Abstract

Although China SFDA approved Genedicine as the first commercial gene therapy product, worldwide in 2003, the scientific basis together with the ethical review capacity building is not so strong. Firstly, the author briefly introduces the history of ethical and regulatory thinking on gene therapy in China. Secondly, the author argues that: although significant progress had been made in disseminating gene therapy knowledge to the general public, gene therapy is in many cases accepted as a routine medical intervention for a variety of diseases in China. A fundamental root of such a therapeutic misconception is financial conflict of interest in the field of gene therapy. Finally, the author points out that the balance between “to benefit” and “no harm” is both a scientific evaluation and a moral judgment. “Do no harm” should be the priority in gene therapy clinical trials as long as there are major technical problems unsolved.

Key-words:

Gene therapy, Conflict of interest, Patient interest, Risks and benefits, China.