Defendant 1 and 10 others

Prosecutor

Park Jong-man (prosecution), Jinscin (Public Trial)

Law Firm ELD Partners et al.

Seoul Central District Court Decision 2012Da3639 Decided December 27, 2012

All appeals filed by the prosecutor against the Defendants are dismissed.

【Summary of Grounds for Appeal】

As the case of illegal rebates, the Medical Devices Act and the Medical Service Act stipulate that the employees of a medical institution shall not receive economic benefits, etc., and Defendant 1, 2, 3, 4, 5, 8, 9, and 10 are employees of a medical institution. Although economic benefits, etc. belong to a medical institution, it can be deemed that the above Defendants, who are employees of the medical institution, indirectly receive economic benefits, etc., even if they belong to the medical institution, and thus, they do

In addition, it is not clearly distinguishable from the receipt of rebates by a medical institution and the receipt of it by its employees and the receipt of it to vest in the medical institution's benefits. The Medical Service Act, etc., which provides for the subject of punishment for its employees, is to punish the cases where the benefits accrue to the medical institution through the employees of the medical institution, such as this case. The reason why the amendment of the Medical Service Act was submitted is not to impose administrative disposition on the medical institution, but to supplement the defects of the punishment for the medical institution, and the reason why the amendment of the Medical Service Act was submitted is not only to supplement the defects of the punishment for the medical institution, but also to apply the form of the act in breach of trust, and if not, the large hospital is excluded

In addition, economic benefits received between the Defendants are “illegal rebates for the purpose of sales promotion” prohibited by the Medical Service Act.

Therefore, although the Defendants’ act of receiving money constitutes a medical institution and the Medical Devices Act, the lower court determined that the Defendants, who are employees of the medical institution, received economic benefits, were not the above Defendants, but the medical institution to which they belong, and sentenced them not guilty on the grounds that the Defendants, who are employees of the medical institution or distributors of the medical device, do not constitute a crime. The lower court erred by misapprehending the legal principles as to Articles 88-2 and 23-2(2) of the Medical Service Act and by misapprehending the legal principles as to the facts charged in this case.

【Trademark】

[Summary of the facts charged of this case]

공동피고인 공소외 1 주식회사와 피고인 11 주식회사는 각 의료기기 판매 등을 목적으로 하는 법인이고, 공동피고인 공소외 3은 공소외 1 주식회사의 대표이사, 공동피고인 공소외 4는 공소외 1 주식회사의 이사이고, 피고인 6은 피고인 11 주식회사의 운영본부장, 피고인 7은 피고인 11 주식회사의 컨설팅사업부 부장, 피고인 1은 ○○○○○병원의 행정부원장, 피고인 2는 △△△△병원의 행정부원장, 피고인 3은 □□병원의 경영기획실장, 피고인 4는 ◇◇의료원의 운영지원본부장, 피고인 5는 ☆☆☆☆병원의 행정지원실장, 피고인 8은 ▽▽▽병원의 구매부장이고, 피고인 9는 ◎◎◎◎◎병원의 운영본부장, 피고인 10은 공소외 2 학교법인의 사무처 사업부장이다.

1. Regarding Nonindicted Co. 1

A. Defendant 1

The defendant is a vice-president of an administrative office at ○○○ Hospital who is engaged in administrative affairs, such as hospital revenues and expenditure management.

No defendant shall receive economic benefits, etc. provided by a distributor or lessor of a medical device for the purpose of promoting distribution, such as inducing the adoption or use of a medical device.

피고인은 2010. 12. 24.경 안양시 (주소 1 생략)에서 공소외 1 주식회사의 공소외 3, 4로부터 공소외 1 주식회사에서 공급하는 인데버 레절루트(ENDEAVOR RESOLUTE), 버사스텝(VERSASTEP), 세퍼레이터 액세스 시스템(SEPARATOR ACCESS SYSTEM) 등 1,225개 의료기기에 대한 채택·처방유도 등 판매촉진을 목적으로 제공되는 17,647,190원을 지급받아 경제적 이익등을 취득한 것을 비롯하여 그 때부터 별지 범죄일람표Ⅰ 순번 (1) 내지 (12) 기재와 같이 총 12회에 걸쳐 합계 378,912,280원을 지급받아 의료기관 종사자로서 의료기기에 대한 채택·사용유도 등 판매촉진을 목적으로 제공되는 금원을 교부받아 경제적 이익등을 취득하였다.

B. Defendant 2

The Defendant is the Deputy Director of △△△△ Hospital, who is engaged in administrative affairs, such as hospital revenues and expenditure management.

No defendant shall receive economic benefits, etc. provided by a distributor or lessor of a medical device for the purpose of promoting distribution, such as inducing the adoption or use of a medical device.

On November 30, 2010, the Defendant received economic benefits, etc. from Nonindicted Co. 1 Co. 4 in Seoul ( Address 2 omitted), from Nonindicted Co. 1 Co. 4, and received from Nonindicted Co. 1 Co. 1, 2010, a total sum of KRW 229,680,00 from Nonindicted Co. 1 Co. 4, 201, for the purpose of promoting the sale of medical devices, such as adoption and response inducement of 1,079 medical devices, such as XCE BL ALBESSTRTRTRTR TRCAR, and received from Nonindicted Co. 1 Co. 1, 201, the amount of financial benefits, etc. for the purpose of inducing the sale of medical devices, such as the acquisition of economic benefits, etc., for the purpose of inducing the use of medical devices, as stated in attached Table I (23) through 31).

