Xenotransplantation and artificial organs are developing medical innovations aimed at overcoming the shortage of human organ donors. Advances in technologies such as genome editing, CRISPR-Cas9, and bioengineering provide new hope for managing end-stage organ failure. However, these developments also raise various bioethical and legal concerns, including xenozoonosis risk, animal welfare, informed consent, and justice in healthcare access. This study aims to analyze the bioethical and legal regulatory aspects of xenotransplantation and artificial organs within the context of global trends and Indonesia’s regulatory preparedness. The study used a literature review method with a qualitative descriptive and ethical analysis approach. Data were obtained from national and international journals through Google Scholar, PubMed, and ResearchGate published between 2022–2026. The findings show that xenotransplantation has progressed toward the early stage of clinical application in several countries, although ethical, legal, and biosafety challenges remain significant. In Indonesia, specific regulations regarding xenotransplantation are still limited; therefore, stronger legal regulations, bioethical oversight, and multidisciplinary collaboration are needed to ensure safe and ethical implementation of this technology.
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