The initiative hopes to test how artificial intelligence can make medicines safer, speed development and reduce animal testing. 

Artificial intelligence (AI) is rarely out of the headlines read by the public, nor doctors’ devices when they’re frantically seeking ways to ease their workloads. But a new development from the Medicines and Healthcare products Regulatory Agency (MHRA) is poised to bring perhaps the biggest impacts to date across the medicine safety sphere, from speeding up their development to reducing reliance on animal testing. 

The AI regulatory sandbox will keep patient safety front and centre, improving the assessment of accuracy and safety, better predicting risks and detecting effects that may be escaping notice in current methods.

Doctors might find the programme of particular benefit for how it will explore better usages of clinical data to improve understanding of how medicines work across different groups. Crucially, these will include those often underrepresented in studies, such as children, older people and people from diverse backgrounds. 

The sandbox, which has received funding from the government’s Regulatory Innovation Office, will let innovators test which AI tools have the potential to predict how medicines act within the body, sharing information on their absorption, processing and possible harms.

The MHRA hopes its sandbox will also give companies and researchers a controlled testing environment to work with regulators.

It will test up to five AI-driven approaches in its first phase, starting this summer.

Rapid change for AI

The announcement is the latest in a period of scientific developments pushed by the government, often propelling AI to centre-stage.

Earlier this month, the MHRA also published a landmark report demonstrating that the public recognises the potential benefits of AI in healthcare, as long as its rules appropriately set standards for safety and efficacy. Its recent engagement and evidence-gathering programme found that most respondents feel that existing regulatory approaches need to be adapted to meet the rapid pace of change and development of AI technology, suggesting that they would lend their support to the MHRA’s bigger announcement that followed.

Around the same time, NHS England announced that it’s giving 505,000 of its staff access to new AI tools such as the personal assistant tool Microsoft 365 Copilot. It claims that this could free around two days a month from admin duties.

And November last year saw both the AI for Science Strategy and a commitment to source alternatives to animal testing from the government.

More widely, the news slots neatly into the 10 Year Health Plan, which states: “The NHS is the best placed system in the world to harness the advances we are seeing in AI”.

Welcomed, with warnings 

Although cautioning that there’s still a balance to be found between innovation and accountability, industry experts have shared their backing for an AI development like this making it to British shores.

“The regulatory sandbox model – giving companies a controlled environment in which to test AI tools alongside regulators – is something we’ve seen work well in other jurisdictions, most notably the UAE, and it’s encouraging to see the MHRA now adopting it in a medicines context,” commented Gerard Hanratty, partner and head of health and life sciences at specialist law firm Browne Jacobson.

Patrick Vallance, Baron Vallance of Balham, announced the initiative in a talk as science minister at London Tech Week earlier in June.

Last month, Healthcare Today asked whether AI is actually a help or hindrance to healthcare, which yielded mixed reactions.