by Charlotte Renckens, Deputy Head of Unit, Directorate-General HERA, European Commission, Brussels
HERA, a new player in the global health security landscape
The recent pandemic is a stark reminder that the world is still not fully prepared for emerging infectious diseases, which are a constant threat. In fact, new diseases can emerge at any time, from anywhere in the world. And investing in health preparedness helps us to detect and respond to these diseases quickly and effectively. Climate change is also exacerbating health risks and increases the spread of diseases, such as malaria and dengue fever, while also causing more extreme weather events, such as floods and droughts, which can displace people and damage infrastructure, making it more difficult to provide healthcare services. In addition, the volatility of world events increasingly exposes large populations to health risks. For example, Russia’s war of aggression against Ukraine has displaced millions of people and disrupted access to healthcare.
Ensuring availability of medical countermeasures
The European Health Emergency Preparedness and Response Authority (HERA) was established in the aftermath of the pandemic, in October 2021, to better prepare for and respond to cross-border health threats. Since its inception, it has become clear that although the Covid-19 pandemic was declared over, there is still a lot of work to be done.
HERA strengthens Europe’s ability to prevent, detect, and rapidly respond to cross-border health emergencies. Its core mission is to ensure that the needed medical countermeasures are accessible and available in Europe. Medical countermeasures include vaccines, medicines, personal protective equipment, as well as chemical, biological, radiological and nuclear (CBRN) response equipment. And ensuring their availability starts with supporting the research and development phases.
To this end, HERA invests in the research and development of promising medical countermeasures. It has different funding options at its disposal, such as EU4Health, Horizon Europe, and HERA Invest. The latter is a €100m initiative that provides venture loans to small and medium-sized enterprises developing medical countermeasures to address the most pressing cross-border health threats. The purpose of HERA Invest is to strengthen Europe’s strategic autonomy in the field of health preparedness and response, by incentivising private investment in the development of medical countermeasures that may or may not prove successful.
But HERA’s efforts also cover other strands of work. As we know very well from the Covid-19 pandemic, vaccine production can be crucial to ensure an effective response. HERA’s initiative EU FAB works to ensure sufficient and agile manufacturing capacities for different vaccine types. The EU FAB network comprises vaccine producers in the EU (Belgium, Ireland, the Netherlands, Spain). These facilities are required to maintain a certain level of readiness, such as keeping their equipment up to date and their staff trained. Following the recognition of a public health emergency, HERA may decide to purchase vaccines and activate EU FAB. The EU FAB facilities will then rapidly start production and deliver the vaccines.
Equitable access and distribution of medical countermeasures
European solidarity means ensuring that all Member States can access medical countermeasures when needed. However, in reality, not all markets are always served, and prices may differ. On 24 October 2023, the Commission published a Communication [COM(2023) 672 final] on addressing medicine shortages in the EU. As an example of how to increase access to medical countermeasures, the Commission launches joint procurements, which allow EU countries to pool their purchasing power, and for HERA to negotiate contracts with pharmaceutical companies on behalf of the group. This can help to secure better prices and more reliable supplies of essential medicines and vaccines. In this way, for example, Member States purchased vaccines and medicines against pox viruses, which serve as a tool to respond to outbreaks of the mpox virus but can also be used in case of a re-emergence of smallpox, a major bioterrorism threat.
During emergencies, there often is not enough time to wait for scaled up production, or for procurement contracts to come to fruition. Upon its inception, HERA was allocated €1.2bn to establish stockpiles of medical countermeasures under the rescEU programme, for example to respond to CBRN events. The reserves contain personal protective equipment, vaccines, medicines, diagnostics and so forth. The stockpiles serve as a safety net and can be accessed by countries through the Union Civil Protection Mechanism (UCPM) if an event overwhelms the national capacity to respond. To support national stockpiling efforts, HERA is also exploring more innovative and sustainable ways of stockpiling and working with Member States.
HERA – a promising step forward
HERA’s response capacities have already been tested since the Covid-19 pandemic. Faced with the mpox outbreak in Europe, HERA purchased and rapidly deployed over 109,000 doses of mpox vaccines to EU Member States, Norway, and Iceland. This was the first time that the EU has directly purchased and donated vaccines to Member States. The vaccines were being used to protect people at risk of exposure to mpox. Next to the emergency donations of the vaccines, HERA initiated joint procurements for an mpox vaccine and a therapeutic, allowing Member States to build up their national reserves. The Commission also urgently purchased doses of the mpox treatment and holds them in a rescEU strategic reserve at the disposal of Member States in need.
Even if there is still a lot to be done, HERA’s establishment has already marked a significant step forward in the EU’s health preparedness and response capabilities. Only together can EU countries protect citizens from cross-border health threats. As such, HERA’s work is essential to safeguarding the health and well-being of European citizens.
Charlotte Renckens
is the Deputy Head of Unit of the Emergency Office of the European Commission’s Health Preparedness and Response Authority (HERA), a new organisation established after
Covid-19, aiming to ensure the availability and accessibility of medical countermeasures in the EU. Previously, Charlotte worked as a policy officer in the Commission’s counter-terrorism unit, where she worked on regulating chemicals that can be used as explosives precursors, and where she held the pen for the EU’s counter-terrorism strategy.
