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Background: Recently, the fields of biotechnology and genetic engineering have been given great emphasis by most of the countries from all over the world. It is proven that genetic living organism could be successfully manipulated and redesigned using various applications of biotechnological sciences. Similarly, this overwhelming advancement of science has also encouraged the government of Malaysia to put great emphasis to this biotechnology evolvement. Given that this industry is believed to be the prominent key areas in generating economic growth, various incentives, investments, effective research and medical devices have been successfully conducted and developed. While the use of this novel technology is increasingly tremendous, so does the field of human gene therapy. Current trends signify that gene therapy technique has been widely used as it has been proven to be a successful treatment for cures of epidemic diseases in human at the molecular level. It has nevertheless been found that this technique has been associated with a wide range of ethical and legal issues. In view of this point, this study seeks to examine the legal issues surrounding human gene therapy. On this, special concentration would also be paid to the legal provision and regulation currently enforced in few selected countries governing human gene therapy. Considering that there has been absence of legislative regulation to regulate gene therapy treatment and activities in Malaysia, this study further recommends that it is essentially indispensible for Malaysia to also having a set of legal and regulatory framework in place. To achieve this, this study …