New Procedure for the State Registration of BADs
Biologically active additives (BAD) are generally subject to state registration. New framework standards for such registration have been adopted by Decision of the EEC Counsel No. 34 of June 18, 2018 and include two schemes for product registration:
- Scheme 1r ‒ for products manufactured within the territory of the Eurasian Economic Union (EEU)
- Scheme 2r ‒ for imported products produced outside of the EEU
New certificates of registration will no longer be issued with an unlimited validity period, and will only be valid for five years. Product registration certificates issued earlier under previously effective rules remain in force and will not have to be reissued. The decision also establishes a procedure for issuing certificates of registration and maintaining a unified register of such products.
Russian Ministry of Healthcare Developing IP-Related Amendments to the Law on Pharmaceuticals
The Russian Ministry of Healthcare has started developing amendments to the Federal Law on Pharmaceuticals aimed at bringing the law into line with the rules of the EEU. These rules state that, in the course of the state registration of pharmaceuticals, information on the existence of protected intellectual property rights to the pharmaceutical product (patented in the territory of a member state of the EEU) must be provided.
On this basis, the Ministry of Healthcare wishes to introduce amendments to the law obliging the applicant, in the course of the state registration of pharmaceuticals, to provide information on existing intellectual property rights to the pharmaceutical product (patented in Russia) and a statement confirming that the registration of the pharmaceutical would not violate any third party intellectual property rights.
Russian Ministry of Economic Development Introducing a Draft Law Against “Evergreen” Patents
The Russian Ministry of Economic Development has introduced a draft law dealing with the state registration of patents for invention. This is aimed at so called “evergreen” patents.
The changes will primarily concern new pharmaceuticals. As mentioned by the Ministry of Economic Development, parties often in practice attempt to patent existing pharmaceutical compositions. This allows parties to essentially “renew” expiring patents by “re-patenting” them as new patents beyond what is allowed under the law.
The draft law seeks to restrict the use of certain claims upon characterizing inventions. Specifically, when the Russian Patent Office assesses whether inventions filed for patent registration are actually new, parameters not related to the substance of the inventions will not be taken into account. For example, in a patent application for a pharmaceutical product, it will not be allowed to claim patent protection in relation to the method of treating the disease (eg mentioning the dosage, conditions of use, etc). It is assumed that such approach will stop “double” patenting.
Introduction of an Environmental Tax
The Ministry of Finance of Russia has prepared a draft law suggesting that pollution charges be replaced with an environmental tax. The draft law suggests introducing flat tax rates for the following kinds of negative impact on the environment:
- Emissions into the atmosphere from stationary sources
- Discharge of pollutants into water bodies
- Placement of production and consumption waste by the class of hazard
This change will affect inter alia pharmaceutical manufacturers in Russia.
At this stage the draft law is subject to a regulatory impact assessment procedure. Changes are expected to take effect from January 1, 2020.
We further note that this draft law does not affect the environmental charge that is payable by manufacturers and importers under current legislation.
Subsidies for the Pharmaceutical Industry
The Ministry of Industry and Trade of Russia has drafted amendments to the rules of granting subsidies from the federal budget to compensate the following types of costs:
- Costs incurred implementing projects aimed at arranging and conducting clinical drug trials (Resolution of the Russian Government No. 1045 of October 1, 2015)
- Costs relating to setting up the production of pharmaceuticals and/or pharmaceutical substances (Resolution of the Russian Government No. 1047 of October 1, 2015)
- Costs incurred implementing projects aimed at developing improved analogues of innovative pharmaceuticals that would have a similar pharmacotherapeutic effect (Resolution of the Russian Government No. 1503 of December 30, 2015)
The draft resolutions are published on the portal of regulatory acts for public discussion.
Within the framework of these drafts, subsidies are available to organizations that implement projects aimed at arranging and conducting clinical trials and setting up the production of pharmaceuticals designed for minors.
Furthermore, such organizations and organizations that are residents in priority social and economic development areas and are engaged in the activities stipulated by the resolutions may be entitled to an extra amount of subsidies covering up to 75% of the costs actually incurred. It is further proposed that the set of documents for the execution of a subsidy agreement, as may be submitted by such categories of applicants, be considered on a priority basis.