Over the past weekend, the issue of falsifying vaccine production records has become the focus of public opinion in the whole society. While leaving countless parents worried, anxious and even angry, it has also triggered a new round of questioning: what can we do about this issue involving the health and safety of children other than severe punishment for the enterprises involved According to the vaccine safety incidents in recent years, there are both data fraud in the production process and uncontrolled circulation, and the closed operation of the whole system makes it difficult for the public, especially the most concerned parents, to intervene and supervise From the perspective of the vaccine enterprises involved in this case, the regulatory authorities have launched a case investigation as early as October 2017, and the relevant results have been notified to relevant provinces and cities. However, the closed operation of the information did not give enough attention to some relevant provinces until after this public opinion The closure of a more open, transparent and traceable system of vaccine surveillance by recording fake circulation in production will help improve the current situation of vaccine safety Of course, technology isn't everything, but when it comes to children's health and safety, a 1% improvement is worth a try This paper attempts to explore whether blockchain can create a more transparent and safe environment for the supervision of vaccine production and circulation |
Vaccines have become a national topic, shocking and heartbreaking, and everyone has been searching for the root cause of the problem and how to solve it for a long time. This fake vaccine incident has exposed many problems in the existing vaccine industry
1、 Enterprises are unauthorized to fabricate production records and product inspection records, and change the process parameters and equipment at will, but in the backtracking of the case, it can not be confirmed which part of the record is false.
2、vaccine cold chain distribution is self monitoring by logistics enterprises, and supervision is not perfect from production to transportation.
3、The circulation and sale of vaccines are corrupt and difficult to prosecute.
4、regulatory information is not public, only in the pharmaceutical supervision system.
5、after the vaccine is out of question, it is difficult to trace the whereabouts of the vaccine, and the supervision of the circulation is not enough.
In the midst of the controversy, there is a growing clamour on the vaccine chain. Although some discussions have marketing intentions, it is still worth exploring whether the traceability of blockchain drugs can make the vaccine more reassuring
1、Introduce block chain tracing
Introduce block chain tracing
The traceability system of domestic vaccines and other drugs has been tested as early as 2005. The former state food and drug administration cooperated with citic 21st century technology co., ltd. to build an electronic drug regulatory platform in China
Its particular way is, for each drug sales smallest unit printing Chinese medicine electronic supervision code (code), from manufacturers to distributors at all levels to terminal link such as pharmacy, every drug outbound inbound approved verification records need to sweep code in order to ensure drug end-to-end traceability and sales terminals will be equipped with a digital certificate (key), used to query information in detail
But the system has also raised questions about the centralised storage model used in traditional traceability, in which who maintains the books as the centre becomes the key issue
Whether it is the preservation of the source enterprise, the preservation of the channel business or the preservation of the government, as they are all interested parties in the circulation chain, when the accounting information is unfavorable, such enterprises may choose to tamper the accounting book to invalidate the traceability process
In February 2016,The former state administration of food and drug administration suspended the electronic supervision of drugs. On July 28, 2016, the newly revised GSP removed the related description of the electronic regulatory code and replaced it with the establishment of a drug traceability system in accordance with the relevant requirements of the state to achieve drug traceability
Mechanism conjecture of block chain tracing system
In essence, block chain technology is an untamable database technology of historical records, which provides a new tool for tracing the source
It has the characteristics of decentralization and non-tampering. It does not rely on an organization or individual, and USES credible technology to record all information publicly on public accounts
Once untamable information is established, it is equivalent to determining the unique identity of the physical world's goods in the Internet world, and realizing all tracking and records based on this identity flow
Whether it is presented to consumers or cooperated with the country in the traceability recall of important products, blockchain provides a very good solution
As a result, governments and pharmaceutical distributors around the world are increasingly applying blockchain to solutions that improve security and traceability in their supply chains
There have been many attempts to trace the origin of blockchain drugs in the United States: the FDA began to track prescription drugs using the blockchain in March 2017
In May 2017,A group of companies led by genentech, a pharmaceutical giant, and Pfizer have announced the MediLedger project, which aims to create blockchain tools to manage the drug supply chain, allowing organisations such as wholesalers' hospitals to use blockchain to register all drug-related information and ensure maximum traceability
Through the introduction of block chain, it is necessary for each participant to control the nodes on the network and each transaction requires a consensus, so as to ensure that the products start from production and in all links of the supply chain, and gradually establish the standards consistent with block chain traceability from production quality inspection, warehousing, circulation and inoculation
From the perspective of information flow, all information is in the block chain and the permission of authorized nodes to access information access depends on the role and functions of participants in the supply chain
