As a grass-roots drug administration law enforcement department, the cases it contacts are specific, special and realistic, and there are often cases where the law enforcement basis is only regulatory requirements without specific punishment measures, or the punishment is not strong enough and the operability is not strong. In particular, the treatment of illegal acts of drugs and medical devices in medical institutions is generally only a warning, an order for rectification, and a notification to the health authorities. Without effective punishment provisions, supervision often becomes a mere formality, and it is very difficult to enforce the law at the grassroots level. Compared with the laws, regulations and rules on drugs and medical devices that have been promulgated at present, the Measures greatly supplement the penalties for illegal acts of drug use and medical device management in the Measures for the Supervision and Administration of Drug Circulation (Order No.26) promulgated by the US Food and Drug Administration in 2007. It has strong pertinence, practicability and operability, and is close to the grassroots and reality, which is suitable for grassroots supervision.
First, make specific penalties for violations in the use of drugs that are not clearly stipulated in laws and regulations such as the Measures for the Supervision and Administration of Drug Circulation. Focus on drug users who violate the management system in five aspects: drug purchase and sale, ledger record management, daily quality maintenance, prescription management and pharmacy construction standardization.
Article 38 of the Measures clearly stipulates that "in any of the following circumstances, the food and drug supervision and administration department at or above the county level shall order it to make corrections within a time limit and give a warning; If no correction is made within the time limit, a fine of more than RMB 1000 yuan and less than RMB 1000 yuan shall be imposed: (1) In violation of the provisions of the first paragraph of Article 8 of these Measures, the drug user fails to ask for or save the sales voucher and the relevant information stipulated by the state; (two) in violation of the provisions of the second paragraph of Article 9 of these measures, the drug users do not have a true and complete record of purchase acceptance; (three) in violation of the provisions of the first paragraph of Article 12 of these measures, the drug user fails to prescribe drugs as required ". This makes grass-roots drug administration law enforcement have a strong supervision power over medical institutions' behaviors such as not accepting and sending, not recording, not asking for certificates, not asking for tickets, not storing, transporting and maintaining drugs as required, and such clear punishment did not appear in previous drug laws and regulations.
Article 39 clearly stipulates that "in violation of the provisions of Article 17 of these measures, drug addicts who sell or sell drugs in disguised form shall be ordered by the food and drug supervision and administration department at or above the county level to make corrections, given a warning, and fined less than 2 times the value of the drugs sold or sold in disguised form, but the maximum amount shall not exceed 30,000 yuan." Article 17 stipulates that "drug addicts shall provide drugs to patients by doctors' offices, and shall not sell or sell drugs in disguised form by means of self-selection, trial, free clinic, charity sale and consultation at open counters. This puts a "curse" on the implementation of prescription management system in medical institutions.
Article 40 stipulates that "in any of the following circumstances, the food and drug supervision and administration department at or above the county level shall order it to make corrections, give it a warning and impose a fine of more than 2,000 yuan and less than 20,000 yuan: (1) In violation of the provisions of Article 16 of these Measures, the drug storage room, pharmacy or medicine cabinet set up by a medical institution does not meet the prescribed conditions", while Article 16 stipulates that "the drug storage room, pharmacy or medicine cabinet set up by a medical institution shall have corresponding places and equipment. This has established a clear legal basis for standardizing the management of drug stores in medical institutions and implemented strong supervision.
Two, the "Regulations on the Supervision and Administration of Medical Devices" and other laws and regulations are not clear about the illegal activities of medical device circulation supervision. Focus on the production, operation and use of medical devices units did not implement the claim for certificates and tickets, purchase and sale ledger records, medical device users did not establish a permanent use record of implantable medical devices, and did not have the conditions to use related medical devices to make clear penalties.
