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The State Duma intends to consider in the first reading two draft laws which introduce amendments to the Federal law “On Advertising”. The amendments, specifically, suggest restrictions on the advertising of pharmaceuticals and biologically active and nutritive supplements outside specialized events and medical print media.
After re-registering a maximum producer’s price, a new entry containing the information on the new registered price and the date of the respective order shall be added to the state register of maximum producer prices for essential drugs.
Producers may sell pharmaceuticals at re-registered prices starting from the date of the order on state registration, regardless of the production date of the particular series of the medicine.
Russian Government Order No. 66 dated 13.02.2013 has approved the Strategy for pharmaceutical support in Russia until 2025. The strategy defines the top-priority social and economic objectives of pharmaceutical support to the Russian population in the long term (see also KPMG Pharma Bulletin, Issue #29).
The aim of the strategy is to increase the availability of high-quality, effective and safe pharmaceuticals which meet the requirements of both citizens and the healthcare system, and which are based on the creation of a sustainable and balanced system of pharmaceutical support.
Under the Ministry for Healthcare and Social Development Order No. 986n dated 29.11.2012, an Ethics Committee is to be established that will be responsible for carrying out ethical appraisals of potential clinical trials of pharmaceuticals.
According to the Order, the Committee would act to safeguard the life, health and rights of patients participating in clinical trials. Following the results of an appraisal, the committee would issue a conclusion on the ethical justification of conducting clinical trials of a drug.
At the end of 2012 ARPhP requested the Russian Prime Minister Dmitry Medvedev to bring the Government Resolution No. 688 dated 15.09.2008 "On Adopting the List of Codes for Medical Goods Subject to 10% VAT" into line with the Russian Tax Code and the Federal Law No. 61 dated 12.04.2010 "On Circulation of Pharmaceuticals" (see also KPMG Pharma-Bulletin, Issue #29).
In late February ARPhP received the Ministry’s response that the proposal to exclude a requirement on having a registration certificate for Russian and foreign-manufactured pharmaceutical substances in order to apply a reduced VAT rate was supported by all relevant federal executive authorities.
Regarding the application of a reduced VAT rate to pharmaceuticals during the period when their state registration is being confirmed, according to the Russian Finance Ministry, the introduction of amendments to the law “On the Circulation of Pharmaceuticals” will first be required. The amendments should also stipulate a requirement for submitting an application to confirm pharmaceutical state registration not less than 90 days before the expiration of a registration certificate.
The document has been elaborated to replace the previous Order No. 120 dated 12 March 2012 of the Ministry for Economic Development “On the Conditions for Admitting Goods of Foreign Origin For the Purpose of Placing Orders For Goods For the Needs of Customers”, which ceased to be in force on 31 December 2012 (see KPMG Pharma-Bulletin, Issue #22).
The new draft order has been prepared with account to proposals from the Ministry for Trade, the Ministry for Healthcare, and the Ministry for Sport of Russia with respect to goods manufactured in Russia which should be subject to preferences in 2013. In addition, the draft law stipulates the procedure for granting contract price preferences to participants of state tenders whose applications contain a proposal to supply Russian- and Belorussian-manufactured goods in the amount of 15%.
The Ministry for Economic Development has held public consultations to evaluate Regulation No. 748n dated 26.08.2010 of the Ministry for Healthcare “On Approving the Issuance of Permits to Conduct Clinical Trials of Pharmaceuticals”, in accordance with the Russian Government Resolution No. 633 dated 19 July 2011 “On the Expert Evaluation of Legislative Acts of Federal Executive Authorities For the Purposes of Identifying Provisions That Unjustifiably Complicate The conduct of Business and Investment Activity, and On the Introduction of Amendments to Particular Acts of the Russian Government”.
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