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NEWS
The European Federation of Pharmaceutical Industries and Associations (EFPIA) has published its response to Mario Draghi’s report on the future of European competitiveness, which was commissioned by the European Commission. The EFPIA, in its response, stated that the research based pharmaceutical industry welcomes the report as it aligns with the pharmaceutical industry’s ambition to position Europe as the leading hub for research, development and manufacturing of new diagnostics, treatments and vaccines. MedTech Europe also published a statement welcoming the report as it believes that a robust, competitive, and innovation-driven medical technology industry is required for building resilient and sustainable health systems. MedTech also agreed with Draghi's viewpoint that closing innovation gaps must be Europe’s first priority as significant improvements are required in the short/mid-term to the medical devices industry to boost efficiency and overall fitness for sustainability, all while leveraging digital health technology innovation.
NEWS
The European Federation of Pharmaceutical Industries and Associations (EFPIA) and Medicines for Europe have met with European Commission President von der Leyen on 8 April 2025 to warn of industry investment risks. EFPIA's member survey showed €103.2bn of planned 2025–2029 investments may shift to the US, with €16.5bn at immediate risk. Medicines for Europe presented a 5-point action plan addressing potential US tariffs, highlighting that the EU exclusively supplies 20% of US-approved active pharmaceutical ingredients. Both organisations called for urgent policy changes to maintain EU pharmaceutical competitiveness.
NEWS
The European Federation of Pharmaceutical Industries and Associations (EFPIA) has raised three key criticisms and recommendations regarding Regulation (EU) 2020/852 (the EU Taxonomy Regulation) and its Technical Screening Criteria (TSC) in a blog post. First, the TSC do not adequately reflect the sustainable practices of the pharmaceutical industry. The criteria for manufacturing active ingredients and medicinal products are too narrow, focusing only on naturally occurring, biodegradable, or mineralised ingredients, and requiring new products to be substitutes for existing non-biodegradable ones. This fails to recognise the industry's innovation efforts driven by unmet medical needs, the necessity of stable, non-biodegradable molecules for effective treatments, and the lack of biodegradability data required by regulators. Second, the 'all or nothing' approach, where a medicine can only be considered sustainable if it meets all criteria, is counterproductive. It fails to incentivise progress and improvements in environmental impacts, as some thresholds are unrealistic or unachievable for the pharmaceutical industry. This could make the industry less attractive to investors and hinder the enhancement of patient outcomes. Third, the taxonomy provides only selective transparency on the industry's sustainability efforts, overlooking the overall benefits of medicinal products and the potential reduction in healthcare-related environmental burdens through improved patient outcomes.
PRACTICE NOTES
Background to the EU Pharma package The reform of the EU pharmaceutical legislation, also known as the ‘EU pharma package’, is the most significant overhaul of the pharmaceutical regulatory framework in more than two decades. It forms part of the implementation of the Commission’s Pharmaceutical Strategy for Europe, adopted on 25 November 2020. The reform is intended to revise and replace the core EU legislation governing medicinal products for human use, including: • Directive 2001/83/EC, the Pharmaceutical Code, as amended, which establishes the regulatory framework for the authorisation, manufacture, classification, labelling, distribution, sale and advertising of medicinal products for human use • Regulation (EC) 726/2004, the EMA Regulation, which establishes the European Medicines Agency (EMA) and lays down the centralised procedure for the authorisation and supervision of medicinal products The package also incorporates and revises the regimes for orphan medicinal product (OMP) and paediatric medicinal products, currently set out in: • Regulation (EC) 141/2000, the Orphan Medicines Regulation, which lays down the criteria for designating certain medicinal products as orphan drugs to prevent,
PRACTICE NOTES
Background to the EU pharma package The reform of the EU pharmaceutical legislation, also known as the ‘EU pharma package’, is the most significant overhaul of the pharmaceutical regulatory framework in more than two decades. It forms part of the implementation of the Commission’s Pharmaceutical Strategy for Europe, adopted on 25 November 2020. The reform is intended to revise and replace the core EU legislation governing medicinal products for human use, including: • Directive 2001/83/EC, the Pharmaceutical Code, as amended, which establishes the regulatory framework for the authorisation, manufacture, classification, labelling, distribution, sale and advertising of medicinal products for human use • Regulation (EC) 726/2004, the EMA Regulation, which establishes the European Medicines Agency (EMA) and lays down the centralised procedure for the authorisation and supervision of medicinal products The package also incorporates and revises the regimes for orphan medicinal product (OMP) and paediatric medicinal products, currently set out in: • Regulation (EC) 141/2000, the Orphan Medicines Regulation, which lays down the criteria for designating certain medicinal products as orphan drugs to prevent,
