In late March, the Government of the Russian Federation approved the criteria for classifying medications as strategically important (SZLS). The list consists of two sections: the first includes medicines for which the “second‑extra” mechanism will apply, and the second one includes medications for the treatment of socially significant diseases, for which an increased price preference will apply. According to the approved rules and criteria, medications purchased under the “second‑extra” mechanism and those eligible for the increased price preference must be produced in Russia on a full production cycle basis.

Dmitry Zaitsev, the “Pharmstandard” CEO, called the decision to divide the list a balanced one. Further decisions on expanding or reducing the first section of the SZLS should be made based on an analysis of a regulatory impact and the effect of restricting the procurement of medicinal products produced in our country from foreign made substances: 

“Dividing the SZLS list is a balanced and logical decision. In my opinion, the first section should be formed from INNs where the use of a local substance is objectively necessary — that is, where the efficacy of the drug depends on it.” For example, this fully applies to vaccines. Restricting such drugs produced with foreign made substances would be justified.

Initially, it was planned to include vaccines, blood products, and narcotic drugs in the first section of the list of essential medicines. However, in the end, the list became broader: it also included antibiotics and drugs for treating certain infectious and parasitic diseases.

Evidently, the federal authorities have done a great deal of work to find a compromise between the different viewpoints the pharmaceutical market players regarding the advisability of restricting the purchase of Russian drugs made from foreign substances for various categories of medicines. This restriction is a complex decision that regulators have been discussing with industry representatives for a long time, but there is still no unified view on the expected benefits and side effects of this measure.

Some experts talk about a powerful incentive for localizing the production of active ingredients, while others argue against a reduction in the number of Russian manufacturers in specific INNs and an upcoming increase in spending on drug provision due to restricted competition. Time will tell who is right. It will take two to three years to assess the effect of the restriction, and based on the analysis, either expand or reduce the first section of the updated list of essential medicines.

When discussing the requirement which assumes that medicines from this list are to be produced in Russia using a full cycle, it is worth noting that it also recognizes as such the production of substances from foreign raw materials. This is a fairly realistic task, and there are already successful examples of this.

However, the task of producing medicines exclusively from Russian components is significantly more challenging, but there are also positive examples here, particularly among manufacturers of biological drugs. The question is which drugs need to be produced using a full cycle only, and how this will affect their cost for the drug supply function of the health care system. Furthermore, the production of pharmaceutical intermediates for previous‑generation drugs does not solve the problem of local next‑generation drug developments. 

The R&D and manufacturing of medicinal products entail significant financial and temporal investments. Consequently, it is critical to have unambiguous legal frameworks, effective patent protection, and optimised support instruments in place, specifically covering R&D, clinical studies, and research and experimental development (R&D) activities.

Work in all these areas is already underway by federal executive authorities, and additional support measures for the development and clinical trials of new drugs are being announced. All of this will undoubtedly lead to the continued, consistent development of the Russian pharmaceutical industry and its advancement to a new level of technological excellence.