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

The Minister of Health, Welfare and Family Affairs (Attorney Lee Jae-chul et al., Counsel for defendant-appellant)

March 31, 2010

1. The defendant's disposition of suspending the qualification for one month against the plaintiff on March 3, 2009 shall be revoked.

2. The costs of the lawsuit are assessed against the defendant.

The same shall apply to the order.

1. Details of the disposition;

A. From May 2002, the Plaintiff is serving as the diagnosis radiation and doctor of ○○○ Hospital from around 002, and is in charge of the diagnosis radiation and position of the above hospital.

B. The Plaintiff’s observation and research purpose is to confirm the impact of harmful event changes on the development rate between Dlim S (hereinafter “Dlim S”) and Dlim S (hereinafter “PP”) (the clinical trial entrusted with the clinical trial of ○○○○○○○○ Hospital’s import-sale business of Poscky and Posck’s Posck’s Posck’s Posck’s Posck’s Posck’s Posck’s Posck’s 200 on April 1, 2005, jointly with Nonparty 4 and 5, which is the director of the above hospital’s diagnosis and 00 on September 21, 2006, jointly with the above Nonparty 4 and 5 on September 21, 2006, ③ 00 Posck’s 10,3000 Posck’s Posck’s 200 Posck’s 2000

C. The Defendant: (a) received money in the name of research service costs under the aforementioned 1, 2, and 3 PPP contracts by the Plaintiff constitutes an implied solicitation to the effect that the Plaintiff continued to use the ○○○○ Hospital’s ○○○○○○○○○ Hospital “non-frequency” and “ombck” and increased the amount of use; and (b) on the ground that it was an act of unfairly receiving money and valuables in relation to his duties, it was an act of unfairly receiving money and valuables in relation to his duties; (c) Article 53(1)1 and (2) of the Medical Service Act (amended by Act No. 8366 of Apr. 11, 2007); (d) Article 32(1)5 of the Enforcement Decree of the Medical Service Act (amended by Presidential Decree No. 2001 of Apr. 6, 207); and (d) Article 16(a) of the Medical Service Act (amended by Ordinance of the Ministry of Health and Welfare of Apr. 394, 2007).

[Reasons for Recognition] Each entry of Gap evidence Nos. 1 through 4, the purport of the whole pleadings

2. The assertion and judgment

A. The plaintiff's assertion

The instant disposition shall be revoked on the grounds that it is unlawful for the following reasons.

(1) Non-existence of grounds for disposition

The 1,2, and 3PPP contracts concluded by the Plaintiff are lawful and lawful research services contracts. Since the money received by the Plaintiff is not the cost of illegal solicitation, but the cost of legitimate research services under the said research services contract, the Plaintiff did not accept money and valuables in relation to his/her duties.

(2) procedural illegality

Since it is unclear whether the 1, 2, and 3 PPP contracts are legitimate and lawful research services contracts or means for the payment of the price for illegal solicitation, the Defendant requested deliberation to the Central Medical Examination and Conciliation Committee in accordance with Article 32(2) of the Medical Service Act regarding whether the receipt of money and valuables by the Plaintiff under each of the above contracts constitutes an act of impairing the dignity of the Plaintiff and followed the decision. However, the Defendant rendered the instant disposition by itself without complying with such procedures.

(3) A deviation from or abuse of discretionary power

Considering the fact that the 1, 2, and 3PPP contracts are unclear as a means to pay illegal solicitations, the fact that it is unnecessary for the public interest to suspend the Plaintiff’s license for intent, the fact that money and valuables received by the Plaintiff are not used by an individual, and the Plaintiff’s honor and economic losses, the instant disposition is excessively harsh to the Plaintiff.

(b) Related statutes;

Medical Service Act (amended by Act No. 8366 of April 11, 2007)

Article 53 (Suspension, etc. of Qualification)

(1) When a medical person falls under any of the following subparagraphs, the Minister of Health and Welfare may suspend his/her license for a period not exceeding one year. In such cases, matters requiring judgment on medical technology may be determined after hearing opinions of relevant experts:

1. When he has committed an act extremely impairing the dignity of a medical person;

(2) The scope of acts under paragraph (1) 1 shall be prescribed by Presidential Decree.

