Notice of the General Office of the State Council on Forwarding the Opinions of the State Council Economic Restructuring Office and Other Departments on Rectifying and Standardizing the Drug Market
No.22 [2001] of Guangdong Government Office
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Forwarding the State Council General Office to the State Council Economic Restructuring Office and other departments.
Notice on rectifying and standardizing the opinions of the pharmaceutical market
People’s governments of cities, counties and autonomous counties, and relevant units directly under the provincial capital:
Now, with the consent of the provincial people’s government, we will forward the Notice of the General Office of the State Council on Forwarding the Opinions of the State Council Economic Restructuring Office and other departments on rectifying and standardizing the drug market (No.17 [2001] of the State Council, hereinafter referred to as the Notice) to you, and now we put forward the following opinions, please implement them together.
First, rectifying and standardizing the drug market is an important measure to standardize the drug circulation order and promote the healthy development of the pharmaceutical industry. People’s governments at all levels and relevant departments should strictly follow the spirit of the the State Council Notice and the arrangements of the provincial party committee and government for rectifying the market economic order, intensify the rectification of the pharmaceutical market, and severely crack down on illegal and criminal activities of manufacturing and selling counterfeit and inferior drugs. Governments at all levels should be serious and responsible, resolutely oppose all forms of local protectionism, take practical and effective measures, strengthen supervision of the drug market in their respective jurisdictions, and investigate and deal with all kinds of illegal and illegal drug trading.
Two, all levels of health, price, economy and trade, drug supervision, Chinese medicine and other departments should improve the centralized bidding and purchasing system of drugs, and strengthen the supervision of drug bidding and purchasing behavior and price. This year, the main drug varieties of medical institutions at or above the county level in the province should be fully purchased by centralized bidding, and the bidding volume of drugs should reach more than 50% of the usage. On the premise of not exceeding the maximum retail price stipulated by the government, the winning drugs can be priced according to the difference rate stipulated by the bid price; Most of the benefits of reducing drug prices through bidding procurement should benefit patients. All relevant departments should strive to improve the transparency of drug prices. For drugs with market-regulated prices, it is necessary to gradually print retail prices on drug packaging, so as to clearly mark prices. Resolutely crack down on indiscriminate price increases or low-price dumping, maintain normal drug price order, and effectively protect the vital interests of the people.
Three, all localities should combine this year to carry out the "anti misleading, false" advertising market governance special action, comprehensively rectify the drug advertising market order. Focus on the control of illegal, illegal, unscientific, exaggerated efficacy, deceiving consumers; Severely punish acts that interfere with people’s rational and safe use of drugs, and standardize the release order of drug advertisements. Those who publish false drug advertisements after investigation shall be punished according to law.
Four, rectify and standardize the drug market is an important work related to people’s health and social stability and development. Governments at all levels and relevant departments should, in combination with the actual situation of their own departments in the region, pay close attention to formulating implementation plans to ensure that all measures to rectify and standardize the drug market are implemented.
General Office of Guangdong Provincial People’s Government
April 19th, 2001
General Office of the State Council forwarded the State Council Economic Restructuring Office and other departments.
Notice on rectifying and standardizing the opinions of the pharmaceutical market
Guo Ban Fa [2001] No.17
People’s governments of all provinces, autonomous regions and municipalities directly under the Central Government, ministries and commissions and institutions directly under the State Council:
The State Council Economic Restructuring Office, the State Planning Commission, the State Economic and Trade Commission, the Ministry of Health, the State Drug Administration and the State Administration for Industry and Commerce "Opinions on Rectifying and Regulating the Drug Market" have been approved by the State Council, and are hereby forwarded to you, please implement them carefully.
General Office of the State Council of the People’s Republic of China
March 10, 2001
Opinions on rectifying and standardizing the pharmaceutical market
The State Council Economic Restructuring Office, State Planning Commission and State Economic and Trade Commission
Ministry of Health, State Drug Administration and State Administration for Industry and Commerce
(January 19th, 2001)
In order to further implement the spirit of the Notice of the General Office of the State Council on Forwarding the Guiding Opinions of the State Council Economic Restructuring Office and Other Departments on the Reform of Urban Medical and Health System (No.16 [2000] of Guo Ban Fa), deepen the reform of pharmaceutical production and circulation system, promote the transformation of functions of relevant government departments, strengthen supervision, treat both the symptoms and root causes, intensify the rectification of the pharmaceutical market, standardize the order of the pharmaceutical market, and promote the healthy development of the pharmaceutical industry, we hereby put forward the following opinions:
First, crack down on illegal and criminal activities of manufacturing and selling counterfeit and inferior drugs.
