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Vulcan Insight | EU Health Union: A Commission rethink on health crisis response

In the wake of the COVID-19 pandemic, the European Commission proposed on Wednesday to create a European Health Union to better equip the EU for the prevention, preparation and management of health crises. In its communication, the Commission said that in order to save lives and livelihoods it would push for a more resilient EU internal market and a sustained economic recovery.

The draft proposal, which follows on from the State of the Union address by the President of the European Commission Ursula Von der Leyen in February, recommends a reinforced framework for cross-border cooperation against all health threats and to strengthen the EU’s role in international coordination and cooperation to prevent and control these threats and improve global health security.

The Commission’s proposal centres around the need for greater autonomy in declaring an emergency and having more control over the measures taken to save lives. Currently, the EU’s response apparatus can only be triggered in response to the declaration of a Public Health Emergency of International Concern (PHEIC) by the World Health Organisation (WHO). Once triggered, the EU has no powers to enforce the recommendations of the Health Security Committee (HSC), the informal advisory group comprising national health authorities created in 2001 to better coordinate preparedness measures across the Union. Consequently, the Commission propose to enforce a coordinated EU-level response in the HSC with the idea that the European Centre for Disease Prevention and Control (ECDC) would provide targeted recommendations on response measures. The resulting recommendations adopted by the HSC would then be implemented within member states. The Commission also proposes amending the legal framework to allow for the recognition of an emergency at EU level without the WHO PHEIC declaration on the basis of the advice of an independent Advisory Committee.

Once the Commission has triggered a health emergency and the member states are ready to implement the decision of the HSC, the EU’s response hits a snag – the lack of an effective mechanism and structure to have an overview of the demand and supply of critical medical countermeasures and to monitor and support member states in addressing those shortages. To address these issues the Commission proposes a reinforced joint procurement agreement beyond the EU and a suite of measures requiring EMA oversight, specifically;  a permanent EU Executive Steering Group on the shortages of medicines and on medical devices; a permanent EMA emergency Task Force; new EMA Expert Panels on high risk medical devices; a stronger EU clinical trials infrastructure; and the creation of a vaccine monitoring platform. The Commission has also proposed that the Early Warning Response System (EWRS), the EU’s rapid alert system for serious-cross border threats to health, be broadened to include the need for or shortages to medical countermeasures, as well as request, or indeed offers, for cross-border emergency assistance.

The Commission’s vision is broad and constitutes a major re-think in how Europe should be better prepared to address crises like COVID-19. As well as proposing updates to preparedness & response planning and reporting, which includes an EU audit of national capacities to ensure the optimal use of financial support through the EU4Health programmes, as well as the Structural Funds and the support of HorizonEurope, the Commission proposes reinforcing the ECDC by upgrading its surveillance systems and improving national surveillance systems via the upcoming EU4Health programme. The Commission has also turned its attention to improving the coordination for the consolidated microbiological testing standards. A key pillar of this is the controversial use of contact tracing, which poses questions of data protection and privacy. Accordingly, the Commission propose that the ECDC be given the mandate to create an automated system for contact tracing.

What is becoming apparent is that the protection of lives and livelihoods require a lasting solution, in the case of COVID-19: a vaccine. This is why the European Commission wants an EU Health Emergency Preparedness and Response Authority (HERA) to enable the EU and its members to rapidly deploy the most advanced countermeasures to face off a health emergency by covering the whole value chain from conception to distribution and use. To achieve this, HERA will conduct horizon scanning to anticipate threats, identify promising countermeasures, and in the age of disinformation, generate and disseminate knowledge of these responses.

Looking beyond its borders, the Commission propose the creation of an ECDC EU Health Task Force to assist local response outbreaks of communicable diseases within the EU and in third countries. This new task force is expected to contribute to international response teams mobilised by the WTO and others.

If acceptable to the European Parliament and Council, the Commission’s proposal will see the EU acquire greater competence in responding to continental and global health crises.

Compliments of Vulcan Consulting – a member of the EACCNY.