A new regulatory pathway set to improve access to innovative medicine in the UK
Background:
Following Brexit, the Medicines and Healthcare Regulatory Agency (MHRA) has become the UK’s sole body in charge of marketing authorisation. The UK has used this opportunity to launch the Innovative Licensing and Access Pathway (ILAP), which offers certain medicines a new route into the UK market.
What has changed:
The ILAP was announced in December 2020 and came into operation on the 1st January 2021. It promises to bring together UK HTA agencies, NICE and the SMC with the MHRA, along with supporting interactions from the NHS and research agencies such as the National Institute for Health Research (NIHR) and the Health Research Authority (HRA), in a way not previously seen. The objective is to create a streamlined process, allowing certain drugs to enter the regulatory pathway early in their development, including entry based purely off non-clinical data.
How will it work:
Manufacturers must apply on the MHRA website for an Innovation Passport which will determine a products eligibility for the scheme, and if successful, the MHRA will develop a Target Development Profile (TDP). Both the issuing of an Innovation Passport and the development of the TDP will accrue a fee payable to the MHRA.
Criteria for holding an Innovation Passport include being an innovative medicine and having an indication that is considered high priority. A high priority indication includes a life threatening or seriously debilitating disease, a disease with high levels of patient or public need, a treatment for a rare disease or a treatment for special populations such as neonates, children, pregnant women, or the elderly. An Innovation Passport is required for the TDP.
The TDP will act as a roadmap for the product’s development, taking into account different approaches to allow for multi-stakeholder collaboration. This new pathway will utilise many of the regulatory flexibilities introduced in response to the COVID-19 pandemic, such as the use of real world evidence, continuous benefit-risk assessment, novel clinical trial design and horizon scanning.
Expected impact:
It is still to be seen what drug will be the first to go through this process, and how this will play out. However, this scheme aims to facilitate quick and efficient entry to the UK market for innovative, new technologies. The big picture goal is, of course, to see patients in the UK getting access to cutting-edge treatments and receiving top quality care.
For manufacturers, it is a chance to be given unprecedented early access to key stakeholders in the UK, and could well be a far easier and possibly more successful route to achieving access in the UK market taking into account the disruption of Brexit.