National Health Insurance Corporation (Law Firm Doz., Attorneys Nam Jong-Un et al., Counsel for the defendant-appellant)

Madvers Co., Ltd. (Attorney Park Jong-il, Counsel for the plaintiff-appellant)

November 13, 2009

Seoul Western District Court Decision 2008Gahap9204 Decided February 20, 2009

1. Of the judgment of the court of first instance, the part against the defendant in excess of the amount ordered to be paid below shall be revoked, and the plaintiff's claim corresponding to the revoked part

The defendant shall pay to the plaintiff 322,84,356 won with 5% interest per annum from November 15, 2007 to January 22, 2010, and 20% interest per annum from the next day to the day of full payment.

2. The plaintiff's appeal and the defendant's remaining appeal are all dismissed.

3. Of the total litigation costs, 70% is borne by the Plaintiff, and the remainder is borne by the Defendant, respectively.

1. Purport of claim

The defendant shall pay to the plaintiff 1,127,589,292 won with 5% interest per annum from November 15, 2007 to the delivery date of a copy of the complaint of this case, and 20% interest per annum from the next day to the day of complete payment.

2. Purport of appeal

A. The plaintiff

Of the judgment of the court of first instance, the part against the plaintiff falling under the following order for payment shall be revoked. The defendant shall pay to the plaintiff 426,100,720 won with 5% per annum from November 15, 2007 to the service date of the copy of the complaint of this case, and 20% per annum from the next day to the day of full payment.

B. Defendant

The part of the judgment of the first instance against the defendant shall be revoked, and the plaintiff's claim corresponding to the above revocation shall be dismissed.

1. Facts of recognition;

A. Status, etc. of the parties

(1) The Plaintiff is a corporation established pursuant to Article 12 of the National Health Insurance Act and engaged in the management of insurance benefits, the payment of insurance benefit costs, etc., and the Defendant is a corporation that engages in the export and import, manufacture, and sales of drugs.

(2) According to Articles 39(1) and (2), and 42(7) of the National Health Insurance Act, Article 24(3) of the Enforcement Decree of the National Health Insurance Act, and Articles 8(2) and 14 of the Regulations on the Standards for Medical Care Benefits in National Health Insurance, the Minister of Health, Welfare and Family Affairs shall determine and publicly notify the maximum amount which serves as the basis for reimbursement of expenses for medicine subject to health care benefit. Medical care institutions are able to claim and reimburse the purchase cost of medicine to the Plaintiff within the scope of the notified amount. Accordingly, the Minister of Health, Welfare and Family Affairs has publicly announced each medicine subject to health care benefit pursuant to the National Health Insurance Act’s announcement from July 1, 200 when the National Health Insurance Act enters into force on July 1, 200, the Ministry of Health, Welfare and Family Affairs publicly announced the maximum amount of each medicine subject to health care benefit pursuant to the Medical Care Benefit List and Wage Table (hereinafter “the upper amount table”).

(b) Exceptions to the direct production medicine of raw materials:

(1) According to the adjustment criteria under Article 14 of the former Regulations on the Standards for Medical Care Benefits in National Health Insurance (amended by Ordinance of the Ministry of Health and Welfare No. 328 of Oct. 11, 2005), the maximum amount of medicines for which a request for registration has been made shall be determined in a way that the maximum amount of medicines for which a request for registration has been filed is to reduce the maximum amount of medicines for the first time on the table of the maximum amount of identical, identical, identical, and the same amount of medicines among the same contents at the highest price, according to the order of the registration of the medicines (which is referred to as “the new medicines”) recorded thereafter at a certain rate.

(2) However, as an exception to the above mitigation method, the above adjustment standard [Attachment 1] 1.C (c) provides that "where only a part of the series of manufacturing processes, such as where only a partial salt is attached, etc., may be the same as the highest price, among the products of the same kind, dosage, or content (hereinafter referred to as "the same product") already recorded, a special provision for direct production of raw materials may be provided (hereinafter referred to as "the special provision in this case"). This is to facilitate the development of the manufacturing technology of domestic pharmaceutical companies by recognizing the highest price of the same product in the order of registration in the upper price list even if the complete medicine is not a new drug, but a reproduced drug is not a new drug, and thus, if the pharmaceutical company which applied for registration in the upper price list for a specific complete medicine manufactures the raw materials of the relevant product as a raw material, and uses it as a raw material, it is necessary to promote the development of the manufacturing technology of domestic pharmaceutical companies.

