New chief at EU drug watchdog

The European Medicines Agency will welcome a new Executive Director by the end of 2020. The change comes as the EU drug watchdog’s current chief, Guido Rasi, is due to end his tenure in November.

Emer Cooke, currently the Director of the Regulation and Prequalification Department at the World Health Organization (WHO) in Geneva, will take up the reins at a key moment in the Agency’s history. In the wake of Brexit, it has completed a complex relocation from London to Amsterdam and is now in the spotlight as manufacturers scramble to get approval for new vaccines and treatments for COVID-19.

The agency has also had to show some flexibility during the pandemic as clinical trials are paused and protocols for some studies are redrafted. The EMA is expected to have an expanded role in the years ahead and, along with the US FDA, is pushing for greater collaboration between global regulators.

Cooke, an Irish national, will end her four-year spell at the WHO where she leads the Organisation’s global work on health technologies regulation, including prequalification, regulatory systems strengthening and safety activities. Her role also covers assurance of quality, safety, efficacy and performance of health technologies in close conjunction with member states and international partners.

With more than 30 years’ experience in international regulatory affairs, 18 years of which were in leadership roles, Cooke knows her way around the EU medicines system. A pharmacist by training, she worked for the pharmaceutical unit of the European Commission from 1998 to 2002 and at EMA between 2002 and 2016, where she held positions including Head of Inspections and Head of International Affairs.

The EMA Management Board selected Cooke at a virtual meeting in late June before the nominee was formally appointed after a July session with the European Parliament’s Committee on Environment, Public Health and Food Safety (ENVI).

The announcement ends Rasi’s eventful time at the EMA where he first took up the role of Executive Director in 2011. He was forced to resign in 2014 after an EU court found conflicts of interests in his election process. Rasi spent one year as EMA’s Principal Advisor in Charge of Strategy, where he continued to have a strong influence on the direction of the Agency. He was ultimately reappointed to the top job in November 2015.

Rasi has reportedly expressed a desire for a lengthy handover period so that he can ‘train’ his successor in the complex workings of one of Europe’s biggest agencies. However, given Cooke’s experience at the EMA and her knowledge of the EU and global regulatory machinery, Rasi’s time at the Agency is likely to end before 2021.