NICE collaboration creates new route for medicines approval

A collaboration between the UK's National Institute for Health and Care Excellence (NICE), drug regulators, the NHS and equivalent organisation in Scotland has opened a new route for medicine approval in the UK.

The new Innovative Licensing and Access Pathway (ILAP) aims to ease the process between clinical trials and patient access to new medications through closer collaboration and planning between the respective agencies.

The pathway is focused on ensuring that NHS patients can gain access to innovative new medicines in a simpler and faster way.

“NICE has a central role in ensuring flexible and swift access to innovative medicines for patients in England and supporting the life sciences sector to launch their products here,” said Gillian Leng, chief executive of NICE.

The initiative will co-ordinate work between the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), NICE, the Scottish Medicines Consortium (SMC), NHS England and NHS Improvement.

“Partnering with the MHRA and others to build this frictionless pathway to the timely availability of cost-effective medicines is one of the ways NICE is delivering benefits for patients, the NHS, and life sciences industry,” added Leng.

The MHRA and NICE will work together to advise companies on clinical trial design, with the aim of ensuring optimal data is generated for regulatory approval and health technology appraisal.

“The new pathway represents a totally new way of thinking and is a truly collaborative approach between the healthcare system, the pharmaceutical industry and patients with the common goal of getting the best products to the people who need them as safely and quickly as possible,” said Lord Bethell, Minister for Innovation.