KOREA
Appeals court to decide legality of oriental medicine practitioner's use of lidocaine기자명 Koh Jung Min
Published 2024
KOREAN BIOMEDICAL REVIEW
The appeals process of the case concerning an oriental medicine practitioner’s use of lidocaine has been completed, leaving only the trial court's verdict. Lidocaine is a local anesthetic used to numb tissue and relive pain.
The medical community is watching to see if the ruling that banned the use of specialized drugs by oriental medicine doctors, unlike the legal verdict on their use of diagnostic equipment, such as ultrasound devices and electroencephalographs (EEGs), will be upheld.
The Seoul Southern District Court trial addressed whether the use of lidocaine by oriental medicine practitioners was illegal. (Source: The court’s website)
On Thursday, the Seoul Southern District Court's Criminal Division held the final arguments of the appeal hearing against an oriental medicine doctor, initialized as just Mr. A, who was charged with violating the Medical Service Act by mixing local anesthetic lidocaine in a medicine needle.
The oriental medicine practitioner was accused of practicing medicine without a license by injecting 87 patients with lidocaine mixed with bee venom solution into painful areas for two months from November 2021. On Nov. 10, 2023, a lower court found him guilty of unlicensed medical practice, as the use of lidocaine was outside the scope of his license.
“Lidocaine is a specialty drug that must be licensed in Western medicine and used under the direction and supervision of a physician, and so an oriental medicine practitioner cannot prescribe and dispense lidocaine, nor can he administer and use it,” the lower court said. “It is also difficult to believe that Mr. A has been rigorously verified to have Western medical expertise and skills to use lidocaine.”
The court also said that as lidocaine is injected directly into the body with a syringe, “there are health and hygiene risks associated with the use of specialized drugs,” and “it cannot be considered an auxiliary tool for traditional Chinese medicine (TCM) practice since it is an invasive method. It added that specialty drug use could not be authorized for oriental medicine practitioners along the same lines as diagnostic equipment, such as ultrasound and electroencephalographs.
The oriental doctor appealed the first court ruling and immediately appealed. The Association of Korean Medicine (AKOM), a group of oriental doctors, also supported A, arguing that it is legal for a TCM doctor to use lidocaine as an aid. Members of the association attended the final arguments in the second trial.
Defendant argues he ‘used the drug to the lowest limit for pain relief’
In court, Mr. A's defense team presented a video of the actual needle manufacturing and procedure.
Regarding the “health and hygiene harm caused by injecting lidocaine into the body with a syringe” pointed out by the first trial court, Mr. A countered that lidocaine should be viewed as “mixing the drug with a pain-free agent in the process of preparing the needle rather than directly injecting it into the body.” He also said, “In the past 40 years, no acupuncturist has been administratively penalized or convicted for using a syringe in the past 40 years,” citing the Ministry of Health and Welfare’s authoritative interpretation.
The defendant’s legal team also said Mr. A is a practicing acupuncturist with over 20 years of experience and is “the most highly trained professional in the world when it comes to syringes (used for acupuncture).” They argued that acupuncturists are “trained and educated to deal with the risks of acupuncture, which exceed the risks of lidocaine” and that the trial court erred in finding that harm occurred because the acupuncturist administered lidocaine in an invasive manner using a syringe.
The lawyer added that it doesn't matter if the risk of lidocaine itself, not the act of injection, is the issue. Given that the lidocaine was used “at the lowest possible dose of 0.05 cc for pain relief, a dose that is between 200th and 400th of the dose typically used for anesthesia and less than the dose used in allergy testing, how can the risk be assessed as high?” he asked.
‘A wrong ruling that forces oriental medicine practitioners to use only herbal preparations’
The defense team also refuted the first court's ruling that oriental doctors should use licensed medicines based on safety and efficacy review standards. The first trial applied a Supreme Court precedent in 2022 that banned Shinbaro Tablet-Apitoxin Injection by oriental medicine doctors. The notification of the Ministry of Food and Safety (MFDS) has since changed.
“In the MFDS notification on herbal medicines, the criteria for safety and efficacy from an oriental medicine perspective have disappeared. The health center's survey on the use of herbal medicines by oriental medicine practitioners excluded new drugs made from natural products, such as Shinbaro-Apitoxin. Not a single TCM practitioner has been administratively punished or convicted for using Shinbaro or Apitoxin,” the defense lawyer said. “Nevertheless, the first trial listed the scope of TCM practitioners’ use of medicines based on the old notification that had already been changed.”
They continued, “It seems that the first trial was based on the argument that doctors and herbalists should use medicines that have undergone biologics notification and should be used by herbalists. However, the standards for safety and efficacy in drug approval are the same whether it is a biological drug, synthetic drug, or herbal drug.”
The defense added that the claim that there are separate standards for reviewing Chinese herbal preparations based on the principles of Chinese medicine is wrong and does not reflect the actual situation and that ”the type of notification process a drug has undergone cannot be an indicator of a practitioner's licensing behavior.”
