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Project

The system of marking of drugs is not ready to full start - RUIE

Customers: Federal Tax Service (FTS)

Moscow; Government and social institutions

Federal Service for Surveillance in Healthcare (Roszdravnadzor)
Moscow; Government and social institutions

Product: FSIS (individual development)
Second product: Fair Sign

Project date: 2017/01

According to World Health Organization, about 700,000 people annually perish from the counterfeited drugs sold to them. Any country is not insured from this trouble. Trade in counterfeited anticarcinogenic medicines is especially developed. By estimates of the World Economic Forum, the universal cost of counterfeit pharmaceutical products in 2017 exceeded $200 billion.

2019

Unavailability of a system of marking of drugs to full start

The Russian Union of Industrialists and Entrepreneurs (RUIE) addressed the prime minister Dmitry Medvedev and the speaker of the State Duma Vyacheslav Volodin with letters in which it declared unavailability of a system of marking of drugs to implementation on January 1, 2020. Both letters are signed by the president of RUIE Alexander Shokhin, reported on October 8, 2019 RBC.

Marking of drugs

According to RUIE, by September 1, 2019 more than 28 million packagings of 5370 medicines are marked. Upon completion of implementation the system of marking will have to monitor about 6.5 billion packagings of drugs and cover over 1 thousand producers.

Despite "the large volume of works" on preparation for implementation of marking since January 1, 2020, in the letter the "objective circumstances" interfering completion of its implementation are noted. Among them — significant increase in defects when marking, "the sensitive growth" of cost value of medicines, imperfection of the uniform reference book directory of drugs, lack of regulation of data exchange of participants of marking with a federal information system, negative results of tests on drawing marking with 44 signs of the cryptocode at the enterprises and other problems.

«
Above-mentioned factors do not allow to estimate readiness degree as high, said in the letter.
»

At the same time in RUIE declare "high degree determination" markings of the drugs entering the 7 nozologiya program. It is about the most expensive medicines for treatment of genetic and oncological diseases.

In RUIE the number of the participants registered in a system (about 15% of the planned quantity) and also number of the drugs entered into the system (8% of expected volume) caused "serious concern". Such situation, said in letters, speaks about "high risks" for full implementation at the same time of all stages of functioning of a system since January 1, 2020.

According to information from 228 Russian drug manufacturers which is provided by RUIE from 788 production lines only 45% are completely equipped with the equipment for marking.

Among problems which faced during the experiment the producers producing medicines worth up to 20 rub, drawing the identifier with the cryptocode in 44 signs.

«
In this case the problem can be solved due to code injection from 20 characters — it is offered in the letter.
»

RUIE notes that it will allow to use the available equipment without replacement or completion.

Completion, according to the Union of Industrialists and Entrepreneurs, is required also by the Uniform reference book directory of medicines. In it there are no medicines which are contained in the State Register of Medicines that caused impossibility of their registration.

Among other problems in the letter are called lack of regulatory legal acts which would provide the mechanism of inclusion of payment of service in providing codes of marking, lack of regulation of data exchange with an information system and lack of IT solutions for elimination of this problem.

Roszdravnadzor explained that for October, 2019 the scheme of interaction of monitoring of the movement of medicines and the Uniform qualifier of drugs is developed.

«
Correct information will come to the system of marking, and time of starting data on medicines will be significantly reduced,
speaks the adviser to the head of Roszdravnadzor Olga Maleva
»

According to her, market participants insist on strict observance of terms and "oppose transfer of a project startup".

The offered scheme of interaction of a system of marking and the uniform qualifier of drugs was announced also by the CEO "Operator-TsRPT" (the operator of a system of digital marking) Dmitry Alkhazov. According to him, direct integration will allow to remove the current discrepancies. Alkhazov rejected a problem of increase in defects much about he in which letter tells RUIE.

«
Platforms are located as in Russia, and abroad, 1.8 million packagings of drugs with a cryptopart from 44 characters are already produced — the CEO of operator of marking explained, having added that the company is responsible for its implementation at the scheduled time.
»

Minpromtorg said that conduct full-time employment with drug manufacturers, including about difficulties and problems at monitoring system implementation. The ministry noted that based on testing the cryptocode is reduced to 44 characters and producers achieved high-quality printing and the low level of defects.

