Gov Imposes Clinical Trials on Care Workers

On 13 July 2021 the British Government enacted regulations under the Health and Social Care Act 2008 to require all employees in the care sector in England to receive a trial‐stage drug as a condition of employment. This unprecedented measure forces care workers into clinical trials to keep their jobs. For further analysis, see our related update.

Key Points

• Unprecedented Mandate: No previous employment contract has forced participation in a live clinical trial.
• Misleading Impact Assessment: The responsible Minister claimed an impact assessment was completed and published, but no such document was ever submitted.
• Geographic Exclusions: The Scottish and Welsh governments have no intention of imposing similar requirements on their care workers.

Next Steps for Employers and Employees

We will monitor developments over the coming days and weeks and advise employers and staff on compliance and legal recourse as more details emerge.

Regulatory Policy Committee Response

The Regulatory Policy Committee (RPC) has released a statement on the Draft Health and Social Care Act 2008 (Regulated Activities) (Amendment) (Coronavirus) Regulations 2021. The Department of Health and Social Care (DHSC) failed to submit an appropriate impact assessment (IA) to the RPC for independent scrutiny. As this is a qualifying regulatory provision, an IA should have been:

• Produced by the DHSC;
• Submitted to the RPC;
• Reviewed by ministers;
• Presented to Parliament.

The RPC remains open to reviewing a retroactive IA to determine whether it is fit for purpose or not fit for purpose.