On 18 April 2013 Decision of the Government of Russia # 301 dated 06.04.2013 “On establishing a maximum value for initial (maximum) contract prices (lot prices), above which various drugs with international, non-proprietary names cannot be the subject of one contract (one lot), or, in the absence of such non-proprietary names, with chemical or generic names” came into effect.
The document, elaborated by the Russian Ministry for Healthcare in conjunction with the Federal Anti-Trust Service, sets a limit for the value of initial (maximum) contract prices (lot prices) of RUB 1 million, and, for the needs of state and municipal customers in Moscow and St. Petersburg, a limit of RUB 5 million. The Decision also contains a requirement in relation to the purchase of separate lots of drugs, within registered INN (international non-proprietary names) of which there are no registered analogues by formulation and dosage.
On April 4 the Russian Ministry of Justice registered the Russian Ministry for Healthcare Order # 1353n dated 21.12.2012, “On approving the organization and conduct of expert appraisals on the quality, efficacy and safety of medical goods”. Expert appraisals shall be held by the Federal Government Budgetary Institution (under the auspices of Roszdravnadzor), and be based on two stages:
The State Duma Budget and Taxes Committee has backed a government draft law which establishes the procedure for drawing up the list of VAT-exempt imported medical goods. The amendments include changes to the Russian Tax Code related to improving the mechanism for applying VAT exemptions when importing into Russia the most important and essential medical equipment. In particular, the draft law proposes that the Government be authorized to determine the list of medical goods (as well as raw materials and components used in their production) whose import shall be VAT-exempt.
The Ministry for Economic Development has held public consultations to assess the regulatory impact of the Draft Federal Law “On Amendments to the Federal Law “On Circulation of Pharmaceuticals” and to Article 333.32.1. of Part II of the Russian Tax Code”. The Ministry concluded that the Draft law contains provisions which impose excessive administrative and other restrictions on entrepreneurial activity. In particular, the Ministry deemed that introducing pharmaceutical expert appraisals of samples of drugs designated for receiving permits on conducting clinical trials was inappropriate at the first stage of decision-taking on the conduct of clinical research, since quality control methods and regulatory documents are the subject of research during the second stage of expert appraisals.
Accordingly, should the amendments be adopted, the average time to issue a permit for clinical trials could increase significantly, with estimates ranging from six months to a year. According to participants of the public consultations, the average timeframe for issuing permits for clinical trials currently stands at 115 calendar days.
On April 18 the Economic Policy, Entrepreneurship and Innovation Development Committee recommended that the State Duma adopt on its first reading Draft Law No. 246197-6 “On Amendments to the Federal Law “On Advertising”, and to Article 14.3 of the Administrative Code of the Russian Federation”, in relation to the advertising of biologically active additives. In particular, it is proposed to make it compulsory to indicate in biologically active additive advertising that such additives are not medicines; herewith the duration of notification in course of advertising and the minimum size of advertising space required are defined. The draft law also introduces liability for violating the requirements to advertising biologically active additives, which shall apply not only to advertisers, but also to the distributors of advertisements.