Life sciences

Written by Emma Kislingbury and Florence Page

Key developments in 2024

COVID-19 continued to dominate life sciences headlines in 2024.  

The COVID-19 Inquiry has continued in earnest.  Module 3, which focussed on the impact of the pandemic on healthcare systems has recently concluded.  Damning evidence has been heard about the immense toll on healthcare staff, and the detrimental impact on NHS waiting times.

Alongside the Inquiry, around 50 families have begun a product liability group action against pharmaceutical giant AstraZeneca.  They claim that the Oxford AstraZeneca vaccine caused a rare type of blood clot, combined with low platelet levels, which, for some recipients, caused damage in the brain and to multiple other organs.  The group is seeking compensation under the Consumer Protection Act 1987, on the basis that the vaccine was "not as safe as persons generally are entitled to expect".  

The claimants might have been expected to claim under the UK Vaccine Damage Payment Scheme (VDPS), which exists to provide financial support to individuals adversely impacted by vaccines. But the pandemic has identified serious shortcomings with the scheme.  Delays in processing claims, a capped payment of £120,000 (which has not increased since 2007), and a 60% disablement threshold to qualify, have driven some of those impacted to try to pursue manufacturers directly.     

The VDPS will be examined as part of the next module of the Inquiry, in early 2025.  The findings, and any changes which might be implemented to the scheme as a result, will have a direct impact on future litigation, and on the potential risks for vaccine manufacturers.   

What to look out for in 2025:

The new UK Government has identified life sciences as a priority "growth-driving" sector. In October 2024, it published a Green Paper outlining its "pro-business" industrial strategy vision: "Invest 2035: the UK's Modern Industrial Strategy", which recognises that the life sciences sector "offers unparalleled opportunities for future economic growth". The industrial strategy and plans for each sector are due to be published in Spring 2025.

In addition, the recent: "Plan for Change: Milestones for mission-led government", published on 5 December, signposts the Government's intention to publish a 10-Year Health Plan, in Spring 2025.  We predict that the widespread adoption of cutting-edge healthcare technologies, including AI, will play a central role.

These developments highlight the significance of regulation, with the MHRA having already set out plans to reform the regulatory regime for medical devices, which includes software and 'AI as a medical device' (AIaMD). 

The MHRA's AI strategy confirms its intention to take a "proportionate approach" to the regulation of AIaMD, using guidance rather than rigid legislation, to avoid stifling innovation. The MHRA also launched its much anticipated "AI Airlock", which is a "regulatory sandbox" using real-world products, through which the MHRA aims to identify and resolve regulatory challenges specific to AIaMD. This pilot project is due to finish in April 2025, and the results will shape future MHRA guidance.

For those in the life sciences sector, including manufacturers of medical devices (and their insurers), it will be important to monitor how the Government's and MHRA's plans unfold in 2025, and the potential impact that any new policies or guidance will have on bringing new life sciences technologies to market.

Explore Annual Insurance Review 2025