This collection examines pricing, reimbursement and health technology assessment for medicines and digital therapeutics. Topics include clinical assessment, research location, Swiss price reviews and the relationship between launch decisions and market access.
These articles provide general information and are not legal advice.
The EU Health Technology Assessment Regulation has required a Joint Clinical Assessment for new oncology medicines and cell and gene therapies since 12 January 2025; it harmonizes the clinical dossier, not national pricing, and the outcome turns on comparators chosen at trial design.
Germany's medical research act (Medizinforschungsgesetz) has, since 1 January 2025, tied relief from the statutory guardrails on negotiated drug prices and the option of a confidential reimbursement amount, bought with a nine percent discount, to where a company runs its trials and research.
Switzerland's three-year price review cut prices by about 11 percent on average across some 300 products a year in 2023–2025. For US companies with research there, the OECD minimum tax can partly reverse cantonal tax incentives such as the patent box.
Germany's Digital Act rewrote § 134 of the health insurance code (SGB V) so that from 2026 at least 20 percent of the negotiated price of a digital health application (DiGA) turns on measured outcomes, and the directory of the regulator BfArM now admits class IIb software on stricter evidence terms.
Art. 56a of the EU Pharma Package Directive lets a Member State demand a launch; non-compliance can strip regulatory market protection in that territory. For US originators, selective EU launch strategy now carries a direct exclusivity cost.
Germany's July 2026 law raises the usual statutory rebate on patented drugs to 15.5 percent from 2027, changes AMNOG price negotiation and permits class tenders. Its conditions, volume formula and foreign reference-price effects matter for launch and contracting decisions.
Swiss confidential refund rules remain pending while US pricing commitments and public models use different scopes, data and periods. An early Swiss application would not by itself preserve the old method under the proposed transition.
FDA approval does not replace Swiss authorization. Reliance on the US review depends on product eligibility and the dossier; the Swiss holder, insurance listing and protection periods follow separate rules.
The proposed Critical Medicines Act would favor EU manufacturing in certain tenders. For Swiss and US production, the treaty question turns on the goods, supplier, buyer and procurement coverage.
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