知恒法研 | 生物医药行业投融资法律实务——医药医疗行业外资准入（上）- 知恒律师事务所

作者 | 知恒上海律师事务所姚海嵩律师、楼梦茜律师、罗雨婷

Legal Practice for Investment and Financing in the Biopharmaceutical Industry---Foreign Investment Access in the Pharmaceutical and Medical Industry (Part 1)

On September 6, 2024, the National Development and Reform Commission (NDRC) and the Ministry of Commerce (MOFCOM) issued the Special Administrative Measures for Foreign Investment Access (Negative List) (2024 Edition) (hereinafter referred to as the "Negative List"). The Negative List stipulates that medical institutions are limited to Sino-foreign joint ventures and prohibits foreign investment in the development and application of human stem cell and gene diagnosis and treatment technologies. These provisions are consistent with the foreign investment access rules in the Special Administrative Measures for Foreign Investment Access (Negative List) (2021 Edition) and the Special Administrative Measures for Foreign Investment Access in Pilot Free Trade Zones (Negative List) (2021 Edition). However, the 2024 Negative List removed the foreign investment restrictions on "the application of processing techniques such as steaming, stir-frying, honey-frying and calcining of traditional Chinese medicine (TCM) decoction pieces and the production of TCM products with confidential formulas."

2024年9月6日，国家发展改革委、商务部发布的《外商投资准入特别管理措施（负面清单）（2024年版）》（以下简称“《负面清单》”）规定医疗机构限于中外合资、禁止外商投资人体干细胞、基因诊断与治疗技术开发和应用，与《外商投资准入特别管理措施（负面清单）（2021年版）》、《自由贸易试验区外商投资准入特别管理措施（负面清单）（2021年版）》规定的外商投资准入规则保持一致，但删除了对“中药饮片的蒸、炒、炙、煅等炮制技术的应用及中成药保密处方产品的生产”的外资限制。

On September 7, 2024, the Ministry of Commerce (MOFCOM), the National Health Commission (NHC), and the National Medical Products Administration (NMPA) jointly issued the Notice on Carrying Out Pilot Work to Expand Openness in the Medical Field (hereinafter referred to as the "Medical Field Opening Pilot Notice"), proposing to carry out two pilot initiatives to expand openness in the medical field. On April 11, 2025, MOFCOM issued the Work Plan for Accelerating the Comprehensive Pilot Program for Expanding Openness in the Service Sector, proposing to enhance the level of openness and service support in the medical and health care sector. It allows the establishment of non-profit medical institutions through Sino-foreign joint donations according to relevant regulations and permits foreign investors to donate funds to establish non-profit elderly care institutions.

2024年9月7日，商务部、国家卫生健康委及国家药监局三部门联合发布了《关于在医疗领域开展扩大开放试点工作的通知》（以下简称“《医疗领域开放试点通知》”），拟在医疗领域开展两项扩大开放试点工作。

2025年4月11日，商务部发布《关于加快推进服务业扩大开放综合试点工作方案》提出提高医疗康养领域对外开放和服务保障水平，允许以中外共同捐资方式按相关规定举办非营利性医疗机构，允许外商捐资举办非营利性养老机构。

This article will analyze the foreign investment access situation for medical institutions and cell and gene therapy. This is Part 1, focusing on foreign investment access for medical institutions; Part 2 will analyze foreign investment access for cell and gene therapy.

本文将从医疗机构及细胞与基因治疗外资准入情况进行分析，本篇为上篇，主要分析医疗机构的外资准入；下篇将分析细胞与基因治疗的外资准入。

I.Foreign Investment Access for Medical Institutions

(A) General Foreign Investment Restrictions

1. General Foreign Investment (Excluding Service Providers from Hong Kong, Macao, and Taiwan)

Apart from the stipulation that "medical institutions are limited to joint ventures," the Negative List does not further specify equity ratio requirements for Sino-foreign joint ventures. According to the Interim Measures for the Administration of Sino-foreign Equity and Cooperative Medical Institutions, the equity share or interests held by the Chinese party in a Sino-foreign equity joint venture medical institution shall not be less than 30%. The Notice of the Ministry of Health on Adjusting the Approval Authority for Sino-foreign Equity and Cooperative Medical Institutions delegates the approval authority for the establishment, alteration, and termination of Sino-foreign equity joint venture medical institutions to provincial-level health administrative departments. Therefore, provincial health administrative departments can determine approval requirements, including equity ratios, at their discretion based on the regulatory environment within their province. Currently, most regions require the Chinese party to hold no less than 30% equity; however, some regions have made breakthroughs, for example, in Sichuan Province, the Chinese party's equity ratio only needs to be no less than 10%.

