The deputies of the Russian Liberal Democratic Party submitted to the State Duma a draft law which totally bans advertising of pharmaceuticals. Besides, the draft also suggests amendments to the Article 24 of the Federal law “On advertising”, toughening requirements to the advertisement of medical equipment, medical products and medical services.
The Ministry for Economic Development has already elaborated the so-called “Roadmap for pricing improvement for pharmaceuticals for 2012-2014 and further prospective”. The document was approved in the meeting attended by all the interested authorities. However, as per the Ministry’s representative, the document is still subject to further revision.
According to the “roadmap”, pricing improvement should represent a step-by-step transition from direct state pricing regulation to partial reimbursing the customers’ costs for pharmaceuticals by the state, via insurance companies.
In 2013 the new system is to be tested for “pilot” patient groups who are currently receiving pharmaceuticals under state programs; starting from 2014, the system is supposed to cover all the subsidized citizens.
The Order of the Ministry for Economic Development No 120 dd. 12.03.2012 “On conditions of releasing the goods of foreign origin for placing orders for customers’ needs” (please refer to KPMG Pharma Bulletin # 21) came into force. The document stipulates the conditions effective till 31 December 2012 for releasing particular foreign goods as supplies for state and municipal needs.
In particular, a 15% discount to the contract price is granted to Russian and Belorussian pharmaceuticals and medical equipment manufactureres when placing orders for supplies of such godos.
The Ministry for Healthcare and Social Development of Russia elaborated a draft Order stipulating the procedure of importing medical products into the territory of the Russian Federation for state registration. According thereto, medical products could be imported for state registration purposes based on a one-time permission issued by Roszdravnadzor.
The draft is published at the official website of the Ministry for Healthcare and Social Development, for assessing its expected regulatory impact and identifying the provisions which entail excessive administrative and other restrictions.
In particular, the draft permits the circulation of medical products registered according to the new procedure stipulated by the Government of Russia, an authorized federal executive body, starting from 1 July 2012.
However, as of today the respective legislative act approving the new registration procedure for medical products has not been adopted yet.
With this respect, it is suggested to re-schedule the enactment of the article permitting the circulation in Russia of medical goods registered according to the new procedure for 1 January 2013.
The draft law on the Federal Contracting System was adopted by the Government and is supposed to be submitted for the State Duma’s approval soon. According to the experts, the new law already now allows to perform state purchases at a higher quality level: in particular, the document provides for new opportunities for the customers, enabling them to choose the purchasing tool and to correctly justify the volume and price.
The Federal Tariff Service of Russia published the List of maximum wholesale and retail mark-ups to registered prices for ED, established in the regions of Russia (based on the data for the 1st quarter 2012).
The representatives of the Ministry for Healthcare and Social Development note that the work in this respect has just started and the applicable approaches are to be developed, so the timing for introducing the new rules is not certain yet.
Should you have not received any of the previous pharma Bulletin issues, please contact us and we will supply it immediately!
Prepared for you by KPMG Tax Department.