Enforcement Decree of the Medical Service Act (amended by Presidential Decree No. 2001 of April 6, 2007)

Article 32 (Scope of Acts of Degrading Medical Personnel's Dignity)

(1) The scope of acts impairing the dignity of medical persons under Article 66 (2) of the Act shall be as follows:

5. Giving and receiving money and other valuables in connection with his/her duties, such as selection of medical residents;

(2) If there is doubt as to whether a specific act constitutes an act detrimental to dignity under paragraph (1), the Central Medical Examination Conciliation Committee shall deliberate and decide upon it.

Rules on Administrative Dispositions Related to Medical Service (amended by Ordinance of the Ministry of Health and Welfare No. 394 of April 9, 2007)

Article 4 (Criteria for Administrative Disposition)

The criteria for administrative dispositions under Articles 50 through 53 of the Medical Service Act and Article 25 of the Medical Technicians, etc. Act shall be as shown in the attached Table.

[Attachment] Criteria for Administrative Disposition (Related to Article 4)

1. Common standards:

(c) When a violation of Acts and subordinate statutes related to medical treatment falls under any of the following subparagraphs, the administrative disposition agency may reduce the relevant disposition within the scope of mitigation standards of the relevant disposition in consideration of the circumstances, notwithstanding the administrative disposition standards prescribed by these Rules:

(1) Where the suspension of indictment is imposed by a prosecutor on the relevant case subject to mitigation (Qualification, business or business suspension) contained in the main sentence, the reduction shall be made within the scope of 1/2 of the relevant disposition standards.

2. Individual standards:

(a) Where a medical person violates the Enforcement Decree of the Medical Service Act and the Medical Service Act;

When a person gives or receives money or goods in connection with his/her duties, such as selection of major residents, etc., under Article 53 (1) 1 of the Medical Service Act and Article 21 (1) 5 of the Enforcement Decree of the Medical Service Act, suspension of qualifications for two months;

(c) Fact of recognition;

(1) Voluntary Pms are voluntary activities conducted by pharmaceutical companies to collect and investigate side effects of drugs to continuously collect information on the safety of drugs even after the marketing of drugs.

(2) The re-examination system of new drugs, etc. under Articles 26-2 and 34(4) of the Pharmaceutical Affairs Act (amended by Act No. 8365 of Apr. 11, 2007) is distinguished from the aforementioned voluntary Pms in that it is divided into ① that the subject of the re-examination is a drug licensed, ② that the examination is enforced, ③ that the re-examination is limited to three months from the expiration of four to six years.

(3) As to ombk's "ombk" and "non-bombk's "ombk" on January 9, 1995, it obtained marketing approval from the Korea Food and Drug Administration on July 1, 1998, as a steering system administered by the Korea Food and Drug Administration to a patient who photographs each CT and MRI with respect to "non-bombk" on July 1, 1998, and it was not classified as a drug that must undergo a re-examination under the above Pharmaceutical Affairs Act or which must collect and report the side effects by obtaining permission.

(4) Since the opening of the ○○○○ Hospital, the Plaintiff selected the aforementioned “omb” and “non-surk” as a steering system and administered it to the patient. As a doctor of the above hospital, the Plaintiff was chosen to choose the type of steering radiation and the director of the department as a doctor to choose the type of steering system to be used in the above hospital, to continue to use it, and to determine whether to increase or decrease the quantity of use.

(5) From January 2003, Nonparty 6, who is the director of the Red Team of the Mediditrobane, had a doubt about the side effects of the steering system due to the seasonal changes, such as inquiring about the side effects of the steering system from the headquarters of the Medidiff to the global metro of the headquarters of the Medibane, etc. Accordingly, the non-party 6, who is the director of the Medididebane, had a doubt about the side effects of the steering system according to the seasonal changes. Accordingly, the non-party 6, who was approved after arranging the research purpose, plan, method, and result report, etc. on May 28, 2004.

(6) On July 8, 2004, Ahhhyh entered into an entrustment contract with Dlim S. on observation and research, and entrusted the following tasks: ① contract management with a Pms participant ② preparation of an implementation plan for observation and observation and research table (CRF), ③ payment of research expenses, ④ production of Ahys, data verification and confirmation, statistics analysis, report preparation, verification, etc.

