Using Human Fetal Tissue to Create Animal Models of Human Disease: Policy and Ethical Implications for the Pharmaceutical Industry and the Issue of Animal Numbers Used in Research

Abstract

The purpose of this study is to investigate the importance of using human fetal tissue to generate new animal models of human disease. The use of human fetal tissue in research has been a subject of debate for decades despite evident benefits. This is largely due to the significant ethical, legal and social issues associated with obtaining fetal tissue following spontaneous or induced abortion. There are also broader societal concerns about the ethics of abortion itself and the potential for someone to unethically and illegally profit from the sale of tissue from an aborted human fetus. This study is concerned mainly with using human fetal tissue to generate animal models for biomedical research. It explores scientific enablement of humanized models using human fetal tissue and their closer relevance to human disease, modeling a human system in a mouse, legal, ethical and regulatory and policy implications in Pharma, and trends of in vivo models use. This case study will show how using human fetal tissue to generate animal models of human disease has been pivotal in the development of multiple biomedical advancements. It will also show that using fetal tissue to create humanized animal models can mimic most components of the human immune system more closely and has proven to offer great opportunities for the discovery of drugs needed by millions of patients worldwide. Importantly, the study will show that using humanized animal models has a direct effect on reducing the overall number of animals used in research. The study presents a harm benefit analysis, possible solutions such as creating an accreditation program for all entities using human fetal tissue, and policy recommendations for the biotechnology industry.