Let’s talk about the difference between the National Health Commission of the People’s Republic of China, the National Healthcare Security Administration and the National Medical Products Administration. And these three ministries have the closest relationship with our medical personnel. From the perspective of the functions of ministries, the Health Commission has the closest relationship with health care, the National Healthcare Security Administration has a close relationship with medicine and medical insurance, and the National Medical Products Administration has a close relationship with the medicine.
National Health Commission of the People’s Republic of China
National Health Commission’s predecessor is the Health and Family Planning Commission. In March 2018, in the major ministry reform plan of the State Council, the Health and Family Planning Commission was no longer retained, and the Office of the Leading Group for Deepening the Reform of the Medical and Health System of the State Council was no longer established, and set up the Health Commission. The change of name actually reflects the change of the focus of health work, from family planning to national health. The Health and Family Planning Commission’s functions are health work and family planning work, but the concept of family planning has gradually faded. The State regards people’s health is an important symbol of national prosperity and national prosperity.
The core function of the National Health Commission is to improve people’s health and reform of public medical institutions. Compared with the National Healthcare Security Administration and the National Medical Products Administration, the Health Commission has the highest level. The Health Commission is a ministerial-level department, and both Healthcare Security Administration and the Medical Products Administration are vice-ministerial departments. The core functions of the Health Commission include two points: one is to improve people’s health, and the other is to promote comprehensive reform of public hospitals. It’s not difficult to find from its main functions (Table 1) that functions 1, 3, 4, 6, 8, and 10 are all closely related to improving people’s health, functions 2, 7, and 9 are closely related to improving the service level of medical institutions, only function 5 has a greater relationship with medicines, that is, organizing the legislation of national medicine policies and national essential medicine systems.
Why the List of Essential Drugs （EDL） is managed by the National Health Commission? Because the medicines in the EDL are closely related to the health needs of the people. The National Health Commission can best select drugs with appropriate dosage forms and reasonable prices from the perspective of national health and enter to the EDL. In principle, the EDL is adjusted once every three years. The last adjustment was in September 2018. The biggest change is that any province cannot add medicines on the EDL.
Table 1 Main functions of the National Health Commission
|1||To draft laws and regulations for national health policies, draft laws and regulations, policies and plans for the development of public health services, formulate departmental rules and standards and implement them; coordinate and plan the resource allocation of health services, offer guidance for the formulation and implementation of regional health planning.|
|2||To coordinate and deepen the reform of medical and health system; promote comprehensive reform of public hospitals.|
|3||To make and implement the plans of disease prevention and control, the National Immunization Program and interventions for public health issues that seriously endanger people’s health; draw up catalogs for quarantining and monitoring infectious diseases.|
|4||To organize and coordinate the formulation and implementation of policies and measures to cope with the aging population problem, and be responsible for promoting the construction of health service system and the integration of medical care and nursing for the elderly.|
|5||To organize the formulation of national drug policies and national essential medicine system; launch an early warning mechanism for the monitoring of the use and clinical comprehensive evaluation of medicine as well as the drug shortage, give suggestions on the pricing policy of national essential medicine.|
|6||To supervise and manage occupational health, radio-logical health, environmental health, school health, public place health and sanitary standards for drinking water within the scope of its responsibilities; supervise the prevention and treatment of infectious diseases, improve the comprehensive health supervision system.|
|7||To formulate and carry out administrative measures for medical institutions and medical services industry; set up assessment and supervision system for medical service.|
|8||To be responsible for family planning management and services, carry out population monitoring and early warning, study and offer advice on population and family development policies, and improve family planning policy.|
|9||To give guidance to local health authorities and the construction of grass-roots systems for medical care and maternal-child health services as well as the training of general practitioners.|
|10||To take charge of the medical and health care for the appointed personnel of the central government; and take charge of providing medical services at major national conferences and events of the Party and the State.|
National Healthcare Security Administration
In 2018, by integrating the basic medical insurance responsibilities of urban employees and urban residents of the Ministry of Human Resources and Social Security, the new rural cooperative medical insurance responsibilities of the National Health and Family Planning Commission, the price management responsibilities of medicines and medical services of the National Development and Reform Commission, the National Healthcare Security Administration was established. NHSA’s name uses “Security” instead of “Insurance” because its function is not only insurance, but also protection functions such as medical assistance.
The establishment of the NHSA solved the problem of “not paying for the order”. In the past, before the establishment of the NHSA, there was a serious lack of correlation between drug price negotiations and medical insurance payment, which was due to the imperfect system: drug price negotiations were led by the Health and Family Planning Commission, but the medical insurance decided by the Ministry of Human Resources and Social Security. The inconsistency of rights has led to the determination of many drug prices not based on the ability to pay for medical insurance. It was not until the establishment of the National Healthcare Security Administration that the unification of rights solved the problem of “not paying for the order”.
In the past two years, the NHSA has an increasing impact on China’s pharmaceutical industry. Since the beginning of the “4+7” pilot program at the end of 2018, the NHSA has organized 4 batches of national procurements, covering 113 products. The reform of national procurement in the future will present two major trends. One is the procurement in the field of high-priced medical supplies such as orthopedic consumables and coronary stents; the other is national procurement will set reasonable standards for the purchase quantity of drugs, two batches a year, covering 500 products until 2022.
