Han Kun Life Sciences & Healthcare Newsletter

监管实践| Regulatory Practice [2]
1. 国家发展改革委依法对美敦力价格垄断行为罚款1.1852亿元
汉坤评论：2016年12月7日，国家发改委在其网站公布一则新闻称，至少自2014年起，美敦力通过经销协议、邮件通知、口头协商等方式，与其交易相对人达成垄断协议，限定相关医疗器械产品的转售价格、投标价格和到医院的最低销售价格，并通过制定下发各经销环节的产品价格表、内部考核、撤销经销商低价中标产品等措施，实施了价格垄断协议。该行为违反了中国《反垄断法》第十四条第一项、第二项的关于“禁止经营者与交易相对人达成固定向第三人转售产品价格、限定向第三人转售产品最低价格的垄断协议”的规定。
美敦力还采取了纵向限制销售对象和销售区域、限制经销竞争品牌产品的措施，进一步强化了纵向价格垄断协议的实施效果，且美敦力在心脏血管、恢复性疗法和糖尿病相关医疗器械领域处于行业领先位置，其严格限制转售价格的行为，排除、限制了经销商之间的竞争，限制了医疗器械品牌间的竞争，维持了相关医疗器械产品高价，阻碍了市场价格机制正常发挥作用，增加了患者负担，损害了消费者利益，不符合中国《反垄断法》第十五条规定的豁免情形和豁免条件。因此，国家发改委依法责令美敦力立即停止实施价格垄断行为，并处2015年度涉案产品销售额4%的罚款，共计人民币1.1852亿元。
本案是国家发改委在2016年度公开处罚的第三起药品和医疗器械领域价格垄断案件（另外两起分别是2016年1月查处的别嘌醇片垄断协议案和2016年7月查处的艾司挫仑药品案），这显示了国家发改委在配合医改政策推进、规范该行业健康发展的决心和执法力度。
厂商对于经销商在转售价格、销售对象和销售区域方面的限制在医药健康领域广泛存在，此方面的合规工作并非简单的删除相关条款，而是“牵一发而动全身”，涉及厂商销售管理体系的重大改革，须谨慎对待。但《反垄断法》对于该等“纵向限制”的规制并非一棒打死，而是需要个案分析。在国家发改委对美敦力开出巨额罚单的背景下，企业有必要对自身的销售管理体系做专项检查及研讨，并聘请法律专家参与，防范法律风险于未然。
NDRC Imposes RMB 118.52 million fine on Medtronic for Monopoly Pricing
Han Kun Comments: On December 7, 2016, NDRC issued a notice on its website finding that Medtronic had concluded monopoly pricing agreements at least since 2014 by entering into distribution agreements, issuing e-mail notifications or conducting oral consultations aimed at restricting resale prices, bidding prices and minimum sales prices to hospitals of relevant medical device products, and that Medtronic had also implemented such price monopoly agreements through means including developing and circulating product pricing lists and internal assessment measures and by revoking products for distributors’ winning low-cost bids. These acts were found to have violated paragraphs (1) and (2) of Article 14 of the Anti-Monopoly Law of the People's Republic of China, which stipulates that “operators are prohibited from reaching monopoly pricing agreements with trading counterparts to fix the commodity resale prices to a third party or to restrict the minimum resale price of a commodity to a third party."
Medtronic had also taken steps to strengthen the effects of vertical price monopoly agreements, including vertically restricting sales targets and territories and prohibiting distributors from selling competing brand products. Considering Medtronic holds a dominant position in cardiovascular, restorative therapy and diabetes-related medical devices, these price-restricting behaviors would act to eliminate and restrict competition between different dealers and different medical device brands. Through such conduct, Medtronic was able to maintain the high price of related medical device products and hindered the normal functioning of the market price mechanism, which acted to increase patient burdens and harmed the interests of consumers. Since Medtronic did not qualify for an exemption under Article 15 of the Anti-Monopoly Law, NDRC ordered Medtronic to immediately stop the monopoly pricing behavior in accordance with law, and was imposed with a fine equaling to 4% of sales volume of the medical devices involved for 2015, totaling RMB 118.52 million.