C. Defendant 3

The defendant is a person engaged in administrative affairs, such as hospital revenues and expenditure management, as the head of the management planning office of △ Hospital.

No defendant shall receive economic benefits, etc. provided by a distributor or lessor of a medical device for the purpose of promoting distribution, such as inducing the adoption or use of a medical device.

On November 30, 2010, the Defendant received 9,350,000 won from Nonindicted Co. 1 Co. 4 in total nine times in Seoul ( Address 3 omitted) to receive 84,150,00 won in total from Nonindicted Co. 1 Co. 4 for the purpose of sales promotion, such as adoption and inducement of contact with respect to 219 medical devices, such as vialebbane (AMFXNPA), SMH (SESH), SMA, and SIEX (SS). The Defendant acquired economic benefits, etc. from the time of receiving 9,350,000 won in total from Nonindicted Co. 1 Co. 1’s employees to receive 84,150,000 won in total, and acquired economic benefits, etc. provided for the purpose of promotion of sales, such as adoption and inducement of use of medical devices, as employees of medical institutions.

D. Defendant 4

The Defendant is the head of △△ Medical Support Center who is engaged in administrative affairs, such as hospital revenues and expenditure management.

No defendant shall receive economic benefits, etc. provided by a distributor or lessor of a medical device for the purpose of promoting distribution, such as inducing the adoption or use of a medical device.

On November 30, 2010, the Defendant received 50,000,000 won, which was provided for the promotion of sales, such as adoption and inducement of medical devices, from Nonindicted Co. 1 Co. 4 in Seoul ( Address 4 omitted), and received 560,000,000 won in total from that time, and received 12 times in total from Nonindicted Co. 4 to 560,00,000,000 won, which was provided for the promotion of sales, such as adoption and inducement of medical devices, from Nonindicted Co. 1 Co. 1 to Nonindicted Co. 1, 201, and received economic benefits, etc. for the purpose of inducing the adoption and use of medical devices.

E. Defendant 5

The defendant is a person engaged in administrative affairs, such as hospital revenues and expenditure management, as the head of △△ Hospital.

No defendant shall receive economic benefits, etc. provided by a distributor or lessor of a medical device for the purpose of promoting distribution, such as inducing the adoption or use of a medical device.

피고인은 2010. 12. 1.경 경남 (주소 5 생략)에서 공소외 1 주식회사의 공소외 4로부터 공소외 1 주식회사에서 공급하는 프로머스 엘리멘트 스텐트 시스템(PROMUS ELEMENT STENT SYSTEM), 인데버 레절루트(ENDEAVOR RESOLUTE), 버사스텝(VERSASTEP) 등 832개 의료기기에 대한채택·처방유도 등 판매촉진을 목적으로 제공되는 39,535,650원을 지급받아 경제적 이익등을 취득한 것을 비롯하여 그 때부터 별지 범죄일람표Ⅰ 순번 (53) 내지 (61) 기재와 같이 총 9회에 걸쳐 합계 355,820,850원을 지급받아 의료기관 종사자로서 의료기기에 대한 채택·사용유도 등 판매촉진을 목적으로 제공되는 금원을 교부받아 경제적 이익등을 취득하였다.

2. As to Defendant 11 Company

A. Defendant 6 and 7’s co-principal conduct

No distributor or lessor of a medical device shall provide any economic benefit, etc. to any medical person, founder of a medical institution (including the representative or director of a corporation, or any other person engaged therein), or any employee of a medical institution, with an intention to induce him/her to adopt or use a medical device or promote

피고인들은 보건복지부가 고시한 보험상한가 내에서 실거래가를 상환하는 실거래가 상환제 하에서 치료재료에 대하여 실거래가를 모두 보험상한가로 맞추어 국민건강보험공단에 급여청구함으로써 판매이익을 극대화한 후 치료재료 판매이익의 일정부분을 병원에 돌려주는 방법으로 피고인 11 주식회사에서 병원에 판매하는 치료재료인 의료기기에 대하여 채택·사용유도 등 판매를 촉진하기로 공모하여 2010. 12. 3.경 서울 (주소 6 생략) 소재 ▽▽▽병원에서 그 곳 구매부장으로 일을 하는 피고인 8에게 33,069,907원을 지급하여 피고인 11 주식회사에서 ▽▽▽병원에 공급하는 버사스텝(VERSASTEP), 인데버 레절루트(ENDEAVOR RESOLUTE), 시아 스크류 셋트(XIA SCREW SET) 등 1,740개의 의료기기에 대한 채택·처방유도 등 판매촉진을 목적으로 의료기관 종사자인 피고인 8에게 경제적 이익등을 제공한 것을 비롯하여 그 때부터 2011. 2. 1.까지 별지 범죄일람표Ⅱ 기재와 같이 의료기기 채택·사용유도 등 판매 또는 임대 촉진을 목적으로 255,434,594원의 경제적 이익등을 제공하였다.

