The Trump Administration’s efforts to introduce MFN pricing in the U.S. has the potential to reshape global pharmaceutical pricing dynamics, with significant consequences for EU market access, pricing, and patient access - for both new and established therapies. In the EU, many Member States (e.g., France, Germany, Italy, Denmark) are included in the reference country basket for the MFN drug pricing proposals announced to date, including the GLOBE, GUARD, and GENEROUS Models. As a result, pharmaceutical companies may seek to increase prices in Europe - especially in basket countries with traditionally lower pricing - to prevent these low prices from being used as a reference point under the MFN policies. This could lead to upward pressure on European prices, as companies aim to protect their global pricing strategy and maintain higher revenues in the U.S. market. In some cases, manufacturers may need to make difficult product launch decisions in EU Member States.

The MFN proposals come against the backdrop of statutory health insurance schemes in European countries facing severe financing issues, where EU payors have been trying to curb costs for pharmaceutical products. Therefore, the MFN proposals could trigger the EU countries’ payors to negotiate country-specific prices and discounts based on local health economics. Pharmaceutical companies would then need to assess which prices can be reported without breaching confidentiality under the law, and under pricing and reimbursement agreements.

Raising particular concern over pricing disclosures, several of the MFN proposals contemplate the reporting of international pricing information by manufacturers, including rebates, discounts, and other price concessions provided by the company off the list price. Reporting such pricing data poses several challenges, including confidentiality concerns with disclosure of such information. Thus, for companies participating in this voluntary program, arrangements with payors in basket countries will need to be assessed to determine whether these pricing elements are protected by confidentiality, and if so, to what extent.