一、

医疗机构的外资准入

（一）一般外资限制

1、一般外资（香港、澳门、台湾服务提供除外）

除“医疗机构限于合资”外，《负面清单》没有进一步规定中外合资的股权比例要求。根据《中外合资、合作医疗机构管理暂行办法》，中方在中外合资医疗机构中所占的股权比例或权益不得低于30%。

《卫生部关于调整中外合资合作医疗机构审批权限的通知》规定中外合资医疗机构的设置、变更及终止的审批权限下放至省级卫生行政部门，因此各省级卫生行政部门可以根据其省内监管环境酌情确定包括持股比例在内的审批要求。

目前大部分地区要求中方持股不得少于30%；但也有个别地区对此进行了突破，例如在四川省，中方持股比例只要不低于10%即可。

2. Service Providers from Hong Kong, Macao, and Taiwan

(1) Service Providers from Hong Kong and Macao

According to Supplementary Provision II to the <Interim Measures for the Administration of Sino-foreign Equity and Cooperative Medical Institutions>, service providers from Hong Kong and Macao may establish clinics solely in the form of wholly-owned enterprises in Guangdong Province. There are no restrictions on the total investment amount or the investment ratio between parties for clinics established in Guangdong Province through joint ventures or cooperation between Hong Kong/Macao service providers and mainland partners. The Interim Measures for the Administration of Wholly Foreign-owned Hospitals Established in Mainland China by Service Providers from Hong Kong and Macao stipulate that service providers from Hong Kong and Macao may, upon approval by the competent mainland authorities in accordance with the law, establish wholly-owned hospitals in mainland China. The establishment of wholly-owned hospitals by Hong Kong and Macao service providers in mainland China is limited to Shanghai, Fujian, Guangdong, Hainan, and Chongqing. The Notice on Expanding the Geographical Scope for Service Providers from Hong Kong and Macao to Establish Wholly Foreign-owned Hospitals in Mainland China stipulates that from April 1, 2012, the geographical scope for service providers from Hong Kong and Macao to establish wholly-owned hospitals in mainland China was expanded from Shanghai, Chongqing, Guangdong, Fujian, and Hainan to all municipalities directly under the Central Government and provincial capital cities.

(2) Service Providers from Taiwan

According to the Interim Measures for the Administration of Wholly Foreign-owned Hospitals Established in Mainland China by Service Providers from Taiwan, service providers from Taiwan may, upon approval by the competent mainland authorities in accordance with the law, establish wholly-owned hospitals in mainland China. The establishment of wholly-owned hospitals by Taiwanese service providers in mainland China is limited to Shanghai, Jiangsu, Fujian, Guangdong, and Hainan.

The author has also noted the recent case of BenQ Medical Center Group Co., Ltd. (hereinafter referred to as "BenQ Medical"), which is applying for a Hong Kong listing. Registered in the Cayman Islands, it indirectly controls 100% equity of Nanjing BenQ Hospital and Suzhou BenQ Hospital. Its Chinese legal counsel believes that BenQ Medical is ultimately owned by Taiwanese investor Qisda Corporation in accordance with the Interim Measures for the Recognition of Taiwanese Investors Investing via a Third Territory (hereinafter referred to as the "Indirect Investment Measures"); according to the Indirect Investment Measures, BenQ Medical is deemed a Taiwanese investor.