B. Defendant 8

The Defendant is a person who is engaged in administrative affairs, such as hospital revenues and expenditures, as the head of the ▽▽△ Hospital purchasing department.

No defendant shall receive economic benefits, etc. provided by a distributor or lessor of a medical device for the purpose of promoting distribution, such as inducing the adoption or use of a medical device.

피고인은 2010. 12. 1.경 서울 (주소 6 생략)에서 피고인 11 주식회사의 피고인 6, 7로부터 피고인 11 주식회사에서 공급하는 버사스텝(VERSASTEP), 인데버 레절루트(ENDEAVOR RESOLUTE), 시아 스크류 셋트(XIA SCREW SET) 등 1,740개 의료기기에 대한 채택·처방유도 등 판매촉진을 목적으로 제공되는 33,069,607원을 지급받아 경제적 이익등을 취득한 것을 비롯하여 그 때부터 별지 범죄일람표Ⅱ 순번 (1), (2), (3) 기재와 같이 총 3회에 걸쳐 합계 101,197,797원을 지급받아 의료기관 종사자로서 의료기기에 대한 채택·사용유도 등 판매촉진을 목적으로 제공되는 금원을 교부받아 경제적 이익등을 취득하였다.

C. Defendant 9

피고인은 ◎◎◎◎◎병원의 운영본부장으로 병원 수입, 지출 관리 등 행정업무에 종사하는 자이다.

No defendant shall receive economic benefits, etc. provided by a distributor or lessor of a medical device for the purpose of promoting distribution, such as inducing the adoption or use of a medical device.

At around December 3, 2010, the Defendant received 36,104,759 won from Defendant 11 Co., Ltd. to receive 36,104,759 won from Defendant 11 Co., Ltd. for the purpose of facilitating sales, such as adoption and inducement of countermeasures against the medical devices, which were supplied by Defendant 11 Co., Ltd. from Defendant 6, 7, and received 107,030,428 won in total more than three times, and acquired economic benefits, etc. for the purpose of facilitating sales, such as adoption and inducement of the medical devices as YUJIN, 100,030,428 won from Defendant 11 Co., Ltd., and then acquired economic benefits, etc. from employees of medical institutions.

D. Defendant 10

피고인은 공소외 2 학교 ♤♤병원의 의료기관 개설자인 공소외 2 학교법인의 사무처 사업부장으로 학교법인의 수입, 지출 관리 등 행정업무에 종사하는 자이다.

No defendant shall receive economic benefits, etc. provided by a distributor or lessor of a medical device for the purpose of promoting distribution, such as inducing him/her to adopt or use a medical device.

around December 3, 2010, the Defendant supplied Defendant 11 Co., Ltd. from Defendant 6 and 7 to Defendant 11 Co., Ltd., Defendant 22,325,623 won, which was provided for the promotion of sales, such as adoption and response inducement of 1,238 medical devices, including but not limited to NAEAV SPR SPR, and LAPRT, from that time to that time, the Defendant received 22,325,623 won in total and received 47,206,369 won in total and 2 times in total and 47,36,369 won as employees of medical institutions, and received economic benefits, etc. for the purpose of inducing the adoption and use of medical devices.

E. Defendant 11 Company

Defendant 6, who is an employee of the Defendant, provided economic benefits, etc. as stated in the above 2-A of criminal facts in relation to the Defendant’s business, and violated the Medical Devices Act.

【Trademark】

1. Basic factual basis

The following facts can be acknowledged according to the evidence duly adopted and examined by the court below.

A. Co-defendant 1 corporation (hereinafter “Co-defendant 1 corporation”) is a corporation for the purpose of selling medical drugs. Co-defendant 3 is its representative director, Co-defendant 4 is its director, and Defendant 11 corporation (hereinafter “Defendant 11”) is also a corporation for the purpose of selling medical drugs. Defendant 6 is the head of the strategic business headquarters, and Defendant 7 is the head of the consulting business division.

(b) ○○ University Hospital (Defendant 1);

1) Around January 1, 2010, Co-Defendant 1 entered into a contract on vicarious supply of medical devices, etc. with ○○ University Hospital (hereinafter “○○○ Hospital”). Around that time, Co-Defendant 1 entered into a business partnership agreement with ○○ Hospital to pay KRW 70 million per month (information usage fee and rent). In addition, Co-Defendant 1 entered into a contract with ○○ Hospital on January 1, 201 with ○○ Hospital to use information of KRW 100,878,00 per month and to lease the warehouse materials.

2) Co-defendant 1 paid KRW 378,912,280 in total on 12 occasions as shown in Appendix I Nos. 1 to November 30, 2011, when the co-defendant 1 supplied a medical device, such as an ENEAVR RESUTE, to the ○○○○○ Hospital, etc., and paid KRW 17,647,190, around December 24, 2010, and thereafter paid KRW 378,912,280 in total, as described in Appendix I (i) through (ii).

3) Defendant 1 is the Deputy Director of ○○ Hospital in charge of administrative affairs such as hospital revenues and expenditure management.

