The National Bureau of Medical Insurance, the Bureau of City Supervision, and the Weijian Committee come | The medical and medical industry will welcome seven major changes!
Medical Network March 14 News March 13, 1818, the State Council institutional reform program officially unveiled, submitted to the thirteenth session of the National People's Congress for deliberation. According to the program, several major adjustments related to the medical device industry have been established:
1. Revocation of the National Health and Family Planning Commission, State Council Medical Reform Office, Newly Established National Health Committee
2. Withdrawal of State Administration for Industry and Commerce, General Administration of Quality Supervision, General Administration of Pharmacy, Newly Established State Market Supervision Administration
3, Forming the National Medical Insurance Bureau
Related to the withdrawal and establishment of the institutions directly under the State Council, the changes in the responsibilities and functions of various agencies:
1. Integrate the National Health and Family Planning Commission, the State Council Medical Reform Office, the National Aging Office, the Ministry of Industry and Information Technology's lead tobacco control duties, and the State Administration of Work Safety's occupational safety supervision duties into the National Health and Sanitation Committee.
2. Integrate the responsibilities of the State Administration for Industry and Commerce, the General Administration of Quality Supervision, Inspection and Quarantine, and the General Administration of Pharmacy, and the anti-monopoly enforcement duties of the State Development and Reform Commission and the Ministry of Commerce and State Anti-Monopoly Commission into the State Administration of Market Supervision.
Among them, taking into account the special nature of the drug administration, the State Drug Administration shall be set up separately and managed by the State Market Supervision Administration. The Food and Drug Administration shall be set up only at the provincial level. The regulation of drug sales and sales shall be supervised by the city and county markets. Department of uniform commitment.
3, AQSIQ's entry and exit inspection and quarantine management responsibilities and teams will be assigned to the General Administration of Customs.
4. Responsibility for the medical insurance of the Ministry of Human Resources and Health and the Health and Development Planning Commission, the price management duties of the National Development and Reform Commission for medicines and medical services, and the duty of medical assistance for the Ministry of Civil Affairs are integrated into the National Medical Security Bureau.
The following analysis of the above-mentioned institutional reforms and changes in responsibilities can be concluded:
First, the future National Health and Sanitation Committee will focus its work on national health, public health, medical service supervision, and aging. It will delink from the management function of bidding and procurement of pharmaceutical machinery.
The Health and Family Planning Commission is gone, and the Health and Family Planning Commission will not directly administer the procurement of pharmaceutical machinery. This may lead to major changes in the procurement and procurement of reagents and reagents in various regions of the country.
The function of the newly formed National Health and Sanitation Committee, compared with the former National Health and Family Planning Commission, is to focus on treatment and focus on prevention, which will also lead to rehabilitation, pension, medical care, sports and health, tourism and health. The great development of health extension field.
The tens of trillions of large health markets are about to be heated.
Second, the State Council's Health Reform Office, which is responsible for the top-level design of medical reforms and the coordination and communication among various departments, will end its 10-year historical mission and will no longer be the country's most important promoter of medical reform.
Third, the originally scattered medical insurance management functions will be integrated to end the situation in 'Kowloon's flood control.
In the reform of 'Three Medicines Linkage', medicine The reforms have been relatively thorough, health care reform has taken shape, and medical insurance reform has only just begun. With the revocation of the State Council's Medical Reform Office, the establishment of an independent National Medical Insurance Bureau, medical insurance will play a greater role in the future reform of the 'Three Medicines Linkage'. Become the most important promoter of medical reform, coordinating promoters.
The establishment of the National Medical Insurance Bureau will also accelerate the reform of medical insurance itself, speed up the integration of the three guarantees, improve the level of medical insurance, and better protect the medical care of patients.
Fourth, Medicare not only has fund supervision, fee settlement functions, but also is responsible for drug prices, the formulation and adjustment of medical service prices, and is responsible for the formulation and supervision of drug procurement and procurement policies. The functions can be greatly strengthened and centralized.
As a result, the Medicare Bureau, which integrates medical insurance, pricing, and bidding procurement functions, will be able to establish a new control fee based on 'medical insurance payment negotiation' or 'medical insurance reference price', and a price reduction mechanism.
After the National Development and Reform Commission lowered the price and the Health and Family Planning Commission reduced the price, the new era of Medicare-led payment parties will come!
For example, in Fujian Province, which has taken the lead in the reform of the medical insurance management system, medical insurance has directly involved in the bidding and procurement process to limit the purchase price of medicines in medical institutions. hospital Purchase price is greatly reduced.
Fifth, the anti-monopoly law enforcement functions originally dispersed in the National Development and Reform Commission, the Ministry of Commerce, and the State Administration for Industry and Commerce were integrated into the General Administration of Market Supervision. Anti-monopoly law enforcement will also end the situation in 'Kowloon's flood control.
In the past few years, the pharmaceutical industry has become one of the key areas of national antitrust enforcement. With the concentration of anti-monopoly functions, the new market supervision bureau will also strengthen the anti-monopoly law enforcement work in the pharmaceutical industry. In the future, more The monopoly of the pharmaceutical industry, exclusive distribution, and custody, etc., excluding other competitors' behaviors, or will be detected and punished.
Sixth, although the existing State Drug Administration is to be withdrawn and withdrawn, it is placed under the supervision of the General Administration of State Market Supervision. However, it still exists in the form of a separate organization and the province still has to establish the Food and Drug Administration.
This may mean that in medicine, medical instruments The registration and approval supervision, as well as the formulation of regulatory policies for the pharmaceutical industry, are adjusted. There will be no major changes in the future. The major achievements of pharmaceutical and pharmaceutical supervision will not be lost, and existing policies will continue, such as medical devices. Special approval, priority approval, verification of clinical data, vigorous implementation of flight inspection, etc.
