Brexit Bites: EMA cuts off Britain

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The European Medicines Agency has cut Britain out of its contracts 7 months ahead of Brexit.

“You might have been working on a cancer drug for decades and built up so much expertise that you are the absolute specialist in your field and now have to transfer all your knowledge to someone else. It must be like handing over your baby”

The EMA has said that due to the long lead-time involved in assessing drugs, it could no longer award the lead contracts to British people whilst their place in the EU is shrouded with uncertainty until March 2019.

Every drug sold in the EU must go through a drawn-out EMA authorisation process before being administered to the public, and the Medicines & Healthcare products Regulatory Agency (MHRA) in Britain takes on a large chunk of this work.

Mike Thompson, the chief executive of the Association of British Pharmaceutical Industry, told the Guardian yesterday: “Clearly we’ve all been incredibly proud of the MHRA’s role over the last few years. They’d established themselves as one of the most respected regulators across all of Europe and industry. It’s been a British success story.”

In another devastating turn of events, existing contracts with the MHRA are also being reallocated to bloc members and the EMA requires all existing drug assessors to transfer their personal expertise of their specialist fields to peers elsewhere in Europe.

“You might have been working on a cancer drug for decades and built up so much expertise that you are the absolute specialist in your field and now have to transfer all your knowledge to someone else. It must be like handing over your baby,” said one source in the EMA.

Brexit has already cost pharma companies more than just cash and patents as they try and recover from the loss of the EMA’s HQ in London, and with it around 900 jobs. The exodus to their new HQ in Amsterdam has already begun but it’s expected that about 300 staff members would be unable to relocate.

As for the MHRA, they were involved in one-third of all manufacturing inspections and responsible for picking up one-third of all “adverse events” in terms of patient safety. No wonder pharma chiefs are so concerned about the withdrawal of their involvement. The fractured ties between the EMA and MHRA will impact severely on budgets and their ability to retain skilled staff.

An MHRA statement said: “We want to retain a close working partnership with the EU to ensure patients continue to have timely access to safe medicines and medical devices. This involves us making sure our regulators continue to work together, as they do with regulators internationally, and we would like to explore with the EU the terms on which the UK could continue to participate in the EMA.”
Link to the recent article we published on Brexit and big pharma. 

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