Article 41 of the Measures clearly stipulates that "in any of the following circumstances, the food and drug supervision and administration department at or above the county level shall order it to make corrections, give a warning and impose a fine of not less than 3,000 yuan but not more than 30,000 yuan: (1) In violation of the provisions of the first paragraph of Article 19 of these Measures, medical device business enterprises and users fail to ask for or keep sales vouchers and related materials in accordance with state regulations; (two) in violation of the provisions of the first and second paragraphs of article twenty-first, the medical device production and operation enterprises have not issued the sales certificate; (three) in violation of the provisions of the second paragraph of article twentieth and the third paragraph of article twenty-first, the medical device production and operation enterprises and users have no true and complete records of purchase acceptance and sales; (four) in violation of the provisions of the first paragraph of Article 25 of these measures, the user of medical devices has not established and permanently kept the use record of implantable medical devices. "
Article 40 "In any of the following circumstances, the food and drug supervision and administration department at or above the county level shall order it to make corrections, give it a warning and impose a fine of more than 2,000 yuan and less than 20,000 yuan", which stipulates that "(2) In violation of the provisions of Article 24 of these measures, the user of medical devices does not have the prescribed conditions to use medical devices for diagnosis and treatment", and Article 24 stipulates that "the user of medical devices shall meet the following conditions before using medical devices for diagnosis and treatment activities: (1) (3) Technical personnel suitable for the medical devices used; (4) Other conditions stipulated by laws and regulations. "
These regulations provide strong supervision and punishment support for regulating the circulation and use of medical devices.
Third, make clear punishment for the illegal acts of employees in the field of medical device circulation who engage in direct contact with drugs and sterile medical devices without obtaining health certificates.
Article 40 of the Measures stipulates that "in any of the following circumstances, the food and drug supervision and administration department at or above the county level shall order it to make corrections, give it a warning and impose a fine of more than 2,000 yuan and less than 20,000 yuan", which stipulates that "(3) In violation of the provisions of Article 27 of these Measures, pharmaceutical and medical device trading enterprises and users fail to conduct annual health check-ups for personnel who have direct contact with pharmaceuticals and sterile medical devices, and arrange for them to suffer from infectious diseases or other diseases that may contaminate pharmaceuticals and sterile medical devices. Article 27 stipulates that "pharmaceutical and medical device trading enterprises and users shall conduct a health examination once a year for those who are in direct contact with pharmaceuticals and sterile medical devices, and establish health records. Enterprises and users of drugs and medical devices shall not arrange personnel suffering from infectious diseases or other diseases that may contaminate drugs and sterile medical devices to engage in direct contact with drugs and sterile medical devices. This regulation is undoubtedly an efficient "cardiotonic" to ensure the quality and safety of drugs and sterile medical devices.
Four, clear the township government and relevant functional departments of drugs and medical devices regulatory responsibilities.
Defining the subject of supervision responsibility is an important guarantee for the effective implementation of laws, regulations and rules. Article 3 of the Measures clearly stipulates that "the food and drug supervision and administration departments at or above the county level shall be responsible for the supervision and administration of the circulation of drugs and medical devices within their respective administrative areas. The economic and trade departments of the people's governments at or above the county level shall be responsible for studying and formulating the development plans and industrial policies for the circulation industry of drugs and medical devices, guiding the industrial layout, and promoting the management of industries such as technological progress and structural adjustment. The food and drug supervision and administration department at or above the county level shall cooperate with the economic and trade departments to implement the development plan and industrial policy of the circulation industry of drugs and medical devices. The health department of the people's government at or above the county level is responsible for guiding the work related to pharmaceutical affairs management in medical institutions, organizing the implementation of the national basic drug system, and participating in the management of clinical trials of drugs and medical devices. Population and family planning, price, quality and technical supervision, industry and commerce, public security and other relevant departments shall be responsible for the supervision and management of the circulation of drugs and medical devices within their respective functions and duties. The Township People's Government shall assist in the supervision and management of the circulation of drugs and medical devices within its jurisdiction. " First of all, it is clear that the drug supervision department is the main body of quality and safety supervision in the field of medical device circulation. Secondly, it is clear that economic and trade, family planning, price, quality supervision, industry and commerce, public security and other departments perform their duties within the scope of their duties and participate in the supervision of medical devices. Thirdly, it is clear that the township government has the function of coordination and assistance. At the same time, Article 4 of the Measures stipulates that "enterprises and users of drugs and medical devices shall ensure the quality and safety of drugs and medical devices they purchase, sell, store, transport and use." This provides a strong legal support for the construction of a medical device safety responsibility system in which "local governments take overall responsibility, functional departments take their own responsibilities, and enterprises are the first responsible persons". It has laid a solid legal and policy support for the grass-roots drug supervision departments to take the lead in rectifying and standardizing the medical device market and carrying out the safety rectification of medical devices.