This is the third case in 2016 in which NDRC has publicly imposed punishment for monopoly pricing in the drug and medical device industry, following monopoly cases involving allopurinol tablets in January and estazolam in July. These cases clearly indicate NDRC’s determination to facilitate health care reforms and to promote the healthy development of the drug and medical device industry in China.
Currently, it is common for operators to restrict resale prices, sales targets and resale areas in the drug and medical device industry, and it is not enough for compliance efforts to simply involve deleting the relevant contract provisions. Internal compliance requires an overall reform of the business operator’s sales system, which should be treated with caution. In addition, the application of the Anti-Monopoly Law with respect to "vertical restrictions" must also be analyzed on case-by-case basis. In the context of NDRC increasing its efforts to fight against price monopoly behaviors, we recommend enterprises to carry out special inspections of their sales management systems and engage the advice of legal counsel to reduce compliance risks.
2. 重庆市工商局依法对重庆西南制药二厂滥用市场支配地位行为予以处罚
汉坤评论：2016年12月12日，国家工商行政管理总局在其网站公布了重庆市工商局对重庆西南制药二厂滥用市场支配地位行为的处罚决定书。该处罚决定书显示，自2012年7月起，重庆西南制药二厂是全国唯一一家生产、销售苯酚原料药的企业，在全国苯酚原料药市场具有市场支配地位。2014年2月至2014年4月期间，该公司停止向市场任何客户供货；2014年5月至2015年12月期间，该公司仅向6家企业销售苯酚，且这6家企业均不是该公司的老客户。在前述期间，多家厂商向该公司提出了购买苯酚原料药的请求，但均遭拒绝。重庆市工商局认为，重庆西南制药二厂为获取垄断利润，滥用其在全国苯酚原料药市场的支配地位，没有正当理由，拒绝与交易相对人进行交易，排除了其它购买苯酚制剂的医药公司之间和生产企业之间的竞争，侵害了苯酚制剂生产企业的利益，扰乱了苯酚原料药及下游市场的市场竞争秩序，损害了消费者利益，违反了《反垄断法》第十七条的规定，故依据《反垄断法》，责令该公司停止拒绝交易行为，没收其违法所得482883.9元，并处2015年度销售收入1%的罚款，计17240.0元。
本案是全国工商系统自2013年公开竞争执法决定以来公示的第二起医药领域垄断案件。第一起案件是2015年12月22日公示的重庆青阳药业有限公司滥用市场支配地位案。这两起案件均由重庆市工商局具体调查处理，且案由均为“拒绝交易”。这既显示了重庆市工商局在调查处理滥用市场支配地位行为、维护市场竞争秩序方面的力度，也反映了重庆市在规范医药市场健康发展、推动医疗卫生体制改革方面的决心。
值得注意的是，2016年12月2日，一份名为《重庆市公立医疗机构药品采购“两票制”实施方案（试行）》（初稿）的文件开始在网上流传。这意味着重庆市开始强化药品流通领域的监管，拟通过减少流通环节来降低虚高药价。若这一方案最终施行，重庆市医药行业的反垄断执法中可能出现更多典型案例。
此外，作为负责调查处理滥用市场支配地位和垄断协议行为的另一反垄断执法机关，国家发改委自2016年1月1日至今已经公开处罚了三起医药领域价格垄断协议案（分别是2016年1月查处的别嘌醇片垄断协议案，2016年7月查处的艾司挫仑药品案，2016年12月查处的美敦力价格垄断案），并分别开出巨额罚单。
在国家反垄断执法机构重拳出击医药领域垄断行为的背景下，各企业有必要强化自身法律意识和风险意识，并聘请法律专家对自身的销售管理体系做专项检查和相应改革，以最大限度降低自身法律风险。
Chongqing AIC Punishes Chongqing Southwest No. 2 Pharmaceutical Factory Co., Ltd. for Abusing Market Dominant Position
Han Kun Comments: On December 12, 2016, the State Administration for Industry and Commerce (“SAIC”) published a punishment decision issued by Chongqing Municipal Industry and Commerce Bureau (“Chongqing AIC”) relating to Chongqing Southwest No. 2 Pharmaceutical Factory Co., Ltd.’s (“Chongqing Pharmaceutical”) abuse of market dominant position. The decision found that, since July 2012, Chongqing Pharmaceutical, as the only pharmaceutical enterprise that produces and sells phenol API throughout China, occupied a dominant position in the phenol API market. From February 2014 to April 2014, Chongqing Pharmaceutical stopped selling phenol API to any customer in the market. From May 2014 to December 2015, Chongqing Pharmaceutical sold phenol API to only six companies and none