Labeling of medicines is one of the most ambitious and discussed issues in the pharmaceutical industry. The entire pharmaceutical industry supports its introduction, but during the experiment, participants are faced with many problems that perplex not only the performers, but also the organizers of the project. In particular, manufacturers do not understand how to deal with a pandemic. Foreign specialists cannot come to production facilities for commissioning of the equipment, and Russian specialists cannot go abroad for testing and training. How do the experiment participants feel 100 days before the official launch of the drug labeling project?
According to the Director General of the Association of Russian Pharmaceutical Manufacturers Victor Dmitriev, once again the start of the implementation of universal labeling of medicines is in question. If deputies approve the ARPM proposal and stop time is introduced for labeling, this will provide an additional opportunity to work on regulatory and legal documents and acts that provide legal support for the movement of medicines at all stages of the supply chain. “In my opinion, it is time to introduce professional lawyers into the working group of Federal Service for Surveillance in Healthcare (Roszdravnadzor), which has been working effectively for the third year now, to“ immerse ”them in the topic and prepare draft documents verified by the experiment and linked to the current legislation,” said the head of the ARPM.
Large Russian and foreign companies are in the final stages of preparation. So in December 2019, the pharmaceutical company “Servier” announced the launch of a system for labeling and traceability of drugs at the production complex “SERVIE RUS”, located in Moscow. “Considering that Servier was one of the first to start work on a pilot labeling project back in 2017, the plant has already completed the necessary preparatory steps, and we are focused on training employees to work with new equipment, and we are also actively engaged in technical testing of processes related to distribution,” the Servier company emphasized.
“Among the risks for introducing marking within the indicated period, possible difficulties in testing import operations or non-fulfillment by contract manufacturers of obligations due to force majeure circumstances can be noted. It may also be difficult to introduce additional restrictions on the movement of human resources and goods flows,” commented Christoph Vlodarczyk, General Director of the Servier RUS plant.
Another Russian company, R-Pharm, which is one of the first registered participants in the drug movement monitoring (DMM) information system, is also ready to introduce mandatory labeling. The necessary equipment and software installed at the enterprises of the group of companies allow labeling the manufactured products and registering data in the federal system. At the moment, automatic data exchange with state information system (DMM) has been implemented, more than a hundred operations are recorded every day. “We completed commissioning and, with the correct operation of the system, are able to ensure uninterrupted supply of marked products,” assured the company R-Pharm.
But not all participants in the experiment have impeccable training. Manufacturing companies are the most prepared link in the entire supply chain. In the realities of the high preparedness and quarantine measures, the main task remains to maintain drug availability for the population, including price.
“Today, about 60% of pharmacies are registered in the DMM system, new business processes are being actively tuned, and software is being updated. Nevertheless, unresolved issues with testing and establishing clear work in the DMM system for small and medium pharmacy businesses in the regions are especially noticeable today, under quarantine conditions. There are still questions about the transition of regions from UTII to other taxation systems, ”said Victoria Presnyakova, executive director of the SRO Association of Independent Pharmacies (AIP).
SRO Association of Independent Pharmacies supports the ARPM initiative on the possibility of postponing of mandatory labeling depending on stop time of restrictive and quarantine measures. This measure will free up material and human resources, thereby preventing an additional increase in drug prices in crisis conditions.
In general, the pharmaceutical industry supports and continues to actively participate in the project. Experts emphasize that digitalization and labeling of drugs open up new opportunities for healthcare in general. For example, if manufacturers are given the opportunity to receive information on the movement of goods, then they will be able to receive real-time data on how much patients consume a particular medicine, and therefore make a forecast of its future needs. For the uninterrupted supply of quality, safe and effective drugs, this is simply priceless.
Currently, 59,259 participants are registered in DMM, 574239677 packages are marked. But the participants in the experiment note that the system is not ideal. So in February 2020, there was a serious malfunction in 12 nosologies that are already working in this system. After resolving the problems, the companies received the ordered codes, but the Advanced Technology Development Center (ATDC) did not issue any instruction on how to act the system participants in a similar situation. Although companies emphasize the need for step-by-step explanations of certain situations.
Recall, from July 1, 2020, the law on drug labeling comes into force in the country. The purpose of the innovation is to increase the transparency of the turnover of drugs, defeat counterfeit and give the opportunity to track the drug in the online system. In May 2020, Federal Service for Surveillance in Healthcare (Roszdravnadzor) or its structure will test the readiness of the system for the launch of mandatory labeling throughout the product chain.