The UK’s health treatment regulator needs urgent and substantial reform in the name of patient safety, a Parliamentary debate agreed.

Politicians from all parties levelled harsh criticism at the Medicines and Healthcare Regulatory Agency (MHRA) for failing to protect patients but instead protecting the manufacturers.

MP Esther McVey led the 90-minute House of Commons debate in which MPs addressed failings spanning decades, which have caused catastrophic harm.

The #MHRA has a culture of delay and secrecy – Esther McVey

Treatments the MHRA has failed to properly regulate include surgical mesh, Primodos, Sodium Valproate, metal hips, breast implants, anti-depressants and Covid vaccines.

MP Esther McVey said: “The MHRA Yellow Card is currently a voluntary scheme which Drs and the public can report to, but I’d like to echo calls from Sling The Mesh to follow the example of Denmark and Sweden to make it mandatory.”

Her call was backed by MPs across the house – mandatory reporting would enable the MHRA to spot trends of harm from medicines and medical devices, enabling treatments to be paused while the harm is investigated.

The debate heard heartbreaking stories of the persistent failings of the MHRA and how it is funded by industry – a totally unsuitable funding model.

In addition, politicians heard how MHRA Chief Executive, Dame June Raine, bragged in 2022 that the MHRA had become an enabler not a regulator.

Positive news is that the MHRA plans reforms for medical devices including implant cards, to achieve better scrutiny throughout an implant’s lifetime.

During the debate MP Sharon Hodgson -whose mam has been harmed from surgical mesh – paid tribute to “the fantastic campaign work” of Kath Sansom, Marie Lyons, Emma Murphy and Janet Williams in raising awareness of the appalling failings of the MHRA which is supposed to ensure health treatments are safe for patients.

The debate resolved that:

That this House notes that the Medicines and Healthcare Products Regulatory Agency (MHRA) continues to need substantial reform, as recognised by the Independent Medicines and Medical Devices Safety Review (IMMDS), with patient safety concerns persisting and exacerbating since the review’s publication in 2020; believes that the MHRA’s 2017 expert working group report on Primodos was deeply flawed, with IMMDS later concluding the drug had caused avoidable harm; further notes that the yellow card system for reporting suspected adverse drug reactions is failing, with no process for following up on serious or fatal reactions and conflicts of interest, with 75% of the MHRA’s funding being derived from industry fees, a concern raised in the Fourth Report of Session 2004-05 of the Health Committee, The Influence of the Pharmaceutical Industry, HC 42-I, published on 5 April 2005; also notes the MHRA’s delayed response to reports of myocarditis, pericarditis and vaccine-induced thrombotic thrombocytopaenia following covid-19 vaccination, despite action from regulators in other countries; and calls on the Government to fully implement the recommendations in the IMMDS review and to acknowledge the harm done to patients and the financial burden on the healthcare system as a result of the MHRA’s widespread regulatory failures.

Read the story in the Standard