KPMG Pharma Bulletin Issue #4, 2017 (April)
KPMG Pharma Bulletin Issue #4, 2017 (April)
The Federal Anti-Trust Service of Russia has spoken against the launch of the pilot project on introducing the risk-sharing system for pharmaceuticals public procurement developed by the Ministry of Healthcare.
The risk-sharing system envisages that the state pays to the pharmaceuticals supplier only for those medicines that have been effective for patients treatment. However, the FAS believes that launching of the project without regard to antimonopoly implications could result in negative implications for the state budget and could impair the market competition.
According to the FAS’ comments, the risk-sharing system may work only when procuring patent-protected innovative pharmaceuticals which are not included into the ED list, have no generics or bio-similars registered in Russia and have no substitutes.
The list of patients to participate in the pilot project is supposed to be developed in advance (prior to beginning their treatment), however the rules for putting patients on this list have not been defined yet. The legal relationships between pharmaceutical suppliers and the state customer are to be governed by the regulations developed by the regional authorities, as per the Ministry of Healthcare’s proposal. Such regulations should stipulate the pilot project terms, the procedure and timeframes for monitoring the treatment effectiveness and other parameters. According to the FAS, such an approach is unacceptable, as it would result in setting up completely different requirements per regions, thus discriminating the suppliers.
It was also highlighted that the proposed mechanism of implementing the pilot project does not address the consequences of terminating the arrangements between the Ministry of Healthcare and the regional governments.
The Ministry for Industry and Trade has drafted the Government Resolution "On Amendments of the Rules for Granting Subsidies from the Federal Budget to Russian Companies for Partial Compensation of Expenses for Setting up Projects on Manufacturing of Pharmaceuticals and (or) APIs under the Sub-Program "Pharmaceuticals Production Development" of the Russian State Program "Development of Pharmaceutical and Medical Industry" for 2013-2020”.
The document, in particular, extends the list of criteria for subsidizing projects on setting up pediatric pharmaceuticals manufacturing.
The subsidy could be available to the companies which business plan envisages:
− manufacturing of one or more active pharmaceutical ingredients (pharmaceutical substances),
− start of API production within 3 years from entering into the subsidy agreement,
− start of distribution of the manufactured API within 4 years from entering into the subsidy agreement,
− earning revenues from sales of pharmaceuticals exceeding the subsidy amount three-fold or more, cumulatively for 3 years upon the production commencement.
BMCP safety monitoring is conducted by the Federal Service on Surveillance in Healthcare and Social Development (Roszdravnadzor) by means of analyzing the information provided by participants of BMCP circulation, including:
− side effects, adverse reactions, serious adverse reactions, unexpected adverse reactions in course of BMCP treatment,
− individual intolerance, inefficacy of BMCP (adverse reactions),
− specifics of BMCP compatibility with pharmaceuticals, medical devices, food products, other BMCP;
− other facts and circumstances representing a threat to a human life or health in course of BMCP treatment (other information on safety and effectiveness) identified at all the stages of BMCP circulation in the Russian Federation.
On April 14, 2017, the State Duma adopted in the first reading the bill # 54490-7 which proposes to amend the Federal Laws "On Procurement of Goods, Works, Services by Certain Legal Entities" dd. 18.07.2011 # 223-FZ and "On Contract System for Procurement of Goods, Works, Services for State and Municipal Needs" dd. 05.04.2013 # 44-FZ, by excluding public and municipal unitary pharmaceutical companies from the list of entities obliged to apply the above Federal Laws in their procurement activities.
A draft law "On Amendments to the Federal law "On Circulation of Pharmaceuticals" was introduced to the State Duma.
The proposed new wording of Article 30 of the Federal Law "On Circulation of Pharmaceuticals" dd. 12.04.2010 # 61-FZ specifies that, in case of commencing local production of a pharmaceutical which was previously imported to Russia, the documentation on the foreign production site does not need to be submitted for the purposes of amending the registration documents by adding or replacing a production site.
