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觀點(diǎn) | 避免藥品營(yíng)銷(xiāo)中“學(xué)術(shù)推廣商業(yè)賄賂” (中英文)

 漿糊瓢的圖書(shū)館 2019-03-06

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藥品營(yíng)銷(xiāo)領(lǐng)域一直是商業(yè)賄賂高發(fā)風(fēng)險(xiǎn)環(huán)節(jié),也是中國(guó)近些年嚴(yán)厲監(jiān)管和打擊的業(yè)務(wù)領(lǐng)域。無(wú)論是在醫(yī)藥企業(yè)日常運(yùn)營(yíng)中還是在并購(gòu)和資本運(yùn)作中,如何發(fā)現(xiàn)并防范藥品營(yíng)銷(xiāo)商業(yè)賄賂問(wèn)題十分重要。

2016年《最高人民法院、最高人民檢察院關(guān)于辦理貪污賄賂刑事案件適用法律若干問(wèn)題的解釋》進(jìn)一步明確:賄賂犯罪中的“財(cái)產(chǎn)性利益”包括可以折算為貨幣的物質(zhì)利益如房屋裝修、債務(wù)免除等,以及需要支付貨幣的其他利益如會(huì)員服務(wù)、旅游等。新修訂的《反不正當(dāng)競(jìng)爭(zhēng)法》也列舉了商業(yè)賄賂的具體行為類(lèi)型,刪除了“回扣”條款,并增加了“經(jīng)營(yíng)者的工作人員進(jìn)行賄賂的,應(yīng)當(dāng)認(rèn)定為經(jīng)營(yíng)者的行為”的規(guī)定。

上述新法規(guī)的頒布實(shí)施,對(duì)醫(yī)藥企業(yè)藥品銷(xiāo)售合規(guī)工作提出了新的挑戰(zhàn),尤其是醫(yī)藥企業(yè)普遍采用的“以學(xué)術(shù)名義進(jìn)行藥品推廣”方式,其中會(huì)否存在向醫(yī)生、學(xué)術(shù)機(jī)構(gòu)人員輸送“財(cái)產(chǎn)性利益”情況并進(jìn)而被認(rèn)定為商業(yè)賄賂,也是目前醫(yī)藥企業(yè)普遍關(guān)注的問(wèn)題。

本文結(jié)合相關(guān)適用法規(guī)的理解及實(shí)務(wù)操作經(jīng)驗(yàn),對(duì)藥品營(yíng)銷(xiāo)業(yè)務(wù)中“學(xué)術(shù)推廣商業(yè)賄賂”法律風(fēng)險(xiǎn)的認(rèn)定及防范進(jìn)行探討和分析。

風(fēng)險(xiǎn)識(shí)別

通過(guò)學(xué)術(shù)推廣活動(dòng)名義進(jìn)行賄賂,主要是指醫(yī)藥企業(yè)通過(guò)主辦學(xué)術(shù)會(huì)議,或?qū)︶t(yī)藥學(xué)術(shù)會(huì)議主辦單位(各類(lèi)醫(yī)藥行業(yè)協(xié)會(huì)、醫(yī)療機(jī)構(gòu))、參會(huì)醫(yī)生提供資金資助,幫助解決會(huì)議召開(kāi)及參會(huì)醫(yī)生的食宿、交通、注冊(cè)、專(zhuān)家授課等費(fèi)用,誘使利益接受方違背其法定義務(wù)或職業(yè)道德,利用其權(quán)力、影響力,為利益輸送方謀取好處或誘使交易發(fā)生。其風(fēng)險(xiǎn)表現(xiàn)形式包括但不限于:

1.對(duì)醫(yī)藥行業(yè)協(xié)會(huì)主辦的會(huì)議提供贊助;

2.對(duì)醫(yī)療機(jī)構(gòu)主辦的會(huì)議提供贊助;

3.對(duì)行業(yè)協(xié)會(huì)、醫(yī)療機(jī)構(gòu)委托的第三方會(huì)務(wù)公司提供贊助;

4.醫(yī)藥企業(yè)自辦學(xué)術(shù)會(huì)議,邀請(qǐng)并贊助醫(yī)生參加會(huì)議;

5.醫(yī)藥企業(yè)贊助醫(yī)生參與第三方主辦的學(xué)術(shù)會(huì)議,承擔(dān)參會(huì)醫(yī)生的交通費(fèi)、食宿、注冊(cè)費(fèi);

6.以費(fèi)用報(bào)銷(xiāo)的形式,為參會(huì)醫(yī)生個(gè)人提供參會(huì)的交通、食宿、注冊(cè)費(fèi)用。 

風(fēng)險(xiǎn)防范

筆者對(duì)贊助醫(yī)院或協(xié)會(huì)主辦學(xué)術(shù)會(huì)議的合規(guī)建議:

