The Merck "3 Baskets" approach for creating roadmaps to phase out animal testing

Since 2023 the European Commission has been working on a roadmap for phasing out animal testing in chemical safety assessment, and in 2025 the US FDA published a roadmap to phase out animal testing for the pharmaceutical industry. We describe our Merck KGaA strategy across Life Science, Healthcare, and Electronics, introduced in 2021, to reduce animal testing by 50% by 2032 and by 75% by 2040 through our 4R program (Replace, Reduce, Refine, Responsibility). The approach focuses on what we can achieve today and avoids obstructive discussions about unre­solved issues. We have categorized all animal tests currently required for our products into three “baskets” (3B). Basket 1 (Adoption) includes animal tests for which alternatives are available and accepted, including those still required in certain regions. Basket 2 (Adaptation) contains tests for which alternatives are proposed or being developed but that cannot yet be replaced. Basket 3 (Assessment) contains tests for which innovative replacement strategies still need to be developed. This strategy guides effective short-term replacement and directs investments into areas where inno­vation can replace animal testing in the future. It coordinates the way forward for all stakeholders and creates actionable milestones toward a genuine replacement of animal testing. The collabo­rative agreement in 2024 among the members of the European Federation of Pharmaceutical Industries and Associations to adopt the 3B approach, recognized by the European Commission and the European Medicines Agency, highlights its significance as a valuable tool for fostering a more ethical and sustainable science environment across Europe.