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Client Alerts 32 results

Client Alert | 6 min read | 05.12.26

EU Pharma Package: Advertising Compromise Proposal

In our ninth alert in this EU Pharma Package Series, we discussed the proposals of the Commission, Council, and Parliament with respect to advertising of medicinal products.
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Client Alert | 13 min read | 05.06.26

EU Pharma Package: Interplay with the Critical Medicines Act – Status Update

In our eighth alert in this EU Pharma Package Series, we took a “detour” to discuss the interplay between the measures proposed in the Pharma Package and those contained in other important EU initiatives such as the proposed Critical Medicines Act (CMA), and the Medicinal Countermeasures and EU Stockpiling Strategies.
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Client Alert | 11 min read | 04.27.26

The New EU "Pharma Package": Access Conditionalities and Shortage Measures Compromise Proposal

In our seventh alert in this EU Pharma Package Series, we provided an analysis of the increasing focus on shortages of medicinal products in the EU and the prevention and mitigation measures as proposed by the EU institutions.
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Client Alert | 7 min read | 04.20.26

The New EU Pharma Package: The “Bolar” Exemption Compromise Proposal

In our sixth alert in this EU Pharma Package Series, we provided an analysis of the history and interpretation issues for another highly debated topic: the “Bolar” exemption.
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Client Alert | 5 min read | 04.13.26

The New EU "Pharma Package": Global (Orphan) Marketing Authorization Compromise Proposal

In our fifth alert in this EU Pharma Package Series, we provided an analysis of the background and ongoing legal debates regarding the concept of the global marketing authorization (GMA). We discussed in particular the missed opportunities in the Pharma Package to further codify and clarify the GMA, in view of its central role in determining the regulatory data protection (RDP) rights of a medicinal product.
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Client Alert | 3 min read | 04.07.26

The New EU "Pharma Package": Fiscal Imports in the Supply Chain Compromise Proposal

In our fourth alert in this EU Pharma Package Series, we provided an analysis of the long-standing but increasingly debated issue of fiscal imports in the pharmaceutical supply chain and the EU’s evolving approach to this issue.
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Client Alert | 5 min read | 03.30.26

The New EU "Pharma Package": The Transferable Exclusivity Voucher Compromise Proposal

In our third alert in this EU Pharma Package Series, we provided a detailed overview of the diverging positions of the European Commission, the European Parliament , and the Council of the European Union on the transferable exclusivity voucher (TEV) for priority antimicrobials.
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Client Alert | 5 min read | 03.22.26

The New EU "Pharma Package": Regulatory Data Protection Compromise Proposal

In our second alert in this EU Pharma Package Series, we provided a detailed overview of the diverging positions of the European Commission (Commission), the European Parliament (Parliament), and the Council of the European Union (Council) on one of the most debated and anxiously anticipated topics, the regulatory data protection (RDP). While all EU institutions proposed a modulation system, they differed significantly in terms of the baseline period and the structure of the possible extensions.
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Client Alert | 2 min read | 03.12.26

The New EU "Pharma Package": Formal Adoption in Sight

The EU Pharma Package represents the most significant reform of EU pharmaceutical legislation in over two decades, setting the stage for a new era in medicine regulation. Introduced by the European Commission back in April 2023, the proposals are designed to promote innovation, strengthen medicine availability and affordability, reduce regulatory burdens, ensure a fair and competitive European pharmaceutical market, and modernize the EU's pharmaceutical framework. The EU Pharma Package will replace the more than twenty-year-old Directive 2001/83/EC and Regulation 726/2004, and incorporates the separate regulations on orphan and pediatric medicines, thereby bringing the entire regulatory framework up to date.
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Client Alert | 5 min read | 02.18.26

The CeramTec Case, or How to (not) Navigate the Patent to Trademark Transition

The Court of Justice of the European Union (CJEU) recently delivered its judgment in the CeramTec case (C-17/24).
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Client Alert | 13 min read | 12.22.25

European Commission Proposes Biotech Act to Boost Health Biotechnology in the EU

On December 16, 2025, the European Commission published its proposal for a regulation establishing a European Biotech Act to strengthen the EU's biotechnology and biomanufacturing sectors with a primary focus on health.
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Client Alert | 10 min read | 12.22.25

