Welcomed as a much-needed addition to the European response to health emergencies, the Commission's proposal on HERA, the EU's new authority for countering cross-border health threats, still has much room for improvement. Critics object to its lack of ambition, limited transparency and insufficient independence, which some fear may lead to it caving in to the pharmaceutical industry instead of serving the public interest .
The Commission's proposal on the European Health Emergency Preparedness and Response Authority (HERA) was the focus of a hearing held by the European Economic and Social Committee (EESC) on 13 January.
It brought together representatives from European institutions, the WHO and civil society organisations active in the field of health, with the goal of scrutinising HERA's setup and mission. Takeaways from the hearing will feed into the opinion the EESC is preparing on the topic.
The pandemic revealed the need for better coordination to enable the EU and its Member States to tackle public health crises before, during and after they happen. HERA has been equipped to ensure efficient coordination of efforts and protect the health and lives of people living in the EU in the event of public health emergencies, rapporteur for the EESC opinion Ioannis Vardakastanis said.
The EESC is trying to evaluate if this new authority has been effectively designed to protect EU citizens from cross-border health threats and if it takes into account concerns of key stakeholders such as elected representatives, regional and public health authorities and civil society organisations, including patients' associations, equality organisations, as well as service providers, Mr Vardakastanis told the hearing.
The proposal on HERA was presented by Wolfgang Philipp from the European Commission, who said that the new authority would be closing some of the gaps that had become so apparent in Europe's response to the COVID-19 pandemic. It would also work on a pharmaceutical strategy for Europe and on preparing strategies for dealing with infectious diseases as well as all kinds of serious cross-border threats – whether they be chemical, biological or environmental in nature, and whether of accidental or intentional origin.
HERA is not just about dealing immediately with COVID-19; we are already working on a mid- and long-term strategy to cover other potential threats at EU level. This is all based on a modern system for epidemic intelligence and also supply chain intelligence, and the best possible threat assessments, in order to make sure that all needs are covered, Mr Philipp said.
While the participants in the hearing acknowledged HERA's added value for preparing for future threats, they voiced their concern over the insufficient transparency of its structure and decision-making processes, stressing that the authority would only serve its purpose if it was accountable to the public.
The proposed governance structure for HERA and the way it was set up already gave rise to some doubts and specifically to the concern that it would give precedence to the interests of the pharmaceutical industry instead of serving the public interest and acting globally.
We worry that HERA could become not a health but an industrial policy instrument hidden away in the Commission's structure. We see this as a real risk, as the Commission's proposal fails to guarantee proper public scrutiny. We believe that HERA's operations must clearly show that its primary objective is to improve public health and health security, and that it's not about economic considerations, said Piotr Kolczynski of the Standing Committee of European Doctors (CPME).
The HERA proposal envisages cooperation with the pharmaceutical industry via a joint Industrial Cooperation Forum. While acknowledging the importance of partnerships with industry given the nature of HERA's activities, there should be more balance between participation of industry and participation of civil society and other stakeholders' groups, said Rosa Castro, policy manager for the European Public Health Alliance.
It's very clear that industry has been given a permanent seat in HERA and that it will have a voice. But HERA and the EU should steer research and development that is patient-centric and that is driven by the needs of the public. HERA should have a clear mission that puts the public interest above everything and embeds it in all its activities, Ms Castro said, adding that, for example, it has to make sure that R&D programmes prioritise the most vulnerable populations and reach out to disadvantaged communities.
On the other hand, no permanent structure had been foreseen for the involvement of civil society and key stakeholder groups such as healthcare professionals' or patients' organisations in HERA. Civil society had participated in public consultations on HERA but its input remained limited to giving feedback. However, it should be ensured that such organisations are included in the governance and functioning of the new authority on a permanent basis, which would ensure its transparency and make it stronger.
HERA cannot be a coordination tool solely between the Commission and the Member States. And all the stakeholders involved cannot be reduced to the role of observer. The work required in preparing for and responding to crises has to be collective, stressed Christophe Clergeau, rapporteur for the Committee of the Regions' opinion on HERA.
Another objection to the HERA proposal was raised by Caroline Costongs, Director of EuroHealthNet – a European partnership of 64 organisations, agencies and statutory bodies working on public health. Ms Costongs said that HERA failed to provide for measures to strengthen public health systems, which are currently underfunded in all Member States and which are all lacking capacity to contribute to or even benefit from HERA's activities.
These measures need to help build the national and regional capacities for health protection, disease prevention and health promotion – which are all part of future crisis preparedness. However, the current recovery and resilience plans barely invest in public health capacities, as most funds go to hospital and medical infrastracture, Ms Costongs maintained.
According to EuroHealthNet, the HERA proposal should not be too narrowly focused on medical counter-measures. It should be more ambitious and include broader non-medical, more psychosocial approaches. In particular, it overlooks the mental health consequences of the crisis.
Recent statistics from Spain, as reported in the Spanish press, show that more people below 50 died of suicide than of COVID-19, Ms Costong stressed, adding that HERA must cooperate with mental health services and provide a truly coordinated and comprehensive approach, which requires cooperation with the social sector and long-term care services.
Participants agreed that HERA should have a clear global vision, meaning that it should contribute to ensuring equitable global access to medical technology, medicines and know-how.
'Global' doesn't mean Europe on one side and the rest of the world on the other side. 'Global' means that European citizens live within the very same world as other citizens, said Elise Rodriguez of Global Health Advocates, an NGO battling health inequalities through political advocacy.
In Ms Rodriguez's view, HERA should not follow in the footsteps of BARDA, its US counterpart on which it was modelled and which during this pandemic provided significant funding for vaccine companies without obliging them to ensure vaccine access for the rest of the world.
We don't want HERA to become 'Europe first' only, but rather to have a 'public health first' approach that is deeply needed to combat future health threats, Ms Rodriguez stressed.
Concluding the hearing, Mr Vardakastanis said:
Cross-border health threats must be dealt with through collective action that is well coordinated and that brings together all stakeholders without exclusion. We all have a role to play here.
The EESC's opinion on HERA will be debated at its plenary session in March.