Han Kun Life Sciences & Healthcare Newsletter

1、《医疗器械监督管理条例》拟再次修订
汉坤点评：2017年10月31日，食品药品监管总局发布了《医疗器械监督管理条例》修正案（草案征求意见稿）（“《修正意见稿》”）。《医疗器械监督管理条例》自2014年10月重新颁布以来短短两年时间内已历经数次修订。此次修正案意见稿是围绕着今年10月1日发布的《关于深化审评审批制度改革鼓励药品医疗器械创新的意见》（“36条”）提出的改革措施来进行的，重点修改了《修正意见稿》中与36条改革措施相冲突的条款。
此次修正意见稿中的主要变化为：医疗器械上市许可持有人的面世；进口注册代理人需向省食品药品监督管理局备案；部分II类医疗器械不需备案经营；II、III类医疗器械注册检验报告可以自检；接受境外医疗器械临床试验数据；明确要求企业设立不良事件检测岗位；增设处罚到人的条款等。
对于5月份《医疗器械监督管理条例》局部修改的评述请参见：汉坤生命科学与健康专递 （第21期）
对于“36条”的评述请参见：汉坤生命科学与健康专递 （第23期）
Medical Device Supervision and Management Regulations Planned to Undergo Revisions Again
Han Kun Comments: On October 31, 2017, CFDA promulgated a revised draft of the Medical Device Supervision and Management Regulations (Draft for Comment) (the “Revised Draft”). The Revised Draft has been revised several times in a short period of two years since its reissuance in October 2014. The Revised Draft focuses on the reform measures proposed on October 1 in the Opinions on Deepening the Reform of the Evaluation and Approval System and Encouraging Innovations in Drugs and Medical Devices (the “36 Articles”), and those provisions in conflict with the 36 Articles have been revised in the Revised Draft.
The major changes in the Revised Draft are as follows: the medical device marketing authorization holder (“MAH”) system will be launched; import registration agents will file with the provincial CFDA; some Class II medical devices are not required to undergo record-filing; inspection reports for Class II and Class III medical devices can be provided by the companies themselves; the data from foreign clinical trials can now be accepted; companies’ adverse event detection measures are explicitly required to established; and specific penalty provisions for individuals have also been added.
For comments related to the partial revision of Medical Device Supervision and Management Regulations, please refer to the Han Kun Life Sciences & Healthcare Newsletter (Issue 21).
For comments related to the 36 Articles, please refer to the Han Kun Life Sciences & Healthcare Newsletter (Issue 23).
2、保监会再次对《健康保险管理办法（征求意见稿）》公开征求意见
汉坤点评：2017年5月，保监会曾发布第一版《健康保险管理办法（征求意见稿）》，11月15日，保监会又在官网上发布了第二版《健康保险管理办法（征求意见稿）》（“《征求意见稿》”）。
本次《征求意见稿》最大的修订在于首次提及健康管理服务与医保合作，并设专章详细规定了健康管理服务与医保合作的具体内容。根据新规定，保险公司可以将健康保险产品与健康管理服务相结合，提供健康风险评估和干预、慢性病管理、养生保健等服务。
《征求意见稿》明确规定保险公司不得索要客户的基因检测数据，也不得将其作为核保或调费的依据，从而彻底将“保险+基因”的发展模式堵死。基因检测相关数据作为最重要的个人信息，如何防止其被泄露、滥用，乃至引发基因歧视，这既涉及隐私保护又涉及伦理问题。在未找到稳妥的解决方案之前，禁止使用基因检测投保的规定有利于保护个人基因信息。
此次修订还包括如下值得关注的内容：（1）将部分医疗行为导致的意外事故也纳入了健康保险的保障范围，使得健康险的保障更加全面；（2）明确强调健康保险的保障属性。《征求意见稿》在第三条明确提出“坚持健康保险的保障属性”，防止异化为理财产品；（3）要求专设事业部经营健康险业务。《征求意见稿》明确要求除专业健康险公司以外的保险公司经营健康险业务需要成立专门的健康险事业部门，以提高服务的专业性。
China Insurance Regulatory Commission Again Seeks Public Comment for the Measures for the Administration of Health Insurance (Draft for Comment)
Han Kun Comments: In May 2017, China Insurance Regulatory Commission (“Commission”) promulgated the first version of the Measures for the Administration of Health Insurance (Draft for Comment), and the Commission has promulgated a second version of the Measures for the Administration of Health Insurance (Draft for Comment) (“Comment Draft”) on November 15.
