The ABPI sets out its stall for the future of medicines regulation

The ABPI’s Vision Paper - UK medicines regulatory policy and global influence in a post-pandemic world - is well worth a look. 

Offering a positive outlook for the UK as a life sciences leader, the paper organises its wide-ranging recommendations into three categories:

• Patient focus The paper proposes steps to bring in the patient voice and stand behind the Patient Safety Commissioner. This would help to fulfil the recommendations of last year’s Cumberlege Review.
• Innovation focus Existing schemes to support innovative products, such as the Innovative Licensing and Access Pathway (ILAP), receive support, with additional measures such as horizon scanning to identify leading practices being rolled out internationally.
• Future focus Looking more broadly, the paper calls for steps to promote sustainability measures, as well as IT transformation and improvements to patient consent processes in a clinical research context.

The ABPI presents a challenge to the UK regulator, the MHRA. There is certainly a role here for an international, gold-standard authority, helping to shape international standards and offering an innovation-friendly environment for developers.  But to achieve those ends, the MHRA is called upon to set up new networks with international peers and industry partners, and bring in sufficient resource to meet the challenges. Digital and data skills are highlighted as a pressing resourcing need. 

The paper offers a welcome contribution to the current live debate on the UK’s life sciences framework.