Labeling started. What is next?
From July 1, 2020, labeling of drugs becomes mandatory in Russia. However, no one gives guarantees of its uninterrupted operation, especially since the industry announced that it was not ready to start. The State Duma has prepared amendments to Federal Law No. 61 “On the Circulation of Medicines,” which should give the government the right to postpone the introduction of mandatory labeling of medicines in full. In the near future, they will be discussed in the third reading.
The draft law “On Amending Certain Legislative Acts of the Russian Federation Regarding the Provision of Citizens with Medicinal Products, Medical Devices, and Specialized Medical Nutrition Products” provides for the powers of the Government of the Russian Federation to establish a special procedure for introducing into civilian circulation medicines for medical use made from July 1, 2020 years to October 1, 2020. The draft law says that before January 1, 2021, unlabelled drugs produced abroad before October 1 may be imported into the country, with the exception of high-cost nosology drugs. The import procedure will be determined by the Government of the Russian Federation.
It is estimated that the Drug Movement Monitoring (DMM) system will track about 6.5 billion packages, cover over 1000 manufacturers, 2500 wholesale organizations, 35000 medical and pharmacy institutions. Given the scale of this system, it is important to prevent disruptions in its operation that could deprive the population of vital medicines.
Project participants report low preparedness due to the current epidemiological situation in the country and the world. Manufacturers can not finalize commissioning, medical organizations and pharmacies, did not have time to prepare, being at the forefront of the fight against COVID-19 and directing all forces and resources to save patients.
On June 3, at a meeting of the Interfactional Working Group of the State Duma, all risks were analyzed and recommendations were made to the Government of the Russian Federation. In particular, to develop a flexible approach to compulsory labeling of medicines for medical institutions, to conduct additional monitoring of labeling readiness, and not to apply administrative sanctions against enterprises and organizations until October 1 that, due to objective reasons, were unable to work in the DMM system within the established time frame, settle organizational and technological issues, eliminate the problems of inconsistencies between the state register of medicines, state registration documents and a single reference catalog of medicines, which is the information base for the registration of production sites and medicines in the DMM system. To implement all the recommendations, a regulatory framework should be developed and approved. But today it does not exist.
“It was planned that before the start of labeling, the entire system will be tested in combat mode, but this did not happen. Companies that were able to start today are contacting Federal Service for Surveillance in Healthcare (Roszdravnadzor). They note the improper operation of the DMM system,” said Victor Dmitriev, Director General of the Association of Russian Pharmaceutical Manufacturers. - Processing of incoming information takes hours and days, stopping the production process. Calls for technical support of state information system DMM are considered prohibitively long, which causes deep concern about the possibility of ensuring the stability of the system’s operation by the operator from July 1”.
In this regard, manufacturers insist on a mixed electronic-paper workflow. This will allow the product to move smoothly from the manufacturer to the patient, in case of failures that we observe constantly at the preparation stage.
In addition, the responsibility of the operator must be legally approved. “We foresee serious economic consequences. All company losses due to system failures due to the Advanced Technology Development Center should be compensated by the operator. But the most important thing is the life of people, which depends on the time of the medicine application, and this should also be reflected in the legislation, ”said the head of the ARPM.
According to the current legislation, from July 1, 2020, all participants in the turnover of drugs must transmit data on the movement of drugs to the labeling system. And unlabelled drugs produced before July 1 may be in circulation before the expiration date. For non-compliance with the law provides for administrative liability.
Recall that in March the Association of Russian Pharmaceutical Manufacturers sent a letter addressed to the Chairman of the State Duma Vyacheslav Volodin with a request to postpone the start of drug labeling, and in early June, 10 major professional pharmaceutical associations and the All-Russian Patient Union addressed the President of the Russian Federation Vladimir Putin and expressed their concern with the current situation, indicating all the problems and possible consequences that, at the moment, will adversely affect the health care system as a whole.
We will strictly monitor the situation with failures in the work of DMM system and ask all participants of the process to inform about problems in the system, in order to quickly respond to these problems.
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