The biggest revision to the Draft for Comment is to provide for cooperation between health management services providers and health insurers for the first time, and setting up a specific section to specify the details of the cooperation between health management services providers and health insurers. According to the new regulation, insurance companies can combine health insurance products with health management services to provide health risk assessments and intervention, chronic disease management and health care services.
The Comment Draft clearly provides that health insurers are not allowed to ask for customers’ genetic testing data, nor allowed to use these data as a basis for the underwriting or adjusting of fees, which closes the development of “insurance + genetics.” Genetics-related testing data is the most important personal information, and how to prevent it from being disclosed, abused or even triggering genetic discrimination, are questions that not only relate to privacy protection but also relate to ethical issues. In the absence of a secure solution, prohibiting the use of genetic testing for insurance is beneficial for the protection of personal genetic information.
The Comment Draft also includes some revisions worthy of special attention: (1) some damages arising from medical accidents are also covered by health insurance, thus making the guarantee of health insurance more comprehensive; (2) the guarantee nature of insurance is explicitly emphasized. Adhering to the guarantee nature of health insurance is explicitly provided in Article 3 of the Comment Draft; (3) a specialized department is required to operate the health insurance business. The Comment Draft provides that insurance companies, excluding specialized health insurance companies, are required to set up a specialized health insurance department to operate health insurance businesses in order to improve the professionalism of their services.
3、医药电商政策：门槛放宽，监管趋严
汉坤点评：2017年11月1日，CFDA发布《关于加强互联网药品医疗器械交易监管工作的通知》（“《通知》”），该《通知》旨在贯彻落实《国务院关于取消一批行政许可事项的决定》（国发[2017]46号），CFDA将不再受理互联网药品交易服务企业（第三方）审批的申请，即取消医药电商A证的审批。
早在2017年1月，国务院首先取消了互联网药品交易服务企业审批（第三方平台除外），即医药电商B、C证的审批，使得实体药店及医药批发企业开展互联网药品交易服务的时候，不再需要通过省级食品药品经营监督管理部门的审批。而此次医药电商A证审批的取消意味着国家在准入机制上的放开，并且提高了企业进入医药电商的效率。
随着ABC证审核的相继取消，医药电商门槛进一步降低，但政策松绑的同时，对医药电商的监管并未放开。2017年11月10日，CFDA出台《网络药品经营监督管理办法（征求意见稿）》（“《网售药品征求意见稿》”）。
其中如下内容值得关注：（1）网上药店禁止销售或展示处方药。《网售药品征求意见稿》明确规定了“不得通过网络销售处方药”，并且“不得通过网络发布处方药信息”，可见处方药网售红线依旧不能逾越；（2）网上药店须配备职业医师。根据要求，若销售对象为个人消费者的，应当建立线上药学服务制度，配备执业医师，指导合理用药，并在网站当展示《执业药师注册证》，体现了CFDA强调的线上线下同等监管的政策思路。
上述一系列政策出台之后，医药电商行业进入“宽进严管”的时代，国家在支持药品流通企业与互联网加强合作的同时，对于医药电商企业的监管将更加科学而常态化。
Pharmaceutical E-commerce Policies: Easier Access and Stricter Regulations
Han Kun Comments: On November 1, 2017, CFDA promulgated the Circular on Strengthening the Regulation of Drugs and Medical Device Trading on the Internet (“Circular”), which carries out the Decision of the State Council on Cancelling a Batch of Items Subject to Administrative Licensing (Guo Fa [2017] No.46), pursuant to which CFDA will no longer accept examination and approval applications submitted by service enterprises (third parties) engaging in the trading of drugs on the Internet. This will result in cancelling examinations and approvals for pharmaceutical e-commerce type A certificates.
