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In EU Pharmaceutical Package

Switzerland: EU Pharma Package – Tax Implications

by , , and 1 Min Read

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 Data Privacy

The Next EHDS Implementation Wave: What Pharma and MedTech Need to Do Next

by and 6 Mins Read

The European Health Data Space (EHDS) is moving from framework to build phase, with several implementing regulations already adopted and a further wave of technical rules now in preparation. Many of these measures focus on the primary-use framework and will be most relevant to healthcare providers, Member States and electronic health record (EHR) system manufacturers. However, others are big news for businesses preparing for their new obligations as health data holders and health data users.…

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In EU Pharmaceutical Package

EU Pharma Package: When Will the New Rules Apply?

by , , and 4 Mins Read

On 17 September 2026, the Council published its first-reading positions on the proposed EU Pharmaceutical Regulation and Directive. The texts largely preserve the compromise reached in December 2025 described in our earlier alert, and provide the clearest indication yet of the framework that will soon be adopted. Last steps of the legislative procedure  The legislative process is now at a very advanced stage. Although there is no official information on timings, it is expected that…

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In Medical Devices

EU Biotech Act Unveiled: Commission’s Proposal to Turn Europe into a Biotech Powerhouse

by 7 Mins Read

Background On 16 December 2025, the European Commission published its long-awaited Proposal for a Biotech Act with an aim to “build a world-leading health biotech industry” and transform Europe into a “Biotech Powerhouse”. The Proposal recognises that the EU is losing ground to global competitors such as the US and China in developing innovative biological products and identifies insufficient funding, regulatory bottlenecks, and barriers to innovation as key obstacles limiting the EU’s ability to compete…

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In Medical Devices

The EU’s 2025 proposal to simplify the Medical and In-Vitro-Diagnostic Devices Regulations (MDR/IVDR)

by and 16 Mins Read

On 16 December 2025, the European Commission published its proposal to simplify the EU’s Medical Devices Regulation (Regulation (EU) 2017/745) (MDR) and In Vitro Diagnostics Regulation (Regulation (EU) 2017/746) (IVDR). The proposal aims to simplify EU rules for the MedTech industry, support digitalization of regulatory procedures, harmonize divergent practices via strengthened cooperation, and speed up access by introducing timelines to complete conformity assessments. Finally, the proposal also intends to provide clarity on the rules applicable…

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In Medical Devices

Medical Devices and In Vitro Diagnostic Regulations: Brussels Signals It’s Ready to Cut Red Tape?

by and 3 Mins Read

Brussels has finally blinked. On 8 September 2025, the European Commission launched a call for evidence to simplify the MDR and IVDR. The window is short — it closes on 6 October 2025, but the signal is clear: the Commission is ready to revisit rules that have become heavier than the risk they were meant to control. What’s on the table? The Commission wants to use this feedback to: Why now? This move sits alongside…

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In Pharmaceuticals & Biotech

EU and German Courts Clarify Rules on Rx Drug Discounts in latest DocMorris decisions

by , and 7 Mins Read

With its ruling in Apothekerkammer Nordrhein v. DocMorris (Case C-517/23), the Court of Justice of the European Union (CJEU) provided further clarity on the interpretation of EU law concerning the advertising of medicinal products, with a particular emphasis on prescription-only (Rx) medicinal products. Most importantly, the CJEU ruled that advertising unspecified Rx medicinal products by offering price reductions (cash discounts) and payments falls outside the EU law concept of medicinal product advertising. Recently, in a…

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In Medical Devices

The EU AI Act and Medical Devices: Innovation or Insanity Ahead? 

by , and 6 Mins Read

AI as a medical device (AIaMD) in Europe is at a crossroads. As manufacturers grapple with compliance under two separate legal regimes – the EU AI Act (AIA) and EU Medical Device Regulations (MDR) – concerns are mounting around the sluggish pace of Notified Body designations and glaring inconsistencies between the two frameworks. Can the EU stay competitive when the AIA is piling on more regulatory obstacles than ever before? In our blog post, we…

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In Medical Devices

European Commission Proposes Act to Secure Critical Medicines Supply but has Wider Ambitions for Improved Accessibility of Other Medicinal products by Creating a Framework for Collaborative Procurement

by , and 6 Mins Read

On 11 March 2025, the European Commission published the Proposal for a Critical Medicines Act 1, a new Regulation aimed at improving the availability of critical medicines in the European Union. The Proposal has however a wider scope and seeks to introduce collaborative procurement mechanisms and information sharing obligations not only for critical medicines but also medicines which are considered of common interest. 1. Securing Supply of Critical Medicines According to European Health Ministers Europe…

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In Health Data Privacy & Security

European Health Data Space Regulation Published – What’s Next?

by , and 8 Mins Read

On 5th March 2025, the European Health Data Space (EHDS) Regulation was officially published in the Official Journal of the European Union. The EHDS enters into force on 26 March 2025 – this is the beginning of the transition phase towards application. At its core, the EHDS is about three things: (1) empowering patients with new health data rights (primary use); (2) a new pathway to access electronic health data for research and innovation (secondary…

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