Implementation Plan for Supporting the Development of Boao Lecheng International Medical Tourism Pilot Zone Released by Four Ministries

VCBeat (WeChat ID: vcbeat) has learned that on September 16, the National Development and Reform Commission (NDRC) and three other ministries jointly issued the “Implementation Plan for Supporting the Construction of the Boao Lecheng International Medical Tourism Pilot Zone.” The plan states that by 2025, the pilot zone will achieve breakthrough progress in establishing specialized clinical medical centers with advanced technologies and bases for the research, development, and translation of cutting-edge medical technologies, thereby realizing “triple synchronization” of medical technologies, equipment, and pharmaceuticals with international advanced standards. By 2030, medical services and scientific research in the zone will reach a leading position domestically and an advanced level internationally, fully forming industrial agglomeration and brand effects, and establishing itself as a world-class international medical tourism destination and a platform for medical technology innovation. Its key tasks are as follows:

1. Support the introduction of well-known domestic public healthcare resources. Authorize 3–5 public hospitals affiliated with or under the administration of the National Health Commission and the National Administration of Traditional Chinese Medicine to explore providing their brands, trademarks, technologies, management expertise, and other assets to medical institutions within the Pilot Zone through franchising arrangements;Prices for healthcare and telemedicine services are subject to market-adjusted pricing and administered under a filing system.. All franchise revenue obtained by authorized public hospitals shall be entirely used for their own construction and development; the compensation, bonuses, and other benefits of dispatched professional and technical personnel are not included in the franchise revenue and shall be separately agreed upon with the franchisee.

2. Introduce and cultivate medical institutions with internationally advanced standards. Precisely align with renowned international medical institutions and healthcare teams to introduce and develop a cohort of medical facilities characterized by cutting-edge technical expertise and strong market appeal. Support the establishment of several high-end health management institutions and medical tourism and wellness centers.Actively introduce and cultivate third-party medical testing institutions with international standards. Guide overseas pharmaceutical companies to establish after-sales service centers in the pilot zone.

3. Establish a national-level base for exchange in medical education and scientific research. Promote the joint establishment of medical schools by the Pilot Zone and world-renowned medical colleges. Encourage and support key domestic and international research institutes, medical colleges, national key laboratories, and well-known enterprises to set up branches in the Pilot Zone. Relying on public platforms, support the establishment of advanced clinical medicine research centers jointly built by provincial and ministerial authorities. Support the construction of key laboratories in the Pilot Zone, and establish academician workstations (led by heads of national key disciplines and key specialties) and postdoctoral workstations.Conduct Research on the Application of Real-World Clinical Data. Medical institutions within the pilot zone that have obtained relevant international certifications and meet national requirements shall be designated as National Standardized Residency Training Bases.

Support the establishment of clinical trial institutions by top-tier medical institutions in China,Conduct Clinical Trials in Compliance with Laws, Regulations, and Ethical StandardsMulti-center clinical trials conducted by medical institutions, R&D institutions, and other entities stationed in the Pilot Zone as lead units may be regarded as provincial- or ministerial-level research projects. Introduce and cultivate international academic exchange platforms and global healthcare organizations, and host the annual Boao Health Forum. Support the Pilot Zone in hosting international exhibitions for pharmaceuticals and medical devices.

4. Establish national pilot demonstration bases for the transfer and commercialization of pharmaceutical achievements. Explore the implementation ofPilot Program for the Transfer and Commercialization of Achievements from the National Science and Technology Major Project on New Drug Creation, Encouraging the Construction of Industrial Production Bases in Pilot ZonesEncourage and support enterprises in the pilot zone to apply for special projects on new drug innovation and other national science and technology programs, and establish sub-funds in cooperation with the National Guiding Fund for the Transformation of Scientific and Technological Achievements.Implement the Marketing Authorization Holder (MAH) System for Drugs and Medical Devices. Establish a service platform and trading center for the transfer and commercialization of pharmaceutical technological achievements, and host high-level forums and achievement exchange fairs related to science and technology, industry, and capital in new drug development. Cash rewards received by researchers for the commercialization of job-related scientific and technological achievements shall be included in the total amount of the entity’s performance-based salary for the current year, but shall not be subject to the overall cap nor included in the base for calculating such cap.

