Forthcoming rules may significantly impact supply chains, tax positions and financial flows

The proposed EU Pharma Package would require EU wholesale distributors to purchase medicinal products, including through financial transactions, only from sellers holding an EU-issued wholesale distribution authorization (WDA) or manufacturing and import authorization (MIA). As a result, Swiss and other non-EU principal structures, in which products are manufactured in or imported into the EU while invoices are routed through a non-EU entity, may come under pressure once the new rules apply, expected as of Q4/2028. Possible responses, ranging from an EU principal, EU trading branch or EU master distributor to targeted adaptations that preserve the non-EU principal, may have significant transfer pricing, exit tax, corporate income tax, value added tax (VAT) and customs consequences. Groups should assess these implications now, before changing entities, contracts, invoicing flows or functions, so that the regulatory solution does not inadvertently dictate the tax outcome.

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Susanne Liebel-Kotz is the Head of Baker McKenzie Switzerland’s Tax Practice Group and a partner in the Firm’s Zurich office.

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Balthasar Denger is a member of Baker McKenzie's Global Tax, Transfer Pricing and Tax Dispute Resolution groups. He focuses his practice on international tax with an emphasis on transfer pricing and tax dispute resolution.

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Dr. Martin Altschwager, a Partner, is a member of Baker McKenzie’s Pharmaceuticals and Healthcare Practice Group in Frankfurt.

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Els Janssens is a counsel specialised in healthcare life sciences regulatory matters based in Brussels. She has more than 10 years of experience with life sciences industry in the UAE.

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