(c) △△△ Hospital (Defendant 2);

1) Co-defendant 1: (a) supplied medical devices, etc. to the △△△△△ Hospital (hereinafter “△△△△ Hospital”); and (b) drafted a business partnership agreement between the △△ Hospital and the △△ Hospital on March 30, 2007 on the payment of KRW 20,3200,000 per month as information service charges.

2) Co-defendant 1 supplied the △△△△△△ Hospital with medical devices, such as CORFL -PLEASE, and paid KRW 2,5520,000,00 from November 30, 201 to July 29, 2011, including the payment of KRW 2,5520,000,000 per month (=2,320,000 x 1.00 x 1.680,000 won per month in total nine times, as shown in Appendix I (23) to July 29, 2011.

3) At the time of formulating the above business partnership agreement, Defendant 2 participated in the preparation of the above agreement as the head of the administrative support office. From around 2010, Defendant 2 served as the deputy head of the administrative support office and retired on December 31, 2011.

(d) △ Hospital (Defendant 3);

1) Co-defendant 1: (a) supplied medical devices, etc. to the Seocho Medical Foundation Hospital (hereinafter referred to as the “Seoul Medical Foundation Hospital”) on January 2, 2004; and (b) entered into an agreement on the business partnership with the Hospital on January 2, 2004 that paid KRW 5,300,000 per month (excluding surtax) on the use of information, etc.; and (c) from June 1, 2007, the amount was raised to KRW 8,50,000 per month (excluding surcharge).

2) Co-defendant 1 supplied MaMIXAPA and other medical devices (AMFNPA) to △ Hospital on November 30, 2010 and paid KRW 9,350,000 (i.e., KRW 8., KRW 8.5 million x 1.1) from that time to July 29, 2011, together with KRW 8,4150,000,000 per month on nine occasions, as indicated in Appendix I (32) to July 29, 2011.

3) Defendant 3 is in charge of the receipt, disbursement management, etc. of hospitals as the head of the management planning office of △ Hospital.

(e) △△ Medical Center (Defendant 4);

1) Around September 1, 2009, Co-Defendant 1 entered into a contract on the provision of medical appliances, etc. with △△ Medical Center, and around that time, it entered into a business partnership agreement with △△ Medical Center to pay KRW 50 million per month in relation to the sale of medical appliances. From March 1, 2011, the amount increased to KRW 55 million.

2) Co-defendant 1 supplied ○○ Medical Center with medical devices, such as SET of Sscke (XIASREW), and paid KRW 50 million around November 30, 201, including the payment of KRW 50 million around September 30, 201, up to September 30, 201, Nonindicted Co-defendant 1 paid KRW 560 million in total over 12 times, such as the list of crimes Nos. 41 through 52.

3) From around September 2008, Defendant 4 worked as the head of the operation support center at △△ Medical Center and was in charge of purchasing medical devices from Nonindicted Co-Defendant 1.

(f) △△ Hospital (Defendant 5);

1) 공동피고인 공소외 1 회사는 공소외 5 학교법인 ☆☆☆☆병원(이하 ‘☆☆☆☆병원’이라 한다)에게 의료기기 등을 공급하여 오면서 2010. 6. 1.경 ◈◈의료재단 ◐◐◐◐병원(현재의 ☆☆☆☆병원이다)과 사이에 임료로 월 21,538,500원(부가세 별도), 정보이용료로 월 35,941,500원(부가세 별도)을 지급하는 내용의 임대차 및 정보이용계약을 체결하였다.

2) Co-defendant 1 paid KRW 39,535,650 (= KRW 35,941,500 x 1.1) around December 1, 2010 when supplying a medical device, such as a proslor LOM ELEM SETS SYEM, to ○○○○ Hospital, and paid KRW 39,535,650 per month in total, including an amount of KRW 35,535,650,00 (= KRW 35,941,50 x 1.1) from that time until July 25, 2011.

3) Defendant 5 served as a vice-president at △△△ Hospital, and retired on December 31, 201.

(g) ▽▽▽△ Hospital (Defendant 8)

1) On September 29, 2005, Defendant 11 entered into a contract on information and data usage fees (at the time, the usage fees were 2.5% of the sales) with a hospital, and on March 31, 201, between the hospital’s central warehouse and the hospital, Defendant 11 entered into a lease agreement with the hospital regarding KRW 228.76 square meters.

2) 피고인 11 회사는 ▽▽▽병원에게 버사스텝(VERSASTEP) 등 의료기기를 공급하면서 2010. 12. 3.경 33,069,607원을 지급한 것을 비롯하여 그 때부터 2011. 2. 1.까지 별지 범죄일람표Ⅱ 순번 (1), (2), (3) 기재와 같이 총 3회에 걸쳐 합계 101,197,797원을 지급하였다.

3) Defendant 8 has been in charge of the management of revenues and expenditures of the hospital as the head of the purchasing department of the ▽▽△△ Hospital.