2、香港、澳门、台湾服务提供者

（1）香港、澳门服务提供者

根据《<中外合资、合作医疗机构管理暂行办法>的补充规定二》的规定，香港、澳门服务提供者在广东省可以独资形式设立门诊部；对香港、澳门服务提供者在广东省与内地合资、合作设立的门诊部投资总额不作限制，双方投资比例不作限制。

《香港和澳门服务提供者在内地设立独资医院管理暂行办法》规定香港和澳门服务提供者依法经内地主管部门批准，可以在内地设立独资医院。香港和澳门服务提供者在内地设立独资医院限定在上海市、福建省、广东省、海南省和重庆市。

《关于扩大香港和澳门服务提供者在内地设立独资医院地域范围的通知》规定自2012年4月1日起，香港和澳门服务提供者在内地设立独资医院的地域范围，由上海市、重庆市、广东省、福建省和海南省，扩大到所有直辖市及省会城市。

（2）台湾服务提供者

根据《台湾服务提供者在大陆设立独资医院管理暂行办法》，台湾服务提供者依法经大陆主管部门批准，可以在大陆设立独资医院。台湾服务提供者在大陆设立独资医院限定在上海市、江苏省、福建省、广东省和海南省。

笔者也关注到近期正在申请香港上市的明基医院集团股份有限公司（以下简称“明基医院”），其注册于开曼群岛，间接控制南京明基医院、苏州明基医院100%的股权。其中国法律顾问认为明基医院由台湾投资者佳世达科技股份有限公司根据《台湾投资者经第三地转投资认定暂行办法》（以下简称“《转投办法》”）最终拥有；根据《转投办法》，明基医院被视同台湾投资者。

(B) Opening Pilot Initiatives

1. National Level

The Medical Field Opening Pilot Notice issued in September 2024 allows the establishment of wholly foreign-owned hospitals (excluding TCM hospitals, and excluding acquisitions of public hospitals) in Beijing, Tianjin, Shanghai, Nanjing, Suzhou, Fuzhou, Guangzhou, Shenzhen, and the entire island of Hainan.

The Notice on Carrying Out Pilot Work for the Establishment of Wholly Foreign-owned Hospitals, jointly issued by the former National Health and Family Planning Commission (NHFPC) and MOFCOM in July 2014 and still effective, explicitly allowed overseas investors to establish wholly foreign-owned hospitals through new establishment or acquisition in Beijing, Tianjin, Shanghai, Jiangsu, Fujian, Guangdong, and Hainan. In November 2024, the Notice on Issuing the Work Plan for Expanding the Pilot Program for Wholly Foreign-owned Hospitals (hereinafter referred to as the "Wholly Foreign-owned Hospital Expansion Pilot Notice") jointly issued by the NHC, MOFCOM, the National Administration of Traditional Chinese Medicine (NATCM), and the National Administration for Disease Control and Prevention (NCA), allows the establishment of wholly foreign-owned hospitals in Beijing, Tianjin, Shanghai, Nanjing, Suzhou, Fuzhou, Guangzhou, Shenzhen, and the entire island of Hainan. It is important to note that other types of medical institutions (e.g., nursing homes, medical testing laboratories) are not yet within the scope of the opening pilot work; foreign investment can still only participate through joint ventures with Chinese parties.

The promulgation dates of the Notice on Carrying Out Pilot Work for the Establishment of Wholly Foreign-owned Hospitals and the Wholly Foreign-owned Hospital Expansion Pilot Notice are ten years apart. Let's compare the two regulations from the perspectives of pilot regions, investment methods, categories of medical institutions, and investor qualification requirements, as detailed below:

（二）开放试点

1、国家层面

2024年9月颁布的《医疗领域开放试点通知》允许在北京、天津、上海、南京、苏州、福州、广州、深圳和海南全岛设立外商独资医院（中医类除外，不含并购公立医院）。

国家卫生计生委、商务部于2014年7月发布且目前仍有效的《关于开展设立外资独资医院试点工作的通知》（以下简称“《独资医院试点通知》”）就明确允许境外投资者通过新设或并购的方式在北京市、天津市、上海市、江苏省、福建省、广东省、海南省设立外资独资医院。

2024年11月，国家卫健委、商务部、国家中医药管理局及国家疾病预防控制局《关于印发独资医院领域扩大开放试点工作方案的通知》（以下简称“《独资医院扩大试点通知》”）允许在北京、天津、上海、南京、苏州、福州、广州、深圳和海南全岛设立外商独资医院。

需要注意的是，医院之外的其他医疗机构（例如疗养院、医学检验实验室）尚不在开放试点工作的范围中，外资仍仅能通过与中方合资方式参与投资。

《独资医院试点通知》及《独资医院扩大试点通知》的颁布时间相差十年之久，让我们从试点地区、投资方式、医疗机构的类别、投资主体条件等方面对两个规定进行对比，具体如下：

2. Local Level

On December 3, 2024, the Tianjin Municipal Health Commission and other departments jointly issued the Notice on Implementing the Work Plan for Expanding the Pilot Program for Wholly Foreign-owned Hospitals, requiring health departments to establish collaborative mechanisms with relevant departments to optimize and enhance work efficiency. The district health commissions where wholly foreign-owned hospitals are located should conduct operational assessments together with relevant departments and promptly coordinate to resolve difficulties encountered in the pilot program.

