Harmonized rules for future LCAs on pharmaceutical products and processes

Purpose The manufacturing of pharmaceuticals and their occurrence in the environment generated growing concerns of stakeholders. Life Cycle Assessment (LCA) is a suitable tool to identify potential environmental impacts within the whole pharmaceutical value chain. However, existing pharma-LCAs revealed several methodological shortcomings and challenges. To support the development of future LCAs in the sector, draft Product Category Rules (PCR) for pharmaceuticals for human use and their manufacturing processes are proposed. Methods Existing LCA case studies were evaluated and compared based on the methodological requirements according to the ISO 14044 standard. In addition, PCRs from the pharmaceutical sector, generic LCA standards, and product-specific guidelines were reviewed. Subsequently, overlaps between and deviations from these sources were identified. It was determined whether methodological requirements can be adopted from existing standards and guidelines or whether additional rules or specifications for pharmaceutical products are needed. Results and discussion The overall PCR structure was established in alignment with ISO 14044, ISO TS 14027, and the Guidance for PCR development (GPCRD). For the definition of product groups, the third level of the Anatomic Therapeutic Chemical (ATC) classification system was determined as appropriate level of detail (granularity). The methodological requirements, e.g., the definition of goal and scope, inventory analysis, as well as the impact assessment, were set considering the intended application and the product system. However, the majority of these proposed methodological requirements go beyond current practice in existing pharma-LCAs (e.g., definition of an effect-based functional unit). Moreover, the need for specific rules depending on the active pharmaceutical ingredient (API), the galenic formulation, and regional aspects was described and discussed. Conclusions This work tackles current methodological challenges of LCA application in the pharmaceutical sector by providing harmonized rules to guide future studies on pharmaceutical products and processes. However, modelling the use- and end of life phase as well as considering pharma-specific impacts were revealed as remaining challenges.