아. ◎◎◎◎◎병원 (피고인 9)

1) 피고인 11 회사는 ◎◎◎◎◎병원에 의료기기 등을 공급하여 오면서 2006. 4. 1.경 ◎◎◎◎◎병원(당시 상호는 ‘◎◎대학교 ♡♡♡♡♡병원’이었다)과 사이에 정보 및 데이터 이용료 계약을 체결하였고(당시 이용료는 매출액의 2.5%였다), 2011. 3. 31.경 ◎◎◎◎◎병원과 사이에 임료로 월 2,950만 원을 지급하는 내용의 임대차계약을 체결하였다.

2) 피고인 11 회사는 ◎◎◎◎◎병원에게 엑스페디엄 스크류 셋트(EXPEDIUM SCREW SET) 등 의료기기를 공급하면서 2010. 12. 3.경 39,715,235원을 지급한 것을 비롯하여 그 때부터 2011. 2. 1.까지 별지 범죄일람표Ⅱ 순번 (4), (5), (6) 기재와 같이 총 3회에 걸쳐 합계 107,030,428원을 지급하였다.

3) 피고인 9는 2010. 6.경부터 ◎◎◎◎◎병원의 운영본부장으로 병원 수입, 지출 관리 등의 업무를 담당하여 왔다.

I. Non-Indicted 2 School Foundation (Defendant 10)

1) 피고인 11 회사는 2005. 6. 29. 공소외 2 학교 ♤♤병원(당시 상호는 ‘공소외 2 학교 ♤♤♤♤병원’이었다)과 사이에 위탁공동구매계약을 체결하였고, 2005. 12. 1. 공소외 2 학교 ♤♤병원의 개설자인 공소외 2 학교법인(이하 ‘공소외 2 학교’라 한다)와 사이에 매출액의 2.5%를 지급하는 내용의 정보 및 데이터 이용료 계약을 체결하였다.

2) 피고인 11 회사는 공소외 2 학교 ♤♤병원에게 인데버 레절루트(ENDEAVOR RESOLUTE) 등 의료기기를 공급하면서 공소외 2 학교에 2010. 12. 3.경 22,325,623원을 지급한 것을 비롯하여 그 때부터 2011. 1. 6.까지 별지 범죄일람표Ⅱ 순번 (7), (8) 기재와 같이 총 2회에 걸쳐 합계 47,206,369원을 지급하였다.

3) Defendant 10 is in charge of the revenue and expenditure management of the school juristic person as the head of the secretariat of Nonindicted Party 2’s school.

2. Relevant statutes;

former Medical Service Act (State 1) (wholly amended by Act No. 10564, Apr. 7, 201)

Article 23-2 (Prohibition of Acquisition of Unfair Economic Benefits, etc.)

No medical person, founder of a medical institution (including the representative of a corporation, director, or any other person engaged therein; hereafter the same shall apply in this Article) or person engaged in a medical institution shall receive money, goods, benefits, labor, entertainment, or other economic benefits (hereinafter referred to as "economic benefits, etc.") provided by a person who has obtained marketing approval under Article 31 of the Pharmaceutical Affairs Act, a person who has reported items, a drug importer under Article 42 of the same Act, a drug wholesaler under Article 45 of the same Act, or a drug wholesaler under Article 45 of the same Act for the purpose of sales promotion, such as adoption and inducement of drugs: Provided, That the foregoing shall not apply to the provision of samples, support for academic competitions, support for clinical trials, support for clinical trials, product presentation, discount of expenses under the price settlement conditions, investigation after the market, etc. (hereinafter referred to as "providing samples, etc."):

No medical person, founder of a medical institution, nor person working for a medical institution under paragraph (2) shall receive economic benefits, etc. provided by a manufacturer under Article 6 of the Medical Devices Act, an importer of medical devices under Article 14 of the same Act, or a distributor or lessor of medical devices under Article 16 of the same Act for the purpose of facilitating sales, such as adoption and inducement of medical devices: Provided, That the foregoing shall not apply to the provision of samples, etc., which are economic benefits, etc.

Article 88-2 (Penal Provisions)

Any person who violates Article 23-2 shall be punished by imprisonment for not more than two years or by a fine not exceeding 30 million won. In such cases, the economic benefits, etc. acquired shall be confiscated, and if confiscation is impossible, the value equivalent thereto shall be collected

former Medical Devices Act (as before partial amendment by Act No. 11690, Mar. 23, 2013)

Article 18 (Obligations of Distributors, etc.)

A person who may distribute or lease a medical device under this Act shall observe the method of ensuring the quality of medical device at his/her place of business, as prescribed by Ordinance of the Ministry of Health and Welfare, and other matters concerning maintaining the order in distribution

No distributor or lessor referred to in paragraph (2) shall provide any economic benefits, etc. to medical persons, founders of medical institutions (including the representative or directors of a corporation, or other persons engaged therein), or employees of medical institutions with intent to induce them to adopt or use, or promote the sale or lease of medical devices: Provided, That the foregoing shall not apply where the act, such as the provision of samples, is an economic benefit

Article 53 (Penal Provisions)

A person who violates Article 13 (3) (including cases applied mutatis mutandis in Article 15 (6)) or 18 (2) shall be punished by imprisonment for not more than two years or by a fine not exceeding 30 million won.

former Medical Devices Act (amended by Act No. 10564, Apr. 7, 2011; 3)

Article 17 (Matters to be Observed by Distributors, etc.)

