Regulatory innovation has been a topic high on the agenda over the last seven days.
Hot on the heels of last week’s announcement on the Early Access to Medicines Scheme (EAMS), we are now pleased to welcome the launch of the European Medicines Agency’s (EMA) adaptive licensing pilot project.
Adaptive licensing is sometimes called ‘staggered’ or ‘progressive’ licensing and is a prospectively planned process that begins with an early authorisation of a medicine in a targeted/ restricted population. This is followed by iterations of data gathering, and submission and adaptations of the license to expand patient access to the medicine in a staggered manner.
The process underpinning the adaptive licencing model requires engagement from all stakeholders involved in access to medicines, including patient organisations, industry, EMA and health technology assessment bodies, such as NICE. In the proposed adaptive licensing process, these stakeholders confidentially discuss options for development, assessment, licensing, monitoring and reimbursement of a medicine in a ‘safe harbour’ environment. Following these discussions, existing regulatory processes such as scientific advice, conditional marketing authorisations and provisions in the pharmacovigilance legislation for close monitoring of safety will be used to facilitate faster initial licensing and subsequent adaptations.
The ABPI has long called for a more flexible licensing approach. This is in line with the view of the MHRA Innovation in the Regulation of Medicines Expert Group, that we are a member of, which called for “adaptive licensing at the earliest opportunity so that companies could put forward pilot products” in a recent report.
We expect adaptive licensing to help support the development of medicines where there is high unmet need, such as novel antibiotics and medicines for rare diseases, and this pilot is a big step forward. Adaptive licensing could be a significant tool in the armoury to support more efficient medicine development and licensing and ultimately ensure faster patient access to innovative medicines. We encourage all medicine developers to engage with this pilot where appropriate.
Head of Regulatory Affairs