15 juin 2026 | Publication
Switzerland and U.S. Most-Favored-Nation
(MFN) Pricing – One Year In
15 juin 2026 | Publication
Switzerland and U.S. Most-Favored-Nation
(MFN) Pricing – One Year In
With the first anniversary of U.S. President Trump’s MFN drug-pricing executive order of May 12, 2025, U.S. policy to reduce healthcare costs has progressed from rhetoric to implementation. The order requires pharmaceutical companies to offer U.S. consumers prices comparable to those in other high-income countries. Under the respective arrangements, pharmaceutical companies agree to align prices for new medicines with those prevailing in a reference basket of jurisdictions, in which Switzerland is regularly included.
As one of the world’s leading pharmaceutical hubs with a small domestic market, an independent marketing authorization and reimbursement system, and internationally competitive price levels – Switzerland is particularly exposed to U.S. MFN initiatives. At the same time, the Swiss legal framework significantly constrains price increases for medicinal products. Ongoing regulatory developments, in particular the implementation of Cost Containment Package 2, which seeks to limit the growth of compulsory health insurance costs to medically justified levels, are expected to exert additional downward pressure on prices. This is reinforced by a prevailing public and political consensus that remains firmly opposed to price increases.
Switzerland operates a social health insurance system that covers nearly all treatments, including necessary medicinal products and their pricing. Following marketing authorization, marketing authorization holders (MAHs) must apply to the Federal Office of Public Health (FOPH) for inclusion of their product in the publicly available List of Specialties (SL) to obtain reimbursement under mandatory health insurance (MHI). The FOPH assesses new medicines on the basis of effectiveness, appropriateness, and economic efficiency (EAE Criteria), applying, inter alia, international reference pricing (APV) and therapeutic cross-comparison (TQV). These criteria are subject to reassessment every three years. Medicines meeting the EAE Criteria are listed at a maximum price set by the FOPH and accepted by the MAH, typically with a tendency to decrease over time as a result of periodic reviews.
If the MAH does not accept the FOPH-determined maximum price, the medicine will not be listed and is therefore ineligible for reimbursement under MHI. In exceptional cases, reimbursement may nevertheless be granted on an individual basis, in particular in early-access or orphan-disease contexts, including for unlicensed, hors-liste, off-label, or off-limitation uses. Pricing in such cases deviates significantly from the standard framework and often involves substantial reductions, whether negotiated individually or imposed by law.
Against this backdrop, pharmaceutical companies operating in Switzerland face increasing challenges in relation to market access and pricing, particularly for products marketed in parallel in the U.S. These challenges include considerations around mandatory supply obligations, stockpiling, pricing and reimbursement constraints, as well as, conversely, potential options to withdraw from marketing authorization or reimbursement. Companies must also account for unintended consequences of non-entry into, or withdrawal from, the Swiss market, including the risk of parallel imports, compulsory licensing scenarios, and potential implications for regulatory data protection.
In light of these complexities, pharmaceutical companies should carefully evaluate their options, taking into account the economic and legal ramifications alongside patient access and reputational considerations, when pursuing MFN-related strategies, structuring supply and distribution arrangements in Switzerland, or negotiating MFN agreements.
LIR Switzerland Edition 6, Switzerland and U.S. Most-Favored Nation (MFN) Pricing - One Year In
As one of the world’s leading pharmaceutical hubs with a small domestic market, an independent marketing authorization and reimbursement system, and internationally competitive price levels – Switzerland is particularly exposed to U.S. MFN initiatives. At the same time, the Swiss legal framework significantly constrains price increases for medicinal products. Ongoing regulatory developments, in particular the implementation of Cost Containment Package 2, which seeks to limit the growth of compulsory health insurance costs to medically justified levels, are expected to exert additional downward pressure on prices. This is reinforced by a prevailing public and political consensus that remains firmly opposed to price increases.
Switzerland operates a social health insurance system that covers nearly all treatments, including necessary medicinal products and their pricing. Following marketing authorization, marketing authorization holders (MAHs) must apply to the Federal Office of Public Health (FOPH) for inclusion of their product in the publicly available List of Specialties (SL) to obtain reimbursement under mandatory health insurance (MHI). The FOPH assesses new medicines on the basis of effectiveness, appropriateness, and economic efficiency (EAE Criteria), applying, inter alia, international reference pricing (APV) and therapeutic cross-comparison (TQV). These criteria are subject to reassessment every three years. Medicines meeting the EAE Criteria are listed at a maximum price set by the FOPH and accepted by the MAH, typically with a tendency to decrease over time as a result of periodic reviews.
If the MAH does not accept the FOPH-determined maximum price, the medicine will not be listed and is therefore ineligible for reimbursement under MHI. In exceptional cases, reimbursement may nevertheless be granted on an individual basis, in particular in early-access or orphan-disease contexts, including for unlicensed, hors-liste, off-label, or off-limitation uses. Pricing in such cases deviates significantly from the standard framework and often involves substantial reductions, whether negotiated individually or imposed by law.
Against this backdrop, pharmaceutical companies operating in Switzerland face increasing challenges in relation to market access and pricing, particularly for products marketed in parallel in the U.S. These challenges include considerations around mandatory supply obligations, stockpiling, pricing and reimbursement constraints, as well as, conversely, potential options to withdraw from marketing authorization or reimbursement. Companies must also account for unintended consequences of non-entry into, or withdrawal from, the Swiss market, including the risk of parallel imports, compulsory licensing scenarios, and potential implications for regulatory data protection.
In light of these complexities, pharmaceutical companies should carefully evaluate their options, taking into account the economic and legal ramifications alongside patient access and reputational considerations, when pursuing MFN-related strategies, structuring supply and distribution arrangements in Switzerland, or negotiating MFN agreements.
LIR Switzerland Edition 6, Switzerland and U.S. Most-Favored Nation (MFN) Pricing - One Year In