A new system design of online drug management

Source: medical economic news November 17, 2017 with the gradual popularization of wired network, wireless network and mobile network in China, online drug business has ushered in two upsurges of development The first upsurge occurred around 2000, with the rise of various health websites In 2005, in order to implement the opinions of the general office of the State Council on accelerating the development of e-commerce (Guo ban [2005] No 2) issued by the State Council and standardize the purchase and sale of drugs, the State Drug Administration issued the Interim Provisions on the examination and approval of Internet drug trading services The second upsurge occurred today Telemedicine and remote trial have become the norm in the industry In February this year, the State Council issued some opinions on further reforming and improving the policy of drug production and circulation, which was carried out by the State Council [2017] 13 Internet plus drug circulation was strategically planned Recently, the State Food and Drug Administration began to solicit opinions from the whole society on the measures for the supervision and administration of online drug trade (Draft for comments) (hereinafter referred to as the draft for comments), which is not only the revision of the Interim Provisions on the approval of Internet drug trade services, but also a lot of new system designs, which will also affect the future The development of Internet medicine trade in a certain period Simplify procedures, improve circulation efficiency and reduce transaction costs (1) simplify the supervision object into sales behavior and platform service First of all, the draft simplifies the second type of drug Internet transactions (drug manufacturers and wholesale enterprises trade drugs with enterprises other than their own members through their own websites, B2B) and the third type of drug Internet transactions (drug retail chain enterprises provide Internet drug trading services to individual consumers, B2C) in the Interim Provisions on the examination and approval of Internet drug trading services into "Online drug sales activities" Then, it defines "online drug trading platform service" as "a network system that provides trading services for both parties in online drug trading activities" This definition includes not only the first type of drug Internet transaction (providing trading platform for drug manufacturers, drug wholesalers and medical institutions) in the Interim Provisions, but also the platform providing trading services for drug sales to individual consumers In this way, the regulatory process can be simplified into online drug sales management and online drug trading service platform management, and the regulatory thinking is clearer, which can also reduce the transaction cost of the enterprise's political license (2) simplify administrative licensing procedures and strengthen information disclosure In the draft, the relevant provisions of the State Council on the cancellation of the administrative licensing procedures for class I, class II and class III drug Internet transactions will be clearly defined as "the filing management of provincial food and drug regulatory authorities for information related to online drug trading enterprises." However, the enterprise is required to actively publicize the relevant qualification, filing certificate, contact information of the enterprise and displayed drug qualification information on the homepage of the website or business activities, and associate the relevant certificate information with the data query page of the State Food and drug administration On the one hand, it reduces the entry threshold of enterprises participating in the online drug trade, which is conducive to more enterprises participating in the online drug trade and the emergence of more business formats; on the other hand, it also ensures the legitimacy of the business through information disclosure, which is conducive to ensuring the safe use of drugs by patients Strengthen the whole process management to ensure the safety of drug use (1) emphasize the principle of online and offline consistency For online drug distribution, the draft clearly requires to follow the "quality management specification for drug distribution" and establish a drug traceability system Especially for consigned drug wholesale enterprises or consigned third-party enterprises, it is also necessary to implement the "quality management standards for drug distribution" In this way, it is beneficial to bring the network drug management into the whole process management and realize the closed-loop quality management However, it will be more difficult to supervise the delivery of drugs by consigned express companies (2) forbid the network to sell prescription drugs and release information to patients The release of prescription drugs from Internet sales is a hot issue in the Internet plus drug circulation However, the draft did not let go of this provision, but made more stringent provisions than before The third paragraph of Article 8 stipulates that "if the online drug seller is a drug retail chain enterprise, it is not allowed to sell prescription drugs or drugs with special management requirements by the state through the Internet" In addition to the original B2C ban on prescription drugs, this regulation further clarifies that drugs with special management requirements of the state are not allowed to be sold to patients through the network The more significant change is that Article 12 prohibits B2C mode from promoting prescription drugs, that is, "websites selling drugs to individual consumers shall not publish prescription drug information through the Internet" This means that there is no chance for licensed