Sign is “Honest” but unstable

This exact aphorism of the moderator of the panel session, Alexei Kuzmin, became the leitmotif of the entire conference “Mandatory Labeling of Medicinal Products: Preparation and Implementation”, which took place on 26 January in an online format. Participants of all links in the distribution chain of various product groups shared their experience, told colleagues who had not yet entered the mandatory labeling system about the thorny path of preparation for the start.

Pharma representatives shared the problems the industry faced both at the stage of the experiment and during the "combat" mode of operation. It is the instability of the drug movement monitoring (DMM) system that is the main danger for the industry. The launch of an unprepared system on July 1, the cunning of the operator and the lack of legal support of the system led to serious failures and created a deficit in the pharmaceutical market. Only the timely intervention of the Government saved the drug supply system from complete collapse. Government Decree No. 1779 of 02.11.2020 facilitated and simplified the drug labeling system, but did not eliminate all the problems.

Of course, the throughput of the distribution chain has improved, but the system is still far from guaranteed and uninterrupted operation. Therefore, the business unanimously proposes to extend the transition period until July 1, 2021, introducing the "combat" mode in stages: a manufacturer a distributor → a pharmacy or a medical organization. Only in this way, in the opinion of both the industry and the conference participants, it will be possible to avoid the predicted interruptions in medical supplies in the event of the system launching from February 1, 2021.

 “It is necessary to develop and approve criteria for the readiness of the system with the obligatory participation of the regulator, the operator and the business in this process. We also have to once again talk about the need to introduce mandatory financial, and not only, responsibility of the operator for failures in the system, due to which the business bears multimillion losses, ”said the Head of ARPM Victor Dmitriev in his speech.

In solidarity with the speaker, the participants noted the low level of trust in the operator, his refusal to honestly discuss acute problems and distortion of the true picture in the reports, leading to misleading both market participants and the Government.

Participants of the discussion confirmed that the industry needs a labeling system, but the system that is guaranteed to work properly, helping the patient, the regulator, and the business. And the “honest but unstable” system only discredits a good idea, unanimously supported by the pharmaceutical industry.

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