Pinpointing possible market challenges inside the health industry and taking action to redress failures before they develop into vulnerabilities is a key part of HERA’s mission. By planning ahead, we ensure that critical medical countermeasures are available when and where they need to be, supply chains are secured, and the EU’s capacity for self-sufficiency and independence are enhanced.
Identifying critical production facilities and increasing production in times of need
HERA carries out mapping and monitoring of supply chains, manufacturing capacities, and ever-warm production sites to identify critical production sites in advance of future health emergencies – ensuring that key industrial capacities are secured and operational when a crisis hits.
In 2023, a first step was taken towards this goal with the launch of the EU FAB network, a group of vaccine manufacturers in the EU with sufficient and agile manufacturing capacities that will be able to quickly produce essential vaccines in the event of a health emergency.
The objective of EU FAB network is to:
- Close the gap between manufacturing and scaling up of vaccine production
- Ensure the capacity of the industry to produce life-saving medicines
- Reserve manufacturing capacities
- Obtain a priority right for manufacturing of vaccines in case of a future public health emergency
The EU FAB network comprises vaccine producers in the EU (Belgium, Ireland, the Netherlands, Spain), which will cover manufacturing capacities for mRNA, vector-based and protein-based vaccines. Its members are responsible for ensuring that facilities, staff and supply chains are maintained to enable them to quickly start manufacturing at the request of the Commission. The EU FAB will have the capacity to produce up to 325 million vaccines per year, within the EU.
Following the recognition of a public health emergency, the Commission decides to purchase vaccines and activate EU FAB. The EU FAB facilities will then rapidly start production and deliver the vaccines according to the deadlines set in the purchase contracts.
Identifying bottlenecks and market failures
HERA works to identify supply chain bottlenecks both within and outside the EU, as well as market failures that could limit production capacity of medical countermeasures and raw materials during a health crisis, including through collecting feedback from industry via the Joint Industrial Cooperation Forum.
Working with industry to address supply chain dependencies and supporting breakthrough innovation
HERA cooperates closely with industry to address bottlenecks and supply chain dependencies within and outside the EU, shoring up vulnerabilities and helping channel finance towards projects that strengthen the availability and accessibility of medical countermeasures to all citizens.
In April 2024, following the October 2023 Communication from the Commission on addressing medicines shortages in the EU, HERA and the Belgian presidency of the Council launched the Critical Medicines Alliance.
The Alliance serves as a consultative mechanism uniting essential stakeholders from EU Member States, key industries, civil society, and the scientific community. Its primary objective is to identify critical areas and priorities for action, proposing solutions that bolster the supply of vital medicines within the EU, and enhancing efforts to prevent and effectively address shortages.
- Factsheet: Critical Medicines Alliance
HERA is also supporting research and development of new medical countermeasures and the scaling-up of cutting-edge solutions in health and life sciences through HERA Invest, the first European health investment fund to specialise in this area.
With EUR 100 million dedicated to support innovative SMEs in the late phases of clinical trials, HERA Invest makes it easier and safer for European companies to invest in high-risk market areas, ensuring that financing is channelled towards projects that strengthen EU health security and open strategic autonomy.
The first HERA Invest agreement was signed on 7 October 2024, with HERA committing EUR 20 million to support the French biopharmaceutical company Fabentech in the development and deployment of broad-spectrum therapeutics aimed at combating biological threats to public health. Additional investments in other European companies are expected, to strengthen Europe’s preparedness and capacity to manage future health crises.
Building closer partnerships
HERA works to set up new industrial partnerships between key operators in the field of preparedness and organises pan-European matchmaking events for economic operators across the EU.
In addition, HERA aims to establish closer linkages with and build further on the outcomes of relevant programmes and initiatives such as IPCEI Health and EU FAB, strengthening the cooperative EU framework for preparedness actions.