European Commission Proposes Simplifying the Rules on EU Medical and In-Vitro Diagnostic Devices

The European Commission has proposed targeted amendments to the Medical Devices Regulation 2017/745 (MDR) and the In-Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR). The amendments are intended to simplify the rules, reduce the administrative burden, and enhance the predictability and cost-efficiency of notified body certification, while maintaining high public health and patient safety standards.
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Client Alert | 3 min read | 12.17.25

The new EU Bioeconomy Strategy: a regulatory framework in transition

On 27 November 2025, the European Commission adopted the EU Bioeconomy Strategy 2025 (the Strategy), confirming the bioeconomy as a central pillar of Europe’s industrial, sustainability, and competitiveness agenda. The bioeconomy covers activities that deliver sustainable solutions based on biological resources, including biomass, residues, byproducts, and biogenic carbon, across sectors such as agriculture, forestry, fisheries, biomanufacturing, food, health, energy, materials, and construction.
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Client Alert | 6 min read | 11.25.25

Brussels Court Clarifies the EU’s SPC Manufacturing Waiver Regulation Rules

On November 13, 2025, the president of the French-speaking Brussels Enterprise Court ruled in the long-running battle between Sandoz and Regeneron about the correct interpretation of the EU’s Supplementary Protection Certificate (SPC) Manufacturing Waiver Regulation regarding exports to a non-EU market. The Brussels Court dismissed Regeneron’s claim that Sandoz had provided a defective notification and agreed with Sandoz’s interpretation of the Regulation.
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Client Alert | 9 min read | 08.27.25

The New EU “Pharma Package”: Advertising – A Comparison of Commission/Parliament/Council Positions

In this ninth and final alert in our weekly series on the EU Pharma Package, we consider the proposals of the European Commission, European Parliament and the Council of the EU as regards the advertising of medicinal products and we conclude by suggesting various ways in which pharmaceutical companies can already prepare for the upcoming changes.
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Client Alert | 13 min read | 08.20.25

The New EU “Pharma Package”: Interplay with the Critical Medicines Act and Other Shortage Initiatives

In this eighth alert in our weekly series on the EU Pharma Package, we continue our overview of initiatives with respect to security of supply and shortage prevention and mitigation. Our last alert looked at how the Pharma Package seeks to address these issues. However, the Pharma Package does not exist in isolation, and in this alert we will discuss the interplay between its measures and those contained in other important EU initiatives such as the proposed Critical Medicines Act (CMA), and the Medicinal Countermeasures Strategy and the EU Stockpiling Strategy.
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Client Alert | 15 min read | 08.13.25

The New EU “Pharma Package”: Access Conditionalities and Shortage Measures – A Comparison of Commission/Parliament/Council Positions

In this seventh alert in our weekly series on the Pharma Package, we will discuss the increasing focus on shortages of medicinal products in the EU and the prevention and mitigation measures as proposed by the European Commission, the European Parliament and the Council of the EU.
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Client Alert | 10 min read | 08.06.25

The New EU “Pharma Package”: The “Bolar” Exemption – A Comparison of Commission/Parliament/Council Positions

In this sixth alert in our weekly series on the EU Pharma Package, we focus on the proposals of the European Commission, European Parliament and Council of the EU for another topic with a highly debated scope and with diverging interpretations across EU Member States: the “Bolar” exemption.
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Client Alert | 6 min read | 07.30.25

The New EU “Pharma Package”: Global (Orphan) Marketing Authorization

In this fifth alert in our weekly series on the EU Pharma Package, we will delve into the global marketing authorization (GMA) concept which has largely remained untouched in the legislative proposal – aside from an important introduction of the notion of a GMA for orphan medicinal products. We will discuss the missed opportunity to codify existing case law and provide further clarification in this respect.
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Client Alert | 4 min read | 07.23.25

The New EU “Pharma Package”: The Debate on Fiscal Import in the Supply Chain

In our first alert in this weekly series on the EU Pharma Package, we provided some important background and general information about the status of the Pharma Package and how the trilogues work. In the second alert, we discussed the proposed changes to regulatory data protection. Our third alert delved into the different proposals of the European Commission, Parliament, and the Council regarding the transferable exclusivity voucher (TEV) for priority antimicrobials.
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