Addressing Environmental Law Requirements and Risks in the Pharmaceutical Sector

• Jurisdiction: European Union
• Year: 2024

Speaker

Geneviève Michaux and Georgios Symeonidis are legal experts in EU life sciences regulatory law, advising pharmaceutical, biotech, medical device, and food sector companies on compliance, market access, and product lifecycle management.

Geneviève, a Belgian- and French-qualified lawyer, is recognized as a leading regulatory specialist in drug, biologic, medical device, cosmetic, and food law, with expertise in clinical trials, advertising and promotion, pediatric and orphan drugs, and ATMP regulations. She has extensive experience in product liability litigation and regulatory strategy for startups and established companies.

Georgios, an EU regulatory specialist, focuses on clinical research, product classification, marketing authorization, and EU compliance, having worked at an international law firm and the European Commission’s DG SANTE on key legislative developments.

Both frequently engage with EU authorities, contribute to regulatory discussions, and are fluent in multiple languages, ensuring strategic guidance for clients navigating the complex EU regulatory landscape.

Topic

The presentation provides an in-depth analysis of environmental law requirements and risks in the EU pharmaceutical sector, delivered by Geneviève Michaux and Georgios Symeonidis at the ERA Annual Conference on EU Law in the Pharmaceutical Sector 2023. It highlights the increasing role of environmental compliance in pharmaceutical regulations, including the revision of the EU General Pharmaceutical Legislation and Environmental Risk Assessment (ERA) requirements.

A key focus is the expansion of environmental obligations, particularly the new ERA framework, which now includes antimicrobial resistance (AMR), genetically modified organisms (GMOs), and stricter post-authorization monitoring. The session details how regulatory authorities may refuse marketing authorizations (MA) or impose additional environmental conditions on medicinal products that pose risks to public health and ecosystems.

The presentation also explores the Corporate Sustainability Reporting Directive (CSRD), which mandates enhanced ESG (Environmental, Social, and Governance) reporting for pharmaceutical...