EMA executive director Guido Rasi has ended his second term at the helm of the EU medicines regulator, with Emer Cooke taking the wheel and becoming the first women in the role.
Rasi’s second five-year term came to an end on Friday (13 November), with his second stint dominated by the move of the EMA offices from London to Amsterdam – and the associated staff losses and ongoing disruption that has resulted from the UK’s withdrawal from the EU – as well as the pandemic.
Cooke will take over the EMA as the regulator is in the midst of handling the review and authorisation of medicines for COVID-19, including the first vaccines for the coronavirus, and as the regulator continues to work out its future relationship with the UK Medicines and healthcare products Regulatory Agency (MHRA) – which has been a big contributor to its expertise and workload.
Under Rasi, the EMA implemented a suite of reforms including a drive towards transparency – for example making clinical study reports (CSRs) publicly available – and the implementation of sweeping EU directives on pharmacovigilance, clinical trials and falsified medicines.
During his tenure the EMA also implemented new rules to encourage the development of advanced therapy medicinal products (ATMPs) like gene and cell therapies, and the introduction of the PRIME fast-track review for promising medicines.
Cooke is returning to the EMA after a four-year period as head of medicines regulation at the World Health Organization (WHO). She first joined the EMA in 2002 and filled a number of senior roles at the regulator including head of inspections, head of international liaison and head of international affairs before switching to the WHO in 2016.
A pharmacist by training, Cooke has also worked in the pharma industry and at European industry group EFPIA, and according to Rasi is “a strong leader who is committed to steering EMA during this very challenging period and ensuring that the agency’s work on COVID-19-related activities continues uninterrupted.”
In his final message as head of the EMA, Rasi said the number of COVID-19 drugs and vaccines being developed by pharma companies is “encouraging,” and pointing to the agency’s pivotal role “in reviewing the available data packages to ensure that our usual high standards of safety, efficacy and quality are achieved and upheld.”
Cooke meanwhile told Bloomberg that one of the biggest challenges she will face immediately after re-joining the EMA will be monitoring the safety of COVID-19 vaccines, particularly those that are based on new technologies like mRNA.
She also told the newswire that the EMA is adopting a different stance on gauging the efficacy of COVID-19 vaccines from the FDA, which has placed a 50% reduction in disease severity as its threshold for approval, saying guidance on its position will be published soon.
The EMA has already started reviews of Pfizer/BioNTech’s mRNA-based shot BNT162b2 and AstraZeneca/University of Oxford’s adenoviral-based candidate AZD1222.
Rasi’s first five-year term as executive director of the EMA was interrupted in 2014 when his appointment was prematurely annulled by European Union Civil Service Tribunal – on the grounds that the selection process for the post was flawed – only to resume his duties a year later.
Prior to the EMA role, Rasi was director-general of the Italian Medicines Agency from 2008, and previously spent three years as director of the Institute of Molecular Medicine in Rome.
“I am leaving EMA at a time when its mandate is set to be expanded. This is an acknowledgement of the good work and reputation that the agency has built over the last 25 years,” he said.