Building on the lessons learnt from the COVID-19 crisis, including the slow pandemic response, on 16 September the European Commission presented a communication on HERA, the European Health Emergency preparedness and Response Authority, the “missing block” of the European Health Union, as Vice-President Schinas defined it. HERA is set to turn ad-hoc mechanisms deployed during the pandemic into permanent structures for the EU to better respond to and prepare for cross-border health emergencies, while ensuring access to medical countermeasures, including vaccines, antibiotics, and therapeutics. In this article we analyze HERA’s structure, its functioning and the next steps ahead.
THE BACKGROUND & STRUCTURE
What was initially meant to be the EU counterpart to the US Biomedical Advanced Research and Development Authority (BARDA) and a new standalone EU agency, turned out to be a dedicated central structure within the Commission.
This twist might appease member states’ concerns, as some – most notably of France, Denmark, and Spain – had warned the Commission against duplication of competencies and tasks between HERA and existing EU agencies like the EMA and the ECDC. At the same time, as the Commission aims to make HERA fully operational as of early 2022, it consciously avoided getting into changes of the legislative framework for building a fully-fledged agency from scratch. As Health Commissioner Kyriakides put it, “we needed HERA yesterday”.
In terms of its structure, HERA will be led by a board composed of Member States and the Commission, which will define its annual work program and coordinate actions. Pierre Delsaux, currently Deputy Director-General at DG SANTE, was appointed as acting Director-General. To the disappointment of many, the Parliament will be only invited as an observer. The Commission highlighted the importance of dialogue between HERA and national authorities, as well as with the industry – identified as a key partner – following the increased cooperation during the pandemic.
HERA will have two different operational modes and powers depending on whether addressing preparedness or crisis times. During the preparedness phase, HERA will be focusing on assessing health threats and intelligence gathering and analysis; supporting the development of countermeasures; ensuring production; facilitating procurement, stockpiling, and distribution of medical countermeasures; and supporting capacity building in member states.
What stands out is HERA’s role in promoting advanced R&D, notably through EU-wide clinical trials for vaccines and therapeutics. In addition, HERA will ensure the availability of scalable manufacturing capacities to produce countermeasures in the EU, notably through strategic alliances with industry, new industrial partnerships, mapping of supply chains, and allocating around €120m to EU FAB (an emergency response production capacity). Finally, following the success of COVID-19 vaccines procurement, HERA will promote wider use of joint EU-level procurement.
During the crisis phase, HERA will establish a health crisis board, composed of the Commission and one representative from each member state to coordinate crisis urgent actions. The crisis mode would allow HERA to trigger:
- the monitoring of crisis-relevant medical countermeasures;
- their procurement, purchase and manufacturing (notably, giving the Commission a negotiating mandate to act as a central purchasing body and the responsibility to activate the EU-FAB facilities);
- emergency research and use of EU-wide clinical trial networks and data-sharing platforms;
- inventory of production facilities as well as raw materials and devices;
- measures to secure the availability and supply of medical countermeasures (such as facilitating the licensing of intellectual property and know-how as well as implementing procurement initiatives, reserving stockpiles and production capacities).
Finally, HERA will also act at an international level to reinforce access to EU-funded medical countermeasures as well as development, threat assessments, surveillance, and capacity building in third countries.
THE OPERATIONAL BUDGET
HERA will start with €6bn, from the EU’s current multiannual budget, over a 6-year period, up to 2027. Its budget is equivalent to that of BARDA, according to Vice-President Schinas. The additional budget will be drawn from private and national funding. In total, €30bn will go toward emergency preparedness through other programs, namely the Civil Protection Mechanism and Horizon Europe. During the crisis phase, the Council can trigger funding from the Emergency Support Instrument.
This amount might increase, as Ursula von der Leyen referenced in her State of Union Speech “a new health preparedness and resilience mission (…) backed up by Team Europe investment of €50 billion by 2027.”
In terms of the next steps, the measures related to the crisis response mode will now have to be discussed and adopted by the Council. In the longer term, HERA will be reviewed on an annual basis until 2025, when a full review will be carried out.
Next Monday, HERA will also be presented to the European Parliament’s ENVI Committee. Leading MEPs are expected to continue expressing their disappointment for the European Parliament being excluded from negotiations and scrutiny, as well as from the decision on triggering the emergency framework. However, according to Health Commissioner Kyriakides, the Parliament is included in the process, notably by having to vote HERA’s budget. Despite that, the call of MEPs and civil society to ensure that conditions are attached to the allocation of HERA’s funding are likely to continue.
Despite some of these short-term challenges, HERA represents a unique opportunity to advance European science, build stronger public-private partnerships and support a more unified approach in EU health policy. At Edelman, we believe it will be critical for organizations active in the health space (and beyond) to understand how to contribute to the ever-evolving EU health policy agenda, adapt their priorities, and refine their public affairs and communication strategies. If you are interested in discussing this in more detail, then get in touch.
by Dafni Kachrila Skouteli, Account Executive at Edelman Brussels.