“External environmental factors such as the spread of COVID-19 and the war between Ukraine and Russia have made domestic drug supply and demand abnormal. On January 15, Korea Rare Essential Medicines Center appointed Kim Jin-seok (58, Kyungsung University College of Medicine), former deputy director of the Ministry of Food and Drug Safety, as the 13th director.

The KODC, which was established to provide various information on orphan drugs and national essential drugs, is currently managing 511 items of national essential drugs and 315 cases of orphan and essential drugs submitted to the on-site supply and demand monitoring center. A total of 179 items and 14,732 drugs were supplied by the KODC last year, worth 44.2 billion won. Nine free support programs that connect pharmaceutical companies and patients are also in operation, through which 969 new drugs in clinical trials were supplied. Director Kim met with reporters from the Ministry of Food and Drug Safety on the 21st and revealed his ambition to be appointed director of the KODC after 8 months of vacancy.

The following is a Q&A from Director Kim.

▶ As the director was appointed after 8 months of vacancy, it seems that there was a setback in the project.

"There was a long hiatus for eight months after the former director's resignation. During this period, there was a shortage of medicines around the world due to the outbreak of COVID-19 and monkeypox. Korea was no exception, and monitoring of essential national medicines and supply shortages of medicines occurred. We are aware of the need for a domestic supply of drugs, so this year we plan to focus our efforts on the stable supply of national essential medicines. As in the case of last year’s case where the center urgently imported from Australia to solve the domestic shortage of antipyretics and analgesics due to COVID-19, domestic We will develop our capacity so that the center can play a big role in the stable supply of medicines.”

▶ Please explain the promotion project in a little more detail.

“As revealed in the name of the center, the primary goal is to supply medicines that have lost their market function, such as orphan drugs and national essential medicines, from state institutions. Whether it is an orphan drug, an essential drug, or a drug with usage monitoring, a situation in which supply and demand arise means that the function of the market appears in an abnormal situation. It depends on whether or not, but for orphan drugs, at least a network is built with data on suppliers and countries. This year, it plans to build an information network for essential medicines and medicines that require on-site supply and demand monitoring. The Ministry of Food and Drug Safety signed a contract for a consignment project to build an information network last week. Internally, a program is being developed to increase the accuracy of usage statistics for essential medicines. We will complete it within this year so that production and usage can be predicted based on statistical data. "

▶ Recently, there have been cases of drug price adjustments due to shortages, and we know that orphan essential drugs have the biggest concern about profitability. Are there separate studies in this regard?

“Because the center is a non-profit corporation under the Ministry of Food and Drug Safety and does not operate a profit-making business, there is no need to adjust the price of medicines supplied by the center due to a shortage of medicines. There was a case that this center that had an impact on the drug price. Last year, the drug price of 'Natasin Eye Suspension' was adjusted due to the increase in the unit price of medicine."

▶Please explain the on-site drug supply and demand monitoring project.

“The center is operating an on-site supply and demand monitoring center with 7 professional organizations, including the Korea Hospital Pharmacists Association, the Korean Medical Association, the Korean Pharmaceutical Association, the Korea Pharmaceutical and Biopharmaceutical Association, the Global Pharmaceutical Industry Association, the Korea Biopharmaceutical Association, and the Korea Pharmaceutical Distribution Association. Each organization When a request for medicines in need of supply is made through expert consultation, supply-related issues are informed and solutions are sought.”

▶The budget for the center increased from 3.3 billion won last year to 4.6 billion won this year. How will the increased budget be used?

“The main items of the center’s increased budget this year are 490 million won for consignment manufacturing and 600 million won for office relocation, and isoproterenol hydrochloride injection will be introduced as a new consignment manufacturing item to address the need for a stable supply of medicines that have been continuously raised.” We plan to move the center to the Post Tower adjacent to Myeongdong Station in June. The building located along the main road will make it more convenient for users of the center."

▶At the plenary meeting of the Health and Welfare Committee of the National Assembly held on the 9th, it was pointed out that it is necessary to secure personnel exclusively responsible for monitoring the supply and demand situation of medicines in the Korea Rare Essential Drug Center and to establish a close cooperation system with medical and pharmaceutical organizations.

"This year, we plan to strengthen the monitoring of discontinued medicines through the administrative network linked to the Ministry of Food and Drug Safety by further activating the operation of the on-site drug supply and demand monitoring network. In particular, actively promote two-way communication between supply and demand monitoring networks through real-time information sharing with 7 specialized organizations Through this, we intend to strengthen the monitoring of unstable supply together.”