原标题:医疗行业反垄断执法特点及企业合规建设 Anti-monopoly health enforcement trends

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医疗行业逐渐成为中国反垄断执法机构的关注重点。国家发展改革委员会(发改委)和国家工商行政管理总局及省级工商行政管理局(以下统称“工商局”)都将医疗行业反垄断纳入了近两年的工作重点。截至2017年4月底,发改委和工商局累计对11家医药企业开出罚单,罚款总额约人民币1.33亿元。我们预计今年两家执法机构可能会在医疗行业刮起更猛烈的“反垄断风暴”,也可能会陆续调查或处罚一些知名的药企和医疗器械企业。工商局和发改委通过查处一系列案件,在医疗行业领域也积累了较多经验。医疗企业将面对更为严峻的反垄断合规考验。

问:已经处罚的医疗行业垄断案件有什么特点?

答:医疗行业查处的垄断案件主要呈现出如下特点:

(1) 受处罚的企业主体多元化,涉及到民营企业、中外合资企业、外商独资企业、国有企业等各种性质的企业;

(2) 垄断行为类型多样化,执法机构将滥用市场支配地位及达成、实施横向或纵向垄断协议的违法行为一网打尽;

(3) 行业涉及面广、涵盖上下游产业链,处罚对象包括原料药生产商、药品生产和经销商、医疗器械生产商等。

问:查处的垄断行为具体有哪些类型?

答:目前查处的案件不仅涵盖了几大常见的垄断行为,还包括一些相对隐蔽或复杂的垄断行为。截至2017年4月底,工商局在医疗行业共查处三起案件,均为滥用市场支配地位案件,且均是围绕中国某一类原料药市场展开;发改委及省级价格监管部门则共查处五起案件,其中包括一起滥用市场支配地位案、两起横向垄断协议案和两起纵向垄断协议案。值得关注的是,工商局查处的重庆青阳药业有限公司及重庆西南制药二厂的滥用市场支配地位拒绝交易案分别为中国第一例和第二例拒绝交易案件,发改委查处的艾司唑仑药品垄断协议案为《反垄断法》实施以来首例协同行为案件。

问:在横向垄断协议中,执法机构是如何认定协同行为的?

答:在艾司唑仑药品垄断协议案中,三家企业秘密举行会议,就艾司唑仑片剂的集体涨价形成默契。其中,常州四药制药有限公司虽然没有积极参与协商,但对参会期间讨论内容没有提出异议,并在事后跟随采取了一致行动,发改委因此认定常州四药与其他两家企业构成了协同行为。发改委制定的《反价格垄断规定》第六条和工商总局制定的《工商行政管理机关禁止垄断协议行为的规定》第三条分别对如何认定协同行为进行了具体规定。尽管两家执法机构在对协同行为规定的文字表述上略有不同,但基本的考察因素是类似的,即行为的一致性、经营者之间的意思联络、一致行为是否有合理解释、市场结构和市场变化等情况。

问:执法机构对纵向垄断协议的态度如何?

答:纵向价格垄断行为一向是发改委反垄断执法的重点之一,在医疗行业尤其如此。我们预计这一趋势仍会延续。值得关注的是,在美敦力转售价格维持案中,发改委在处罚决定书中不仅明确了当事人美敦力(上海)管理有限公司固定转售价格和限定最低转售价格行为的违法性,而且涉及了其采取的限定经销商的销售区域、禁止经销商销售具有竞争关系品牌的产品等行为。发改委认为“这些限制措施与纵向价格措施并用,进一步强化了固定转售价格和限定最低转售价格的实施效果”。该案也释放出反垄断执法机构在延续此前严格查处纵向价格垄断的执法风格的同时,也已经开始关注其他非价格纵向限制措施的信号。因此,相关企业对纵向的限制措施,无论是涉及价格还是不涉及价格都需要谨慎而为。

问:企业如何应对日益严峻的反垄断合规考验?

答:笔者建议相关医疗企业密切关注反垄断调查的发展趋势和特点。企业可通过如下方式加强反垄断合规建设:

(1) 及时展开风险排查,必要时聘请专业律师协助进行反垄断内部审计;

(2) 对高管和员工(尤其是销售部门)进行反垄断合规培训,并可安排高管和员工进行应对反垄断调查“黎明突袭”的模拟演练;

(3) 对公司产品的定价政策、折扣或返利制度、销售政策、经销商合同等从反垄断法的角度进行审查;

(4) 警惕横向信息交流,包括协同行为,审慎对待敏感信息交换;

(5) 评估自身的市场份额,如可能构成市场支配地位或较强的优势地位,则需要对与上下游企业之间签署的协议进行核查,对非常规终止交易、拒绝交易、排他性安排或其他限制措施或涉嫌不合理的商业条款进行反垄断风险评估;

(6) 如发现存在涉嫌违法行为,则更应尽早咨询专业律师意见,及时制定整改或应对方案。

Q&A

Column

Anti-monopoly health enforcement and compliance trends

The healthcare industry has gradually become a key focal point of the antitrust law enforcement authorities in China. In recent years, the National Development and Reform Commission (NDRC) and the State Administration for Industry and Commerce (SAIC) have incorporated antitrust efforts in the healthcare industry as a focus of their work. As of the end of April 2017, the NDRC and SAIC had fined 11 healthcare enterprises for a total of about RMB133 million (US$19.3 million).

