The report described the continued approval of vaccines to combat COVID-19, the strengthening of cyber-capabilities in the wake of a 2020 attack, and the extension of the agency’s mandate.

WHY IT MATTERS

In 2021, the European Commission, Parliament and Council gave the EMA greater tools enabling it to both support innovation and respond to emergencies, in an acknowledgement of the agency’s vital role in tackling the pandemic.

The EMA approved five treatments and four new vaccines against COVID-19. It also passed regulation on medical devices—a year later than planned because of the pandemic—and took steps towards developing an information network designed to generate data about health patterns across the continent, called the Data Analysis and Real World Interrogation Network (DARWIN EU).

But 2021 was a challenging year for Europe’s medical regulator. A lessons-learned exercise on its response to COVID-19 said that the EMA needed to improve collection and coordination of health data, and enhance data analytics so as to build public trust in vaccines and other medicines, among other findings.

“Due to its critical role in the global response to the pandemic, the EMA found itself in the limelight of public and media attention during 2021,” its executive director, Emer Cooke, stated in the report’s introduction.

ON THE RECORD

Beyond its response to the pandemic, digital developments were central in activities of the agency. It set up a lab for digital innovation, the DigitLab, to explore how AI, machine learning and robotics could improve internal functioning. DARWIN EU, a key initiative, is intended to harness the power of data in the EMA’s decision-making and underpin other EU endeavours like the European Health Data Space. In 2021, the EMA created Darwin EU’s advisory board and took other steps towards developing the project.  

Christa Wirthumer-Hoche, EMA’s outgoing chair of the management board, said DARWIN EU was an example of “harnessing the power of data analytics to support medicine regulation.”

THEIR TAKE

The agency experienced some of the challenges of digital transformation in a cyber-attack in December 2020, which led to emails being leaked and personal data accessed. An investigation was quickly launched, in cooperation with the Dutch police, the EU’s Computer Emergency Response Team (CERT-EU) and Europol, according to the report. “The criminal intrusion into EMA’s IT systems was successfully contained. The Agency and the European medicines regulatory network remained fully functional, and timelines related to the evaluation and approval of COVID-19 vaccines and treatments were not affected.”

Looking forwards, the EMA sees a need to take steps to ensure that beyond COVID-19, it is “fit to tackle the scientific and technological challenges ahead.”

This will include, Cooke observed, the unknown and emerging health threats of the future.