On December 16, 2024, the Guangdong Provincial Health Commission and other departments jointly issued the Work Plan for Expanding the Pilot Program for Wholly Foreign-owned Hospitals in Guangdong Province (Trial), allowing the establishment of wholly foreign-owned hospitals (excluding TCM hospitals, and excluding acquisitions of public hospitals) in Guangzhou and Shenzhen.

Based on current market entity registration rules and medical institution establishment rules, medical institutions, regardless of category, ownership form, affiliation, or service target, must comply with the local Medical Institution Establishment Plan. Local medical institution establishment plans are formulated by health administrative departments of local people's governments at or above the county level. Wholly foreign-owned hospitals involve different ownership forms and investment entities; their establishment first requires unified planning by local regulatory authorities.

2、地方层面

2024年12月3日，天津市卫健委等部门联合发布《关于做好独资医院领域扩大开放试点工作的通知》，卫生健康部门要与有关部门建立协同工作机制，优化提升工作效率。外商独资医院所在区卫生健康委要会同有关部门开展运行评估，及时协调解决试点中遇到的难点问题。

2024年12月16日，广东省卫健委等部门联合发布《广东省独资医院领域扩大开放试点工作方案（试行）》，允许在广州市、深圳市设立外商独资医院（中医类除外，不含并购公立医院）。

基于现行的市场主体登记规则和医疗机构设置规则，医疗机构不分类别、所有制形式、隶属关系、服务对象，其设置必须符合当地《医疗机构设置规划》，而各地医疗机构设置规划由县级以上地方人民政府卫生行政部门制定。外商独资医院涉及不同的所有制和投资主体，其设置首先需要当地监管部门进行统一规划。

3. Shanghai Pilot Work Plan: Expanding High-Level Opening Up in the Medical Field

On December 26, 2024, the Shanghai Municipal Health Commission and other departments jointly issued the Shanghai Work Plan for Deepening the Expansion of the Pilot Program for Wholly Foreign-owned Hospitals (hereinafter referred to as the "Shanghai Pilot Plan"). This plan allows the establishment of wholly foreign-owned hospitals in Shanghai (excluding TCM hospitals, and excluding acquisitions of public hospitals). It encourages the establishment of such hospitals in areas designated for expanded opening-up pilots such as the Pilot Free Trade Zone, Lingang Special Area, Hongqiao Business District, and Dongfang Hub International Business District, as well as in biopharmaceutical industry clusters and central urban areas with concentrated foreign resident populations. Recently, the Shanghai Municipal Health Commission and seven other departments formulated the Key Points of Work for Deepening the Reform of the Medical and Health System in Shanghai in 2025, which also lists exploring the establishment of wholly foreign-owned medical institutions as a key work point, leveraging national strategic zones like the Pudong New Area Modernization Leading Zone, Hongqiao International Central Business District, and Lingang Special Area of the Pilot Free Trade Zone for pioneering trials.

Overseas investors applying to establish a wholly foreign-owned hospital in Shanghai must be legal persons capable of independently bearing civil liability, possess direct or indirect experience in healthcare investment and management, and meet the following conditions: 1. Be able to provide internationally advanced hospital management concepts, models, and service models; 2. Be able to provide internationally leading medical technology and equipment; 3. Be able to supplement or improve local deficiencies in medical service capacity, medical technology, and medical facilities, and expand the diversified service supply landscape. The Shanghai Pilot Plan allows wholly foreign-owned hospitals to hire foreign physicians, physicians from Hong Kong, Macao, and Taiwan, and other health professionals from Hong Kong and Macao for short-term practice according to regulations, but the proportion of Chinese (mainland) personnel in both hospital management and health professional technical positions must not be less than 50% respectively.