All regions and relevant departments should continue to crack down on the illegal and criminal activities of manufacturing and selling fake and inferior drugs on the basis of conscientiously implementing the notice of the State Council on launching joint action to crack down on illegal and criminal activities of manufacturing and selling fake and inferior commodities (Guo Fa [2000] No.32). For major and important cases of manufacturing and selling fake and inferior drugs that have been discovered, drug supervision, public security, industrial and commercial administration, supervision and other departments should trace back to the source, thoroughly identify manufacturing and selling dens, circulation channels, storage places, sales places and people involved, eliminate the root causes of manufacturing and selling fake and inferior drugs, resolutely punish criminals and disciplinary personnel, and especially punish the chief criminals and recidivists who manufacture and sell fake and inferior drugs and constitute crimes quickly and severely according to law. Drug supervision and other departments should adhere to the combination of centralized rectification and strengthening daily supervision, strengthen market supervision and deepen reform, combine counterfeiting with supporting excellent enterprises, improve the drug quality supervision system and inspection system, and purify the drug market environment.
Two, the rectification of all kinds of illegal and illegal drug business behavior.
It is necessary to take practical and effective measures to comprehensively strengthen the management of drug market access, rectify all kinds of illegal and illegal drug sales, ban unlicensed drug sales and illegal transactions, and investigate and deal with giving and receiving kickbacks and other commercial bribery in drug purchase and sale activities. In the work of banning drug markets, it is necessary to implement the responsibility system of local governments and resolutely oppose various forms of local protectionism. Relevant parties should unify their thinking, cooperate with each other, consolidate the achievements of rectifying the pharmaceutical market, and properly handle the aftermath. If the banned illegal drug trading market turns dark or resurfaces, it should continue to be severely cracked down and severely punished. If the problem is serious, the relevant localities, departments and their responsible persons should be held accountable.
Three, strictly implement the drug management system of separating government from enterprise.
Drug supervision and other relevant departments shall, in accordance with the requirements of the Notice of the State Council on Approving the Reform Plan of Drug Supervision and Management System in National Medical Products Administration (Guo Fa [2000] No.10), follow the principle of separating government from enterprises, separating supervision and law enforcement from industry management functions, highlighting supervision and management, being unified and efficient, and being consistent in responsibilities and rights, speed up the reform of drug supervision and management system and improve the drug supervision and management system. Drug supervision and other departments should be completely decoupled from their affiliated pharmaceutical companies or pharmaceutical institutions affiliated in various forms and names, and should not maintain economic interests with any pharmaceutical institutions. In the development of pharmaceutical industry and enterprises, we should support and play the role of industry self-regulatory organizations.
Four, promote the development and alliance of superior pharmaceutical enterprises.
Resolutely break departmental or local monopolies, ownership restrictions and administrative protection that hinder fair competition, adjust policies and regulations that are not conducive to giving full play to the positive role of market mechanisms, establish a drug quality management monitoring system organized by relevant state departments, cancel repeated testing, repeated examination and approval, and repeated issuance of "quasi-sales licenses" for pharmaceutical enterprises in various places, and cancel restrictions on pharmaceutical enterprises in other regions from entering the local drug market in the name of filing and registration. We should give full play to the role of market mechanism and optimize the structure of pharmaceutical industry. It is necessary to create an environment of fair competition, support superior pharmaceutical enterprises to expand their business scale through acquisitions and mergers, promote the development of marketing methods such as drug agency distribution and chain operation, and form a number of cross-regional, large-scale, intensive and high-level pharmaceutical enterprise groups to play a key role in drug production and circulation.
Five, reverse the situation of low-level duplication of drug production.
Local people’s governments at all levels should make up their minds to rectify small pharmaceutical factories and shut down a number of small pharmaceutical factories that pollute the environment, waste resources, do not conform to industrial policies and industry development plans, have low-level redundant construction, fail to meet GMP standards for pharmaceutical production enterprises or fail to operate normally. Drug regulatory authorities should clean up and rectify the hospital preparation room, and hospitals that can normally supply preparations in the market shall not repeat production, and hospitals that do not have preparation conditions shall not be renewed.
Six, clean up and rectify the drug circulation enterprises
Cleaning up and rectifying drug circulation enterprises should be combined with the work of drug business renewal. Drug circulation enterprises that have an imperfect quality assurance system, irregular business practices and fail to meet the conditions for renewal shall not be renewed; Drug circulation enterprises that are insolvent, on the verge of bankruptcy, or fail to meet the quality management standards (GSP) for drug business within a certain period of time will be resolutely disqualified; Drug circulation enterprises that cannot operate drugs normally and mainly rely on renting office buildings, warehouses and other properties to survive should be rectified, and those that engage in illegal investment operations should be investigated and punished according to law until their drug business licenses are revoked.
Seven, improve the centralized bidding system of drugs.
The health department should standardize the management of drug use in medical institutions, expand the varieties of drugs purchased by centralized bidding, and gradually bring the main drug varieties into the scope of centralized bidding and purchasing. Strict examination and management should be carried out on important links in drug procurement by tender, such as bid evaluation methods and the composition of expert database for the whole society, so as to ensure the openness, fairness and impartiality of drug procurement by tender. Health, drug supervision, price authorities and other departments should supervise the bidding and purchasing behavior and price of drugs. The retail price of drugs purchased by bidding should be reasonably set based on the actual purchase price. The benefits of reducing drug prices through bidding should mainly benefit patients, and medical institutions can share a certain proportion.
