The online pharmaceutical market is booming, and strengthening big data supervision is key to preventing risks

      The COVID-19 pandemic altered public medication purchasing and healthcare-seeking habits, driving rapid growth in online pharmaceutical sales. How to effectively regulate and prevent safety risks will be a key focus going forward.

　　Recently, Li Danrong, Deputy Director of the Data Center of the Southern Institute for Pharmaceutical Economics, State Drug Administration, stated at the Jiangsu First Medical Device Informatization Development Summit and Unveiling Ceremony of Jiangsu Medical Device Big Data Center that in 2020, online sales of retail pharmaceuticals reached 159.3 billion yuan, an increase of 59.1 billion yuan over the previous year, representing a year-on-year growth of 59%. The absolute value of online growth was more than three times that of offline sales.

　　In recent years, relevant departments have continuously encouraged the expansion of online medical service scope, promotingonline and offlinesynergistic development of medical care; promoting the internet-based medical insurance first-visit system and appointment-based triage system; allowing the sale of prescription drugs on third-party platforms to ensure the continuity of online medication purchases after remote consultations; stipulating that qualified internet hospitals can voluntarily "sign contracts" to be included in the medical insurance designated scope through their affiliated physical medical institutions; and implementing consistent online and offline reimbursement policies for "Internet +" medical insurance payments. Driven by these policies, more than 900 internet hospitals have emerged nationwide, with a remote medical collaboration network covering all prefecture-level cities, and more than 5,500 secondary and above hospitals offering online services. This has led to exponential growth in online business, with both internet medicine and online medical device transactions experiencing rapid development.

　　However, the virtual, hidden, easily transferable, and cross-regional nature of the internet increases the difficulty of e-commerce regulation. Illegal cases shifting from offline to online (or combined) also increase the safety risks of medical device and drug use.

　　Currently, there are many compliance risk points in online sales of pharmaceuticals and medical devices. These include a lack of self-protection awareness, unauthorized use of business qualifications by illegal merchants; displaying licenses and permits (mini-programs, mobile apps); exceeding the scope of business operations; failure to publicly warn about products with quality issues or safety hazards; failure to update information in a timely manner (licenses, website qualifications, etc.); and failure to report to regulatory authorities as required. Other compliance risk points include: unrigorous product classification management (prescription drugs, Class II and III medical devices); untimely information tracking (OTC to prescription drugs, adjustments in medical device classifications); untimely updates to instructions for use, with exaggerated advertising; inadequate management of special management or prohibited online sale of drugs; failure to publicly warn about drug use, inadequate pharmaceutical services; and loopholes in commodity promotion management, including bundling and giving away drugs.

　“Management has flaws, and there is a lack of awareness of public safety regarding the use of drugs and medical devices,” said Li Danrong.

　　How can we ensure the safety of medical device and drug use while improving people's livelihood?

　　On June 25, the Jiangsu Medical Device Big Data Center was officially unveiled. Lian Ruqiang, director of the Jiangsu Medical Device Big Data Center, introduced that the Big Data Center is jointly promoted by the Jiangsu Provincial Drug Administration, the Jiangsu Provincial Institute of Industrial Technology, the Gaochun District People's Government, and the Southern Institute for Pharmaceutical Economics of the State Drug Administration. It has currently imported 27 databases related to the medical device field in China, covering data across the entire chain from intellectual property, research and development, production, sales, and regulation, providing important support for Jiangsu's medical device supervision and high-quality industrial development.

　　Through the ecological development of medical device data, the center's data application platform can fully understand the dynamics of medical device market entities and products, collect and plan information related to safety regulation, further carry out trend assessments and policy implementation risk prediction, and present comprehensive information on medical device enterprises in nearly a hundred dimensions using mind maps and data visualization, promoting the transformation and upgrading of Jiangsu's medical device industry, improving the level of scientific regulation, and improving the business environment, driving the industry's continuous, healthy, and orderly high-quality development through big data analysis.

　　Hong Xiaoshun, former party secretary and deputy director of the National Drug Administration Information Center, believes that big data should not only analyze and process collected data to create products, but also use market feedback to feed back into the database, ultimately providing improvement suggestions for enterprise product process transformation and product quality and safety. With the establishment of the big data center, it will surely promote the high-quality development of the medical device industry.

　　“Our goal is to establish a national medical device online sales monitoring platform and system, using information technology to monitor, collect evidence, and deal with online sales of medical devices, improving the government's online safety supervision level for medical devices and ensuring public online medical device safety,” said Li Danrong.

Source: Yicai Global