Navigating global policy shifts: Insights from ISPOR Europe 2025

Recent healthcare reforms in the United States are setting new benchmarks for global pharmaceutical pricing. The Most-Favored-Nation (MFN) pricing model, for example, aims to align drug prices across affluent countries. While this may lower U.S. costs, it could raise prices in Europe as manufacturers adjust their global strategies.

Another initiative is the GENEROUS Model (GENErating cost Reductions for U.S. Medicaid).ⁱ This five-year pilot program launching in January 2026 will align Medicaid drug prices with those in select countries, including Canada, Japan, Switzerland, and major European markets. While voluntary, the program may ripple through global pricing strategies, impacting access and affordability. On top of this, the U.S. is leveraging tariffs under Section 232 (national security) and Section 301 (unfair trade practices) to incentivize domestic drug production and pressure other governments to increase spending on innovative medicines.ⁱⁱ These policies, coupled with initiatives like direct-to-consumer drug distribution platforms, are reshaping global pharmaceutical supply chains and market dynamics in ways Europe must keep pace with.

China is emerging as a rising competitor, not through policy changes but by transforming its pharmaceutical ecosystem. The introduction of a Commercial Insurance List (Category C) allows high-cost therapies to gain market access through private insurance before transitioning to public reimbursement systems.ⁱⁱⁱ This approach enables innovative contracting methods and faster access to therapies.

China’s accelerated drug approvals, growing R&D capabilities, expanding clinical trial landscape, and streamlined reimbursement processes are attracting significant investment from multinational companies. This challenges Europe to remain competitive in securing investments and ensuring equitable access to therapies.

Europe’s revision of its General Pharmaceutical Legislation aims to address supply chain security, harmonize health technology assessment (HTA) processes, and foster innovation. The Critical Medicines Act, introduced alongside this revision, seeks to strengthen supply chains and promote solidarity among EU member states.^iv

While these efforts are essential for Europe’s competitiveness, the slow pace of implementation and fragmented approaches across member states remain challenging. To stay ahead, Europe must ensure these frameworks deliver predictability and transparency for stakeholders.

The EU Health Technology Assessment Regulation (HTAR), implemented in January 2025, represents a significant step forward. By introducing Joint Clinical Assessments (JCAs) for oncology and advanced therapy medicinal products (ATMPs), HTAR aims to streamline evidence generation and accelerate access to innovative therapies.

Still, challenges like methodological differences across member states and the need for contextualized decision-making persist. Full implementation across all drug categories by 2030 will require sustained collaboration and investment.