钛媒体注:本文来自链得得App新推出的区块链技术分析系列栏目【大文观链】,由链得得App独家作者马文佩,对区块链、数字货币市场中前端技术方案进行应用层讲解与热点事件的技术层分析。每个工作日与大家一同分享“链圈技术宅”的那些头脑日常。
titanium media note: from the series of technical analysis of block chains newly launched by App from the chain [Maternal View], with App's exclusive author, Mavenpe, performing a technical layer analysis of application-based interpretation and hotspot events at the front end of the block chain and digital money market. & & ldquao; the chain-circle technology house & rdquao; those brain routines are shared with everyone every working day.
七月中旬,一起性质恶劣的医疗丑闻引爆了舆论。国家领导人、地方负责人先后做出批示,对涉事企业进行严查,给老百姓一个交代。
In mid-July, a terrible medical scandal triggered public opinion.
在对涉事企业的口诛笔伐中,对监管机制的反思也成为了争论的热点,我国药品、医疗监管又一次面临巨大的信任危机。在舆论发酵的过程当中,与“信任”息息相关的区块链也被不少人当做了解决问题的良方。
Rethinking regulatory mechanisms has also become a hot topic of debate in the context of the rhetoric of the enterprises involved, and there is yet another huge crisis of trust in medicine and medical regulation. In the process of public opinion fermentation, the links with & ldquao; trust & & rdquao; and the link to the boom have also been used by many as a way of solving the problem.
23日,李笑来在微博上宣称区块链技术可以用于疫苗溯源和保真。在李笑来公布他的想法之前,7月13日,疫苗事件仍未曝光的时候,创业板公司易联众董事会秘书李虹海在一次信息披露活动中表示,公司已经与蚂蚁金服通过区块链技术在疫苗溯源、处方外流等方面开展合作。23日,易联众开盘涨停。
On 23 March, Li laughter announced on Twitter that block chain technology could be used for vaccine traceability and preservation. On 13 July, before Li laughter announced his idea, when the vaccine incident had still not come to light, Li Yonghai, Secretary of the Board of Directors of the Enterprise, stated in an information disclosure campaign that the company had cooperated with the ant gold suit through block chain technology in the areas of vaccine traceability and prescription outflows.
除了对现有溯源体系的不信任外,市场看好易联众的原因还包括阿里对区块链溯源体系的构建经验。去年11月,天猫宣布其境外商品的跨境溯源服务正式上线。
In addition to the mistrust of the existing traceability system, the market is easily connected by Ali's experience in building the block-chain traceability system. Last November, Skycat announced that its cross-border traceability service for goods outside its borders was officially online.
在这个场景中,支付宝用户从天猫针对来自澳洲、新西兰26个商品、奶制品,提供了关于每一瓶奶制品的身份证的溯源码服务。支付宝用户扫一扫溯源码可以清晰地看待这个奶制品从生产商到整个物流,包括质检、海外仓到国内仓库,包括生产日期、流转日期的全链路的端到端的商品流通的记录。
In this scenario, paying treasure users provide an identification card service for each bottle of dairy products from Skycat for 26 commodities and dairy products from Australia and New Zealand. A clean-up of paying treasure users provides a clear view of the chain-to-end flow of this milk product from the producer to the logistics as a whole, including quality checks, offshore warehousing to domestic warehouses, including the end-to-end of the entire chain on the date of production, date of transfer.
而更早些时间,今年6月份,顺丰就对外发布了“顺丰医药供应链‘方案+’”和“顺丰医院‘方案+’解决方案”。方案中就包含了顺丰医药溯源平台并且已经实现落地。
Earlier this year, “ &lsquao; &rsquao; &rdquao; and & & & & & & & & & & & & & & & & & & & & & & & & & & & & & & & & & & & & & & & & ; the solution & & & & & & & & & & ;. The program includes and is already in place.
将区块链技术引入疫苗溯源体系中,究竟有没有必要?区块链能解决问题吗?首先我们需要对现有的疫苗溯源体系有一些大体的认识。
What is not necessary to introduce block chain technology into vaccine traceability? Does block chains solve the problem? First, we need some general understanding of the existing vaccine traceability system.
