Market Access Think Tank

As Europe moves forward with major legislative reforms affecting the biopharmaceutical industry and global drug pricing pressures continue to rise, life sciences companies must adjust their market access strategies. The EU Pharmaceutical Package and the proposed Critical Medicines Act point to significant changes in incentives, expectations around supply security, and pricing dynamics. This session will explore these related legislation as well as the industry’s response.

• Assessing how the EU Pharmaceutical Package may change incentives, regulatory protections, and pricing frameworks
• Examining how evolving EU legislation could affect reimbursement negotiations and national market access pathways
• Exploring practical approaches to maintaining competitive and sustainable market access, in light of regulatory and geopolitical volatility

Most Favored Nations Pricing (MFNP) proposals in the United States, combined with expanding International Reference Pricing (IRP) regimes in Europe, are intensifying global pricing pressures and reshaping launch strategy. Policymakers seek to benchmark prices across borders and manufacturers face growing uncertainty about how U.S. pricing reforms may impact world markets.

• Analysing how renewed U.S. MFNP proposals could discourage or delay U.S. pharmaceutical manufacturers from launching products in Europe
  • Assessing the added layer of complexity tariffs introduce into already strained pricing and supply strategies
• Examining the impact on high-demand therapeutic areas such as GLP-1 medicines
• Considering how pricing decisions in one major market can cascade globally, affecting launch sequencing and long-term revenue strategy

With the first Joint Clinical Assessments (JCAs) underway, stakeholders are beginning to see how the EU HTA Regulation operates in practice. This session will move beyond theory to examine early implementation experiences, practical challenges, and emerging areas for refinement.

• Case studies and practical takeaways from the first JCAs, including timelines, scientific dialogue, and dossier preparation challenges
• Analysing how EU-level clinical assessments are influencing (or not influencing) national pricing and reimbursement outcomes
• Highlighting diverging perspectives from industry and Member States on efficiency, added value, and administrative burden
• Understanding what guidance or structural adjustments may be needed as implementation expands to additional therapeutic areas

As the EU HTA Regulation and Joint Clinical Assessments begin operating alongside national pricing and reimbursement processes, there are greater coordination demands, increased scrutiny of evidence, and tighter timelines.

This practical, industry-focused session will move beyond policy discussion to provide concrete guidance on how to navigate the operational and strategic realities of an HTA assessment.

• Building evidence generation plans early to align clinical development with EU HTA expectations
• Managing parallel EU-level and national procedures without duplicating effort or creating inconsistencies
• Structuring dossiers effectively and avoiding common procedural pitfalls
• Ensuring strong coordination between regulatory, market access, and HEOR functions
• Planning launch sequencing and timing in light of JCA outcomes and national reimbursement pathways

Public procurement mechanisms are increasingly central to access, pricing pressure, and supply resilience. With the proposed Critical Medicines Act, the EU is signaling a shift toward embedding security of supply, diversification, and strategic autonomy directly into procurement frameworks.

• Analyzing how the Critical Medicines Act may reshape procurement criteria to prioritize resilience, diversification, and security of supply
• Highlighting the interaction between EU and national procurement law, competition rules, and industrial policy objectives
• Reviewing the potential shift from lowest-price criteria to broader “most economically advantageous tender” approaches
• Understanding the implications for manufacturers’ market access and supply chain strategies

Pricing and reimbursement outcomes in Europe are shaped by a complex mix of HTA conclusions, national budget constraints, political priorities, and cross-border price referencing. While attention often focuses on the five major EU economies, lower-priced and mid-sized markets can significantly influence broader European pricing dynamics and global launch strategy.

• Reviewing how HTA outcomes translate into real-world pricing and reimbursement decisions across Member States
• Highlighting key differences among the five major European economies and how their approaches compare with lower-priced markets such as Poland, Romania, Greece, Portugal, and Slovakia
  • Assessing the strategic relevance of additional regional blocs, including the Benelux countries, Scandinavia, and the Baltics
• Understanding how lower-priced markets can influence international reference pricing baskets and broader European price corridors
• Practical best practices for engaging with national pricing and reimbursement authorities