Eight, promote the electronic trading of medical commodities.
Establish and improve the electronic trading system of medical commodities certified, supervised and managed by relevant government departments, actively promote the electronic trading of medical commodities, give full play to the role of electronic trading system as a bridge between drug production, circulation and consumption, communicate information in time, realize fast trading, and use this system to entrust centralized bidding and purchasing of medical commodities, bring trading behavior into a standardized and open track, and correct unhealthy trends in the purchase and sale of medical commodities from the system.
Nine, strengthen the construction of rural drug supply network
It is necessary to effectively solve the problem of lack of regular and stable drug supply channels in the vast rural areas and strengthen the construction of rural drug supply networks. Encourage large and medium-sized pharmaceutical wholesale enterprises to merge with small pharmaceutical wholesale enterprises, extend the sales network to the county level, and develop rural drug sales outlets to facilitate farmers to purchase drugs. Promote centralized bidding and purchasing drugs through rural health service network. In remote areas, rural health service management can also be integrated, and township hospitals can purchase drugs for rural doctors in a unified way to prevent counterfeit and inferior drugs from flowing to rural areas and ensure the safety of farmers’ medication.
Ten, the implementation of separate accounting and management of medicine.
Health departments and medical institutions at all levels should actively implement the policies and measures of separate accounting and management of medicines, and strictly implement the relevant provisions on the management of two lines of revenue and expenditure. On the basis of standardizing financial subsidies and adjusting the price of medical services, the outpatient pharmacy of medical institutions will be gradually changed into a pharmaceutical retail enterprise, with independent accounting and tax payment according to regulations, and equal competition with social retail pharmacies will promote the socialization, specialization and intensification of drug circulation, improve efficiency and reduce costs.
Community health organizations, outpatient departments and individual clinics can only distribute commonly used and first-aid drugs approved by provincial health and drug supervision departments. Health and drug supervision departments should pay close attention to formulating the catalogue of commonly used and first-aid drugs and related management measures, and implement the above measures as soon as possible at the grassroots level.
Eleven, accelerate the implementation of the classified management system of prescription drugs and over-the-counter drugs.
Drug supervision and other departments should actively cooperate, improve policies, standardize and manage the sales of prescription drugs as soon as possible. On the basis of ensuring safety and effectiveness, in order to meet the needs of people’s self-care, speed up the selection of over-the-counter drugs and expand the circulation channels of over-the-counter drugs. Class B OTC drugs can be sold in retail stores of daily necessities upon approval.
Twelve, improve the management of new drug research and approval.
It is necessary to revise the standards of new drugs and encourage the research and innovation of new drugs. If the technical content is not high and the research and production are repeated at a low level, the drug regulatory authorities should strictly check and not approve the production. Those who resort to deceit in the approval of new drugs should be dealt with severely according to law. The policies and regulations, working procedures and time limits of new drug approval management should be open to the public and subject to social supervision.
Thirteen, increase the intensity of drug price supervision.
Gradually implement the system of drug price publicity and the system of printing retail prices on drug packaging, and increase the supervision of drug prices. This work starts with some drugs with market-regulated prices and is gradually extended to all kinds of drugs sold in China. It is necessary to make it clear that the price stipulated by the state is the highest price limit, and to retail drugs in hospitals or pharmacies, it is allowed to sell or print the price below but not above the public price.
Fourteen, strengthen the supervision and management of drug advertising.
Drug regulatory authorities at all levels and administrative departments for industry and commerce should conscientiously implement the spirit of the Notice of the State Drug Administration and the State Administration for Industry and Commerce on Strengthening the Examination and Management of Prescription Drug Advertisements (No.14 [2001] of the State Administration of Medicine) and gradually stop advertising prescription drugs in the mass media. Drug regulatory authorities should strictly examine all kinds of drug advertisements in accordance with the relevant provisions, and supervise and inspect their daily publication and broadcasting. If illegal or illegal drug advertisements are found, they should take timely measures to deal with them accordingly. The administrative department for industry and commerce should intensify the investigation and punishment of illegal and illegal drug advertisements, and effectively regulate the release order of drug advertisements.
Fifteen, comprehensively implement the measures to rectify and standardize the drug market.
Rectifying and standardizing the pharmaceutical market is related to the vital interests of the broad masses of the people, to the healthy development of the pharmaceutical industry and health undertakings, and to the overall situation of reform, opening up and stability. All regions and relevant departments should attach great importance to it, strengthen leadership, unify their thinking, raise awareness, overcome local and departmental departmentalism, and comprehensively use legal, economic, administrative and public opinion means in a spirit of being highly responsible to the country and the people to conscientiously rectify and standardize the drug market.
All provinces, autonomous regions and municipalities directly under the Central Government shall, in accordance with the above opinions and in combination with the actual situation in the region, pay close attention to formulating implementation plans, make careful arrangements and organize them carefully to ensure that all measures to rectify and standardize the drug market are implemented. The relevant departments of the State Council will timely supervise and inspect the implementation of this opinion in various regions.