Located in Boao Town, Qionghai City, Hainan Province and close to the core area of the Boao Forum for Asia, Boao Lecheng International Medical Tourism Pilot Zone of Hainan Free Trade Port (hereinafter referred to as “Lecheng Pilot Zone”) is the only “special medical zone” in China. On February 28, 2013, the State Council approved the establishment of the Lecheng Pilot Zone, and endowed it with nine unique supporting policies, which can be summarized as “four special licenses”, namely licensed medical care, licensed studies, licensed operations and licensed international exchanges. Later, with the approval of the State Council, the national departments such as National Development and Reform Commission, the Ministry of Commerce, the National Medical Products Administration have successively granted Lecheng with a series of special preferential policies.
The Lecheng Pilot Zone has always been practicing the original aspiration of “serving the people’s health”, keeping in mind the three missions of “letting Chinese people access and use the world’s most advanced medical products sooner, promoting the development of China’s health industry, and boosting the reform of China’s medical and health services”. Guided by comprehensively deepening reform and opening up, it puts institutional integration and innovation at a prominent position. From policy breakthroughs, to industrial construction and then to innovation orientation, the Lecheng Pilot Zone has created several “first” or “only” things in the country or the province, and achieved a breakthrough from zero to one among the key parks of Hainan Free Trade Port. It has taken initiative in China to establish the first Medical Care and Drugs Administration to pilot the regulatory reform of “medical care and drugs”. It has established the only complete-process traceability platform for medical products still not marketed in China to realize the real-time tracking and management of licensed medical products throughout the process. It has established the only bonded warehouse of licensed medical products in China, which has greatly improved the import efficiency of licensed medical products. It has built the only permanent exhibition hall for global innovative medical products in China, the “Ever Lasting International Innovation Medicine Exhibition”, which has attracted 80 international medical product manufacturers from 16 countries. It has released the only “global licensed drug insurance” in China to promote the construction of an industrial ecosystem covering “medical care, insurance and drugs”. It has released the first institutional integration and innovation plan of Hainan Free Trade Port and the first specific regulations of Hainan FTP, “Regulations of Boao Lecheng International Medical Tourism Pilot Zone”, to promote the high-level reform and opening up of the Lecheng Pilot Zone through legislation and unleash the policy dividend of Hainan FTP.
Up to now, 17 medical institutions have opened for business in Lecheng, and more than 20 ones are under construction. The international influence of the Lecheng Pilot Zone continues to increase, attracting attention from major multinational pharmaceutical enterprises, internationally renowned medical institutions, medical parks and international talents, and developing into a hot land for global innovation and entrepreneurship at a faster pace.
Nearly 4/5 out of the world’s top 30 pharmaceutical companies have established direct cooperation with the Lecheng Pilot Zone. More than 200 kinds of innovative medical products still not marketed in China have been introduced into the Lecheng Pilot Zone, which has basically been “in sync” with the world’s advanced level in three aspects, namely medical technology, devices and drugs, and ushered in a new landscape of high-quality development. It has laid a solid foundation for the construction of a new highland for the opening up of medical care and an important window for domestic and international double circulation, promoted the Free Trade Port to make early harvest in medical care and better satisfy the people’s growing demands for medical and health services.
Real-world study is an important part of the National Medical Products Regulatory Science Action Plan, and one of the major institutional innovations of Hainan Free Trade Port. The Lecheng Pilot Zone has taken the lead to pilot the real-world data application in China and provide a “green channel” for international innovative medical products to enter the Chinese market at a faster pace, which has far-reaching significance on the registration and regulation reform of medical products. The Hainan Institute of Real World Data has been established to undertake the related work of the NMPA Drug and Medical Device Regulatory Science Research Base. It has also established the first key laboratory of real-world study in China, NMPA Key Laboratory for Real-World Data Research and Evaluation in Hainan. Based on the actual conditions of Lecheng, it has built the first regional real-world data collection, governance and application platform in China. This platform has four major characteristics, namely mechanism innovation, technological innovation, regulatory innovation and service innovation. It is an important practice and exploration for China to establish new standards, methods and tools for real-world study. As an emerging interdisciplinary field, real-world study involves such disciplines as clinical care, biostatistics, and information data. In order to strengthen talent cultivation, the Lecheng Pilot Zone and Hainan University co-established the first postgraduate program aimed to cultivate “real-world data application” masters and doctors, the only master and doctoral degree program related to real-world study, in an effort to build a high-end talent cultivation base in the field of real-world study in China.
According to the relevant guiding principles of the NMPA and based on the actual conditions of real-world study in the Lecheng Pilot Zone, Lecheng has built the first regional real-world data collection, governance and application platform in China. This platform has four major characteristics, namely mechanism innovation, technological innovation, regulatory innovation and service innovation. It is an important practice and exploration for China to establish new standards, methods and tools for real-world study, which is of great significance for enabling China to deepen the reform of medical products review and approval system.
Since the launch of the real-world data application pilot program in the Lecheng Pilot Zone, three medical products, namely XEN Glaucoma Treatment System, CATALYS precision laser system and Pralsetinib Capsule, have been registered and approved by the NMPA with the clinical evaluation assisted by the real-world data of Lecheng, which have been marketed in China at a faster speed. With the aid of real-world data of Lecheng, the application of three medical products for registration has been accepted by the NMPA, which include YUTIQTM, artificial cochlea implant and thermal ablation system. The pilot program of real-world data application in Lecheng has laid a solid practical foundation for the NMPA to apply real-world data in the regulatory decision-making for clinical evaluation of medical products and the formulation of laws and regulations such as related guiding principles, which has contributed the wisdom of Lecheng and strength of Hainan to the reform of Chinese medical products review and approval system, accelerating the registration and approval of foreign innovative medical products in China and benefiting more Chinese patients.
In the Lecheng Pilot Zone under construction in Hainan Free Trade Port, the reform and innovation will never stop. By 2025, the Lecheng Pilot Zone will make breakthroughs in building an advanced clinical center with characteristic technology and a cutting-edge medical technology R&D base, and “synchronize” with the international advanced level in terms of medical technology, devices, and drugs. By 2030, medical services and scientific research in Lecheng will take the lead in China and reach the international advanced level, fully realize an industrial agglomeration and brand effect, and be built into a world-class international medical tourism destination and medical technology innovation platform.
