Hainan to allow establish wholly foreign-owned hospitals

On Sept 8, the Ministry of Commerce of the People's Republic of China announced the release of a clarifying notice regarding the pilot program for medical sector opening up, which was issued in conjunction with the National Health Commission and the National Medical Products Administration.

The Chinese government has recently announced new guidelines for biotechnology companies operating within the country. Foreign-owned enterprises are now allowed to conduct research and develop treatments using human stem cells, gene diagnosis, and gene therapy in four specific free trade zones: Beijing, Shanghai, Guangdong, and Hainan. These enterprises may now register products for sale, apply for listings, and begin production within these regions. Once a product has been registered, launched, and approved for production, it may be used nationwide. Any foreign-invested enterprise planning to pilot a project in China must comply with all relevant laws and administrative regulations. In addition, they must meet the requirements of human genetic resource management, medical clinical trials (including international multicenter clinical trials), medical registration and marketing, medical production, ethical review, and other regulations. They must also fulfill all relevant management procedures.

The proposal is to allow the establishment of wholly foreign-owned hospitals in Beijing, Tianjin, Shanghai, Nanjing, Suzhou, Fuzhou, Guangzhou, Shenzhen, and the entire island of Hainan (excluding traditional Chinese medicine, excluding mergers and acquisitions of public hospitals). The specific conditions, requirements, and procedures for establishing a wholly foreign-owned hospital will be notified separately.

The notice requires that the competent departments in charge of commerce, health, human genetic resources, and medical supervision and management in pilot areas must be divided according to their respective responsibilities. They must increase policy promotion efforts, proactively connect with willing foreign-invested enterprises, and strengthen services. At the same time, they must strengthen interdepartmental consultations and implement supervision and management of pilot enterprises within their respective responsibilities in accordance with the law. They must identify and prevent risks in a timely manner and promote the pilot work of expanding the opening up of biotechnology and wholly-owned hospitals. They must ensure the effectiveness of the pilot work.