Regulatory Problems in Radionuclide Therapy and Suggestions for Systematic Improvement

방사성동위원소 치료의 제도적 문제점과 개선

Radionuclide therapy has been used for more than 50 years and proved to be a safe and effective modality. However, the patients' right to have the excellent medical service is seriously disturbed by excessive regulations of government institutions such as Korea Institute of Nuclear Safety (KINS), Health Insurance Review Agency (HIRA) and Korea Food and Drug Administration (KFDA). For example, the patients should wait for more than 6 months to have I-131 treatment in many hospitals it is strongly recommended to mitigate the regulations to resonable levels to solve the problems. If HIRA allow the hospitals to charge reasonable rate for radionuclide therapy room, then more hospitals would invest to build the radionuclide therapy rooms and the patients' waiting time would decrease. The waiting time would also decrease, if KINS allow 2 patients to share a radionuclide therapy room. Finally, it is strongly recommended to lower the threshold for approval of new therapeutic radiopharmaceuticals by KFDA, which would allow new effective therapeutic raoiopharmaceuticals to be introduced to clinical practices more easily.