(3) On the other hand, a practical assessment committee for calculating the maximum amount of medicine has been in charge of the pharmaceutical specialized assessment committee of the Health Insurance Review and Assessment Service. In accordance with the result of deliberation by the 5th committee in 2004, if the manufacturing company of the complete medicine holds more than 50% of the shares of the manufacturing company of the drug as a result of the deliberation by the 5th committee, the said special provision

C. The details of determination of the maximum amount of the drug in this case

(1) On October 11, 2004, 2004, the company Daehee Chemical Co., Ltd. (hereinafter “Shee Chemical”) reported the manufacture items of pharmaceutical products to the Minister of Food and Drug Administration around the same day with respect to the “Sehee Pluscopic scopic scopic scopic scopic scopic scopic scopic scopic scopic scopic scopic scopics” (hereinafter “Scopic scopic scopic scopic scopic scopic”).

(2) On December 2, 2004, the Defendant reported the manufacture items of the medicine to the Minister of Health and Welfare around December 21, 2004 with respect to the pharmaceutical products produced by the Defendant (the main ingredient of the instant pharmaceutical product is the Kuminpo City pent; hereinafter “the instant pharmaceutical product”). On December 21, 2004, the Defendant filed an application for medicine decision (application for medical care benefits) with the Minister of Health, Welfare and Family Affairs (application for the instant pharmaceutical product). The instant pharmaceutical product registered as the same medication at the time of filing the application for the said pharmaceutical decision was indicated below [Do Table 1]. The Defendant, on the ground that “the Defendant owns 50% of the shares of the scars chemical producing Kupo City pent (the main ingredient of the instant pharmaceutical product)” among the pharmaceutical products registered as the same medication, demanding the Defendant to determine the maximum amount of 479 won equivalent to the maximum amount of 10 malknex of scarpool medicine.

【Doide 1】

On February 2, 1995, the date of registration of the upper limit of the product name of the business entity included in the main text 1.1. Han-gu Han-si, Han-si, 122 won, Han-si, Han-si, 142 won in Han-si, Han-si, 142 won in Feb. 3, 1992; 10.8.1.4, 1989, treatment medicine industry treatment xta-si, 10.8,00 won in 185,00 won in 185,000 won in 197.1.5, 1989, Han-gu, Han-gu, Han-si, Han-si, Han-si, Ka-si, Ka-si, Ka-si, Ka-si; 10.6.8,000 won in Ka-si, 194.7,000 won in 19.17.194

(3) In the process of going through the deliberation process by the Pharmaceutical Specialized Evaluation Committee, the above committee considered that the Defendant’s share holding ratio of the Plaintiff’s scarke chemical does not exceed 50%, and thus, the maximum amount of the instant drug was 109 won, which is the lowest price of 90% pursuant to attached Table 1-1-A. (3) of 1.3, the Defendant received an additional transfer of 1,00 shares of scarke chemical (which is 40,000 shares issued) from the Nonparty on January 10, 2005, and filed an objection with the above committee. Accordingly, on April 22, 2005, the Pharmaceutical Special Evaluation Committee deliberated on the maximum amount of the instant drug as 479 won, on April 22, 2005, on the ground that “The Defendant’s share holding ratio of scarchemical chemical exceeds 50% as of the date, it may be applicable to the instant special provisions.”

(4) Accordingly, on May 16, 2005, the Minister for Health, Welfare and Family Affairs revised and announced the upper limit amount list including the new listing of the instant medicine in the upper limit amount list and the contents that set the upper limit amount as KRW 479, in accordance with the Ministry for Health, Welfare and Family Affairs Notice No. 2005-33 (hereinafter “Notification No. 1”), which was enforced from June 1, 2005.

