1. Reason for amendment
With the amendment of the Bioethics and Safety Act(Act No. 17783, promulgation on December 29, 2020, enforcement on December 30, 2021) in relation to gene therapies and gene tests and, based on institutional committees’ review related to gene therapy research and counseling system of national committees, regulations on report to meet the purposes of gene test institutions, liability of gene test institutions for the assessment of expert level and education of employees, and certification for gene test institutions to perform gene tests for consumers are promulgated, the aim is to decide legally delegated matters and matters needed for execution thereof.
In addition, it is intended to improve matters on the registration and functions of and delegation to institutional committees for which the issues of burden of management have been raised in the field due to insufficient regulations concerned and to improve the regulations on the treatment of gene test records in case of suspension/closing of test institutions and on the consent to embryo preservation depending on the collection time of reproduction cells.
2. Main content
A. Liability for institutional committees’ review of gene test research plans is established, and matters on the review standard and procedure to request national committees are decided to meet the counseling system of national committees (Article 42-2).
B. As gene test institutions shall be reported to meet their purposes, the standards and procedures needed for report and acceptance thereof, etc. to meet the purposes are established, and changes in the purposes shall be reported (Article 46).
C. As the liability for assessment of expert level of gene test institutions is established, matters on the content and procedure, etc. of assessment are decided (Article 48).
D. As a certification system is executed for gene tests to be conducted directly for consumers, matters needed for the standards and procedure of the certification, management of gene test items, post-certification institution management, and designation of education institutions, etc. are established (Articles 48-2 through 48-5).
E. With the liability of gene test institutions for the education of employees established, matters on the content and method, etc. of the education are decided (Article 48-6).
F. In relation to information including advertisement materials to be supplied to the subjects of gene tests to be conducted directly for consumers, the legal basis for review and approval of the adequacy is provided, and the necessary matters are decided (Article 50).
