Antigen test kits are hard to find, but selling them on social media is illegal.
Compiled from: Jiangxi Court
After the 'New Ten Measures' were announced, community epidemic prevention and nucleic acid testing were no longer carried out on a large scale as before, but turned into precise prevention, scientific epidemic control, and appropriate relaxation. However, some people took advantage of the 'relaxation' to find loopholes, seizing the opportunity to sell antigen test kits and various medicines such as fever-reducing drugs in their social circles. Among them, many bought low and sold high, and some were even deceived in the process.
Case review
On March 30, 2020, the National Medical Products Administration issued the "Regulatory Requirements and Standards for Novel Coronavirus Test Reagents and Protective Equipment in China," classifying novel coronavirus test reagents as Class III medical devices.
In addition, according to the "Notice from the General Office of the National Medical Products Administration on Properly Carrying Out Quality and Safety Supervision of COVID-19 Antigen Test Reagents," during the epidemic prevention and control period, retail pharmacies and medical device business enterprises that have obtained a drug business license or medical device business license and have corresponding storage conditions may sell COVID-19 antigen test reagents.
The Jiangxi High Court reminded that enterprises are the main operators of Class III medical devices and must obtain a medical device business license. Individuals cannot engage in the business of Class III medical devices (including Class II), and it is illegal for individuals to sell COVID-19 antigen test kits on social networks such as WeChat Moments.
If the antigen test reagents sold by an individual are counterfeit or substandard products, or if they are sold as genuine products while actually being fake or unqualified products pretending to be qualified, and the sales amount is relatively large, it may also constitute the crime of producing and selling counterfeit goods.
"Criminal Law of the People's Republic of China"
Article 140 [Crime of Producing and Selling Counterfeit or Shoddy Products]
Producers or sellers who adulterate products, pass off fake products as genuine, inferior products as high-quality, or substandard products as standard, with sales amounts between 50,000 and 200,000 yuan, shall be sentenced to fixed-term imprisonment of not more than two years or criminal detention, and shall also, or solely, be fined between 50% and two times the sales amount; for sales amounts between 200,000 and 500,000 yuan, the penalty shall be fixed-term imprisonment of not less than two years but not more than seven years, along with a fine between 50% and two times the sales amount; for sales amounts between 500,000 and 2 million yuan, the penalty shall be fixed-term imprisonment of not less than seven years, along with a fine between 50% and two times the sales amount; for sales amounts exceeding 2 million yuan, the penalty shall be fixed-term imprisonment of 15 years or life imprisonment, along with a fine between 50% and two times the sales amount or confiscation of property.
Regulations on the Supervision and Administration of Medical Devices
[6] Article 42
For those engaged in the operation of Class III medical devices, the operating enterprise shall apply for an operating license to the department responsible for drug supervision and administration of the municipal people's government at the district level where it is located, and submit the relevant materials that meet the conditions stipulated in Article 40 of these regulations.
The department responsible for drug supervision and management that accepts the application for a business license shall review the application materials, organize verification if necessary, and make a decision within 20 working days from the date of acceptance of the application. If the conditions prescribed by regulations are met, a license shall be granted and a medical device business license issued; if the conditions prescribed by regulations are not met, the license shall not be granted and the reasons shall be explained in writing.
The operating license for medical devices is valid for 5 years. If an extension is required upon expiration, the renewal procedures shall be handled in accordance with the relevant laws and regulations on administrative licensing.
[1] The author's perspective
In recent years, many supplies have been linked to the trends of the COVID-19 pandemic. For example, in the early days, masks sold out overnight, and they were hard to come by. Now that restrictions have gradually eased, and with fewer nucleic acid testing sites, every household buys some antigen test kits in preparation. However, the kits were once in short supply, leading some people to raise prices, selling them at double the cost, or forcing the bundling of other items, and more extremely, counterfeits and substandard products appeared. This not only disrupts the market economy but also affects social stability. Therefore, Chinese laws and regulations have early on restricted the operators of such test kits and the extent to which prices can increase, to prevent skyrocketing prices from impacting people's livelihood. However, many people, seeing the immediate profit in this industry, are tempted to make a quick buck. Moreover, with the relatively mature development of micro-businesses, they think they can earn money in their social circles, but they overlook that certain special laws and regulations have specific provisions for such goods, making them unknowingly commit illegal acts. As the saying goes, a gentleman loves wealth, but acquires it through proper means. No matter what business you engage in, you must first be aware of the legal boundaries, which is also the baseline of morality.