(5) However, the Defendant did not notify the Ministry of Health and Welfare or the Health and Welfare Review and Assessment Service, etc. of this fact despite the fact that all of the stocks held on May 15, 2005, the day before the first notice of this case was given, were transferred again to the Nonparty.

(d) Particulars of changes in the upper limit amount;

(1) From June 2007, the Minister of Health, Welfare and Family Affairs received a high-amount amount using the special provisions of this case, and conducted a full-scale investigation into the medicines whose method of supplying raw materials was modified by the method of raw material import, etc., and subsequently, on August 16, 2007, announced that the medicines subject to the special provisions of this case were planned to establish a new obligation to inform the Ministry of Health, Welfare and Family Affairs of such matters.

(2) On October 31, 2007, based on the above findings of the investigation, the Minister for Health, Welfare and Family Affairs revised and announced the upper limit amount list including the change of the upper limit amount of the drug in this case to KRW 109 won under the Ministry for Health, Welfare and Family Affairs Notice No. 2007-98 (hereinafter “Notice No. 2”), which was enforced from November 15, 2007.

(3) On the other hand, the Minister for Health, Welfare and Family Affairs had not adjusted the maximum amount due to changes in the method of supplying raw materials or changes in the equity ratio of the raw material production company before October 2007.

[Reasons for Recognition] The facts without dispute, Gap evidence 1 through 10, Gap evidence 11-1, 2, Gap evidence 12, Gap evidence 14-17, the fact inquiry result of the court of first instance to the Minister of Health, Welfare and Family Affairs, the fact inquiry result of the court of first instance to the Health, Welfare and Family Affairs, and the purport of the whole pleadings.

2. Determination

A. Requests for restitution of unjust enrichment

(1) The plaintiff's assertion

The notice No. 2 of this case was made on the ground that there was an original defect in the notice No. 1 of this case. The legal nature of the notice constitutes revocation of administrative act that takes effect retroactively to the time when the subject disposition took place, not to withdraw administrative act that takes effect in the future. Therefore, since the notice No. 1 of this case recognized a maximum amount of KRW 479, which is the maximum price for the drug of this case, is legally revoked, and since the maximum amount of KRW 109, which is a new maximum amount is recognized by the notice No. 2 of this case, the part exceeding KRW 109, which is the maximum amount to be duly recognized by the plaintiff, out of the medical care benefit costs paid to the medical care institution, shall be deemed to have been paid without any legal cause. Accordingly, the defendant is obligated to pay the plaintiff the amount

(2) Determination

㈎ 보건복지부 고시인 약제급여·비급여목록 및 급여상한금액표는 다른 집행행위의 매개 없이 그 자체로서 국민건강보험가입자, 국민건강보험공단, 요양기관 등의 법률관계를 직접 규율하는 성격을 가지므로 항고소송의 대상이 되는 행정처분에 해당한다고 할 것이다( 대법원 2006. 9. 22. 선고 2005두2506 판결 참조). 한편, 행정처분이 아무리 위법하다고 하여도 그 하자가 중대하고 명백하여 당연무효라고 보아야 할 사유가 있는 경우를 제외하고는 아무도 그 하자를 이유로 무단히 그 효과를 부정하지 못하는 것으로, 이러한 행정행위의 공정력은 판결의 기판력과 같은 효력은 아니지만 그 공정력의 객관적 범위에 속하는 행정행위의 하자가 취소사유에 불과한 때에는 그 처분이 취소되지 않는 한 처분의 효력을 부정하여 그로 인한 이득을 법률상 원인 없는 이득이라고 말할 수 없는 것이다( 대법원 1994. 11. 11. 선고 94다28000 판결 참조).

