Articol
Navigating global policy shifts: Insights from ISPOR Europe 2025
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Casper Paardekooper
The global healthcare landscape is undergoing tectonic shifts, driven by geopolitical and policy changes. Europe’s pharmaceutical industry finds itself caught in the middle of mounting pressures from U.S. healthcare policy changes and competition from China’s evolving pharmaceutical ecosystem.
At ISPOR Europe 2025, I had the privilege of moderating an educational symposium titled “Navigating Global Policy Shifts: Implications for Europe’s Pharmaceutical Pricing, Market Access, and HTA Landscape.”
The session drew over 300 participants and featured a fantastic panel of experts:
Together, we explored how global policy shifts are influencing Europe’s healthcare systems, the opportunities for Europe to adapt and thrive, and the need for collaboration to foster innovation in an increasingly complex landscape.
The session drew over 300 participants and featured a fantastic panel of experts:
- Neil Grubert, Independent Global Market Access Consultant
- Anja Schiel, Senior Advisor, Norwegian Medicinal Products Agency
- Christoph Glaetzer, Chief Global Value and Access Officer, Johnson & Johnson Innovative Medicine
Together, we explored how global policy shifts are influencing Europe’s healthcare systems, the opportunities for Europe to adapt and thrive, and the need for collaboration to foster innovation in an increasingly complex landscape.
Global policy shifts and their impact on Europe
U.S. policy trends: MFN pricing, the GENEROUS Model, tariffs, and direct-to-consumer platforms
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.
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’s role: Innovative contracting, accelerated approvals, and significant investments
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.
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.
Japan and the Middle East
Japan, once the second-largest pharmaceutical market, faces challenges in balancing cost containment with attracting industry investment. Meanwhile, the Middle East—particularly Saudi Arabia and the UAE—has emerged as a promising region for early drug launches, fostering innovation and expanding access to therapies. These developments add complexity to Europe’s competitive landscape.
Europe’s response: Balancing innovation and sustainability
EU General Pharmaceutical Legislation revision
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.
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.
EU HTAR: Harmonizing health technology assessments
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.
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.
Opportunities for Europe
Despite the challenges, Europe can emerge stronger by leveraging its strengths and adapting:
To capitalize on these strengths, Europe must modernize its value frameworks, accelerate innovation cycles, and foster deeper collaboration across borders and ministries.
- Universal healthcare systems: Europe’s commitment to universal healthcare provides a foundation for equitable access to therapies.
- Cross-border collaboration: Initiatives like Beneluxa and Nordic HTA partnerships are fostering regional alignment and knowledge sharing.
- Regulatory predictability: Europe’s stable regulatory environment makes it an attractive market for pharmaceutical investments.
To capitalize on these strengths, Europe must modernize its value frameworks, accelerate innovation cycles, and foster deeper collaboration across borders and ministries.
The ISPOR Europe 2025 symposium highlighted the urgency for Europe to adapt to global policy shifts while preserving its commitment to equitable and sustainable healthcare. Recognizing the societal value of healthcare innovation, not as a cost but as an investment, is crucial for driving progress. By modernizing HTA frameworks, accelerating access to innovative therapies, and fostering collaboration, Europe can emerge stronger, balancing cost containment with investment in innovation.
Want to dive deeper into these topics? Join us for our upcoming webinar, featuring the same panelists, where you’ll gain actionable insights into the future of pharmaceutical pricing, market access, and HTA in Europe. Register now to secure your spot and stay ahead of the curve in navigating global healthcare policy shifts.
Want to dive deeper into these topics? Join us for our upcoming webinar, featuring the same panelists, where you’ll gain actionable insights into the future of pharmaceutical pricing, market access, and HTA in Europe. Register now to secure your spot and stay ahead of the curve in navigating global healthcare policy shifts.
About the author:
Casper Paardekooper is Head of Pricing, Policy and Stakeholder Engagement, Europe at Cencora. Prior to this role, he has been responsible for the Life Sciences practice and the Value, Access & Policy Center of Excellence at strategic consultancy Vintura, for more than 10 years, where he focused on access policy, market access strategy, value demonstration and value-based healthcare in Europe. Casper is a trusted advisor to many large biopharma companies and brings more than 15 years of experience as strategy consultant in life sciences and healthcare.
Disclaimer:
The information provided in this article does not constitute legal advice. Cencora, Inc., strongly encourages readers to review available information related to the topics discussed and to rely on their own experience and expertise in making decisions related thereto.
*Sources continued below
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Sources
i. CMS - Centers for Medicare & Medicaid Services. GENEROUS (GENErating cost Reductions fOr U.S. Medicaid) Model. Accessed on November 28, 2025. https://www.cms.gov/priorities/innovation/innovation-models/generous
ii. CONGRESS.GOV. Trump Administration Tariff Actions (Sections 201, 232, and 301): Frequently Asked Questions. Accessed on November 28, 2025. https://www.congress.gov/crs_external_products/R/PDF/R45529/R45529.4.pdf
iii. Gene Online. China Unveils New Policy to Boost Innovative Drug Development and Market Access. Accessed on November 28, 2025. https://www.geneonline.com/china-unveils-new-policy-to-boost-innovative-drug-development-and-market-access/
iv. European Commission. Commission proposes Critical Medicines Act to bolster the supply of critical medicines in the EU. Accessed on November 28, 2025.
https://ec.europa.eu/commission/presscorner/detail/en/ip_25_733
