The responsibility of the Drug Movement Monitoring (DMM) operator must be legally secured

The Interfactional Working Group on Improving the Legislation in the Sphere of Medicinal Provision of Citizens and the Circulation of Medicines of the State Duma supported the proposals of the participants of the meeting, which took place online, on the need to amend by-laws regulating the functioning of the DMM system. In particular, they talked about the Order of the Ministry of Industry and Trade of Russia dated 09/11/2019. No. 3381.

Recall that on February 1, ARPM sent a letter to the Minister of Industry and Trade Denis Manturov with a proposal to amend the standard form of the contract for the provision of services for the provision of labeling codes to subjects of drug circulation. According to experts from the Higher School of Economics, the costs already incurred by the business to prepare for labeling introduction are impressive and comparable to the launch of several generics. In addition, the business constantly incurs losses due to the unstable operation of DMM system. At the same time, the operator responsible for the uninterrupted operation of the system leaves the company alone with these problems, although it is the main reason for them. “The operator’s irresponsibility brought the problem of failures, which was perceived as a“ childhood disease ”of the system start, into the problem of a“ chronic disease ”that destroys a well-functioning body of drug circulation,” noted ARPM General Director Victor Dmitriev. — We have the opportunity to correct the situation conservatively, yet, making adjustments to the Order of the Ministry of Industry and Trade. Otherwise, the industry will suffer irreparable harm, and at the same time, the goal to prevent counterfeit and substandard drugs from entering circulation will remain a utopian idea. "

Losses lead to a significant increase in production costs and a decrease in the profitability of enterprises, and then either an increase in prices or the withdrawal of the drug from the market.

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