South Korea to inspect clinics suspected of illegally selling obesity self-injection drugs
In short
South Korea's Ministry of Health and Welfare said on 22 October that it will carry out on-site inspections, together with local governments, of medical institutions suspected of illegally dispensing and selling obesity self-injection drugs on their premises. The targets are institutions with high nationwide supply volumes. Violations can bring prison terms, fines or licence suspensions under the law.
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South Korea's Ministry of Health and Welfare said on 22 October that it will conduct on-site inspections, together with local governments, of medical institutions suspected of illegally dispensing and selling obesity self-injection drugs on their premises. According to Yonhap and Newsis, the targets are institutions with high supply volumes nationwide. [ 1 , 2 , 3 ]
The reports explain that self-injectables are prescription drugs made for patients to administer themselves. Under the Pharmaceutical Affairs Act they must be used after a doctor's prescription and a pharmacist's dispensing. An exception applies when a medical institution injects the drug to teach the patient how to do so. Yonhap and Newsis wrote that in-house dispensing and sale is possible only in that case, and Newsis said the ministry had guided institutions accordingly. [ 1 , 2 , 3 ]
The ministry said that some institutions are now selling considerable quantities directly without injecting the drug into patients, and that such cases are rising sharply. Yonhap said the issue arose over the in-house sale of obesity self-injection drugs such as Wegovy and Mounjaro. [ 1 , 2 , 3 ]
The inspections will check compliance with the principle of separating prescribing and dispensing, and the ministry plans to take action under the relevant laws where violations are found. Seoul Economic Daily and Newsis reported that violating the principle can bring up to one year in prison or a fine of up to 10 million won under the Pharmaceutical Affairs Act. Under the Medical Service Act, failing to issue a prescription can bring a 15-day licence suspension on the first offence and 30 days for a repeat offence within two years. [ 1 , 3 ]
The ministry said it will keep checking supply volumes of the drugs by institution after this inspection and step up supervision of illegal in-house dispensing and sale. [ 1 , 3 ]
Kwak Sun-heon (곽순헌), the ministry's health care policy official, said demand for obesity self-injection drugs is increasing but must not lead to illegal drug sales outside the principle of separating prescribing and dispensing, according to Seoul Economic Daily and Newsis. He said the ministry will strengthen management and supervision so that the principle is faithfully observed in the field. [ 1 , 2 , 3 ]
Why it matters
The inspections test whether clinics follow the rule that these prescription drugs must go through a doctor's prescription and a pharmacist's dispensing. The ministry said it will keep monitoring supply volumes by institution after this round.
Key facts
- The Ministry of Health and Welfare announced on 22 October that it will conduct on-site inspections with local governments. [ 1 , 2 , 3 ]
- The inspections target institutions with high nationwide supply volumes of obesity self-injection drugs that are suspected of illegal in-house dispensing and sale. [ 2 , 3 ]
- Under the Pharmaceutical Affairs Act, self-injectables are prescription drugs that must be used after a doctor's prescription and a pharmacist's dispensing; injecting the drug at the institution to teach the patient is an exception. [ 1 , 2 , 3 ]
- The ministry said some institutions sell considerable quantities without injecting the drug into patients, and that such cases are rising sharply. [ 1 , 2 , 3 ]
- Violating the prescribing-dispensing separation principle can bring up to one year in prison or a fine of up to 10 million won under the Pharmaceutical Affairs Act. [ 1 , 3 ]
- Yonhap named Wegovy and Mounjaro as examples of the obesity self-injection drugs involved. [ 2 ]
Confirmed by several sources
- The ministry will inspect institutions suspected of illegal in-house dispensing and sale of obesity self-injection drugs, with local governments. [ 1 , 2 , 3 ]
- The ministry said it will take action under the relevant laws if violations are found. [ 1 , 2 , 3 ]
- Under the Medical Service Act, failing to issue a prescription can bring a 15-day licence suspension on the first offence and 30 days for a repeat offence within two years. [ 1 , 3 ]
- The ministry said it will keep checking supply volumes by institution after this inspection. [ 1 , 3 ]
Still unclear
- How many institutions will be inspected, which ones, and when the inspections will take place. The documents describe the targets only as institutions with high supply volumes suspected of violations and give no number, names or schedule.
- How large the increase in direct sales has been. The documents say cases are rising sharply but give no figures.
- Whether any violations have been found. The inspections had only been announced when the documents were published.