1. Reasons for Amendment
The current Bioethics and Safety Act restricts diseases for which genetic tests may be conducted on embryos and fetuses, and the relevant diseases are listed in the Enforcement Decree and Notice. Diseases have been added via expert consultation National Bioethics Committee deliberation when requested by families with diseases or by experts, etc. However, due to a lack of regulations on the standards and procedures for adding diseases, consultations and Committee deliberations are not held on a regular basis and there are lengthy waits for amending the Notice as required when adding a disease. Families with hereditary diseases also face difficulties in healthy family planning and safe childbirth as it is difficult for them to predict when a disease may be added to the list. Accordingly, this Amendment specifies standards for adding diseases for which genetic tests may be conducted on embryos and fetuses, and aims to prescribe procedures for adding diseases by establishing an advisory committee to periodically review whether diseases should be added in accordance with the standards. It also reduces the time taken to add a disease by changing the method to make a public announcement instead of adding the name of the disease to the current Notice.
2. Major Provisions
A. Prescribe standards and procedures for selecting diseases for which genetic tests may be conducted on embryos and fetuses (Article 21 and Article 21-2)
1) Recent advancements in medical science and technology have identified several genes as the cause of rare and hard-to-cure diseases. This has resulted in growing demand for diseases to be added to the list, and there is a greater need to specify the standards, frequency, and procedures for reviewing diseases.
2) Change the method for adding diseases by having an advisory committee review diseases on a quarterly basis based on the specified standards for disease addition instead of adding diseases via expert consultation and National Bioethics Committee deliberation on an irregular basis without standards or procedures.
