New legislation is being laid in the UK Parliament today (12 December) that will change the regulatory framework for clinical trials in the country.
Lawmakers hope that the overhaul – the biggest in 20 years – will make the sector more efficient, streamlining the process of bringing new treatments to the NHS. The new framework will remove duplicative requirements and will embed into law the combined review and notification scheme for some clinical trial initial applications and amendments.
Smarter leaders trust GlobalData
According to Matthew Alderton, a partner in the health and life sciences team at UK and Ireland law firm Browne Jacobson, the changes are well overdue.
He said: “This new legislation will be welcomed with open arms by the life sciences industry, which has for a long time been calling for measures to streamline the slow and cumbersome clinical trials process.
“By removing granular and duplicative requirements in the proposed new framework, standardising the approvals and contracting process to reduce set-up times, and providing more flexibility at a broader level to the clinical research environment, there is real hope this can drive new inward investment and international market entrants into UK life sciences.”
Today’s legislation will enter into law next year following a 12-month implementation period, with lawmakers hoping its introduction will reduce unnecessary administrative burdens on trial sponsors – particularly those taking a risk-based approach – without compromising patient safety.
How well do you really know your competitors?
Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.
Thank you!
Your download email will arrive shortly
Not ready to buy yet? Download a free sample
We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form
By GlobalDataThe reforms are also intended to protect trial participants, facilitate the development of new medicines, remove obstacles to innovation and ensure legislation enables trial sponsors to work across countries.
The introduction of the new legislation is part of a broader overhaul by the Medicines and Healthcare products Regulatory Agency (MHRA), supported by health system partners including the Health Research Authority (HRA), academia and researchers. Reforms were developed through a series of stakeholder workshops, seeking the views of a wide range of organisations and individuals from across the clinical research sector, including patient representatives.
Following the workshops, a public consultation took place between January and March 2022, which received more than 2,000 responses. The government response was published in March 2023.
MHRA chief executive Dr June Raine called the new framework “a major milestone for clinical trials regulations”, adding: “These reforms protect the safe development of pioneering new treatments for the benefit of patients and the NHS, setting the UK as one of the best places in the world to conduct research for patients, researchers and innovators.”
The new regulations will be accompanied by guidance from the MHRA and HRA to embed meaningful public involvement in clinical trials and increase participant diversity. The regulatory bodies hope this will demonstrate the UK’s potential as a research base that can improve care and minimise health inequalities.
The new legislation aligns with recommendations from the Lord O’Shaughnessy review, published in May 2023, and further emphasised in Lord Darzi‘s Independent Investigation of the NHS in England, published in September 2023.
Both documents identified potential changes, which could make the UK more attractive for commercial clinical trials to effectively bring them to NHS patients.