The State Council cancelled the examination and approval of service enterprises (excluding third-party platforms) engaging in drug trading on the Internet in January 2017, which meant cancelling of the examination and approval of pharmaceutical e-commerce type B and C certificates. Therefore, drugstore operators and wholesale drug enterprises will no longer need to obtain examination and approval from the provincial CFDA when they engage in drug trading on the Internet. And the cancellation of the examination and approval of the type A certificate means that the State has opened up the market entry mechanism and improved the efficiency of enterprises entering the pharmaceutical business.
With the cancellation of the A, B and C certificates, the threshold for pharmaceutical e-commerce has been further lowered. However, at the same time of policy loosening, the regulations for the pharmaceutical business have not been released. On November 10, 2017, CFDA promulgated the Supervision and Administration of Selling Drugs Online (Draft for Comment) (“Online Drug Sales Draft”).
The following points in the Online Drug Sales Draft are worthy of special attention: (1) it prohibits online drugstores from selling or displaying prescription drugs. The Online Drug Sales Draft explicitly stipulates that online sellers may not sell prescription drugs or display any prescription drug information online, meaning that the online filling of prescriptions remains a redline that cannot be crossed; (2) online drugstores are required to have licensed pharmacists. According to the requirements of the Online Drug Sales Draft, online drug sellers are required to have an online drug service system and licensed pharmacists to guide the reasonable use of drugs; if drugs are sold to individual consumers, the Licensed Pharmacist Registration Certificate is also required to be displayed, reflecting the same regulations for online and offline sales which is a policy that the CFDA has emphasized.
After the introduction of a series of policies, the pharmaceutical e-commerce industry has entered into the era of easing market entry and tighter regulation. While China supports the cooperation between the pharmaceutical distributors and the Internet, the supervision of the pharmaceutical distributors will be more rational and normalized.
4、CFDA相继出台关于接受境外临床试验数据的具体文件
汉坤点评：依据36条关于接受境外临床试验数据的要求，CFDA于2017年10月20日出台《接受境外临床试验数据的技术要求（征求意见稿）》（“《药品境外临床试验数据意见稿》”），并于11月14日出台《接受医疗器械境外临床试验数据技术指导原则（征求意见稿）》（“《医疗器械境外临床试验数据意见稿》”），上述两则规定作为36条的后续配套政策，对于接受药品和器械的境外临床试验数据提出了具体的技术要求。
《药品境外临床试验数据意见稿》明确了接受和承认境外临床试验数据的条件：首先应符合我国注册相关要求，药品上市许可持有人应确保其真实性、完整性、准确性和可溯源性，并接受国家食品药品监督总局的监督检查，其次还应证明不存在人种差异。
《医疗器械境外临床试验数据意见稿》则提出了接受医疗器械境外临床数据的三大原则：伦理原则、依法原则和科学性原则，同时也在文中清楚地列明了接受境外临床试验资料时考虑的三类因素和技术要求：不同国家技术审评要求的差异、受试人群的差异以及临床试验条件差异，上述差异可能对临床试验数据造成一定影响。
CFDA Promulgates a Series of Specific Documents regarding Acceptance of Data from Foreign Clinical Trials
Han Kun Comments: Pursuant to the requirements for accepting the foreign clinical trial data in the 36 Measures, CFDA has promulgated the Technical Requirements for Accepting Data from Foreign Clinical Trials (Draft for Comment) (“Foreign Drug Trials Draft”) on October 20, 2017, and promulgated the Technical Guidelines for Accepting Medical Device Data from Foreign Clinical Trials (Draft for Comment) (“Foreign Medical Device Trials Draft”). As follow-up supporting policies, the two foregoing regulations provide specific technical requirements for data from the foreign clinical trials of drugs and medical devices.
The Foreign Drug Trials Draft clarifies the following conditions for accepting and recognizing the foreign clinical drug trial data: firstly, the data must comply with the relevant registration requirements in China; secondly, drug MAHs are required to ensure the authenticity, integrity, veracity and traceability of the data. It must also be shown that racial differences do not affect the results of the clinical trial data.
The Foreign Medical Device Trials Draft provides three principles for accepting foreign medical device clinical trial data: the principles of ethics, law and science, and at the same time, lists three factors and technical requirements to be taken into consideration when accepting documents from foreign clinical trials: differences of technical review requirements between the different countries, differences among the test subjects, and clinical trial conditions which may have an effect on the clinical trial data.