Divergent views clashed prominently between Americo Zampetti, the EU Delegation’s Minister Counsellor for Global Health, and MEP Tilly Metz (Greens/EFA) during the December 8, 2025, European Parliament SANT committee meeting. Their debate centered on the WHO Pandemic Agreement’s Annex on Pathogen Access and Benefit Sharing (PABS), with Zampetti advocating an open access policy for pathogen samples linked to voluntary benefit-sharing contracts, warning that conditional access could deter R&D efforts. In contrast, Metz pushed for mandatory prior benefit-sharing and enforceable tracking to ensure equitable global access and transparency, coupling concerns with criticism of the opaque WHO negotiation process.
The meeting occurred amid ongoing negotiations for the Annex expected to be adopted by May 2026. The session also encompassed a public hearing on antimicrobial resistance (AMR), including scientific challenges, innovation ecosystems, regulatory hurdles, and EU policy frameworks, concluding with rare-disease research ecosystem issues.
Zampetti called for a narrowly scoped Annex geared towards adoption and pragmatic implementation, citing geopolitical pressures such as U.S. bilateralism that could undermine a broad or conditional Annex. Prof. Maurizio Scarpa proposed structural reform in rare-disease research, advocating for a "28th regime"—a novel multinational clinical trial framework—and mandatory interoperability between European Reference Networks (ERNs), registries, and genomic initiatives, aiming for long-term sustainability and funding guarantees.
On AMR, experts like Prof. Emmanuel André and Dr. Frank Smrekar pitched detailed policy innovations: Dr. Smrekar pushed for platform-based authorization schemes and guarantee funds for bacteriophage therapies, while Louise Norton-Smith highlighted the need for mixed push–pull incentives, harmonized valuation metrics, and subscription models to revive antibacterial R&D. Meanwhile, some MEPs, such as Vytenis Andriukaitis (S&D) and Stine Bosse (Renew), endorsed scaling EU financial support and regulatory reforms but focused more on advocacy than numeric targets or binding deadlines.
The policy orientations reveal a cleavage between increasing EU-level institutional oversight and the necessity of trade-offs for political feasibility, with Zampetti favoring streamlined, enforceable measures that maintain flexibility. Metz and others align more with strengthening sovereignty of WHO mandates via binding conditionality and enhanced transparency to safeguard equitable benefits. In AMR, policy framings split between strengthening regulatory supervision and incentive structures targeting innovation, versus calls for expanded surveillance and inclusion of agriculture and environmental concerns.
Stakeholders impacted include EU regulatory bodies, which would see gains in clearer mandates and enforcement tools under a focused PABS Annex but face challenges in balancing geopolitical constraints. Pathogen sample suppliers and researchers confront trade-offs between access openness and benefit-sharing obligations, affecting research incentives. In AMR, pharmaceutical and biotech SMEs stand to benefit from innovative push–pull incentive schemes but require stable funding and clearer regulatory paths, while EU consumers potentially gain from accelerated antibiotic innovation. Conversely, industries like pig and poultry farming may confront increased scrutiny and operational adjustments due to antibiotic usage concerns highlighted.
Next steps likely involve EU institutions refining their negotiation mandates for the PABS Annex to reconcile geopolitical complexities with equity goals, while advancing trilogue discussions centered on pharmaceutical incentives and the Biotech Act to bolster AMR innovation and rare-disease networks. The European Parliament’s emphasis on pragmatic, fiscally sustainable measures signals ongoing engagement balancing ambition with political realism in these high-stakes health policy domains.