Gene Fusion is common phenomenon when we perform the biomedical research or medical practices. For example, when we try to make aseptic piglet for producing cells, tissues or organs which will be used in transplantation, human gene may be inserted into the piglet`s bodies. Or when we transplant the animal cells, tissues or organs into the human bodies, gene fusion also may happen. Some suggest that gene fusion should be banned. They argue that gene fusion will harm to human identity and human dignity and new severe diseases may wildly spread. Human dignity is supreme principle and human identity is core concept, but those are very general and vague concepts. Safety issue is more important in practice. There are two dimensions in risk analysis of gene fusion; risk of the patient who are taken the animal cells, tissues or organs, and the risk of the human species. Risk to individual patient may be overcome by informed consent of the patient. But the risk to human species is not overcome by individual`s informed consent. If we can`t prevent risk to human species when we perform gene fusion, those kinds of gene fusions should be banned. There are some provisons in which aim to regulate gene fusion. bans fusion of eggs, sperm and embryos of animals and humans. That also bans fusion of more than two human embryos. But there is no provision that regulates the somatic cell gene fusion. When we try to regulate biotechnology, including gene fusion, ethical guidelines and clinical guidelines are more effective means than legal regulatory framework. In legal regulatory framework, procedural regulation is more important than substantial regulation.