of them were longtime customers. During this period, a number of manufacturers proposed to purchase phenol API from Chongqing Pharmaceutical, but all requests were rejected. Based upon those facts, Chongqing AIC believed that Chongqing Pharmaceutical abused its dominant position in the phenol API market in order to obtain monopoly profits. The company refused to trade with trading counterparts without good cause, which would exclude competition among phenol manufacturers and thereby damage the interests of the relevant phenol manufacturers. The behavior of the company also acted to disrupt orderly competition in the phenol API and downstream markets, which acted to undermine the interests of consumers. Therefore, Chongqing Pharmaceutical’s dominance abusive behavior was found to be in violation of Article 17 of the Anti-Monopoly Law. Chongqing AIC ordered Chongqing Pharmaceutical to stop the behavior of refusing to trade with customers and punished the company, including by imposing a fine of up to 1% of its sales volume for 2015, totaling RMB 17,240.0, and confiscating illegal income amounting to RMB 482,883.9.
This is the second pharmaceutical monopoly case to be published by SAIC since the release of the competition law enforcement decision in 2013, and follows the December 22, 2015 publication of the Qingyang Pharmaceutical Co., Ltd. market dominant position abuse case. Chongqing AIC investigated and handled both cases, and both violators were punished due to their refusal to trade with counterparties. This represents Chongqing AIC’s increased efforts to fight against abuse of market dominant positions and market order disrupting behaviors, its determination to promote healthcare system reforms and to facilitate the healthy development of the pharmaceutical market in Chongqing.
It is worth noting that on December 2, 2016, a document entitled Implementation Plan for Application of Dual Invoice System for Public Hospitals Drug Procurement in Chongqing (Pilot) was released on the Internet, which indicates that the Chongqing government has begun to strengthen the regulation of the drug distribution sector and intends to curb exceptionally high drug prices by reducing intermediate distribution links. If the law is ultimately put into force, we can expect to see more of these representative cases emerge in anti-monopoly law enforcement in Chongqing.
In addition, NDRC, another anti-monopoly law enforcement authority, has handled three price monopoly violation actions in the pharmaceutical industry since January 1, 2016 (i.e., the 1/1/2016 allopurinol tablets monopoly agreement case, 7/2016 estazolam case, 12/2016 Medtronic price monopoly case) and all violators have been heavily punished.
In light of the anti-monopoly law enforcement authorities cracking down on pharmaceutical monopoly behaviors, we recommend pharmaceutical enterprises to enhance their legal and risk awareness. Pharmaceutical enterprises should engage legal counsel to conduct special reviews of their sales management systems and to correct any issues detected, so as to reduce legal risk to the maximum extent.
