New breakthrough of cross-border policy in the process of internationalization of China's biomedical industry

The free flow of cross-border resources in biomedical industry plays an important supporting role in promoting the internationalization of biomedical industry China has also carried out a series of pilot projects in some regions to ensure the cross-border flow of innovative resources on the basis of controllable risks This paper focuses on three aspects: innovation essentials, medical resources and product import 1、 The facilitation policy of cross-border flow of innovation elements breaks through the cross-border flow of innovation elements in biomedical field, which is mainly manifested in four aspects: employment and Entrepreneurship of foreign talents, overseas capital investment, import of R & D materials and international R & D cooperation 1 Overseas high-end talents in biomedical field in employment and Entrepreneurship of foreign talents play an important supporting role in promoting innovation and entrepreneurship and introducing foreign advanced technology However, at present, there are still many obstacles in obtaining visas and limiting the practice of foreign natural persons, and many places have also made beneficial explorations on the convenience of cross-border free flow of foreign talents For example, Hainan has carried out the pilot project of international talent management reform, allowing foreign and Hong Kong, Macao and Taiwan technical and technical personnel to obtain employment and permanent residence in Hainan in accordance with the regulations, and allowing excellent foreign students who have obtained master's degree or above in Chinese universities to obtain employment and Entrepreneurship in Hainan The policy innovation focus of cross-border talent flow can be broken through in three aspects as a whole: (1) strive for national support and explore entrepreneurial visas and residence permits in the field of biomedicine (2) We will support foreign high-level talents with permanent residence permits to set up science and technology-based enterprises and give them the same treatment as Chinese citizens (3) Foreign experts are allowed to apply for work permit extension when they are over retirement age 2 In terms of overseas capital investment, in order to attract overseas capital with experience in early biomedical project operation and support the development of innovative and entrepreneurial biotechnology companies, we can strive for the pilot policy of biomedical financial capital opening, and allow enterprises with cross-border investment and financing and trade settlement needs to open free trade accounts At the same time, we should solve the problems caused by the strict restrictions on capital and financial project transactions in the current free trade account, appropriately relax the control on enterprises and non-bank institutions' overseas loans and overseas issuance of bonds through the free trade account, adopt the management demand consistent with the international market loans to overseas loans through the free trade account, and reduce the financing cost of enterprises The investment risk of biomedical science and technology innovation project is reduced in the medium term (development and maturity period) and the later stage (investment exit and follow-up investment period) At this time, the demand for cross-border financial services is more shifted to the demand for daily operation and scale expansion, which requires the import and export of technology trade and related financial services such as financing, settlement and exchange, merger and acquisition, centralized financial management and transnational operation (follow-up investment) Follow-up 3 At the level of R & D materials import, there are many kinds of biomedical R & D imported products A laboratory needs more than 4500 kinds of R & D materials every year, 85% of which need to be imported In particular, special items with Class A and class B risks and animal and plant-derived biomaterials with class I and II risks need more complex risk assessment business, and many regions in China still have strict control over the import of high-risk R & D materials, and lack of fast customs clearance service platform At present, relevant platforms have been built in Beijing, Shanghai, Guangzhou and other places to carry out policy innovation in promoting the import of fetal bovine serum, shortening the isolation period of SPF mice, rapid customs clearance of clinical samples for 22 hours, etc., solving the problems of difficult import and slow import of research and development materials, which plays an important supporting role in ensuring the synchronization of research and development of biological medicine in China with that in the world Although many colleges and universities in China can enjoy the tax-free policy of imported biological reagents, due to the extremely complex process and procedures for tax exemption and reduction, which takes a long time, many colleges and universities will give up the application for tax-free policy In the future, it is necessary to innovate the tax-free service process of account management, simplify the tax-free process and related procedures, and promote the implementation of the bonded R & D policy 4 At present, in the aspect of R & D cooperation, the domestic biomedical R & D entities must conduct complicated pre-approval when they cooperate in R & D, which hinders the international exchange of biomedical innovation We can strive for national policy support, select enterprises for pilot, change pre-approval to post supervision, and classify scientific research activities aimed at new drug research and development into application development, which can be started after filing 2、 In terms of medical resource cross-border cooperation policy breakthroughs 1 In view of the current high standard trade rules, which have higher requirements on the flow of natural persons, doctors can apply for national authorization, optimize the approval procedures of foreign doctors' medical registration, and simplify the approval materials At present, Guangdong, Hong Kong and Macao Bay area is exploring qualified Hong Kong, Macao and foreign medical personnel to directly practice research in Hengqin, and transfer the authority of issuing residence permit to Hengqin Hainan Boao Lecheng International Medical Tourism pilot area has obtained