ILAP – Following agreement by Welsh Ministers the All Wales Therapeutics and Toxicology Centre (AWTTC) will have joined established partners of the Innovative Licensing and Access Pathway as of Monday 4th of October 2021.
Other established partners of the ILAP include the Medicines and Healthcare products Regulatory Agency (MHRA), the National Institute for Health and Care Excellence (NICE) and the Scottish Medicines Consortium (SMC).
ILAP was launched in January in order to assist with easing the processes by which new medicines are developed and assist with reducing the time taken from the clinical trial phase through to the NHS. The collaboration of these established partners holds the potential of major benefit to the Life Sciences Industry and NHS patients alike. ILAP aims to deliver safe, early and financially sustainable patient access to new medicines by providing means for partners to work together and support the companies developing them.
Possible methods of support may include advisement on clinical trial designs, health technology assessments, and development of licensing and access routes and discussions on commercial and managed access issues. A roadmap will be developed for each product in the ILAP detailing support provided by ILAP partner organisations throughout its progression through development to access.
To enter the pathway, companies are required to apply for the Innovation Passport designation and this will be assessed against three criteria by the ILAP Steering Group, comprising of members from all partner organisations. The unique feature of having the regulator and health technology assessment agencies jointly involved ensures that they will all be in the process from the outset.
The first Innovation Passport was granted to Belzutifan, a treatment developed by MSD (UK) for adults with a rare genetic disorder that causes cancer, namely Von Hippel Lindau disease.
ILAP currently focuses on medicines however there are plans to develop further processes for the rapid evaluation of new and emerging medical technologies which could include Diagnostics, medical devices, genomics and ‘hybrid’ technologies and so forth.
For more information and insight about ILAP please follow the link below https://www.gov.uk/guidance/innovative-licensing-and-access-pathway