Ethical reflection on human gene therapy in the Chinese context

Area of Science:

• Biomedical Ethics
• Gene Therapy Regulation
• Public Health Policy

Background:

• China approved Genedicine, the first commercial gene therapy, in 2003, but scientific and ethical oversight remains underdeveloped.
• Dissemination of gene therapy knowledge has occurred, yet public perception often misconstrues it as a standard medical treatment.
• Financial conflicts of interest are identified as a significant factor contributing to this therapeutic misconception.

Purpose of the Study:

• To review the historical development of ethical and regulatory frameworks for gene therapy in China.
• To analyze the reasons behind the public's acceptance of gene therapy as a routine intervention.
• To emphasize the ethical imperative of prioritizing patient safety in gene therapy clinical trials.

Main Methods:

• Historical review of ethical and regulatory documents related to gene therapy in China.
• Analysis of public perception and acceptance of gene therapy.
• Examination of financial conflicts of interest within the gene therapy field.
• Ethical analysis of the benefit-harm balance in clinical gene therapy.

Main Results:

• Despite early approval of a commercial gene therapy product, China's ethical review capacity is not robust.
• Gene therapy is frequently perceived as a routine medical intervention, a misconception fueled by financial conflicts of interest.
• The balance between therapeutic benefit and potential harm requires careful scientific and moral consideration.

Conclusions:

• "Do no harm" must be the paramount principle in gene therapy clinical trials, especially given unresolved technical challenges.
• Strengthening ethical review capacity and addressing financial conflicts of interest are crucial for responsible gene therapy development in China.
• A clear distinction between experimental therapy and routine medical intervention is essential for patient safety and informed consent.