立法动态︱Legislative Developments [1]
3. 《药物临床试验质量管理规范（修订稿）》公开征求意见
汉坤评论：2016年12月1日，CFDA发布《药物临床试验质量管理规范（修订稿）》，并公开征求意见。现行有效的药物临床试验质量管理规范（“GCP”）于2003年制定实施，存在众多与新形势不相容之处。本轮修订自2014年启动，曾于2015年2月公布过一版修订稿，但一直未发布正式版。2015年修订稿对2003年GCP修改不大，而本次修订从结构、内容上则有较大改变。
本次修订稿将所强调的受试者权益保护、临床试验安全与质量保证等原则性内容置于总则；而后专章规定伦理委员会、研究者、申办者的责任和义务，明确各主体，包括CRO、监查员、稽查员等的行为规范，要求申办者作为最终责任人，在合同中明确各方职责；研究者手册和必备文件管理章节则进一步规范了试验操作和试验数据记录。
本次修订稿还借鉴了“7.22”药物临床试验数据自查核查的经验。例如，不予批准的药品大多存在数据不可溯源、修改数据等问题，因此修订稿中明确要求申办者应把保护受试者的权益、保障其安全以及试验结果的真实、可靠，作为临床试验的基本出发点；鼓励使用通过系统验证的电子数据管理系统；要求源数据的修正必需留痕，不能掩盖初始数据等。
Administrative Regulations on the Quality of Clinical Drug Trials (Revised Draft) Released for Public Comment
Han Kun Comments: On December 1, 2016, CFDA promulgated the Administrative Regulations on the Quality of Clinical Drug Trials (Revised Draft) for public comment (the “Draft”). The current version of the Good Clinical Practice was enacted in 2003 (the “GCP”), which has failed to keep pace with actual developments in several respects. This current round of revisions was launched in 2014, and an earlier revised version was published in February of 2015, which saw limited modifications compared to the GCP. However, the Draft significantly changes the GCP in terms of both structure and content.
The Draft states the principles of protecting trial subjects' rights and interests and guaranteeing the safety and quality of clinical trials in its general rules, and has a special chapter that sets forth the responsibilities and obligations of ethics committees, researchers and trial applicants. The Draft also specifies the codes of conduct for CROs, inspectors and auditors, requires trial applicants to assume ultimate responsibility and requires an agreement specifying the responsibilities of each party to be concluded. The researcher handbook and essential documentation chapter further standardizes the testing operations and test data records.
The Draft also draws on experience from the "7.22" clinical drug trial data self-inspection program. For example, considering that the majority of drug registrations are rejected due to untraceable and/or modified data, the Draft clearly requires applicants to first carry out drug trials with the view of protecting subjects’ rights and interests and ensuring the authenticity and accuracy of the trial data. Applicants are also encouraged to use verified electronic data management systems. In case of data modifications, applicants should preserve the modifications and should not conceal initial data.
行业热点丨Industry News [2]
4. 国内最大医械知识产权案尘埃落定
汉坤评论：近日，广东省高级人民法院对深圳迈瑞生物医疗电子股份有限公司和深圳市理邦精密仪器股份有限公司之间的最后两起专利侵权案和1起商业秘密侵权案作出终审判决。自此，两家医疗器械领域的龙头企业之间的12起知识产权诉讼纠纷落下帷幕，迈瑞生物全部胜诉，获赔金额达到2800余万元。然而，为此胜诉判决，迈瑞公司表示付出了很大的维权成本。
医疗器械行业属于知识密集型的高科技产业，涉及医药、器械、电子等多个技术领域，知识产权是企业的核心竞争力。因此需要企业前瞻性地制定适合企业发展的知识产权战略，根据技术特性的不同采用专利和商业秘密等武器来对技术进行保护。企业应当即时监测潜在的侵权行为，并迅速做出反应，制定合理对策。考虑到医疗器械产品的更新换代迅速，诉前禁令的获得以及快速的判决尤为重要。对于医疗器械的竞争企业或上下游企业来说，可以通过知识产权许可和谈判来获得双赢。
Judgment Issued in the Largest Domestic Medical Device-related IP Case
Han Kun Comments: Recently, the Guangdong Provincial High People's Court issued final judgments with respect to alleged patent and trade secret infringement claims initiated by Mindray Biomedical Electronics Co., Ltd. (“Mindray”) against EDAN Instruments, Inc., which marked the end of a total of 12 intellectual property disputes between the two enterprises. Mindray gained a complete victory and obtained compensation amounting to RMB 28 million. However, Mindray also bore a heavy burden in the process.
