Patients and pharma stand to benefit from Innovative Licensing and Access Pathway scheme 25 May 2021
PharmaMedic Consultancy is currently supporting several clients with their applications to the MHRA’s new Innovative Licensing and Access Pathway scheme (ILAP). The pathway forms part of a bold vision for the UK to incentivise and support life sciences development as we emerge into a post-Brexit regulatory and clinical trials environment.
The programme enables organisations of all sizes to work closely with the MHRA, National Health Service Executive, Scottish Medicines Consortium and other stakeholders on a new medicine development and reimbursement pathway. Already, the scheme has attracted significant interest from medicines developers. The first so-called ‘Innovation Passport’ was awarded to belzutifan, a medicine for adults with von Hippel Lindau disease developed by MSD (UK). This rare genetic disease is caused by mutations in the VHL tumour suppressor gene. More recently, in May 2021, HyBryte™, a treatment for early-stage cutaneous T-cell lymphoma (CTCL) in adults was awarded the designation. No doubt, further announcements from other organisations will follow. A successful Innovation Passport designation triggers the MHRA and its partners to create a living “Target Development Profile” (TDP) document which sets out a roadmap for the product towards patient access within UK healthcare. A successful ILAP application is a significant boon for drug developers and stands to accelerate the time to market for innovative treatments. Most importantly, the approach also benefits patients who will get faster access to vital new therapies.
The scheme has established flexible entry points so that sponsors with mid-stage development global dossiers and early entrants with only non-clinical data can apply depending on the available data. However, the MHRA does caution that the earliest possible engagement will allow companies to benefit most from the initiative. Notably, the scheme is not advised for organisations with products at later stages.
As an initiative to support innovation, the eligibility criteria focus on areas of high unmet patient or public health need, rare diseases, special populations and clinically significant contributions to efficacy and safety profile, patient care and quality of life.
The introduction of the passport is one of a suite of initiatives designed to cement the UK’s position in the global life sciences industry and create a prominent clinical trials ‘superpower’. It also reflects an ongoing focus on cross-stakeholder and industry/public collaboration that has been such a critical feature of the COVID-19 response and a mainstay of the successful innovations we have seen during this period.
To discuss how PharmaMedic can help guide you through the ILAP application process, get in touch at email@example.com.