㈏ 그런데 이 사건의 경우, 이 사건 제1고시 이전에 피고가 대희화학의 주식을 모두 처분함으로써 이 사건 특례규정을 적용받을 수 없었음에도 불구하고 이 사건 의약품에 대하여 상한금액을 금 479원으로 하는 위 고시가 이루어졌음은 앞서 본 바와 같으나, 2005. 4. 22. 약제전문평가위원회의 심의 당시까지도 피고는 대희화학의 주식 52.5%를 보유하고 있는 상태였을 뿐만 아니라 피고가 위 주식을 처분한 것은 이 사건 제1고시가 있기 하루 전이었던 점 등에 비추어 볼 때, 이 사건 제1고시가 중대하고 명백한 하자로 인하여 당연무효에 해당하는 것이라고 볼 수는 없다. 한편, 이 사건 제2고시는 종전의 행정처분인 이 사건 제1고시의 내용을 변경하는 새로운 행정처분일 뿐 종전의 행정처분의 효력을 소급적으로 소멸시키는 행정행위의 취소에 해당하는 것이라고 볼 수는 없다. 결국, 이 사건 제1고시가 당연무효라거나 소급적으로 취소되었다고 볼 수 없는 이상, 위 고시에 터 잡아 피고가 요양기관들과 사이에 의약품거래를 함으로써 어떠한 이득을 얻었다고 하더라도 이를 들어 법률상 원인 없이 이득을 얻은 것이라고 볼 수는 없다. 원고의 위 주장은 이유없다.

B. Compensation for damages caused by tort

(1) Occurrence of damages liability

㈎ 행정청이 그 상대방으로부터 일정한 사정에 관한 고지를 받았더라면 어떠한 행정처분을 하지 않았을 것임이 경험칙상 명백한 경우에는 신의성실의 원칙상 그 상대방은 행정청에게 그와 같은 사정을 고지할 의무가 있다고 할 것이며, 그와 같은 고지의무의 대상이 되는 것은 직접적인 법령의 규정뿐 아니라 관습상 또는 조리상의 일반원칙에 의하여도 인정될 수 있다.

㈏ 그런데 이 사건의 경우, ① 원료직접생산 의약품에 대한 특례는 완제의약품의 제조자가 원료의약품까지 생산하는 경우 그 원료합성기술에 들인 노력을 보상하고 기술개발을 장려하기 위하여 일반적인 복제의약품과는 달리 예외적으로 최고가를 인정하는 제도인 점, ② 행정청이 이 사건 특례규정에 대한 유권해석을 통해 원료의약품을 직접 생산하는 경우뿐만 아니라 원료의약품 생산회사의 지분을 과반수 이상 보유하고 있는 경우에도 이 사건 특례규정을 적용하여 왔다면 그와 반대로 원료의약품 생산회사의 지분을 과반수 이상 보유하고 있지 아니한 경우에는 이 사건 특례규정을 적용하지 아니하였을 것임은 명백한 점, ③ 피고가 원료의약품 생산회사인 대희화학의 지분 과반수 이상을 보유하고 있음을 들어 이 사건 특례규정의 적용을 적극적으로 요구한 이상 그 지분을 처분하는 등 행정처분의 근거가 되는 사실관계에 변동이 발생하였다면 이러한 사정을 행정청에 고지하여야 할 조리상의 의무가 있다고 봄이 상당한 점, ④ 피고는 당초 약제전문평가위원회의 검토 단계에서 상한금액이 금 109원으로 검토되자 대희화학의 지분을 추가매수하여 이의신청을 하는 등 적극적인 행위를 하였음에도 불구하고 지분을 처분하는 단계에서는 위 위원회나 건강보험심사평가원 등에게 그와 같은 처분사실을 고지하는 등의 아무런 조치도 취하지 아니한 채 이 사건 제1고시에 터 잡아 이 사건 의약품의 판매행위를 계속하여 왔던 점 등에 비추어 보면, 피고는 신의칙상의 고지의무 위반에 따른 불법행위책임을 부담한다고 할 것이다.

