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Dr. Martin Altschwager LL.M.

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In EU Pharmaceutical Package

Switzerland: EU Pharma Package – Tax Implications

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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…

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In EU Pharmaceutical Package

Council Clears Path to Trilogue on Pharma Package with Reduced Market Protection and stepped up Access Obligations

by , , , and 7 Mins Read

Political compromise raises questions around feasibility implementation and EU’s innovation edge After nearly two years of negotiations, the Council of the EU has adopted its negotiating position on the proposed revision of the pharmaceutical legislation on 4 June 2025. This milestone reached under the Polish presidency follows intense debate and numerous concessions among Member States. The most divisive issues of access to medicines and incentives for pharmaceutical innovation are likely to remain a balancing act…

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In Pharmaceuticals & Biotech

Agreement Reached on EU Substances of Human Origin (SoHO) Regulation

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On 14 December 2023, Council and the European Parliament reached a major political agreement on the Substances of Human Origin (SoHO) Regulation. This Regulation will replace the Blood Directive and the Tissues and Cells Directive, combining both legal texts into one. In addition, the Regulation will extend its protection to any SoHO regardless of whether it meets the definition of ‘blood’, ‘tissue’ or ‘cell’ to avoid that certain groups of donors or recipients are left…

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In EU Pharmaceutical Package

The EU Pharmaceutical Package From a National Perspective: Member States’ First Reactions

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The Proposal to revise the EU Pharmaceutical legislation has generated unprecedented levels of attention, not only across the industry but also amongst Member States with some countries already positioning themselves in favour or against some of the measures included in the proposed Regulation and Directives. In this article we review some of these positions, which focus mostly on the incentives regime and on the management of shortages. France In March 2023, a month before the…

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