In September 2020, European Commission (EC) Chairwoman Ursula von der Leyen announced the launch of the European Health Emergency Preparedness and Response Authority (HERA) structure,[1] (Autoridad Europea de Preparación y Respuesta ante Emergencias Sanitarias, por sus siglas en inglés), and in February 2021,[2] what would be the basis[3] of this R&D initiative, which aims improve the response to global health crises, starting with the current one. Following public consultation in the spring, the EC is expected to make its proposal public tomorrow.
HERA is launched with the intention to remain in place after the COVID-19 pandemic, and with the aim of generating knowledge, and providing a permanent structure for risk measurement modelling, global surveillance, technology transfer, manufacturing capacity, supply chain risk mapping, flexible manufacturing capacity, and research and development of vaccines and medicines;[4] in other words, generating the knowledge and tools necessary to ensure that we can be more agile in dealing with potential future pandemics.
This is a timely and necessary initiative that will strengthen European R&D in global health and help achieve a better response to current and future pandemics. However, we are concerned that, once again, we are missing the opportunity to turn a structure that should serve the general interest into one that panders to the interest of the private sector and its particular needs. This has already happened with other initiatives such as IMI, where, despite repeated requests, and even recommendations through their assessments, they have shown the need for greater transparency in the selection of research priorities, as well as in their governance structures.
Therefore, in order to ensure that the public interest is included as a guiding principle of HERA, the following elements need to be introduced:
Firstly, it is essential for HERA to respond to the health needs of citizens and to make a commitment to innovation. Therefore, R&D agendas need to be aligned with these public health priorities and the needs of society.
Secondly, it is necessary for this structure to make science and innovation more accessible to the people, this being the core on which the programme is articulated and sustained. It is therefore crucial to allow independent science to guide the decision-making process.
Under this premise, it will also be essential to seize the opportunity and make all products, data and findings resulting from publicly funded research accessible public assets, so that all this investment is returned to society. This would make it possible to use public funding as a lever to guarantee the accessibility and affordability of the end products. Social return, accessibility, product suitability and affordability should be the key elements on which HERA is built.
Fourthly, results orientation should be the main framework on which HERA-funded initiatives are built and reported. In the same terms, their real impact must be assessed, with the aim of determining their scope and scale. This will require responsible and equitable planning and measurement of social and public health impact.
Fifthly, and in more practical terms, it will be essential to add clauses to funding to ensure accessibility and affordability of deliverables, as well as open access to data and know-how, preventing intellectual property from becoming a barrier to knowledge transfer.
Last but not least, it is essential to establish a transparent structure, with strong public governance and accountability mechanisms.
If Europe is to respond to cross-border global health crises in the future in an effective, mutually supportive and coordinated manner under the principle of general interest and public health, these proposals need to be included from the outset of HERA as part of its vision and mission.
Now is the time to do it.
[1] European Health Emergency Preparedness and Response Authority (HERA)
[2] In September 2020 Chairwoman Ursula von der Leyen announced the launch of HERA and on 17 February 2021 the HERA Incubator initiative
[3] communication-hera-incubator-anticipating-threat-covid-19-variants_en.pdf (europa.eu)
[4] Preparing Europe for the increased threat of variants (europa.eu)
