Photo of Max Jerman

Max Jerman

Max Jerman is an associate in the Life Sciences Practice group. Max advises clients across a wide range of regulatory and compliance issues in the pharmaceutical, food, and cosmetics sectors, with a focus on EU and Italian regulatory advice. He is a native Italian and Slovenian speaker.

On February 26, 2026, the European Union published Directive (EU) 2026/470 on the simplification of the Corporate Sustainability Due Diligence Directive (“CSDDD”) and the Corporate Sustainability Reporting Directive (“CSRD”) in its Official Journal, clearing the final step in the Omnibus I legislative process.

This blog post: (i) summarizes the substance

Continue Reading EU CSDDD/CSRD Omnibus Published in Official Journal: Transposition, Delegated Acts, and Guidelines Are Next

On November 5, 2025, the Spanish Ministry for Ecological Transition and Demographic Challenge (“MITECO”) adopted a Resolution setting out the National Plan for the control of compliance with access and benefit-sharing (“ABS”) obligations under Regulation 511/2014 implementing the Nagoya Protocol in the European Union.  The National Plan sets out a “risk-based” control system to ensure that life sciences companies in, e.g., the pharmaceutical, plant breeding, cosmetic and other sectors operating in Spain utilize genetic resources (“GRs”) and associated traditional knowledge (“ATK”) in compliance with ABS rules of the country where the GRs and ATK are accessed. We provide more details below.

Building on the existing ABS framework in Spain, and in particular on the Royal Decree 124/2017, the MITECO adopted a National Plan setting out a “risk-based” control system, mandating the competent authorities of the Autonomous Communities (“the authorities”) to perform controls on users of certain sectors that are more likely at risk of utilizing GRs and ATK in violation of ABS rules.  

Continue Reading ABS Enforcement Expected in Spain: Spain Adopted a National Plan to Enforce Access and Benefit-Sharing Rules

The Spanish Ministry for Ecologic Transition and Demographic Challenge (“MITECO”) has launched a public consultation on a Draft Royal Decree (“Draft Royal Decree”) that would impose strict energy efficiency and sustainability requirements on data centers in Spain.  The proposed requirements of the Draft Royal Decree are broader and stricter than the requirements on data centers set out in the EU’s Directive (EU) 2023/1791 (the “Energy Efficiency Directive” or “EED”) that the Draft Royal Decree aims to transpose.  Among other things, the Draft Royal Decree imposes requirements to report on the socio-economic impact of data centers; and to comply with the European Code of Conduct on Data Centre Energy Efficiency (“EU CoC”), and with industry best practices.  The Draft Royal Decree is subject to an ongoing public consultation and interested parties may submit their comments until September 15, 2025.

In this blog post we outline the requirements of the Draft Royal Decree that are stricter than those of the EED.

Continue Reading Spain Proposes Strict Sustainability Requirements for Data Centers

On October 12, 2023 the Italian Data Protection Authority (“Garante”) published guidance on the use of AI in healthcare services (“Guidance”).  The document builds on principles enshrined in the GPDR, national and EU case-law.  Although the Guidance focuses on Italian national healthcare services, it offers considerations relevant to the use

Continue Reading Italian Garante Issues Guidance on the Use of AI in the Context of National Healthcare Services