NICE initiates new Innovative Licensing and Access Pathway for medicines

The new pathway developed by NICE for medicines to go from clinical trials to NHS patients is now in action.

Medicines and approvals

The UK National Institute for Health and Care Excellence (NICE) has announced that a new streamlined licensing and patient access process for new medicines opened on 1 January this year. 

According to NICE, companies can now submit medicines for the new Innovative Licensing and Access Pathway (ILAP) following close collaboration between the NICE, drug regulators, the National Health Service (NHS) and equivalent organisations in Scotland.

The new route for the approval of medicines aims to smooth the journey from clinical trials to NHS patients through closer collaboration and planning between the agencies involved in each step. NICE says it will mean NHS patients will have access to innovative new medicines sooner.

The scheme will co-ordinate work by the Medicines and Healthcare products Regulatory Agency (MHRA), NICE, the Scottish Medicines Consortium (SMC) and NHS England and NHS Improvement (NHSE&I) to support and advise companies launching their medicines in the UK.

Professor Gillian Leng CBE, Chief Executive of NICE said: “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. 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.”

NICE will be working with the MHRA to provide advice for companies on clinical trial design to ensure optimal data is generated for both regulatory approval and health technology appraisal.

The NICE Scientific Advice and Office for Market Access services will also contribute to supporting products in the ILAP.

Dr June Raine CBE, Chief Executive of the MHRA commented: “Transforming the way innovative medicines reach patients in the UK is… an imperative. And the time to do it is now. We are transforming the MHRA, making the regulator an enabler of innovation. Our ILAP has established new partnerships to robustly and safely support all new medicines at any point in their development and most important of all, involve patients in all aspects of decision-making.”