Considering the significant weaknesses in health systems and lack of European level coordination exposed during the COVID-19 crisis, in September the European Commission launched the executive and regulatory package putting in motion the European Health Emergency Preparedness and Response Authority’s (HERA). The future HERA will provide health security governance at EU level and is the core pillar of the so-called European Health Union announced in November 2020.
A super authority for European-level management of health emergencies
The Commission’s Communication envisages an agency that ‘strengthens Europe’s ability to prevent, detect, and rapidly respond to cross-border health emergencies, for example by ensuring the development, manufacturing, procurement, and equitable distribution of key medical countermeasures.
The Commission acknowledges that the lack of coordinated response against COVID did come with a human and economic cost across the continent. To avoid this from happening again, the core mission of HERA will be:
- To strengthen health security coordination within the Union during preparedness and crisis response times, and bring together the Member States, the industry, and the relevant stakeholders in a common effort.
- To address vulnerabilities and strategic dependencies within the Union related to the development, production, procurement, stockpiling and distribution of .
- To contribute to reinforcing the global health emergency preparedness and response architecture.
The Commission aims for HERA to have a broad mandate to act in two stages:
1) in the preparedness phase, HERA’s competences shall include five tasks on intelligence monitoring, production, stockpiling and distribution capacity of medical countermeasures, general capacity building, response planning, and training. The Communication explains each of these areas in detail.
2) in the crisis phase, the Commission will inform the Council about the need to respond to the crisis with EU level action. The Council has received a “Proposal for a Regulation on a framework of measures for ensuring the supply of crisis-relevant medical countermeasures in the event of a public health emergency at Union level”, which will grant additional powers to HERA through swift emergency measures such as: the establishment of a Health Crisis Board to coordinate urgent action; monitoring mechanisms; the procurement, purchase and manufacturing of crisis-relevant medical counter measures and raw materials needed to address the crisis; the activation of EU FAB facilities to make available reserved surge manufacturing capacities for vaccines and medicines; emergency research and innovation plans; inventory of crisis-relevant medical counter measures production facilities, and emergency funding.
To conduct these activities, HERA will be allocated an indicative budget of 6 billion EUR until 2027, drawn from various instruments of the Multiannual Financial Framework (MFF), such as the EU4Health programme, Horizon Europe, and the Union Civil Protection Mechanism.
It is important to note that, unlike EU agencies which are typically decentralised, HERA is planned to be established as an internal structure of the European Commission Directorate General for Health and Food Safety (DG SANTE). Such structure has two setbacks: the first is that not being conceived as an agency, HERA will have a less prominent role than previously announced by the Commission. The second is that the European Parliament will not have a word on how HERA era is built nor its mandate during an emergency, because the European Commission proposal for a Regulation on HERA will be adopted on the legal basis of article 122 of the Treaty of the Functioning of the European Union (TFEU), where Commission asks the Council to intervene in emergency cases without involving the Parliament.
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What about patients?
The resulting European Commission Communication launching HERA follows an open public consultation over the first half of 2021 and in which EFA participated. In our response, we welcomed the initiative for a strong and well-equipped HERA to centralise and help coordinate efforts otherwise disperse, and as a body who will truly act as a ready coordinator for a quick and accurate response in times of health emergencies without borders.
From a preparedness point of view, EFA is glad to see a focus on climate change-related challenges too, including those related to Chemical, Biological, Radiological and Nuclear (CBRN) threats. The fact that HERA is born with the ambition to at least conduct threat assessments and intelligence gathering on an exhaustive list of health threats such as “globalisation, climate change, natural and man-made disasters, biodiversity loss, habitat encroachment as well as armed conflicts and terrorism” is very welcomed by our patient community.
Accordingly, we hope that HERA’s monitoring competences will help establish a much-needed early warning system that will enable prevention and anticipation of future cross-border health threats related to climate change, such as wildfire smoke, volcano gases, extreme weather events such as temperature rise and flooding. It will also consider the consequences of biodiversity changes and loss, such as increased (foreign species) pollen counts, all having a severe and widespread impact on the airways of people exposed, in particular those with allergies or allergic asthma.
Regarding management of ongoing crises, EFA emphasised the need to improve the EU framework to prevent health risks and supply chain disruptions of medicines and medical devices, which were not avoided during the COVID-19 pandemic and impacted patients. Moreover, in our response to the mid-term evaluation of the 3rd EU Health Programme, EFA regretted the insufficient action that the European Commission had developed to address cross-border healthcare threats.
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HERA as a health emergency coordinator - Relations with EMA, ECDC, and stakeholders
The European Commission Communication goes beyond simply establishing HERA, as the creation of the new authority responds to the need for better coordination of EU existing bodies such as the European Medicines Agency (EMA) and the European Centre for Disease Prevention and Control (ECDC). How do they collectively fill the existing gaps and complement each other?
While the Commission acknowledges the efforts of EMA and ECDC during the COVID-19 crisis, it nevertheless notes their limited mandate and tools. These have been proposed to be strengthened with the European Parliament and Council amending Regulation (EC) No 851/2004 establishing a European Centre for disease prevention and control and the Regulation of the European Parliament and Council on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices. These proposals are currently at the co-decision procedure stage at the European Parliament and the Council.
HERA will complement this scenario with a broad range of complementary powers to provide added value:
- Compared to the ECDC, who mainly does surveillance and collects data, HERA will have a stronger anticipatory and response-focused dimension in terms of threat assessments.
- EMA’s advice on the safety, effectiveness and quality of medical products will be a key input to HERA’s much broader work on development and production capacities, stockpiling and deployment of vaccines, therapeutics, and diagnostics. For example, HERA will address market challenges and failures and boost the Union’s open strategic autonomy. It will therefore coordinate EU and Member State efforts to reduce supply risks, secure resilient supply chains and excessive external dependency, and to increase potential production capacity, Member States and their citizens will get access to vaccines, therapeutics and diagnostics earlier and at a greater scale.
The proposal’s Annex offers a comparative overview of the competences of the three main health agencies (EMA, ECDC, and HERA) both at the preparedness and the crisis phase.
In our response to the consultation on HERA, EFA highlighted the key role of coordination between HERA and existing structures in health policy, such as EMA and ECDC. With regards to EMA, we suggested synergies on promoting research and planning on the development and supply of medical countermeasures, also during non-emergency time, for example by supporting scientific research and fostering large-scale trials. Therefore, we are glad to see the plans of HERA to work with EMA in the context of European clinical trial networks, such as the first EU-wide network for COVID-19 vaccine trials (VACCELERATE).
Moreover, EFA has expressed its request that HERA engages closely with stakeholders through mechanisms that ensure input from civil society and citizens, in particular patients. Regarding the kind of health emergencies we have experienced, and are likely to experience, patients with allergies, asthma and COPD are among the first affected either through exposure to environmental threats or like with COVID-19, at risk of adding to their chronic respiratory disease a severe infectious episode. Therefore, we are ready to support HERA’s Advisory Board in its crucial mission to be a forum of information exchange, coordination and setting jointly preparedness priorities, and to bridge our members, who are in direct contact with patients with allergy and respiratory diseases, to European level action and information.
What’s next?
HERA is expected to become operational in early 2022 and EFA is looking forward to see it alive and to inform and support its activities. But this must be two ways. The EU needs a modern agency with structures and support for involvement of patients and citizens groups. For this, it can follow the example of the EMA.
Links
Find European Commission information establishing HERA, here.
Read EFA's response to the consultation here.
You can check the timeline here