Brussels – A substantial promotion, but not with flying colours. That’s what emerges from the European Court of Auditors‘s assessment of the work of the Union’s health structures during the Coronavirus emergency, the title of which seems quite telling: “EU medical agencies need to be immunised better.” The Luxembourg-based body notes in its report how, although their work was satisfactory, the bloc’s two main health agencies were caught off guard by the outbreak of the pandemic from COVID-19, which exposed “shortcomings and gaps” that Brussels has since tried to remedy. However, without fully succeeding.
According to the Court’s report published Wednesday (Sept. 4), in short, “it is still premature to regard the EU as fully prepared to tackle major public health emergencies.” The Luxembourg auditors focused mainly on the European Medicines Agency (EMA) and the European Center for Disease Prevention and Control (ECDC). According to their assessment, ”
the ECDC initially under-estimated the seriousness of the situation, having considered the likelihood of the virus being introduced into the EU as low”, recognising “the need for immediate targeted action” only on March 12, 2020, that is, three days after our country had already entered lockdown.
João Leão, the ECDC member responsible for drafting the report, acknowledged that EU medical agencies were not the only ones who were “overwhelmed by the force and speed of the COVID-19 pandemic” but added that now “lessons learned must be applied effectively at EU level so that history does not repeat itself.” Among the major difficulties encountered by the ECDC, especially at the outset, was the absence of a standard methodology at the level of the Twenty-Seven to track the spread of COVID-19—both for mapping infections and counting deaths.
The court pointed out that “more reliable techniques could have been used more often” and that the ECDC, in several situations, moved too late in disseminating “risk assessments, guidance and public information.” However, even when the Centre’s recommendations arrived, the states deliberately chose to ignore them, for example, in the case of travel restrictions that the ECDC had deemed substantially ineffective. The court’s judgment on EMA, however, is more positive. The report says that even 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” while also helping “to counter medical shortages” in the later stages of the emergency. “The only real issue,” the analysis continues, “was that the EMA was unsuccessful at promoting EU clinical trials” in the Union territory.
Now, in an attempt to close the gaps that have emerged, the European Commission has clarified and strengthened the mandates of both bodies—as well as their budgets, which have been increased from €61 million in 2020 to €90 million in 2023 for the ECDC and from €358 million to €458 million for the EMA. At the same time, Brussels has also initiated legislative proposals to reform EU pharmaceutical legislation to accelerate authorisation processes to approve new medicines. However, the Court warned, as much as the new measures may go to remedy the issues highlighted, the risk now is that the regulatory and organisational framework has become “more complex”. For example, the establishment in 2021 of the Health Emergency Preparedness and Response Authority (HERA) to oversee the development, production, and distribution of medicines, vaccines, and other products in emergencies ended up at least partially duplicating the functions and responsibilities of the ECDC.
English version by the Translation Service of Withub
