The European Commission launched HERA, a new authority to ensure preparedness and response to future health emergencies within the Union.
The European Commission launched HERA, a new authority to ensure preparedness and response to future health emergencies within the Union.
COVID-19 caught Europe and many other regions of the world by surprise. They were not prepared and struggled to find enough protective equipment, ventilators and medication to treat seriously ill citizens. Only due to a huge ad-hoc effort and investment, it was possible to fight the disease, gear up research and develop vaccines in a very short time. Already in mid-2020, it thus became clear in the EU that such a situation must be avoided in the future by all means; and steps will need to be taken towards better preparedness and response to health emergencies.
These steps towards more preparedness culminated in the launch of a new European Health Emergency Preparedness and Response Authority (HERA), presented by the European Commission (EC) as a Communication to the European Parliament (EP) and the Council on 16 September. HERA shall serve to prevent, detect and rapidly respond to health emergencies by anticipating threats through intelligence gathering, by building the necessary response capacities, and by ensuring the production and distribution of relevant medical countermeasures. HERA will work on two different levels, before crises with preparedness and during a health crisis with emergency responses.
In the preparedness mode, HERA will work with other EU institutions such as the European Medicines Agency (EMA) and the European Centre for Disease Prevention and Control (ECDC) and national health agencies and the industry to improve the readiness for health emergencies. Threat assessments, modelling to forecast outbreaks and supporting research and innovation including clinical trials for the development of new medical countermeasures will be among HERA’s main activities. Together with industry, HERA will address market challenges and boost capacity in order to avoid manufacturing or supply chain bottlenecks in the case of an emergency. In the crisis mode, HERA can switch to emergency operations, which will allow for fast decisions and the activation of emergency measures such as funding, monitoring, targeted development, procurement and purchase of medical countermeasures. In this mode, HERA will operate under a high-level Health Crisis Board with the President of the EC at its helm, and can profit from the EU FAB facilities, a network of ever-warm production capacities for vaccines and medicines. This will also include the generation of an inventory of facilities, raw materials, equipment and infrastructure.
HERA will be closely linked to research and innovation. It builds on the HERA Incubator, which was launched under Horizon Europe in February 2021 with the aim to tackle new variants of the COVID-19 causing virus SARS-CoV2. The Incubator brought together science, industry and public authorities for clinical trials and vaccine production, and consortia also include partners from Switzerland. Part of HERA’s budget will continue to stem from Horizon Europe next to contributions from the EU4Health Programme. The group of Commissioners overseeing HERA will consequently also include Mariya Gabriel, Commissioner for Innovation, Research, Culture, Education and Youth, next to Commissioners Schinas, Kyriakides and Breton. At the launch event, Mariya Gabriel called “research and innovation a central piece in HERA as the new authority sets out to promote and support the development of medical technologies and their production”.
HERA’s launch was announced in the State of the Union Address (SOTEU) of Commission President Ursula von der Leyen on 15 September. It will be a key pillar of the European Health Union, introduced on the same occasion the year before. For the coming years from 2022-2027, HERA will benefit from a budget of €6 billion, which will stem from the Multiannual Financial Framework (MFF) and the Next Generation EU recovery funds. Additional funding will come from other EU programmes such as the Recovery and Resilience Facility, REACT-EU, Cohesion Funds, the INvestEU Programme and the Neighbourhood, Development and International Cooperation Instrument, enlarging the total financial envelope to almost €30 billion. HERA will not become an agency of its own; it will be set up as an internal EC structure, in order to ensure a fast launch and full operations by the start of 2022. The respective Council Regulation on a framework of medical countermeasures for public health emergencies will be discussed and adopted by the Council over the upcoming months. A first call for the EU FAB to vaccine and therapeutics manufactures will be launched in early 2022.