Salud por Derecho welcomes the Council conlusions calling on the European Commission to keep health as a priority in the next five-year term. Although the key areas of focus for strengthening the European Health Union are indeed relevant, we want to make our contribution regarding the “evaluation of the post-pandemic EU health emergency governance framework “1, in particular, the review of operations of the Health Emergency Preparedness and Response Authority (HERA). After the failure of the negotiations of the Pandemic Treaty to reach a conclusion before the 2024 WHA General Assembly, it is important to strengthen the pandemic prevention, preparedness and response (PPPR) in the region, for which HERA is an important actor.
Established in 2021 as a pillar of the European Health Union, the review of HERA presents therefore an important opportunity to assess the extent to which its mandate and tools have contributed to strengthening health emergency preparedness and response in the region. Our input is divided into 5 points that touch upon HERA’s performance, gaps, structure and governance, scope of mandate, tools and resources, complementarity, and status.
STRENGTHENING GOVERNANCE FOR PUBLIC HEALTH: INTEGRATING TRANSPARENCY AND ACCOUNTABILITY INTO HERA
Transparency, good governance, and accountability must form the cornerstone of HERA’s operational framework. It is imperative that HERA functions as a robust and independent public authority, with transparent public health missions, and maintains accountability, especially during emergencies. Moreover, stakeholder engagement, including civil society, healthcare professionals, and researchers, should be integral to HERA’s operations.
The current governance system lacks sufficient transparency and clear stakeholder involvement beyond information exchange in setting HERA’s priorities, as well as during the development of activities. It is crucial to formally incorporate stakeholders into HERA’s governance structure. These stakeholders, devoid of commercial interests, should participate in periodic reviews of HERA’s priorities to ensure alignment with public health needs and prevent any undue influence from the industry.
Regarding private actors, HERA should ensure complete transparency regarding its interactions, including contracts, meetings, and input received. Additionally, parliamentary scrutiny is essential for HERA, similar to agencies like the European Medicines Agency (EMA), to enhance accountability and democratic oversight.
PRIORITIZING PUBLIC INTERESTS: ENHANCING HERA’S ROLE IN ADDRESSING NEGLECTED HEALTH AREAS
Mechanisms must ensure that public investments remain aligned with public interests and that neglected areas receive the necessary support. A research agenda prioritizing public interests is crucial, requiring transparent, participatory, and globally aligned research priority-setting mechanisms, along with flexible instruments and a dedicated budget to promote it.
Specifically, HERA should enhance its role in antimicrobial resistance (AMR) research and development (R&D) by ensuring that all supported products adhere to robust conditionalities based on public interests. These conditionalities should encompass a global access plan, transparency measures, and affordability considerations. Drawing from international experiences, HERA should incorporate a public and transparent stewardship and access plan akin to that of CARB-X. Additionally, HERA should foster partnerships with initiatives like the Global Antibiotic Research and Development Partnership (GARDP) or the Global Accelerator for Paediatric Formulations (GAP-f), which address critical biomedical R&D gaps.
While HERA has contributed to neglected tropical diseases (NTDs) through partnerships such as CEPI, access to NTD treatments must transcend EU-centric biosecurity logics. Global access plans are imperative for deploying these tools in endemic countries. There is a pressing need for HERA to play an expanded role in addressing NTDs, benefiting both the global community and the European population, particularly amid shifting disease distribution patterns due to climate change. To fulfill this purpose, HERA should engage as both a contributor and coordinator, strengthening ties with systems integrators such as the Drugs for Neglected Diseases Initiative (DNDi).
MITIGATING PUBLIC HEALTH CHALLENGES BEYOND EMERGENCIES AS A PREVENTION STRATEGY
To expand the mandate beyond health emergencies in a proactive manner, HERA should address various challenges beyond immediate crisis response. These challenges include tackling anti-competitive practices, preventing the abuse of dominant market positions, and mitigating unjustified high prices that may impede Member States’ ability to effectively address public health issues, including health emergencies. Such challenges could result in shortages, substantial impacts on public budgets, and potentially lead to future health crises.
