Clarification of the mechanism for the official approval of pharmaceuticals

On 26 November 2019, the Russian Government adopted a resolution clarifying the mechanism for the official approval of pharmaceuticals that are released into circulation in Russia (ie shipments of pharmaceuticals to pharmacies, clinics, etc).

A year ago, in November 2018, the relevant amendments were introduced to the Law on Pharmaceuticals. Those amendments replaced the mechanism of mandatory certification or the adoption of a declaration of compliance for pharmaceuticals with a different procedure, namely, by manufacturers or importers submitting information on pharmaceuticals to the Russian regulator (Roszrdavnadzor) (except immunobiological pharmaceuticals that are subject to a slightly different procedure). Now the Russian Government has established a mechanism for this procedure, which takes effect from 29 November 2019, so that the new procedure will become fully workable.

From now on, the introduction of pharmaceuticals into circulation in Russia will be done with the involvement of testing laboratories of accredited federal institutions that will accept samples of pharmaceuticals for a quality assessment. Overall, the Russian Government and Roszdravnadzor believe such procedure is expected to be much quicker and more efficient than earlier, while preserving the appropriate quality of pharmaceuticals.

For the avoidance of confusion, these changes do not affect the state registration (marketing authorisation) mechanism for pharmaceuticals, which remains the same.

New rules for granting subsidies to pharmaceutical companies

On 16 November 2019, the Russian Government has adopted new rules for granting subsidies to producers of pharmaceuticals and medical products (Resolutions of the Russian Government No. 1464 and 1463 of 16 November 2019).

The new rules will enter into force on 1 January 2020 and replace the existing rules provided for by Resolutions of the Russian Government No. 1045 and No. 1047 of 1 October 2015, and No. 1503 of 30 December 2015.

Under the new regulation, pharmaceutical companies can apply for the compensation of costs associated with the implementation of projects aimed at developing modern technologies and organising the production and sale of competitive pharmaceuticals / medical products on the basis of such technologies.

The new rules provide for the following key amendments in comparison with the current regulation:

  • the subsidy recipients are companies developing modern technologies; a list of such technologies has not yet been adopted by the Russian Government.
  • subsidies are granted on a competitive basis. The competitive selection process is to be conducted by the Russian Ministry of Industry and Trade.
  • the subsidy amounts are differentiated depending on the modern technology. The thresholds are to be set by the Russian Government on an annual basis.
  • the list of compensated costs/obligations include:
    • employee salaries and insurance contributions;
    • material costs (except for capital investments in fixed assets);
    • overheads (except for representation expenses, travel expenses, expenses for the organisation and participation in exhibitions);
    • costs for the work (services) provided by third parties engaged by the producer to implement the project (including costs of foreign service providers engaged in clinical trials and the registration of pharmaceuticals and medical products).

Government opposition to the online sale of prescription drugs

On 16 December 2019, the Russian government issued a negative opinion on the amendments to the draft law on the distant sale of medicine, which provides for the legalisation of online trading for prescription drugs from 1 January 2022. In pharmacies, the sale of prescription drugs continue to grow and has already exceeded 51% of the total market.

One of the controversial issues is who should deliver the medicine - pharmacists or regular couriers? The State Duma considered that the delivery of medicine by specialists with a pharmaceutical education would make the law inoperative in view of the difficulties involved in engaging such specialists. The bill also does not resolve the issues related to the accounting of prescription forms and the verification of the authenticity of prescriptions sent to the pharmacy remotely. Electronic prescriptions are set to be launched in the beginning of 2022.