(2) Scope of damages

㈎ 불법행위로 인한 재산상 손해는 위법한 가해행위로 인하여 발생한 재산상 불이익, 즉 그 위법행위가 없었더라면 존재하였을 재산 상태와 그 위법행위가 가해진 현재의 재산 상태의 차이를 말하는 것이다( 대법원 2008. 10. 23. 선고 2007다44194 판결 참조). 그런데 이 사건의 경우, ① 피고의 불법행위가 없었더라면 이 사건 의약품의 상한금액이 금 479원이 아니라 금 109원으로 결정되었을 것이나, 위 상한금액의 차이는 피고가 얻을 수 있었던 이득의 최고치를 산정하는 근거가 될 수 있을 뿐인 데다가 피고가 설사 그러한 이득을 얻었다고 하더라도 아래와 같은 사정에 비추어 볼 때 그러한 이득액 상당이 곧바로 원고의 손해액으로 귀착된다고 할 수는 없는 점, ② 피고가 이 사건 특례규정의 적용을 받지 못한 채 그 상한금액이 금 109원으로 결정되었다고 하더라도 이 사건 의약품을 제조·판매하였을 것이라는 특별한 사정을 인정할 만한 증거는 없는 점, ③ 요양기관들은 이 사건 의약품이 판매되지 아니하였더라면 그와 동일제제인 다른 의약품을 구매하였을 것임이 분명한 점 등에 비추어 볼 때, 원고가 입은 손해는 이 사건 의약품이 이 사건 제1고시에 터 잡아 판매됨에 따라 원고가 부담한 공단부담금과 이 사건 의약품과 동일제제의 다른 의약품이 같은 기간 동안 같은 수량만큼 판매되었을 경우에 원고가 부담하였을 공단부담금의 차액이라고 봄이 상당하다(손해배상의 범위와 관련하여 원고는 ‘원고가 국민건강보험법 제52조 제4항 에 따라 요양기관이 그 가입자로부터 부당하게 징수한 금액에 대하여는 이를 직접 환수하여 가입자에게 지급할 수 있는 권한을 보유하고 있는 반면, 이 사건 의약품을 사용하였던 환자들이 피고에 대하여 개별적으로 손해배상청구소송을 제기할 것을 기대하는 것은 사실상 불가능한바, 원고가 공단부담금 부분에 대한 손해배상과 함께 환자본인부담금에 대한 손해배상까지 아울러 청구할 수 없다고 한다면 이는 결과적으로 피고가 당해 부분에 대하여 취득한 위법한 이득을 보유하는 것을 사실상 인정하는 결과가 되어 지극히 부당하다고 할 것이므로, 원고는 민법 제734조 의 사무관리 또는 조리를 근거로 하여 이 사건 의약품을 사용하였던 환자들이 입은 손해부분까지도 피고에 대하여 이를 청구할 수 있다’는 취지로 주장한다. 그러나, 민법 제734조 소정의 사무관리에 관한 규정에 터 잡아 타인의 권리를 소송상 행사할 수 있다고 볼 수는 없고, 원고가 주장하는 바와 같은 사정을 들어 조리상 원고에게 환자들을 위한 소송수행권이 인정된다고 볼 수도 없으므로, 원고의 이 부분 주장은 받아들일 수 없다).

㈏ 아래 각 사실은 당사자들 사이에 다툼이 없거나, 갑 13, 20호증의 각 기재와 이 법원의 건강보험심사평가원에 대한 각 사실조회결과에 변론 전체의 취지를 더하여 보면, 이를 인정할 수 있다.

1) After the Defendant’s enforcement of the first announcement of this case, the volume of the instant drug sold from June 1, 2005 to November 14, 2007, prior to the enforcement of the second announcement, was 3,047,557. Of these, 20 out of the amount was 446 won, 198 won, 448 won, 3,047, 339 won, and the remaining 3,459, 773,005 won (46 won x 20%) + (478 won x 198 won) + (479 won x 3,047,339 won). Of the price of the instant drug, the charges borne by the Plaintiff were 1,294,360 won, 194, 2396, 205 won, 3636, 24639 won, 205 won, and 3639 won.

2) Meanwhile, from the second half of 2005 to the second half of 2007, the sales volume and sales amount of 9 medicines identical to the instant medicines are as listed below [Do attached Table 2]. The annual average sales amount of 330 won (gold KRW 4,905,169,000 ± 14,827,554 ± KRW 14,827,554; hereinafter the same shall apply).

