In their new action plan, the UK government candidly accepts the impact of over-regulation and sets out plans to reduce the burden on business.
Citing countries such as Singapore and Australia who have continued to improve their regulatory systems, the plan acknowledges feedback from business and trade associations that regulation can be too complex and duplicative. There is a lack of certainty and predictability from regulators who have become too risk averse.
The plan is centred around three key actions:
- Cutting administrative costs for business by 25% by the end of the Parliament.
- Reduce uncertainty across the regulatory system by simplifying the duties of regulators.
- Challenge excessive risk aversion in the system, strengthening accountability and formalising performance reviews for regulators.
Area of interest to the IVD sector are:
- From July 2025, new regulations will allow the safe development of highly personalised and critical medicines to be manufactured and supplied for patients in hospitals or in their homes, at the point of care.
- This year 40% of Technology Appraisals were completed in 240 working days after Marketing Authorisation, and NICE’s transformation aims to reduce this further to 60% for appraisals started in 2025/26.
- The MHRA and NICE will tackle information sharing and collaboration between technical experts to remove delays to patient access to medicines.
- MHRA and NICE will launch a fully ‘Integrated Scientific Advice’ service, accessed through a single point of entry.
- Government will undertake an exercise to understand how much regulation is costing businesses. Ahead of the 2025 Spending Review, all Departments will consider where there may be benefits from merging or consolidating the regulators that they sponsor.
On Digital and AI in Healthcare the new Regulatory Innovation Office will:
- Work with DHSC and MHRA, to launch a second year of the ‘AI Airlock’. The next phase will work with a new cohort of candidates to identify and address a new set of regulatory challenges
You can find the action plan here.
