The government will expand the public supply of medicines that are essential for patient treatment but are not stably supplied in Korea. The government will directly supply items with high clinical need among medicines that patients had been purchasing directly from overseas.
The Ministery of Food and Drug Safety said on the 14th that, as a follow-up to the plan to strengthen support for rare and severe intractable diseases, it has shifted 10 medicines that had been brought in for self-treatment to public supply through the emergency import of medicines system. Starting this year, the government plans to convert at least 10 items annually into emergency import medicines.
The emergency import of medicines system allows the government to directly supply certain overseas medicines not approved in Korea after considering clinical need and the possibility of substitution with other medicines. The Korea Orphan & Essential Drug Center secures the medicines overseas and supplies them to domestic patients and medical institutions.
The items converted this time are medicines that are essential for patient treatment or have high import volumes into Korea, making direct government supply necessary. Key items include: ▲ rifampicin injection used to treat tuberculosis patients ▲ cisatracurium injection ▲ hydroxocobalamin injection used to treat cyanide poisoning patients ▲ levothyroxine injection used to treat mucocele syndrome ▲ tobramycin inhalation used to treat cystic fibrosis patients infected with Pseudomonas aeruginosa.
The Ministery of Food and Drug Safety is also actively identifying medicines for emergency import that have become hard to obtain in clinical settings due to product withdrawals or supply suspensions by pharmaceutical companies. Based on supply requests from medical institutions, the pharmacy sector, and professional societies and organizations, the agency newly recognizes items as emergency import medicines and resumes domestic supply. Recently, four items, including cisatracurium injection and avexitilamab injection, were newly recognized as emergency import medicines.
When the revised Pharmaceutical Affairs Act takes effect in Nov., legal grounds will be established for public supply operations such as emergency imports and made-to-order manufacturing for medicines with unstable supply.
A Ministery of Food and Drug Safety official said, "We will continue to expand the public supply system so that medicines needed for patient treatment can be supplied stably, thereby guaranteeing patients' right to treatment."