The "Measures for the Supervision and Administration of Drug Online Sales" (hereinafter referred to as the "Measures") issued by the State Administration for Market Regulation will come into force on December 1, 2022.

The "Measures" stipulates the management of drug online sales, platform responsibility performance, supervision and inspection measures and legal responsibilities.

The document clarifies that seven categories of drugs are not allowed to be sold online, and online sales of prescription drugs are subject to a real-name system.

  Specifically, the "Measures" require the online sales of prescription drugs to implement a real-name system, and to conduct prescription review and deployment according to regulations; it is stipulated that prescription drugs and non-prescription drugs should be displayed separately, and it is clear that packaging, labels and other information should not be directly displayed on the main page and home page of prescription drug sales; Before passing the prescription review, no information such as instructions shall be displayed, and services related to the purchase of prescription drugs shall not be provided, which is intended to emphasize the management requirements of "prescription before drug" and prescription review.

  Prescription drugs have always dominated the pharmaceutical sales market.

Data shows that from 2015 to 2020, the compound annual growth rate of online retail prescription drug sales in China was 53%, of which the growth rate from 2019 to 2020 reached 79%, and the market size in 2020 will reach about 25 billion yuan.

  Previously, "selling medicines" through consultation and guidance was the source of profit for some Internet medical companies.

For example, when some Internet medical apps provide prescription drug sales services, although users are required to upload prescription certificates, the prescription review system is useless.

It is not uncommon for a user to upload a photo without any text and completely irrelevant to the prescription when submitting a drug purchase request.

The pattern of falsely reviewing prescriptions and purchasing medicines before supplementing prescriptions has existed for a long time.

The profit-driven model promotes excessive drug use, which brings hidden dangers to both medical quality and patient safety.

  The state has continuously strengthened the supervision of online sales of prescription drugs.

In June this year, the "Internet Diagnosis and Treatment Supervision Rules (Trial)" was officially released. The rules also clarified that when medical institutions conduct Internet diagnosis and treatment activities, the prescriptions should be issued by the receiving physicians themselves, and the use of artificial intelligence to automatically generate prescriptions is strictly prohibited.

It is strictly prohibited to provide a drug to a patient before a prescription has been issued.

It is strictly forbidden to make prescriptions or supplements for commercial purposes.

  The relevant person in charge of the Medical Federation stated that the "Measures" mentioned that "drug online retail enterprises shall not directly publicly display information such as prescription drug packaging and labels on the main page or home page of prescription drug sales. Provide services related to the purchase of prescription drugs”.

That is to say, it is necessary to "prescribe the prescription before the medicine", and this requirement is in line with the "Detailed Rules for the Supervision of Internet Diagnosis and Treatment (Trial)".

"The online sales of prescription drugs has gone through three stages: clear prohibition, open exploration and orderly release. The clarification and refinement of regulatory requirements provides a path for the development and construction of the industry, and facilitates the promotion of healthy development." said the relevant person in charge of the Medical Association. .

  According to Zhao Rui, an expert in quality control management of Weimai Internet Hospital, the announcement of the "Measures" consolidates the third-party platform's responsibilities in the supervision and management of drug quality, distribution, and prescription circulation, as well as the responsibilities of entering pharmacies to review qualifications, sign, file, and trace. .

The "Measures" emphasize the display and sales management of prescription drugs. Before passing the prescription review, the platform shall not display information such as instructions, nor provide services related to the purchase of prescription drugs, which will help to prevent the behavior of "buying drugs first and then replenishing prescriptions".

"We have seen that the final "Measures" have also improved the punishment compared to the previous draft. Overall, the national regulatory authorities are formulating more detailed management measures for the online sales of drugs, which is not conducive to eliminating the chaos in the industry. For third-party platform companies, it is necessary to continuously improve the supervision mechanism, invest in quality supervision teams and professional pharmacist teams, strengthen information traceability management such as drug logistics, and ultimately consumers’ safety and rights will also be guaranteed. Guaranteed." Zhao Rui said.

  The State Administration for Market Regulation stated that it is necessary to implement the "four strictest" requirements and strengthen the supervision measures of supervision departments at all levels.

Clarify the division of responsibilities of drug supervision and administration departments at all levels in the supervision of online drug sales and the jurisdiction to investigate and deal with illegal acts, require strengthening the monitoring of drug online sales, and investigate and deal with illegal acts found in monitoring according to their duties in accordance with the law.

Strengthen the control of drug safety risks, and if there is evidence to prove that there may be potential safety hazards, it is clarified that the drug regulatory authorities can take measures such as warnings, interviews, rectification within a time limit, and suspension of production, sales, use, and import.

In addition, the "Measures" also clarified the corresponding legal responsibilities for illegal online sales of drugs in accordance with the law.

  Beijing Business Daily reporter Yao Qian