其另外一个核心功能是在医药产品追溯中实现特殊和隐私数据的隐私保护。药企不愿意共享很多特殊信息给其他人，区块链技术就能使存在于不同药企的信息通过区块链共享出来，同时保证了信息的安全。
The transformation of supply chain by block chain can be divided into the following steps：
1、Pharmaceutical companies can attach RFID tags to drugs, and each batch of drugs is assigned a unique identification number, including its identification number and stored parameter information such as temperature guarantee period, to monitor and review the status dynamics and product flow in real time 2、At each stage of the supply chain, participants can use the identification code to write the drug flow information to the authorized nodes of the block chain. When trading with another node, the two nodes need to reach a unified agreement and digital signature 3、The cold chain - time temperature indicator label and other iot equipment are used to accurately monitor the cold storage conditions of vaccines, and the chain storage certificate is under the supervision of a third party authority 4、Consumers can get accurate information about the direction of medicine by scanning the code |
In the process of traceability, the product information document can contain the following aspects
1、Product specification information: the required information can display the product production process files, including batch production lines and other information, and is also the most concerned information of the consumer role
2、Product liability party information: the list of authorized participants should be kept up to date in chronological order
3、Timestamp: when a new input record is generated in the product information document, the system will automatically record the time point of information input, providing protection against tampering
4、Location information: in order to understand the logistics route of the product, when a participant enters the product information, the system will record the corresponding geographical location with the location information of the participant. The conditional system can provide accurate location information through GPS data
在此系统下，最大的作用就是把数据搬到链上，使数据可溯源，防篡改，补齐现有数据断点：
1、Precision and recall: in the block chain system, if the drug in the process of transportation interruption or missing, and stored in the data on the distributed books can provide fast track channel for all parties, locate drug last block chain traceability system will be a detailed record of drug information, can be specific to a particular batch when drug problems, can achieve precise recall
2、Clear accountability: if each node coordinate block chain and cover scope of information, to produce vaccines by the department of examination and approval of vaccine production enterprise sales vaccine dealers purchasing vaccine of the centers for disease control and the use of vaccines hospital doctors all included in the system, regulators can according to the relevant information on the supply chain traceability problem of link, the liability for the problem
Ideally, medicines in the supply chain can be traced back to the procurement of raw materials
2、Intelligent contract
The state food and drug administration of the People's Republic of China has issued a GMP(production quality management standard certificate) to each pharmaceutical enterprise. GMP is a set of compulsory standards applicable to the food industry of pharmaceutical enterprises. It requires enterprises to form a set of operational norms from the aspects of quality control of packaging and transportation of raw material personnel facilities and equipment to help enterprises improve their health environment
If the issuance of GMP certificate is embedded in the block chain traceability chain, if the enterprise fails to meet the requirements, the GMP certificate will be automatically revoked. Once the certificate is revoked, the production operation of the pharmaceutical enterprise will be stopped automatically and the corporate credit record will be recorded tamperably, which will be associated with the enterprise credit and other information to further increase the cost of evil
On the contrary, if the enterprise can keep good reputation, it can speed up the application and approval process of GMP through credit score
3、Trust concerns: there are three obstacles to drug traceability in block chain
The emergence of block chain drug traceability system provides a good start for drug traceability
However, technology is only a tool, and the problems at the technical level are very simple. However, problems other than technology are very complex, and it is impossible to eliminate the following obstacles to trace the drugs in the blockchain during the incubation period of all violations due to the intervention of technology
Obstacle 1: the problem of origin fraud and subcontracting
Blockchain can only provide information technology, and cannot solve the problem of counterfeiting and dropping packets
Obstacle 2: reliability of data sources
In other words, it can guarantee that the uploaded data will not be tampered with, but it cannot guarantee that the data itself will not be true due to human factors. Besides legal and moral constraints, it also needs to cooperate with other sensor technologies of the Internet of things to collect the original data
Obstacle 3: stakeholder involvement
Drug supply chain is a complex system, which involves the sharing intention of various stakeholders. It still needs some education work to guide the enterprise chain
Conclusion:
Blockchain is only a tool, which cannot change the phenomenon of artificial fraud, but through the introduction of more technical means of a multi-party transparency system, it can enable the producer and supervisor consumers to cross-verify the data and form a more binding supervision mechanism
It is not easy to solve the security problems in the pharmaceutical field by simply relying on technology
To drug safety as a first step, is to make the drug information for each patient transparent vaccine is one of the greatest invention in the modern society, it put an end to the infant mortality is high and keeps people out of the fear of disease, we can't because the vaccine system, will reject even refused to this great invention forward to under the continuous improvement of the legal and technical system, national can regain confidence in the system of vaccine