The European Medicines Agency (EMA) released its annual report for 2018, within which leadership figures from the agency detailed how operations had been affected and the challenges that had been thrown up by the Brexit referendum.
Chair of the EMA’s management board, Christa Wirthumer-Hoche, explained how central the issue had become for the agency during 2018, by noting that “Brexit featur[ed] on the agenda of every meeting of the board”, in her foreword to the report.
Wirthumer-Hoche explained that key to these discussions were two-fold: to ensure business continuity and to undertake staff retention measures.
The latter has been an area of concern for the agency, with it previously announcing that it expected ‘significant staff losses’ of around 30% of its workforce due to the relocation to Amsterdam.
Noël Wathion, deputy executive director for the agency, has led the EMA’s operational and relocation efforts ahead of Brexit.
The report included an interview with Wathion where he discussed some of the challenges that the agency has had to address, including the work its internal Brexit task force had instigated to ensure it remains operational, “even if we encounter considerable staff losses.”
In terms of the size of staff losses, Wathion stated that annual turnover is ‘comparable’ to previous years but continued to note that the larger chunk of employees would leave the agency during the first half of 2019.
Wathion added that this meant certain activities had to be curtailed to “preserve as far as possible our core business of protecting human and animal health.”
Guido Rasi, the EMA’s executive director, outlined exactly where the agency had reined in non-core activity.
“A concrete example that underlines this point is the delay to the update of our guidelines on the development of new medicines to treat haemophilia A and B. There are exciting new developments based on novel therapies underway. However, we had to temporarily stop the revision of the current guideline to be able to concentrate on Brexit and relocation,” Rasi explained.
He also noted that the agency has not been able to continue its efforts to proactively publish clinical trial data, and the additional strain that had been placed on its IT systems caused delays on the potential upgrades to the system.
As a result, Rasi warned, “We cannot rule out a longer-term impact on this agency unless the commitment is made to invest the necessary resources again in future.”