The Chairman of the Government of the Russian Federation signed the Decree dd. April 14, 2017 # 698-R approving the list of non-food goods, for which companies and individual entrepreneurs must use cash-register equipment when selling such goods in retail markets, fairs, exhibition centers and other areas designated for trade.
In particular, the list includes:
− pharmaceuticals and materials used for medical purposes code 21 ОКПД 034-2014 (КПЕС 2008);
− orthopedic devices — code 184.108.40.206 ОКПД 034-2014 (КПЕС 2008).
A draft law "On Amendments to Part 1 of Article 93 of the Federal law "On Contract System for Procurement of Goods, Works, Services for State and Municipal Needs" was introduced to the State Duma.
The bill proposes that, should pharmaceuticals be prescribed to a patient by a medical commission under the therapeutic indications, the maximum value for such pharmaceuticals procured by the state from a sole supplier should be increased from RUB 200 thousand to RUB 600 thousand.
On 17 April, the Russian Ministry of Justice registered the Order of Roszdravnadzor # 1636 dd. 03.03.2017, which amends the Departmental Order # 40-I/13 dd. 16.01.2013 "On Approval of the Template of the Registration Certificate for a Medical Device", introducing the following changes:
− the item "Manufacturer" is specified,
− the value "Code per All-Russian Сlassifier of Products" (OKP) is replaced by the value “Code per All-Russian Classifier of Products by Types of Economical Activities” (OKPD).
The Ministry for Industry and Trade prepared a draft Resolution amending the list of foreign-manufactured medical devices restricted from access to public procurements.
In particular, it is proposed to add the following codes to the list approved earlier by the Government Resolution # 102 dd. 05.02.2015:
− stents for coronary arteries (OKPD: 220.127.116.11, 18.104.22.1681, OKPD2: 22.214.171.124);
− stents for coronary arteries exuding pharmaceuticals, with an absorbable polymer coating (OKDP: 126.96.36.199, 188.8.131.521, OKPD2 - 184.108.40.206).
The criteria for inclusion into the restricting list are: 1) existence of at least two Russian manufacturers of identical medical devices according to GOST standard, and 2) the percentage share of foreign components used for manufacturing the medical device (should not exceed 50% of the final product’s price).
The draft Federal law "On Amendment to Article 149 of the Russian Tax Code in Part of VAT Exemption for Financial Lease of Essential Medical Devices" was submitted to the State Duma.
.Under the current version of the said Article 149, a VAT exemption applies for sale of essential medical devices listed as per the Government Decree dd. 30 September 2015 #1042, while financial lease of those is VAT-able under the general rules.
For the purposes of harmonizing the taxation, the bill proposes the VAT exemption for lease-out of the duly registered essential medical devices under contracts for financial lease with the right for redemption.
The Ministry of Healthcare placed for public discussions the draft Order "On Approval of Criteria for Assessing the Quality of Medical Care". These criteria are proposed for use by when delivering medical care by duly licensed entities, in order to assess the timeliness of medical aid, the correctness of preventive, diagnosis, treatment and rehabilitation methods, degree of achievement of the expected clinical outcome.
The quality criteria are to be applied per groups of diseases (conditions) and per regime of medical care (outpatient, day hospital and inpatient).
The Federation Council has approved the law "On Amendments to Article 13 of the Federal law "On Compulsory Social Insurance for Temporary Disability and Maternity" and Articles 59 and 78 of the Federal Law "On the Fundamentals of Healthcare Protection of the Citizens of the Russian Federation", enabling the use of medical certificates (sick-leave notes) both in paper and in electronic form.
The law enters into force from July 01, 2017.
In accordance with the Government’s Resolution #394 dd. 31.03.2017, the State Program "Healthcare Development" is supplemented with two new sub-programs and activities for priority projects:
− Organizing the obligatory medical insurance for the Russian citizens;
− Development of emergency medical aid.
The program also integrates a number of new activities, in particular, introduction of the automated monitoring system for pharmaceuticals circulation from a manufacturer to an end-user, in order to protect the population from counterfeit pharmaceuticals and to promptly remove from the market counterfeit and poor-quality drugs.
The previous Pharma Bulletin issues are accessible our site.
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