• China's New Regulation on Health Care and Medical Big Data Might Unlock Online Sales of Prescription Drugs
  • September 9, 2016 | Authors: Stephen E. (Steve) Gillette; Alexis S. Gilroy; Kevin D. Lyles; Cristiana Spontoni; Soleil E. Teubner
  • Law Firms: Jones Day - Palo Alto Office ; Jones Day - Washington Office ; Jones Day - Columbus Office ; Jones Day - Brussels Office ; Jones Day - San Francisco Office
  • On June 21, 2016, the State Council of the People's Republic of China issued a circular titled Opinions on Promoting and Standardizing the Application and Development of Health Care and Medical Big Data ("Opinions"). The Opinions state that China aims to promulgate a regulatory framework for sharing and protecting health care and big data and to establish a cross-department data-sharing structure by the end of 2017. In addition, industry insiders believe that China might eventually lift the ban on online sales of prescription drugs in 2018.

    The Opinions state that China will accelerate the establishment and consummation of a database that centers on electronic health records, medical records, and prescriptions; opening up the channels for data sharing and building such a data-sharing platform will have a profound impact on the digital health and telemedicine industry. Under the current structure of China's health care industry, hospitals hold most prescription information, and prescriptions can be issued only by licensed pharmacists. Selling prescription medicine has long been a "forbidden zone," beyond the reach of most telemedicine operators. According to the draft Measures Regarding the Administration of Drug Information Service over the Internet ("Draft") issued by the China Food and Drug Administration in 2014, telemedicine operators can sell prescription drugs by prescription only under the rules governing medicine classification. While the Draft is viewed by the industry as the legal authorization for selling prescription drugs online, the industry has failed to see a breakthrough since 2014.

    The Opinions could be a green light to the industry to authorize selling prescription drugs online. The sharing of electronic prescriptions, if accomplished, would make it possible to release hospitals' prescription information to qualified recipients. This will benefit the digital health and telemedicine industry tremendously. How the Opinions would be implemented is unclear and remains to be seen.