Novartis and Tencent Announce Strategic Collaboration on Digital Healthcare Initiatives

Pharmaceutical Network, September 19 – Tencent and Novartis are collaborating on drug traceability and other areas. Following Alibaba, another internet giant has entered the field of drug traceability.

 

 

On September 18, Novartis China and Tencent officially signed a strategic cooperation memorandum in Shanghai. The two parties announced that they will launch pilot projects in areas such as drug traceability, medication services, disease management, and medical science popularization.

 

 

In other words, Tencent has also begun to engage in drug traceability. Recently, the draft guidelines issued by the National Medical Products Administration mentioned encouraging information technology enterprises to act as third-party technical institutions, providing drug traceability information services to holders, pharmaceutical distributors, and user entities.

 

Furthermore, the marketing authorization holder may either establish its own drug traceability system or engage the services of a third-party technical institution. Drug distribution and usage entities shall cooperate with the marketing authorization holder in constructing the traceability system and upload the corresponding traceability information to the system.

 

It is understood that at present, third-party drug traceability platforms and self-built traceability platforms by pharmaceutical companies coexist. The third-party drug traceability platforms are mainly dominated by AlibabaHealthrepresented by “Ma Shang Fang Xin” and AiChuang Technology’s “linklink,” while a few pharmaceutical companies, such as Harbin Pharmaceutical Group, have also launched their own drug traceability platforms.

 

Take Alibaba Health’s “Ma Shang Fang Xin” platform as an example. It is reported that its primary customers are currently concentrated among pharmaceutical manufacturers, with downstream and midstream pharmaceutical distributors andPharmacyRelatively limited. The function for verifying drug authenticity has been initially implemented, but the traceability and reconstruction of the entire drug distribution process are still under development.

 

However, Harbin Pharmaceutical’s drug traceability platform is primarily designed for staff at pharmaceutical retail outlets, posing certain barriers to consumer use.

 

 

In addition to the fact that the entities responsible for establishing drug traceability systems may be diverse, the Draft for Comments also stipulates that marketing authorization holders of drugs shall select specific coding rules compliant with this standard for coding based on the coding objects.

 

Some experts have stated that this means the future drug traceability industry will feature the coexistence of multiple codes.

 

However, experts recommend that at the national level, a unified coding standard should be adopted in the construction of the drug traceability system, preferably aligned with international standards by using the GS1 (Global Standard 1) standard.

 

Sai Bo Lan (mic366) has learned that the China Chemical Pharmaceutical Industry Association is currently leading efforts to implement GS1 standards for drug traceability. This initiative is also a key priority for the association in the first half of the year.

 

Experts further expressed their expectation that the National Medical Products Administration (NMPA) would adopt the GS1 standard as the national standard. Currently, the GS1 coding standard is widely used internationally.

 

The current mixed standards, or rather the lack thereof, may lead to market chaos. Without a national coding standard, the entire industry remains fragmented and cannot be managed in a unified manner.

 

Furthermore, it must be recognized that regulatory authorities worldwide have established their own drug traceability systems to strengthen pharmaceutical regulation and enhance drug traceability.

 

As for whether the pilot program led by the China Pharmaceutical Industry Association will be further expanded, whether multiple codes will coexist in the long term, and how different entities will respond to potential unification of multiple codes, these issues still await further answers.

 

 

According to the "Guiding Opinions on the Construction of Drug Information Traceability System (Draft for Comments)" released by the National Medical Products Administration on August 24, drug holders, drug wholesale enterprises, and drug retail enterprises each have their own responsibilities in the complete drug traceability chain.

 

 

The marketing authorization holder and entities engaged in the distribution and use of drugs shall each bear their respective responsibilities. The marketing authorization holder and entities engaged in the distribution and use of drugs are the primary parties responsible for drug quality and safety, and they are obligated to ensure traceability.

 

The marketing authorization holder bears the primary responsibility for establishing the drug traceability system. Distribution enterprises and user entities shall actively cooperate with the marketing authorization holder to establish a comprehensive drug traceability system and fulfill their respective traceability obligations.

 

The marketing authorization holder shall fulfill the responsibilities for informatized traceability management of drugs, assign unique traceability identifiers to each level of sales packaging units of the product in accordance with the coding requirements specified by the drug regulatory authorities, so as to achieve informatized traceability.

 

The marketing authorization holder shall provide relevant traceability information to downstream enterprises or medical institutions when selling drugs, to facilitate verification and feedback by such downstream enterprises or medical institutions. The marketing authorization holder shall be able to obtain timely and accurate information on the entire process of circulation and use of the drugs it manufactures.

 

 

Pharmaceutical wholesale enterprises shall request relevant traceability information from upstream suppliers during drug procurement and verify such information upon drug acceptance; when selling drugs, they shall provide relevant traceability information to downstream enterprises or medical institutions.

 

 

Drug retail and usage entities shall request relevant traceability information from upstream enterprises when procuring drugs, and verify such information during drug acceptance; when selling drugs, they shall maintain detailed sales records and promptly update the corresponding status indicators of the sold drugs.

 

Notably, the draft opinion proposes that full coverage of the informatized drug traceability system be basically achieved by the end of 2022. This timeline is seven years later than originally envisioned by the China Food and Drug Administration (CFDA). It can be said that the development of China’s drug traceability system has undergone numerous twists and turns.

 

 

“40 Milestones of China’s Pharmaceutical Reform and Opening-Up,” compiled by the China Pharmaceutical Enterprise Management Association, includes the establishment of a drug traceability system.

 

On February 20, 2016, the China Food and Drug Administration issued an announcement to suspend the implementation of relevant regulations on electronic drug supervision, which meant that the electronic drug supervision code, which had been implemented for eight years, was halted.

 

Just one month prior, Hunan Yangtianhe Grand Pharmacy filed a lawsuit with the Beijing No. 1 Intermediate People's Court, alleging that the China Food and Drug Administration’s mandatory implementation of the electronic drug supervision code constituted an administrative violation and should be immediately halted.

 

Looking back another year, the China Food and Drug Administration issued the "No. 1 Document" titled "Notice onPharmaceuticals“Announcement on Matters Concerning the Comprehensive Implementation of Electronic Drug Supervision by Production and Operation Enterprises,” requiring that full traceability of drug production, distribution, and use be achieved by the end of 2015.

 

Why Is the Vigorously Promoted Electronic Supervision Code Being Discontinued? According to the China Food and Drug Administration, this is primarily because the existing electronic supervision code policy is inconsistent with the requirement to strengthen enterprises’ primary responsibility.

 

However, the plaintiff, Yangtianhe Pharmacy, argued that barcodes and other identifiers for drug authenticity verification and traceability were already present on previous drug packaging, making it unnecessary to implement an additional electronic supervision code.

 

Amid ongoing industry debates over whether to abolish the electronic supervision code, in September 2016, the China Food and Drug Administration (CFDA) issued the “Opinions of the General Administration on Promoting the Improvement of Traceability Systems by Food and Drug Producers and Traders,” which clearly specified the requirements for traceability work and the attribution of responsibility: drug producers and traders shall bear the primary responsibility for establishing drug traceability systems.

 

　　PharmaceuticalsQuality traceability system can help pharmaceuticalEnterpriseBuild a pharmaceutical internet ecosystem platform that integrates data across all upstream and downstream supply chain segments and connects with consumers.

 

As of August 2018, Shanghai and Jiangsu took the lead in implementing pharmaceutical traceability. Drug regulatory authorities in Shandong, Anhui, Hunan, Wuhan, and other regions have successively issued plans for building drug informatization traceability systems, and enterprises are actively advancing the construction of drug traceability systems.