疫苗作为国家医疗卫生体系的关键一环,始终受到全世界各国的高度重视。在疫苗问题上,几乎全世界都对其实行了最严格的监管,整体安全性要求高于治疗性药品。2011年和2014年,中国疫苗监管体系通过了世卫组织参照国际标准对各国的监管体系进行的定期评估,宣布发现中国疫苗监管体系达到或超过了世界卫生组织关于按照国际标准运作的全部指标。这意味着中国的疫苗企业可以申请特定产品预认证。通过世卫组织预认证表明特定产品的生产符合国际质量、安全和有效性标准;只有通过了预认证的疫苗才能参加联合国儿童基金会(UNICEF)用全球疫苗和免疫联盟(GAVI)资金进行的疫苗采购。
In 2011 and 2014, China’s vaccine regulatory system adopted a regular WHO assessment of national regulatory systems in line with international standards, declaring that China’s vaccine regulatory system met or exceeded all WHO targets for operating in accordance with international standards. This means that China’s vaccine industry can apply for product-specific pre-certification.
我国的药品溯源体系是在2016年修订的《药品经营质量管理规范》中规定建立的。规范规定,
Our drug traceability system was established by the Code for the Management of Quality in the Operation of Drugs, as amended in 2016.
“企业应当在药品采购、储存、销售、运输等环节采取有效的质量控制措施,确保药品质量,并按照国家有关要求建立药品追溯系统,实现药品可追溯。企业应当建立能够符合经营和质量管理要求的计算机系统,并满足药品追溯的要求。”
& ldquo; an enterprise should take effective quality control measures in the procurement, storage, sale, transportation, etc. of medicines, ensure their quality, and establish a drug traceability system in accordance with the relevant requirements of the country, allowing for their traceability. An enterprise should establish a computer system that meets operating and quality management requirements, and meet the drug traceability requirements. & & rdquo;
在追溯系统之前,我国医药行业使用的是药品电子监管码,即药品包装上的20位数字的条形码,可以实现药品从生产到流通各个环节的全程跟踪。在《药品经营质量管理规范》中被叫停,更换为自建的追溯系统。
Prior to the retroactive system, the pharmaceutical industry in our country used the electronic drug control code, the 20-digit bar code on the drug package, which allows for the complete follow-up of medicines from production to circulation.
但实际上,链得得大文手边的一盒生产于同年10月的药品包装上依然印着这个过期的药品电子监管码。
In practice, however, a box of pharmaceutical products produced with a large print chain in October of the same year still bears the outdated electronic regulatory code for the drug.
当然,除了企业自建之外,也有一些第三方企业提供的药品追溯平台。2016年阿里健康上线了其旗下的第三方药品信息追溯平台“码上放心”,其可追溯产品除了药品之外还包括食品、酒类、生鲜、保健品、农牧产品等。
There are, of course, a number of drug-retroactivity platforms offered by third-party firms, in addition to their own. The third-party drug-retroactivity platform & ldquo & & & rdquo &, in 2016, Ali’s health is on the line; its retrospective products include, in addition to medicines, food, alcohol, fresh food, health products, agricultural products, etc.
也就是说,目前的药品溯源机制是由企业自身建立,或主动为第三方提供数据建立的。这样的体系毫无疑问是中心化的,其可信任程度值得打一个问号。
In other words, the current drug traceability mechanism is established by the enterprise itself, or by providing data to third parties on its own initiative. There is no doubt that such a system is central and that its degree of trust is worth a question mark.
对于目前的药品溯源系统来说,其问题主要来自于三点:
For the current drug traceability system, the problem arises mainly from three points:
1、 数据是否可信的问题。一方面,企业自建的溯源系统全部掌握在企业自身手中,造假几乎毫无成本。另一方面,第三方溯源机制非常忠实的发挥了它的作用,生产企业一旦对源头数据造假,溯源机制就形同虚设。实际上,本次的疫苗丑闻最初就来自于国家药品监督管理局在检查中发现该企业冻干人用狂犬病疫苗生产存在记录造假的问题。
On the one hand, the company's home-grown traceability system is in the hands of the enterprise itself, with little cost. On the other hand, the third-party traceability mechanism plays its role faithfully, and once the producer falsifies the source data, the back-up mechanism becomes ineffective.
2、 溯源体系中“码货分离”作假掉包的问题。以目前向公众开放的第三方溯源系统“码上放心”为例,链得得大文扫描了某药品外包装上的“码上放心溯源码”,随后出现了该药品的详细信息:
& & ldquao; code separation & rdquao; question of counterfeiting. uses the third-party traceability system currently open to the public & & & rdquao; for example, the chain has a large text-scanning & ldquao on an overpack of a drug; the code & rdquao; and detailed information on the drug has subsequently emerged:
由该溯源系统可知,这个盒子的确是真的。但是其里面的药呢?生产厂家不能把条码印在药片上,也就不能保证药品在流通过程中没有被掉包。目前的药品溯源系统中,条码和RFID(射频识别)的应用范围最广,但依然无法避免造假的可能性。
It is true that the box is real, as can be seen from the system. But what about the medicine in it? The manufacturer cannot print bar codes on the pill, nor can it guarantee that the drug will not be switched in the course of the flow.
