicines and Healthcare products Regulatory Agency (MHRA), the National Institute for Health and Care Excellence (NICE), and the NHS [1][2][3].
Launched in January 2021, post-Brexit, ILAP offers an accelerated route to bring new medicines rapidly to the UK market. It aims to improve the traditionally lengthy process by creating a more integrated and parallel assessment pathway for regulatory approval and health technology evaluation, reducing delays between licensing and NHS use [3][4].
Key features of how ILAP facilitates faster access include:
- Joint early engagement and coordination between MHRA and NICE to streamline both regulatory approval and health technology assessment simultaneously, avoiding the historic disconnect where medicines get approved but not recommended for NHS use [2][4].
- Innovation Passport scheme, awarded to qualifying products to guide them through an enhanced, supportive process that addresses regulatory and market access challenges early on, helping products reach patients sooner [3].
- Encouragement for pharmaceutical companies to engage early, ideally registering products three years before marketing authorization, allowing parallel regulatory and value assessments and thus faster patient access, targeting medicines 3-6 months sooner to patients compared with previous pathways [4].
- A broader joined-up regulatory approach that not only covers medicines but also integrates with related mechanisms for innovative medical devices (IDAP) to support NHS-wide access under unmet clinical need authorizations [2].
In summary, ILAP improves patient access to breakthrough medicines in the NHS by providing a coordinated, streamlined pathway from innovation through licensing to adoption, reducing waiting times and enhancing integration across UK healthcare regulatory and funding bodies [1][2][3][4]. The initiative does not specify the type of medicines it targets but involves collaboration from the early stages of clinical development.
The success of ILAP is contingent on its ability to deliver transformative new medicines more quickly. The stakeholders in the initiative include the UK's national health system, the regulator, and health technology assessment bodies. It is unique in that it offers an end-to-end access pathway for collaboration, and it does not mention any timelines for its implementation [1][2][3][4].
- The Innovative Licensing and Access Pathway (ILAP), with its focus on joint early engagement and coordination between the Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE), is designed to facilitate the quicker adoption of health-and-wellness-focused transformative new medicines within the National Health Service (NHS).
- To improve health-and-wellness outcomes and reduce waiting times for patients, ILAP encourages pharmaceutical companies to engage early in the development process, providing an accelerated, coordinated, and streamlined pathway for groundbreaking science-driven medicines to be brought rapidly to the UK market.
