根据中国（上海）自由贸易试验区（以下简称“上海自贸区”）网站报导，2014年7月22日，德国阿特蒙集团、银山资本与外高桥集团三联发展公司（以下简称“外高桥集团”）、外高桥医保中心，就设立上海自贸区阿特蒙医院共同签署了战略合作协议。此举标志着国内首家外资（投资人不包括港澳台企业[1]）医院将落户上海自贸区。
The announcement of a cooperative framework agreement relating to the establishment of Artemed Hospital in China (Shanghai) Pilot Free Trade Zone (the “Shanghai FTZ”) signals that the first wholly foreign-owned hospital[1] will be launched in the Shanghai FTZ. As reported, the cooperative framework was entered into between German-based Artemed Group,Silver Mountain Capital, Shanghai Waigaoqiao 3U-Development Co., Ltd. (the “3U-Developement”)and Shanghai Waigaoqiao Medical Center on 22 July 2014.
本文将结合上述背景，回顾我国对设立外资医疗机构从限制到逐步放开的制度变迁，并将在此基础上简要介绍及评价在上海自贸区设立外资医疗机构的主要规定及实践。
Based on the above investment project, this bulletin provides a brief review of the changes in China’s policies on foreign investmentin medical services, and further introduces the current major requirements and practices of the Shanghai FTZ in relation to the establishment of foreign-owned medical institutions.
一、设立外资医疗机构的制度变迁
I．Policy Changes on Foreign Investment in Medical Services
自上世纪90年代我国在医疗领域对外资开放，允许外商及港澳台投资者以合资或合作形式设立医疗机构以来，我国又陆续允许港澳台投资者以独资形式设立医疗机构。2010年11月26日，卫生部（现卫生和计划生育委员会）、商务部、财政部、人力资源和社会保障部会同国家发改委共同发布了《关于进一步鼓励和引导社会资本举办医疗机构的意见》（以下简称“《意见》”），提出对具备条件的境外资本在我国境内设立独资医疗机构进行试点，逐步放开。2011年12月24日，国家发改委及商务部发布修订的《外商投资产业指导目录》，取消了外商投资医疗机构限于合资、合作的限制。2013年9月18日，国务院发布《中国（上海）自由贸易试验区总体方案》（以下简称“《自贸区总体方案》”），允许外商在上海自贸区设立独资医疗机构，至此，上海自贸区成为了我国设立外资医疗机构的首个试点地区。
Since China opened the door to foreign investment in medical services in the 1990s, China has allowed foreign investors and HongKong, Macau and Taiwan investors to establish medical institutions in the form of Sino-foreign equity or cooperative joint ventures. Subsequently, China further permitted Hong Kong, Macau and Taiwan investors to establish wholly-owned medical institutions.On 26 November 2010, China indicated that it would allow eligible foreign investors to set up wholly foreign-owned medical institutions on a pilot basis and then gradually cancel the restrictions in this regard.Such announcement was issued in the Opinionson Further Encouraging and Guiding Private Capital in Setup of Medical Institutions (the “Opinions”), which was jointly promulgated by the Ministry of Health (currently, the Health and Family Planning Commission, the “HFPC”),the Ministry of Commerce, the Ministry of Finance, the Ministry of Human Resources and Social Security together with the National Development and Reform Commission.On 24 December 2011, the National Development and Reform Commission and the Ministry of Commerce jointly released the revised Catalogue of Industries for Guiding Foreign Investment,which removed the restriction that provided that foreign investors could onlyinvest in medical institutions in the form of Sino-foreign equity orcooperative joint ventures.On 18 September 2013, the State Council published the Overall Plan for the Shanghai FTZ (the “Overall Plan”). According to the Overall Plan, foreign investors are permitted toestablish wholly foreign-owned medical institutions in the Shanghai FTZ. As such, the Shanghai FTZ has become China’s first pilot program to allow foreign investors to establish medical institutions as wholly foreign-owned entities.
