The European Parliament's Committee on Public Health (SANT) witnessed pronounced differences mainly between Kateřina Konečná (Non-Inscrits) and supporters like Marta Temido (S&D) and Stine Bosse (Renew) on the oversight and governance of the Health Emergency Response Authority (HERA). Konečná sharply criticized the current arrangement where HERA operates within the European Commission, lamenting a lack of parliamentary scrutiny over significant expenditures approaching €30 billion and calling for a possible upgrade to a full EU agency by 2025. In contrast, Temido and Bosse acknowledged HERA's strategic value and advocated for strengthening agency cooperation, although they recognized complex internal coordination and communication challenges.
This debate unfolded during the SANT committee meeting on December 1, 2025, covering multiple healthcare themes including agency governance, rare diseases, disabled cancer survivorship, and newborn screening harmonization.
Concrete proposals emerged notably on rare diseases and newborn screening. Sophie Turner and Vytenis Andriukaitis pushed for a coordinated EU Action Plan with ring-fenced funding extending to 2034. Technical experts like Joke Wuyts and Annabelle Calomme recommended creating mandatory interoperable registries using standard codes to address diagnostic delays and treatment access disparities. On newborn screening, Thomas Minten presented measurable targets including implementing EU-wide evidence assessment structures, Joint Action Plans, and training funded by the EU, estimating costs at €50–150 per newborn, totaling about €300 million annually. These detailed plans illustrate a move towards greater EU integration and EU-level coordination to reduce national disparities and improve patient outcomes.
Conversely, some MEPs provided less detailed statements emphasizing the importance of addressing administrative inefficiencies or broader communication improvements without specifying concrete measures. For instance, Marta Temido endorsed enhancing communication channels and integrating One Health approaches without detailed implementation steps.
The debate revealed key cleavages including calls for increasing HERA’s institutional strength and transparency versus retaining it as a Commission service; the push for a binding, well-funded EU rare disease plan versus concerns about feasibility and national sensitivities; and harmonizing newborn screening across member states to reduce disparities versus respecting national sovereignty and budgetary constraints.
Impacts vary widely among stakeholders: EU regulatory bodies face pressure for enhanced transparency and accountability mechanisms, while national authorities might grapple with ceding some sovereignty and adapting to EU-wide standards. Patients and healthcare providers in the rare disease sector could benefit from improved diagnostic timeliness and equitable treatment access, though health systems might incur administrative and operational costs to comply with new data and screening requirements. Industry could see shifts due to patient-led governance and early dialogue rules, with potential impact on innovation incentives.
Looking ahead, these discussions are likely to feed into forthcoming SANT reports and amendments on discharge files and rare diseases. The Parliament appears poised to pursue stronger EU coordination mechanisms while balancing oversight demands and member state prerogatives, signaling ongoing debates about integration depth and governance models in EU health policy.