Implementing Safe and Sustainable by Design (SSbD) into pharmaceutical innovation

Pharmaceuticals are essential in modern healthcare but can also pose threats for the environment, starting from their resource intensive synthesis to the release of active compounds into ecosystems. The new framework of Safe and Sustainable by Design (SSbD) by the European Commission addresses simultaneously safety and sustainability during chemical and material development. The general SSbD framework needs to be implemented and targeted to different fields and materials. We present here a sector-specific implementation of the SSbD framework to pharmaceuticals, ensuring that drug efficacy and patient safety remain paramount while assessing the environmental and socio-economic impacts. We propose three levels of integration of the SSbD framework, demonstrating where and how safety and sustainability criteria can be most effectively integrated during pharmaceutical R&D. Each of the SSbD framework's steps is interpreted to address unique pharmaceutical concerns. The approach aligns the Hazard Assessment with pharmaceutical regulation and environmental screening; Safe Production and Processing with Good Manufacturing Practices (GMP); Exposure and safety during exposure with pharmacokinetics models such as ADME; Environmental Sustainability Assessment with metrics such as Process Mass Intensity (PMI) and Ex-Ante Life Cycle Assessment (LCA) and the Socio-Economic Assessment with tools like Life Cycle Costing (LCC), Social LCA (S-LCA) and the Handprint approach. Finally, a cost analysis confirms that embedding SSbD during the pharmaceutical R&D increases expenditures only slightly. The suggested approach provides a practical roadmap for aligning pharmaceutical innovation with pressing ecological and societal goals without compromising the crucial pursuit of effective, life-saving therapies. • We propose a tailored roadmap for the implementation of SSbD for pharmaceuticals. • Three integration levels are introduced to embed SSbD in real-world drug development. • Aligns ADME, PMI, LCA, and Handprint Approach for sustainable pharmaceuticals. • A cost analysis shows that SSbD implementation adds <0.2 % to the R&D costs.