2013年11月13日，上海市人民政府发布了《上海自贸区外商独资医疗机构管理暂行办法》（以下简称“《暂行办法》”），在《自贸区总体方案》授权的基础上细化了设立外资医疗机构的准入条件及审批程序，从实质上进一步推动了外资医疗机构的发展。
On 13 November 2013, Shanghai Municipality further promoted the development of foreign investment in the medical servicesindustry by clarifying the required qualifications and conditions and the application procedures for the establishment of wholly foreign-owned medical institutions in the Shanghai FTZ. Such reforms were announced in the Provisional Measure on the Administration of Wholly Foreign-ownedMedical Institutions in the Shanghai FTZ (the “Provisional Measure”).
二、上海自贸区关于设立外资医疗机构的主要规定
II．Major Requirements of Shanghai FTZ in relation to the Establishment of Foreign-owned Medical Institutions
基于《自贸区总体方案》以及《暂行办法》搭建的制度框架，外国投资者目前在上海自贸区设立独资医疗机构主要须遵循下述规定。
Pursuant to the Overall Plan and the Provisional Measure,foreign investors who intend to establish wholly foreign-owned medical institutions shall comply with the following provisions.
1.准入条件
- Qualification Requirements and Conditions
《暂行办法》要求拟设立的外资医疗机构须符合上海市区域卫生规划和医疗机构设置规划中有关促进社会办医的精神和要求，并执行国家卫生和计划生育委员会（以下简称“国家卫计委”）制定的《医疗机构基本标准》。
The Provisional Measure provides that any wholly foreign-owned medical institution, prior to establishment, shall comply with the spirit and requirements under the health plan and the medical institution plan of Shanghai in relation to the promotion of private capital to set up medical institutions,and shall adopt the standards as provided in the Basic Standards for the Medical Institutions promulgated by the HFPC.
《暂行办法》进一步要求，申请设立独资医院的外国投资者必须是能够独立承担民事责任的法人，并应具有直接从事医疗机构投资与管理5年以上的经验；在此基础上，该外国投资者还应(i)能够提供国际先进的医疗机构管理经验、管理模式和服务模式；(ii)能够提供具有国际领先水平的医学技术和设备；或（iii)可以补充或改善所在地在医疗服务能力、医疗质量、技术、资金和医疗设施方面的不足。上述条件并不具备客观的判断标准，为在上海自贸区内设立外资医疗机构设置了较高的门槛，也为地方政府审查核准相关项目申请保留了较大的自由裁量空间。
The Provisional Measure further requires that the foreign investors in the wholly foreign-owned medical institution shall be legal persons able to independently bear civil liability, and shall have directly engaged in the investment and management of medical institutions for more thanfive years.In addition, the foreign investor shall also meet one of thefollowing conditions: (i) capable of providing internationally advanced management experience, management methods and service methods of medical institutions; (ii) capable of providing internationally advanced medical technology and equipment; or (iii) capable of supplementing or improving the local medical service capacity, medical technologies, medical funds and medical facilities. No specific basis has been provided for the above general conditions, which may result in a high bar for foreign investors to establish wholly foreign-owned medical institutions, and may also leave the local authorities with wide discretion to examine and approve the relevant investment.
尽管目前《暂行办法》仍然规定拟设立的外资医疗机构须满足最低投资总额2000万元人民币及经营期限不长于20年（可经批准续展）的要求，但根据2014年6月28日国务院批准的《中国（上海）自由贸易试验区进一步扩大开放的措施》（以下简称“《扩大开放措施》”），外资医疗机构最低投资总额和最长经营期限的限制已被取消，外商独立投资规模较小的医疗机构如诊所等不存在法律障碍。
The Provisional Measure currently retains the provisions specifying that the wholly foreign-owned medical institution shall be an independent legal person with a total investment of no less than RMB 20 million and with a business term of no longer than 20 years (renewable upon application). However, these requirements were abolished in the Measures for Further Expanding Opening-up of China (Shanghai) Pilot Free Trade Zone (approved by the State Council on 28 June 2014). Thus, there will be no additional legal obstacles for foreign investors to establish small-scale medical institutions, such as clinics, in the Shanghai FTZ.
