Debate on a motion on the performance of the Medicines and healthcare products regulatory agency

This debate was originally scheduled for 12 December 2024.

The motion to be debated focuses on the MHRA’s performance in relation to patient safety matters, including:

• the agency’s work on the hormone pregnancy test Primodos
• the Yellow Card System and safety monitoring, including in relation to the agency’s response to reports of serious side effects associated with covid-19 vaccines
• MHRA funding and the influence of the pharmaceutical industry
• the implementation of recommendations made by the Independent Medicines and Medical Devices Safety (IMMDS) review (the Cumberlege review).

The Medicines and Healthcare products Regulatory Agency

The MHRA is an executive agency of the Department of Health and Social Care (DHSC). It is responsible for the regulation of medicines and medical devices in the UK. The MHRA’s primary role is to ensure the safety and effectiveness of medicines (including vaccines), medical devices and blood components for transfusion.

The MHRA is the UK licensing authority for medicines and issues marketing authorisations (licences) for medicines.

It is also responsible for monitoring the safety of medicines and medical devices. The agency collects information about medicines safety from manufacturers, health services and other regulators. It also uses data submitted to the Yellow Card scheme. The scheme collects reports of side effects and safety concerns from healthcare professionals and members of the public.

The Independent Medicines and Medical Devices Safety review

The Independent Medicines and Medical Devices Safety (IMMDS) Review was chaired by Baroness Cumberlege. Its aim was to “make recommendations for improving the healthcare system’s ability to respond where concerns have been raised about the safety of particular clinical interventions, be they medicines or medical devices”.

The review examined three issues of concern: the hormone pregnancy test Primodos, pelvic mesh, and the use of sodium valproate in pregnancy. The report of the review, First Do No Harm, was published in July 2020.

Recommendation 6 from the IMMDS review focused on reform of the MHRA. It said that the agency needed “substantial revision particularly in relation to adverse vent reporting and medical device regulation” and to improve engagement with patients.

The IMMDS review also raised concerns about the Yellow Card scheme, arguing that it should be better known and used. These concerns were echoed in the Infected Blood Inquiry report in May 2024.

The government accepted the IMMDS review’s recommendations about the MHRA and said that the agency had started a programme of work to address these concerns. In July 2021, the MHRA published a delivery plan, Putting patients first: A new era for our agency, setting out its plans to improve in these areas.

In March 2024, the then government said that the MHRA “champions patient safety over any other priorities including commercial interests”.

MHRA performance metrics

Bodies representing the pharmaceutical industry have raised concerns about the MHRA’s performance of its regulatory functions, including the speed at which it considers applications for medicines licences and clinical research.

The MHRA regularly published performance data in these areas. In its most recent report it said that data up to October 2024 demonstrated that applications for licences for established medicines and for clinical research studies were being assessed within expected timescales.

Library briefings

Hormone pregnancy tests (15 August 2024)

Infected Blood Inquiry: recommendations for recognition, healthcare and patient safety (22 August 2024)

Infected Blood Inquiry: compensation (24 September 2024)

Debate on pelvic mesh and the Cumberlege review (4 December 2024)

The Independent Medicines and Medical Devices Safety Review (2 February 2022)

Safety of Covid-19 vaccines (18 October 2022)

Coronavirus: Covid-19 vaccine roll-out frequently asked questions (15 September 2021)