The operational nature of a wholly foreign-owned hospital can be for-profit or non-profit. However, the following points require attention during establishment: 1. It shall not establish psychiatric hospitals, infectious disease hospitals, hematology hospitals, TCM hospitals, integrated TCM and Western medicine hospitals, or ethnic minority medicine hospitals; 2. The hospital's clinical departments shall not register Hematology; 3. The hospital shall not carry out medical treatments and diagnostics with high medical and ethical risks, mainly including human organ transplantation technology, human assisted reproductive technology, prenatal screening and prenatal diagnosis technology, inpatient psychiatric treatment, experimental treatment of new tumor cell therapy technologies, etc.; 4. The hospital information management system shall be connected to the municipal and district medical service supervision platforms; servers storing electronic medical records, medical equipment information, etc., shall be located within the territory of China. Therefore, wholly foreign-owned hospitals must pay high attention in their daily operations to requirements concerning human genetic resources, health and medical data, and high-risk medical technologies to ensure compliant operation.

Following the promulgation of the Medical Field Opening Pilot Notice in September 2024, three wholly foreign-owned hospitals have been established in Tianjin, Guangzhou, and Shanghai:

On December 16, 2024, Tianjin Municipality issued the first Practice License for a wholly foreign-owned tertiary general hospital, officially confirming Pengrui Li General Hospital (Tianjin Pengrui Li Hospital) as China's first wholly foreign-owned tertiary general hospital.

On January 2, 2025, Guangzhou Baiyun Pengrui Li Hospital was approved by the Guangdong Provincial Health Commission to settle in Guangzhou, becoming the first newly established wholly foreign-owned hospital in Guangdong after the Medical Field Opening Pilot Notice was issued.

On March 14, 2025, Shanghai DeltaHealth Hospital officially obtained the Medical Institution Practice License issued by the Shanghai Municipal Health Commission, becoming the nation's first wholly foreign-owned cardiovascular specialty hospital.

Additionally, on April 14, 2025, the 2025 Hainan Free Trade Port Global Industrial Investment Promotion Conference was held in Haikou, Hainan. Sanya plans to introduce Singapore's Pengrui Li Group to establish Hainan Free Trade Port's first wholly foreign-owned hospital project.

3、上海试点工作方案，扩大医疗领域高水平对外开放

2024年12月26日，上海市卫健委等部门联合发布《上海市深化外商独资医院领域扩大开放试点工作方案》（以下简称：试点方案），允许在上海市设立外商独资医院（中医类除外，不含并购公立医院）。

鼓励在自贸试验区、临港新片区、虹桥商务区、东方枢纽国际商务区等扩大开放试点区域、生物医药产业集聚区域和外籍人士集中居住的中心城区设立外商独资医院。近日，上海市卫生健康委员会等八部门制定了《2025年上海市深化医药卫生体制改革工作要点》，亦把依托浦东新区现代化建设引领区、虹桥国际中央商务区、自由贸易试验区临港新片区等国家战略承载区，先行先试探索举办外商独资医疗机构列入工作要点。

申请设立外商独资医院的境外投资者应当是能够独立承担民事责任的法人，具有直接或间接从事医疗卫生投资与管理的经验，并符合1、能够提供国际先进的医院管理理念、管理模式和服务模式；2、能够提供具有国际领先水平的医学技术和设备；3、可以补充或改善当地在医疗服务能力、医疗技术和医疗设施方面的不足，拓展多元化服务供给格局。

该试点方案允许外商独资医院按规定聘用外国医师、港澳台医师、港澳其他卫生专业技术人员短期执业，但全院管理和卫生专业技术人员的中方（内地）人员占比均不得少于50%。

外商独资医院的经营性质可以是营利性或者非营利性，但设立过程中需要注意的是：1、不得设立精神病医院、传染病医院、血液病医院、中医医院、中西医结合医院、少数民族医医院；2、医院的诊疗科目不得登记血液内科；3、医院不得开展医疗和伦理风险较高的诊疗活动，主要包括人体器官移植技术、人类辅助生殖技术、产前筛查和产前诊断技术，精神科住院治疗，肿瘤细胞治疗新技术试验性治疗等；4、医院信息管理系统应当接入市、区医疗服务监管平台，电子病历、医用设备等信息存储服务器应当位于我国境内。