They also noted that there have already been cases where prosecutors have decided not to prosecute a TCM practitioner for using lidocaine injections. In that case, the prosecutor argued that “the use of lidocaine was necessary to relieve pain in the course of herbal treatment, and therefore the use of lidocaine in the clinic. It cannot be said that the practitioner intended to practice Western medicine, they added.
“Lidocaine is not used alone for medical purposes. It depends on what the procedure is. If you use lidocaine to practice TCM, then the use of lidocaine is also a subordinate and instrumental purpose for TCM,” the defense team said. “Looking at the overall behavior, it cannot be said that it is related to TCM.”
‘Why should only oriental medicine patients endure pain?’
The lawyer also said that the first trial court's judgment that Mr. A, an oriental medicine doctor, had “sufficiently verified western medical expertise and skills” to use lidocaine was wrong. The reasoning was that the test was based on whether the doctor was “properly trained” rather than whether he was “practicing medicine other than what he was licensed to do. He said that Chinese medicine already provides sufficient education on the use of lidocaine.
“The general manual of oriental medicine specialists and textbooks on acupuncture teach the use of lidocaine. It even states that lidocaine should be used during bee venom acupuncture to prevent pain shock,” the defense team said. “A TCM practitioner should diagnose according to KCD disease codes (like a medical doctor). They learn how to diagnose and treat diseases according to modern medicine. Western medicine accounts for 75 percent of the total education in Chinese medicine schools. How can you say that a TCM doctor cannot use lidocaine because they are not properly educated?”
They continued, “The Supreme Court stated that new areas of oriental medicine can be created to reflect the changing development of medicine. Why should a patient who comes to an oriental medicine clinic have to endure pain to be treated? Naturally, it should be possible to prevent pain shock and reduce pain (by using lidocaine).”
“Chinese acupuncturists and American acupuncturists use lidocaine. In the U.S., Canada, the U.K., and Australia, lidocaine is also available to dental hygienists, who are non-medical personnel. In Korea, nurses and midwives, who are public officials dedicated to health care, can use it,” they said.
Requesting acquittal, they said, “A universal remedy should be universal, not monopolized by certain professions. The law should be interpreted to keep the options open to healthcare consumers within a reasonable range, not monopolized by certain professions.”
The prosecution made no arguments other than asking the court to dismiss the defense's appeal.
‘As a medical professional, I tried to provide better treatment methods’
In his closing statement, Mr. A stated that, as a medical professional, he used lidocaine to improve patient care and asked the court to consider the challenges faced by oriental medicine practitioners.
“Despite the great effectiveness of acupuncture, the procedure was painful, and some patients had allergic reactions. Even I was uncomfortable with the procedure because of the pain when I inserted the needles myself, and this made me think about how to reduce the pain felt by patients,” he said.
“We oriental medicine practitioners also consider the patient's compliance level and make various efforts to reduce the procedure's pain,” he said. “It would be very frustrating for our patients to have a good treatment that is helpful for many conditions and then have it become unavailable in the future.”
Sentencing by the appeals court will be made at 2 p.m. on Oct. 17.
On Thursday, the Seoul Southern District Court's Criminal Division held the final arguments of the appeal hearing against an oriental medicine doctor, initialized as just Mr. A, who was charged with violating the Medical Service Act by mixing local anesthetic lidocaine in a medicine needle.
The oriental medicine practitioner was accused of practicing medicine without a license by injecting 87 patients with lidocaine mixed with bee venom solution into painful areas for two months from November 2021. On Nov. 10, 2023, a lower court found him guilty of unlicensed medical practice, as the use of lidocaine was outside the scope of his license.
“Lidocaine is a specialty drug that must be licensed in Western medicine and used under the direction and supervision of a physician, and so an oriental medicine practitioner cannot prescribe and dispense lidocaine, nor can he administer and use it,” the lower court said. “It is also difficult to believe that Mr. A has been rigorously verified to have Western medical expertise and skills to use lidocaine.”
The court also said that as lidocaine is injected directly into the body with a syringe, “there are health and hygiene risks associated with the use of specialized drugs,” and “it cannot be considered an auxiliary tool for traditional Chinese medicine (TCM) practice since it is an invasive method. It added that specialty drug use could not be authorized for oriental medicine practitioners along the same lines as diagnostic equipment, such as ultrasound and electroencephalographs.
The oriental doctor appealed the first court ruling and immediately appealed. The Association of Korean Medicine (AKOM), a group of oriental doctors, also supported A, arguing that it is legal for a TCM doctor to use lidocaine as an aid. Members of the association attended the final arguments in the second trial.
Defendant argues he ‘used the drug to the lowest limit for pain relief’
In court, Mr. A's defense team presented a video of the actual needle manufacturing and procedure.
Regarding the “health and hygiene harm caused by injecting lidocaine into the body with a syringe” pointed out by the first trial court, Mr. A countered that lidocaine should be viewed as “mixing the drug with a pain-free agent in the process of preparing the needle rather than directly injecting it into the body.” He also said, “In the past 40 years, no acupuncturist has been administratively penalized or convicted for using a syringe in the past 40 years,” citing the Ministry of Health and Welfare’s authoritative interpretation.