As a knowledge-intensive industry, medical device manufacturing involves multiple technologies, including pharmaceutical, device, electrical and so on. Intellectual property is truly at the core of competitiveness among enterprises in this sector. Therefore, to gain a competitive advantage, medical device manufacturing enterprises should develop forward-looking intellectual property strategies and protect their technologies based upon their technical characteristics, including applying for patents or trade secrets for those technologies. In addition, enterprises should monitor and detect potential infringements in a timely manner and take prompt responsive measures as soon as any infringement is detected. In view of the nature of rapid upgrades of medical device products, it is also of great importance to seek pre-trial injunctions or judgments to be issued as soon as possible. Medical device manufacturers may also obtain IP licenses and negotiate with other competitive enterprises and upstream and downstream enterprises to achieve mutually beneficial outcomes.
5. 北京统一医保药品报销范围，优化医疗资源分配
汉坤评论：北京市人社局近期召开新闻发布会称，北京从2016年12月1日起统一社区医院和大医院的医保药品报销范围。今年8月的北京分级诊疗制度建设2016-2017年度重点任务发布会上，北京人社局就曾透露将统一医保药品报销范围，对糖尿病、高血压、冠心病、脑血管病四类慢性病患者，社区医生开具药量将从一个月延长至两个月。另外，居家上门医疗服务将纳入医保，社区卫生机构建立的治疗型家庭病床的报销起付线减半，并实现家庭病床和社区卫生机构或医院的双向转诊，24小时内转诊的起付线连续计算。
目前，北京城镇职工社区医疗报销比例为90%，比其他医院高20%。上述医保政策的实施，以及其中的成功经验在全国推行的预期，均将有利于患者首诊流量下沉至社区医院，优化医疗资源分配，推进分级诊疗改革的开展。但社区医院流量、面积有限，如何实现药物合理采购与配置、储存，是否利用第三方物流配药等问题，还有待在实践中进一步摸索，并完善相关制度。
Beijing Unifies the Scope of Drug Reimbursements to Optimize the Allocation of Medical Resources
Han Kun Comments: Recently, Beijing Municipal Human Resources and Social Security Bureau (the “Bureau”) held a press conference to announce that, from December 1, 2016, community hospitals and other hospitals will be subject to a unified medicare drug reimbursement catalogue. The Bureau had revealed its intention to unify the scope of drug reimbursements earlier in August at the 2016-2017 Beijing Tiered Diagnosis and Treatment System Construction Key Issues Task Conference. Under the reformed system, community doctor-prescribed drugs are eligible for a two-, rather than one-, month reimbursement period with respect to patients diagnosed with four types of chronic diseases, including diabetes, hypertension, coronary heart disease and cerebrovascular disease. Home medical services will be covered by the medical insurance. The reimbursement threshold for homecare beds supported by community health institutions will be reduced by half. A two-way referral system is to be implemented between homecare beds and community health institutions or hospitals, and patients referred between two locations within a 24-hour period will have their medical reimbursement thresholds calculated on a continuous basis.
At present, the reimbursement ratio for community medical institutions in Beijing is 90%, 20% higher than other hospitals. The abovementioned health insurance policy, upon being promoted nationally, will help guide patients to community hospitals for initial diagnoses. This will help to optimize the allocation of medical resources and promote tiered diagnosis and treatment system reforms. However, considering the limited space and intake capacity of community hospitals, how to reasonably procure, allocate and store drugs, and whether there is a need to employ third-party logistics companies will need to be explored in practice. Relevant systems also need to be further improved.