South Korea's Ministry of Food and Drug Safety will shift 10 medicines that patients had been importing on their own, including a tuberculosis treatment, into a government-supplied "emergency import" program. Four more drugs that have become hard to obtain at medical sites after pharmaceutical companies withdrew them or halted supply were also newly added to the program, expanding public provision of essential medicines.
The measure follows up on the government's plan to strengthen support for rare and severe intractable diseases announced in January this year, the ministry said on the 14th. Among the drugs that patients had been buying and bringing in from overseas for self-treatment through the Korea Orphan & Essential Drug Center, the ministry converted 10 items that are in high demand at medical sites or are imported in large volumes.
The emergency import program allows the government to supply directly, through the Korea Orphan & Essential Drug Center, overseas medicines that are not licensed in South Korea but are essential to treatment and difficult to replace with other drugs. Unlike the previous approach, in which patients had to obtain overseas medicines individually, the government manages the supply chain.
The items being converted include rifampicin injection, used for patients with severe tuberculosis who cannot take oral medication; tiopronin tablets, which prevent stone formation in patients with cystinuria; hydroxocobalamin injection, a treatment for cyanide poisoning; and levothyroxine injection, used to treat coma caused by severe hypothyroidism. Tobramycin inhalation solution, used to treat Pseudomonas aeruginosa infections in patients with cystic fibrosis, is also on the list.
Treosulfan injection, used in conditioning before hematopoietic stem cell transplants, the hypertension drug labetalol, and phentolamine injection, used for conditions such as pheochromocytoma, will also be converted. The total number of converted items is 10.
Drugs whose domestic supply has been halted or whose licenses have been withdrawn are also included in the program. The ministry added four items that have become hard to obtain at medical sites because of product withdrawals or supply halts by pharmaceutical companies: cisatracurium injection, axatilimab injection, epoprostenol injection and hydrocortisone injection. Cisatracurium is used to relax muscles during general anesthesia or sedation of critically ill patients, and axatilimab treats chronic graft-versus-host disease that can develop after hematopoietic stem cell transplants.
The institutional basis for public supply of essential medicines will also be strengthened. When the revised Pharmaceutical Affairs Act takes effect in November, it will provide a legal basis for emergency imports and made-to-order manufacturing of national essential medicines with unstable supply. Based on this, the ministry plans to expand public supply of drugs that the private sector cannot provide reliably.
