The Medicines and Healthcare products Regulatory Agency (MHRA) has published full details of a new end-to-end access pathway designed to help get new medicines to NHS patients in “the shortest time possible”.
The UK-wide Innovative Licensing and Access Pathway (ILAP) was first launched in 2021 to reduce the time to market for innovative medicines by offering drug developers a single platform to collaborate with the MHRA and UK health technology assessment (HTA) bodies.
The pathway has now been refreshed to offer a more streamlined and integrated process to support the development of medicines that can be introduced into the NHS to address unmet clinical needs “at the earliest opportunity”.
The new ILAP has been launched by the MHRA, HTA bodies and the NHS in response to feedback from stakeholders and the recommendations of the Pro-innovation Regulation of Technologies Review, and boasts a number of key improvements compared to the original pathway.
This includes involving the NHS as a “core partner” and focusing on operational planning and system preparedness, as well as providing a single point of contact for each product.
The updated pathway has also been designed to enhance bespoke services through more selective entry and dialogue between ILAP partner organisations and developers, enable more effective planning by providing predictable delivery timelines, and allow developers to interact early with patients and the NHS to facilitate smoother routes for routine access and system-wide adoption.
June Raine, MHRA chief executive, said: “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… for the benefit of public health.”
The MHRA added that the ILAP partners will be “taking an iterative approach” to allow the pathway to be adapted and improved over time “in response to an evolving life sciences landscape, and patient and stakeholder feedback”.