«
The term of system implementation of monitoring is established by the law as on January 1, 2020. Till October, 2019 the issue of change of terms was not discussed — emphasized in the ministry.
»

The chief information officer of TsV "Leaked" Victor Gorbunov declared the companies technology determination. According to him, the level of readiness of big networks is rather high. Victor Gorbunov considers that you should not postpone marking date.

«
The project already goes three years, the industry was tired of waiting. It is necessary to start since January 1. For the first half a year all issues will be resolved in an operating mode, and everything will earn as it is necessary — it is optimistic.
»

The CEO of Neofarm network Evgeny Nifantyev also agrees with it.

«
Nevertheless knew that January, 2020 will come. Who did not manage to be connected yet — hands in legs and to join. It is not necessary to deceive himself postponement, it is necessary to prepare sledge in the summer — he told.
»

Other market participant, the president of Akrikhin company Denis Chetverikov, sees the negative scenario in case of postponement of date of implementation of marking.

«
Then it turns out that all those costs, both financial, and time which we incurred will be unjustified. And we not the only Russian company which is at the high level of readiness. If there are market participants who did not manage to make everything in time, it is their wine. Postponement will create an unfair situation[1],
concludes Chetverikov
»

Testing of the IC MDLP with solutions 1C

The Center of Development of Perspective Technologies (CDPT) and 1C Company announced on February 4, 2019 conducting joint testing of upgraded versions of software products "1C: Retail. Drugstore", "1C: Management of pharmacy chain" and products of the line "1C: Medicine" with support of an information system of monitoring of the movement of medicines (ICs MDLP).

For the purpose of development of the IC MDLP in versions of software, relevant for February 4, optimization current and completion of the new business processes implemented in a system including taking into account proposals of participants of turnover of medicines is performed.

The most important updating is the possibility of free merchandising of medicines between the registered and unregistered participants of turnover. Now the registered participants do not need to wait when in a system their partners and partners are registered, and it is possible to automate completely the business processes taking into account marking. This opportunity significantly reduces an implementation time of a system of marking and traceability as in separate companies, and in general on the industry, emphasized in TsRPT.

Solutions 1C use special library for integration with MDLP. It allows to provide unity of methodical and interface solutions and also timely support of changes. On the basis of the documents of an inventory control created in program 1C documents for data transmission in the MDLP FSIS system are created. It allows to organize data exchange with MDLP FSIS without double entry of data.

All developers on the 1C:Enterprise 8 platform can use this integration library that will allow to support quickly a FSIS of MDLP not only in solutions which are issued by 1C Company, but also in numerous developments for the pharmaceutical market which are offered by partners of 1C and independent developers, said in TsRPT.

«
Now the registered participants of an experiment thanks to the corresponding functionality can announce that they implement medicines to the participant of turnover who is not registered in a system. Existence of a broad spectrum of the domestic software which is specially intended for automation of process of marking of drugs gives to participants of the pharmaceutical market all opportunities for successful preparation for start of obligatory marking — the product area director of Pharm of TsRPT Anton Kharitonov told.
»

2018

As the system of marking of drugs in Russia will work

In December, 2018 the prime minister Dmitry Medvedev signed four documents — three resolutions and one order — which defined an implementation order in Russia of the system of marking and tracking of medicines. Documents will give the chance to implement the changes made in December, 2017 to the law "About Drug Circulation". Resolutions are dated on December 14, the order — on December 18. Texts of documents can be found on the website of the government.

The first resolution fixes regulations on a monitoring system of medicines. According to the document, drug manufacturers should apply on their primary and secondary packaging special means of identification, and their carriers, distributors, sellers, etc. should enter information on drugs into a monitoring system of the movement of these goods. Such marking becomes obligatory since January 1, 2020.

According to other resolution, given which contain in a monitoring system of the movement of medicines should be published in the Internet "including in the form of open data". The resolution becomes effective since October 1, 2019.

According to the order of the government, Operator-TsRPT LLC became operator of a monitoring system of the movement of drugs. TsRPT should become operator of a single system of goods marking which is going to be created in Russia by 2024.

