EMA Transitions May Affect Drug Approvals and Public Health Safety

Because the headquarters of the European Medicines Agency (EMA) must be located in a country within the European Union (E.U.), the agency will need to move its London headquarters by 2018, when Great Britain will formally exit, or “Brexit,” the E.U. Agency officials are concerned that this transition could jeopardize access to new medicines and safety reviews on existing treatments.

“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,” EMA Executive Director Guido Rasi said in an interview with Reuters.

The EMA headquarters was established in London in 1995, with a staff of more than 890 employees. An internal employee survey showed that 19 percent to 94 percent of employees would resign, depending on which new city is chosen for the new headquarters. Among the top choices for employees are Amsterdam, Barcelona, Vienna, Milan, and Copenhagen because those cities already house E.U. agencies.

A mass exodus of clinical and administrative staff could stall the approval of cancer drugs and therapies for rare diseases, Dr. Rasi explained. “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.”

Public safety is also at risk, he added, as the transition could cause delays in regulators’ responses to issues with side effects or quality.

E.U. leaders are expected to make a final decision on November 20.

Source: Reuters, October 3, 2017.