| A Company V. Shanghai Public Health Bureau(Case of Mandatory Administrative Action) | | 某公司诉上海市卫生局行政强制决定案 |
BASIC FACTS | | |
Plaintiff: a company Address: Guo Shouqing Rd., Zhangjiang High-tech Park, Shanghai | | 原告：上海某公司。 |
| Legal Representative: Qiu Zhigen, Chairman of the board of directors of this company | | 法定代表人：仇志根，该公司董事长。 |
| Defendant: Shanghai Public Health Bureau Address: Hankou Rd., Huangpu District, Shanghai | | 被告：上海市卫生局。 |
| Legal Representative: Liu Jun, Director of Shanghai Public Health Bureau | | 法定代表人：刘俊，该局局长。 |
| Shanghai Public Health Bureau made the Mandatory Health Administrative Decision No. 381 on January 16, 2004, stating that a company in Shanghai (hereinafter referred to as a company) violated Article 21 of the Administration Measures for Blood Stations (Interim)due to unlawful gathering of blood. In accordance with Article 48 of the Administrative Measures for Blood Stations, it was decided to ban a company from running such business and confiscate its three YSD-35-125 and one YSD-35-125 liquid nitrogen biological containers. A company refused to accept the decision, thus it lodged an administrative lawsuit in the People's Court of Huangpu District of Shanghai (hereinafter referred to as Huangpu District Court). | | 上海市卫生局(以下简称卫生局)于2004年1月16日作出第381号卫生行政强制决定，认定上海某公司(以下简称某公司)实施了未经许可擅自采集血液的行为，违反了卫生部《血站管理办法(暂行)》(以下简称管理办法)第二十一条的规定。根据管理办法第四十八条之规定，对某公司作出取缔、没收YSD-35-125液氮生物容器3只、YSD-35-200液氮生物容器1只的卫生行政强制决定。某公司不服，向上海市黄浦区人民法院提起行政诉讼。 |
| The plaintiff alleged that, according to the medical theories and the relevant documents of the Ministry of Public Health, the umbilical blood did not fall within the category of whole blood or the category of component blood as defined in the Administrative Measures for Blood Stations. A company was engaged in storing the hematogenic stem cells of umbilical blood as well as the research and development of relevant products, which was different from establishing a blood station. The mandatory administrative decision that was made by applying the Administrative Measures for Blood Stations to this case wasn't supported by sufficient proofs, and thus constituted a violation of procedure and wrong application of law, thus the decision should be revoked. | | 原告诉称：根据医学理论及卫生部文件的有关规定，脐带血不是管理办法所规定的全血或者成分血；我公司从事的是脐带血造血干细胞储存和相关产品的研究、开发，并非开设血站。卫生局适用管理办法作出行政强制决定依据不足，程序违法，适用法律错误，应予撤销。 |
| The plaintiff presented the following proofs: | | 原告提交以下证据： |
| 1. The business license of a company issued by Shanghai industry and commerce administrative department, which was used to prove that a company was allowed to engage in the business of storing stem cells of umbilical blood, and therefore had not conducted any unlawful business activity. | | 1．上海市工商行政管理部门向某公司核发的营业执照，用以证明某公司系经批准从事脐带血造血干细胞储存业务，其没有非法经营行为。 |
| 2. The document - “Safe Blood and Blood Products”- of the World Health Organization, which was used to prove that umbilical blood did not constitute whole blood for clinical use, nor did it constitute blood as defined in the Administrative Measures for Blood Stations. | | 2．世界卫生组织文件资料《安全血液和血液制品》，用以证明脐带血不属于临床用全血，并非管理办法中所定义的血液。 |
