Hello. I am attorney Lee Young-kyung at Cheongchul Law Firm.

This column examines the first instance, appellate, and Supreme Court rulings that upheld a one-month medical license suspension against a physician who issued prescriptions for 2,644 patches containing narcotic substances for "off-label purposes," finding that the conduct constituted an "unethical medical practice" under former Medical Service Act Article 66(1)(i) and Enforcement Decree Article 32(1)(ii). The case carries important implications for medical professionals and healthcare institutions regarding professional ethics, the limits of narcotic prescriptions, and responses to license suspension dispositions.

[Question]

If a physician issues multiple prescriptions containing narcotic substances to patients and receives a confirmed summary order for the criminal offense of "issuing prescriptions for off-label purposes," is the medical license suspension disposition lawful, and can the physician contest the disposition by arguing "therapeutic purpose" or "abuse of discretion"?

[Answer]

The first instance, appellate, and Supreme Court all held that the one-month medical license suspension was lawful. Issuing narcotic prescriptions for "off-label purposes" constitutes "unethical medical practice" under former Medical Service Act Article 66(1)(i) and Enforcement Decree Article 32(1)(ii). The provisions do not violate the principles of clarity or prohibition of blanket delegation. The factual findings of the confirmed criminal summary order serve as compelling evidence in administrative litigation, so the "therapeutic purpose" argument was not accepted. The claim of abuse of discretion was also rejected based on conformity with disposition standards and multiple prior suspension records.

1. Case Overview and Disposition Background

The plaintiff, a physician operating a hospital in Seongbuk-gu, Seoul, received a confirmed summary order on April 1, 2022 with a KRW 10 million fine for the criminal facts that "from May 19, 2019 to June 18, 2020, he issued prescriptions for 2,644 Durogesic D-Trans patches containing the narcotic fentanyl (hereinafter "fentanyl patches") to 23 patients on 382 occasions for off-label purposes." Accordingly, on November 7, 2023, the Minister of Health and Welfare imposed a one-month medical license suspension on the plaintiff pursuant to former Medical Service Act Article 66(1)(i) and Enforcement Decree Article 32(1)(ii), and the plaintiff filed an administrative lawsuit seeking its revocation.

2. Issues and Relevant Laws

The issues in this case were: (i) whether the legal basis of the disposition violates the principles of clarity, prohibition of blanket delegation, and proportionality; (ii) whether the disposition reason of "issuing prescriptions for off-label purposes" is recognized (therapeutic purpose argument); (iii) whether there were procedural defects; and (iv) whether the one-month suspension constitutes abuse of discretion.

Former Medical Service Act Article 66 (License Suspension, etc.) (1) The Minister of Health and Welfare may suspend the license of a medical professional for up to one year if the professional falls under any of the following […]
1. When the professional commits an act that severely damages the dignity of medical professionals
(2) The scope of acts under paragraph (1) item 1 shall be prescribed by Presidential Decree.

Former Medical Service Act Enforcement Decree Article 32 (Scope of Acts Damaging the Dignity of Medical Professionals) (1) The scope of acts damaging the dignity of medical professionals under Article 66(2) of the Act shall be as follows.
2. Unethical medical practice

3. Rulings of the First Instance, Appellate, and Supreme Courts

A. First Instance (Seoul Administrative Court): Claim Dismissed

The first instance court held that (i) the legal basis of the disposition does not violate the principles of clarity, prohibition of blanket delegation, or proportionality; (ii) "unethical medical practice" means "medical practice that undermines the high level of morality and professional ethics expected of medical professionals by social convention and damages public trust in medical professionals"; (iii) the criminal facts of the confirmed summary order serve as compelling evidence in administrative litigation, so the "therapeutic purpose" argument was not accepted; and (iv) the one-month suspension falls within the disposition standards and, given the multiple prior suspension records, does not constitute abuse of discretion, thereby dismissing the claim.

B. Appellate Court (Seoul High Court): Appeal Dismissed

The appellate court adopted the first instance ruling in its entirety while supplementing the plaintiff’s prior license suspension records in detail (3 months in January 2002, 8 days in April 2008, 5 months and 7 days in October 2009, and 3 months in October 2022). It additionally noted that the plaintiff, having multiple prior suspension records, could have sufficiently foreseen the present disposition, and dismissed the appeal.

C. Supreme Court (Judgment of April 30, 2026, 2025Du34890): Appeal Dismissed

The Supreme Court defined "unethical medical practice" as "medical practice that contravenes the legislative purpose of the Medical Service Act to protect and promote public health, and the expectations and trust of ordinary citizens in medical professionals by social convention, and that bears moral culpability sufficient to justify the disadvantage of license suspension." The Court further held that "unethical medical practice" may include not only violations of express provisions of the Medical Service Act and related laws, but also violations of the morality and professional ethics required of medical professionals by social convention and reason. The arguments regarding violations of clarity and prohibition of blanket delegation, absence of disposition grounds, procedural defects, and abuse of discretion were all rejected, and the appeal was dismissed.

4. Implications for Medical Professionals and Healthcare Institutions

A. Scope of "Unethical Medical Practice" – Includes Violations of Professional Ethics

The Supreme Court made clear that "unethical medical practice" is not limited to violations of express provisions of the Medical Service Act and related laws, but extends to violations of morality and professional ethics required of medical professionals by social convention and reason. It is therefore difficult to conclude that "there is no obvious violation of the law, so it is safe," and proactive review of whether internal medical practices carry moral culpability from the perspective of social convention and professional ethics is necessary.

B. Risk of "Off-Label" Findings in Narcotic Prescriptions and the Impact of Criminal Summary Orders

Repeated and large-volume prescriptions of narcotic analgesic and sedative patches such as fentanyl are subject to intensive scrutiny by investigative agencies and the Ministry of Health and Welfare. Prescriptions based solely on patient complaints, without appropriate medical records or pain assessment, carry a significant risk of being deemed "off-label," and the factual findings of confirmed criminal judgments (including summary orders) serve as compelling evidence in administrative litigation. Therefore, if a fine-only summary order is accepted lightly, it becomes extremely difficult to contest the facts at the subsequent medical license suspension or revocation stage. Physicians should seek legal counsel from the investigation stage onward.

C. Risk of Medical License Revocation from Accumulated Suspension Records

In addition to this case, the plaintiff had multiple prior suspension records (3 months in 2002, 8 days in 2008, 5 months and 7 days in 2009, and 3 months in 2022), and the first instance court expressly noted that "the defendant may revoke the plaintiff’s medical license based on the accumulated suspension records" (Medical Service Act Article 65(1)(ii)). Repeated suspension dispositions can lead to license revocation, making active response to each individual disposition critically important.