On July 1, compulsory labeling of medicines began. On the same day, the industry learned about Government Decision No. 955, signed on the eve, “On the Peculiarities of Putting Medicines into the Civil Circuit for Medical Use”. Despite the numerous appeals of industry associations to the authorities, their fears about problems with the launch of the system and a possible lack of drugs are still left without proper attention and the Resolution did not remove all the issues of the industry.
According to the decree, an interdepartmental commission of representatives from the Ministry of Health, the Ministry of Industry and Trade, the Federal Customs Service, Federal Service for Surveillance in Healthcare (Roszdravnadzor) and the Advanced Technology Development Center (ATDC) will agree to enter to the civilian circulation medicines produced from July 1 to October 1, 2020 or imported into Russia during the same period without labeling. Why did the Decree come out without a regulatory impact assessment mandatory in these cases? Why was there no consultation with the industry? Why did not the business representatives enter the commission? Why is the authorization rather than the notification nature of the decision approved? Why have so far not been approved the standard forms of contracts for the provision of services for the provision of labeling codes and registration devices for the issue of drug circulation entities that comply with the current provisions of the Decree of the Government of the Russian Federation of March 20, 2020 No. 311?
“It is not clear by what criteria they will allow or prohibit the sale of unlabelled products. The industry fears that competition in the market will die out: someone was banned, and someone was allowed. Moreover, the participation of the Federal Antimonopoly Service’s (FAS) representative in the Interagency Commission is not provided. And it is not necessary to speak about the corruption-generating nature of the permitting procedure, ”the head of the ARPM emphasized.
To obtain permission for the release of products without labeling, manufacturers need to provide a large number of documents. In particular, “copies of contracts for the supply and installation of equipment for applying identification tools to each of the production sites indicated in the application, as well as the development or refinement of software in order to ensure information interaction with the monitoring system in Russian” — this information is confidential and cannot be freely available.
Participants in the process suffer financial losses due to the operation of an incomplete system, frequent failures and the lack of an operator’s prompt response.
“For some companies, everything goes smoothly, but others have to stop production not for an hour or two, but sometimes for a day. We had a case when on Friday, the operator promised to give an answer on a technical failure within a day, and the answer came on Monday. The real answer and troubleshooting took 72 hours. Who will compensate the losses to manufacturers? We insist on the operator’s responsibility in case of such failures,” said Victor Dmitriev, Director General of the Association of Russian Pharmaceutical Manufacturers.
The industry is waiting for answers to the questions posed. The success of any undertaking depends largely on the degree of confidence in the process. Today, the degree of confidence is low. To raise it and successfully implement the project is our common task.