Lincoln Tsang Discusses UK Medtech Regulation in Pharma Intelligence

Lincoln Tsang, partner and head of Ropes & Gray’s european life sciences practice, recently shared insight with Pharma Intelligence on the UK’s latest medtech regulatory processes.

The article explores innovation adoption, budget promises, regulation reliance, and a combination approach to product regulation, noting that the planning and preparation will count for little if not accompanied by sound execution.

The UK remains on the cusp of potentially significant system advances in medical devices and diagnostics regulation with the Medicines and Healthcare products Regulatory Agency (MHRA) identifying seven pillars of work to flesh out the government’s vision for devices and the Life Sciences Council (LSC) setting an end-of-April deadline to assess proposals on three key areas of activity for developing the UK’s national sovereign medtech system. Prospective timelines for three statutory instruments have also been issued but concern is rising in the industry that the instrument establishing the 12-month deferral of the end standstill period from 30 June 2023 to 30 June 2024, as signaled by the MHRA, has still not yet been formally adopted into law.

In this article, Lincoln provides his thoughts on a comprehensive approach to be taken by UK authorities and policy makers that prioritises or facilitates, among others, a proportionate and enabling ecosystem to promote innovation and patient access, including an NHS that embraces innovation from a pricing and access perspective.