作者：金杜律师事所医疗法律事务组
限定经销商的产品转售价格的条款是医药行业所使用的经销协议中的常见条款，但该等条款一直以来却存在着构成《中华人民共和国反垄断法》(“《反垄断法》”)项下纵向垄断协议的法律风险。鉴此，2010年作为中国纵向垄断协议第一案的北京锐邦涌和科贸有限公司(“锐邦”)诉强生(上海)医疗器材有限公司和强生(中国)医疗器材有限公司(“强生”)案引起了医药行业企业的强烈关注。该案判决对《反垄断法》纵向垄断协议相关条款的具体实施以及医药企业对相关风险的规避都将具有重要指导意义。2013年8月1日，上海市高级人民法院对该案做出了终审判决，以下对本案一审和终审的过程及主要判决内容进行简要概述，以供医药行业企业参考：
Continue Reading “锐邦”诉“强生”案尘埃落定——上海高院终审确认“限定转售价格条款”是否违法应经过“合理性原则”的判断
By King & Wood Mallesons’ Compliance Group
Recently, allegations of a massive bribery scheme on the part of the Chinese unit of a famous British multinational pharmaceutical company have grabbed headlines in China and abroad. China’s Ministry of Public Security officially announced on July 11 that senior executives of this company are under criminal investigation on suspicion of using travel agencies to bribe government officials, hospitals, doctors, and medical industry associations in a scheme to increase sales. Some of the company’s senior executives and employees are also suspected of taking bribes from third party vendors.
Continue Reading COMPLIANCE-Watchword of Healthcare Companies and Possible Other Companies in China
作者：金杜律师事务所法律合规组
在过去的几个星期，中国政府部门对一家著名的英国跨国药企采取的一系列行动不断登上了国内和国际媒体的头版头条。中国公安部于7月11日正式宣布，该公司的部分高级管理人员涉嫌为增加产品销量，而通过旅行社向政府官员、医院、医生和医疗行业协会等大肆行贿，目前已对相关人员展开刑事侦查。另外，该声明还指出该公司的一些高管及员工同时涉嫌收受供应商的商业贿赂。
Continue Reading 合规：在华医疗企业和其他高风险企业关注的问题
by King & Wood Mallesons’ Compliance Group
On July 2, the National Development and Reform Commission (“NDRC”) announced that it is investigating costs and prices charged by 60 foreign and domestic drug makers. Concerned pharmaceutical manufacturers should be aware that the investigation process imposes certain rights and obligations on the manufacturers and the investigating authorities alike.
Continue Reading China’s Investigation into Drug Pricing: What You Need to Know
作者：金杜律师事务所法律合规组
7月2日，国家发展和改革委员会宣布将对60家本国和跨国医药企业展开药品成本价调查。对此，相关医药企业有必要对政府和企业在价格调查过程中的相关权利和义务进行了解。
Continue Reading 面对中国政府的药品价格调查应当了解的事情
By King & Wood Mallesons’ Healthcare Group
In April 2013, the Supreme People’s Court (“SPC”) issued the“Supreme People’s Court’s Annual Report of Intellectual Property Cases”, in which the SPC included 34 typical intellectual property and competition cases from 2012 and summed up 37 issues of application of law with universal significance. In this regard, we made a summary of the patent cases related to the pharmaceutical industry in the report, for the purpose of assisting pharmaceutical enterprises in drafting patent applications.
Continue Reading Insights on Drafting Pharmaceutical Patents from the “Supreme People’s Court’s Annual Report of Intellectual Property Cases”
作者：金杜律师事务所医疗法律事务组
2013年4月，最高人民法院(“最高院”)从2012年审结的知识产权和竞争案件中精选了34件典型案件，归纳出37个具有普遍指导意义的法律适用问题，发布了《最高人民法院知识产权案件年度报告》。我们就该报告中涉及药物的专利案件做出如下简要归纳和总结，供医药企业撰写专利申请时参考。
Continue Reading 《最高院知识产权案件2012年年度报告》给医药领域专利撰写带来的启示
作者：金杜律师事务所医疗法律事务组
2012年9月19日，国家药监局发布了《药品和医疗器械行政处罚裁量适用规则(征求意见稿)》(“征求意见稿”) 并公开征求意见。征求意见稿适用于各类药监局具有行政处罚量裁权的药品及医疗器械相关违法案件。
Continue Reading 更多明确，减少自由裁量——对药品和医疗器械行业行政处罚拟定新规
By King & Wood Mallesons’s Healthcare Group
On 19 September 2012, SFDA released the Rules on Imposing Administrative Penalties for Drugs and Medical Equipment (Consultative Draft) (the “Draft”) and sought feedback from the public. The Draft shall apply to all types of violation regarding drugs and medical equipments, where SFDA has discretion on imposing administrative penalties.
Continue Reading MORE CERTAINTY, LESS DISCRETION —— Proposed New Rules on Administrative Penalty over Drug and Medical Equipment Industry
By King & Wood Mallesons’s Healthcare Group
Although the existing laws and regulations already establish certain rules and general principles for product promotional activities by pharmaceutical enterprises, the RDPAC Code of Practice 2012 (“RDPAC Code”) has further refined and defined the relevant requirements and standards for medical promotion and seeks to establish a bright line industrial practice.
Continue Reading RDPAC Code of Practice 2012