A person who may distribute or lease medical devices under this Act shall comply with the quality assurance method at his/her place of business and other matters concerning the maintenance of order in distribution, as prescribed by Ordinance of the Ministry of Health and Welfare.

No distributor or lessor referred to in paragraph (2) shall provide any economic benefits, etc. to medical persons, founders of medical institutions (including the representative or directors of a corporation, or other persons engaged therein), or employees of medical institutions with intent to induce them to adopt or use, or promote the sale or lease of medical devices: Provided, That the foregoing shall not apply where the act, such as the provision of samples, is an economic benefit

Article 44-2 (Penal Provisions)

A person who violates Article 12 (3) (including cases applied mutatis mutandis in Article 14 (5)) or 17 (2) shall be punished by imprisonment for not more than two years or by a fine not exceeding 30 million won.

3. The judgment of the court below

The lower court determined as follows on the existence of the constituent elements of the instant case and sentenced each of them not guilty under the former part of Article 325 of the Criminal Procedure Act.

According to the records, the Defendants constitute a medical person, etc. or a dealer of medical devices as stipulated in Article 23-2(2) of the former Medical Service Act, Articles 17(2) through 18(2) of the former Medical Devices Act, and joint penal provisions (hereinafter “instant provisions”). However, the instant provisions are punished only where a medical person, etc. received economic benefits, etc. or provided it to a medical person, etc., and do not regulate the case where a medical institution itself receives economic benefits, etc.

Furthermore, Article 45(1) of the Political Funds Act explicitly provides that if a political party receives an illegal donation, it shall be punished by the constituent members who directly committed the act. In fraud, bribery, etc., the provisions of this case provide that the economic benefits, etc. belong to a third party. However, there is no such express provision. However, the provisions of this case also stipulate that the amendment to change the term “persons working for medical institutions” in the provisions of this case to “medical institutions (including the relevant medical institution employees. In the case of a juristic person, including the representative, director, and other employees of the juristic person)” shall be submitted to the National Assembly on November 1, 2012. The legislative review materials of this case were submitted to the National Assembly, and there is no evidence to the effect that the legislative review materials of the National Assembly directly enjoy economic benefits, etc., even if a medical institution directly enjoys economic benefits, etc., (3) Article 88-2 of the Medical Service Act provides necessary confiscation and additional collection, but the interpretation of the above provisions should be limited to those employees who actually enjoy economic benefits, etc.

4. Judgment of the court below

A. Whether the money of this case constitutes an economic interest with the aim of sales promotion

In light of the following facts acknowledged by the evidence duly admitted and investigated by the court below, the money of this case constitutes an economic interest prohibited by the provisions of this case.

1) Non-Indicted 6 stated that “Non-Indicted 6 of the △△ Medical Personnel stated to the effect that “Non-Indicted 6 entered into a contract to receive the monthly fixed amount of KRW 50 million in the concept of dividing profits between △△ Medical Personnel and Non-Indicted 1, and that the written agreement on the business partnership on September 1, 2009 (Article 1304-1307 of the Investigation Record) was prepared after July 18, 201” (No. 3rd 1146 of the Criminal Litigation Record, No. 1 of the Investigation Record No. 370, 385-387 of the Investigation Record).”

2) Defendant 4 stated that “The amount of KRW 50 million received from Nonindicted Company 1 is the amount that ○○ Medical Center received from Nonindicted Company 1 provides in order to continue supplying the medical device, and the part of the profits from the medical device purchased by Nonindicted Company 1 is returned” (No. 646-647 of the Investigation Record No. 2).

3) 공동피고인 공소외 4는 ‘공소외 1 회사에서는 실제 공급가액과 거래명세서 가액의 차액부분 중 일정부분을 매월 각 병원에 돌려주고 있다, ◇◇의료원과의 기존의 업무제휴 합의서는 월 5,000만 원을 지급하는 것이었는데, 이 사건 수사 과정에서 ◇◇의료원에 대한 금전지급이 문제되자 변호사의 자문을 받아 기존의 명목을 창고임차료 및 정보데이터이용료로 나누는 내용으로 업무제휴 합의서를 소급해서 다시 작성하였다(2009. 9. 1.부터는 정보제공료 월 1,500만 원, 임차료 월 3,500만 원, 2011. 3. 1.부터는 정보제공료 월 1,700만 원, 임차료 월 3,800만 원), 위 5,000만 원 등은 정보제공과는 아무런 관련이 없다, 정보제공이용료의 산정기준 역시 없다, 공소외 1 회사에서는 ◇◇의료원 외에도 ○○대학교 ○○병원, ▤▤▤ 의료원, △△△△병원, □□병원, ☆☆☆☆병원 등에도 주기적으로 금원을 주었는데, 이 또한 보험상한가와 구매가격과 차이를 이용하여 이익을 나누어 가진 것이다’라는 취지로 진술하고 있다(수사기록 제2권 제933~947쪽, 1059~1066쪽).

