On June 10, 2021, the Law on Hainan Free Trade Port went to effect. The law confirms the reduced negative lists of foreign investment, tax advantages in the corporate income tax and the individual income tax, and the facilitation of cross-border capital flows in the Hainan Free Trade Port (“FTP”).
In the series of reforms in the FTP, the fields of foreign-related health care and medical devices has attracted attention.
I The Boao Lecheng International Medical Tourism Pilot Zone, Hainan (the “Pilot Zone”)
According to The Implementation Plan for Supporting the Construction of the Boao Lecheng International Medical Tourism Pilot Zone, issued in September 2019, and the Regulations on the Boao Lecheng International Medical Tourism Pilot Zone, issued in June 2020, the main policies about foreign-related health care and medical devices are as follows:
1. Encouraging foreign investors to set up medical institutions in the Pilot Zone, and lower restrictions on the ratio of foreign capitals.
2. Supporting the introduction of advanced international health management institutions, medical tourism and health centers, independent medical testing institutions and some other medical institutions in the Pilot Zone.
3. Supporting the establishment of medical colleges and universities in the Pilot Zone with well-known foreign medical colleges and encouraging famous scientific research institutes, medical colleges, laboratories, and enterprises worldwide to set up branches in the Pilot Zone.
4. Supporting the introduction of international academic exchange platforms and encouraging the holding of international conferences and exhibitions in the medical and health fields in the Pilot Zone.
5. Medical institutions in the Pilot Zone are entitled to carry out technical research and translational applications in stem cells, immune cell therapies, monoclonal antibodies, gene therapies, tissue engineering and other new technologies in the Pilot Zone.
6. Imported medicines (excluding vaccines) and medical devices in urgent clinical needs can be stored in the warehouses in the Pilot Zone before being approved and can be cleared through customs progressively to ensure that they can be used immediately in the Pilot Zone after approval.
7. Patients are allowed to take qualified imported medicines out of the Pilot Zone for use after filing.
8. Expanding the scope of imported healthy food and health care equipment and allowing to use imported special medical food approved abroad but not in China, after filing.
9. Foreign medical staff, patients and accompanying personnel can enjoy convenient policies and measures in departure and arrival, stay and residence in the Pilot Zone.
10. Encouraging the commercial health insurance and cross-border commercial health insurance and establishing commercial health insurance services in line with global commercial insurance and payment systems.
11. Research on the applications of clinical Real-World Data (“RWD”) in the Pilot Zone, using RWD in the approval process of medicines and medical devices in order to accelerate the process to market.
II Breakthroughs in the application of the RWD
In September 2019, according to two implementation plans (the Implementation Plan for Supporting the Construction of Boao Lecheng International Medical Tourism Pilot Zone and the Implementation Plan for the Pilot Work of Clinical Real-world Data Application in Boao Lecheng International Medical Tourism Pilot Zone ), it was decided to conduct the RWD research on urgent clinical needed imported medical devices in the Pilot Zone.
On January 3, 2020, the National Medical Products Administration (NMPA) issued the Trail Guidelines for Real World Evidence Supporting Drug Development and Review, which standardizes the Real-World Evidence’s definition (“RWE”), the drug regulatory decisions, and the communication with evaluation institutions.
On August 27, 2020, the National Center for Drug Evaluation (CDE) issued the Trail Guidelines for Real World Research in Support of Children's Medicine Development and Review, which focuses on the current Real-World Study (“RWS”) to support the development of children's medicine research in China and the application of all categories of children's medicines, including chemicals, traditional Chinese medicines and biological products.
On September 1, 2020, according to the Systematic Integrative Innovation Reform Program of Boao Lecheng International Medical Tourism Pilot Zone in Hainan Free Trade Port, RWD on medical devices that have not been approved in China but have been registered to be used in the Pilot Zone can be converted into RWE for approval in China. This RWD application could shorten the time for foreign innovative medical devices to enter the Chinese market and reduce registration and approval costs.
On November 24, 2020, the NMPA issued the Trail Technical Guiding Principle for The Application of Real-World Data in Clinical Evaluation on Medical devices, which standardizes and guides the application of RWD in clinical evaluations of medical devices. RWD includes, but is not limited to, hospital medical records, regional health care data, health insurance data, health records, public monitoring data, patient self-reporting data, data generated by mobile devices, etc., as well as data generated by medical devices during the whole process of production, distribution, transportation, storage, installation, use, maintenance, cancellation and disposal. As all medical devices cannot be marketed simultaneously globally, applicants may locally collect RWD and use RWE obtained from in the countries or regions where medical devices have been approved in order to accelerate the approval process in China, which could avoid the re-opening of clinical trials in China.
As an example, on March 26, 2020, Allergan's XEN® Glaucoma Treatment System has been approved by NMPA for the Chinese market on the basis of the RWD collected in the Pilot Zone, which becomes the first medical device quickly and successfully approved in China by using RWE.