MHRA loses EMA contracts in wake of Brexit

pharmafile | September 3, 2018 | News story | Sales and Marketing EMA, MHRA, UK, brexit, contracts, politics, regulation 

The EMA has awarded Britain’s regulatory body the MHRA just two contracts this year, as the European agency suggested that the uncertainty surrounding Brexit has made Britain off limits for new regulatory contracts.

Despite having bid for 36 different contracts this year, the MHRA were only awarded two, both of which were for drugs in which evaluation had already begun. In contrast, in both 2015 and 2016, the MHRA was awarded 22 separate contracts. During this period the UK lead Europe in regards to the number of contracts it received from the European regulator.

However as the United Kingdom moves toward Brexit Day at the end of March 2019, the British government are still in the process of negotiating a deal with the European Union. “We couldn’t even allocate the work now for new drugs because the expert has to be available throughout the evaluation period and sometimes that can take a year” said a spokesperson for the EMA.

The loss of contracts will act as a significant blow to the MHRA, who receive around £14 million each year from the EMA. Martin McKee, the professor of European health at the London School of Hygiene and Tropical Medicine commented that: “The MHRA has benefited enormously from its close links with the EMA. The fracturing of those links will impact severely on its budget, much now from the EMA, and its ability to attract and retain skilled staff.”

The MHRA commented in a statement: “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.”

Louis Goss

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