| 3. The Notice of the Ministry of Public Health about Printing and Distributing the Basic Standards for Blood Stations (No. 448 [2000] of the Ministry of Public Health), which was used to prove that the hematogenic stem cells of umbilical blood did not constitute component blood as defined in this document, nor did it constitute the blood as defined in the Administrative Measures for Blood Stations. | | 3．卫医发(2000)448号《卫生部关于印发＜血站基本标准＞的通知》，以证明脐带血造血干细胞不属于该文件所规定的成分血，因而亦非管理办法中所定义的血液。 |
| 4. The Proposal on Accelerating the Perfection of Hematogenic Stem Cell Banks in China, which was used to prove that as of that time, the administrative regulations of our country only concerned public banks, and no administrative licensing was required for providing storage service for anyone's own stem cells. | | 4．《关于加快健全中国造血干细胞库的建议》，用以证明目前为止我国的行政法规所涉及的仅仅是公共库，为自体进行干细胞储存服务的行为不需要经过卫生行政许可。 |
| The defendant argued that the plaintiff's purpose was to collect umbilical blood, to separate stem cells from the umbilical blood and use the stem cells for treatment. From the view of medical science, umbilical blood is blood. The umbilical blood gathered by the plaintiff falls within the category of “blood for a clinical purpose” as provided in the Administrative Measures for Blood Stations”. The defendant pleaded that the court maintains the mandatory administrative decision. | | 被告辩称：被告的目的是为了采集脐带血、提取干细胞，并用于治疗。在医学上，脐带血即是血液，原告采集的脐带血是管理办法中的“用于临床的血液”。请求维持该行政强制决定。 |
| The defendant submitted the following evidence: | | 被告提交以下证据： |
| 1.One copy of publicity materials produced by the plaintiff entitled The First Gift To a Baby after Birth, which was used to prove that the plaintiff itself regarded umbilical blood as blood, and that its purpose was to gather blood and use it for clinical use. | | 1．原告制作的宣传资料一份，名称是《宝宝诞生的第一份礼物》，用以证明原告自认脐带血是血液，其目的是为了采集血液，并应用于临床。 |
| 2. The Rectification Report issued by the plaintiff on December 18, 2003, which was used to prove that the plaintiff gathered blood unlawfully. | | 2．2003年12月18日原告出具的《整改报告》，用以证明原告未经许可擅自采集血液。 |
| 3. The agreement concluded between the plaintiff and Shanghai Pudong New District Gongli Hospital, which was used to prove that the plaintiff entrusted hospitals to gather umbilical blood for it. | | 3．原告与上海市浦东新区公利医院签订的协议，用以证明原告采集血液系委托医院进行。 |
| 4. Two news reports from News Morning and Youth Daily, which were used to prove that the plaintiff was aware that gathering blood was subject to the authorization of the health administrative department, but it still unlawfully gathered blood. | | 4．《新闻晨报》、《青年报》的新闻报道两篇，用以证明原告明知采集血液应当得到卫生行政部门的许可，但仍然实施了非法采集血液的行为。 |
| 5. The on-the-spot inspection transcripts made by administrative law enforcers on January 16, 2004, which were used to prove that there were instruments and equipment that could be used for the unlawful gathering of blood present in the business place of the plaintiff. | | 5．2004年1月16日行政执法人员制作的现场检查笔录，用以证明原告经营场所内有非法采集脐带血的仪器和设备。 |
