Government plans for a quicker, virtually automatic approval of new medicines is a dangerous U-turn for patient safety, say campaigners.

Worse, it flies in the face of the Cumberlege First Do No Harm report, which called for a major overhaul of the MHRA to strengthen regulations and help prevent future health scandals like, Mesh, Primodos and Sodium Valproate.

Instead of heeding the warning however, the new speedy sign-off, weakens regulations and is a bitter twist as its announcement was made by MP Jeremy Hunt – the very person who called for a review into improved patient safety when he launched the Independent Medicines and Medical Devices Safety Review in 2018.

During his announcement this month, Hunt said: “From 2024 they (MHRA) will move to a different model to allow rapid, often near automatic sign off for technologies already approved by trusted regulators in other parts of the world. At the same time they will set up a swift new approval process for the most cutting edge medicine and devices to ensure the UK becomes a global centre for their development, and with an extra 10 million pounds of funding over the next 10 years, they will put in place the quickest simplest regulatory approval in the world for companies seeking rapid market access.”

The irony is that during a debate in Parliament in 2021, Hunt said: “There has been the most terrible oversight of women’s medicine and medical devices. Until we implement the (nine) recommendations in the (First Do No Harm) report, there will not be just a lack of justice, but also a risk of repeat … This is of course about justice, but it is also about learning. This time, it was Valproate, Primodos and Mesh. Next time, it will be different medicines and medical devices … Until these nine recommendations are implemented, we will not be able to have the certainty that these mistakes will not be repeated.”

Campaigners hoped that with better regulation and oversight the MHRA could spot early warnings and trends of harm and suspend high risk health care treatments, in the name of patient safety.

However, the new government plans feel like a step backwards.

The changes have been made possible by the UK leaving the European Union under Brexit. It means the UK can create its own set of rules – mark its own exam papers – when it comes to drug and device approval.

This would not be so worrying if there were tough systems in place to ensure complications are being properly tracked. But our calls for this has fallen on deaf ears.

Three key areas we believe are urgently needed to improve patient safety:

• Mandatory reporting of complications to the MHRA Yellow Card by doctors. Despite the mesh, Primodos and Valproate scandals, it’s still voluntary for clinicians to report adverse events. Our repeated calls to make it mandatory have been ignored. Two thirds of mesh complications were missed due to voluntary reporting, enabling two decades of harm before anyone realised the scale of the pelvic mesh disaster.
• Sunshine Payment Act. Sling The Mesh was successful in having S92 added to the Health & Social Care Act 2022, but this now needs enacting, making it law that industry openly declares payments made to doctors, hospitals, researchers. We believe health care charities should also be added to the list. Again, our pleas to enact this are being ignored.
• Choosing patients who will challenge the status quo. We have noticed that the MHRA like to work with inexperienced patients or those who will not challenge the status quo. A Sling The Mesh admin did not get a role as a patient rep for the MHRA, for example, after being asked in interview if she could prove she never had, and never would, criticise the MHRA publicly or on any social media.

As patient safety campaigners, we are determined that future generations will not be harmed as we have been, but this latest development feels like it’s opening the doors to the next medical scandal.

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Further Reading:

I think it’s important that if you’re treating me I know who’s paying you – Carl Heneghan First Do No Harm Report Theme 7: 2:53

Jeremy Hunt said in Parliament in 2020 “I commissioned this report (First Do No Harm) because I knew that many lives had been ruined because we did not act quickly enough to deal with problems … but the results are far more shocking and disturbing than I ever imagined at the time. Thousands of lives have been blighted by what went wrong in the most terrible way. Does the Minister agree that the central issue is not about the three areas alone, but about all medicines and devices where there is no one for patients and people who are suffering to go to with the confidence that they will be listened to?”

Steve Barclay’s speech to the Association of British Pharmaceutical Industry Annual Conference April 2023

Key Takeaways from Barclay’s speech:

• The Government will take a pro-innovation approach to regulation. From next year the Government will allow near auto sign off for medicines.
• The UK leaving the European Union means the UK can take control of rules and regulations, providing an opportunity to take the lead in an innovative regulatory approach and responding quickly to the innovations of tomorrow.
• The Government pro-innovation approach to regulation is why in the Budget an extra £10 million in funding was given to the MHRA to fast-track the regulatory process.
• Near auto-approval from 2024 will free up regulatory resource to focus on other areas, such as Artificial Intelligence in medical devices.
• Fast-tracking innovation to patients is “something everyone in the NHS buys into”.
• The scalability of industrial innovation is key and whilst the UK is good at introducing pilots, it needs to become better at fast tracking innovations

The Health Research Service joins the NHS Innovation Service. Launched earlier this year, the NHS Innovation Service provides support for healthcare innovators from the first stages of an idea, through to the innovation being adopted. The service acts as a front door for innovators to make it easy for them to find the support they need to develop new ideas that meet the NHS’s biggest challenges. Innovators can get in touch with the service for advice on how to turn ideas into viable business propositions, and find out more about the processes they need to follow. They will then be matched with the most appropriate organisation to guide them through their journey.