2.“一口受理”的设置审批 - “One-stop” Approval
《暂行办法》规定，外资医院的设置审批与登记将“一口受理”快速办理。企业只要提交的材料齐全（包括申请材料、项目建议书、可行性研究报告、外国投资者的注册登记证明、法定代表人身份证明和银行资信证明、项目选址报告、土地使用/租赁证明、建筑平面图、外国投资者具有直接从事医疗机构投资与管理5年以上经验的证明材料等），上海卫生计生部门、上海自贸区管委会、上海自贸区工商部门将在40个工作日内出具批准或不批准的书面文件。与之前《意见》中要求外资医疗机构的设立须经商务部及卫生部审批相比，该规定将审批权限下放到了上海市及上海自贸区层面，大大简化了外商独资设立医院的审批程序。
A quicker approval and registration mechanism has been established under the Provisional Measure, which allows investors to submit, at one location, all the approval and registration materials to different authorities.If the investor submits complete application materials, then the investor can obtain a written reply as to whether the application has been approved, within 40 business days, from the Shanghai HFPC, the Administration Commission and the Administration for Industry and Commerce of the Shanghai FTZ. Such application materials include, but are not limited to, the application, the project proposal, the feasibility study report, the registration certificate of the foreign investor, the identification certificate of the legal representative, the bank credibility letter, the site selection report, the land use/leasing supporting documents, the architectural plans and the document to evidence the foreign investor’s five-year direct experience in the investment and management of medical institutions.The Provisional Measure delegates the relevant approval and registration to the Shanghai Municipality and the Shanghai FTZ level, which differs from the previous requirements under the Opinions, which specified that the establishment of wholly foreign-owned medical institutions shall be subject to the approval of the Ministry of Commerce and the Ministry of Health. This reform greatly simplifies the approval and application procedures for foreign investors to establish medical institutions.
三、上海自贸区关于设立外资医疗机构的主要实践
III．Major Practices of Shanghai FTZ in relation to the Establishment of Foreign-owned Medical Institutions
根据公开资料显示，阿特蒙医院将落户于目前上海自贸区唯一的医疗用地——外高桥F2-02地块，项目计划占地面积约1.03万平方米。外高桥集团为该地块的土地使用权人，并将为阿特蒙医院建设约1.72万平方米的物业，供其长期租赁使用。代建经营物业是国内开发区用以吸引优质项目资源经常使用的隐性财政补贴手段，如辅之以承租方可以自由行使的回购权，实际上具有为项目提供融资的功能，有利于投资者降低项目建设及运营之初的资本支出。
According to publicly available information, Artemed Hospital will be launched on the only plot of land zoned for medical purposes in the Shanghai FTZ—Waigaoqiao F2-02 land, which covers an area of approximately 10,300 square meters.3U-Development owns the land use rights for such land, and will construct acompound covering 17,200 square meters for Artemed Hospital’s long term use.Constructing and operating the development through agovernment-owned agent is a common measure taken by governments of development zones to grant benefits to investors so as to attract high-quality investments.If such measure is accompanied by buy-back rights, it serves a financingfunction, which benefits the investor by allowing the investor to reduce its capital expenditure on construction and operation at the preliminary stage of the project.
