Omnibus I – Understanding the EU’s Simplification Package and What It Means for the Off-Patent Sector
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Life Cycle Assessment (LCA): Understanding its role – and why it’s not a good fit for off-patent medicines
This session explored the theory and practical implications of Life Cycle Assessments (LCAs) for the pharmaceutical off-patent sector. It began with an overview of what LCAs are — comprehensive tools used to assess environmental impacts across all product life-cycle stages — and underlined their limitations when used for product comparison. Medicines for Europe explained why LCAs, while valuable, may not suit the off-patent medicines industry, given data complexity, costs, and the risk of market distortion if applied in tenders. The session also featured insights on France’s EcovaMed tool and the BSI PAS 2090. The discussion confirmed that while LCAs have value, more practical, sector-specific methods — such as targeted carbon footprinting — may be better suited to advancing sustainability in the off-patent medicines sector.
Getting Ready for the Green Claims Directive
This session provided a practical introduction to the Green Claims Directive and its relevance for the off-patent pharmaceutical industry. Following a clear overview of the proposed rules, two business cases offered complementary insights: Nestlé shared cross-sector lessons from their early preparations, while Zentiva presented the pharma perspective, highlighting sector-specific challenges and readiness steps. The session concluded with a practical checklist to help companies begin internal planning.
Chemicals in the Spotlight: What PFAS, F-Gases, REACH and Other EU Rules Mean for Generic and Biosimilar Medicines
This session explored key EU chemicals legislation developments, including PFAS restrictions, the revised F-Gas Regulation, and REACH reform, and their potential impact on pharmaceutical manufacturing. Industry and regulatory experts highlighted compliance challenges, substitution issues, and the importance of early preparation.
Trends in the Inclusion of Sustainability Criteria in Procurement
This session examined emerging procurement policies across Europe, with insights from the Czech Ministry of Health, an overview of divergent national approaches (UK, France, Nordics), and company experiences on aligning operations with evolving sustainability requirements.
Principles of Responsible Manufacturing of Antibiotics (AMR Industry Alliance)
The webinar featured insights on certification processes, procurement perspectives from the Nordic Procurement Forum, and practical industry case studies.
EU Deforestation Regulation (EUDR)
Legal experts from Mayer Brown presented an in-depth overview of the EUDR, its scope, due diligence requirements, and compliance challenges, followed by a discussion on best practices.
Implementation of the Corporate Sustainability Reporting Directive (CSRD)
This session explored the implications of the CSRD for our sector, featuring concrete industry experiences.