The implementation of new rules for the sale of drugs on the Internet is imminent strong supervision to curb potential risks
Psychotropic drugs, Chinese medicine formula particles will be prohibited
December 1, China's regulatory approach to the sale of drugs on the Internet, "Drug Network Sales Supervision and Administration" (hereinafter referred to as "Measures") came into force, the sale of drugs on the Internet will be legally binding, there are rules to follow, really usher in the era of strong regulation.
According to the previous "Drug Network Sales Prohibition List (Draft)", vaccines, blood products, narcotic drugs, psychotropic drugs, toxic drugs for medical use, radioactive drugs, pharmaceutical chemicals, medical institution preparations and Chinese medicine formula granules for the policy and regulations clearly prohibit the sale of drugs online. Other drugs prohibited through the network retail sales include injections (except hypoglycemic drugs), compound preparations containing ephedrine (excluding proprietary Chinese medicines containing ephedra), and varieties with high risk of drug use are prohibited through the network sales.
State Drug Administration party members, deputy director Xu Jinghe said, as the Internet continues to develop in depth, "Internet +" bred and gave birth to the new industry of drug network sales, drug network sales in the cultivation of new business models, empowering retail enterprises, the convenience of the masses to buy drugs and other aspects played an important role. At the same time, we are soberly aware that the Internet has broken the time and space constraints, expanding the associated subjects, extending the chain of responsibility, to social governance has also brought new challenges, the network drug sales problems frequently.
Industry insiders pointed out that the "approach" revealed that the regulatory attitude tends to be strict and standardized, while following the operation of the regulatory "online and offline consistent principle", the online sale of prescription drugs separate display, first prescription after the drug, to ensure the authenticity of the prescription and other provisions are also more stringent and specific.
The demand for online drug sales has increased, and the risk of regulation has increased dramatically
In recent years, various segments of the pharmaceutical industry chain have been online and offline overall layout, with logistics and distribution and other third-party services to enhance the ability to support the growth of online drug retail terminals grew significantly. According to the data provided by the Southern Institute of Pharmaceutical Economics of the State Drug Administration, the growth rate of pharmaceutical retail online sales in 2021 has slowed down, but is still the highest among the four major terminals, with annual sales expected to be 289.9 billion yuan in 2022, a growth rate higher than 32%, and the industry continues to maintain high growth.
Among them, with the online sales of prescription drugs and medical insurance payments continue to liberalize, online purchase of prescription drugs patients gradually increased. Sales data from more than 200 pharmacies on the Tmall and Jingdong platforms show that from January to July 2022, online prescription sales were 14.47 billion yuan, up 48.9% year-on-year.
"Internet sales are virtual, hidden, dispersed, cross-regional and other characteristics, especially drug network sales there are many types of subjects, different types of subjects with different risk differences, different management methods, etc., to supervision and management, law enforcement jurisdiction, case investigation, evidence fixation and other regulatory actions bring challenges." Yuan Lin, director of the Department of Drug Regulation of the State Drug Administration, said.
Guo Changmao, deputy director of the Southern Institute of Pharmaceutical Economics of the State Drug Administration, said that the regulation of Internet information is a worldwide problem, and there is a trend of illegal cases gradually shifting from offline to online, which on the one hand improves people's livelihood and at the same time increases the risk of drug safety.
Guo Changmao said that the current risks and dangers of online drug sales include irregularities in the flow of online prescriptions, indiscriminate over-prescription and drug abuse. The main responsibility of the third-party platform to implement the lack of goods on the shelves beyond the scope of business, through the false license qualification to obtain third-party platform membership, to carry out illegal business practices. There is an exaggeration of the scope of application or other misleading and deceptive means to carry out online sales activities are more prominent; consumers' awareness of the rational use of drugs is weak, the abuse of prescription drugs cause injuries occur from time to time.
Strengthen regulatory efforts to adhere to the "network to control the network"
It is reported that the "approach" focus on the main responsibility of drug network sales, from the establishment of a sound management system of the relevant parties, regulate the sale of prescription drugs, to carry out network monitoring and other aspects, continued to carry out drug network sales governance, to maintain the drug network sales environment.
Yuan Lin said that the construction of drug network sales quality management system. The "Measures" to protect the quality and safety of drugs as the core, requiring drug network sales enterprises and third-party platforms to improve system construction, comprehensive strengthening of drug network sales quality management. On the one hand, drug network sales enterprises should establish and implement drug quality and safety management, online pharmacy services and other systems. There are quality problems or safety risks of drugs, should take appropriate risk control measures in accordance with the law. On the other hand, third-party platforms should establish drug quality and safety management institutions, establish and implement drug quality and safety management, inspection and monitoring systems, drug network sales enterprises resident in the platform to carry out qualification audits to ensure that the resident enterprises continue to meet the statutory requirements.
Create a safe and convenient environment for the sale of prescription drugs. In view of the special nature of the prescription drugs themselves, the "approach" around the safety and convenience of the public to purchase drugs, the prescription drug network sales system has been systematically designed. The first emphasizes the authenticity and reliability of the source of prescriptions, "Measures" requires drug network sales enterprises to implement a real-name system for the purchase of prescription drugs, and take effective measures to avoid the repeated use of prescriptions. Secondly, the establishment of risk warning notification system. The "Measures" require the risk warning information of prescription drugs prominently displayed under each drug display page, fully informed of the relevant risks; to distinguish between prescription drugs and non-prescription drugs on display. Thirdly, the implementation of closed-shelf sales of prescription drugs. Prescription drug sales main page, home page face shall not directly and publicly display the prescription drug packaging, labeling and other information. Before passing the prescription audit, no information such as instructions shall be displayed, and no services related to the purchase of prescription drugs shall be provided.
Explore the use of information technology, automation, intelligent technology to innovate the regulatory model, to build a scientific and efficient long-term mechanism for the regulation of drug network sales. The Measures" requires that drug supervision and management departments should strengthen the monitoring of drug network sales, the provincial drug supervision and management departments to establish a drug network sales monitoring platform, should be connected to the national drug network sales monitoring platform to achieve data docking. In addition, the third-party platform in the implementation of the daily audit management obligations of the resident enterprises, should give full play to the advantages of the Internet technology tools in safeguarding drug quality and safety, and continue to strengthen the compliance of the platform business governance, and regulatory authorities to create a good online sales environment. Encourage the establishment of automated information reporting mechanisms in the form of open data interfaces with regulatory departments. In order to build a new model of coordination and cooperation, co-management and governance, and continue to improve the level of drug safety governance. (Reporter Liang Qian)
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