PRACTICE NOTES
The table lists completed European Commission phase I merger investigations since 13 June 2013. For information on ongoing Commission merger investigations, see EU mergers–ongoing cases tracker. For information on completed Commission phase II merger investigations, see EU phase II mergers—closed cases tracker. For information on completed EU merger enforcement actions, see EU mergers enforcement actions—closed cases tracker. For details of appeals before the General Court, see General Court appeals—ongoing cases tracker; for details of appeals before the Court of Justice, see Court of Justice appeals—ongoing cases tracker. 2026 Parties (Case number) Industry sector Decision Société Générale/Vodafone/OXG Glasfaser (M.12567) Wired, wireless, and satellite telecommunication activities • Cleared—25/09/2026 (simplified merger procedure)M.12567—Société Générale/Vodafone/OXG Glasfaser• Notification—03/09/2026 Aequita/Sabic Europe (M.12513) Manufacture of other organic basic chemicals • 25/09/2026 (simplified merger procedure)• Notification—0309/2026 Kesko/Dahl (Denmark, Norway, Sweden) (M.12516) Wholesale of other machinery and equipment • Cleared—24/09/2026 (simplified merger procedure)• Notification—02/09/2026 M&G/Arini/reno De Medici (M.12612) Manufacture of pulp, paper and paperboard • Cleared—24/09/2026 (simplified merger procedure)M.12612—M&G/Arini/reno De Medici• Notification—01/09/2026 Genstar Capital/Stone Point/Ascensus Group (M.12610) Other activities auxillary to financial services, except insurance and pension funding •
PRACTICE NOTES
The table lists all completed European Commission phase II merger investigations since 2000 as well as other merger related investigations (eg failure to notify). For information on ongoing Commission merger investigations see EU mergers—ongoing cases tracker. For information on completed Commission phase I merger investigations see EU phase I mergers—closed cases tracker. For information on completed EU merger enforcement actions see EU mergers enforcement actions—closed cases tracker. For details of appeals before the General Court, see General Court appeals—ongoing cases tracker; for details of appeals before the Court of Justice, see Court of Justice appeals—ongoing case tracker. 2026 Case Industry sector Issues Decision TIL/Hutchison Ports/TERCAT (M.11811) Sea and coastal freight water transport Horizontal overlaps horizontal overlaps in the relation to the provision of container terminal services • Notification withdrawn—11/08/2026• Deadline suspended—08/01/2026• Deadline extended—15/12/2025• Referred to phase II—10/12/2025 UMG/Downtown (M.11956) Sound recording and music publishing activities Horizontal overlaps in the wholesale distribution of recorded music and the supply of artist label services • Cleared, subject to commitments—13/02/2026M.11956—UMG/Downtown• Commitments submitted—11/12/2025• Statement of objections issued—24/11/2025• Deadline suspended—02/09/2025•
NEWS
MLex: The EU’s method for counting platform users is creating legal uncertainty beyond current fee disputes involving Big Tech companies such as Meta and TikTok. For smaller and hybrid services, the lack of a clear counting methodology could determine whether they cross the EU's digital services law's 45 million-user threshold and come under direct European Commission supervision. Those questions are likely to become clearer once the EU court rules on pending challenges, and if that requires the Commission to give more details on the calculation.
NEWS
Mlex: EU institutions failed to reach agreement on EU AI Act amendments after 12 hours of talks, with disputes over how the law interacts with sectoral rules blocking progress. Negotiations were paused, with a new meeting expected in around two weeks, raising concerns about delays to time-sensitive provisions on high-risk AI systems.
NEWS
Law360, London: The EU will delay planned trade countermeasures for the next six months, including tariffs on over €93bn of US goods entering the bloc, as the EU and US work toward implementing the framework trade deal agreed to on 27 July 2025, a spokesperson for the European Commission said
GLOSSARY
Preliminary ruling is a decision rendered by the CJEU on a question referred by a court or a tribunal of a member state on the interpretation of Union law or the validity of a Union act.
NEWS
The Council of the EU has published its decision, Council Decision (EU) 2024/1277 of 29 April 2024, in the Official Journal of the EU on 3 May 2024 authorising the European Commission to participate on behalf of the EU in negotiations with the World Intellectual Property Organization (WIPO) to conclude an international legal instrument creating the first global disclosure mechanism for patents ‘materially/directly based on’ genetic resources and associated traditional knowledge.