- The EU’s medical agencies were not fully prepared for a protracted pandemic
- They nevertheless adapted and responded well to the COVID-19 crisis
- Attempts to boost health crisis readiness further need to stand the test of time
The health crisis caused by the COVID-19 pandemic caught the EU partially off guard. Even though the two EU medical agencies in charge of the situation eventually did well, the pandemic also highlighted shortcomings and gaps that recent EU measures have sought to address. However, according to a report published today by the European Court of Auditors, it is still premature to regard the EU as fully prepared to tackle major public health emergencies.
The two EU medical agencies – the European Centre for Disease Prevention and Control (ECDC) and the European Medicines Agency (EMA) – were on the front line of the COVID pandemic response. However, the auditors note that the ECDC initially under-estimated the seriousness of the situation, having considered the likelihood of the virus being introduced into the EU as low. It only recognised the need for “immediate targeted action” as late as 12 March 2020, three days after Italy declared a national lockdown.
“Like many other bodies, the EU’s medical agencies were overwhelmed by the force and speed of the COVID-19 pandemic”, said João Leão, the ECA member responsible for the audit. “Four years later, the lessons learned must be effectively applied at EU level so that history doesn’t repeat itself.”
The ECDC did start to collect data on the pandemic, but the number of reported infections was highly dependent on individual member states’ testing strategies. This was also true of the way deaths were attributed to COVID-19. The EU auditors emphasise that more reliable techniques, such as analysing virus concentrations in wastewater, could have been used more often. In addition, the risk assessments, guidance and public information that the ECDC issued sometimes came too late (e.g. guidance on face masks and contact-tracing only came in April-May 2020, i.e. towards the end of the first wave). The auditors also highlight the fact that several countries did not heed the ECDC’s advice, as illustrated by prolonged travel restrictions which the Centre did not consider effective.
For its part, the EMA adapted quickly to the situation, note the auditors. In the early stages of the pandemic, the Agency reached out to potential developers of vaccines and treatments, and took several other measures to speed up the authorisation process. The auditors also found that the EMA helped to counter medical shortages during the pandemic. The only real issue was that the EMA was unsuccessful at promoting EU clinical trials.
Drawing on the lessons learned from the early stages of the pandemic, the European Commission adopted a series of decisions and plans. The ECDC’s and the EMA’s mandates have been clarified and strengthened, while proposals to revise the EU’s pharmaceutical legislation aim to speed up the authorisation processes for new medicines. Such measures certainly fill some of the gaps in the EU’s capacity to respond to health emergencies. However, the auditors warn that the upshot has been a more complex organisational framework. HERA, the Health Emergency Preparedness and Response Authority, was set up in 2021 to oversee the development, production and distribution of medicines, vaccines and other products when an emergency strikes. The issue is that some of HERA’s responsibilities and powers are similar to those of the ECDC. The auditors therefore call for close cooperation so that work is not duplicated unnecessarily.
Background information
The mission of the European Centre for Disease Prevention and Control (ECDC) is to identify, assess and report current and emerging threats to human health from communicable diseases. It had a budget of €61 million in 2020 and €90 million in 2023. The European Medicines Agency (EMA) is responsible for the scientific evaluation of applications for centralised marketing authorisations of medicines. The EMA had a budget of €358 million in 2020 and €458 million in 2023. Both agencies are responsible for the European Economic Area (EEA), which consists of the 27 EU member states plus Iceland, Liechtenstein and Norway.
This audit is part of a series of reviews and audits carried out by the ECA on the EU response to the COVID-19 pandemic, including special reports on EU COVID-19 vaccine procurement, Food safety during COVID-19 and the EU Digital COVID Certificate.