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Scathing Report On UK Health Care System Failings Calls For Big Changes

 
• By Vibha Sharma

A damning UK report makes uncomfortable reading about how thousands of women suffered avoidable harm from the anti-epileptic drug sodium valproate and two other medical interventions and how safety concerns raised were dismissed, overlooked and ignored.

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Report Found That Doctors Rejected Patient Concerns About Medicines Safety • Source: Shutterstock

An independent review of the UK’s medicines and medical devices safety framework has found the system to be astonishingly “disjointed, siloed, unresponsive and defensive” when it comes to addressing concerns patients have over treatments. It has failed to listen to their concerns and when, belatedly, it has decided to act it has too often “moved glacially.”

The review, chaired by Baroness Julia Cumberlege, found that the UK system, which includes drug and medical device companies and...

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Orphan Drug Trial Sponsors ‘Playing Catch-Up’ With Regulators – But Automation Can Help

 
• By Eliza Slawther

Clinical trial sponsors in the rare disease space face “big safety demands” from regulators, which can be challenging for those with limited resources. A CRO founder makes the case for “embedding automation” into the clinical trial process to keep pace with regulatory requirements.

UK MHRA: Bacteriophage Developers Wanted ‘More Clarity’ On UK Framework

 
• By Eliza Slawther

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Respiratory Treatments Hit Hardest By HTA Terminations In England

 
• By Leela Barham

Exclusive analysis by the Pink Sheet explores how non-submissions by pharmaceutical companies to England’s health technology appraisal body are impacting the availability of medicines on the National Health Service.

MHRA Backs Bacteriophage Innovation To Fight Antimicrobial Resistance

 
• By Eliza Slawther

The UK regulator wants to help companies to develop bacteriophages for the treatment of infections. Its first guidance on this topic offers advice to researchers and sets out the regulatory requirements they will need to meet.

More from Europe

UK MHRA: Bacteriophage Developers Wanted ‘More Clarity’ On UK Framework

 
• By Eliza Slawther

Julian Beach, interim executive director of healthcare quality and access at the UK drug regulator, the MHRA, tells the Pink Sheet how the agency is responding to increased efforts to develop bacteriophage therapies.

New Pricing Agreements And Greater Transparency: What A US MFN Policy Could Mean For France

 
• By Francesca Bruce

A potential MFN drug pricing policy in the US could also lead to a greater push for collaborative action in the EU, such as joint procurement among the member states, says one European industry expert.

EU Pharma Reform Package Clears Big Political Hurdle After Council Adopts Position

 
• By Neena Brizmohun

The Council of the EU has made several key amendments to the legislative reform package, which it will now negotiate with the European Parliament.