Changes to EU regulations
The regulatory environment in Europe has changed drastically within the last four years. Rulings by the German Administrative Court and the European Court of Justice, along with a proposed pharmaceutical directive, have changed the way non-EU companies can operate within the EU pharmaceutical market. These changes primarily affect Swiss pharmaceutical companies that sell medicinal products to EU wholesalers (i.e. Swiss invoicing).
Pharmaceutical legislation reform – latest development
The Council finalised its position around mid-June 2025 on the new Union Code for medicinal products. Article 166 still obliges EU wholesale distributors to ensure that both the physical flow and the financial flow of medicinal products originate only from EU/EEA WDA holders. The Council text therefore further entrenches the German and ECJ rulings into the proposed directive.
Key challenge for Swiss pharmaceutical companies
The core issue lies in the procurement of medicinal products for EU wholesalers from Swiss-based pharmaceutical companies. EU health authorities are challenging the practice of EU wholesalers obtaining supplies from Swiss-established companies through Swiss invoicing, while products are already stored and released for the EU market. This practice is increasingly being viewed as non-compliant, potentially leading to major findings during EU GDP (Good Distribution Practice) inspections and risking critical supply chain disruptions.
Actions to be taken
- Review EU supply chains from a regulatory/quality, operations/supply chain, tax and transfer pricing perspective: Companies need to examine their current supply chain for EU-stored products sold by Swiss entities.
- Assess business operating models: A thorough evaluation of existing operational structures is crucial to identify areas that may not comply with the new regulations.
- Implement sustainable solutions: Develop and put in place new operational models that align with the updated regulatory requirements.
- Seek expert assistance: Consider partnering with PwC to assess and validate potential options to mitigate a potential business model disruption.
Adapting to the new regulatory landscape
The evolving EU regulatory landscape poses a significant challenge for Swiss pharmaceutical companies active in the European market. Yet with the right assessment, planning and execution, businesses can adapt and thrive. Acting now is essential to maintain compliance and avoid disruption to operations.
With the proposed directive set to take effect by 2026, the window for action is limited. At PwC, we’ve supported multinational corporations, SMEs and start-ups alike in shaping and implementing cross-functional, cross-border operating models – ensuring EU patients continue to access high-quality Swiss medicines without interruption.
Next steps
Let's discuss the impact of these regulatory changes on your operating model and supply chain. Our team is ready to assist.
