1. Reason for revision

The proposed revision aims to supplement some insufficiencies found in the operation of current systems by proposing a method in which a detailed standard is established for adding pharmaceutical prices to essential national medicines using domestic raw materials, primarily by specifying the “Pharmaceutical Price System Improvement Plan for Compensating the Innovation Value of New Drugs and Ensuring Health Security” as announced by the government in December 2023; by partially revising the criteria for the designation of drugs to prevent withdrawal and cost preservation, and the criteria for calculating a company's own equivalent price for drugs with minimum unit indication; and by establishing new criteria for evaluating drugs that require evaluation by considering their impact on health and medical care and the categories of risk-sharing drugs.

2. Main contents

a. Liability of pharmaceutical manufacturers, etc. to apply for an adjustment of the upper limit price of drugs (Article 3 (3) of the draft).

b. Establishment of criteria for evaluating drugs requiring evaluation by considering their impact on health and medical care (Article 7 (1) 2 and Appendix 1-2 of the draft).

c. Adjustment of the maximum reduction rate of the upper limit prices of drugs whose use is linked with their prices (Article 8 (2) 1 and Subsections (a) to (c) of Article 8 (2) 3).

d. Reorganization of the criteria for calculating generic drug prices and surcharges (Appendix 1 of the draft).

e. Establishment of new categories for risk-sharing arrangements applicable to medicines (Appendix 2 of the draft).

f. Revision of the Standard on the designation of drugs subject to withdrawal prevention and cost preservation (Appendix 5 and Form 2, Form 4, and Form 5 of Attachment).