Getting it right from the start is the preferred choice for any business and bringing medicines to market is no exception. As of 1 January 2021, the UK implemented a new regulatory and access pathway with a value proposition of end-to-end collaboration between the medicine developers, the regulatory agency, the health technology assessment (HTA) agencies, the payer, patients, and other partners. The key aim is to reduce the time to market for innovative medicines.
Following the departure from the European regulatory system, the UK government as part of its vision for life sciences has taken the opportunity to create an innovative regulatory framework, which is aimed at supporting and enhancing innovation and accelerating routes to market1. Led by the MHRA, the Innovative Licensing and Access Pathway (ILAP) offers a new approach for companies who wish to reduce the time to market and increase patient access to innovative medicines. The pathway is open to developers from an early stage, even for products in the preclinical phases of development.
The ILAP brings together the MHRA, NICE, NHS England, the Scottish Medicines Consortium (SMC), and other supporting partners such as Health Research Authority (HRA). The pathway places a target development profile approach (which is similar to the Trans-Pacific Partnership concept used by companies) at the core and this can help to identify pitfalls, break down silos, and support the allocation of expert resources where they add the most value. Having NICE, SMC, and NHS England involved from an early stage is unique for ILAP and incorporates the needs of payers as well as regulators early in the process, thus improving the chances for a medicine to be taken up quickly by healthcare providers once approved, increasing patient access.
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