⚠️ Medicines and Healthcare Products Regulatory Agency

Commons Chamber

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The debate in Parliament highlighted serious concerns about the Medicines and Healthcare products Regulatory Agency (MHRA), focusing on its urgent need for substantial reform due to persistent patient safety issues and regulatory failures. MPs discussed historical and recent failures of the MHRA, including delayed responses to vaccine side effects and inadequate systems for reporting adverse drug reactions. The session underscored the necessity for the MHRA to improve transparency, accountability, and its engagement with patients to restore public trust and ensure safety in the pharmaceuticals sector.

Summary

  • MHRA Reform and Accountability: Esther McVey initiated a debate highlighting the need for substantial reform at the Medicines and Healthcare Products Regulatory Agency (MHRA), pointing to persistent safety concerns and regulatory failures.

  • Primodos Case: Criticism was raised about the flawed 2017 expert working group report on the drug Primodos, which was later found by the Independent Medicines and Medical Devices Safety Review (IMMDS) to have caused avoidable harm.

  • Yellow Card System Issues: The current voluntary system for reporting adverse drug reactions is failing due to under-reporting, lack of follow-up on serious or fatal incidents, and conflicts of interest given that 75% of the MHRA’s funding comes from industry fees.

  • Delayed Action on Vaccine Side Effects: The MHRA was criticized for its slow response to reports of serious side effects from the AstraZeneca vaccine against Covid-19, which included conditions like myocarditis and vaccine-induced thrombotic thrombocytopaenia.

  • Call for Government Action: The House called on the Government to implement IMMDS recommendations, acknowledge the harm caused to patients, and address the financial issues this has imposed on the healthcare system.

  • Need for Transparency and Communication: Concerns were expressed about the lack of transparency within the MHRA, especially regarding the release of data related to vaccines and the need for better communication with the public and healthcare professionals.

  • Over-prescription Concerns: Members discussed the problem of over-prescription in the UK, highlighting the need for better regulation regarding antidepressants and other medications, including clearer warnings and support for withdrawal.

  • Patient Safety and Trust: The overarching theme was the need for the MHRA to prioritize patient safety and rebuild public trust by acting transparently, promptly addressing safety concerns, and fostering a culture of inclusive decision-making.

  • Government and MHRA’s Response: The Minister for Secondary Care noted progress in some areas like IT system upgrades for better monitoring and legislative reforms for medical devices, but acknowledged the need for ongoing improvement, especially in communication and patient involvement in regulatory processes.

  • Resolved Motion: The House agreed to push for the reforms of the MHRA, emphasizing accountability, transparency, and patient-centric approaches in its operations.

Divisiveness

The session demonstrated moderate disagreement displayed through critiques of MHRA processes and historical analysis of regulatory inefficacies. Members raised specific concerns, but these were largely aligned in agreeing on the need for reform, with little indication of divisive interpersonal debates or ideological clashes. For example, there was bipartisan agreement on the need to address the issues raised by the IMMDS review and improve patient safety.