Masterarbeit

Comparative Analysis of Sustainability Requirements for Medicinal Products: A Transatlantic Perspective between the European Union and the United States ***

Carina Uhe (2025)

Summary:

Language: English

This thesis undertakes a comparative legal analysis of how environmental sustainability is integrated into the regulation of medicinal products in the European Union (EU) and the United States (US). It addresses two interrelated research questions: how sustainability requirements for medicinal products in the EU compare to those in the US and what the principal similarities and differences are between the EU’s proposed pharmaceutical legislation and the current US framework in addressing environmental sustainability. Methodologically, the study combines a structured review of primary legislation and guidance (European Commission and European Medicines Agency; US Food and Drug Administration and Environmental Protection Agency), a scoping review of the academic and grey literature, a decision‐analysis matrix with qualitative risk assessment, and two illustrative company case studies (Novartis; Teva).

Findings indicate a marked asymmetry. The EU’s reform trajectory, centred on the 2023 pharmaceutical reform proposals and complemented by adjacent instruments, advances a lifecycle approach that strengthens environmental risk assessment (ERA), enables post-authorisation risk-mitigation measures (RMMs) as enforceable obligations and enhances transparency. By contrast, the US regime concentrates environmental review at the point of authorisation under the National Environmental Policy Act with extensive categorical exclusions, while most environmental controls operate through media or facility-based instruments that are only loosely coupled to product lifecycle regulation. For multinational companies, the EU model sets a de facto global baseline for stewardship, supply-chain controls, disclosure, and design incentives, albeit with non-trivial data and capability demands.

The discussion translates these results into actionable recommendations: 

i. proportionate, trigger-based lifecycle obligations,

ii. standardised, machine-readable ERA artefacts,

iii. public templates for risk-mitigation and 

iv. adoption by companies of an EU-aligned global baseline to reduce regulatory friction. 

The thesis concludes that near-term, pragmatic transatlantic convergence is feasible through technical crosswalks, shared data standards and post-authorisation triggers, offering scope to minimise duplicative burden while improving environmental outcomes.

Pages: 66

Annexes: 0, Pages: 0