(1)事前審查會(huì)議性質(zhì),確保會(huì)議屬于與診療技術(shù)相關(guān)的學(xué)術(shù)性會(huì)議;(2)避免將醫(yī)院內(nèi)部業(yè)務(wù)科室、職能部門(mén)或協(xié)會(huì)內(nèi)部機(jī)構(gòu)作為贊助對(duì)象;(3)簽訂書(shū)面協(xié)議,明確贊助資金僅能用于會(huì)議本身,確保專(zhuān)款專(zhuān)用;(4)贊助資金必須“公對(duì)公”,并由受贈(zèng)單位出具公益事業(yè)捐贈(zèng)統(tǒng)一票據(jù)或會(huì)議贊助發(fā)票,避免將贊助款交給個(gè)人或某個(gè)部門(mén)。

筆者對(duì)贊助醫(yī)生參加第三方會(huì)議或企業(yè)自辦學(xué)術(shù)會(huì)議的合規(guī)建議:

保留醫(yī)生真實(shí)參會(huì)的材料。注意留存邀請(qǐng)函、會(huì)議通知、會(huì)議議程、參會(huì)醫(yī)生的注冊(cè)費(fèi)用發(fā)票、現(xiàn)場(chǎng)簽到、現(xiàn)場(chǎng)照片、PPT等會(huì)議材料,證明學(xué)術(shù)會(huì)議本身及醫(yī)生參會(huì)的真實(shí)性;

合理安排參會(huì)行程和選擇會(huì)議地點(diǎn)。贊助醫(yī)生參加第三方會(huì)議時(shí),行程時(shí)間安排應(yīng)適當(dāng)緊湊;行程路線安排應(yīng)避免非正常經(jīng)過(guò)旅游城市或景點(diǎn),并滯留時(shí)間較長(zhǎng)。企業(yè)自辦會(huì)議的不宜將會(huì)議地點(diǎn)選擇在風(fēng)景區(qū)內(nèi);

避免無(wú)關(guān)費(fèi)用支出。費(fèi)用支出上應(yīng)該僅限于正常的交通、住宿、餐飲、注冊(cè)費(fèi)用,避免出現(xiàn)景點(diǎn)門(mén)票、導(dǎo)游服務(wù)費(fèi)、導(dǎo)游加班費(fèi)、用途不明的雜費(fèi)等與會(huì)議無(wú)關(guān)的非正常費(fèi)用;

贊助指向性不應(yīng)過(guò)于明確。不應(yīng)與醫(yī)生個(gè)人簽訂贊助協(xié)議,也不宜與醫(yī)院簽訂指向性過(guò)于明確的贊助協(xié)議;

贊助費(fèi)用標(biāo)準(zhǔn)避免過(guò)高。贊助醫(yī)生參加第三方會(huì)議,如會(huì)議主辦方對(duì)住宿、餐飲有統(tǒng)一安排的,應(yīng)以主辦方的安排為準(zhǔn),不宜另外提供明顯更高價(jià)位的食宿安排;企業(yè)自辦會(huì)議或第三方會(huì)議主辦方對(duì)住宿、餐飲沒(méi)有安排時(shí),注意將人均消費(fèi)控制在合理的范圍內(nèi);交通費(fèi)用方面避免安排頭等艙、頭等座。

原文登載于《商法》雜志2018年第8期

Avoid “academic promotion commercial bribery” in medicine marketing

Medicine marketing has long had a high risk of being prone to commercial bribery. As such, it is not surprising this has been a business that China strictly regulates and has cracked down on in recent years. It is important to uncover, as well as prevent, commercial bribery in medicine marketing, be it in daily operations, in mergers and acquisitions or capital operations of pharmaceutical enterprises.

The Supreme People’s Court and the Supreme People’s Procuratorate jointly issued in 2016 further clarifications on the interpretations concerning some issues on the application of the law in handling cases of corruption and bribery. The clarifications cover “property interests” in bribery crimes, including material benefits, such as house decoration and debt relief, which can be converted into money and other benefits like membership services and travel. The newly revised law against unfair competition also enumerates the specific types of commercial bribery, where the “kickback” clause is deleted and the provision, “where the employee of a business operator offers bribes, such act should be found to be an act of the operator”, is added.

The promulgation and implementation of these new regulations pose new challenges to the compliance work of pharmaceutical enterprises in medicine sales, especially their widespread use of “medicine promotion in the name of academics”, including cases of “property interests” being tunnelled to doctors and academic staff and, thus, deemed to be commercial bribery. This is also a common concern of pharmaceutical enterprises.

