The Association of the British Pharmaceutical Industry (ABPI), the BioIndustry Association (BIA) and the Centre for the Advancement of Sustainable Medical Innovation (CASMI) have hosted a one-stop-shop event on adaptive licensing, giving medicines developers across the life sciences sector the opportunity to further enhance their understanding of how they can engage with this important initiative.
The event, which was attended by 85 people from industry, patient groups and others involved in medicines development, heard from speakers including Earl Howe, parliamentary under secretary of state for quality, Dr Hans-Georg Eichler from the European Medicines Agency (EMA), Dr Daniel O'Connor, Medicines and Healthcare Products Regulatory Agency (MHRA), Dr Sarah Garner, National Institute of Health and Clinical Excellence (NICE) and Dr Tony Soteriou, Department of Health.
Lord Howe described adaptive licensing as a “golden opportunity” to demonstrate the strength of life sciences in the UK. He went on to say that if used successfully it will demonstrate that regulation is “not a noose which stifles but rather a safety mechanism which can release medicines to patients in need.”
To date, 14 companies have submitted applications for the adaptive licensing pilot, and the EMA will communicate shortly which of these will be taken forward. The opportunity to submit live assets for consideration remains open until further notice.
Key topics of discussion included the fact that this pilot involves a “coalition of the willing” including regulators, payors, industry and patients in a discussion in a safe harbour environment. There was great emphasis on the need for trust and open and honest dialogue between all involved. It was recognised that this approach now allows, an adaptive mindset, using multiple data sources to help patients. This recognises a shift from a blockbuster development strategy to one that considers smaller patient populations from the outset.
Various challenges were discussed including the capacity of EMA, MHRA and NICE to deal with potential additional workload, and it was confirmed that they are adequately resourced. Another concern was how adaptive licensing pricing will fit in a global product development strategy, and whether it is realistic for all European payors to accept greater uncertainty. A clear distinction was made between risk and uncertainty; this pilot is designed to allow the acceptance of greater uncertainty, not increased risk. Agreement on pricing and reimbursement will be fundamental to the success of the pilot, and going forward marketing communications will need to adapt to reflect products that are approved through adaptive pathways.
Bina Rawal, ABPI’s Research, medical and innovation director, said: “The ABPI has long called for a more agile and flexible licensing approach and we welcome the EMA pilot, which will explore the adaptive licensing approach with real medicines in development. This event has helped to explain how this step change will be implemented. Once we have addressed some of the outstanding challenges, the ABPI expects adaptive licensing to help support the development of medicines where there is high unmet need, such as novel antibiotics and medicines for dementias and rare diseases. Scientific progress and innovation are a continuum, requiring a progressive approach from medicines developers, regulators, NHS, NICE and patients in the best interests of all of us.”