1. Accelerate the improvement of medical service standards.Accelerate the Import Approval of Drugs and Medical Devices in the Pilot ZoneClinical use data that meet the requirements for a small quantity of urgently needed imported drugs and medical devices within the pilot zone may be used for registration applications for imported drugs and medical devices. Support is provided for carrying out research projects on cutting-edge clinical medical technologies, such as stem cells, to obtain safety data that meet the requirements for further conducting clinical trials or registration applications. The translation and application of research projects on cutting-edge clinical medical technologies, such as stem cells, shall be conducted in accordance with the requirements of the Administrative Measures for the Clinical Application of Medical Technologies.

Implement filing-based management for the contract manufacturing of traditional Chinese medicine (TCM) preparations by medical institutions and for TCM preparations manufactured using traditional techniques. Permit the inter-institutional allocation and use of in-house hospital preparations among domestic medical institutions within the Pilot Zone, provided that they comply with national regulations.Support the establishment of specialized health and pension insurance institutions, and remove foreign equity caps on health insurance and life insurance companies.. Establish a national sub-center for the review and evaluation of imported drugs and medical devices in the Pilot Zone. Expand the scope of application of the pilot policy for the limited import of clinically urgent drugs and medical devices to eligible medical institutions within the Pilot Zone.

2. Actively promote the integrated development of healthcare and tourism. Fully leverage the brand effect of the Pilot Zone, its favorable ecological environment, and the abundant tourism resources in the surrounding areas,Vigorously develop high-end medical check-ups, health management, medical services, traditional Chinese medicine (TCM) wellness and healthcare, and specialized convalescent care products and services.Actively introduce a group of leading medical tourism institutions, strengthen the development of health and wellness products, and design specialized tourism itineraries. Develop third-party professional medical intermediary service agencies, build specialized medical tourism triage platforms, and intensify promotional efforts for high-end diagnostic and treatment services. Leverage tourism resources in surrounding towns and villages to develop extended medical tourism projects, such as integrated medical and elderly care, leisure and wellness, and healthy agriculture.

1. Facilitate medical diagnosis and treatment for patients both within and outside China. Research and introduce policies and measures to streamline entry, stay, and residence procedures for foreign medical personnel, patients, and their accompanying individuals seeking medical care in the Pilot Zone. Based on patient registration and commitment, allow patients of medical institutions in the Pilot Zone to take imported drugs in reasonable quantities for personal use out of the Pilot Zone under specified conditions.

In accordance with the principle of “limited quantities for personal use,” promptly formulate administrative measures for the removal and use of imported drugs within the Pilot Zone. Expand the scope of imported health foods and healthcare-related medical devices from abroad, and conditionally permit the importation and use within the Pilot Zone of special medical purpose foods that are marketed overseas but not yet launched in China. Encourage commercial insurance institutions to develop health insurance products tailored to diverse needs and streamline claims procedures. Adjust and optimize the airspace structure in the Boao area, and guide an increase in the number of flight operations at Boao Airport. Promote the establishment of an aviation port at Boao Airport at an appropriate time.

2. Improve policies for talent development. Establish high-end specially appointed positions in eligible hospitals and research institutions within the pilot zone, implementing tenure-based management and negotiated salary systems. Develop a recruitment system for high-level talent that aligns with international standards.Delegate the authority for reviewing senior professional titles in the health sector to the Pilot Zone, and implement a pilot socialized evaluation mechanism.. Allow professionals in healthcare and tourism from state-owned enterprises and public institutions to take on part-time jobs and receive additional compensation in the Pilot Zone in accordance with regulations.

