Relocation of the European Medicines Agency could cause delays, health hazards as employees are not willing to work in a number of countries, including Malta.
Access to new medicines and safety checks on existing treatments will be jeopardised if politicians pick a new home for Europe’s London-based drugs regulator that is unacceptable to staff, its executive director said.
Earlier this week, a leaked survey of the European Medicine’s Agency 900 staff revealed that between 19 and 94 per cent of employees were likely to leave after the UK left the EU, depending on which of 19 possible locations is chosen.
Nearly nine out of 10 staff said they would leave the agency if it relocated to Malta. EMA staff ranked Malta a lowly 16th in order of preference – ahead of only Sofia, Warsaw and Zagreb. According to the survey, if the EMA relocated to Malta, 86 per cent of the staff would opt to leave.
EMA chief Guido Rasi said cancer drugs and therapies for rare diseases could be particularly affected by an exodus of key scientific and administrative staff.
“Oncology is a good example. The pipelines are very promising for new cancer options and, if there is severe disruption, those might be delayed or prove impossible to approve.”
Currently based at London’s Canary Wharf, London, since 1995, the EMA acts as a one-stop-shop for approving and monitoring the safety of drugs across Europe. Besides its staff of 900 scientists and officials, the agency receives as many as 36,000 visitors a year. At stake is not only the smooth running of the EU’s drug approval process – vital for both patients and companies – but also public safety, if regulators fail to react to a side-effect problem or quality issue in a timely fashion, Rasi said.
The EMA deals with more than a million reports of adverse drug reactions every year
The EMA deals with more than a million reports of adverse drug reactions every year. It also inspects manufacturers worldwide and in recent years has suspended hundreds of drugs that fall short of testing standards.
“Europe now is called on to decide not where to relocate an agency but how to protect an activity that is crucial for public health,” Rasi said in an interview.
Because the work of regulating medicines is delegated by EU member states to the EMA, there is no back-up plan if the agency is relocated from 2019 in a city where it is impossible to operate effectively due to staff losses.
Rasi said that in a worst-case scenario, the agency would simply no longer be able to function. Drug approvals would grind to a halt and Europe might have to import medicines – something that would require new legislation. According to the survey, picking Amsterdam, Barcelona, Vienna, Milan or Copenhagen as the new headquarters would be the best option for retaining staff.
All of the top five candidate cities favoured by EMA staff are in countries that already host one or more EU agencies.
Rasi said the scale of the potential staff exodus was “much worse than anticipated” but reflected the upheaval facing employees, many of whom have children established in London schools and working spouses in the city.
“This has not been reflected upon enough,” he said.
EU leaders will make the final location decision by means of a vote by 27 EU ministers at a meeting of the General Affairs Council (Art 50) on November 20 in Brussels.
The need to ensure business continuity could clash with another cherished ambition of spreading the bloc’s agencies more evenly across Europe, particularly in eastern member states.
Relocating the EMA before Britain leaves the EU in March 2019, as current plans dictate, involves a very tight schedule.