The two EU health agencies, while not ready for a pandemic of magnitude, responded to the best of their ability despite obstacles in the coordination with member states, concluded a report by the European Court of Auditors.
ADVERTISEMENTThe European Medicines Agency (EMA) and the European Centre for Disease Prevention and Control (ECDC) responded well to the COVID-19 pandemic, though some weaknesses need to be addressed with a view to a future health crisis, according to a report by the European Court of Auditors today (4 September).
As the Commission and the agencies are now implementing the lessons learned from the pandemic the report concluded “it is too early to tell whether this will be sufficient to prepare the agencies adequately for future public health emergencies.”
When COVID-19 was declared a pandemic in 2020 the ECDC and EMA had to adapt their work, reallocate resources and coordinate with 27 member states on how to respond to an unprecedented threat of a magnitude none of the agencies were ready to handle.
Four years later, the European Court of Auditors (ECA) analysed their response to the pre-pandemic strategies already in place and the initiatives born out of the crisis.
EU auditors identified that although the preparedness plans both agencies had in place were not ready for such a "severe and protracted pandemic, they responded as soon as its extent became clear.”
One of the main barriers identified by the ECA is the lack of quality data member states shared with the EU agencies which hindered their response by making it impossible to compare information such as the number of cases or causes of death.
At the beginning of the pandemic, ECDC’s monitoring was mainly based on the number of infections, hospitalisations and deaths reported by member states. However, according to EU auditors, data collection became challenging at the peak of the pandemic as member states' data systems were not harmonised.
According to the report, ECDC found that some countries significantly under-reported the number of infections and deaths, while others did not report any of the additional variables requested in the given deadline.
EU auditors identify the reasons for these inconsistencies as the “lack of any integration between national and EU systems” together with the increased workload on national and regional health systems.
Vaccine authorisation against the clock
The biggest challenge for the EMA was the authorisation and licensing of the COVID-19 vaccines. Due to time constraints, all vaccines and most treatments in the EU had to be approved under a centralised procedure, meaning that the EMA was responsible for the broad approval of the bloc.
Many were granted conditional marketing authorisations and were assessed under a rolling review procedure that allowed the agency to use data from ongoing trials, which sped the process up.
All these measures allowed vaccines to be approved for sale in the EU before or within days compared with third countries, EU auditors added. All COVID-19 vaccines were recommended unanimously and validated by the Commission within days of EMA’s recommendation.
“We compared the public and internal versions of public assessment reports and found no material omissions of public interest information about the safety and efficacy of the vaccines concerned,” added the report, recognising the transparency of the agency during the whole process.
Lessons learned
EU auditors asked the two agencies and the European Commission to improve coordination between themselves and with member states to facilitate information exchange and avoid work duplication.
Welcoming the report, ECDC noted that several improvements are already taking place as part of its reinforced mandate adopted in 2022 and at its own initiative.
ADVERTISEMENTLast year, the agency reviewed its public health emergency plan, which included better preparation for future protracted pandemics, and it is also supporting member states to improve the automation and digitalisation of their surveillance systems.
The European Medicines Agency also welcomed the ECA conclusions and added that it has committed to reviewing the criteria and processes for the implementation of rolling reviews in future public health emergencies to ensure that resources are used as efficiently as possible, given that during the COVID-19 pandemic this placed a significant pressure on the network’s resources.
As requested by the report, the EMA assured that it is committed to make its information more accessible to a wider audience, in particular for medicines of high interest during future public health emergencies.
A European Commission's spokesperson told Euronews that the European Health Union that was put in place since 2020 "clearly addresses the lessons learned from the pandemic, including strengthening the mandate of these agencies, as well as the coordinating role of the Health Security Committee."
ADVERTISEMENTThe spokesperson added that the Commission has several initiatives -the new Regulation on Serious Cross Border Health Threats and the proposed reform of EU pharmaceutical legislation- to "ensure that we can better respond to future crises and have more resilient health systems."
This story was updated to include the European Commission's reaction to the report.
