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How MFN is reshaping global market access
Strategic implications for launch sequencing and patient access
Innovation in the pharmaceutical industry continues to accelerate. In the coming years, the market is expected to see a steady flow of new therapies, including gene therapies, RNA-based treatments, cell therapies, and other specialized modalities.1 These advances create new opportunities for patients, but they also increase the complexity of launch, pricing, and access planning.
At the same time, the commercialization environment is becoming more complex. Policy changes, funding pressures, and global competition are reshaping the conditions under which new therapies reach market.
In that context, the Most Favored Nation, or MFN, pricing framework is becoming an important consideration for pharmaceutical companies evaluating global launch strategy.
At the same time, the commercialization environment is becoming more complex. Policy changes, funding pressures, and global competition are reshaping the conditions under which new therapies reach market.
In that context, the Most Favored Nation, or MFN, pricing framework is becoming an important consideration for pharmaceutical companies evaluating global launch strategy.
While much of the discussion around MFN has focused on policy design and near-term pricing risk, its broader significance may be strategic. MFN has the potential to influence where companies launch, how they sequence filings, and how they protect price integrity across interconnected markets.
Why MFN matters now
MFN links U.S. federal drug pricing to prices in other markets. As a result, pricing decisions that were once made largely market by market can have broader commercial implications. A lower price in one geography may affect pricing outcomes in another, particularly when reference pricing mechanisms are involved.
This shift does not affect every product or company in the same way. However, it does increase the need for coordinated planning across pricing, market access, regulatory, and commercial teams. For many organizations, launch sequencing is becoming a core element of global price architecture rather than a downstream market access decision.
This shift does not affect every product or company in the same way. However, it does increase the need for coordinated planning across pricing, market access, regulatory, and commercial teams. For many organizations, launch sequencing is becoming a core element of global price architecture rather than a downstream market access decision.
Emerging impact on launch planning
One early signal of this shift is the apparent slowdown in new drug launches across Europe in the months following renewed U.S. attention to international reference pricing (IRP) and MFN-related policies. According to GlobalData, new drug launches in EU markets fell by approximately 35% in the 10 months after the May 2025 U.S. executive order, compared with the previous 10-month period.2 While launch patterns are influenced by a range of regulatory and commercial factors, the trend suggests that pricing considerations may be playing a more prominent role in geographic launch timing and sequencing.
There are several reasons why a company may delay or forgo filing in a given region, including development priorities, evidentiary requirements, resource constraints, and portfolio strategy.
The implications may differ by company type. Large pharmaceutical manufacturers may be better positioned to manage pricing complexity across multiple assets and geographies. They often have broader infrastructure, more established European operations, and greater flexibility in how they manage portfolio risk.
For smaller biotech companies, the stakes may be higher. A single-asset company may have limited room to absorb pricing trade-offs across markets. In those situations, launch sequencing can become a strategic decision not only about market entry, but also about preserving future pricing flexibility.
There are several reasons why a company may delay or forgo filing in a given region, including development priorities, evidentiary requirements, resource constraints, and portfolio strategy.
The implications may differ by company type. Large pharmaceutical manufacturers may be better positioned to manage pricing complexity across multiple assets and geographies. They often have broader infrastructure, more established European operations, and greater flexibility in how they manage portfolio risk.
For smaller biotech companies, the stakes may be higher. A single-asset company may have limited room to absorb pricing trade-offs across markets. In those situations, launch sequencing can become a strategic decision not only about market entry, but also about preserving future pricing flexibility.
Europe’s role in the access landscape
Europe remains a critical market for pharmaceutical manufacturers, both because of its scale and because of its influence on global reference pricing. At the same time, it remains a fragmented access environment.
A single EMA approval does not lead to a single access outcome. Instead, companies must navigate country-specific pricing, reimbursement, and health technology assessment (HTA) processes. Time from EMA authorization to patient access can vary significantly across member states.3 This complexity is further evolving with EU-level changes such as Joint Clinical Assessment, which may influence pricing and reimbursement dynamics across markets.
In an MFN environment, that variation becomes more strategically important. Delays in one market may carry consequences beyond that market, especially when pricing decisions influence future negotiations elsewhere.
A single EMA approval does not lead to a single access outcome. Instead, companies must navigate country-specific pricing, reimbursement, and health technology assessment (HTA) processes. Time from EMA authorization to patient access can vary significantly across member states.3 This complexity is further evolving with EU-level changes such as Joint Clinical Assessment, which may influence pricing and reimbursement dynamics across markets.
In an MFN environment, that variation becomes more strategically important. Delays in one market may carry consequences beyond that market, especially when pricing decisions influence future negotiations elsewhere.
The European Union pharmaceutical reform adds another layer of complexity. Proposed changes that tie portions of regulatory exclusivity to launch commitments across member states may encourage broader access, but they also create new trade-offs for manufacturers balancing access goals with pricing exposure.4 For companies planning global launches, Europe remains commercially important. In an MFN-sensitive environment, it is also becoming a more consequential determinant of launch timing, price signaling, and downstream access strategy.
Implications for access and competitiveness
The broader concern is not simply whether companies change launch order. It is whether changes in launch behavior could contribute to wider access gaps over time.
When companies delay filings in key reference markets, patient access may be delayed not only in those countries, but also in other markets that depend on them for pricing or regulatory benchmarks. This can create a longer and more fragmented path from approval to real-world availability.