the support of the state's pilot policy in the practice of overseas doctors, that is, to enjoy the practice time of overseas doctors in the pilot area to be relaxed to three years The people's Government of Hainan Province may formulate and implement relevant measures for overseas medical technology and medical personnel to practice in the pilot area in combination with the actual situation of the pilot area itself, and report to the Ministry of health for the record The pilot areas are encouraged to pilot the access of TCM Prevention and health care institutions and personnel, service standards, and service project access and fees 2 The open medical service industry can refer to the similar policies of Hainan International Medical pioneer zone, apply for the decentralization of the approval authority for the introduction of foreign medical devices, and break through the provisions of the drug administration law, so as to realize the "simultaneous use of Chinese and foreign drugs" in the region We will strive to relax the access of medical institutions, remove the restrictions on joint ventures and cooperation, simplify the approval procedures for foreign investment and joint ventures, shorten the approval period, and make the approval conditions and procedures more transparent and predictable For example, the Hainan Boao Lecheng International Medical Tourism pilot area has obtained the policy support of the opening of national medical services, that is, to allow overseas capital to establish medical institutions in the pilot area, to gradually remove the restrictions on the equity ratio of overseas capital of joint-venture or cooperative medical institutions, and to gradually release the foreign capital to establish wholly-owned medical institutions in the pilot area 3 In recent years, the facilitation of cross-border delivery of telemedicine has shown a good growth trend The global average annual growth rate is about 17% In particular, in 2018, the state continuously issued the first implementation rules in the field of Internet diagnosis and treatment, Internet hospitals, and telemedicine services China's Cross-border telemedicine will usher in greater development opportunities However, due to China's strict restrictions on cross-border data flow, the development of cross-border telemedicine is facing greater repression Therefore, for places with large demand, they can apply for cross-border telemedicine pilot projects First, they can build a special channel for international Internet data to the international communication entrance and exit, and take telemedicine as a breakthrough to improve the access speed, stability and convenience of the website; second, they can try to formulate relevant international transaction rules first 4 In terms of blood samples for gene testing, since 2017, Beijing has innovated the import supervision mode of blood samples for gene testing, tried first, simplified customs clearance procedures on the premise of ensuring national biological safety, and improved the speed of customs clearance of blood samples imported by domestic gene testing enterprises The plan of Guangdong, Hong Kong and Macao Bay Area released in 2019 also clearly points out to promote the cross-border use of blood and other biological samples in universities, scientific research institutions and laboratories within the bay area to optimize management and promote the development of clinical medical research 5 Cross border sharing of medical data can improve medical research Guangdong, Hong Kong and Macao Dawan district is actively promoting the use of cross-border medical data in the limited units in Dawan district 3、 Policy breakthroughs in the import of biomedical products In March 2019, Shanghai issued the implementation plan of "several measures to support the deepening reform and innovation of free trade pilot zone" to expand the function of Zhangjiang cross border science and technology innovation supervision service center, establish a fast review channel for stem cell products, and carry out clinical research on foreign listed stem cell products after quick review and approval 2 New drug import The international medical tourism pioneer zone of Boao Lecheng in Hainan has achieved policy breakthrough For the drug import registration applications approved by foreign countries according to law and not approved by China's registration, special approval can be applied according to the requirements of the regulations on the administration of special approval of new drug registration For the applications of medical institutions in the pioneer zone that need to import a small amount of drugs (excluding vaccines) urgently due to clinical needs, the people's Government of Hainan Province shall For examination and approval, the authority shall be delegated from the State Council to the provincial level Shanghai has formed a pilot work plan for designated medical institutions to use foreign listed new anti-tumor drugs first, which is currently being submitted to the State Council for approval The clinical data generated by the use of licensed imported drugs by medical institutions in specific regions can be an important basis for the registration and listing of imported drugs in China 4、 Summary: the free flow of cross-border resources of biomedical industry plays an important supporting role in promoting the internationalization of biomedical industry On the basis of controllable risks, China has carried out a series of pilot projects in some places The cross-border policy breakthroughs mainly include innovation elements, medical resources and product imports, including: (1) Promote the employment and Entrepreneurship of foreign talents, attract overseas capital investment, encourage the import of R & D materials and R & D cooperation; (2) optimize the registration and approval procedures of foreign doctors, open the medical service industry, optimize the cross-border delivery process of telemedicine, innovate the regulatory model of blood sample import for genetic testing and promote the cross-border sharing of medical data; (3) optimize the import review process of new scientific and technological products And promoting the import of new drugs China's breakthrough in cross-border policies in the field of biomedicine ensures the cross-border flow of innovative resources to a certain extent, and helps to accelerate the internationalization of biomedical industry.