On November 14, CFDA issued the measures for the Supervision and Administration of online Drug Operation (draft for soliciting opinions) (hereinafter referred to as the draft for soliciting opinions), which once again made the pharmaceutical e-commerce industry feel the cold winter. In this nearly 6000-word document, there are two key messages: first, Internet platforms are not allowed to sell prescription drugs; second, websites that sell drugs to individual consumers are not allowed to publish prescription drug information through the Internet. The scale of China's prescription drug market is nearly one trillion yuan. The industry has been looking forward to the release of online prescription drugs. Many pharmaceutical e-commerce companies even "rush" in violation of regulations. However, this draft for comments can be described as pouring cold water on the industry.

    Online and offline illegal sales of prescription drugs

After experiencing the noise of "double 11", the pharmaceutical e-commerce companies who had not had time to compete for performance suffered a head-on blow. On November 14, CFDA issued the Measures for the Supervision and Administration of Online Drug Operation (Draft for Comments). This opinion draft, which some industry insiders call the "retrogression" of the pharmaceutical e-commerce regulatory policy, has made stricter regulations on the online sale of prescription drugs. Among them, it is required that "online drug sellers who are drug batch retail chain enterprises shall not sell prescription drugs or drugs with special management requirements of the state through the Internet"; "websites selling drugs to individual consumers shall not publish prescription drug information through the Internet." Industry insiders believe that according to the draft opinion, the door to the online sale of prescription drugs that the industry had been looking forward to has been closed, and the intention of the regulatory authorities is very obvious: medicine is a big deal, and supervision will only become stricter.

In fact, although prescription drug supervision has been shouting and shouting, online and offline violations are not uncommon. A reporter from Nanfang Daily conducted an investigation at the beginning of last year and found that prescription drugs sold illegally were easily bought in nearly ten online pharmacies. In response, the Guangdong Food and Drug Administration pointed out that the Food and Drug Administration has always attached importance to the supervision of Internet drug trading companies, but there are problems in the supervision, such as imperfect laws and regulations, failure to implement the main responsibility of enterprises, and weak consumer awareness of safe drug use.

And offline pharmacies are also the hardest hit areas for illegal sales of prescription drugs. "clove garden", the largest doctor community in China, recently conducted a small survey, inviting members of clove garden forum to choose 2 kinds of prescription drugs from the list, including roxithromycin, amoxicillin, levofloxacin eye drops, quick-acting heart-saving pills, zhenju antihypertensive tablets and betaloc, to see if they can be successfully purchased in offline pharmacies. among 42 participants, 40 people successfully purchased prescription drugs in offline pharmacies, one of them only bought proprietary Chinese medicines (prescription drugs), while western medicines had to be prescribed. There are 2 people completely failed to buy. Among the netizens participating in the activity, there is no lack of first-tier cities in Beishangguang.

Mr. Chen, a member who participated in the event, said that he bought azithromycin dispersible tablets and levofloxacin eye drops at the price of 35.5 yuan and 37 yuan respectively in a relatively large chain drugstore in Guangdong, which cost a total of 72.5 yuan. At the time of purchase, the clerk asked to register the ID number, but never mentioned the prescription. Like Mr. Chen, there are a small number of people who need to register their ID card information. Most people just "take the medicine and pay for it" and leave when buying prescription drugs. The whole drug purchase process is unimaginable.

In addition, some members have successfully purchased prescription drugs on several pharmaceutical e-commerce platforms through online orders, and no prescription is required.

    Pharmaceutical e-commerce or seek transformation

According to incomplete statistics from the Ministry of Commerce, the total sales of my country's pharmaceutical e-commerce reached 47.6 billion yuan (including medical devices) in 2015; it quickly climbed to 61.2 billion yuan in 2016. While the pharmaceutical e-commerce is heating up rapidly, it also exposes the existing problems: such as illegal sales of counterfeit and shoddy products; illegal sales of prescription drugs; exaggerated publicity and non-drug impersonation of drugs are common; pharmaceutical services are not in place, and distribution links are risky. From this perspective, it is not difficult to understand why the CFDA banned the sale of prescription drugs online.

The relevant person in charge of Dingxiangyuan pointed out that it is more urgent and necessary to introduce targeted and operational supervision measures. In fact, there are many mature models of online drug sales abroad. Take the United States as an example, the implementation of the system of separation of medicine, pharmacies will strictly classify and manage prescription drugs and over-the-counter drugs. Prescription drugs must be sold with a (electronic/paper) prescription from a U.S. physician. If a pharmacy sells prescription drugs without a prescription, or if a doctor prescribes them to a patient at will, it will be a felony. At the same time, each pharmacy can check the registration data of all doctors in the United States from the Internet computer. If the prescription is not sure whether it is prescribed by a doctor, the salesperson needs to call the doctor and verify it before selling the medicine. In order to ensure the authenticity of the prescription label, in addition to signing the name, the doctor must also press the fingerprint in the "doctor's fingerprint area" in the lower left corner of the prescription label for verification, so that the prescription label is officially effective. The pharmacy must check the ID card information and confirm the prescription information before giving the medicine, and then register it. The advantages of this are: first, it can strictly manage prescription drugs; second, pharmacies can grasp customer medication information, so as to provide better services, such as finding adverse reactions and early drug recalls; third, it can cultivate fixed customer groups.

In addition, the U.S. government has also created a public drug sales platform, where online drug dealers sell drugs on the platform after backstage approval. After placing an order, consumers go directly to the nearest physical store to pick up the medicine. This online and offline integration model effectively solves the problems of drug safety, transportation links, and difficulty in purchasing drugs.

It is reported that on November 23, a conference on "International Comparative Study of Internet Drug Management and Regulatory Policies" was held at the State Food and Drug Administration to listen to the opinions of the industry. According to a person attending the meeting, "it is estimated that there will be another year from the draft for soliciting opinions to the landing of the policy, and the opinions of various provincial bureaus will be collected in the middle, and it is expected that there will be a gap between the final policy introduction and the draft for soliciting opinions." Liu Qian, founder of the invited Unicorn Studio, wrote an article entitled "The Life and Death of Pharmaceutical E-commerce", pointing out that if the final draft of the policy still chooses the most conservative position, pharmaceutical e-commerce is not completely dead. For example, it can transform to an Internet hospital, completely integrate into the drug distribution system of offline hospitals or temporarily abandon the drug business.