At the same time, it is important to avoid overgeneralization. MFN exposure varies by therapy type, patient population, and reimbursement context. Rare disease and highly specialized assets may face different pressures than broader commercial products. Early access pathways, including named-patient and compassionate use programs, may also provide flexibility in some cases, although these options are not always used consistently.
When companies delay filings in key reference markets, patient access may be delayed not only in those countries, but also in other markets that depend on them for pricing or regulatory benchmarks. This can create a longer and more fragmented path from approval to real-world availability.
At the same time, it is important to avoid overgeneralization. MFN exposure varies by therapy type, patient population, and reimbursement context. Rare disease and highly specialized assets may face different pressures than broader commercial products. Early access pathways, including named-patient and compassionate use programs, may also provide flexibility in some cases, although these options are not always used consistently.
Strategic considerations for pharma leaders
For pharmaceutical leaders, MFN reinforces the need to treat launch planning as a cross-functional pricing and access decision. Several priorities stand out:
Reassess launch sequencing early
Teams should evaluate how first-launch markets may shape long-term pricing flexibility, reference pricing exposure, and downstream access options across the portfolio.
Strengthen cross-functional coordination
Pricing, market access, regulatory, health economics and outcomes research (HEOR), and commercial teams need aligned decision-making earlier in development to reduce late-stage trade-offs.
Expand scenario planning
Companies should model alternative filing and launch pathways across key markets to understand potential effects on reimbursement timing, pricing corridors, and access risk.
Use early access pathways selectively
Named-patient and compassionate use pathways may help address patient need while preserving flexibility ahead of full commercialization.
Adjust strategy to portfolio structure
Large diversified manufacturers and smaller biotechnology companies face different exposure levels and may require different geographic launch models.
These priorities also reflect common pitfalls organizations face when managing MFN and international reference pricing (IRP) exposure across markets.
Looking ahead
MFN is one part of a broader shift in global commercialization. It sits alongside manufacturing changes, tariff pressures, evolving policy frameworks, and increased international competition. Together, these trends are making launch strategy more interconnected and more complex.
Emerging policy proposals, including the pending GLOBE and GUARD models, could add further complexity to this evolving landscape. While these initiatives have not been finalized and their ultimate impact remains uncertain, they are increasingly influencing discussions around pharmaceutical pricing, investment commitments, and market access strategy. As companies navigate MFN-related considerations, they may need to account for a broader range of policy scenarios when making launch sequencing and pricing decisions.
For pharmaceutical companies, the challenge is to balance three priorities: sustainable pricing, timely patient access, and continued incentives for innovation. In a more interconnected pricing environment, decisions made in one market may increasingly shape access outcomes in others. The companies best positioned to compete will align pricing, access, regulatory, and launch decisions earlier and with greater discipline across markets.
Emerging policy proposals, including the pending GLOBE and GUARD models, could add further complexity to this evolving landscape. While these initiatives have not been finalized and their ultimate impact remains uncertain, they are increasingly influencing discussions around pharmaceutical pricing, investment commitments, and market access strategy. As companies navigate MFN-related considerations, they may need to account for a broader range of policy scenarios when making launch sequencing and pricing decisions.
For pharmaceutical companies, the challenge is to balance three priorities: sustainable pricing, timely patient access, and continued incentives for innovation. In a more interconnected pricing environment, decisions made in one market may increasingly shape access outcomes in others. The companies best positioned to compete will align pricing, access, regulatory, and launch decisions earlier and with greater discipline across markets.
*Kaynaklar aşağıda listelenmiştir
For additional perspectives on MFN-related pricing risk, policy interactions, and implementation challenges, see our related insights on global pricing dynamics and MFN/IRP strategy.
About the author:
Guillaume Nebout, PharmD, MBA, is Vice President, International Strategic Accounts and Commercialization at Cencora. A healthcare and life sciences executive, he brings experience across clinical practice, global pharmaceuticals, and large-scale commercialization programs. He has led digital health, innovation, and partnership initiatives across Europe. In his current role, he focuses on strategic account leadership, global launch execution, and cross-functional alignment. He is an elected member of the French National Academy of Pharmacy.
Yasal Uyarı:
Bu makalede verilen bilgiler yasal tavsiye niteliğinde değildir. Cencora, Inc., okuyucuları tartışılan konularla ilgili mevcut bilgileri gözden geçirmeye ve bunlarla ilgili kararlar alırken kendi deneyim ve uzmanlıklarına güvenmeye şiddetle teşvik eder.
Sources:
1. Boston Consulting Group. New Drugs Modalities 2024. Accessed on June 29, 2026. https://www.bcg.com/publications/2024/new-drug-modalities-report
2. Reuters. Drugmakers delay some European launches with a wary eye on Trump's pricing policies. Accessed on June 29, 2026. https://www.reuters.com/business/healthcare-pharmaceuticals/drugmakers-delay-some-european-launches-with-wary-eye-trumps-pricing-policies-2026-03-31/
3. EFPIA. New data from EFPIA reveals multiple factors leading to unequal access to medicines for patients across Europe. Accessed on June 29, 2026. https://www.efpia.eu/news-events/the-efpia-view/efpia-news/new-data-from-efpia-reveals-multiple-factors-leading-to-unequal-access-to-medicines-for-patients-across-europe/
4. European Commission. EU Pharmaceutical Reform: Incentives to steer innovation and achieve public health objectives. Accessed on June 29, 2026 64fdc425-c78d-4f08-aa34-4e6fd1f07bf4_en