3. Enhance service management efficiency. Deepen the “streamlined approval” reform, implement “one-stop” services, and ensure that applicants need to visit no more than once. The Hainan Provincial Health Commission, the Market Supervision Administration, and other relevant departments shall establish branch offices in the Pilot Zone to fully represent their respective provincial-level authorities in fulfilling service and regulatory responsibilities. Establish the National Medical Tourism Research Institute in accordance with prescribed procedures to provide intellectual support for the Pilot Zone.

1. Improve the access and exit mechanisms for medical services. Establish an evaluation and review system for medical projects entering the Pilot Zone, strictly control market entry, and strengthen the assessment of medical technologies associated with these projects. Enhance the ethical review framework by establishing a Medical Ethics Committee in the Pilot Zone, support the improvement of ethical review capabilities for Traditional Chinese Medicine (TCM), and strengthen ethical oversight of clinical research and applications. Strictly enforce licensing and acceptance inspections for the practice registration of healthcare institutions. Strengthen regulatory oversight of business collaborations among healthcare institutions, and establish a filing and management system for external collaborations involving medical institutions in the Pilot Zone.

The establishment of Sino-foreign joint venture and cooperative medical institutions shall strictly comply with relevant national regulations. The "Administrative Measures for Project Exit in the Pilot Zone" shall be rigorously implemented, and a mandatory exit mechanism shall be enforced against projects that fail to fulfill the framework agreements for park entry, investment agreements, and letters of commitment, or that engage in illegal or non-compliant activities.

2. Innovate the comprehensive regulatory model. Actively explore regulatory approaches suited to the development of new medical technologies, new products, new business formats, and new models.Build a world-class domestic platform for traceability management of licensed drugs and medical devices, covering the entire process of importation, approval, usage, and regulation., achieving networked data sharing among drug regulatory authorities, customs, and all hospitals within the Pilot Zone. A regulatory model of “bonded warehousing first, quarantine inspection later” is implemented for low-risk special items, such as monoclonal antibodies, introduced into the Pilot Zone.

3. Strengthen the implementation of responsibilities and regulatory accountability. Hainan Province shall accelerate the formulation and gradual improvement of relevant standards, operational procedures, and administrative measures for medical care and pharmaceuticals in the Pilot Zone. Measures for interim and ex-post supervision shall be issued to strengthen the accountability mechanism, with strict accountability and disciplinary actions taken against those who violate regulations or discipline, or neglect or abuse their duties. Medical and health institutions established in the Pilot Zone shall bear primary responsibility for lawful practice, standardized service delivery, service quality, and safety within their own institutions and among their external partner organizations.

Strengthen oversight of the professional conduct of personnel in medical and health institutions, strictly investigate and punish illegal, non-compliant, and unethical practices, and pursue criminal liability in accordance with the law for acts constituting crimes. Establish and improve credit records for medical and health institutions and their personnel, and encourage industry associations to conduct evaluations of medical quality, service capacity, and other relevant metrics.

4. Strengthen risk assessment and tracking warnings.Establish and improve mechanisms for the prevention and handling of medical disputes.Publicly disclose service prices and other information in accordance with the law. Establish and improve emergency response mechanisms, strengthen medical regulatory capacity within the zone, intensify routine inspections, promptly identify and properly address potential risks and hazards, and ensure the safe operation of the park. Strengthen full-process supervision of pharmaceuticals and vaccines, implement the strictest vaccine regulatory system, impose severe penalties on violators without leniency, and seriously investigate and handle cases of negligence and dereliction of duty. Enhance publicity and education on relevant laws, regulations, and policies to continuously raise the awareness of legal compliance among enterprises in the park. Properly guide public opinion and respond timely and effectively to societal concerns.

Image and source: National Development and Reform Commission

[Infographic] Implementation Plan for Supporting the Development of the Boao Lecheng International Medical Tourism Pilot Zone