4) Article 2 of the Information Use Agreement between Co-defendant 1 and the ○○ Hospital and Article 2 of the Medical Treatment Materials Lease Agreement only states leased real estate “10 per annum 110 per annum above the second floor of the building,” but does not specify its location, etc. and does not clearly state it (Article 4 of the Investigation Record No. 1899 of the Investigation Record).

5) Nonindicted 7 stated to the effect that “The information on the order of the medical institution is necessary at the hospital first” (Article 8, title 3735-37, title 8, title 3736 of the Investigation Records).

6) Article 3(6) of the Agreement on Business Partnership entered into between Co-Defendant 1 and △ Hospital states that “The interest from co-purchase shall be paid monthly 8,500,000 won (excluding surtax) for strategic alliance in accordance with the ratio agreed between both parties.” Defendant 3, who is the head of the management planning office of △ Hospital, stated to the effect that “The difference between the upper limit of the purchase price claimed by △ Hospital to the National Health Insurance Corporation shall be the profit, and the rent shall be the difference between the upper limit of the purchase price claimed by △ Hospital to the National Health Insurance Corporation.” (Article 99 of the Investigation Records No. 4262-4263 of the Investigation Records).”

7) 공동피고인 공소외 1 회사와 ◈◈의료재단 ◐◐◐◐병원(현재의 ☆☆☆☆병원이다)과 사이에 체결된 임대차 및 정보이용 계약서 제2조에서는 임대부동산을 ‘(주소 9 생략) 내 연건평 124.5평’이라고만 기재하고 있을 뿐 그 위치 등이 구체적으로 특정되지 않고 막연히 기재되어 있다(수사기록 제6권 제2532쪽).

8) Although Defendant 1 paid the rent from April 30, 201 to the ▽▽△△ Hospital, the lease agreement was drafted on March 31, 201. Although Defendant 1 used part of the ▽▽▽▽▽△ Hospital from the end of 2009, Defendant 11 was paying the rent from April 30, 201, despite having been using it from the end of 2009, it appears to have suspended the payment of information usage fee and changed the method of paying warehouse rent (Article 5029-5 of the Investigation Records, No. 1029-5045 of the Investigation Records). Moreover, Defendant 11 was using only part of the leased part of the part of the part that was leased from the ▽▽▽△△△ Hospital (Article 10 of the Investigation Records, No. 5051 of the Investigation Records).

9) ◎◎◎◎◎병원의 물류팀장인 공소외 8은 ‘병원과 피고인 11 회사가 보험상한가로 청구한 이익을 나누어 그 중 일부는 피고인 11 회사가 갖고 일부는 병원이 가진 것이다’라는 취지로 진술하고 있다(수사기록 제11권 제5439쪽).

10) 공소외 2 학교 ♤♤병원의 물류팀 과장인 공소외 9는 ‘피고인 11 회사는 병원의 월 매출의 2.5%를 법인에게 정보이용료 및 임대료 형식으로 지급했다’라는 취지로 진술하고 있다(수사기록 제11권 제5311~5312쪽).

11) If the instant money is an information use fee, it should be considered in determining the amount or rate, but in this case, the amount, quality, and type of specific information should be considered. However, in this case, without such specific calculation criteria, the information use fee was determined on a daily rate of 60% of the profit (the difference between the insurance premium received by a medical institution from the National Health Insurance Corporation and the amount actually purchased by Co-Defendant 1 or Defendant 11 from the wholesaler, etc.) or 2.5% of the sales (However, there is only difference between Co-Defendant 1’s fixed amount system and Defendant 11’s fixed rate system).

12) The resolution of the legal issues regarding “information data use fee”, which is the internal document of Defendant 11 (No. 10, 4774 of the investigation record), the re-establishment of a private university hospital model (No. 10, 4800 of the investigation record), the plan for the alteration of the method of paying “information data use fee” (No. 10, 4966 of the investigation record), the calculation sheet of logistics warehouse rent (No. 10, No. 4976 of the investigation record), the logic review of the feasibility of information use fee (No. 4983 of the investigation record), the statement of the related persons (No. 2, No. 939-940 of the investigation record No. 4, Nonindicted 10 of the investigation record, Nonindicted 10 of the investigation record, Defendant 762, 4784-478 of the investigation record, and Defendant 11’s employees) appears to have been held by the Co-Defendant 1 and the company were to receive rebates from the medical institution.

13) ▥▥대학교병원의 경우 피고인 11 회사에게 오히려 구매대행수수료로 구입금액의 0.2~0.64%를 지급하였다(수사기록 제10권 제4631쪽).

Moreover, Co-Defendant 1 or Defendant 11 supplied medical appliances to medical institutions after being supplied with medical appliances at a lower price than insurance prices by each medical device wholesaler, and the medical institutions that pay the price of supply receive benefits from the National Health Insurance Corporation. As such, the division of the difference between the insurance prices and the actual supply prices between the medical institutions, Co-Defendant 1, and Defendant 11 should be criticized as an act detrimental to the sound insurance finance.

