On November 30th, the 39th meeting of the Standing Committee of the Sixth People's Congress of Hainan Province reviewed and approved the "Regulations on the Management of Medical Drugs and Devices in the Boao Lecheng International Medical Tourism Pilot Zone of Hainan Free Trade Port" (hereinafter referred to as the "Regulations"), consisting of 19 articles, which will come into effect on January 1, 2023.
1、 Background and significance
On February 28, 2013, the Boao Lecheng International Medical Tourism Pilot Zone (hereinafter referred to as the Pilot Zone) in Hainan was established with the approval of the State Council. The pilot zone aims to promote the "three synchronization" of medical technology, equipment, and medical equipment with international advanced levels, leveraging the policy advantages of "four concessions" such as licensed medical treatment, licensed research, licensed operation, and licensed international exchange, and striving to create a new highland for international medical tourism opening up to the outside world. In order to further promote the continuous release of the dividends of the "four concessions" policy, the pilot zone innovates the park management system of "statutory institutions+platform companies", implements minimalist approval reform, and pioneered the integrated supervision model of medical drugs and devices in the country. The pilot zone's medical drug regulatory agency is established as an administrative agency jointly dispatched by the Provincial Health Commission and the Provincial Drug Regulatory Bureau to the pilot zone. The multiple institutional integration and innovation measures in the pilot zone have broken the barriers of traditional multi agency approval and supervision, especially the integrated supervision model of medical drugs and devices, which has achieved a new breakthrough in licensed drugs and devices from "patients waiting for drugs" to "patients waiting for drugs", effectively promoting the rapid development of the pilot zone. However, there are also bottlenecks such as unclear regulatory authority and outdated regulatory and service mechanisms, There is an urgent need for targeted institutional design at the legislative level.
The Standing Committee of the Provincial People's Congress conscientiously implements the decisions and deployments of the Provincial Party Committee, adheres to the precise and effective connection between legislation and reform decisions, and takes a "small incision" legislative form based on the actual needs of high-quality development and high-level management services in the pilot area. It focuses on the key and difficult issues of medical drug and device management in the pilot area, promotes the management and service innovation of medical drug and device in the pilot area through the formulation of the "Regulations", and implements an integrated regulatory mechanism for medical drug and device management, Clarify corresponding powers and responsibilities, strengthen management and services in key areas such as licensed pharmaceuticals and equipment, innovate diversified regulatory methods such as classified supervision, intelligent supervision, and credit supervision that combine key supervision with inclusive and prudent supervision, improve management and service levels, and enhance the standardization and binding force of relevant innovative measures.
The formulation of the "Regulations" in accordance with the law is an important measure to deeply implement the spirit of the 20th National Congress of the Communist Party of China and the strategic framework of "one book, three foundations, four beams, and eight pillars" clearly defined at the 8th Provincial Party Congress; It is the only way to improve the regulatory system of Hainan Free Trade Port, optimize the legal, international, and convenient business environment, and prevent and resolve risks; It is a fundamental requirement to accelerate the construction of a higher-level health island, comprehensively promote the deep integration of medical tourism, health management, international exchanges, and comprehensively improve the development level of the pilot zone. The promulgation and implementation of the "Regulations" is conducive to promoting the establishment of a higher level of medical drug and device management model and management standards that are in line with international standards, providing legal protection for the construction of a new development pattern in the pilot area and promoting high-quality development.
2、 Main content
（1） Implement an integrated regulatory mechanism for medical drugs and devices. In order to consolidate the innovative achievements of the integrated supervision system for medical drugs and devices in the pilot area, improve the efficiency of collaborative supervision, and avoid "multiple management", the "Regulations" clarify the legal status, responsibilities, and powers of the medical drug regulatory agencies in the pilot area:
One is to clarify that the medical drug regulatory agency in the pilot area, as a joint administrative agency dispatched by the health and drug supervision and management departments of the provincial people's government, is responsible for the supervision and management of medical drug devices in the pilot area, and authorizes it to exercise corresponding administrative approval, administrative punishment, and administrative compulsory powers.
The second is to clarify the main responsibilities, supervision and inspection measures, and jurisdiction system for illegal cases of the medical and drug regulatory agencies in the pilot area, and to clarify their law enforcement boundaries by compiling a list of powers and responsibilities.
Thirdly, it is stipulated that the health and drug supervision and management departments of the provincial people's government should strengthen the overall planning and business guidance of the supervision and management of medical drugs and devices in the pilot area, and clarify the work responsibilities of the Qionghai Municipal People's Government and its relevant departments, as well as the management agencies and customs of the pilot area.
