The Standing Committee of the Provincial People's Congress issued the Regulations on the Hainan Free Trade Port Boao Lecheng International Medical Tourism Pilot Zone.

Chapter I General Provisions

Article 1 These Regulations are formulated in accordance with relevant laws and administrative regulations and in light of the actual situation of the province in order to promote the development of the Boao Lecheng International Medical Tourism Pilot Zone of Hainan Free Trade Port (hereinafter referred to as the Pilot Zone).

Article 2 The Pilot Zone shall, in accordance with the relevant requirements of the construction of the Hainan Free Trade Port, benchmark the highest international standards, innovate systems and mechanisms, and take the lead in piloting in industrial policies, investment promotion, medical innovation, tourism services, cross-border trade in services, etc., promote the development of international medical tourism and high-end medical services with high-level opening, and build a world-class international medical tourism destination and medical technology innovation platform.

Article 3 The Provincial People's Government shall strengthen the organizational leadership of the construction of the Pilot Zone, decide on major issues in the construction of the Pilot Zone, and establish an assessment and evaluation mechanism.

The Provincial People's Government Leading Organization for the Construction of the Pilot Zone shall be responsible for the guidance, supervision, promotion and coordination of the construction of the Pilot Zone, and study major issues in the construction of the Pilot Zone.

The relevant departments of the Provincial People's Government shall be responsible for the specific guidance, coordination and service work of the construction of the Pilot Zone in accordance with the division of responsibilities.

Article 4 A management agency shall be established in the Pilot Zone. The management agency is a statutory agency that performs corresponding administrative management and public service duties in the pilot zone. It is specifically responsible for the comprehensive coordination, development and construction, operation management, industrial development, investment promotion, system innovation, enterprise services and other work of the pilot zone, and exercises corresponding administrative approval and administrative punishment powers in accordance with authorization or entrustment.

The management agency of the pilot zone shall, in accordance with the principle of streamlining and efficiency, independently decide on the establishment of institutions, positions, personnel recruitment, salary standards, etc. within the total salary range, except for personnel appointed in accordance with relevant regulations.

Senior management personnel and other staff of the management agency of the pilot zone may be selected and hired from abroad.

Article 5 The management agency of the pilot zone may establish a development and operation company in accordance with the law, entrust the development and operation company to be responsible for the construction and operation of industrial investment, infrastructure and public service facilities in the pilot zone, and participate in the organization and implementation of park management services.

Article 6 The People's Government of Qionghai City and its relevant departments shall be responsible for exercising the social management functions of the pilot zone, and the specific scope shall be stipulated by the Provincial People's Government.

The People's Government of Qionghai City and its relevant departments shall support the development of the pilot zone in terms of planning, investment promotion, infrastructure construction, system innovation, policy implementation, etc.

Article 7 The provincial and Qionghai Municipal People's Governments and their relevant departments shall delegate or entrust the relevant management powers to the pilot zone management agency in accordance with the law.

For management powers that are not suitable for delegation or entrustment, the relevant departments of the provincial and Qionghai Municipal People's Governments may set up resident agencies in the pilot zone in accordance with regulations.

The relevant departments of the provincial people's government, the pilot zone management agency, and the resident agencies shall clarify the management powers in the pilot zone, compile a list of powers and a list of responsibilities in accordance with the law, and announce them to the public after approval.

Chapter II Development and Construction

Article 8 The pilot zone management agency is responsible for organizing the preparation of the pilot zone control detailed plan and industrial development plan, etc., and implement them after approval.

The relevant plans of the surrounding areas of the pilot zone shall be linked with the pilot zone control detailed plan and industrial development plan.

Article 9 The pilot zone shall strictly implement the ecological environment protection system and the ecological protection red line management system, strictly implement resource conservation and utilization and environmental access thresholds, improve the ecological environment protection infrastructure and measures, and adhere to green, low-carbon and circular development.

Article 10 The pilot zone shall strengthen the overall planning and synchronous construction of infrastructure such as road networks, power grids, optical networks, gas networks, water networks, production and living supporting services, and promote the integrated development of industry and city.