However, drug regulatory agencies will no longer be set up at the city and county levels. The supervision of the specific drug sales and sales activities shall be undertaken by the market supervision departments of the cities and counties. This will affect the 330,000 arms dealers and further observations are needed.
In particular, are unfair competition practices such as commercial bribery, bundling and sales in the purchase and sale of medical devices, and will the authorities be more investigated as the power of market supervision authorities is greatly concentrated?
In addition, the production of the first type of medical device that was originally under the jurisdiction of the local food and drug administration bureau will be received by the provincial food and drug administration bureau. The second type of medical device will be received. Will the processing of production licenses be received in the hands of the State Food and Drug Administration? This also requires further observation.
Seventh, the inspection and quarantine functions and teams of the General Administration of Quality Supervision, Inspection and Quarantine were assigned to the General Administration of Customs. This is a medical device that takes importation routes. enterprise And physicians will have a direct impact.
The concentration of imported medical device's immigration inspection functions may lead to stronger supervision of imported medical devices and stricter accountability. Don't forget that medical device '1018' cases are dominated by customs, and are combined with multiple departments. This case has caused many companies and people in the industry to be investigated and arrested in the past two years, resulting in the use of color ultrasound, anesthesia machines and other equipment used by many medical institutions across the country to be identified as refurbished. The old medical device.
In the future, refurbishment and smuggling of imported medical devices will face more severe crackdowns.
Attached: List of main contents related to the pharmaceutical industry in the institutional reform plan of the State Council
Formation of National Health Committee
The plan proposes that the National Health and Family Planning Commission, the State Council's Office of the Leading Group for the Reform of the Medical and Health System Reform, and the Office of the National Working Committee for the Aging, the Ministry of Industry and Information Technology lead the responsibility for fulfilling the Framework Convention on Tobacco Control, and the National Safe Production Supervision. The responsibility for the supervision and management of occupational safety and health of the General Administration of Administration is integrated, and the National Health and Sanitation Commission is established as a department of the State Council.
Its main responsibilities are to formulate national health policies, coordinate the advancement of deepening the reform of the medical and health system, organize the formulation of a national essential medicine system, supervise and administer public health, medical services, health emergency response, take charge of family planning management and service work, and formulate measures to deal with population aging. Medical care combined with policy measures.
The National Committee on Ageing is retained and the daily work is undertaken by the National Health and Sanitation Committee. The China Aging Association hosted by the Ministry of Civil Affairs has been replaced by the National Health and Hygiene Committee. The State Administration of Traditional Chinese Medicine is administered by the National Health Committee.
No longer retain the National Health and Family Planning Commission. No longer set up the State Council to strengthen leadership of the reform of the medical and health system.
Establish the State Market Supervision and Administration Bureau
The plan puts forward the responsibility of the State Administration for Industry and Commerce, the responsibility of the General Administration of Quality Supervision, Inspection and Quarantine, and national food drug Responsibilities of the General Administration of Supervision, the National Development and Reform Commission’s price supervision and inspection and enforcement of anti-monopoly enforcement duties, the integration of responsibilities of the Ministry of Commerce’s managers to enforce anti-monopoly law enforcement and the State Council’s anti-monopoly committee office, and the establishment of the State Market Supervision and Administration Bureau as a direct under the State Council. mechanism.
Its main responsibilities are: responsible for comprehensive market supervision and management, unified registration of market entities and establishment of information publicity and sharing mechanisms, organization of comprehensive supervision of market supervision, implementation of anti-monopoly law enforcement, standardization and maintenance of market order, organization and implementation of strategies for strengthening the country’s quality, and responsibility for industry Product quality and safety, food safety, special equipment safety supervision, unified management measurement standards, inspection and inspection, certification and accreditation.
Taking into account the special nature of drug supervision, the State Drug Administration shall be set up separately and administered by the State Market Supervision Administration. Market supervision shall be managed in a graded manner, drug regulatory agencies shall be set up only at the provincial level, and supervision of drug sales and sales shall be conducted by the city. The county market supervision department takes charge.
Responsible for the entry and exit inspection and quarantine management duties and teams of the General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China to the General Administration of Customs. The State Food Safety Commission and the Anti-Monopoly Committee of the State Council shall be retained. The specific work shall be undertaken by the State Market Supervision Administration. The National Certification and Accreditation Regulatory Commission, The responsibility of the National Standardization Administration Committee is assigned to the State Market Supervision and Administration Bureau, and the foreign reserves are reserved.
No longer retained the State Administration for Industry and Commerce, the General Administration of Quality Supervision, Inspection and Quarantine, the State Food and Drug Administration.
Forming the National Medical Insurance Bureau
The plan proposes that the basic medical insurance for urban employees and urban residents of the Ministry of Human Resources and Social Security, the responsibility for maternity insurance, the new rural cooperative medical responsibility for the National Health and Family Planning Commission, and the price management responsibility for medicines and medical services of the National Development and Reform Commission , The Ministry of Civil Affairs has integrated the functions of medical assistance, and established the National Medical Insurance Bureau as a direct agency of the State Council.
Its main responsibilities are to formulate policies, plans, standards and organize the implementation of medical insurance systems such as medical insurance, maternity insurance and medical assistance, supervise and administer the relevant medical security funds, improve the country's remote medical treatment management and expense settlement platform, and organize the formulation and adjustment of pharmaceutical products. , Prices and charges for medical services, Formulation of tendering and procurement policies for pharmaceuticals and medical consumables, and supervision of implementation, supervision and management of medical services related to medical institutions and medical expenses.
At the same time, in order to improve the efficiency of the collection and management of medical insurance funds, the basic medical insurance premiums and maternity insurance premiums shall be levied by the taxation department.