Background: Despite their benefits, transgenic products have been challenged continuously because of their potential consequences on human and ecosystem health. So, production, application and trade of transgenic products has complex and contradictory dimensions that has resulted in developing domestic as well as international protocols during the last two decades. Methods: The objective of present research is to review ethical and legal considerations in biosafety laws worldwide, especially in national biosafety law of Iran. By applying the available data, above mentioned factors were investigated in different countries.
Conclusion: In many regions, including EU, Japan and Malaysia, there are statutory and regulatory laws for the production and trade of transgenic products. There are, also, some questions on ethical issues on application of transgenics in which modification of an organism entity is the most important. To judge about ethical considerations of organism modification, we have to answer some serious questions. Although Iran is not yet an official producer and there is no any official import of transgenics, but it is predicted that the country joins to the producers and consumers in near future. National biosafety law of I.R. Iran, passed on 2009, however, has some legal deficiencies in the aspect of developing a comprehensive legal framework for transgenic products. The most important case in this view is the necessity of a legal system for these products and civil liability of operators. An important critic to this law relates to strict liability and system of payment for damages to the victims.