eEUView - PUBLIC HEALTH
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The fight against the COVID-19 pandemic has highlighted the need and urgency for Europe to have rapid reaction mechanisms in place to protect its citizens. The 2019 coronavirus has highlighted the discrepancies in assessments between the 27 countries, both of the threat to health and of the measures to be taken to help citizens. For this reason, the EU has passed three Regulations. One to broaden ECDC's mandate, another to address major cross-border threats to health and the third to tackle emergencies together. To ensure that the EU now has the tools it needs to better prepare for and respond to public health emergencies.​

Brussels, 4 January 2023
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With the entry into force of the new rules, Europe has a strong legal framework to enhance EU capacity in the key areas of prevention, preparedness, surveillance, risk assessment, early warning and response.
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EU regulation on serious cross-border threats to healt

The COVID-19 pandemic has demonstrated that the EU's mechanisms for managing health threats suffer from general weaknesses, which make it essential to adopt a more structured approach at EU level in order to deal more effectively with future health crises.

​Calls were made for a more coherent and coordinated approach to EU health crisis preparedness and management.

The provisions on health safety, established by decision no. 1082/2013/EU on serious cross-border threats to health, provided a limited legal framework for coordination at EU level, based essentially on the Early Warning and Response System (EWRS) as well as on the exchange of information and on cooperation in the Health Security Committee.

​The first lessons learned from the COVID-19 pandemic have shown that previous provisions were not sufficient and for this reason a new Regulation has been adopted by EU.

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The new Regulation grants:
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• sound preparedness planning and a more integrated surveillance system;
• improved capacity to ensure accurate risk assessment and targeted response;
• robust joint procurement mechanisms for the procurement of medical countermeasures;
• the possibility of adopting common measures at EU level to address future cross-border threats to health.

EU regulation expanding the competences of the European Center for Disease Prevention and Control (ECDC

The founding Regulation of the ECDC Center had to be modified to ensure consistency with the other new Union instruments and with the new Regulation on serious cross-border threats to health.

Now the Center is tasked with providing epidemiological information and related analyses, epidemiological modelling, anticipation and forecasting, relevant risk assessments and recommendations, setting out options for the prevention and control of communicable diseases.

Its actions will be consistent with a "One Health" approach, ie one that recognizes the interconnections between human and animal health and the environment. The Center will have to monitor the capacity of national health systems to respond to threats related to communicable diseases, as it is useful for the purposes of national preparedness and response plans.

​The Center will support the implementation of actions funded by relevant Union funding programs and instruments and related to communicable diseases.

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 It will provide guidance for treatment and case management through an assessment of the latest data and support Member States' efforts to respond to outbreaks and outbreaks in Europe and in third countries, including on the ground. Furthermore, the Center shall promptly provide the public with objective, reliable and easily accessible information on communicable diseases. The Center will also have to establish clear procedures for cooperation with public health operators in third countries and with competent international organizations in the field of public health, thus contributing to the EU's efforts to strengthen preparedness and capacity for partner response.

This Regulation introduces operational procedures that are in line with the general objectives of the Union, including a stronger Health Union, a well-functioning internal market, complementarity with the EU Civil Protection Mechanism, sustainable health systems and resilient communities and an ambitious research and innovation agenda. There will be input and synergies with the EU agenda for the Digital Single Market and the future European Health Data Area, including by encouraging innovation and research, facilitating information sharing (including real-time data) and promoting the development of an EU-wide IT infrastructure for epidemiological surveillance and monitoring.
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Ultimately, the Regulation makes ECDC stronger and will be able to issue recommendations to Member States on preparedness for health threats, host a new EU Reference Laboratory Network of Excellence and set up an EU Health Task Force to rapid interventions in case of serious outbreaks.

​EU regulation on a framework of measures to ensure the provision of crisis-relevant medical countermeasures in the event of an EU-wide public health emergency

To ensure effective operations and actions in times of public health emergencies, the new Regulation now allows for the establishment, within HERA, of a Health Crisis Council which will rapidly coordinate at EU level the provision of medical countermeasures and the access to them.

​The regulation also provides for the activation of the mechanisms foreseen under "EU Fab" and emergency research and innovation plans as well as access to emergency funding.

In summary, the Regulation provides:

• the establishment of a health crisis council to ensure coordination and integration of approaches to medical countermeasures of crisis relevance at Union level in the event of a public health emergency
• Establishing mechanisms for monitoring, triggering emergency funding, procurement and purchasing of raw materials and crisis-relevant medical countermeasures, including rapid and robust assessment of supply chains and capacity productivity of the producers, possibly also through site visits before the conclusion of a preliminary purchase agreement or an innovation partnership;

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• the activation of mechanisms envisaged within the EU Fab in order to make available additional production capacity reserves to guarantee the supply of raw materials and medical countermeasures relevant to crises;
• the activation of contingency research and innovation plans in consultation with Member States and the use of clinical trials networks, as well as arrangements and platforms for rapid data sharing at Union level; and
• measures concerning the production of crisis-relevant medical countermeasures, including the establishment of an inventory of the production and production facilities of these countermeasures, and of the raw materials, consumables, devices, equipment and infrastructure of relevance to crises, including measures to increase its production in the EU.

​Conclusions

Now the EU has an organization and tools that should limit the damage of epidemic waves, with the benefit of citizens and national medical structures.
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The three Regulations apply without transposition into national laws, but Member States have to put in place all internal procedures with administrative implementing provisions.

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