EU medical agencies were not fully prepared, but responded appropriately

In a special report, the European Court of Auditors has assessed the response of EU health agencies to the COVID-19 pandemic. It is the first comprehensive review of the performance of the two agencies during a health crisis. The assessment by the Court of Auditors is twofold: Although the European Centre for Disease Prevention and Control (ECDC) and the European Medicines Agency (EMA) were not fully prepared for a prolonged pandemic, their overall response was appropriate. Both agencies had public health contingency plans that were immediately activated. However, these plans did not provide for any expansion of capacity in the event of a severe, prolonged pandemic.

Weaknesses

The ECDC "underestimated" the coronavirus outbreak in China for several weeks. The Court of Auditors ruled that the ECDC changed its assessment accordingly, based on additional information that became known. The ECDC provided guidance and support to Member States which, although not always available in a timely manner, was particularly appreciated in countries with limited scientific capacity. However, national decision-makers did not always follow the cautious recommendations. The judgement passed by the Court of Auditors on a very important challenge in the European Union (EU) is interesting. The data collected by the ECDC on the coronavirus and the pandemic experiences of the Member States were often not comparable.

The Court's assessment of the EMA's marketing authorisation and assessment of COVID-19 vaccines and therapies is interesting. With the support of the European Commission, the EMA used regulatory flexibility to speed up the assessment procedure for COVID-19 vaccines and therapies, in particular through resource-intensive "rolling reviews". Here, the approach "could have been applied more selectively", according to the Court of Auditors, as the rolling review was also applied to products that did not justify such a resource-intensive procedure.

Three recommendations

The Court makes three recommendations:

• The ECDC should continue to improve its internal organisation as well as its procedures, systems and publications in order to be better prepared for future health emergencies.
  
• The EMA should optimise its procedures and the dissemination of information in order to be better prepared for future pandemics.
  
• In cooperation with the ECDC and the EMA, the European Commission should clarify the respective responsibilities of the European Health Emergency Preparedness and Response Authority (HERA), the ECDC and the EMA and improve coordination.
  

The final report of the Parliament has the same message

In its final report of the special committee on findings from the COVID-19 pandemic and recommendations, the European Parliament also drew lessons for the future (COVI) (see news 07/2023). The crystal clear statement: The EU was unprepared for the COVID-19 health crisis. In the report, MEPs call for greater investment in healthcare and research & development, the introduction of monitoring plans for emerging health threats and ensuring the transparency of production and supply chains. It also aims to improve the strategic autonomy of the EU with regard to key pharmaceutical ingredients and medicinal products and to develop an EU strategy for combating long and post COVID. MEPs are also calling for a European day of remembrance for those who died during the COVID-19 pandemic.

Looking ahead

In response to the pandemic, important EU initiatives have already been taken in recent years, such as the legislative package on the European Health Union, the establishment of HERA and the pharmaceutical reform. The European Commission, the competent authorities as well as the Council and the European Parliament want to continue to learn the lessons from the pandemic. In the Court's view, it is still too early to judge whether these measures are sufficient to appropriately prepare the agencies for future public health emergencies.