Table 2 Main functions of the National Healthcare Security Administration
|1||To draft laws and regulations, policies and plans for the Medical insurance, maternity insurance, medical assistance, formulate departmental rules and standards and implement them.|
|2||To organize the formulation and implementation of medical security fund supervision and management measures, establish and improve medical security fund safety prevention and control mechanisms, and promote the reform of medical security fund payment methods.|
|3||To organize the formulation of medical security financing and treatment policies, improve the dynamic adjustment and regional adjustment and balance mechanism, coordinate urban and rural medical security treatment standards, and establish and improve a treatment adjustment mechanism commensurate with the level of financing. Organize the formulation and implementation of long-term care insurance system reform plans.|
|4||To organize the formulation of a unified urban and rural medical insurance catalog and payment standards for medicines, medical consumables, medical service items, medical service facilities, etc., establish a dynamic adjustment mechanism, formulate the medical insurance catalog access negotiation rules and organize their implementation.|
|5||To organize the formulation of policies for the prices of medicines, medical consumables, and medical service facility charges for medical service items, establish a mechanism for the reasonable determination and dynamic adjustment of medical insurance payment medical service prices, promote the establishment of a market-led social medical service price formation mechanism, and establish price information monitoring and information release system.|
|6||To formulate and supervise the implementation of bidding and procurement policies for drugs and medical consumables, and guide the construction of a bidding and procurement platform for drugs and medical consumables.|
|7||To formulate and organize the implementation of designated medical institution agreements and payment management measures, establish a sound medical security credit evaluation system and information disclosure system, supervise and manage medical service activities and medical expenses included in medical insurance, and investigate and deal with violations of laws and regulations in the medical security field.|
|8||Responsible for medical security management, public service system and informatization construction. Organize the formulation and improvement of remote medical treatment management and expense settlement policies. Establish and improve the transfer and continuation system of medical security relations.|
National Medical Products Administration (NMPA)
The National Medical Products Administration (NMPA) was established separately from the National Food and Drug Administration (CFDA) In March 2018, considering the importance of drug regulation, the State separately established the NMPA, which is managed by the State Administration for Market Regulation (SAMR). Although both the NHSA and the NMPA are vice-ministerial departments, the NHSA and the SAMR are directly managed by the State Council. The NMPA is managed by the SAMR. So there are certain differences in the functions of the NHSA and the NMPA.
The functions of the NMPA involve the supervision and management of the entire life cycle of drugs, medical devices and cosmetics. With the unremitting efforts of the NMPA, the supervision and management of Chinese medicines has been gradually improved.
Recently, with the normalization of clinical data verification, continuous improvement of priority review and consistency evaluation systems, the time for drug review and approval has been greatly reduced and the quality of medicines is also greatly improving. The NMPA is also changing from a guidance department to a service department.
Table 3 Main functions of the National Medical Products Administration
|1||To supervise the safety of drugs (including traditional Chinese medicines (TCMs) and ethno-medicines, the same below), medical devices and cosmetics.|
|2||To undertake standards management for drugs, medical devices and cosmetics; to organize the formulation and publication of the Chinese Pharmacopoeia and other drug and medical device standards, organize the drafting of cosmetic standards, organize the formulation of the classification management system, and supervise the implementation thereof; to participate in formulating the National Essential Medicine List, and assist in the implementation of the national essential medicine system.|
|3||To regulate the registration of drugs, medical devices and cosmetics; to develop the registration system, conduct strict review and approval for marketing, improve measures to facilitate the review and approval process, and organize the implementation thereof.|
|4||To undertake quality management for drugs, medical devices and cosmetics; to develop Good Laboratory Practices (GLP) and Good Clinical Practices (GCP), and supervise the implementation thereof; to develop Good Manufacturing Practices (GMP) and supervise the implementation thereof in line with NMPA’s responsibilities; to develop good practices on the distribution and use of medical products and guide the implementation thereof.|
|5||To undertake post-market risk management for drugs, medical devices and cosmetics; to organize the monitoring, evaluation, and handling of adverse drug reactions, medical device adverse events, and cosmetic adverse reactions; to undertake emergency response management for drugs, medical devices and cosmetics in accordance with law.|
|6||To undertake management of qualifications for licensed pharmacists; to formulate regulations of qualifications for licensed pharmacists, and guide and supervise the registration of licensed pharmacists.|
|7||To organize and guide the supervision and inspection of drugs, medical devices and cosmetics; to develop the inspection system, investigate and punish illegal activities during the registration process for drugs, medical devices and cosmetics in accordance with law, and organize and guide the investigation and punishment of illegal activities during the manufacturing process in line with NMPA’s responsibilities.|
|8||To engage in international exchange and cooperation in the regulation of drugs, medical devices and cosmetics, and participate in developing relevant international regulatory rules and standards.|
|9||To guide the work of drug regulatory departments of all provinces, autonomous regions, and municipalities directly under the Central Government.|
|10||To complete other tasks assigned by the CPC Central Committee and the State Council.|