The Russian Ministry of Health has prepared amendments to the second part of the Tax Code, providing for a reduction in the fiscal burden on pharmaceutical manufacturers

The proposed measures include reducing the fees for recognizing drugs as orphan drugs and making changes to registration materials. The amount of state fees for the examination of drugs may be reduced by 50%. The draft document is posted on the federal portal for public discussions of bills.

Thus, the regulator intends to reduce the cost of conducting an examination of documents for recognizing a drug as an orphan drug from 420 to 190 thousand rubles. The changes will also affect amendments to the registration dossier: currently, an examination of drug quality control methods costs 490,000 rubles. The Ministry of Health proposes to reduce it to 290,000 rubles. If a drug sample is not provided for examination, the fee will be 190,000 rubles. They want to set the same amount for an examination of the ratio of expected benefit to possible risk of using a drug when adjusting the position of the registration dossier.

In addition, the Ministry of Health proposes to cancel the requirement to conduct part of the international multicenter clinical trials (CT) in Russia in the clause on conducting an examination of the quality of the drug and an examination of the ratio of the expected benefit to the possible risk of using the drug during its state registration. It is also planned to completely remove fees for issuing permits to conduct CT, international multicenter and post-registration studies of the drug - now pharmaceutical companies are charged 5,000 rubles for these documents.

For medical products circulating on the common market in the EAEU, it is proposed to introduce two subparagraphs. The regulator plans to establish duties:

• for issuing a permit to conduct a clinical or clinical laboratory test of a medical device by entering an entry in the register of issued thematic permits - 2,500 rubles;

• for the examination of the application for permission to carry out the same procedures, a decision is made on the possibility or impossibility of carrying them out based on the study. The amount depends on the class of the medical device: for class 1 - 32,000 rubles, for class 2a - 48,000 rubles, for 2b - 64,000 rubles, for class 3 - 104,000 rubles.

At the same time, the Ministry of Health intends to cancel seven preferential cases exempting from paying duties. They were applied to procedures, applications and documents prepared before the entry into force of the law "On the circulation of medicines" (No. 61-FZ of April 12, 2010).

The process of including medical devices in the list of goods exempt from VAT in the country is also simplified. Instead of a full registration certificate, market operators will only need to indicate the number and date of state registration from the subject register. Similar changes will affect products that qualify for a reduced 10% tax rate.

As explained by the Ministry of Health, the amendments were developed within the framework of the Pharma-2030 strategy and to implement the provisions of Federal Law No. 1-FZ of January 30, 2024. The latter, in particular, allowed not only registered drugs to be recognized as orphan drugs, but also unregistered ones.

* Source : GxP News.

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