[1] Matters concerning the stability and effectiveness of drugs in the market on which a pharmaceutical manufacturer obtained permission or filed a report, and whether the “after-market survey” is prohibited to collect information necessary for appropriate use (negative)

[2] Whether the suspension of license can be subject to investigation after the marketing of drugs and the receipt of the price therefor, in a case where it can be assessed that the status of a public official is related to his/her duties, or that the price for adoption of a specific drug or continuous prescription is included in the medical personnel’s duties (affirmative)

[3] In a case where hospital diagnostic radiation and doctor Gap concluded a research service agreement with the pharmaceutical company Eul and received KRW 50 million in relation to Eul's duties, the Minister of Health and Welfare unfairly accepted money in relation to his duties, and the Minister of Health and Welfare rendered a disposition of suspending the qualification of doctor Gap for one month, the case affirming the judgment below holding that the above disposition is unlawful

[1] In full view of the fact that the former Pharmaceutical Affairs Act (wholly amended by Act No. 8201 of Jan. 3, 2007) with the aim of providing for matters concerning pharmaceutical affairs and thereby contributing to the improvement of national health, there is no provision prohibiting voluntary surveillance or management activities of drug manufacturers (including importers; hereinafter the same shall apply) concerning the stability of drugs in the market, and Article 28(3)1 of the former Enforcement Rule of the Pharmaceutical Affairs Act (wholly amended by Act No. 434 of Jan. 15, 2008) excludes the "testing conducted for the observation of clinical effects and the investigation of abnormal response with regard to the matters regarding the matters regarding the stability and effectiveness of drugs in the market" as a whole referring to the matters concerning the stability and effectiveness of drugs in the market and a series of measures to collect information necessary for the appropriate use of the drugs in the market after obtaining permission from the manufacturer or reporting the permission from the manufacturer.

[2] In cases where the “after-marketing survey” of drugs and the receipt of the price therefor can be deemed as having been conducted in relation to the duties of a public official or as including the nature of consideration for adoption of a specific drug or continuous prescription in relation to the duties of a medical person, etc., they may be deemed as subject to suspension of license because they constitute “an act of unfairly receiving money or goods in relation to duties” under Article 21(1)5 of the former Enforcement Decree of the Medical Service Act (wholly amended by Presidential Decree No. 20292, Sept. 28, 2007) (amended by Act No. 10325, May 27, 2010). The same applies to cases where a medical person violates Article 23-2 (Article 8-2) of the former Enforcement Decree of the Medical Service Act (wholly amended by Presidential Decree No. 20292, May 27, 2010), prohibiting him/her from receiving economic benefits provided for the purpose of sales promotion, such as adoption of drugs, etc.

[3] In a case where hospital diagnostic radiation and doctor Gap entered into a research service agreement with the pharmaceutical company Eul to receive KRW 50 million in relation to their duties, the Minister of Health and Welfare unfairly accepted money and valuables in relation to the duties and issued them for one month of the suspension of doctor license, and notified it, the case affirming the judgment below holding that the above disposition is unlawful on the ground that it is difficult to conclude that Gap received money and valuables unfairly in relation to his duties in light of all the circumstances such as research purpose and progress

[1] Article 28 (3) 1 of the former Enforcement Rule of the Pharmaceutical Affairs Act (wholly amended by Ordinance of the Ministry of Health and Welfare No. 434 of Jan. 15, 2008) (see current Article 31 (3) 1) / [2] Article 53 of the former Medical Service Act (wholly amended by Act No. 8366 of Apr. 11, 2007) (see current Article 66), Articles 23-2 and 88-2 of the Medical Service Act, Article 21 (1) 5 of the former Enforcement Decree of the Medical Service Act (wholly amended by Presidential Decree No. 20292 of Sep. 28, 2007) (see current Article 32 (1) 1 of the former Enforcement Decree of the Medical Service Act) / [3] Article 53 (1) 1 of the former Medical Service Act (wholly amended by Act No. 8366 of Apr. 11, 2007) (see current Article 208 (19)

Plaintiff (Law Firm Suwon, Attorneys Kim Young-hoon et al., Counsel for plaintiff-appellant)

The Minister of Health and Welfare

Seoul High Court Decision 2010Nu16150 decided November 3, 2010

The appeal is dismissed. The costs of appeal are assessed against the defendant.

The grounds of appeal are examined.

Article 53 of the former Medical Service Act (wholly amended by Act No. 8366 of Apr. 11, 2007) provides that the Minister of Health and Welfare may suspend the license for a period not exceeding one year if a medical person “when he/she has committed an act significantly impairing his/her dignity as a medical person.” Article 21(1)5 of the former Enforcement Decree of the Medical Service Act (wholly amended by Presidential Decree No. 20292 of Sept. 28, 2007; hereinafter the same) provides that the scope of such act shall be prescribed by Presidential Decree. Article 21(1)5 of the former Enforcement Decree of the Medical Service Act (wholly amended by Act No. 20292 of Sept. 28, 200

Meanwhile, in full view of the fact that the former Pharmaceutical Affairs Act (wholly amended by Act No. 8201 of Jan. 3, 2007) provides for matters concerning pharmaceutical affairs and provides for appropriate matters concerning pharmaceutical affairs and prohibits voluntary surveillance or management activities of pharmaceutical manufacturers (including importers; hereinafter the same shall apply) for the stability of drugs in the market, and Article 28(3)1 of the former Enforcement Rule of the Pharmaceutical Affairs Act (wholly amended by Ordinance of the Ministry of Health and Welfare No. 434 of Jan. 15, 2008) provides for matters concerning pharmaceutical affairs for the purpose of contributing to the improvement of national health, the examination conducted to observe clinical effects and investigate abnormal reaction of drugs in the market is excluded from those subject to approval of the Commissioner of the Korea Food and Drug Administration, the so-called "after-market investigation", which refers to a series of measures to collect information necessary for the appropriate use of drugs in the market with the permission and reporting by a pharmaceutical manufacturer.

However, in the event that an investigation after the market and the receipt of the price therefor are conducted in relation to the duties of a public official, or where it is deemed that the nature of the price for adoption of a specific drug or continuous prescription is included in the duties of a medical person, it may be subject to suspension of license as it constitutes “an act of unfairly receiving money or goods in relation to duties” under Article 21(1)5 of the former Enforcement Decree of the Medical Service Act (amended by Act No. 10325, May 27, 2010). (The current Medical Service Act, which is in force after the amendment of Act No. 10325, May 27, 2010, prohibits medical personnel from receiving economic benefits provided for the purpose of promoting sales, such as the adoption of drugs (Article 23-2) and imposes imprisonment for not more than two years or a fine not exceeding 30,000 won (Article 8-2

The court below acknowledged the facts as stated in its reasoning based on the employment evidence, and determined that the Defendant’s disposition of suspending the Defendant’s license suspension against the Plaintiff, based on the premise that the Plaintiff was unfairly receiving money and other valuables in relation to his duties, was unlawful, on the premise that the Plaintiff’s act of receiving money and other valuables in relation to his duties was unlawful. The court below determined that the Defendant’s disposition of suspending the Defendant’s license suspension against the Plaintiff, which was conducted on the basis of the premise that the Plaintiff’s act of receiving money and other valuables unfairly in relation to his duties, was unlawful.

In light of the above legal principles and records, the judgment of the court below is just and acceptable, and there is no violation of law such as incomplete hearing as alleged in the grounds of appeal.

Therefore, the appeal is dismissed, and the costs of appeal are assessed against the losing party. It is so decided as per Disposition by the assent of all participating Justices.

Justices Min Il-young (Presiding Justice)