The authors foresee the two law enforcers potentially raising a more forceful ‘antitrust windstorm’ in the healthcare sector this year, and possibly investigating and penalizing in succession certain well-known pharmaceutical and medical device enterprises. Through the investigation and handling of a series of cases, the NDRC and SAIC have accumulated a significant amount of experience in the healthcare sector, and healthcare enterprises are about to face a more serious antitrust compliance challenge.

Q: What are the distinctive features of the already punished healthcare industry antitrust cases?

A: The antitrust cases that have been investigated and handled in the healthcare industry manifest the following defining features: (1) the enterprise entities that have been subjected to penalties are diverse, involving enterprises of various natures, such as private enterprises, Sino-foreign equity joint ventures, wholly foreign-owned enterprises, state-owned enterprises, etc.; (2) the types of antitrust acts are variegated, with the law enforcement authorities penalizing not only the abuse of dominant market position but also the violations of reaching and implementing of horizontal or vertical monopoly agreements; and (3) the cases extend over a broad area, covering both the upstream and downstream of the industry chain, with the recipients of penalties including active ingredient producers, pharmaceutical producers and distributors, medical device producers, etc.

Q: What are the specific types of antitrust behaviours that have been investigated?

A: The cases that have been investigated and handled to date not only cover commonly seen antitrust behaviour, but also include certain relatively obscure or complex ones. As at the end of April 2017, the SAIC had investigated three cases in the healthcare industry, all of which included abuse of dominant market position in certain active ingredient markets in China; and the NDRC and provincial-level pricing authorities had handled a total of five cases, including one case of abuse of dominant market position, two horizontal monopoly agreement cases and two vertical monopoly agreement cases. It is worth noting that the cases of abuse of dominant market position to refuse a deal involving Chongqing Qingyang Pharmaceutical and Chongqing Southwest No. 2 Pharmaceutical Factory, investigated and handled by the SAIC, were the first and second refusal to deal cases in China. Furthermore, the Estazolam drug cartel case investigated and handled by the NDRC was the first concerted practice case since the implementation of the Antitrust Law.

Q: How do the authorities determine a concerted practice in a horizontal monopoly agreement?

A: In the Estazolam case, three enterprises held secret meetings, reaching a tacit understanding on a collective increase in the price of Estazolam tablets. Although Changzhou Siyao Pharmaceutical did not actively participate in the conspiracy, it did not object to the collusion and later followed the other two companies’ lead. The NDRC determined that it engaged in a concerted practice. Article 6 of the Provisions on Anti-Price Monopoly, formulated by the NDRC, and article 3 of the Provisions for Administrative Authorities for Industry and Commerce on Prohibiting the Conclusion of Monopoly Agreements, formulated by the SAIC, set out specific provisions on the determination of concerted practice. Despite the fact that there are nuanced differences between the two articles, both consider the following major factors when analyzing whether concerted practice has occurred: uniformity; the exchange of information; reasonable explanations; and the market structure and market changes.

Q: What is the law enforcement authorities’ attitude towards vertical monopoly agreements?

A: Vertical price monopoly has always been one of the priorities of the NDRC’s antitrust law enforcement, particularly in the healthcare industry. The authors envision that this trend will continue. It is worth noting that, in the Medtronic resale price maintenance case, the NDRC, in its penalty decision, not only clarified the illegality of the fixed resale price of Medtronic (Shanghai) Management and its setting of a minimum resale price, but also touched upon such acts taken by it as limiting the sales territory of distributors, prohibiting distributors from selling products of competing brands, etc. The NDRC held that “these restrictive measures were implemented together with the vertical pricing measures, further strengthening the anticompetitive effect of maintaining the resale prices and setting minimum resale prices”. This case, while indicating that antitrust law enforcers should continue their strict enforcement in vertical pricing monopolies, also sees them beginning to pay attention to other non-pricing vertical restrictive measures. Accordingly, it is necessary for relevant enterprises to act prudently with respect to vertical restrictive measures, regardless of whether they involve pricing or not.

Q: How should enterprises respond to the increasingly serious antitrust compliance challenge?

A: The authors recommend that healthcare enterprises closely watch development trends in, and features of, antitrust investigations. Enterprises can strengthen their antitrust compliance in the following ways: (1) promptly conducting a risk screening and, if necessary, engaging a professional lawyer to assist in conducting an internal antitrust audit; (2) providing antitrust compliance training to senior officers and employees (particularly sales departments) and arranging for senior officers and employees to participate in drills for responding to ‘dawn raids’ in antitrust investigations; (3) examining the company’s product-pricing policy, discount or rebate system, sales policies, distributor contracts, etc., from the perspective of the Antitrust Law; (4) being vigilant for horizontal information exchanges, including concerted practice, and prudently handling sensitive information exchanges; (5) assessing one’s own market share, and if the same could constitute a dominant market position or relatively strong advantageous position, conducting a check of the agreements executed with upstream and downstream enterprises, and conducting an antitrust risk assessment regarding irregular terminations of dealing, refusals to deal, exclusive arrangements, other restrictive measures or commercial terms suspected of being unreasonable; and (6) if a suspected violation of the law is discovered, seeking legal opinion as soon as possible and promptly formulating a rectification or response plan.

作者:安杰律师事务所合伙人顾正平、律师孙思慧

Michael Gu is a partner and Sun Sihui is an associate at AnJie Law Firm

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