Sweden aligns with EU-wide interpretation on wholesale financial transactions

The pharmaceutical sector has encountered uncertainty regarding supply security in recent years, particularly when products within the EU are owned by entities located outside the EU/EEA.

Sweden has issued a ruling at the end of October 2025 that confirms the treatment of financial transactions and non-physical title transfers within EU pharmaceutical wholesale chains.

However, a consensus is now emerging across the EU with another court ruling in Sweden.

The German Administrative Court highlighted in 2021 that controlling the entire supply chain is vital, involving not only the physical goods, but also the financial ownership. Europe's Court of Justice concurs, requiring EU wholesalers to source exclusively from authorised suppliers. The Swedish Court of Appeal has joined this perspective, declaring that EU-based wholesalers and distributors must only procure from EU authorised vendors. The draft directive for human medicinal products aims to reinforce this approach with Article 166 in EU law, applicable across all member states.

Essentially, EU wholesalers, or those belonging to a group within the EU, may only procure (including via financial transactions) from Wholesalers possessing EU authorisation. For wholesalers and distributors, more stringent documentation checks and a riskier landscape are anticipated if dealings involve non-EEA suppliers, which are considered non-compliant under the new rules. The message is unequivocal: the EU aims for both financial paths and physical ones to be situated in the EU to ensure accountability and safety of the supply chain.

The Swedish Court of Appeal recently made a ruling that focuses on how financial and non-physical ownership transfers interlace with EU wholesale practices. The ruling confirmed that financial purchase transactions are regarded as wholesale distribution, requiring an EU wholesale distribution authorisation (WDA). This aligns with past rules from Germany, the CJEU, and directly points to the forthcoming Article 166's direction.

Sweden’s decision confirms that EU pharmaceutical practices should focus beyond physical goods handling. Wholesale companies must source from EU/EEA-authorised suppliers, with financial transactions being no exception. Article 166 will establish explicit sourcing guidelines for all wholesalers and distributors in the EU, reinforcing that even temporary non-EEA involvement does not exempt compliance.

Solutions exist to retain the strategic role of a Swiss headquarters, provided it aligns with EU/EEA regulatory expectations. PwC Switzerland has developed and implemented practical, pressure-tested solutions to preserve strategically beneficial Swiss bases while satisfying EU rules.

Our pharmaceutical legal-regulatory expert team has stayed abreast of these developments from the outset, guiding numerous companies to adapt their models in light of the German and CJEU case law, draft Article 166, and now the Swedish confirmation. We’ve helped modify existing structures according to Germany’s, the CJEU’s, Article 166, and now Sweden’s rulings, and assisting companies in cultivating EU-compliant operating models. Our team blends expertise from various cross-functional domains to translate legal necessities into practical solutions, preserving continuity of supply, optimising processes and controls, and meeting inspection expectations across EU/EEA.