SL Insight Newsletter #29

The inclusion of a medicinal product in the Specialty List (SL) is a decision of vital economic importance for marketing authorization holders. Pricing, limitation clauses, pricing models, and cost-consequence models—all these elements of an inclusion decision can shape a product’s market position in Switzerland for years to come. Effective legal protection against onerous elements of the decision should therefore be a given. In practice, however, the reality is different.

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1. New admissions: Are listing and restrictive conditions an inseparable package?

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When a new drug is added to the SL, a single listing decision is issued that includes all elements of the listing: the manufacturer’s list price, any restriction clauses, and pricing models with reimbursement obligations. The FOPH has consistently used this structure to incorporate onerous provisions as an integral part of the listing decision.

This results in a structural gap in legal protection with direct consequences for patient access: In practice, a marketing authorization holder can only challenge an onerous condition by withdrawing the product from the market. This is because anyone who files an appeal against a single element of the order risks having the entire listing suspended due to the suspensive effect.

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2. Temporary Listings: Perpetuating the Legal Loophole

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The Federal Labor Court (BAG) has recently exacerbated this gap in legal protection through another change in practice: the general imposition of time limits on entries in the Specialty List. The BAG has begun to impose time limits on virtually all entries in the Specialty List. As a result, the structural problem inherent in the new entry procedure is not merely a one-time issue, but is perpetuated on a recurring basis.

An appeal against the adverse aspects of this decision will once again result in a stay of execution for the entire listing.

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3. Cost-consequence models: A possible ray of hope

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With the introduction of cost-following models (KFM) through Cost Containment Package 2 and their incorporation into the KVV, there are signs of a potential improvement in legal protection in one area for the first time in a long while.

The key difference from previous pricing models lies in their legal classification: Structurally, the KFM constitutes a public-law levy. According to the established case law of the Federal Supreme Court, state levies must be based on a sufficiently specific legal basis and must be determined by an administrative decision against which an appeal may be lodged (BGE 135 I 130 E. 7.2; Art. 5 VwVG).

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4. Summary

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In current practice, effective legal protection against SL decisions has been largely undermined. The introduction of cost-sharing models creates, for the first time, a normative basis on which this situation can be successfully addressed. Marketing authorization holders are well advised to immediately review every new cost-sharing model decision for compliance with the KVG and KVV as soon as the revised KVV takes effect—and to explore legal recourse in the event of deviations.

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