3、供应链复杂的问题。药品供应链虽然在强监管之下,但依然免不了“人多手杂”。这条长而复杂的供应链上包括了原料供应、制药厂商、运输、储存、经销商、药房、医院、病区、患者等角色。复杂的供应链带来了复杂的利益关系,在这个过程当中,制药厂商只是其中的一部分,其追溯系统一方面无法顾及整个供应链,缺乏头部信息,另一方面也缺乏一个可信任的第三方对整个生产流通环节进行监控和监管。
The supply chain of is a complex issue. The supply chain of drugs, while under strong regulation, is still unstoppable & & & & & & & & & & & >. This long and complex supply chain includes the roles of raw material supply, pharmaceutical manufacturers, transport, storage, distributors, pharmacies, hospitals, disease zones, patients, etc. The complex supply chain brings with it complex interests, in which pharmaceutical manufacturers are only part of a process in which the retroactive system fails to take into account the entire supply chain and lacks head information, on the one hand, and a trusted third party is lacking to monitor and regulate the entire chain of production flows.
那么,在这种情况下,区块链技术能够做什么呢?
So, in this case, what can block chain technology do?
首先,区块链是一个去中心化的系统。IDHUB创始人曲明在接受采访时告诉链得得大文,区块链技术毫无疑问可以在企业、供应链、监管、社会监督或消费者之间建立一条去中心化、可信的公有链,将药品数据上链。
First, the
在区块链药品监管和溯源体系中,药品的生产和流转信息将被记录为数据块,添加到链条中,每个区块有一个独特的加密哈希,用于跟踪该区块以及相关链条中的其他区块。区块中的数据不允许修改,彻底杜绝了在生产和供应链中出现造假的可能性。
In the block chain drug control and traceability system, information on the production and flow of drugs will be recorded as a data block and added to the chain, each block with a unique crypto-Hashi to track the block and other blocks in the chain. Data in the block will not be allowed to change, eliminating the possibility of forgery in the production and supply chain.
其次,上链的数据可以包括药品的详细信息。这些数据可以包括产品生产信息:包括产地、生产批号、生产日期、有效期等;还包括产品的运输信息:物流批次、运输环境、储藏环境等;最后,详细信息中还可以包含产品的流转信息:产生厂商、经销商、药房、医院、病区等。
Second, data on the upper chain of data may include information on the production of products: origin, lot number, date of production, period of validity, etc.; transport information on products: logistics batch, transport environment, storage environment, etc.; and, finally, details may also include information on the flow of products: manufacturer, distributor, pharmacy, hospital, disease area, etc.
去年9月,基因工程(GeneTech)和辉瑞(Pfizer)等制药公司联合推出了基于MediLedger区块链药品追踪项目,并进行试点应用。该项目旨在将制药商、批发商和医院等药品供应链上的节点都能够在区块链上记录药品流转数据以利用区块链证明药品的原产地和运输数据。
In September of last year, pharmaceutical companies such as GeneTech and Pfizer jointly launched and piloted the MediLedger block chain-based drug tracking project, which aims to make it possible to record drug flow data on the sector chain on the supply chain of pharmaceutical products such as pharmaceutical manufacturers, wholesalers, and hospitals to prove drug origin and transport data using the block chain.
最后,除了流转数据上链对药品进行溯源之外,曲明认为,区块链技术可以在药品监督和管理方面做得更多:构建一个去中心化的、独立的第三方监督体系,避免了供应链、生产和监管部门之间的利益纠葛影响到溯源系统的可靠性。曲明认为,将区块链技术引入药品、食品监管,乃至于将区块链应用于政务数据中,将逐步构建一个独立于监管机构的、去中心化的、绝对可信的第三方监管平台,最终成为政务信息化、透明化的改革抓手。
Finally, in addition to the traceability of medicines in the chain of flow data, it is argued that block-chain technologies can do more in drug monitoring and management:
这样看,相对于目前采用的中心化的追溯体系,将区块链技术引入其中的确可以减少中心化带来的种种弊端。但是,区块链技术就能够避免疫苗事件的再次发生吗?
In this way, the introduction of block chain technology into a centralized system, as opposed to the one currently in use, would certainly reduce the disadvantages of centralization. But, would block chain technology prevent the recurrence of vaccine incidents?
