The role of the Korea Orphan and Essential Drug Center (KOEDC) has become more prominent as the Lee Jae Myung administration has made “strengthening the supply chain of national essential drugs” a key national priority.

As a candidate, President Lee said on his social media, "In the last five years, the supply of about 100 national essential drugs has been suspended due to sluggish sales and deteriorating profitability. Disruptions in the supply of essential drugs eventually damage people. The government will take responsibility and support the supply of essential drugs."

"We will expand the emergency introduction of essential drugs through this center and actively support Korean pharmaceutical companies," Lee said, referring directly to KOEDC under the Ministry of Food and Drug Safety (MFDS).

Kim Young-rim, who took office in May as the CEO of KOEDC, met with a group of journalists on Tuesday to explain the center's key initiatives and future directions. Kim's remarks were in line with President Lee's policy.

“The issue of drug supply is important globally," Kim said. “We will actively identify and pursue government tasks to ensure a stable supply of rare and essential drugs and strengthen the center's functions. Although we are a small organization of about 30 people, we will grow into a ‘small but strong agency.’”

Strengthening field monitoring and emergency introduction of essential drugs

Kim's priorities included strengthening the field monitoring system for nationally essential drugs and enhancing the link with urgently needed drugs.

"We will conduct more thorough management and analysis of medicines with concerns about supply disruptions to quickly designate them as urgently imported items and shorten their introduction period in Korea," Kim said. "We will also prioritize the supply of urgently imported medicines and overhaul the management system to maintain appropriate inventory levels."

She added that the center would also strive to lay the foundation for domestic self-sufficiency of national essential drugs.

“We plan to expand domestic order production for new products with urgent healthcare needs and establish a system to produce and supply raw materials for essential drugs highly dependent on foreign countries," Kim added. 

KOEDC is conducting a research project on “Stable domestic supply of national essential drugs.” The first project was conducted from 2022 to 2023, and the second project has been underway since last year. The final research results will be published next year.

“As a result of the first project, we secured the foundation for self-sufficiency for two finished drugs and three raw materials," said Ahn Myung-soo, head of KOEDC's Essential Drug Support Headquarters. "For example, in the case of Myung In Pharm’ Benserazide, we previously used Chinese raw materials, but we successfully developed it domestically and registered it as a raw material with the MFDS."

“However, it is up to the pharmaceutical company's judgment whether (the raw material) will be used as a finished drug," he said. "It may not be used due to drug price issues, but it has been registered in the DMF (Drug Master File) so that it can be used whenever necessary," Ahn said. “Hankook Korus Pharm is also licensed to export amiodarone injection. Commercialization is also possible if technology transfer and R&D continue."

Scarce acetaminophen gains ground for self-sufficiency

KOEDC has also recently secured the foundation for self-sufficiency for acetaminophen. 

"We started researching acetaminophen in the first phase of the project and ended it during the second phase," Ahn said. "We have succeeded in domestic self-sufficiency of raw materials and finished drugs."

"Since we developed the raw materials first, we can produce them independently of global supply chain issues," he said. "We plan to apply for an item license from the MFDS for the finished drug soon."

KOEDC CEO Kim said, "To stabilize the supply chain of rare and essential drugs, securing budget and manpower is more important than in the past. We will do our best to strengthen the center by closely communicating with the new government and related ministries, including the Korea Disease Control and Prevention Agency (KDCA)."