The last resolution concerns features of creation of a monitoring system of the movement of drugs. According to the document, all legal entities and the SP involved in turnover of drugs against hemophilia, a mukovistsidoz, hypophysial nanizm, disease to Gosha, malignant new growths lymphoid, haematogenic and related to them fabrics, multiple sclerosis and also applied after organ transplantation or fabrics should be registered in a monitoring system from July 1 to July 8, 2019. Further, if the new legal person begins to participate in turnover of such drugs, it and will have seven days on registration.

As it is explained on the website of the government, vital and essential drugs and also medicines for treatment of rare diseases should be entered into a monitoring system first of all. As the prime minister at a meeting of the government commission on digital development noted, these are quite expensive medicines, besides, them not really much.

Within 21 days after registration in a monitoring system these legal persons provide the readiness for information exchange with a system and send to the operator of a system the request for passing of the corresponding testing. Then within two months after testing they enter into a monitoring system data on drugs — since October 1, 2019.

According to the same resolution drug manufacturers who are engaged in their packaging and other owners of registration certificates of medicines should send to the operator of a monitoring system the request for receiving the device of registration of issue of means of identification of drugs and receiving remote access to these devices. It should be made within 21 days from the moment of registration in a monitoring system.

Those participants of turnover of drugs who do not trade in them at retail should submit the application for receiving registrars of leaving to the same time, and release free of charge or at a discount, bringing thus out of turnover.

In return the operator of a monitoring system should provide applicants with devices of registration of issue of means of identification of drugs. Having it can be done provided remote access to such registrar which is in infrastructure of the operator. Also the operator is responsible for providing applicants with registrars of leaving. Registrars should be provided within 30 days from the date of obtaining requests. Applicants sign with the operator agreements, "containing, including conditions of providing such equipment and its procedural service on a grant basis".[2]

Transfer of a FSIS of MDLP on the Fair Sign platform

On November 1, 2018 the information system of monitoring of the movement of medicines (ICs MDLP) passed from Federal Tax Service of the Russian Federation into a single national system of marking and tracing of goods Fair Sign. "The center of development of perspective technologies" ("Operator-TsRPT") became operator of a system. Read more here.

5.5 thousand participants and 700 medicines are registered

As the deputy manager of Roszdravnadzor Valentina Kosenko told on May 15, 2018 in St. Petersburg within the Russian Pharmaceutical Forum, marking of medicines already at a stage of a pilot project confirmed the efficiency. In particular, individual marking at a stage of a pilot project allowed to reveal offenses for the total amount over 500 million rubles. In addition to identification of "a repeated throw", implementation of marking provides counteraction to illegal production of medicines, to their illegal import and turnover, prevents unfair competition in the field of turnover of medicines and also allows to standardize and unify accounting procedures of deliveries and distribution of drugs.

Everything, for May, 2018, over 5.5 thousand participants and 700 medicines are registered.

Vladislav Shestakov, the director of FBU "The State Institute of Medicines and Ought the Practician" of the Ministry of Industry and Trade of the Russian Federation so commented on intermediate results of transition to marking of medicines: "By 1/1/2020 connection of 99% of licensees to a monitoring system is expected. 5 enterprises (1% from a total quantity) are not in time to fixed term and are going to connect a system during 2020. It is obvious that implementation of marking will continue also after 2020, however according to producers, all medicines of paramount value from lists 7VZN and ZhVLNP will be in a monitoring system exactly to the termination of the Pharma-2020 program.

The amount of substandard medicines in network decreased twice

In January, 2018 the head of Roszdravnadzor Mikhail Murashko reported that in 2017 the quantity of poor-quality products, medicines in network decreased more than twice.

«
Offenses which are connected with illegal sale on the Internet were revealed. A large number of criminal cases was opened both on counterfeited, and on substandard, unregistered to products: to medical products and medicines, - quote Murashko RIA Novosti[3].
»

Roszdravnadzor expects to win by the end of 2020 against a counterfeit and a counterfeit the licensed network of drugstores<i> (a photo - statnews.com)</i>
Roszdravnadzor expects to win by the end of 2020 against a counterfeit and a counterfeit the licensed network of drugstores (a photo - statnews.com)

Earlier in January he reported that thanks to marking it was succeeded to reveal crimes in the field of the address of medicines for the amount more than 100 million rubles[4].

Mikhail Murashko also predicted that by the end of 2020 in Russia the counterfeit and a counterfeit will not get to the licensed network of drugstores in general.

