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Higher Costs, Higher Fees, Higher Drug Prices: The UK No-Deal Brexit Bonus

 
• By Ian Schofield

A freestanding UK Medicines and Healthcare products Regulatory Agency with a dedicated authorization route for new drugs OKd by the European Medicines Agency and national incentives for pediatric and orphan drug development are just some of the likely outcomes of a no-deal Brexit as described in a consultation document just released by the government. In many cases companies will end up paying again for services they currently receive from the EMA, and, the government says, they may pass these extra costs onto the national health service in the form of higher prices.

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The UK will set up its own drug approval procedures in the event of a no-deal Brexit

If the UK regulator, the MHRA, becomes a standalone agency and has to take on extra regulatory work from the EU in the event of a no-deal Brexit, it will have to charge the pharmaceutical industry additional fees, and companies may well decide to pass on these costs in the form of higher drug prices to the National Health Service.

This is one of the sobering conclusions drawn by the government in documents issued on Oct. 4 as part of a consultation on the likely regulatory and financial impact...

More from United Kingdom

Why Hympavzi Secured English Funding For Hemophilia B But Not Hemophilia A

 
• By Neena Brizmohun

Pfizer told the Pink Sheet it would work with the health technology assessment institute, NICE, with the hope of making Hympavzi available to patients with hemophilia A via the National Health Service.

ClinicalTrials.gov Or ISRCTN: Getting Transparency Right For UK Trials

 
• By Vibha Sharma

ISRCTN’s systems are being redesigned to facilitate compliance with upcoming requirements in the UK’s clinical trials legislation.

Spain Beats England To Tevimbra Reimbursement Recommendations

 
• By Francesca Bruce

Spanish authorities have published more pricing and reimbursement reports as part of a new drive to increase transparency.

Managed Access Agreement Fails To Help BioMarin’s Brineura Secure Routine Reimbursement In England

 
• By Francesca Bruce

BioMarin’s ultra-rare disease drug Brineura has breached cost-effectiveness thresholds for highly specialized treatments in England and looks set to be denied routine funding on the National Health Service.

More from Europe

Europe’s UPC Issues Landmark Ruling On Second Medical Use Claims

 
• By Neena Brizmohun

The verdict by the Unified Patent Court in the dispute between Sanofi/Regeneron Pharmaceuticals and Amgen explains what companies should look out for when deciding whether infringement has taken place when it comes to second medical use patents.

Autolus’s Aucatzyl And GSK’s Blenrep Among 10 New Drugs To Get EMA Nod

 
• By Vibha Sharma

The European Medicines Agency has OKd 10 new medicines for EU-wide approval, including a CAR-T therapy for treating acute lymphoblastic leukemia. Two drugs were, however, rejected.

EMA Rejects Treatments For Pediatric Myopia & CTCL

 
• By Vibha Sharma

EU marketing applications for drugs aimed at slowing myopia progression in children and for treating cutaneous T-cell lymphoma have been turned down by the European Medicines Agency.