The defendant’s legal team also said Mr. A is a practicing acupuncturist with over 20 years of experience and is “the most highly trained professional in the world when it comes to syringes (used for acupuncture).” They argued that acupuncturists are “trained and educated to deal with the risks of acupuncture, which exceed the risks of lidocaine” and that the trial court erred in finding that harm occurred because the acupuncturist administered lidocaine in an invasive manner using a syringe.
The lawyer added that it doesn't matter if the risk of lidocaine itself, not the act of injection, is the issue. Given that the lidocaine was used “at the lowest possible dose of 0.05 cc for pain relief, a dose that is between 200th and 400th of the dose typically used for anesthesia and less than the dose used in allergy testing, how can the risk be assessed as high?” he asked.
‘A wrong ruling that forces oriental medicine practitioners to use only herbal preparations’
The defense team also refuted the first court's ruling that oriental doctors should use licensed medicines based on safety and efficacy review standards. The first trial applied a Supreme Court precedent in 2022 that banned Shinbaro Tablet-Apitoxin Injection by oriental medicine doctors. The notification of the Ministry of Food and Safety (MFDS) has since changed.
“In the MFDS notification on herbal medicines, the criteria for safety and efficacy from an oriental medicine perspective have disappeared. The health center's survey on the use of herbal medicines by oriental medicine practitioners excluded new drugs made from natural products, such as Shinbaro-Apitoxin. Not a single TCM practitioner has been administratively punished or convicted for using Shinbaro or Apitoxin,” the defense lawyer said. “Nevertheless, the first trial listed the scope of TCM practitioners’ use of medicines based on the old notification that had already been changed.”
They continued, “It seems that the first trial was based on the argument that doctors and herbalists should use medicines that have undergone biologics notification and should be used by herbalists. However, the standards for safety and efficacy in drug approval are the same whether it is a biological drug, synthetic drug, or herbal drug.”
The defense added that the claim that there are separate standards for reviewing Chinese herbal preparations based on the principles of Chinese medicine is wrong and does not reflect the actual situation and that ”the type of notification process a drug has undergone cannot be an indicator of a practitioner's licensing behavior.”
They also noted that there have already been cases where prosecutors have decided not to prosecute a TCM practitioner for using lidocaine injections. In that case, the prosecutor argued that “the use of lidocaine was necessary to relieve pain in the course of herbal treatment, and therefore the use of lidocaine in the clinic. It cannot be said that the practitioner intended to practice Western medicine, they added.
“Lidocaine is not used alone for medical purposes. It depends on what the procedure is. If you use lidocaine to practice TCM, then the use of lidocaine is also a subordinate and instrumental purpose for TCM,” the defense team said. “Looking at the overall behavior, it cannot be said that it is related to TCM.”
‘Why should only oriental medicine patients endure pain?’
The lawyer also said that the first trial court's judgment that Mr. A, an oriental medicine doctor, had “sufficiently verified western medical expertise and skills” to use lidocaine was wrong. The reasoning was that the test was based on whether the doctor was “properly trained” rather than whether he was “practicing medicine other than what he was licensed to do. He said that Chinese medicine already provides sufficient education on the use of lidocaine.
“The general manual of oriental medicine specialists and textbooks on acupuncture teach the use of lidocaine. It even states that lidocaine should be used during bee venom acupuncture to prevent pain shock,” the defense team said. “A TCM practitioner should diagnose according to KCD disease codes (like a medical doctor). They learn how to diagnose and treat diseases according to modern medicine. Western medicine accounts for 75 percent of the total education in Chinese medicine schools. How can you say that a TCM doctor cannot use lidocaine because they are not properly educated?”
They continued, “The Supreme Court stated that new areas of oriental medicine can be created to reflect the changing development of medicine. Why should a patient who comes to an oriental medicine clinic have to endure pain to be treated? Naturally, it should be possible to prevent pain shock and reduce pain (by using lidocaine).”
“Chinese acupuncturists and American acupuncturists use lidocaine. In the U.S., Canada, the U.K., and Australia, lidocaine is also available to dental hygienists, who are non-medical personnel. In Korea, nurses and midwives, who are public officials dedicated to health care, can use it,” they said.
Requesting acquittal, they said, “A universal remedy should be universal, not monopolized by certain professions. The law should be interpreted to keep the options open to healthcare consumers within a reasonable range, not monopolized by certain professions.”
The prosecution made no arguments other than asking the court to dismiss the defense's appeal.
‘As a medical professional, I tried to provide better treatment methods’
In his closing statement, Mr. A stated that, as a medical professional, he used lidocaine to improve patient care and asked the court to consider the challenges faced by oriental medicine practitioners.
“Despite the great effectiveness of acupuncture, the procedure was painful, and some patients had allergic reactions. Even I was uncomfortable with the procedure because of the pain when I inserted the needles myself, and this made me think about how to reduce the pain felt by patients,” he said.
“We oriental medicine practitioners also consider the patient's compliance level and make various efforts to reduce the procedure's pain,” he said. “It would be very frustrating for our patients to have a good treatment that is helpful for many conditions and then have it become unavailable in the future.”
Sentencing by the appeals court will be made at 2 p.m. on Oct. 17.
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