ARPM: The three-step system of preferences does not consider all the aspects of byproducts manufacture

The 18th All-Russian conference PharmMedCirculation took place in Moscow. The  event brought together representatives of healthcare, pharmaceutical business and authorities to discuss a wide range of issues of state regulation of pharmaceutical and medical markets.

    ARPM Director General, Victor Dmitriev was a co-moderator of the conference on the technological aspects of pharmaceutical production. The members of the conference discussed different aspects of production from the transfer of technologies to risk management.

    Representatives of Sanofi and Roche shared their experience with the transfer of production technologies. Companies are faced with the same issue when the plant that is receiving a new technology is not equipped well and the launch of the whole project is postponed. Also, there is a problem with qualified personnel as well as a language barrier. This problem could be solved by holding special programs to support the staff of the recipient company during all stages of the transfer.

    Mr. Dmitriev noted that the design of the system of state preferences should be  thoroughly evaluated. “The proposed by the Ministry of Industry and Trade three-step system of state preferences is more relevant for medicines of chemical synthesis, however, in the production of biotechnological medicines, there are more steps and no financial benefits from substance production in Russia. Sometimes it is enough to have just one plant to fulfill the world demand for a particular substance,” said Mr. Dmitirev.

    The participants also spoke about risk management in pharmaceutical production. Director of quality control in “Akrikhin”, Olga Malakova spoke about the system of risk management. Risk evaluation should be used with a precise legal compliance, based on scientific knowledge and aimed to protect patients. The voiced opinion brought up a discussion and the experts were able to share there thoughts and experience amount each other.

    “The experience of the foreign partners is very important to us. The realization of the phasing of production and quality control is important in the transfer of technologies. It should be considered not only by producers but also by the regulators that initiate legal changes that put in relation the level of production and preferences in public procurements. These suggestions should be discussed with the professional community and with consideration if the interests of healthcare and patients. Only after that, they should be implemented,” concluded Mr. Dmitriev. 

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