Brexit Costs EMA Almost €60M in 2019
Regulatory News | 21 November 2019 |
Conversations about the cost and impact of Brexit tend to focus on the UK, but the Brexit-related relocation to Amsterdam and other activities cost the European Medicines Agency (EMA) €59.6 million ($66 million) in 2019, according to the latest tally.
By comparison, EMA spent €15.5 million ($17 million) on Brexit-related expenses in 2018. About 90% of EMA's budget comes from pharmaceutical industry fees, according to the European Parliament, which compares with about 65% of FDA's drug budget coming from industry user fees.
The announcement of the Brexit-related budget costs comes as EMA has relocated its headquarters from London to Amsterdam and as EMA is working on a scenario in which the UK will become a third country and no longer will engage as (co)-rapporteur for new marketing authorisation applications via the centralized procedure.
And although the Brexit deadline has been pushed back to 31 January 2020, EMA staff will likely move into their new permanent offices and workspaces in Amsterdam in January 2020, the agency said.
EMA previously said its total available workforce in Amsterdam is about 730, which is about 20% less than the 900 staffers EMA had in London. EMA said that 74% of those who left the agency in 2018 left by resignation, which was double the average resignation rate for the preceding five years.
“In order to be best prepared to address future challenges with the existing workforce, EMA is reviewing its organisational structure and looking to set up task forces that will focus on key priorities for the European medicines regulatory network such as digital business transformation, data analytics and methods, regulatory science and innovation and clinical trials and manufacturing strategy,” EMA said.
Other activities the EMA has had to undertake include redistributing the UK's portfolio of over 370 centrally authorized products to rapporteurs and co-rapporteurs in preparation for Brexit.
As far as the potential for drug shortages in the EU as a result of Brexit, EMA last September said the number of centrally authorized medicines for which there are concerns of Brexit-related supply disruptions declined from 108 to 39 (25 human medicines and 14 veterinary medicines). In March, EMA’s management board said the prospect for centrally authorized products to be at risk of shortage “continues to decrease.”
EMA Budget
By comparison, EMA spent €15.5 million ($17 million) on Brexit-related expenses in 2018. About 90% of EMA's budget comes from pharmaceutical industry fees, according to the European Parliament, which compares with about 65% of FDA's drug budget coming from industry user fees.
The announcement of the Brexit-related budget costs comes as EMA has relocated its headquarters from London to Amsterdam and as EMA is working on a scenario in which the UK will become a third country and no longer will engage as (co)-rapporteur for new marketing authorisation applications via the centralized procedure.
And although the Brexit deadline has been pushed back to 31 January 2020, EMA staff will likely move into their new permanent offices and workspaces in Amsterdam in January 2020, the agency said.
EMA previously said its total available workforce in Amsterdam is about 730, which is about 20% less than the 900 staffers EMA had in London. EMA said that 74% of those who left the agency in 2018 left by resignation, which was double the average resignation rate for the preceding five years.
“In order to be best prepared to address future challenges with the existing workforce, EMA is reviewing its organisational structure and looking to set up task forces that will focus on key priorities for the European medicines regulatory network such as digital business transformation, data analytics and methods, regulatory science and innovation and clinical trials and manufacturing strategy,” EMA said.
Other activities the EMA has had to undertake include redistributing the UK's portfolio of over 370 centrally authorized products to rapporteurs and co-rapporteurs in preparation for Brexit.
As far as the potential for drug shortages in the EU as a result of Brexit, EMA last September said the number of centrally authorized medicines for which there are concerns of Brexit-related supply disruptions declined from 108 to 39 (25 human medicines and 14 veterinary medicines). In March, EMA’s management board said the prospect for centrally authorized products to be at risk of shortage “continues to decrease.”
EMA Budget
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