[Attachment 2]

본문내 포함된 표 ？ 제품명 2005년 하반기 2006년 상반기 2006년 하반기 2007년 상반기 2007년 하반기 합계 1. 한서타목시펜정 7,483 1,578 1,274 1,508 1,610 13,454 913 193 155 185 196 1,642 2. 한불구연산타목시펜정 722 480 ？ ？ ？ 1,684 103 68 ？ ？ ？ 651 3. 타목센정 10㎎ 544,337 487,455 377,132 321,853 273,962 2,004,752 97,414 87,340 67,692 57,727 49,175 359,348 4. 대우타목시펜정 10㎎ 157,983 145,037 156,208 121,884 112,821 693,947 29,080 26,707 28,832 22,537 20,855 128,011 5 대화타목시펜정 66,544 71,579 70,189 65,839 21,856 296,012 12,577 13,528 13,266 12,444 4,131 55,946 6. 광동타목시펜정 499,135 462,408 470,473 346,521 218,599 1,997,142 95,802 88,726 89,816 66,151 41,726 382,221 7. 목사펜정 612,685 583,118 445,034 397,231 400,389 2,438,464 122,333 116,254 88,359 78,529 79,104 484,579 8. 놀바덱스정 1,595,410 1,338,801 1,347,020 1,212,739 1,104,451 6,598,429 757,995 633,267 637,048 573,632 522,349 3,124,291 9. 타모프렉스정 10㎎ 94,418 105,726 168,077 170,702 245,208 784,150 45,193 50,620 79,017 79,916 114,214 368,960 ？ ？ ？ ？ ？ 합계 판매량 14,827,554 판매금액 4,905,169

** The upper part by product is sold (unit: set) and the lower part is the selling price (unit: 00 won).

㈐ 따라서, 원고가 입은 손해는 아래와 같이 계산된다.

1) The difference between the pharmaceutical price in cases where other pharmaceutical products of the same pharmaceutical product as the instant pharmaceutical product have been sold in the same quantity for the same period

(446 won-330 won) ¡¿ 20 + (448 won-30 won) ¡¿ 198 + (479 won-330 won) ¡¿ (479 won-330 won) ¡¿ 3,047, 339 others = 454,079,195 won

2) Corporation charges calculated according to the ratio of the difference in the price of the above drug.

(1,297,349,345 won ¡À1,459,773,05 won ¡À) ¡¿ 454,079,195 won = 403,55,446 won

(3) Limitation of liability

On the other hand, the National Health Insurance Act and other relevant Acts and subordinate statutes do not explicitly stipulate that a pharmaceutical manufacturer shall inform the Minister of Health, Welfare and Family Affairs of the reason for the occurrence of a cause for which the maximum price is recognized by the special provisions of this case. The Minister of Health, Welfare and Family Affairs did not take measures to adjust the maximum amount for reasons such as changes in the method of supplying raw materials or changes in the equity ratio of the raw materials producer until October 2007. After the first announcement of this case, the Minister of Health, Welfare and Family Affairs did not take follow-up measures to manage and supervise the validity of the determination of the maximum amount of the drug of this case or the supply of raw materials after the lapse of two years. In full view of all the circumstances, it is reasonable to limit the defendant's liability for damages to 80% in light of the ideology of the damage compensation system that fair sharing of damages.

(4) Sub-determination

Therefore, the defendant is obligated to pay to the plaintiff the amount of 322,844,356 won (amounting to 403,55,446 won x 80%) and damages for delay calculated at the rate of 5% per annum under the Civil Act from November 15, 2007 to January 22, 2010, which is the date when the decision is rendered by the court of first instance, to the day when the defendant has fully paid the amount of the obligation.

3. Conclusion

Therefore, the plaintiff's claim of this case is justified within the scope of the above recognition, and the remaining claims are dismissed without merit. Since the part against the defendant who ordered payment in excess of the above recognition amount among the judgment of the court of first instance which partially different conclusions is unfair, it is revoked and the plaintiff's claim corresponding to the revoked part is dismissed. The plaintiff's appeal of this case and the defendant's remaining appeal are dismissed without merit. It is so decided as per Disposition.

Judges Gangnam-gu (Presiding Judge)