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新规引发“药代”模式转变

转载2017-04-01 合规行业专业圈

* 以下文章由环球律师事务所供稿。中文为英文原文的简述,仅供参考。*


On February 9, 2017, the State Council issued the Opinions on Further Reform andImprovement of Drug Manufacturing and Distribution Policies国务院办公厅关于进一步改革完善药品生产流通使用政策的若干意见 (the “Opinions”) [1]. The Opinions require relevant government authorities (including but notlimited to the National Health and Family Planning Commission (NHFPC), ChinaFood and Drug Administration (CFDA) and commercial counterparts) to implement17 items to further reform China’s pharmaceutical and healthcare industry,covering almost all major aspects including drug approval, manufacturing anddistribution of pharmaceutical products. 

 

Article 11 of the Opinions specifically provides that CFDA shall enhance the regulationof medical representatives (“MRs”) by establishing the registration and filingsystem of MRs and the registration information will be made available to thepublic.  Moreover, it is stipulated that MRs shall only be allowed toconduct activities of “academic promotion” and “technical consultancy,” and NOT allowed to “assume sales responsibility.” Any violation shall be enteredinto their individual credit record.  This item calls for significantimpacts on MRs and the relevant drug/medical device companies. Below we providea brief summary as well as a preliminary observation on this topic for yourreference. 

 

1. Impacts on MRs

 

1) Definition and Scope of MRs

 

It is provided in the Opinions that the CFDA shall soon establish and implement aregistration and filing system for MRs, and the regulation of MRs will betightened.  However, the scope of MRs is yet to be clearly defined - whoshall be registered as “MRs” in the system? Do MRs include the sales manager,marketing manager and each of the sales and marketing staff in a drug/medicaldevice company? 

 

2) Filing and Registration of MRs

 

Secondly, how to file and what information shall be provided for such registration (asthe registration information will be available to the public)?  Will MRsdo the registration individually or will the company do the registrationcollectively for its MRs?  

 

3) Consequence of Violation

 

Thirdly, how will the registration record influence the MRs’ individual credit record? Will the MRs’ violation of laws related to the Opinions influence theirfinancial credit record? 

 

Also, it is not clear that whether the drug/medical device company will be penalized ifits employees (i.e. the MRs) violate the Opinions.  If so, what will bethe punishments?  Drug/medical device companies should closely monitor anysubsequent developments. 

 

For the time being, the local CFDA cannot provide details of the above issues andsignificant uncertainties still exist.

 

4) MRs Individual Occupational Risk

 

Violation of the Opinions may affect MRs’ personal credit records, which increases the iroc cupational risk.  However, it is not clear what activities will bedeemed as violations, since the exact meaning of "drug sales responsibilities" is yet to be clarified.  On the other hand, theincreasing occupational risk to MRs may diminish people’s willingness to workas MRs, which might cause the companies to have to pay more “incentives” toattract MRs. 

 

2. Impacts on Corporate Responsibility

 

It is generally provided that MRs are only allowed to conduct activities of “academicpromotion” and “technical consultancy,” and NOT allowed to “assume sales responsibility.”  

 

By allowing “academic promotion,” MRs are now legally recognized and permitted totake their promotion roles – which is actually a notable positive side - in anacademic way, such as hosting academic events to promote pharmaceutical products.  The permission of “technical consultancy” gives MRs the optionto work as a technical consultant, especially when dealing with sophisticated medical device products.  By explicitly ruling out “sales responsibility,”it seems that the lawmakers expect drug/medical device companies to revisetheir KPI system and incentive scheme for MRs (so that the MRs’ remunerationmode of “base salary plus bonus calculated based on sales achievement” may, tosome extent, also be required to change) by removing the salesvolume/value-related KPIs.  In this regard, it is anticipated that MRsshould be taking promotion roles, rather than working as sales.  However, inreality, it is difficult to separate “promotion” and “sale,” since promotionand sales personnel work extremely closely in product distribution

 

Speaking from the companies’ perspective, if the companies decide not to use the saidKPI system, how would they evaluate the performance of their sales force? If they decide to continue using the sales volume/value–related KPI system, is it proper to use sales volume/value–related KPI system to evaluate MRs’ non-drug sales activities?  

 

The changed responsibilities might require different and additional skill sets tofulfill an MR’s tasks.  However, it is not uncommon that MRs lack medicaleducation or medical professional training.  If they are only allowed tobe engaged in “academic promotion” or “technical consultancy” activities, theMRs team may need to reorganize and some of them may be laid off, which mightbring more potential labor disputes to the companies.

 

More clarity for this is to be provided by the CFDA when the specific agency rulescome out, and we will keep an eye on this.

 

Considering that the Opinions provide clear (while quite general) guidance on the MR issue,companies are not required to take any immediate action before implementationdetails are made available through agency rulemaking.  But they shouldstart internal assessment and preparation for the upcoming change in regulatory environment.

 

2017  2  9 日,国务院办公厅发布了《关于进一步改革完善药品生产流通适用政策的若干意见》(以下简称“意见”)。该意见要求包括国家卫生和计划生委员会、国家食品药品监督管理局(以下简称“食药监”)在内的有关政府部门继续推进深化中国药品医疗行业改革。该意见几乎覆盖了医药行业涉及的所有主要方面,包括药品的许可、生产和流通环节。

 

意见第 11 条提出,食药监将加强对医药代表(以下简称“药代”)的管理,建立药代的登记备案制度,登记备案信息及时公开。此外,药代只能从事学术推广、技术咨询,不得承担药品销售任务,其失信行为将记入个人信用记录。将对药代和企业产生影响。


1.对药代的影响

 

在意见中,提及药代的登记备案制度,但对药代的定义和范围、登记备案的流程、以及失信行为如何影响药代的个人信用记录尚未做出明确规定,待食药监进一步作出详细规定。

 

同时,意见第 11 条明确,失信行为将影响药代的个人信用记录,将增加他们的职业风险,增加的职业风险可能降低药代工作积极性,公司将需要支付高薪来吸引药代。

 

2.对公司责任的影响

 

根据意见第11条,药代仅允许从事学术推广、技术咨询等活动,并不能承担销售任务。这可能促使药品企业调整药代与药品销量挂钩的绩效考核和激励制度。

 

如果药代仅能从事学术推广和技术咨询工作,意味着药代团队有可能需要重组,有些药代可能会被解雇,公司也有可能因此面临着潜在的劳动纠纷。

 

 

对上述问题有待食药监出台更明确的实施细则,而我们也将持续关注。

 


[1]国务院办公厅关于进一步改革完善药品生产流通使用政策的若干意见 国办发〔2017〕13号



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