Moving from Rhetoric to Reality on Europe's HERA Health Crisis Center

Things have got a bit more interesting this month with the European Union's new health innovation center for combating health crises, which has now published a work program for 2022, announced a $6.5 billion budget, and issued a raft of invitations to submit research projects.

When this column wrote about the Health Emergency Preparedness and Response Authority (HERA) last August, the message was mainly at the political level—about how Europe was going to plan its way to better resilience against health crises. HERA's mission was glowingly—indeed breathlessly—described as "to support the development of cross-cutting technologies and solutions sustaining multiple potential future threat responses (e.g., vaccine platform technologies, or the application of digital tools and artificial intelligence) as well as the development of specific countermeasures, including through clinical trials and data infrastructure." But it was a bit short on detail.

That has changed as from mid-February. Of the $1.5 billion, nearly a quarter million has been allocated for projects that promote advanced R&D of medical countermeasures and related technologies, and a similar sum for "addressing market challenges and failures"—shorthand for subsidizing research in needed areas.

A priority is to develop or adapt the already-authorized vaccines against COVID-19 variants. Ten contracts have been signed to date. Equally important is the plan to boost the therapeutics portfolio against COVID. The European Commission recently concluded two framework contracts for the acquisition of monoclonal antibodies with Roche for Ronapreve (a combination of casirivimab and imdevimab) and with GlaxoSmithKline for Xevudy (sotrovimab). Discussions with other companies are ongoing for other promising COVID therapeutics, such as oral antivirals from MSD and Pfizer, says the EU. And calls for project proposals have already been issued for more than a dozen R&D areas.

Work is expected to start this year, with deliverables in 2023 on "preclinical development of the next generation of immunotherapies for diseases or disorders with unmet medical needs"—with a budget of $35 billion, and for developing the next generation of vaccines, with a similar budget. The same levels of funding are available for new methods for "the effective use of real-world data and/or synthetic data in regulatory decision-making and/or in health technology assessment," and for "scaling up multi-party computation, data anonymization techniques, and synthetic data generation."

Projects under the Innovative Health Initiative (which has superseded the European public-private partnership known for the last decade and a half as the Innovative Medicines Initiative) and under the European partnership with developing countries on clinical trials qualify for tens of millions of dollars in support. And there is also handsome provision for support to a coalition for epidemics preparedness, for R&D on pandemic preparedness on hypothesized pathogens, for setting up a "European smart health innovation hub," and a European partnership on "transforming health and care systems."

Materials science also gets a look-in, with projects on smart and multifunctional biomaterials for health innovations and 2D materials-based devices and systems for biomedical applications also standing to receive tens of millions more. Coordination of a large-scale EU platform for multicenter clinical trials and data platforms, support for Phase III clinical trials for selected vaccines/therapeutics,and funding for research into "options for implementing a flexible (multi-technology) EU manufacturing and innovation capacity for vaccines and therapeutics" are also in the work program.

And as befits an initiative aimed at countering future health threats, attention is also devoted to antimicrobial resistance (AMR), with funding provided for an AMR technology review, a gap analysis on AMR medical countermeasures brought to market, new technologies with breakthrough potential, and a needs assessment in the EU member states and among stakeholders. In the same vein, preparations are to be supported for a feasibility study on stockpiling of medical countermeasures in the area of resistant SARS-CoV2, pandemic influenza, AMR, emerging infectious diseases such as certain viral haemorrhagic fevers, and vector-borne diseases.

Altogether, a healthier picture than six months ago—but a prompt to check back later in 2022 to see just how much is happening to turn the rhetoric to reality.