Medical network February 21 - the state council on December 27, 2016, "" much starker choices-and graver consequences-in" deepening the reform of medical health system planning, in the description of the key tasks emphasizes "to establish perfect drug information tracing system, forming complete varieties, the whole process of full traceability and supervision chain". At the same time, the file mentioned, "should strive to 2020, establish the ex-factory price of basic information traceability system."
The programmatic document for the mechanism of drug traceability reconstruction direction began in early 2016. Interpreted the personage inside course of study to this, the trace behavior change behavior for the enterprise by the government, means to "drug electronic monitoring code" and "drug electronic monitoring network" as the main body of the drug traceability system will be torn down.
The change of policy: from the government's responsibility to corporate responsibility
In January 2016, the general office of the state council issued "important product traceability system construction opinion", the first clear by the pharmaceutical production enterprise liable drug traces the first main body. The indications are that the opinions on the important driving force of what happens at the end of the year in 2015, pharmacy, drug firms collective "challenge" national functional departments, to cancel drug electronic monitoring code events; By the end of the affair "success" to the end, is also accelerated the subsequent creation of relevant documents and the adjustment direction of clear.
In July 2016, the state drug supervision administration issued notice, the involved in the drug supply quality management norms ", "drugs trace" modify the content, the most significant change is deleted the stipulations about the "drug electronic monitoring code".
In September the same year, the state drug supervision administration formally issued "about promoting the food and drug production operator's opinions on improving the traceability system, the core is still emphasize the pharmaceutical production enterprise in drug traces the first subject on the question of responsibility. According to sources close to the country is to promote drug bidding way back technical standards, drug traces the set of rules.
Series of related policies introduced intensive, has clearly reflect the direction of national for drug traceability system. Review of the construction process of national drug tracing system, in 2006, the state drug supervision administration (the former national drug regulatory authority) start building drug traceability system, the system provided by citic 21st century building, technical support, standards and other supporting services, covering varieties from special drugs extend gradually to the prescription and over-the-counter drugs, health to ali to buy citic in the 21st century, with "drug electronic monitoring code" and "drug electronic monitoring network" as the main body of the drug traceability system has been basically forming.
, according to the country by the end of 2016, the national pharmaceutical production enterprise must complete "fu code", but due to the aforementioned reasons, changes abruptly. Contrast before and after the policy change, the most obvious orientation segregation is that, before the government is the main responsibility of medicine back, undertake the task of standards, system structure, drug companies you just need to join the system in accordance with the requirements; After, the enterprise become drug traceability, the main responsibility of the government only for standards and regulatory responsibilities.
This disruptive policy changes, the surface is a "lawsuits", and a deeper endowment is the cause of irreconcilable contradictions between the government and enterprises. Government departments for the traceability system centered on the core demands of safety, security regulatory demands, on the contrary, enterprise management and development from its own perspective.
Changes of the market: from government-led to dominate the market
"About promoting the food and drug production operator's opinions on improving the traceability system regulation: encourage producers and operators to use information technology to establish the food and drug traceability system. Encourage enterprise information technology as a third party, for the production operators to provide professional services product traceability. The food and drug supervision departments at all levels shall not be forced to food and drug producers and operators to accept the designated professional information technology enterprise trace service.
Follow the rules as a drug traceability system construction important basis of "market-oriented", thus drawing a series of changes in the field of subordinate, mainly manifested in two aspects:
A tracing system is set up/provide the diversity of main body. From the original policy and industry practice shows that the context of the new drug traceability system can not only from within the enterprise, also can come from a third party, thus arises:
(1) represented by Harbin pharmaceutical group, such as the pharmaceutical production enterprise self-built system, its advantage is that can meet the personalized needs of their own and the operation data of the "privatization" demand, high cost disadvantage lies in evaluation can be as high as tens of millions of yuan (industry) and the problem of lack of professional;
(2) information technology enterprises as a "third party" to the drug companies to provide standardized system, the main responsibility to "business" to help meet the requirement and regularity;
(3) information technology enterprises play a role of "intermediate" as a "platform", simply speaking, is information technology enterprises, respectively, in the form of "1 - N" docking government departments and the pharmaceutical enterprise, so as to realize the data transmission between them, play to the function of technology service provider.
From government monopoly to competition in the market, we can foresee, in the field of "product" drug tracing system, there will be more and more participants join; And with sufficient competition, in the evolution of the role of the market rule, I'm afraid can only keep one of the few "brand.
Second, the drug tracing system will take "code" as the medium to carry more functionality. When a pharmaceutical production enterprise for traceability system (product attribute) buyers, do not rule out from the position of "buyer's market", according to the requirements for product promotion put forward all kinds of "rationalization" requirements, or to promote the function of tracing system from single to multiple, and even to some extent, can change the traceability system has been labeled the "cost".
, for example, in all the data in the process of drug circulation is expected to realize the value of the future, such as to dynamically grasp the information such as distribution channels, inventory, regional differences, so as to develop targeted response; Even, in data to accumulate scale to form a "big data", will form the possibility of more supply chain support. , of course, only from the dimension of the analysis, has the resources and technical advantages of service provider or "platform" technology will become the mainstream of the future industry.
Accuracy of change: from "the one thing a yard" to "batch management"
On suspicion of unfair competition, drug electronic monitoring code was stopped, but only from the point of view of the trace precision, known as the "drug identification card," said the drug electronic supervision code "yard" thing, certainly at the current drug traces the technological frontier.
National policy guidance is to encourage drug traces the implementation level of "minimum packaging", rather than force, or at the risk of avoid "improper protection" (currently visible to implement "a content one yard third-party enterprise only healthy ali a). But such statements or cause drug traces the overall process of regression. For cost reasons, the enterprise or choose a relatively lower cost of batch management system. "Batch" because there is no guarantee that the "uniqueness", has been proved in many issues exist loophole, such as circulation of goods problems, such as "unauthorized" problems still exist, such as the lack of a strong "one thing a yard" traceability, avoid and control of these problems can only rely on enterprise self-discipline.
Special attributes to determine drug, drug trace the necessity of implementing "one thing a yard", national department never palliative backward due to avoid conflict. From the developing trend of drugs back, "the one thing a yard" beyond "a yard" is inevitable.
First of all, from the international experience: Japan, in 2006 start tracing system construction, for prescription drugs for "the one thing a yard" principle, the overall project has been completed in 2015; The European Union, launched in 2011 the traceability system, for prescription drugs/OTC practice the principle of "one thing a yard", the whole project is expected to be completed in 2017; The United States, in 2015 start tracing system construction, for prescription drugs/OTC practice the principle of "one thing a yard, the whole project is expected to be completed in 2023. Despite the start-stop time of drug traces the construction, but the one thing a yard "has become a common choice, is not difficult to judge the direction of development.
Second, drug traceability system in the future will carry more and more government regulation, for now, involving the drug regulatory department mainly include food drug safety, drug circulation), health development planning commission), and drug safety, health department (health monitoring), the national development and reform commission (price control), apparently "batch management" can't carry such a variety of regulatory requirements.
Only in health monitoring, for example, in the context of "batch management", the target product has the possibility of "secondary sales", providing a space for replacement of the equivalent products. Drug traces the emphasized "origin can be traced back to, to be found out," but the realization of the results must be based on the tracing system of high accuracy rather than a thick line, we hope that relevant departments can balance and develop the detailed back as soon as possible. |
