what would happen if suddenly the companies producing drugs and personal protective equipment will stop? Precisely this question arose today, the pharmaceutical market, because according to the law from 1 July must start total labeling all traded on our market pharmaceuticals. Most manufacturers have already prepared the production lines to the new requirement. Today in the information system of monitoring the movement of pharmaceuticals (IP MDLP) was more than 60 thousand members, already marked more than 800 million packages of drugs.
But some market participants until the start is not ready, if you have any problems with the equipment. It is mainly imported, but foreign manufacturers because of the restrictive measures are unable to come to Russia for testing production processes, and our specialists are unable to go abroad for an internship. Some providers delayed production of mechanical parts of the equipment necessary for its modernization in connection with the deficiencies identified during testing. And that means that since July 1, such production must be stopped. And this can result in a shortage of the drugs.
In February – in the first phase of the new system of labeling of drugs included in the program “12 high-cost nosologies” – already there was a serious technical failure. He showed the vulnerability of the system, causing interruption in the movement of drugs throughout the supply chain. The accident confirmed the necessity of development of algorithms of correcting such problems in the future, as each such force majeure may result in a shortage of certain drugs, and even loss of human lives.
the seriousness of the problem first outlined by the producers themselves. At the end of March, when it became clear that it is necessary to introduce restrictive measures to contain the pandemic and urgent reorientation of many hospitals, Association of Russian pharmaceutical manufacturers (ARPM) has appealed to the state Duma with a request to delay the implementation of the system total marking time of a pandemic. The request was also supported by the chamber of Commerce and the Russian Union of Industrialists and entrepreneurs. For the postponement of the acts of the participants in the distribution chain. But others declare full readiness for the start of the markings and asked not to postpone it.
ARPM agrees in General with the Ministry of industry and trade of the Russian Federation that those producers who are already ready to run system, can start on 1 July – this will allow you to test the performance of the system for monitoring the movement of drugs throughout the supply chain – from manufacturer to the end user, whether a medical institution or a buyer of drugs in the pharmacy.
– can’t slow down those ��already ready, – said General Director of ARPM Victor Dmitriev. But those who because of restrictive measures may not accurately prepares to start July 1, should be given the opportunity to log in after the lifting of restrictions, while still ensuring that patients who are not getting fines and continuing to develop the industry.
– our Association consists of over 30 companies representing the whole distribution chain: manufacturers, distributors, pharmacy chains, most of which in high degree of readiness to start labeling from 1 July – confirmed Executive Director, Union of professional pharmaceutical organizations Liliya Titova. – But how ready are all the links, with full confidence it is impossible to say, as there had been extensive testing of the system “manufacturer-warehouse-pharmacy”. It was planned to spend in the first half of 2020, but in relation to the current epidemic situation of the staff, that should do the adjusting, refining information programs, interaction with the marking system, works in remote mode, which significantly slows down the process. In addition, a number of companies repurpose their power to issue sanitizers, medical masks and medicines used in the treatment of coronavirus. Many hospitals also redeveloped, hospitals and pharmacies are under extreme pressure to provide patients with necessary drugs, medical devices. Considering all these difficulties, we turned to the deputies of the state Duma with the request to move the scheduled time of starting the marking at a later date – at least six months.
Most pharmaceutical companies are fully prepared for mandatory labeling of products and have invested in the necessary infrastructure significant funds – the Director of the Union “Medical and pharmaceutical projects. XXI century” Dmitry Chagin. – Of course, they wouldn’t want to date the beginning of the operation of the system was removed. Worse situation from distributors and pharmacies – not all of them installed and tested necessary for monitoring the movement of drugs, the equipment, and therefore support the transfer start. But the true picture we don’t know yet. The Ministry of industry and trade of the Russian Federation invited all participants in the distribution chain to the end of April to report on readiness for full operation of the system. But any findings from these reports are still not published. Waiting for pharmaceutical companies and a certain return on the cost of the monitoring system – namely, as promised in the beginning, receive marketing studies on the movement of labeled drugs – their logistics, purchasing volumes by region, etc. when putting the system into operation will be delayed, such data producesate this year will not get.
– the position of the National pharmaceutical chamber is that to move the date of introduction of mandatory labeling is inappropriate, – says the Executive Director of the Union “NFP” Elena Nevolina. But it would be correct to run it in test mode to wait for violations of new requirements no one was fined. We had a long and carefully prepared for this innovation, trained staff pharmacy, and the transfer is only to relax the employees. Good companies are nearly all ready, why should they be lagging? In addition, in local mode – “sandbox” – a new mode of operation will not work as in the real world. And after starting the system monitoring the movement of drugs to identify all its weaknesses, the imperfections – they will be easy to modify.
soon the situation plans to consider at its meeting of inter-factional working group of the State Duma to improve the legislation in the sphere of pharmaceutical services and medicines, reported in ARPM its leader the Deputy Andrei Isaev. The participants of the pharmaceutical market we hope that will be taken an informed decision.
Revaz Yusupov, Deputy Director General, development Center of advanced technologies:
– the Introduction of labelling of medicines takes place in 2017. During this time, issued more than 950 million codes participants were more than 61 thousand companies, representing 94 percent of Russia and 80 percent of foreign manufacturers, 71 percent of pharmacies, including nearly 100 percent concessional. From October 2019 marking is obligatory for products from the category “12 high-cost nosologies”. The system is fully operational. Nevertheless, regular stress testing is to optimize and scale its work, introducing new solutions increasing the comfort of work of the companies.
Since the start of the experiment discovered the breach on half-billion roubles, it came to light secondary sales of expensive drugs to treat serious diseases, which the state purchased for hospitals. At the end of 2019, the Ministry considered that the circulation of poor quality medicines has decreased in 2,5 times. An indirect effect was that marking before it became mandatory, has reduced the cost of hundreds of drugs. In 2018 more than 440 drugs fell in the price of steel and cost less than 20 rubles, calculated by the analytical company DSM Group. This is due to the fact that drugs are cheaper than 20 rubles marked through CBT, free for manufacturers.
during the crisis all over the world in different industries has increased the illegal trafficking of goods. According to Interpol, the proportion of antiviral drug counterfeiting worldwide increased by 18 percent, and the number of teased��to antimalarial drugs, which are used, in particular, for the treatment COVID-19 increased by two. According to research, 35 per cent of fake drugs in the world spreads through the Internet, which has become one of the main channels of sales of the counterfeits.
In Russia the crisis of legalized remote trade. This solution will work effectively only in conjunction with mandatory labelling of medicines. Digital tracking of drugs will allow to protect the consumer, guaranteeing the legal origin and the quality of medicines. In addition, the state in real time will be able to analyze the supply of goods and ensure their availability in each region, to control that no one is manipulating the prices and not create an artificial shortage, to support honest entrepreneurs.
