General life sciences

Trackers

Practice Notes: Life sciences tracker—EU and Life sciences cases tracker—EU are intended to be used to track the progress of EU legislative proposals, consultations and judgments relevant to the life sciences sector.

Access to documents

In recent years, we have witnessed a constantly growing interest from all stakeholders (the general public, patients associations, physicians, the pharmaceutical industry and academia alike) to get access to information concerning medicinal products. Under this pressure, both legislators and medicines regulatory authorities have moved towards a more generous approach, giving access to a larger set of documents and information related to the quality, safety and efficacy of medicinal products, than ever before. In the EU, the European Medicines Agency (EMA) is the regulatory body responsible for the protection and promotion of human and animal health. Some of the EMA’s key responsibilities

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Latest EU Law News

EIOPA revokes Guidelines and amends Opinion to align with upcoming DORA

The European Insurance and Occupational Pensions Authority (EIOPA) has announced that, in anticipation of the Digital Operational Resilience Act (DORA) coming into application, it will be withdrawing two previously published Guidelines and amending part of an Opinion. The two Guidelines and Opinion are all related, at least in part, to the use of information communication technology (ICT) by undertakings, and by withdrawing them, EIOPA aims to avoid duplications and overlaps with DORA. The changes will take effect from 17 January 2025.

EIOPA publishes strategic plan and work programme for 2024-2026

The European Insurance and Occupational Pensions Authority (EIOPA) has published its Single Programming Document for 2024-2026, outlining the organisation's strategic priorities and planned activities for the coming years, including the Annual Work Programme for 2024.EIOPAoutlines the evolving macro-economic, political, environmental, technological and sectoral context impacting its work. This includes factors like economic uncertainty, inflation, digitalisation trends, climate change effects, new regulations like the Digital Operational Resilience Act (DORA), Solvency II review, and the expected growth in EIOPA's tasks.

ACER issues opinion on rules for European Network of Network Operators for Hydrogen

The Agency for the Cooperation of Energy Regulators (ACER) has issued its Opinion on the draft statutory documents for the European Network of Network Operators for Hydrogen (ENNOH). ACER has welcomed the draft documents but suggested enhancements to support ENNOH's establishment. The agency emphasised the importance of the timely transposition of certification provisions from the Hydrogen and Decarbonised Gas Market Directive by Member States. ACER's Opinion now awaits the European Commission's response, which is due by 20 March 2025. If favourable, future hydrogen transmission network operators will have until 20 June 2025 to adopt and publish the statutory documents.

Court of Justice clarifies limits on national restrictions for plant-based food labelling (Protéines France and others)

EU law analysis: On 4 October 2024, the Court of Justice ruled in Case C-438/23 that EU law precludes Member States from adopting national measures that prohibit the use of meat-related terms for plant-based products unless a legal designation for such products is established. The Court held that the harmonisation provided by Regulation (EU) No 1169/2011 on food information to consumers (FIC Regulation) prevents Member States from setting thresholds for plant proteins to allow limited use of meat-related terms. This decision is significant for practitioners in food law and consumer protection, as it underscores the primacy of EU regulations in ensuring consistent consumer information and preventing market fragmentation. The ruling also highlights the need for clear legal designations to avoid misleading consumers while promoting fair competition in the food industry. Written by Nicolas Carbonnelle, partner at Bird & Bird LLP.