The People's Government of Qionghai City and the management agency of the pilot zone shall establish a development and construction coordination mechanism to coordinate the construction and management of infrastructure, public service facilities and other supporting facilities in the pilot zone and surrounding areas, and promote regional integrated layout and linkage development.

Article 11 The provincial people's government shall provide financial support to the pilot zone through various means such as bond funds, special funds, and subsidies.

Article 12 The land use in the pilot zone shall comply with the detailed control plan and industrial development needs of the pilot zone, implement a strict land conservation and intensive use system, and improve the efficiency of land use.

Article 13 The provincial people's government shall coordinate the annual planned indicators of new construction land in the pilot zone, and give priority to the annual planned indicators of new construction land for key industries and key projects.

In the pilot zone, flexible and diverse land supply methods such as allocation, transfer, lease, valuation and capital contribution or equity investment can be adopted. It is allowed to use rural collective business construction land for industrial project construction by means of transfer, lease, capital contribution or equity investment.

Article 14 Industrial buildings, offices, commercial buildings, apartments, parking spaces and other properties that belong to the assets of the management agency of the pilot zone and are built on the land supplied by the pilot zone for a fee shall be used for industrial support, public service facilities, talent housing, etc. in the pilot zone.

Chapter III Industrial Development

Article 15 Support the provision of public hospital brands, trademarks, patents, technologies, services, management, etc. to medical institutions in the pilot zone in the form of franchising, and encourage public hospitals to settle in the pilot zone.

Article 16 Encourage domestic and foreign capital to invest in medical institutions in the pilot zone, and relax restrictions on foreign capital shareholding ratios. Private medical institutions enjoy equal treatment with public hospitals in terms of medical service access, social insurance designated points, professional title evaluation, grade evaluation, scientific research and teaching, and discipline construction.

Support the introduction and cultivation of internationally advanced health management institutions, medical tourism and health centers, third-party medical testing institutions and other medical institutions in the pilot zone.

Article 17 Support the construction of advanced technology clinical medical research centers, clinical trial institutions and key laboratories and other medical research institutions in the pilot zone, and establish medical schools in cooperation with world-renowned medical schools. Encourage key scientific research institutes and medical schools at home and abroad, national key laboratories, and well-known enterprises to set up branches in the pilot zone.

Support the introduction and cultivation of international academic exchange platforms and international medical organizations in the field of medical health in the pilot zone, and encourage the holding of international conferences and exhibitions in the field of medical health.

Article 18 Support the construction of a national pilot demonstration base for the transfer and transformation of medical achievements in the pilot zone, explore the transfer and transformation of major national science and technology projects for major new drug creation, and encourage the construction of industrialized production bases, medical technology achievements transfer and transformation service platforms and trading centers.

Article 19 Medical institutions in the pilot zone can conduct research and transformation applications of new technologies such as stem cells, immune cell therapy, monoclonal antibody drugs, gene therapy, and tissue engineering in the pilot zone.

Article 20 Encourage the application of clinical real-world data in the pilot zone, explore the use of clinical real-world data for drug and medical device product registration, and shorten the time to market.

Article 21 The pilot zone may establish a regional preparation center to undertake or accept commissions to prepare preparations for medical institutions in the pilot zone.

Preparations for medical institutions may be adjusted and used in the pilot zone, and the specific measures shall be formulated by the drug supervision and administration department of the provincial people's government.

The registration management of Chinese medicine preparations entrusted to medical institutions and prepared using traditional techniques shall be implemented.

The drug supervision and administration department of the provincial people's government shall strengthen the management of the registration, preparation, and use of preparations of medical institutions in the pilot zone to ensure the safety and effectiveness of the preparations.

Article 22 The tourism and culture administrative department shall, together with the management agency of the pilot zone and the health and health management department, promote the integrated development of medical care and tourism, rely on the province's tourism resources, guide the development of high-end physical examinations, health management, medical services, traditional Chinese medicine health care, special health care and other medical and health products and services, strengthen the development of medical and health care products and the design of tourism routes, and develop medical and health care, leisure and health care, healthy agriculture and other medical tourism extension projects.

Travel agencies at home and abroad are encouraged to provide professional medical tourism intermediary services for the pilot zone, increase the promotion of medical tourism, and provide full-process medical tourism services.

