From July 1, marking starts in manual mode
Around the introduction of mandatory labeling of drugs in Russia there has been controversy for several years. Today the situation has escalated. There will be no postponing of start labeling. The inter-factional working group on improving the legislation in the field of drug provision recommended the Government a safe entry into the system from July 1. The Ministry of Health assured the deputies that there would be no problems with drug provision.
Manufacturers, distributors, pharmacies and medical institutions are not 100% ready both technically and legally. Final commissioning has not been completed. Most manufacturers have imported equipment installed, and only foreign experts can complete installation and testing of the system. But the borders are closed. Today there are ways to resolve this issue, but taking into account quarantine and preventive measures, they will be able to get into production in at least 5 weeks.
The situation with COVID-19 postponed the training and education of specialists in hospitals and pharmacies, all the efforts of medical workers and pharmacists are aimed at preserving the life and health of patients.
Deputies are aware of the situation. And they understand that now there are problems for a number of International nonproprietary names (INN). However, postponing of the labeling is considered inappropriate, based on the results of testing the system. But there was no full-fledged combat testing of the system under load along the entire distribution chain.
“Test runs are pieces of the system. And it’s very sad that this position is reaching a high level. An illusion of victory is created, which will lead to serious and significant problems,” says Yaroslav Narcissov, Director of the BIOTIKI Medical Research and Production Complex LLC.
“Now there is no way to test the system in real working mode. How can the government guarantee that there will be no disruptions? ”, indignantly declared San Pharma CEO Arthur Valiev.
“Readiness indicator is an indicator of connection to the system. There the numbers are good: we adapted our addresses, tested from the point of view of electronic signatures, we partially have equipment, but we did not see any packaging in circulation, we trained employees on fingers and pictures, ”commented the executive director of the Association of Pharmacy Institutions “SoyuzPharma” Maria Litvinova.
The industry’s arguments are listened, but not heard in the State Duma. The main example is the drug labeling system of 14 high cost nosologies launched in October 2019. But there also not everything is going smoothly. In February, a serious malfunction occurred. The operator Advanced Technology Development Center (ATDC) tried to keep silent about what had happened, but it was discovered by manufacturers and people felt it. The All-Russian Union of Patients is sounding the alarm, demanding to suspend labeling for highly cost nosologies and to postpone the start of introduction for all drugs.
“The introduction of a labeling system should not create problems for doctors and patients in drug provision. The quality of life and the health of millions of citizens depends on drugs,” said Yury Zhulev, co-chair of the All-Russian Union of Patients. - The problem is already there. In Ivanovo, beneficiaries are given drugs with a torn off label code, pasted with tape, or asked to return the packaging back to the pharmacy. Patients, often disabled, agree on everything in order to get a preferential medicine. ”
Despite everything, the labeling starts July 1. The lower chamber made recommendations for “soft entry into the system”. However, for each decision a specific document is needed.
“We will not apply tax regime changes to pharmacies. We will not apply fines. We won’t do much, it’s necessary to do a tremendous amount of work and make plenty of by-laws that will regulate these standards, isn’t it easier to postpone this deadline in one document on January 1 and start it in normal test mode from July 1,” said Maria Litvinova.
“The system will not fully work, but it will be launched. In manual mode, we will find out who has not started labeling since July 1, and a specific road map will be compiled with each manufacturer,” Alexander Petrov emphasized.
“The introduction of an unprepared action into this system will lead to a collapse. We will launch and test on July 1, but the pharmaceutical industry is very regulated and the regulators have no concept of “test”, no concept of “try”, but there is strict adherence to GMP rules,” Yaroslav Narcissov noted.
The introduction of drug labeling is required to be smooth. No patient should be left without drugs. From the manufacturer to the farthest pharmacy - the whole chain must be ready so that a person can receive vital medicines.
“The one, who is ready, must launch, and who is not ready for objective reasons, must enter the system gradually without penalties. At this time, the first labeled packages will appear, the mechanism of action will be worked out, and the first errors will be revealed. For this, it is needed to approve the necessary regulatory framework in a short time,” said Victor Dmitriev, Director General of the Association of Russian Pharmaceutical Manufacturers.
“The real readiness of the industry will come only as a result of the regular processing of significant volumes of medicines in the “combat mode”. - Ravil Gimadiev, general director of investment and technology holding Original Group, is certain.
Because of the COVID-19 pandemic, regulators all over the world are striving to remove barriers as much as possible and ensure the availability of drugs and the uninterrupted drug supply of the population. Faced with misunderstanding and obstacles, the 10 largest industry organizations and the All-Russian Union of Patients on June 2 asked the President of the Russian Federation Vladimir Putin to figure out the situation and postpone the labeling from July 1 to a later date.
Will there be penalties for manufacturers, pharmacies, distributors, if they work with unlabeled products? What awaits the pharmaceutical industry in Russia from July 1 - time will tell. One thing is certain that in one day the drugs will not disappear from the shelves of pharmacies. Companies were creating and are creating stocks of drugs, and until their expiration date, they can be sold without labeling.
“If we do not have regulatory documents, then all that is proposed is voluntarism. Lack of the drugs may increase, in today's conditions this is not permissible. There is a law, there are requirements, and the patient should be at the head of everything,” the ARPM head summed up during the roundtable “Labeling of Medicines” on the air of Komsomolskaya Pravda radio.