Based on the understanding and practical experience of relevant applicable laws and regulations, this article discusses and analyses the identification and prevention of legal risks related to “academic promotion commercial bribery” in medicine marketing.

Risk Identification

Bribery in the name of academic promotional activities mainly refers to situations where pharmaceutical enterprises, in hosting an academic conference, provides financial support to sponsors (all kinds of pharmaceutical profession associations and medical institutions) and participating doctors. The pharmaceutical enterprises also help with expenses for board and lodging, transportation, registration and expert instructions for the conference. As for participating doctors, they induce the benefit receivers to violate their legal obligations or professional ethics and use their power and influence to seek benefits or induce transactions for the bribe givers. The risk manifestations include, but are not limited to:

1.Sponsoring conferences organized by pharmaceutical profession associations;

2.Sponsoring conferences organized by medical institutions;

3.Sponsoring third-party conference service companies entrusted by the profession association or medical institution;

4.Inviting and sponsoring doctors to attend the academic conferences held by the pharmaceutical enterprises themselves;

5.Sponsoring doctors to participate in academic conferences held by third parties and bearing the expenses for transportation, board and lodging, and registration fees of the attending physicians;

6.Providing expenses for transportation, board and lodging and registration to participating doctors in the form of expense reimbursement.

Risk prevention 

The writer of this article makes the following compliance suggestions for sponsoring hospitals or associations to hold academic conferences:

i. Review the nature of the event in advance to ensure it is an academic conference related to treatment technologies;

ii. Avoid sponsoring the internal business department or functional department of a hospital or an internal organization of an association;

iii. Sign a written agreement to make clear that the sponsorship funds can only be used for the conference so as to ensure the exclusive use of the special funds;

iv. Sponsorship funds must be “public to public”, and the receiving unit shall issue the uniform bill for donation of public welfare undertakings or the invoice for conference sponsorship to avoid giving sponsorship money to individuals or certain departments.

This writer also makes the following compliance suggestions for sponsoring doctors to attend third-party conferences or academic conferences held by enterprises themselves:

a. Retain materials connected to the doctors’ actual attendance. It should be noted that the invitation letters, conference notices, agendas, invoices of registration fees of the participating doctors, sign-in forms, photos of the scene, PPT and other conference materials, should be retained to prove the authenticity of the academic conference itself and the doctors’ attendance.

b. Reasonably arranging the schedule and choosing the venue. When a doctor is sponsored to attend a third-party conference, the travel time should be arranged appropriately tight; the itinerary should be arranged in such a way as to avoid the abnormal passage through the tourist city or scenic spots and long stays. For conferences that enterprises host, it is not suitable to choose a venue in scenic places.

Avoiding extraneous expenses. Expenses shall be limited to the normal expenses of transportation, accommodation, catering and registration, and the occurrence of abnormal expenses not related to the conference, such as entrance tickets, tour guide service fees, tour guide overtime fees, and miscellaneous expenses for unknown purposes irrelevant with the conference should be avoided.

Sponsorship should not be too specific. It is neither advisable to sign sponsorship agreements with individual doctors, nor sign sponsorship agreements with hospitals that are too specific in their direction.

Avoiding too high sponsorship fees. To sponsor a doctor for a third-party conference, if the organizer has a unified plan for board and lodging, its arrangement shall be followed and it is not advisable to offer other alternatives at higher price ranges. When the organizer of the enterprise’s own conference or third-party event makes no arrangement for board and lodging, attention should be paid to keeping the consumption per person within a reasonable range. First-class cabins and seats should be avoided in terms of transportation costs.

Original source: CBLJ Issue 8, 2018

胡曉華

天達(dá)共和合伙人

北京辦公室 公司與證券部

Cindyhu@east-concord.com

+8610 6510 7012

胡曉華律師專(zhuān)注于資本市場(chǎng)證券、公司并購(gòu)與重組、合規(guī)及法律風(fēng)險(xiǎn)防控。胡律師曾作為司法部與英國(guó)的青年律師合作項(xiàng)目選拔的優(yōu)秀青年律師,赴英國(guó)倫敦大學(xué)進(jìn)修英國(guó)法律,并作為客座律師在英國(guó)司力達(dá)律師事務(wù)所倫敦總部及香港分所學(xué)習(xí)公司融資方面的律師實(shí)務(wù)。胡律師曾獲得過(guò)北京市優(yōu)秀律師、朝陽(yáng)區(qū)首屆優(yōu)秀女律師等殊榮,并多次被《亞洲法律評(píng)論》(AsiaLaw Profiles)評(píng)為公司并購(gòu)及重組領(lǐng)域亞洲領(lǐng)先律師。


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