Article 23 The pilot zone shall promote the inheritance and cultural dissemination of traditional Chinese medicine, promote scientific research and innovation of traditional Chinese medicine, and promote international cooperation and service trade development of traditional Chinese medicine.

Article 24 Urgently needed imported drugs (excluding vaccines) and medical devices to be used in the pilot zone can be stored in batches in the bonded warehouse of the pilot zone before approval, with one entry and multiple customs clearances to ensure immediate pick-up and immediate use after approval.

Patients of medical institutions in the pilot zone are allowed to take qualified imported drugs out of the pilot zone for use in accordance with relevant regulations of the province after filing a commitment.

The pilot zone is allowed to expand the scope of imported health foods and medical devices for health care. Under the conditions of complying with relevant regulations, the pilot zone is allowed to import and use special medical foods that are listed overseas but not listed domestically.

Article 25 Foreign medical personnel, patients and accompanying personnel who go to the pilot zone for diagnosis and treatment shall enjoy the facilitation policies and measures for entry and exit, stay and residence of Hainan Free Trade Port.

Article 26 The Pilot Zone shall establish a cooperation mechanism between insurance financial institutions and medical institutions in the Pilot Zone, encourage the development of diversified, characteristic and personalized commercial health insurance products, simplify claims procedures, and explore the establishment of commercial health insurance services that are connected with the international commercial insurance payment system.

Support insurance financial institutions and overseas institutions to cooperate in the development of cross-border commercial health insurance products in the Pilot Zone.

Article 27 In accordance with the relevant provisions of the Hainan Free Trade Port, the Pilot Zone shall implement a liberalization and facilitation system for cross-border capital flows, relax restrictions on foreign direct investment, cross-border financing, and personal cross-border transactions, and simplify procedures such as foreign exchange registration, foreign debt registration, capital remittances, and foreign exchange settlement and purchase.

Article 28 Enterprises and individuals in the Pilot Zone shall enjoy preferential policies on tariffs, corporate income tax, and personal income tax in accordance with the relevant provisions of the Hainan Free Trade Port tax system.

Article 29 Practicing physicians (including overseas) whose main practice institutions are in the Pilot Zone may directly practice in other medical institutions in the Pilot Zone.

Nurses (including overseas) may practice at multiple locations in the Pilot Zone.

Article 30 The pilot zone shall introduce high-level talents and urgently needed talents from home and abroad, independently identify high-level talents in the pilot zone, and appropriately relax the conditions such as diploma, age, and professional title for urgently needed talents in light of the actual situation.

Relevant management departments shall optimize the talent guarantee mechanism and provide convenience in terms of talent visas, stay and residence, talent immigration, housing, medical care, employment, project and reward application, and education.

The pilot zone shall independently carry out the evaluation of senior professional and technical titles in the health series in accordance with relevant national and provincial regulations.

Professional and technical personnel and management personnel in medical, health, tourism and other fields of state-owned enterprises and institutions may work part-time and receive salary in the pilot zone in accordance with regulations.

Chapter IV Service Management

Article 31 Implement and deepen the reform of extremely simplified approval in the pilot zone, and encourage the management agencies of the pilot zone to explore reform practices and innovate management models in light of actual needs.

The management agencies of the pilot zone shall simplify the approval process, shorten the approval time limit, and improve the efficiency of administrative approval services for approval matters within their authority.

The management agency of the pilot zone shall establish a mechanism to ensure the landing of investment projects, implement a responsibility system for project tracking services throughout the process, provide high-quality and convenient services such as full-process agency and co-organization for major investment projects, and promptly coordinate and solve problems in project approval, construction and production and operation.

Article 32 The health and health management department of the provincial people's government shall, together with the management agency of the pilot zone, formulate standards and implementation measures for the establishment of medical institutions in the pilot zone.

The management agency of the pilot zone shall, together with the health and health management, drug supervision and management and other departments of the provincial people's government, conduct industrial compliance review and medical technology advancement assessment on the settled projects according to their respective responsibilities.

The management agency of the pilot zone shall establish an exit mechanism for bad market entities in the pilot zone to ensure the healthy development of the medical tourism industry.