According to the Federal Tax Service (FTS), since the beginning of an experiment in February, 2017 as of January, 2018 in the system of marking of drugs about 1 thousand the largest representatives of a pharmotrasla are registered and about 3.5 million packagings of medicines are marked[5].

Prolongation of an experiment on marking of drugs

In January, 2018 the chairman Governments of the Russian Federation Dmitry Medvedev signed the resolution on prolongation of an experiment on marking of separate types of drugs till December 31, 2018.

Later the head of Roszdravnadzor Mikhail Murashko explained that increase in time for an experiment on marking of drugs will allow producers of medicines to be prepared better[6].

«
Deputies of the State Duma considered necessary to prolong the implementation term (the system of marking) for one year … it, of course, will give additional a period of time for training of all producers and the pharmaceutical organizations, - quote Murashko RIA Novosti.
»

2017

Postponement of term of obligatory marking for 2020

In December, 2017 deputies of the State Duma changed the term of obligatory marking of drugs — since 2019 for 2020. Producers asked time[7] until 2023]. Earlier in November ten producers of inexpensive drugs addressed the speaker of the lower house of parliament Vyacheslav Volodin with a request to delay marking implementation.

They insisted that its implementation since 2019 will lead to disappearance of inexpensive drugs as they do not manage to buy the special equipment, and much of them lack for it means.

Start of equipment manufacturing by Rostec for marking of drugs

The State Corporation Rostec within development of "digital" health care announced on October 16, 2017 start of serial production of the equipment for marking of medicines. The operator of the project appoints the Center of development of perspective technologies. The project investment cost, according to the industrial director of a radio-electronic cluster of State Corporation Rostec Sergey Kulikov, exceeded 20 million euros.

Capacities of two enterprises of Avtomatika concern where 8 types of the equipment intended for serialization, aggregation and applique of control signs will be issued are involved in production process. Further based on these plants it is going to unroll a service and repair depot.

As explained in Rostec, the created equipment is still focused only on the market of medicines. It is expected that it will allow to control origin of drugs and to reveal poor-quality, counterfeit products on counters of drugstores — using the special protective mark on packaging. However technical competences which the Avtomatika concern will receive in localization process will allow to create further the similar equipment and for other commodity groups.

As you know, the foreign equipment used for marking of medicines — more expensive and costly in operation. In the localized equipment a considerable part of technical elements and nodes will be the Russian production that will allow to reduce its price and cost of ownership. In particular, by estimates of Sergey Sakhnenko, the CEO of Automatic equipment, the solutions made by concern will be about 40% cheaper than foreign analogs.

He also specified that as of October 16, 2017 process of creation and testing of pilot samples and also formalizations of design documentation is complete while the start of serial production is planned for December, 2017.

During 2018 it is going to supply to the market to 1200 different sets of the marking equipment for pharmproizvoditel and distributors of means of marking, Sergey Kulikov added.

Obligatory marking of drugs

Obligatory marking of 100% of medicinal products will be entered since January 1, 2019 within the priority project "Implementation of an Automated System of Monitoring of the Movement of Medicines from the Producer to the End Consumer for Protection of the Population against Counterfeited Medicines and Operational Removal from Turnover of Counterfeit and Substandard Medicines".

The monitoring system will monitor about 8 billion packagings of medicines a year and, presumably, will cover over 350 thousand participants of turnover among whom — about 1 thousand domestic and foreign manufacturers of medicines, more than 100 thousand medical and 250 thousand pharmaceutical organizations.

Since January 1, 2017 marking of medications in Russia is performed in a voluntary order, on an experimental basis.

Start of the program

On January 30, 2017 the prime minister Dmitry Medvedev during the meeting with Deputy Prime Ministers announced signing of the document which gives start to the mechanism of marking of packagings of drugs special codes. According to him, it is a part of work on counteraction to turnover of counterfeited, counterfeit products.[8]

In Russia the start is given to the project on marking of packagings of drugs by special codes
In Russia the start is given to the project on marking of packagings of drugs by special codes
«
It is absolutely obvious how it is important to trust security and quality of medicines that drugs were this, but not counterfeit. Today we initiated creation of a special automated system which will allow to trace all stages of the movement of these products: from the producer to drugstore or hospital. As a result any person using the special device, the scanner in drugstore or the smartphone if it has such and there the program is installed, will be able to check origin of packaging, to be convinced that it is legal, but not some counterfeit products, - the prime minister noted.
»

«
However, before introducing such system through the whole country, it is necessary to test its opportunities, to reveal potential problems, and already according to the results of an experiment to make the decision on obligation of marking for all market participants - producers, distributors, pharmacy chain, - Medvedev added.
»

According to the Deputy Prime Minister Arkady Dvorkovich, direct contractors are Roszdravnadzor and the Federal Tax Service – regarding an information system. Eventually all medical institutions, all trade organizations and also producers of medicines and distributors will be participants. 100% of the produced drugs are about 6 billion packagings.