（2） Strengthen the management and services of key areas such as urgently needed imported drugs and medical devices (i.e. licensed medical devices) in clinical practice. The use of licensed medical equipment and external cooperation with medical institutions are special policies granted by the state to pilot areas. In order to improve the legal practice level of medical drug and device related activities in the pilot area, promote the healthy development of the medical industry in the pilot area, the "Regulations" fill in management gaps, refine management and service measures, and clarify corresponding legal responsibilities:
Firstly, strengthen the supervision and service of the entire process of licensed medical devices, clarify that licensed medical devices should only be used for specific medical purposes in designated medical institutions, and be limited to the approved indications for imported drugs and the applicable scope of imported medical devices; Provide full process data collection, analysis, and supervision for the application, procurement, customs clearance, transportation, warehousing, and use of licensed pharmaceutical equipment; Require designated medical institutions to strengthen the management of physician prescriptions and the use of licensed medical devices, establish and implement systems for the transportation, storage, diagnosis and treatment of licensed medical devices, case tracking and observation, monitoring and reporting of adverse reactions to imported drugs and medical devices, risk management, traceability management, recall and destruction; The pilot area is clearly defined to provide full process services such as import customs, logistics, warehousing, and display for licensed pharmaceutical equipment, and regulations are made for the supervision and related requirements of warehousing services for licensed pharmaceutical equipment.
The second is to strengthen the supervision of foreign cooperation among medical institutions, stipulating that medical institutions conducting medical cooperation should report to the medical drug regulatory agency in the pilot area for filing and make it public to the public, and clarifying the scope of medical cooperation.
（3） Strengthen regulatory innovation. In order to deepen the reform of "delegating powers, regulating powers, and providing services" in the pilot area, strengthen and standardize the supervision of medical drugs and devices during and after the incident, and create a stable, fair, transparent, and predictable business environment, the "Regulations" adhere to the concept of combining delegating powers, optimizing services, further improving regulatory rules, innovating regulatory methods, and strengthening collaborative supervision:
One is to implement classified supervision. Implement key supervision on activities related to high-risk medical drugs and devices that involve significant safety or ethical risks, as well as complex and difficult ones; While strengthening key supervision, in order to leave sufficient development space and create a favorable environment for new technologies, new formats, and new models of medical drug devices, a comprehensive and prudent regulatory mechanism that is compatible with the nature and characteristics of new technologies, new formats, and new models of medical drug devices is clearly established. The administrative law enforcement observation period system is implemented, and situations where administrative penalties may not be imposed or administrative coercive measures may not be implemented are specified.
The second is to implement intelligent supervision. In order to improve the precision and intelligence level of supervision, establish a clear information platform for medical drug and device supervision, conduct full process and intelligent supervision and management of medical drug and device related activities, and clarify the legitimate use of regulatory data. It is stipulated that relevant data reviewed by the medical drug regulatory agency in the pilot area can be used as evidence for implementing administrative penalties and enforcement.
The third is to implement credit supervision. In order to improve the efficiency of credit supervision, it is necessary to establish a clear credit record for medical drugs and devices, conduct credit evaluation, implement graded and classified supervision, and implement trustworthy incentive measures such as giving priority to handling and reducing the proportion of spot checks in accordance with the law, as well as dishonest punishment measures such as not applying the credit commitment system and being listed as a key regulatory object.
The fourth is to implement joint supervision. In order to transform traditional regulatory methods, break down fragmentation, establish and improve cross departmental law enforcement linkage response and collaboration mechanisms, clarify the joint supervision and inspection mechanism established by the medical drug regulatory agencies in the pilot area, together with the management agencies in the pilot area, customs, Qionghai Municipal People's Government and relevant departments, and achieve the sharing and exchange of medical drug and device risk information.
（4） Improve regulatory and service levels. The "Regulations" embody supervision in services, promote supervision through services, promote the integration and mutual promotion of supervision and services, maximize the benefits of enterprises and the people, clearly require the support and cultivation of new technologies, new formats, and new models of medical and pharmaceutical equipment in the pilot area, establish a smooth and effective communication mechanism, strengthen the promotion of relevant laws and regulations and service guidance, optimize the regulatory process, And it is stipulated that the pilot area should provide face-to-face handling of government service matters through an integrated online government service platform, and implement one window acceptance and one network access for government service matters.