pharmacists to review prescriptions in the online drug sales (3) positioning quality management and online pharmaceutical service for licensed pharmacists in online pharmaceutical trading The word "licensed pharmacist" appeared four times in the draft, while the "Interim Provisions on the examination and approval of Internet drug trading services" only appeared once First, the service requirements of the online drug trading platform are "having a drug quality management organization, with more than two licensed pharmacists to undertake the drug quality management work", and the number of licensed pharmacists is required for the relatively large-scale online drug trading platform In addition, it also stipulates that the platform providing transaction services to individual consumers "shall have the functions of online pharmaceutical service and consumer evaluation", so as to facilitate the retail chain enterprises to meet the system requirements when selling drugs to patients   Second, the original interim provisions only explicitly required that "licensed pharmacists should be responsible for online real-time consultation" for B2C mode, while the draft for comments made it clear that "online pharmaceutical service system should be established, licensed pharmacists should be equipped, and rational drug use should be guided", institutionalized online real-time consultation of licensed pharmacists, and stipulated that "licensed pharmacists registration" should be displayed on the homepage of website or business activity homepage Certificate Because B2C mode only allows the sale of over-the-counter drugs, the main role of licensed pharmacists is to guide the rational use of over-the-counter drugs Obviously, this is more stringent than the requirements of offline physical drugstores However, the draft does not make clear whether the licensed pharmacists are full-time professional posts or can practice more, which may be due to the unbalanced development of licensed pharmacists in various provinces, giving local governments certain administrative discretion Third, the number of licensed pharmacists is short of punishment terms The draft only stipulates in Article 44 that the registration certificate of licensed pharmacist shall not be displayed, and the administrative penalty that can be given is "order to make corrections and impose a fine of not less than 5000 yuan but not more than 20000 yuan" There is no specific penalty clause for the unqualified provision of licensed pharmacists, which is easy to make the provision of licensed pharmacists fail The division of labor is clear, and the innovation of supervision means (1) the system design of division of labor is carried out, and the supervision process is straightened out First, data sharing between departments, judicial transfer Article 33 of the draft puts forward a tentative plan for data sharing and cooperative handling of cases among public security organs, Internet information departments and communication management departments The specific mechanism needs to be implemented in actual operation Second, we should decentralize power and strengthen regulatory efficiency In Article 3 of the draft, it is specified that the national drug regulatory department shall be responsible for the "supervision and administration of national online drug distribution" and the Municipal Drug regulatory department divided into districts shall be responsible for the "supervision and administration of online drug distribution within its own administrative region" In addition, in Article 10 and 19, it is specified that the provincial drug regulatory department shall be responsible for the filing of enterprise qualification information and issue the Filing Certificate In this way, the daily supervision of online drug distribution is mainly in the charge of the Municipal Drug Supervision and administration department which is close to the enterprise, which is different from the original Interim Provisions Third, to cover the blind spots of supervision and realize closed-loop supervision The biggest challenge faced by the network drug business is that there is no boundary between wired network, wireless network and mobile network Once there is a problem, there will be no supervision Article 30 of the draft puts forward a solution to this problem: "if the business address can be determined, the local food and drug administration shall investigate and deal with it; if the business address cannot be determined, the local food and drug administration shall transfer the illegal website to the communication administration for handling." (2) innovate the regulatory means to realize the regulatory means specified in the draft of intelligent regulatory consultation emphasizing the role of big data Article 32 proposes to establish a "network drug trade monitoring system", and Article 38 proposes that "technical monitoring records and information traceability data of network drug trade activities" can be used as evidence of administrative penalties and administrative coercive measures Conclusion: the draft for consultation is conducive to the implementation of the requirements of the State Council for "release of drug administration service", the safety and effectiveness of patients' drug use, and the strengthening of the allocation of licensed pharmacists and the realization of intelligent supervision However, it will also face the challenges of new business forms, such as telemedicine (medical institutions sell drugs to patients), remote audit party, and "online ordering store access" and "online ordering store delivery" stipulated in the No 13 document of the State Council How to ensure the safety of drug use for patients and promote the development of online drug trade is a long-term research topic.