The fact that tracking at circulation of medicines will be performed irrespective of the nature of packaging is basic. So for example, it is not necessary to unpack the full large parties for check of each specific medicine. Control will be exercised in large packagings at pass through a production line, by deliveries to wholesale warehouses, in medical institutions and retail chain stores.

In total, it is approximately about 350 thousand participants of turnover. It is about one thousand producers (about a half – domestic, a half – foreign), about 100 thousand medical institutions and about 250 thousand other organizations.

At the first stage a system will pass the approbation period. Participation in a system will be voluntary within one year. Already now, according to Dvorkovich, declared key producers of medicines determination to participate in this work, including vital. Also readiness was confirmed by the main distributor networks and a number of the largest regions, including Moscow. In Moscow work will begin with Zelenograd which is a part of Moscow and a part of the Moscow region.

It will be possible to read out the corresponding tags both own phones, and scanners. The equipment for municipal drugstores will buy the city authorities. Private drugstores when there comes the obligation period, will have to purchase scanners at own expense.

Project pluses, according to Dvorkovich, are first of all that protection against counterfeit turnover, turnover of counterfeited products will be provided, so, the producer will win. And at the expense of this prize they will have an opportunity to remove from the price an additional margin which is established today to be insured from risk of turnover of counterfeit products so, eventually cost value and the profit of the relevant organizations should not suffer, the Deputy Prime Minister considers.

«
But all this will be approved within a year during an experiment. The preliminary results will be summed up on December 1, 2017, - he noted.
»

Dmitry Medvedev added that scanners should be definitely tested, sealed that there was a guarantee that there will be no unauthorized penetrations and attempts via these scanners to sell counterfeited drugs.

«
It will be checked in the coming months. The pilot period is for this purpose necessary, - Dvorkovich explained.
»

As expected, the information system will be ready by June, 2017, respectively, all main actions will be performed in the second half of year. Till this time it is going to coordinate actions of all participants of turnover all knew how a system what effects of detection of counterfeited products functions.

«
Informing citizens and also patients of medical institutions how all this works will be performed. Thus, we hope for serious, social including, effect, - the Deputy Prime Minister added.
»

«
Effects should be clear: if counterfeited medicine which by means of this scanner or some other way is defined as a counterfeit, as counterfeit medicine is delivered, investigation – as administrative, and, quite possibly, criminal should be initiated, - Dmitry Medvedev concluded.
»

The experiment on marking of medicines is made within implementation of the priority project "Implementation of an Automated System of Monitoring of the Movement of Medicines from the Producer to the End Consumer for Protection of the Population against Counterfeited Medicines and Operational Removal from Turnover of Counterfeit and Substandard Medicines" which passport was approved at a meeting of presidium of Council at the President of Russia for strategic development and priority projects on October 25, 2016.

According to the document, in 2017 the experiment on a voluntary basis will be made, and in 2018 it is going to cover marking 100% of the medicines which are in civil circulation.

  • By 12/31/2018 it is going to cover individual marking 100% of medicines.
  • For providing requirements participants of turnover of medicines should implement at the enterprises the system of traceability with transfer of data in MDLP FSIS.
  • The functional customer – the Russian Ministry of Health
  • The operator of a system – FTS

Approach of 1C to the solution of integration tasks

The separate library is developed for support of a FSIS of MDLP. Support of MDLP will be added to industry solutions of 1C company for retail drugstores, hospital drugstores, dental clinics, the organizations of wholesale.

The library will be available to all partner network of 1C company that will give the chance of its implementation not only in solutions which company 1C, but also in all solutions which are made to base on 1C: Enterprise platforms by independent developers is developed.

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Notes