Nathalie Moll, Director General of EFPIA, sets out why pharma market access now sits at the centre of Europe’s industrial and health policy choices. Her assessment, published at PharmaBoardroom, shows that declining investment and uneven reimbursement threaten both patient outcomes and regional economic strength. Health economics teams therefore need to recalibrate how they model value and advise on pricing strategies that sustain innovation while respecting fiscal limits.

Shifting Investment Patterns and Their System Consequences

Over two decades Europe has lost around a quarter of its global share of pharmaceutical R&D investment, with roughly 60,000 fewer clinical trial places available to patients in the last ten years. These trends affect research infrastructure, employment and future supply capacity. When companies perceive limited returns through current reimbursement decisions, capital moves elsewhere. Health economists must therefore incorporate these dynamics into budget impact models that extend beyond immediate pharmacy costs to capture effects on hospital admissions, workforce productivity and carer support.

Policy Implications for Value Assessment and Pricing

The revised EU pharmaceutical legislation and the proposed Biotech Act signal recognition that life sciences form a strategic sector. Yet the final texts stopped short of delivering the predictability and speed required for sustained investment. National approaches to pricing and clawback mechanisms continue to fragment the picture. When member states treat pharmaceutical spend in isolation, they risk accelerating the very loss of manufacturing and trial activity that undermines long-term system resilience. Broader considerations such as ethnic heterogeneity, weight regain, and cardiometabolic outcomes further complicate single-product evaluations and require more sophisticated evidence frameworks.

Reimbursement Decisions and Budget Impact Realities

Full reimbursement availability has fallen from 42 percent in 2019 to 28 percent today, while access gaps between countries reach 88 percent. These figures illustrate that the issue extends beyond delay to outright non-availability. Payers face pressure from competing demands, including defence spending. Market access directors therefore need evidence packages that quantify system-wide efficiencies rather than relying solely on short-term budget impact. The EU HTA Regulation offers a route to reduce duplication, yet only if joint clinical assessments replace rather than add to the existing 27 national processes.

Recommendations for Companies, HTA Bodies and Health Systems

Companies should model the probability of timely, broad reimbursement as a core input to development decisions and engage early with joint HTA processes. HTA bodies and payers need to test whether new frameworks genuinely streamline evidence requirements and reward added clinical value. Member states should review tendering and clawback policies to avoid penalising products whose wider economic contribution exceeds their direct cost. Finally, industrial strategies must include explicit targets for clinical trial activity and link these to predictable intellectual property incentives. Such steps can begin to reverse the current cycle in which restricted access discourages investment and further constrains access.

This reflection draws on the interview with Nathalie Moll.