Raising concerns about the MHRA: Letter to Steve Brine MP from the APPG on Pandemic Response and Recovery (9 February 2024)

Summary

In this letter to Health Secretary Steve Brine MP, members of the All Party Parliamentary Group (APPG) on Pandemic Response and Recovery raise serious concerns about the approach of the Medicines and Healthcare Products Regulatory Agency (MHRA) to patient safety. They outline problems within the MHRA that continue to put patients at serious risk of harm. The letter also highlights the role of the Independent Medicines and Medical Devices Safety Review (IMMDS), in its thorough investigation of Primodos, sodium valproate and pelvic mesh in bringing some of these concerns to the fore. It points to recent evidence presented to the APPG that indicates that the MHRA is at the heart of wider endemic failings, with issues uncovered so far being "the tip of a sizeable iceberg of failure."

The letter outlines concerns about the following areas:

• The Yellow Card Scheme
• Conflicts of interest and transparency
• History of regulatory failures in the MHRA

It calls on the Health and Social Care Select Committee to investigate these issues and make recommendations to the government on:

• legislative changes as to who is obligated to report adverse drug reactions.
• funding changes to the MHRA.
• separation of regulatory approval duties from post marketing pharmacovigilance.
• more inclusion of patients.
• greater transparency across the board.
• proper enforcement of Part 14 of the Human Medicines Regulations 2012.