On April 13, Government Decree No. 500 was issued, which temporarily suspended the previously issued 431 Decree. The industry perceived this as a victory of common sense. As early as April 7, the Association of Russian Pharmaceutical Manufacturers contacted the Ministry of Industry and Trade for clarification on the enforcement of the Government Decree of April 3, No. 431 “On establishing the characteristics of the circulation of medical devices and restrictions on the wholesale and retail trade of medical devices and on the list of such products” prepared by this authority. The document assumed not only strict regulation regarding the procurement of medical goods: medical masks, gloves and other protective equipment necessary in the context of the coronavirus pandemic, but also the monopolization of this process with all the negative consequences arising from this.
In addition to medical facilities, pharmaceutical manufacturers who use personal protective equipment (PPE) in their work could also become victims of innovations.
“Initially, the mechanism for implementing this decision was not thought out, the criteria for effectiveness and its consequences were not calculated. The production of pharmaceuticals is associated with compliance with Good Manufacturing Practices (GMP) and the provision of personal protective equipment for personnel to work in cleanrooms. This is extremely important and supply disruptions are unacceptable. The enterprises have signed and 100% paid contracts for uninterrupted supply of PPE, ”said Victor Dmitriev, Director General of the Association of Russian Pharmaceutical Manufacturers.
Decree 431 introduced a new, previously unknown to lawyers, term — coordinating operator, Roskhimzashita was appointed as one, and all supplies of medical devices should be carried out only through it or regional operators licensed to carry out pharmaceutical activities and supply medicines for treatment diseases from the list of "14 high cost nosologies ".
According to industry experts, this would inevitably lead to a lack of personal protective equipment throughout the country.
“One-authority management is the foundation of centralized and sustainable emergency management. Unfortunately, the 431 decree revealed serious flaws in the one-authority management. Once again, we have to discuss the need to create a single regulator for the industry, especially in such difficult situations that we are experiencing today,” said Victor Dmitriev.
After a wave of letters and indignation of specialists, the action of 431 decree was suspended. The industry is waiting for its complete abolition.
ARPM Press Service