Moreover, from a crisis preparedness perspective, HERA should proactively address situations where monopolies are established over breakthrough technologies, such as critical platforms like mRNA technology, which may be essential in responding to acute crises. Anticipatory action by HERA before crises occur is crucial. In times of crisis, flexibility and adaptability are paramount. Therefore, an overly strict definition of health technologies within or outside HERA’s scope may hinder effective responses to emergent challenges, as unconventional commodities or procedures not traditionally considered indispensable may play vital roles.
The scope of health emergencies should not be restrictive and include, for instance, ‘major events’ as recognized by the Commission [Article 4 (3) of Regulation (EU) 2022/123]. HERA can significantly contribute to achieving its mission and address a wide range of access issues related to the affordability and accessibility of products. By broadening its scope, it can be better prepared to effectively tackle emerging challenges and ensure the timely availability of essential medical products and technologies to safeguard public health.
ENSURING ACCESSIBILITY AND AFFORDABILITY: SAFEGUARDING PUBLIC INVESTMENT RETURNS WITH HERA
HERA must ensure the accessibility and affordability of the outputs it supports through a clear access and intellectual property (IP) management framework. Global lessons underscore the necessity of conditioning funding to guarantee public returns. Safeguards must be in place to ensure public investment returns, affordability, and equitable access to medical countermeasures.
HERA should commit to principles that serve the public interest, including transparency, global access plans (particularly for Low- and Middle-Income Countries), open data, knowledge and technology transfer, accessibility strategies such as non-exclusive licensing, and building upon alternative innovation models to the current market and Intellectual Property Rights (IPR)-dominated model. In that sense, HERA Invest and other related R&D investment endeavors should be designed with these principles from the beginning, in order to avoid downstream access issues.
In this regard, a clear global vision is essential for HERA to lead effective global action in health emergencies. Transparent global supply chains and mechanisms for global access to medical tools are imperative to combat vaccine, diagnosis, and treatment inequities and enhance pandemic response. Thus, purchase and supply agreements and advanced market commitments, such as those concluded in Q2/Q3 2022, should be governed by strict transparency.
HERA should treat health technologies resulting from public investments as global public goods. For this purpose, HERA should support both patent pool platforms, such as the Medicines Patent Pool, as well as sustainable not-for-profit manufacturing infrastructure at the EU level, in coordination with current proposals being debated at the European Parliament, such as the European Medicine Facility.
Cooperation with non-commercial research institutions can enhance coordination and transparency in clinical trials, both independent and commercial, and research and development (R&D), in alignment with existing initiatives such as EDCTP3
GLOBAL COLLABORATION FOR HEALTH EQUITY: EMPOWERING LMICS THROUGH HERA’S INITIATIVES
One of the defining elements of many public health emergencies or crises is their globalized nature, which transcends national boundaries. If HERA wants to be adequately prepared for emergencies, the most effective, efficient, and socially just approach is to take proactive steps to enable and empower LMICs outside the Union before a crisis occurs, rather than reacting after the fact. Therefore, HERA should also facilitate sustainable, public-health-driven regional production partnerships with these countries, enabling them to better address future crises. This benefits not only the EU but the global community as a whole.
Recent Team Europe Initiatives such as MAV+ may not be sufficiently innovative to achieve this objective, as they rely on market and IPR logics that have not proven effective during past health emergencies. Therefore, HERA should be considered other measures that facilitate technology and knowledge transfer and the scaling up of local production capacities.
Additionally, HERA should learn from past experiences during COVID-19 or MPOX procurement agreements to prevent situations of health technology hoarding, which directly affects global availability during times of limited supply and leads to unnecessary loss of life-saving technologies in the long run. In preparing for future emergencies, HERA should ensure that measures for equitable access are in place for initiatives such as the EU-FAB network, aligning with a comprehensive approach to trans-boundary emergencies and the guiding principle 2 of the European Global Health Strategy. This effort is not only about global justice; it should also be understood as a public health imperative for the EU region in an interconnected world where everyone’s health and safety depend on ensuring that no one is left behind.
