Wednesday, February 28, 2024

UK Medicines Regulator a "Serious Risk" to Patient Safety

from Medscape UK

The All-Party Parliamentary Group (APPG) on pandemic response and recovery has raised "serious patient safety concerns" about the Medicines and Healthcare products Regulatory Agency (MHRA), along with other aspects of a system that, "far from protecting patients, continues to put them at serious risk".

In a letter to Health Secretary Steve Brine, APPG co-chairs Esther McVey and Graham Stringer, with 26 cosignatories, highlighted the Independent Medicines and Medical Devices Safety (IMMDS) investigation of Primodos, sodium valproate, and pelvic mesh scandals, which found the response of the healthcare system was not sufficiently robust, speedy, or appropriate, causing some patients to suffer life-changing or fatal, avoidable harm.

Subsequent evidence "leads us to believe that serious patient safety concerns persist beyond even the findings of the IMMDS review", the APPG signatories wrote. "The MHRA is at the heart of these far wider endemic failings," and "those cited in this letter merely represent the tip of a sizeable iceberg of failure."

Medscape News UK has reported increasing concern worldwide about the degree to which medicines regulators are captured by the drug industry. A 2022 BMJ investigation found serious conflicts of interest potentially influencing health policy and approval decisions. Regulatory agency members and expert advisers had financial interests in products being licensed, including several experts on COVID-19 vaccine advisory committees with financial ties to vaccine manufacturers that regulators did not always disclose...

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