B. Whether the Defendants received economic benefits, etc.

The facts charged of this case reveal that Defendant 1, 2, 3, 4, 5, 8, 9 (hereinafter “Defendant 1, etc.”) who is an employee of a medical institution and Defendant 10, who is an employee of a medical institution founder, received economic benefits, etc. as shown in the facts charged with the purpose of sales promotion from Co-Defendant 3, 4, or Defendant 6 and 7 on the part of Co-Defendant 1 and Defendant 11.

따라서, 피고인 1 등과 피고인 10이 공소사실과 같은 경제적 이익등을 받았느냐에 관하여 살펴 보건대, 앞서 본 바와 같은 사정들, 즉, ① 공동피고인 공소외 1 회사가 정보이용료나 임차료 등에 대한 계약을 체결하고 이에 대한 금원을 지급한 것은 피고인 1 등이 속한 의료기관들인 ○○○병원, △△△△병원, □□병원, ◇◇의료원, ☆☆☆☆병원, ▽▽▽병원, ◎◎◎◎◎병원인 점, ② 피고인 1 등은 위 의료기관들의 실무담당자로 계약 체결에 관여하거나 의료기관의 수입·지출 등의 업무를 담당하기는 하였으나, 공동피고인 공소외 1 회사나 피고인 11 회사로부터 경제적 이익등을 받은 사실이 전혀 없는 점, ③ 따라서, 이 사건 금원의 귀속주체는 피고인 1 등이 아니라 그들이 소속되거나 관련된 의료기관으로 보아야 할 뿐만 아니라 피고인 1 등은 의료기관의 실무담당자일 뿐이지 의료기관의 이러한 행위에 대해 형사상의 책임을 질 만한 지위에 있다고 보기 어려운 점, ④ 또한, 원심에서 설시한 바와 같이 이 사건 조항들은 의료인 등이 경제적 이익등을 받거나, 의료인 등에게 이를 제공했을 경우만을 처벌하는 것으로 규정하고 있어서 이 사건에서와 같이 ‘의료기관’이 경제적 이익등을 받은 경우에는 이 사건 조항들에 해당한다고 해석하기 어려운 점, ⑤ 피고인 10 역시 피고인 11 회사 측의 피고인 6, 7로부터 경제적 이익등을 받은 사실이 없고, 의료개설자인 공소외 2 학교의 실무담당자일 뿐 의료개설자의 이러한 행위에 대해 형사상의 책임을 질 만한 지위에 있다고 보기 어려운 점, ⑥ 또한, 피고인 11 회사는 2005. 6. 29. 의료기관인 공소외 2 학교 ♤♤병원과 사이에 위탁공동구매계약을 체결하고 공소외 2 학교 ♤♤병원에 의료기기를 공급하여 오면서 공소외 2 학교 ♤♤병원으로부터 정보 및 데이터를 받아왔는데, 단지 2005. 12. 1. 정보 및 데이터 이용료 계약을 공소외 2 학교 ♤♤병원이 아닌 공소외 2 학교법인와 사이에 체결한 것으로 인해 그 동안 공소외 2 학교에 금원을 지급하여 온 점, 피고인 10은 공소외 2 학교법인의 사무처 사업부장으로서 이 사건 금원을 비롯한 학교법인 전체의 수입, 지출 관리 등의 행정업무를 담당하여 왔고, 의료기기 공급, 정보 제공 등은 공소외 2 학교 ♤♤병원과 피고인 11 회사 사이에 이루어진 점 등에 비추어 볼 때, 피고인 10으로서는 공소외 2 학교의 이 사건 금원 수수행위가 ‘의료기관 개설자의 종사자로서 의료기기 판매업자로부터 의료기기 채택·사용유도 등 판매촉진을 목적으로 경제적 이익등을 제공받는 것이라는 점’에 대한 인식이 있었다고 보기 어려운 점 등을 종합하면, 검찰이 제출한 증거만으로는 피고인 1 등과 피고인 10에 대한 공소사실을 인정하기에 부족하고, 달리 이를 인정할 증거가 없다.

Therefore, the facts charged of this case against Defendant 1, 2, 3, 4, 5, 8, 9, and 10, and Defendant 6, 7, and 11, premised on the provision of economic benefits, etc. to the above Defendants, fall under a case where there is no proof of crime, and thus, they are acquitted pursuant to the latter part of Article 325 of the Criminal Procedure Act. The court below found Defendant 1 not guilty pursuant to the former part of Article 325 of the Criminal Procedure Act, but it is justifiable in its conclusion.

【Determination】

Therefore, since the appeal by the prosecutor against the defendants is without merit, it is dismissed in accordance with Article 364 (4) of the Criminal Procedure Act. It is so decided as per Disposition.

Judges Jeon Soo-hun (Presiding Judge)

1) Article 23-2 of the current Medical Service Act was partially amended by Act No. 10565 on April 7, 2011, and it will enter into force one year after its promulgation by the Addenda.

2) Article 18 of the current Medical Devices Act was partially amended by Act No. 11690 on March 23, 2013, and is enforced from the date of promulgation under Article 1(1) of the Addenda.

3) Article 18 of the former Medical Devices Act, amended by Act No. 10564, Apr. 7, 2011, shall enter into force on the date six months have elapsed after its promulgation under Article 1 of the Addenda.