A pilot project on the traceability of pharmaceutical substances will start in Russia in October.

The Ministry of Industry and Trade, together with a number of relevant departments, will launch a pilot project in the Russian Federation on the traceability of pharmaceutical substances in October this year. Pharmaceutical companies participating in the pilot will submit information about the origin and place of production of the components of their products to the information system developed by CRPT. According to representatives of the pharmaceutical industry, the launch of the pilot in the future will allow companies with full-cycle production to receive additional preferences at government tenders, which, in turn, will stimulate business interest in further localization in the Russian Federation.

In mid-October, a project will start in the Russian Federation that will make it possible to trace the origin of pharmaceutical substances. Its operator will be CRPT. A draft government resolution on this, prepared by the Ministry of Industry and Trade, was published on Friday on the portal regulation.gov.ru. Let us recall that in September last year, the Association of Pharmaceutical Manufacturers of the EAEU proposed to a number of departments responsible for regulating the Russian pharmaceutical market to begin recording data on the movement of pharmaceutical substances in a special information system in order to ensure control over their origin and provide full-cycle pharmaceutical manufacturers with preferences in government procurement (see “Kommersant”) ” dated September 21, 2022). In particular, we are talking about the introduction of the “second wheel” principle – the unconditional priority of suppliers with the capacity to produce a full cycle (from the molecule of the active substance to the finished drug) in one of the EAEU countries (see “Kommersant” dated November 16, 2021). Currently, most of the substances used to produce Russian drugs are imported (according to SBS Consulting, at least 75%) and come from India, China and the EU.

As follows from the draft resolution, it is precisely the goals of import substitution that are stated as strategic for the pilot. It will begin on October 15 and will last until the end of 2024. By the end of this year, the CRPT, together with the Ministry of Industry and Trade, will determine the parameters of the information system and the composition of information about raw materials or medicines, which allows one to uniquely identify its unit, source of origin and place of production. Pharmaceutical companies that join the experiment will download the relevant data from their own CRM systems and enter them into the CRPT information system. The list of substances includes more than 100 commodity items of the EAEU Commodity Nomenclature for Foreign Economic Activity – both chemical compounds, serums and cell cultures. In addition to business, the Ministry of Health, the Ministry of Digital Development, the FSB, the Federal Tax Service, the Federal Customs Service and Roszdravnadzor will also take part in the pilot.

As the press service of the CRPT explained to Kommersant, “tracing of pharmaceutical substances will be organized on principles similar to the tobacco industry.” “The tracking system for pharmaceutical raw materials is a logical extension of the functionality of the previously launched drug labeling system. The state will receive a convenient interface for operational control of the origin of a pharmaceutical substance and determining the feasibility of providing preferences at state auctions, including up to specific series,” says the CRPT. The company’s press service emphasized that they will finance the pilot from their own funds, without attracting budget funds.

As the head of the EAEU AFP Alexey Kedrin notes, although it is not yet clear to pharmaceutical companies how much information they will have to provide, manufacturers hope that participation in the pilot will not require significant expenses from them. “Most likely, we will be talking about some modification of corporate information collection systems that many companies already have. We expect that five to six companies from our association alone will take part in the experiment,” he notes. These include the Biocad company, its vice president for corporate relations and communications Alexey Torgov told Kommersant. “The traceability system will allow us to create fair competition in the market and eliminate cases when foreign pharmaceutical substances are imported into the Russian Federation and subsequently passed off as a locally produced product,” he says. According to the president of the Active Component company, Alexander Semenov, his company also plans to take part in the pilot. In the very near future, thanks to the traceability system, companies that have invested in the creation of full-cycle production facilities in the Russian Federation will be able to receive preferences at state auctions. “We expect that the system will be created and launched in test mode no later than April next year, and we will have about nine months to test it. After that, in 2025, the system will begin to be used when conducting government tenders for medicines on the “second wheel” principle,” he says.

Although the need to deepen the localization of drug production in the Russian Federation is beyond doubt, notes the head of the Association of Russian Pharmaceutical Manufacturers, Viktor Dmitriev, it is unclear why a new mechanism should be created to verify the origin of pharmaceutical substances. “The Agreement on the Rules for Determining the Country of Origin of Goods in the CIS, which Russia signed in 2009, also stipulates that a company can obtain an ST-1 certificate from the Chamber of Commerce and Industry of the Russian Federation. This document certifies the place of origin of the goods and is recognized by both customs authorities and government buyers,” he says.

Anastasia Manuilova