阿特蒙医院计划分三期建设。一期将建设并首先运营医疗影像中心、第三方独立诊断中心、医疗培训中心、研发中心、演示中心、肌骨疾病中心。二期和三期的综合门诊中心、心血管疾病中心、腹腔疾病中心、肺部疾病中心的建设，将根据一期经营状况及市场需求逐步推进。综合性医疗机构投资巨大，各种专业科室设置复杂，仅就法律问题而言，涉及医疗机构资质取得、设备及药材的采购及进口、医师雇佣及注册、医疗服务价格审批及监管等一系列挑战。阿特蒙医院以分期建设方式积累经验分散风险，逐步探索细分医疗服务市场的容量，不失为谨慎的风险控制方式。
As currently planned, Artemed Hospital will be constructed in three phases. Phase I will involve the construction and operation of the medical image center, the third-party independent diagnosticscenter, the medical training center, the research and development center, the demonstration center and the muscle and bone diseases center. Subsequently, the comprehensive outpatient center and the inpatient center in the fields of cardiovascular diseases, celiac diseases and lung diseases will be gradually constructed and operated in Phase II and Phase III, according to the operation and market needs of Phase I.The establishment of a comprehensive medical institution is an enormous investment, involving the set up of complicated departments with various medical specializations. From a legal perspective, establishing a medical institution is subject to a series of challenges including, but not limited to, obtaining a license for the medical institution, the procurement and import of equipment and medical materials, the employment and registration of doctors and the approval and regulation of theprices of medical services.Artemed Hospital, through itsconstruction in phases, achieves the accumulation of experience and the distribution of risk, and also leaves room for the investor to gradually explore the market needs of the medical services market segment, which can be regarded as a prudent manner of risk control.
一期建设完成后，阿特蒙医院计划引进境外医疗团队，以提供国际水平的医疗服务。但是，《外国医师来华短期行医暂行管理办法》规定，外籍医师在国内短期行医注册的有效期不超过一年，虽然在期限届满后可以重新注册，但外籍医师在国内长期执业似乎并不为现行法律所鼓励。
Upon completion of the construction of Phase I, Artemed Hospital plans to bring in foreign doctors and therapists, so as to realize the provision of international-level medical services. However, it seems that the current Chinese laws do not encourage foreign doctors to practice in China for a long period. Inaccordance with the requirements of the Foreign Doctors’ Short-term Practice in China, foreign doctors can only be granted practicing licenses in Chinafor one year, although such period can be renewed upon expiration.
四、简评
IV．Conclusion
上海自贸区有关外资医疗机构的规定，关注点仍然在于解决外资医疗机构设立、变更及终止的程序及审批问题。至于外资医院运营中的关键问题，如医师执业、培训及晋级，外籍医师注册，高端医疗设备引进，税收政策，外资医院与中国及国际医保接轨等配套细则尚待明确和完善。
The current requirements of the Shanghai FTZ mainly focus on the procedure and approval issues for the establishment of foreign-owned medical institutions; the requirements do not provide detailed rules for the operation of the same.Further clarification is expected to be released in respect of the key issues in the operation of the foreign-owned medical institutions,such as the practice, training and promotion of doctors, the practicing licenses for foreign doctors, the import of advanced medical equipment,the tax policies as well as the arrangements between Chinese and international medical insurance companies and foreign-owned hospitals.
但上海自贸区内首家外资医院的设立，无疑将为上述问题的探索和解决提供宝贵的实践经验。2014年7月25日，国家卫计委、商务部发布了《关于开展设立外资独资医院试点工作的通知》，将境外投资者独资设立医院的试点扩大至北京市、天津市、上海市、江苏省、福建省、广东省及海南省七个地区。在政策的鼓励和推动下，相信在中国设立及运营外资医疗机构的路径将更加明朗，我们也将对此保持持续关注。
However, it is believed that the establishment of the first wholly foreign-owned hospital in the Shanghai FTZ will lead to valuable knowledge related to the exploration and solution of the above issues. On 25 July 2014, the HFPC and the Ministry of Commerce promulgated the Notice regarding Establishing Wholly Foreign-owned Hospitals. According to the Notice,foreign investors are further permitted to set up wholly foreign-owned hospitals in seven additional pilot regions, including Beijing,Tianjin, Shanghai,Jiangsu Province, Fujian Province, Guangdong Province and Hainan Province.It is believed that, with the continuing promotion and encouragement of foreign investments in medical services under national policies, the path for foreign investors’ participation in the investment and operation of medical institutions will become increasingly certain.We will continue to follow the relevant updates in this regard, and will issue subsequent bulletins as necessary.
[1] 除文义另有所指外，本文所称外商均不包含港澳台企业。
[1] Unless the context otherwise requires, theforeign investors mentioned herein shall not include Hong Kong, Macau and Taiwaninvestors.