Five, timely release the recently explored and innovative institutional measures for the effective use of drugs and medical devices in the form of laws and regulations, and effectively enhance the legal effect of these institutional measures. The "Measures" establish its legal effect in the form of rules around five effective measures, such as standardizing pharmacy management, daily supervision and inspection records of drug operation and use, medical integrity construction, medical device information supervision and drug "two networks" construction.
Article 16 of the Measures stipulates that "the drug storage rooms, pharmacies or medicine cabinets set up by medical institutions shall have corresponding places, equipment, storage facilities, sanitary environment and other conditions. The specific conditions shall be jointly formulated and announced by the food and drug supervision and administration department and the health department of the provincial people's government." This provides legal support for promoting medical institutions to standardize pharmacy management.
Article 26 stipulates that "the food and drug supervision and administration department at or above the county level shall establish and improve the system of daily supervision and inspection, certification follow-up inspection and spot check inspection, and strengthen the supervision and inspection of the circulation of drugs and medical devices. The food and drug supervision and administration department at or above the county level shall establish a quality and safety credit management system for pharmaceutical and medical device enterprises and users, record the illegal acts of quality and safety credit of pharmaceutical and medical device enterprises and users, and announce them to the illegal units. " This provides legal support for implementing the daily supervision and inspection record system of drug operation and use and promoting the construction of medical integrity.
Article 34 stipulates that "the food and drug supervision and administration department at or above the county level shall strengthen the monitoring and system construction of the electronic network for the circulation of drugs and medical devices, and promote the information management of the circulation network of drugs and medical devices. Enterprises engaged in the production, operation and use of drugs and medical devices shall establish a computer management system for the operation and use of drugs and medical devices, timely input the purchase, sale and use information of drugs and medical devices, and accept the supervision of the food and drug supervision and administration department. The information and trading services of drugs and medical devices through the Internet shall comply with the provisions of relevant state laws and regulations. " This provides legal support for promoting information supervision of medical equipment.
Article 35 stipulates that "the food and drug supervision and administration department at or above the county level shall establish and improve the rural drug supply and quality and safety supervision network, strengthen the standardized management of the rural drug market, and ensure the quality and use safety of rural drugs." This provides legal support for further promoting the construction of "two networks" of drugs and building the integration of urban and rural medicine.
Six, increase the supervision and punishment of unlicensed drugs. Article 35 of the Measures for the Supervision and Administration of Drug Circulation promulgated by the US Food and Drug Administration stipulates that "in violation of the provisions of Article 13 of these Measures, if a pharmaceutical production or trading enterprise knows or should know that others are engaged in the production and trading of unlicensed drugs, it shall be given a warning, ordered to make corrections and fined not more than 10,000 yuan. If the circumstances are serious, a fine of not less than 10,000 yuan but not more than 30,000 yuan shall be imposed. " Only the act of providing drugs to unlicensed production and business units is punished, and the act of providing drugs to unlicensed users is not explicitly punished. Article 37 of the Measures clearly stipulates that "in violation of the provisions of the second paragraph of Article 7 of these Measures, pharmaceutical production and wholesale enterprises sell drugs to drug addicts who do not have legal qualifications, the food and drug supervision and administration department at or above the county level shall order them to make corrections, give them a warning and impose a fine of 65,438+100,000 yuan; If the circumstances are serious, a fine of 6,543,800 yuan or more and 30,000 yuan or less shall be imposed. " This will form a complete supervision chain for unlicensed production, management and use of drugs.