The European Commission has unveiled the first building blocks of a broader health package aimed at increasing the range of preparedness tools to respond to future cross-border health threats.
The package presented on Wednesday (11 November) consists of a draft regulation on serious cross-border threats to health and a proposal to extend mandates of both EU’s infectious disease (ECDC) and medicines (EMA) agencies.
More proposals within the framework of this plan, like the much-awaited EU’s beating cancer plan and the new pharmaceutical strategy, are set to be disclosed in the coming weeks.
Under the new proposed rules, the EU agency for infectious diseases control will be able to declare an emergency situation at the European level triggering the emergency response mechanisms.
The response to such threats will be strengthened by national pandemic preparedness plans that member states will develop with the support of the EU’s health agencies, which will be ultimately audited and stress-tested by the EU executive.
In case an outbreak of a communicable disease is reported, a new EU health task force within the ECDC will be deployed to member states as well as to third countries to assist local response.
“With today’s proposals, we are taking the first steps towards the European health Union, giving us stronger legislation to act and support member states in situations of serious cross border threats to health,” said Health Commissioner Stella Kyriakides.
Carrot without stick
As health competence is currently in the hands of member states, the whole regulation is mostly based on non-binding recommendations.
“We are able to propose the health union package respecting the treaty and this needs to be clear,” Kyriakides pointed out.
When it comes to risk management, the proposed rules can only offer options to member states and they merely stick to enhancing coordination of the national measures during outbreaks.
Asked why member states should follow what the EU is recommending under the European health union framework, Kyriakides said the ECDC’s proposals will be translating into concrete advantages for the citizens when implemented.
“I am optimistic that member states will be looking at this step as a step forward in the right direction,” she added.
However, the EU has already often experienced failures in the management of the first wave of the COVID-19 pandemic, which resulted in an uncoordinated response across the bloc.
According to Kyriakides, stronger EU agencies will mean more coordination and real-time reaction.
The reinforcement of the agencies will cost €605 million in the forthcoming seven-year budget and will include the hiring or new staff members for the ECDC (73), the EMA (40) and the Commission’s DG SANTE (21).
The news comes after the European Parliament has reduced cuts to the EU4Health Programme for strengthening the resilience of health systems.
The ECDC’s mandate will be reinforced with the capacity to mobilise and deploy EU Health Task Force to assist local response in member states, while EMA will monitor and mitigate the risk of shortages of critical medicines and medical devices.
Before unveiling the health package, the Commission has confirmed having authorised a contract for up to 300 million doses of the vaccine developed by BioNTech and Pfizer.
All clinical observations on vaccines will be properly addressed once the authorisation request is submitted, said Kyriakides, adding that, although respecting concerns in relation to side effects and length of duration, all vaccine candidates need to go through the EMA’s scrutiny.
For the Health Commissioner, having the vaccine by the end of 2020 and early 2021 is the “positive scenario.” “But the whole world is watching, so you can have twists and turns,” she added.
Speaking of the COVID-19 mutation in minks that is also transmitted to humans reported in Denmark, she said the Commission is following the situation extremely closely and expects a risk assessment from the ECDC over the next days.
[Edited by Zoran Radosavljevic]