(7) On July 2004, Dlim S. prepared a detailed research plan and an example of a show of results, observation and research contract form, and prepared an implementation plan in detail. The main contents are as follows (hereinafter “instant observation and research”).

* Research Period: August 2004 to August 2007 (three years)

* The number of estimated investigations: 32,000 persons or more

* The selection of an investigating agency: The investigating agency shall select Shovah as Chovah and verify Dlim Chovah.

* Subject-matter and method of investigation: Each patient shall be examined or investigated to record in the questionnaire the following matters:

1) Basic information on a person: Investigation sheet and medical record number, investigation agency information, name, gender, date of birth, age, pregnancy, and weight of the person subject to investigation;

(ii) Basic medical information and examination information prior to administration: diagnostic name, risk factor, inspector, and date of examination;

(iii) The current status of the administration of this subject: the type of the administration, the concentration of the administration, the total amount of the administration, and the course of the administration;

(d) Sick-use medical supplies: Whether there are medical-use drugs, names of medicines (name of products), dosages and administrations per day, and the purpose of administration;

(v) matters pertaining to surgery or other sediment operations;

6) Survey on harmful cases: Final investigation time, existence, degree, progress, time of occurrence, and duration of harmful cases, symptoms or signs observed, etc.

(vii) an overall safety assessment;

8) Evaluation of validity

* Method of Investigation

1) A request for investigation: Dlim S shall enter into an observation and research contract with an agency in charge of investigation or with a doctor in charge of investigation, approve ZH, provide an investigation plan and a survey report to the agency in charge of investigation or with a doctor in charge of investigation, and explain the method and guidelines for the preparation of the data.

2) Request for recovery and re-inspection of the questionnaire: ZHK shall visit a physician in charge of the investigation once a month to recover the questionnaire and recover all the survey slips within the research period.

* Items and Methods of Analysis

1) Explosive composition: it shall prepare a list of days, such as the number of survey acceptances, the number of recovered documentary evidence, the number of documentary evidence subject to safety evaluation, and the number of documentary evidence subject to effective evaluation;

2) Items for analysis: Items for analysis of safety (such as the present rate of the harmful cases, the analysis of seasonal factors, etc.), effective analysis items (final evaluation of validity).

*The method of analysis: the method of safety analysis, effectiveness analysis

*Report and Handling of Harmful Cases: All harmful cases occurring in the course of the principal administration shall be recorded in the page of the observation and research table, and all harmful cases occurring in the course of the study shall be reported to the Kentral Safet Un and the Korea Food and Drug Administration.

*Attachment: An observation and research report on the tide (including the corresponding period from January to December in the items of investigation).

(8) In light of the number of survey certificates, Ghhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhh

(9) Through the process of selection and verification of the above survey institution, ○○○○ Hospital was selected as a survey institution and researcher in March 2005, and dlimcs ecs ecs ecs ecs ecs ecs ecs ecs ecs ecs ecs ecs ecs ecs ecs ecs ecs ecs ecs ecs ecs ecs ecs ecs ec

*For the purpose of investigation: Observation and study to verify the effects of seasonal change factors on the rate of harmful cases in the use of the non-sub-speak

* The period of investigation: April 1, 2005 to July 31, 2005

* Contract show/Investigation Expenses: 650 examples (50,000 won per case)

*The method of investigation: A physician in charge of the investigation shall keep records in the questionnaire for all patients from the time of request for the investigation to the time of request, and shall sign and notify the requester of the investigation in succession.

(10) On September 21, 2006, the Plaintiff entered into a second PPPP contract (the period: from September 21, 2006 to January 31, 2007; the same as the first PPPP contract with the exception of 300 cases); and the third PPPP contract with the same procedure on February 12, 2007 (the research period: from February 12, 2007 to March 31, 2007; the contract increase number: 100 cases, respectively.).

(11) After the expiration of the investigation period in the first, second, and third PPP contracts, the Plaintiff prepared a complete survey report in accordance with the increase number and delivered all of them to Ghz. Of them, two cases of adverse effects during the performance of research services under the first PP contract were discovered and entered in the survey report.

