SOUTH KOREA Law and Practice Contributed by: Keum Nang Park, Eileen Jaiyoung Shin, Jeonghoon Hong and Soo Yeon Park, Lee & Ko
8.5 Regulation of Prescriptions and Dispensing by Pharmacies After the separation of prescribing and dispens- ing in 2000, only physicians can prescribe drugs in hospitals, and only pharmacists can dispense drugs in pharmacies (this applies to the case of outpatient only, and dispensing drugs in pharma- cies within the hospital is possible for inpatients). In order to prevent the over-prescription of nar- cotic or psychotropic drugs such as propofol, monitoring of prescription details is performed through HIRA’s big data management system.
There is a difference in the way pharmaceuti- cals and medical services are covered by health insurance. In the case of pharmaceuticals, prod- ucts not listed on the reimbursement list are not covered by health insurance (positive-listing system). When a manufacturer or importer sub- mits a request for reimbursement for a pharma- ceutical product that has obtained marketing authorisation (MA), the product undergoes an evaluation of reimbursement appropriateness by HIRA. Subsequently, negotiations with the NHIS determine the maximum reimbursement amount. This process establishes the product’s eligibility for health insurance coverage, the cri- teria for such eligibility, and the maximum reim- bursement amount. Finally, the MOHW includes the product on the reimbursement list. However, in the case of medical services, the MOHW stip- ulates medical services not covered by health Pharmaceuticals and Medical Devices Where drugs are concerned, it is the principle of the positive listing system to determine the eligibility for reimbursement and reimbursement amount on the basis of HTA (health technology assessment – ie, cost-utility analysis). In the case of pharmaceuticals for treatment of cancer or orphan diseases, however, economic evalu- ation may be omitted if certain criteria are met. Meanwhile, for medical devices, the cost-effec- tive analysis would play a minor role only to a limited extent in determining the eligibility for reimbursement and reimbursement amount. insurance (negative-listing system). 8.4 Cost-Benefit Analyses for
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