Entries by Josefine Sommer

18 05 '26

EU Pharma Package: Compromise Text Published – Best Efforts Required (Part 2)

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After a 10-year process, the compromise text of the new EU General Pharmaceutical Legislation (GPL or Pharma Package) has been published and will soon become law. This blog post discusses the 10 most important changes for company pipelines, transition mechanisms, interaction with other laws, and next steps, and concludes that best efforts will be required from all stakeholders, including Member States, to make the new provisions work and create an attractive environment for medicinal products in the EU – including the interaction between with the Critical Medicines Act (compromise text adopted on 12 May 2026) and the Biotech Act (which is in progress).

14 04 '26

Navigating the European Health Data Space Regulation: An (Uneasy) Marriage Between EHDS and GDPR (Part 2)

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The European Health Data Space Regulation (EHDS Regulation) took effect on March 26, 2025. Most of its secondary use provisions will apply from March 2029, and implementation at EU and Member State level will have to take place between 2027 and 2035. Health data represents over 30% of the world’s data assets, yet less than 3% is utilized for secondary purposes such as research, regulatory, or public health purposes, a persistent “data-to-value” gap. This update examines how the EHDS Regulation seeks to close that gap by introducing a more prescriptive legal framework for access to health data for (certain) secondary use purposes whilst still aligning with requirements under EU privacy law; and what life sciences companies should be doing now to anticipate such secondary use obligations, data access requests, and opportunities.

19 12 '25

EU Pharma Package: Sharp New Tools With Limited Protections (Part 1)

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Last week, concluding a seven-year process, the Council of the European Union and the European Parliament agreed on the EU Pharma Package consisting of a new Pharmaceutical Directive and Pharmaceutical Regulation. The Package introduces pivotal changes to the EU pharmaceutical legislation, most significantly the introduction of new launch and supply obligations with only limited safeguards and a reduction and modulation of regulatory data protection and market protection, requiring companies to re-think their pipeline strategies. The provisional agreement now needs to be endorsed by both the Council and the Parliament before being formally adopted and entering into force upon publication in the Official Journal of the European Union. The final text is expected to become available in the coming weeks.

23 09 '25

Navigating the European Health Data Space Regulation: What Life Sciences Companies Need to Know About Secondary Use Implementation (Now) – A Tracking Tool (Part 1)

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The European Health Data Space Regulation took effect on March 26, 2025. While its key requirements regarding the secondary use of health data will not apply until March 2029, these provisions are set to bring about substantial changes for life sciences companies operating within the EU. This blog marks the beginning of a dedicated series of blogs exploring the implementation of the EHDS Regulation, with a particular focus on secondary use obligations. Our aim is to keep life sciences organizations informed about the latest EHDS Regulation developments, by offering an overview of relevant publications, consultations, and guidance on emerging best practices.

28 08 '25

EU Pharma Review: Trilogue negotiations under the shadow of U.S. MFN pricing

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The coming months will be crucial for the so-called “Pharma Package”, the largest revision of EU pharmaceutical law since 1965. So-called “trilogue” negotiations are being held between the European Commission (“Commission”), the European Parliament (“Parliament”) and the Council of the European Union (“Council”), based on documents showing their positions (see draft Pharmaceutical Directive (“PD”) and draft Pharmaceutical Regulation (“PR”) published on 17 June 2025). Will the Pharma Package make the EU more competitive as has been claimed, despite reducing and ‘modulating’ IP rights and regulatory exclusivities? The stakes are high. For one of the proposals being considered (obliging companies to launch in all EU Member States), the stakes have been raised further by the growing risk that the U.S. administration will use prices in certain EU Member States as a “Most Favored Nation” (“MFN”) benchmark for U.S. prices. Maarten Meulenbelt, Josefine Sommer, Chris Boyle and Zina Chatzidimitriadou discuss the EU institutions’ trilogue positions in the context of broader legal, economic and political changes.

28 07 '25

Will the EU Become the Most Attractive Place for Life Sciences? How the EU Woos Biotech

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The European Commission made a lofty commitment in its recently published Life Sciences Strategy to position the EU as the world’s most attractive place for life sciences by 2030. To succeed with this vision, EU lawmakers must ensure that these efforts will truly cut red tape and accelerate innovation rather than simply adding new layers of regulation. They must also ensure that these efforts are not undermined by other legislative changes affecting the EU’s biotech industry.

22 07 '25

EU Critical Medicines Act Seeks to Enhance Supply and Access Requirements

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The European Commission has proposed a new Critical Medicines Act aimed at reinforcing the security of supply and ensuring the availability of critical medicines and medicines of common interest across the EU. The Act introduces new obligations for pharmaceutical companies such as enhanced supply chain transparency, mandatory stockpiling, and regular reporting obligations. At the same time, it creates opportunities for investment and funding to expand EU-based manufacturing, diversify supply chains, and foster innovation. By shifting procurement practices to include award criteria beyond price considerations by prioritizing quality, supply security, and EU production, the Act aims to address vulnerabilities in the current supply system and reduce reliance on third countries. However, to avoid becoming another layer of red tape for industry, a final Critical Medicines Act must carefully balance new regulatory requirements with the need to maintain competitiveness and support a resilient, innovative pharmaceutical sector.

22 10 '24

European Regulator Clarifies Guidance on the Use of AI in the Medicinal Product Lifecycle

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The European Medicines Agency (EMA) has published a final reflection paper on the use of AI in the drug lifecycle, which provides important insights into the expectations from the EMA to clinical trial sponsors, as well as marketing authorization (MA) applicants and holders who use AI systems. Josefine Sommer and Zina Chatzidimitriadou explain.