Listen to Our In-Depth Interview

The global pharmaceutical world is being reshaped by two powerful and divergent regulatory forces. In this crucial interview, we explore the significant changes sweeping the industry in 2025, driven by the US "America First" agenda and the EU's ambitious "Pharma Package." Press play to understand how regulation is now being used as an instrument of industrial and geopolitical strategy.

---

About This Discussion

This interview covers the distinct regulatory changes sweeping the global pharmaceutical world, driven by two powerful forces: the US "America First" agenda and the EU's ambitious "Pharma Package".

Key Topics Covered:

• US "America First" Industrial Policy

  The US is pushing an aggressive industrial policy with punitive trade measures, such as potential tariffs of up to 245% on Chinese APIs. Legislation like the Biosecure Act aims to limit outsourcing, sending a "shock wave through established global supply chains," while a broader regulatory freeze creates internal tension.

• EU's Comprehensive Pharma Package

  This is the biggest reform in over two decades. A core idea is recalibrating exclusivity periods for new drugs to an "8 + 1 + 1 model," forcing companies to treat the EU as a single integrated block. New obligations include an "obligation to supply" to prevent shortages and a new HTA regulation that will "systematically shorten that high margin commercial life cycle in the EU."

• Divergent Approaches and AI

  The interview highlights AI regulation as a clear example of these divergent paths. The EU has a comprehensive, cross-sector AI Act, while the US FDA uses a risk-based credibility assessment framework. This necessitates a "dual-track compliance strategy" for multinational pharma companies.

• Impact on Pharmaceutical Companies

  The era of a single optimized global manufacturing or regulatory plan is "over, gone." Companies must "fundamentally re-evaluate pretty much everything," building bifurcated supply chains, conducting EU exclusivity audits, and setting up distinct AI governance functions to build "agility and resilience" into their core operations.

The discussion emphasizes that regulation is now being used as an "instrument of industrial policy, even geopolitical strategy," creating a "geopolitical chessboard" for pharmaceutical companies and raising questions about the future of access to medicines, innovation, and global collaboration itself.