I finally had time to finish applying Google Translate to the document issued on May 23, 2019 by the Comprehensive and Planning Finance Department of the China National Drug Administration (CNDA), called “State Drug Administration: Action Plan to Accelerate the Promotion of Smart Drug Supervision”. I originally thought “Smart Drug Supervision” was solely related to supply chain supervision, serialization and traceability, but that’s only a part of their plan.
Now that the document is translated (download the English translation here), it’s still not very easy to fully comprehend, but there are a few observations that give me some confidence in my understanding. The document appears to be an action plan for the State Drug Administration (China’s FDA counterpart) that fits into the much larger China government action plan known there as “Internet+” or “Internet Plus”. Internet+ is China’s commitment to expanding the use of the internet and digital technologies to make their country more competitive, and in fact, to surpass the rest of the world in the use of digital technology. Internet+ has a number of branches, including Internet+Manufacturing, Internet+Finance, Internet+Government, Internet+Agriculture and, of course, Internet+Healthcare or Internet+Medical System. That last one is the one this new document focuses on, but it is clearly a part of that much larger program.
These component initiatives mirror others around the world. The German government promoted “Industry 4.0”. You’ve heard of the “Internet of Things” (IoT), or the “Industrial Internet of Things” (IIoT), and now there is the “Internet of People” (IoP) (isn’t that just Facebook?). In Healthcare, western governments have used the term “Digital Health” to refer to the application of new (mostly internet) technology to improve the delivery and accuracy of healthcare, mainly at the provider-patient interface. These all appear to be kind of like parts of China’s “Internet+” plan. The difference is that “Internet+” in China encompasses all of those things at the same time. Being a centrally planned government, they allocate huge sums of money and resources to all of them at the same time, unlike any of the, mostly voluntary, programs in other countries. They appear to be very serious about using Internet+ to leapfrog the rest of the world—particularly the United States—in technology and subsequently economically (see the negative side of that in this video “Inside China’s Quest For Global Tech Dominance”). It’s the new “space race”.
If you doubt China’s ability to leapfrog the United States in a short time, pay close attention to how fast they built the high-tech Tesla Model 3 factory near Shanghai (Gigafactory 3). Tesla signed the deal with the Shanghai government to build a factory 8 months ago. It will apparently be the first factory in China ever to be owned by a foreign company: Tesla, an American company (of course, the financing is from China). They acquired the land six months ago, they broke ground on an open field of weeds and mud in January this year. This is what it looked like on June 22, 2019. They claim the first cars will begin rolling off the production line in September. It’s a race.
BUT DOES IT INCLUDE A SERIALIZATION MANDATE?
OK, but does the Internet+Healthcare plan include a serialization mandate? Yes and no. There is a section that covers “Drug traceability collaborative service and supervision system construction”. In that section the CNDA calls for
“…local regulatory authorities […] to carry out pilot demonstrations in the fields of drug traceability supervision, application of unique identification of medical devices, electronic licenses, production process supervision, and risk analysis, and promote the intelligent upgrading of regulatory measures.”
But, again, they use the phrase “…are encouraged..” rather than “…shall…”. To those of us in the west, that’s not a mandate, but I suspect in China, it is how a mandate might be worded so-as to be less “in-your-face”, but everyone probably knows exactly what it means. Just do it. But I’m not a China expert. It’s just a suspicion.
Task #9 outlined in the document says that the “National Bureau” will establish, a drug traceability collaborative service and supervision system by first,
“…building a drug traceability collaborative service platform, provide public services for enterprises, the public, and regulatory departments, and play the role of ‘bridge’ and ‘hub’ in the traceability system to provide pharmaceutical companies with the basic information of the product, the filing and management services of the drug traceability code coding rules, and the address service of different drug traceability systems, to assist in the interconnection and interoperability of different drug traceability systems, the regulatory requirements of data acquisition, the drug to achieve traceability data cleaning, association and complete traceability data standardization.” (the translation is a little fuzzy here.)
“…build a national drug traceability supervision system to achieve the source of drugs, traceable, emergency recall and emergency deployment. Through the application and summary analysis of drug traceability data, monitor the flow of drugs, and play the role of retrospective information in the work of problem product recall and emergency response mechanism, and further explore the application value of drug traceability information in supervision and inspection, product sampling and daily supervision. Early warning, analysis, and judgment of circulation anomalies.” (Fuzzy here too.)
But China is a lumbering giant, you say? A backward country, it will take them years to catch up to the technologies we here in the United States are about to apply to meeting our Drug Supply Chain Security Act (DSCSA), you say? Under the heading “Promote regulatory transformation and upgrading with technology”, the document says,
“Accelerate the application of new technologies such as mobile Internet, Internet of Things, big data, artificial intelligence, blockchain, etc. in drug smart supervision, strengthen supervision of new formats such as drug network sales, and strengthen upstream and downstream regulatory data collection and information sharing.”
If they build it like they built the Tesla Model 3 factory, we’re about to be left in the blockchain dust.