我们回头看看这次疫苗事件的根源:
We look back at the root causes of the vaccine incident:
2017年11月,国家食品药品监督管理总局通报在抽检中发现长春长生百白破疫苗效价指标不达标。2018年7月,国家药品监督管理局通报长春长生狂犬病疫苗生产记录造假。在通报中,药监局表示长春长生编造生产记录和产品检验记录、随意变更工艺参数和设备,违反药品管理法和药品生产质量管理规范。
In November 2017, the Directorate-General for the Supervision of Food and Drugs reported that, in the course of a test, it had found that the price index for long-term life was not satisfactory. In July 2018, the Directorate-General for the Supervision of Drugs informed him that the records of production of long-term rabies had been falsified. In the circular, the Directorate-General for the Control of Drugs indicated that long-term life-long production records and product-testing records, random changes in process parameters and equipment were in violation of the law on the management of medicines and the norms governing the quality of drug production.
也就是说,在这次事件中,对于涉事企业编造生产记录、产品检验记录的情况,区块链技术也毫无价值——上链的数据本身就是编造的,再可靠的溯源系统也形同虚设。
In other words, in the event of the incident, the block chain technology was of no value to the enterprises involved in compiling production records and product testing records & mdash; & mdash; chain data were themselves fabricated, and the re-reliable traceability system was also non-existent.
超脑链Ultrain创始人郭睿在接受采访时告诉链得得大文,区块链技术虽然能解决一部分问题,但在这次事件中表现出的漏洞显然不是能够依靠技术解决的。
In an interview, Mr. Guo, founder of Ultrain, told the chain that, while block chain technology could solve some of the problems, it was clear that the loopholes displayed in the incident could not be resolved by technology.
同样,他也认为,将区块链技术引入监管系统中也并不能解决传统中心化溯源系统中存在的溯源体系中“码货分离”作假掉包的问题。如何将药品映射到链上,保证链上数据与药品本身严格对应仍然是需要进行研究的。
Similarly, he argued that the introduction of block chain technology into the regulatory system would not solve the problem of dating systems that existed in traditional centralized traceability systems & & ldquo; code separation & & rdquao; counterfeiting. How to map the drug into the chain, ensuring that the data on the chain corresponded strictly to the drug itself would still need to be studied.
综上所述,将区块链技术引入药品溯源系统同样会面临着传统溯源系统面临的问题,仅仅能做到改善目前的状况而已,不能指望区块链应用到药品监管系统后能够解决所有问题。但从另一个角度来说,区块链对于药品监管系统的核心价值是提出了一个较传统系统更为完善的解决方案,将溯源体系“去中心化”,引入社会、消费者的共同监督,从而实现生产厂商、消费者、监管部门的交叉验证,从而提高犯罪分子的犯罪成本,达到减少类似恶性事件发生的目的。同样,这种去中心化、多方监管的机制也能够有效的避免2016年疫苗案中出现的监管缺位的情况。
In conclusion, the introduction of block chain technology into the drug traceability system faces the same problems as the traditional traceability system, which merely improves the current situation and cannot be expected to solve all problems when the block chain is applied to the drug control system. But, from another perspective, the core value of the
区块链技术虽然应用场景广阔,但它并不是万能的。在更多情况下,引入区块链技术的意义在于打破传统的“中心化”模式,将机构和社会运作透明化,从而提高效率、降低信任成本。但同时业界也需要警惕,一些不法分子通过“炒概念”、吃“人血馒头”的方式渲染“区块链万能论”,从而实现“割韭菜”的真正目的,将真正做事的、优秀的区块链项目从市场中驱逐出去。(本文独家首发链得得)
In more cases, the introduction of block chain technology means breaking the traditional & ldquo; centralizing & & rdquo; models that make institutions and societies more transparent, thereby increasing efficiency and reducing the cost of trust. At the same time, industry also needs to be vigilant, with some outlaws passing through “ ” ” & & ldquao; & & ldquo; & & & & & ; & & & & & & & & ; & & & & & & & & & & ; & & & & & & & & & & & ; the real purpose of & & & & & & & & & & & & ;,, &,, & & & & & & & & & & & & & & & & & & & & & & & & & & & ; & & & & & & & & & ; ; & ; & & & & & & ; ; ;, ;,,, & & & & &,,, &,,,, & &,, &, & & &, &,,, &,,,,,,,,,, ),,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,
本文原发布于链得得,授权钛媒体App发布,作者:大文
This paper was originally published in the chain of events, authorizing titanium media to publish at App.
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