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For each principle, key questions and illustrative examples are provided to help embed ethical reasoning in pharmacovigilance practice, arguing technical and regulatory tools alone cannot resolve dilemmas from rapid innovation, resource limits, and global inequities.",{"@graph":14,"@context":73},[15,34,56],{"@type":16,"itemListElement":17},"BreadcrumbList",[18,23,27,31],{"item":19,"name":20,"@type":21,"position":22},"https://docshare.wps.com","Home","ListItem",1,{"item":24,"name":25,"@type":21,"position":26},"https://docshare.wps.com/document/","Document",2,{"item":28,"name":29,"@type":21,"position":30},"https://docshare.wps.com/document/healthcare/","Healthcare",3,{"item":32,"name":10,"@type":21,"position":33},"https://docshare.wps.com/document/pharmacovigilance-and-bioethics-the-importance-of-a-neglected-relationship/407951/",4,{"url":32,"name":10,"@type":35,"image":36,"author":41,"headline":10,"publisher":44,"fileFormat":47,"inLanguage":8,"description":12,"dateModified":48,"datePublished":49,"encodingFormat":47,"isAccessibleForFree":50,"interactionStatistic":51},"DigitalDocument",{"url":37,"@type":38,"width":39,"height":40},"https://docshare.wps.com/thumbnails/pharmacovigilance-and-bioethics-the-importance-of-a-neglected-relationship/407951.png","ImageObject",300,407,{"name":42,"@type":43},"Marglet","Person",{"url":19,"name":45,"@type":46},"DocShare","Organization","application/pdf","2026-10-30","2026-09-28",true,{"@type":52,"interactionType":53,"userInteractionCount":55},"InteractionCounter",{"@type":54},"ViewAction",8,{"@type":57,"mainEntity":58},"FAQPage",[59,65,69],{"name":60,"@type":61,"acceptedAnswer":62},"What relationship does the study focus on between bioethics and pharmacovigilance?","Question",{"text":63,"@type":64},"The study examines the critical but often neglected link between bioethics and pharmacovigilance, showing how both disciplines support evidence-based therapy and respect for patient rights.","Answer",{"name":66,"@type":61,"acceptedAnswer":67},"Which bioethical principles are used to guide pharmacovigilance practice in the study?",{"text":68,"@type":64},"The study uses four core principles: autonomy, beneficence, non-malefficence, and justice, pairing each with pivotal questions and illustrative examples.",{"name":70,"@type":61,"acceptedAnswer":71},"Why are regulations and digital tools not sufficient to resolve pharmacovigilance ethical dilemmas?",{"text":72,"@type":64},"Because ethical dilemmas can arise from rapid scientific innovation, resource constraints, and global inequities; 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Drug Saf. Regul. 5:1698515 .  \ndoi: 10.3389/fdsfr.2025.1698515  \nCOPYRIGHT  \n© 2025 Alvaro, Müller, Chhibber and Fuentes. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY) . The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.  \nPharmacovigilance and bioethics: the importance of a neglected relationship  \nGiuseppe Alvaro 1*, Michael Müller 1, Richa Chhibber 2 and Robert Fuentes 3  \n1Institute of Pharmaceutical Sciences, Albert-Ludwigs-Universität, Freiburg, Germany, 2Independent drug safety expert, London, United Kingdom, 3Drug InfoNomics, LLC, Sarasota, FL, United States  \nThis study examines the critical, yet often neglected, link between bioethics and pharmacovigilance—disciplines that collectively aim to ground drug therapies in robust evidence and respect for patient rights. Despite their shared mission, scholarly dialogue between these fields remains sparse. This gap is bridged by tracing their historical foundations and addressing key ethical challenges in pharmacovigilance through the lens of four core bioethical principles: autonomy, beneficence, non-maleficence, and justice. For each principle, pivotal questions and illustrative examples are outlined, offering guidance on embedding ethical reasoning into pharmacovigilance practice. It is argued that while regulations, standard operating procedures, and digital tools are indispensable, they cannot alone resolve the ethical dilemmas posed by rapidscientific innovation, resource constraints, and global inequities, and they may reduce safety professionals to mere task executors. Consequently, it is imperative that alongside technical and regulatory progress, pharmacovigilance fosters the study and application of ethical principles in every aspect of its operation. This transformation will recast it from a purely technical function into an equitable guardian of public health, ensuring sound decision-making, promoting public trust, and delivering maximal benefit while upholding human dignity worldwide.  \nKEYWORDS  \npharmacovigilance, bioethics, autonomy, beneficence, non-maleficence, justice, drug safety, public health  \n1 Introduction  \nBioethics and pharmacovigilance are modern disciplines that have rapidly developed in the second half of the 20th century alongside the rapid expansion ofscientific and technical knowledge applied to medicine. This is not accidental: while medical advances have indeed enabled the treatment of once incurable diseases, they have also raised ethical questions and introduced unprecedented risks to human health that must be rigorously evaluated and managed.  \nBoth bioethics and pharmacovigilance aim to ensure that drug treatment and new drug development are based on the integrity of scientific evidence, proper evaluation of the benefit–risk ratio, and respect for patient rights. Based on these premises, a rich production of articles and books investigating the relations and potential synergies between these two disciplines might be expected, but this is not the case. One of the mo","cbCainuWXCb8HnGc","https://ap.wps.com/l/cbCainuWXCb8HnGc","pdf",1025250,16,"English","# Introduction\n## History and role of pharmacovigilance","[{\"question\":\"What relationship does the study focus on between bioethics and pharmacovigilance?\",\"answer\":\"The study examines the critical but often neglected link between bioethics and pharmacovigilance, showing how both disciplines support evidence-based therapy and respect for patient rights.\"},{\"question\":\"Which bioethical principles are used to guide pharmacovigilance practice in the study?\",\"answer\":\"The study uses four core principles: autonomy, beneficence, non-malefficence, and justice, pairing each with pivotal questions and illustrative examples.\"},{\"question\":\"Why are regulations and digital tools not sufficient to resolve pharmacovigilance ethical dilemmas?\",\"answer\":\"Because ethical dilemmas can arise from rapid scientific innovation, resource constraints, and global inequities; the study argues that technical and regulatory measures alone cannot fully resolve these challenges.\"}]","Pharmacovigilance and bioethics: the importance of a neglected relationship | PDF",1790577077]