Entries by Maarten Meulenbelt

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.

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.

09 09 '24

Are the revisions to the EU’s ‘Bolar’ system compatible with TRIPS?

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The EU’s proposal to speed up generic and biosimilar market access by expanding the “Bolar exemption” to pricing and reimbursement procedures raises significant international IP law concerns, as it is probably incompatible with its obligations under the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). Maarten Meulenbelt, Chris Boyle, Lauren Shapiro, Maryanne Kamau, and Alix Vermulst explain.

19 03 '24

EU’s Overhaul Of Pharma Legislation Amended With Uneasy IP Compromises

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On March 19, 2024, a set of 100 “Compromise Amendments” to the European Commission’s far-reaching overhaul of the EU’s rules for medicines, the Pharmaceutical Review, was adopted by the European Parliament’s ENVI Committee. Maarten Meulenbelt, Chris Boyle and Zina Chatzidimitriadou explain the main changes, associated risks, and next steps.

28 04 '23

The EU’s Pharmaceutical Review Needs To Remain Grounded In Economic Reality

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The Review proposes to reduce IP rights across the board, with incentives to prolong them. Can any of these incentives work? Maarten Meulenbelt, Chris Boyle, and Zina Chatzidimitriadou discuss how the real-world effects of the Review have not been assessed, and where there is room for improvement in its critical provisions.

20 03 '23

Missing Numbers: Seeking to Substantiate The Leaked EU Pharmaceutical Review

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Pharma companies are currently assessing how the Pharma Review will affect their portfolios. Maarten Meulenbelt and Maria Koutsoupia discuss the need for analysis from the EU to support the Review’s claims, for example on the allegedly ‘invisible’ effect of losing €640 million in annual orphan drug revenues.