| 6.The inquiry transcripts made by administrative law enforcers on August 29, 2003, which were used to prove that the plaintiff obtained a business license in March 2003, but it failed to obtain the administrative licensing for gathering blood. The plaintiff began to gather umbilical blood from July, 2003, and it had business relationships with 20 odd hospitals. By the time when the inquiries were made, the plaintiff had obtained 18 samples of umbilical blood hematogenic stem cells. | | 6．2003年8月29日行政执法人员制作的询问笔录，用以：证明原告于2003年3月取得营业执照，但未获得采集血液的行政许可，原告自2003年7月起开始采集脐带血，与20多家医院存在业务关系，至调查询问时，原告已有18份脐带血造血干细胞样本。 |
| 7.The transcripts made by the administrative law enforcers of the answers to the inquiries made by the legal representative of the plaintiff, which were used to prove that the plaintiff was engaging in the businesses of collecting, separating and storing umbilical blood. | | 7．2004年1月16日行政执法人员对原告法定代表人制作的询问笔录，用以证明原告开展的业务是收集、分离、储存脐带血。 |
| Upon cross-examination during the court trial, a company held that Proofs 1 and 2 presented by the defendant could only prove that it was engaged in the business of storing the hematogenic stem cells of umbilical blood, but failed to prove that it was engaged in the business of gathering blood. Proof 3 of the defendant did not state whether or not the proof was obtained before or after the concrete administrative act was made, thus it could not prove that a company had ever unlawfully gathered blood. Proof 4 was an untrue report, it could not prove that a company had ever unlawfully gathered blood. Proof 5 contained a statement - “[the administrative law enforcers] fail[ed] to find any act of unlawful gathering of blood during the on-the-spot inspection”, which could prove that a company hadn't gathered blood unlawfully. Collecting blood and gathering blood as mentioned in Proofs 6 and 7 were different concepts, the umbilical blood could only be gathered by a hospital within a 2 hour time period during the course of delivery in the delivery room, which could only prove that a company provided the lying-in women with the service of storing the hematogenic stem cells of umbilical blood. | | 经庭审质证，某公司认为：被告证据1、2只能说明某公司从事的是脐带血造血干细胞储存的业务，而不能证明其从事采集血液的业务；证据3未说明该证据是作出具体行政行为之前还是之后取得的，且只能说明为产妇采集脐带血的是医院，并非某公司；证据4是失实报道，不能证明某公司实施了非法采集血液的行为；证据5中有“经现场检查未发现采集血液的行为”的表述，证明某公司没有采集血液的行为；证据6、7中表述的收集和采集血液系不同概念，脐带血只能由医院在产房中、在分娩的两个小时内采集，只能说明某公司是为产妇提供脐带血造血干细胞储存服务的。 |
| ．．．．．． | | 卫生局对某公司证据的真实性、合法性没有异议，但认为：原告证据1不能证明上诉人从事脐带血相关业务已经得到卫生行政许可；证据2和证据3无证明力；证据4仅仅是建议，目前在脐带血库的管理上，对公共库和自体库未作区分，而某公司自认系脐带血自体库的主张，承认了其存在采集血液的行为。 |
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| | 上海市黄浦区人民法院经审理查明： |
| | 2003年8月，上海市媒体对某公司经营脐带血干细胞库业务的有关情况进行报道后，卫生局经调查取证，认定某公司实施了未经许可擅自采集血液的行为，于2004年1月16日作出第381号卫生行政强制决定，并于当日送达给某公司。 |
| | 上海市黄浦区人民法院认为： |
| | 根据《中华人民共和国献血法》(以下简称献血法)和管理办法的规定，卫生行政管理机关是对采供血进行监督、管理的行政主管机关。某公司委托医院采集脐带血，目的是分离干细胞后进行储存，以备用于储存人临床治疗血液性疾病。献血法和管理办法虽未对血液中全血的组成、成分血的种类予以详细列明，但从医学及法律规范的角度分析，脐带血应属于血液中全血的范畴，故某公司采集血液的事实成立。同时，上述法律和规章均明确规定，采集血液须以取得卫生行政许可为前提，某公司未得到卫生行政部门批准擅自采集脐带血，卫生局据此适用献血法和管理办法的规定，对其作出取缔的行政强制决定，适用法律正确。卫生局在作出被诉具体行政行为之前，进行了调查取证，之后亦制作了强制决定书，并送达给某公司，行政程序合法。但卫生局在取缔某公司违法行为的同时，决定对某公司液氮生物容器予以没收，而没收是法律规定的行政处罚措施，卫生局作出没收决定时，必须适用《中华人民共和国行政处罚法》(以下简称行政处罚法)规定的处罚程序，卫生局在决定没收某公司液氮生物容器时，没有依法适用处罚程序，虽然该处罚尚未执行，但亦构成程序违法。 |
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