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Luxembourg – In the Corona pandemic, the two medical agencies of the European Union (EU) have, from the point of view of the European Court of Auditors, done a good job overall, despite some shortcomings.

The Court comes to this conclusion in a special report published today on the work of the European Centre for Disease Prevention and Control (ECDC) and the European Medicines Agency (EMA) during the pandemic.

However, the EU auditors call for improvements in aspects such as the speed of publication of information and the collection of comparable data. According to the authors, the report is the first comprehensive assessment of the performance of both agencies in a health crisis.

The EU has recently taken steps to remedy deficiencies and gaps, the European Court of Auditors announced today. However, the EU is “not yet fully prepared to deal with major public health emergencies”.

“We found that the two agencies generally responded well to the COVID-19 crisis within their respective powers and capacities,” the report says. While they were not fully prepared for a severe and prolonged pandemic, they responded as soon as the extent of it became clear.

According to the report, in 2020, when the pandemic began, the two agencies had budgets of 61 million euros (ECDC) and 358 million euros (EMA), respectively. In 2023, the budgets were 90 million euros and 458 million euros, respectively.

Situation initially underestimated

One of the points of criticism is, for example, the ECDC’s initially hesitant handling of the SARS-CoV-2 outbreak. “After China reported the first cases of the new coronavirus, the ECDC initially underestimated the seriousness of the situation for a few weeks,” the auditors judge. The ECDC’s tasks include assessing health risks and communicating about them.

“Like many other institutions, the EU’s medical agencies were caught off guard by the force of the rapidly spreading coronavirus pandemic,” said João Leão, the member of the Court of Auditors responsible for the audit, according to a statement. The lessons learned from the pandemic must now be effectively implemented at EU level so that history does not repeat itself.

The audit report also criticises the fact that, for example, guidelines on important topics such as protective masks and contact tracing were not always available in a timely manner, so that some Member States had already issued their own guidelines with differing recommendations.

National decision-makers have also not always followed the ECDC’s recommendations, for example, they have stuck to travel restrictions for longer, contrary to the ECDC’s advice. The data collected by the ECDC on the Member States have also not always been comparable, for example because of different national testing strategies and criteria for corona-related deaths.

Ongoing review very resource-intensive for EMA

Regarding the work of the EMA, it is noted that efforts to proactively promote more comprehensive clinical trials in the EU have not been very successful.

While the agency has managed to limit the impact of the pandemic on most of its other activities, there have been delays in inspections. The crisis procedures put in place were appropriate, but the ongoing review of COVID-19 vaccines, for example, is very resource-intensive.

The Court criticises the work of both agencies for not always being easily accessible to laypersons, for example by providing information in technical English.

According to the report, the ECDC saw healthcare professionals and policy makers as the most important target groups, but according to its communication strategy for 2022 to 2027, it also explicitly wants to address EU citizens. At the EMA, the transparency of reporting on COVID-19 products has improved during the pandemic, the Court notes.

Gaps in emergency plans

“Both agencies had drawn up detailed public health emergency plans, which were immediately activated, but in accordance with the existing legal and financial framework, they did not address an expansion of capacities in the event of a severe and prolonged pandemic,” the report said.

The ECDC’s emergency plan, for example, had some gaps, meaning it was not flexible enough. There was hardly any personnel capacity to support member states.

The international networks of both agencies have proven useful, the Court of Auditors states. While the EMA had drawn up a list of activities that could be treated as secondary in emergency situations, this was not the case with the ECDC.

The report recommends that the ECDC further improve its internal organisation, procedures, systems and publications to better prepare for health emergencies.

Specifically, it is recommended to continue working on a robust European surveillance system for infectious diseases to enable the collection of comparable data. Internal procedures would need to be streamlined in order to issue more up-to-date and practical guidelines.

In addition, information in clear language is needed for the general public. The EMA is being called upon, among other things, to optimise the procedures and the dissemination of information to laypeople.

It goes on to say that the EU Commission should work with the two agencies to clarify the respective responsibilities of the European Health Emergency Preparedness and Response Authority (HERA), the ECDC and the EMA and improve coordination.

The HERA Directorate-General was set up in 2021 – after initial lessons learned from the pandemic, according to the report. This was intended to close gaps in the operational structure, but according to the report, there have so far been some overlaps with ECDC mandates.

The auditors also acknowledge that the EMA was still significantly affected by Brexit and was in crisis mode. The authority had moved from London to Amsterdam, and some of the staff had resigned or applied for leave. The crisis mode, which was aimed at maintaining operations, was maintained until the end of the pandemic.

How the auditors proceeded

The auditors were primarily interested in the measures taken by both agencies. For example, they spoke to employees of the ECDC and EMA and looked at public and internal documents. They also interviewed representatives of national health authorities and drug agencies.

“Particular attention was paid to the EMA’s process for evaluating COVID-19 vaccines,” it says. However, the Court did not assess whether the EMA’s recommendations were justified, “but only whether the EMA had carried out a thorough analysis in accordance with the agreed rules and guidelines.” © ggr/aerzteblatt.de