(12) At the time of collecting and reviewing the survey report from the doctor in charge of the investigation including the Plaintiff and reviewing the data as set out in the collected survey report, the results of the process of correcting errors in the survey report through Query Republic Report (the method of checking and directly correcting the survey report sent by the relevant hospital and checking the accuracy of the data in the absence of such a method of directly inquiring the relevant hospital). If some significant side effects are discovered in the process of examining the survey report collected as above, it was reported directly to the Korea Food and Drug Administration, or reported to the PSUR, which is the safety reporting system of European countries through its head office, to the Korea Food and Drug Administration, and also included two adverse effects found by the Plaintiff as above.

(12) On August 7, 2008, the Plaintiff received an investigation by an investigative agency on the charge of taking advantage of breach of trust as to the act of receiving the said money, and was subject to the suspension of indictment from the prosecutor of the Seoul Central District Prosecutors' Office, and the Defendant issued the instant disposition based on the suspension of indictment.

(13) Meanwhile, in relation to the observation and research of this case, Nonparty 1, 2, and 3 concluded a PP contract with Dlim S for the purpose of confirming the effect of seasonal change factors in the use of the non-sub-frequency, and charged research service costs on the charge of taking property in breach of trust. However, on February 10, 2010, the Seoul Central District Court Decision 2008 High-Ma1091 Decided February 10, 201, rendered a judgment of not guilty on the ground that “the money received under the above contract was received as a consideration for the solicitation of new supply or continuous use of the aforementioned scopic.”

[Ground of recognition] Evidence Nos. 9, 12 through 17, and 24

D. Determination

(1) In general, an importer of a drug shall undergo re-examination and re-evaluation of a drug permitted for imported items in accordance with the relevant provisions, such as the Pharmaceutical Affairs Act, and shall submit a report and take necessary measures, as prescribed by the Regulations on the Management of Safety Information on Drugs, etc., when he/she obtains new data or becomes aware of information related to the safety and effectiveness of a drug permitted or reported. If there is doubt that an imported drug is subject to recovery, etc., the risk of the relevant drug shall be assessed without delay, and necessary measures, such as immediate suspension of sale, etc., shall be taken for the relevant drug within the designated date according to the risk assessment class, and the importer and seller of the drug shall be liable for the same duties as the manufacturer of the drug, such as taking necessary measures, such as recovery or return of the drug subject to recovery, or taking other measures to prevent other hazards. Thus, where voluntary marketing is necessary, the importer and seller of the drug may implement such measures

(2) In addition, according to the above facts, the purpose of this study is to investigate the side effects of the steering system in accordance with seasonal changes rather than the investigation of the general side effects of the steering system, and the purpose of this study is to investigate the side effects of the steering system, and ② to enter into a contract with Dlim Cream Es., a specialized agency for clinical trials, and to take part in the above research performance through division of work, ③ to collect and examine the contents of the survey list as appropriate items to investigate the side effects due to seasonal changes, ④ to collect and examine most of the survey reports, and ④ to correct the errors of the empirical report through Quvalue Res. ⑤ to determine the selection of hospital subject to investigation and the number of the evidentiary reports were made fairly and objectively, and vi) to report such results to the Commissioner of the Korea Food and Drug Administration and the head office.

(3) In light of the above circumstances, the Plaintiff entered the research findings in the research sheet as stipulated in the contract, and the Defendant’s act of taking the instant disposition by recognizing that the Plaintiff’s acceptance of money and valuables related to the Plaintiff’s Pms is unfair in relation to his duties is based on the investigation by an investigative agency and the suspension of prosecution by the prosecutor. However, in light of the fact that the Plaintiff rendered a judgment of innocence on the grounds that “no evidence exists to prove that the money received under the above contract was received in return for the solicitation of new supply of the above early service or continuous use of the said early service,” it is difficult to conclude that the Plaintiff is an unfair money and valuables received in relation to the duties received under the 1,2, and 3P contracts.”

Therefore, the disposition of this case based on the premise that the plaintiff received unfair money in relation to his duties is unlawful, so this part of the plaintiff's assertion is with merit.

3. Conclusion

Thus, without examining the remaining arguments of the plaintiff, the plaintiff's claim of this case seeking the revocation of the disposition of this case is justified.

Judges Kim Jong-chul (Presiding Judge)