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避免药品营销中“学术推广商业贿赂”

 浆糊瓢的图书馆 2019-01-19

药品营销领域一直是商业贿赂高发风险环节,也是中国近些年严厉监管和打击的业务领域。无论是在医药企业日常运营中还是在并购和资本运作中,如何发现并防范药品营销商业贿赂问题十分重要。

 

2016年《最高人民法院、最高人民检察院关于办理贪污贿赂刑事案件适用法律若干问题的解释》进一步明确:贿赂犯罪中的“财产性利益”包括可以折算为货币的物质利益如房屋装修、债务免除等,以及需要支付货币的其他利益如会员服务、旅游等。新修订的《反不正当竞争法》也列举了商业贿赂的具体行为类型,删除了“回扣”条款,并增加了“经营者的工作人员进行贿赂的,应当认定为经营者的行为”的规定。

 

上述新法规的颁布实施,对医药企业药品销售合规工作提出了新的挑战,尤其是医药企业普遍采用的“以学术名义进行药品推广”方式,其中会否存在向医生、学术机构人员输送“财产性利益”情况并进而被认定为商业贿赂,也是目前医药企业普遍关注的问题。

 

本文结合相关适用法规的理解及实务操作经验,对药品营销业务中“学术推广商业贿赂”法律风险的认定及防范进行探讨和分析。


风险识别


通过学术推广活动名义进行贿赂,主要是指医药企业通过主办学术会议,或对医药学术会议主办单位(各类医药行业协会、医疗机构)、参会医生提供资金资助,帮助解决会议召开及参会医生的食宿、交通、注册、专家授课等费用,诱使利益接受方违背其法定义务或职业道德,利用其权力、影响力,为利益输送方谋取好处或诱使交易发生。其风险表现形式包括但不限于:

 

1.对医药行业协会主办的会议提供赞助;

2.对医疗机构主办的会议提供赞助;

3.对行业协会、医疗机构委托的第三方会务公司提供赞助;

4.医药企业自办学术会议,邀请并赞助医生参加会议;

5.医药企业赞助医生参与第三方主办的学术会议,承担参会医生的交通费、食宿、注册费;

6.以费用报销的形式,为参会医生个人提供参会的交通、食宿、注册费用。 


风险防范


笔者对赞助医院或协会主办学术会议的合规建议:

 

(1)事前审查会议性质,确保会议属于与诊疗技术相关的学术性会议;(2)避免将医院内部业务科室、职能部门或协会内部机构作为赞助对象;(3)签订书面协议,明确赞助资金仅能用于会议本身,确保专款专用;(4)赞助资金必须“公对公”,并由受赠单位出具公益事业捐赠统一票据或会议赞助发票,避免将赞助款交给个人或某个部门。

 

笔者对赞助医生参加第三方会议或企业自办学术会议的合规建议:

 

保留医生真实参会的材料。注意留存邀请函、会议通知、会议议程、参会医生的注册费用发票、现场签到、现场照片、PPT等会议材料,证明学术会议本身及医生参会的真实性;

 

合理安排参会行程和选择会议地点。赞助医生参加第三方会议时,行程时间安排应适当紧凑;行程路线安排应避免非正常经过旅游城市或景点,并滞留时间较长。企业自办会议的不宜将会议地点选择在风景区内;

 

避免无关费用支出。费用支出上应该仅限于正常的交通、住宿、餐饮、注册费用,避免出现景点门票、导游服务费、导游加班费、用途不明的杂费等与会议无关的非正常费用;

 

赞助指向性不应过于明确。不应与医生个人签订赞助协议,也不宜与医院签订指向性过于明确的赞助协议;

 

赞助费用标准避免过高。赞助医生参加第三方会议,如会议主办方对住宿、餐饮有统一安排的,应以主办方的安排为准,不宜另外提供明显更高价位的食宿安排;企业自办会议或第三方会议主办方对住宿、餐饮没有安排时,注意将人均消费控制在合理的范围内;交通费用方面避免安排头等舱、头等座。


原文登载于《商法》杂志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

胡晓华


天达共和合伙人

北京办公室 公司与证券部


Cindyhu@east-concord.com


+8610 6510 7012

胡晓华律师专注于资本市场证券、公司并购与重组、合规及法律风险防控。胡律师曾作为司法部与英国的青年律师合作项目选拔的优秀青年律师,赴英国伦敦大学进修英国法律,并作为客座律师在英国司力达律师事务所伦敦总部及香港分所学习公司融资方面的律师实务。胡律师曾获得过北京市优秀律师、朝阳区首届优秀女律师等殊荣,并多次被《亚洲法律评论》(AsiaLaw Profiles)评为公司并购及重组领域亚洲领先律师。

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