What HERA could mean for global health security

The European Commission’s new Health Emergency Preparedness and Response Authority, or HERA, has received mixed reactions from authorities and health experts since its launch. Some think it’s a “huge asset” for the European Union to address future health threats, while others question its ambition and the exclusion of the European Parliament in its creation. But for global health experts and members of civil society who’ve seen inequities in access to COVID-19 vaccines and other products amid the pandemic, a key question for the new entity is how will it ensure global access to “medical countermeasures” — medicines, vaccines, diagnostics, and other medical supplies to be used in a public health emergency — to benefit not just Europe but globally. What the EU says A European Commission official told Devex that “HERA will not succeed if it becomes a European silo. Or if it works for Europe first. If HERA’s outlook is not global, it will not deliver on its mission.” The official said COVID-19 has “clearly demonstrated that unilateral responses to health emergencies are limited not only in reach but also in results,” and that among the responsibilities HERA has is to cooperate with “global actors to ensure availability and access of needed medical countermeasures both for the Union and for third countries,” during a health emergency. But there are questions among global health experts and civil society members on how that will be practiced. “If the EU wishes for HERA to become a truly global project, it will need to treat the results of the activities it funds as global public goods.” --— Rosa Castro, manager, European Alliance for Responsible R&D and Affordable Medicines HERA in a nutshell HERA was designed to equip the European Union with the tools, mechanisms, and adequate resources to be better prepared in case of another health emergency. It has a preparedness and emergency phase function, and a governance structure that includes a board composed of one representative per EU member state, the European Commission, and an observer from the European Parliament. This is different from the Health Crisis Board that can be activated during an emergency, which has a more expanded membership that involves other European Union bodies such as the European Medicines Agency and the European Centre for Disease Prevention and Control, and potentially other experts. HERA will have a budget of €6 billion ($7.05 billion) from the 2022-2027 Multiannual Financial Framework. But other EU funding sources such as the InvestEU Programme, the Neighbourhood, Development and International Cooperation Instrument, and individual EU member states, are also expected to contribute to EU health system preparedness and resilience efforts. European Commission officials clarified that HERA is not an agency. The proposed regulation put forward to the European Council last week is meant to give HERA “extra powers” in case of a health crisis. When the European Commission, in consultation with member states, decides — independently of the World Health Organization, although a European Commission official said “constant connections with WHO will be ensured” — to declare a serious cross-border health emergency in the EU, that regulation, if adopted, allows the European Council to activate an emergency framework, which allows HERA to carry out a number of measures. These include the establishment of a Health Crisis Board; the procurement, purchase, and manufacturing of “medical countermeasures” and raw materials; the establishment of an inventory of production facilities for “crisis-relevant medical countermeasures”; and the activation of emergency funding. “HERA will not succeed if it becomes a European silo. Or if it works for Europe first. If HERA’s outlook is not global, it will not deliver on its mission.” --— A European Commission official What’s the issue then? HERA has been likened to the Biomedical Advanced Research and Development Authority, or BARDA — an agency under the U.S. Department of Health and Human Services that invested billions in private sector companies to advance the research and development of multiple COVID-19 vaccines and other medical technologies. But Rosa Castro, manager at the European Alliance for Responsible R&D and Affordable Medicines, speaking in an individual capacity, said though BARDA provided significant funding to vaccine companies, allowing them to de-risk their investments, it did not include clear obligations for companies to ensure access to the vaccines for the rest of the world. “The US BARDA prioritised ‘America First’ and has faced problems with the lack of incorporation of access clauses in contracts negotiated with pharmaceutical companies,” she said. “If the EU wishes for HERA to become a truly global project, it will need to treat the results of the activities it funds as global public goods.” The inclusion of access clauses in contracts with private companies would help protect the public’s interest, Castro said. For example, clauses ensuring medical countermeasures are affordable, accessible, and available; introducing open access and open data requirements; and prioritizing public ownership, control, and management of resulting Intellectual property rights when possible. “Unfortunately, there are no indications that these recommendations will be considered,” she said. “If anything, it seems that the proposal is prioritising a sense of urgency … So I doubt that specific clauses will be used in the contracts with manufacturers in the absence of a clear mandate to do so.” Suerie Moon, co-director at the Global Health Centre at the Graduate Institute of International and Development Studies in Geneva, said, overall HERA’s establishment is a “positive development for Europe.” But HERA needs to collaborate with — instead of competing against — other entities such as BARDA and Coalition for Epidemic Preparedness Innovations that are already in the global ecosystem and are funders of medical countermeasures. Why it matters According to a data analysis conducted at the Global Health Centre, European countries funded about 60% of CEPI’s investments in COVID-19 vaccine research & development. If HERA and CEPI were to adopt common policies on access, such as shared conditions on their funding, this could strengthen both parties’ negotiating power with the pharmaceutical industry, she said. “But if HERA and CEPI and BARDA, for example, compete against each other for candidate technologies from private firms, they'll undermine each others' negotiating leverage,” she said. “For this reason, negotiating [an] agreement on common international rules that all major countermeasure R&D funders will abide by is essential — it can make collaboration the smarter and feasible choice for all, rather than the counterproductive competitive dynamic we've seen in Covid-19,” she added.