The ABPI is pleased that the report has highlighted the need to:
• progress on the delivery of important regulatory innovation,
• make best use of existing regulatory flexibility, and
• learn from developments abroad, that support the development of innovative medicines.
The UK Early Access scheme for medicines was a priority topic in the BIS Strategy for Life Sciences. If appropriately set up, it could facilitate patient access to medicines where there is high unmet medical need up to a year before marketing authorisation. It will also act as an important example of how the UK can drive innovative regulation, linking across key UK bodies to achieve this. However, the scheme would benefit from a workable funding and access mechanism to be truly successful and the ABPI hopes this is achieved soon.
The MHRA group also examined the Food and Drug Administration (FDA) ‘Breakthrough’ designation provisions and the ABPI welcomes any work to ensure similar support for innovation exists in the EU, including the proposed link between a similar designation and the proposed UK Early Access scheme.
The MHRA Innovation Office is a single point of contact to support SMEs and academic units with limited regulatory expertise when developing innovative products. It is important to support UK innovation, and the ABPI welcomes the development of this resource.