UK medicines regulator needs more resources, drugmakers say

Unlock the Editor’s Digest for free

Roula Khalaf, Editor of the FT, selects her favourite stories in this weekly newsletter.

Britain’s medicines regulator needs more resources and its staff better training, pharmaceutical companies said on Wednesday, warning that the body’s stretched capacity is deterring domestic investment.

Four in five drugmakers said the UK’s regulatory environment, headed up by the Medicines and Healthcare products Regulatory Agency, counted against the country when they were considering where to invest, in a survey published by the Association of the British Pharmaceutical Industry.

More than 80 per cent of respondents involved in investment decisions said the MHRA’s “capacity and predictability” was the biggest factor deterring investment in manufacturing or clinical trials. Concerns were also voiced about employee development.

The report comes as the Labour government vows to tackle the shortcomings of UK watchdogs, which have struggled to adapt to the challenges posed by Brexit, including hiring expert staff and handling approvals of new products.

The MHRA was widely praised for becoming the first western regulator to approve a Covid-19 vaccine during the pandemic, but it has since been hit by budget cuts.

When the UK left the EU, the European Medicines Agency, the bloc’s regulator, moved from London to Amsterdam. The MHRA has since sought to build alliances with peer bodies overseas to keep the small UK drug market attractive, so that patients do not fall behind in the queue to access new treatments.

Richard Torbett, ABPI chief executive, said the MHRA had “long been regarded as a well-respected, global leader” but that “events in recent years have tested its resilience and capabilities”. Industry wanted to help the MHRA “regain its world-class reputation”, he added.

In October science secretary Peter Kyle announced a Regulatory Innovation Office, which aims to reduce red tape for businesses in cutting-edge sectors such as engineering biology.

In its general election manifesto, Labour said the new body would help “update regulation, speed up approval timelines and co-ordinate issues that span existing boundaries”. But details of how it will operate will depend on the outcome of the next Spending Review, which is expected to be completed in June next year.

Senior Whitehall figures said the body would focus on “three or four regulators” that would benefit from targeted support in order to provide a template for improving others.

The push to improve regulators comes as the UK looks to attract more pharmaceutical companies to run clinical trials by promoting the health service as a way of reaching many potential participants quickly.

Respondents said a post-Brexit restructure of the MHRA in 2021 had left it unclear who to contact, and that it was more difficult to predict how long the regulator would take to consider applications

The industry group called on the watchdog to improve the transfer of “institutional knowledge” from more experienced employees to newer ones, and from the private sector to it.

The MHRA should also be allowed to keep any surplus from fees charged to drugmakers, so that it can invest and plan for years ahead, the report found. The agency was able to keep surpluses before a change, recommended by the Office for National Statistics, in 2019.

Dame June Raine, MHRA chief executive, said the ABPI report endorsed the agency’s vision for its future “as an agile and accessible regulator, enabling innovation, and with an international voice”.

The agency was “overhauling” clinical trial rules, relaunching a faster path for regulatory submissions and introducing the first framework in the world for drugs manufactured in medical facilities, she added.  

The Department for Science, Innovation and Technology did not respond to a request for comment.