Article 33 For medical institutions established in the pilot zone, the "Approval for the Establishment of Medical Institutions" will no longer be issued, only the "Medical Institution Practice License" will be issued.

Applications for the establishment of medical institutions in the pilot zone and applications for the deployment of Class A large medical equipment can be approved together.

Article 34 The pilot zone shall improve the medical ethics review system and strengthen the ethical review of clinical research and application.

The provincial people's government health and drug supervision and administration departments stationed in the district shall strengthen the supervision of the medical institutions and practitioners in the pilot zone to comply with medical ethics norms.

Article 35 The provincial people's government intellectual property management department shall, together with the pilot zone management agency and other relevant departments, strengthen the intellectual property protection in the medical and health field of the pilot zone, improve the diversified intellectual property dispute resolution and rights protection assistance mechanism and the foreign-related intellectual property law enforcement cooperation mechanism, and encourage medical institutions to actively apply for international patents and register international trademarks.

Article 36 Medical institutions in the pilot zone shall establish a medical waste management responsibility system and fully implement the responsibility for medical waste management.

The provincial people's government health and drug supervision and administration departments stationed in the district and the Qionghai Municipal People's Government Ecological Environment Management Department shall supervise and manage the medical waste management in the pilot zone in accordance with the division of responsibilities.

Article 37 The provincial people's government health and drug supervision and administration departments stationed in the district shall strengthen the supervision and inspection of drugs and medical devices in the pilot zone, promptly investigate and deal with illegal acts, and ensure the quality and safety of drugs and medical devices.

The pilot zone shall establish a drug and medical device traceability management platform, implement traceability management for the entire process of drug and medical device import, approval, use, and supervision, and realize networking and sharing among health and health management departments, drug supervision and administration departments, customs, and all medical institutions in the pilot zone.

Article 38 The provincial people's government health and health and drug supervision and administration departments stationed in the zone shall implement all-round supervision over the operation of medical institutions in the pilot zone, medical and health practitioners, clinical application of medical technology, order of medical and health service industry, and medical and health industry, to ensure medical quality and medical safety.

The provincial people's government health and health and drug supervision and administration departments stationed in the zone shall strengthen supervision over the business cooperation of medical institutions in the pilot zone, and establish a filing management system for foreign cooperation of medical institutions in the pilot zone.

Article 39 The management agency of the pilot zone shall, together with the relevant departments of the provincial and Qionghai municipal people's governments, establish credit records of medical institutions and practitioners in accordance with relevant national regulations, publish, publicize, and share the credit information of medical institutions and practitioners in a timely manner in accordance with the law, and implement joint incentives for trustworthiness and joint punishment for dishonesty.

Medical industry associations are encouraged to conduct evaluations of medical quality, service capabilities, etc. of medical institutions in the pilot zone.

Article 40 The health and health management, drug supervision and management and other departments of the Provincial People's Government shall, together with the Pilot Zone Management Agency, establish an early warning system mainly for preventing medical risks, improve emergency response plans and handling mechanisms for emergencies, supervise and guide medical institutions to strengthen medical risk management and improve the identification, assessment and prevention and control measures of medical risks, and prevent various risks.

Chapter V Legal Liability

Article 41 If the Pilot Zone Management Agency, the relevant departments of the Provincial and Qionghai Municipal People's Governments and their staff abuse their power, neglect their duties, or engage in favoritism and fraud in the service and management of the Pilot Zone, the directly responsible supervisors and other directly responsible persons shall be punished according to law; if a crime is constituted, they shall be punished according to law.

Criminal liability shall be pursued.

Article 42 The pilot zone shall establish an innovative fault tolerance mechanism. For any of the following circumstances, it may be dealt with leniently, mitigated or exempted from liability in accordance with relevant national and provincial regulations:

Mistakes caused by lack of experience and trial and error in promoting reform and innovation in the pilot zone;

Mistakes in exploratory experiments that have no clear restrictions;

Unintentional negligence in promoting reform and development;

Other circumstances stipulated by laws and regulations for lenient, mitigated or exempted liability.

Chapter VI Supplementary Provisions

Article 43 These Regulations shall come into force on the date of promulgation.