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KPMG Pharma bulletin, Issue #5, 2014
KPMG Pharma bulletin, Issue #5, 2014
Related content
In this issue:
- Ministry for Healthcare to present new EDL by mid-summer
- Ministry for Industry and Trade announces the first results of the compliance audit on GMP standards
- The Duma supports deferral of decentralization of pharmaceutical procurements under the “7 Nosologies” program
- Ministry for Industry and Trade to develop state import substitution program by autumn
- Regulations developed on providing public service on licensing of pharmaceutical activities
- Draft amendments to the Federal Law “On Circulation of Pharmaceuticals” submitted to the Russian Government
Ministry for Healthcare to present new EDL by mid-summer
The Ministry for Healthcare is compiling a new list of essential and vital drugs. The Ministry has requested assistance from healthcare and pharmaceutical institutions and also from non-governmental associations that protect patients’ rights.
Their representatives will propose the medicines that should be included or excluded from the list of essential and vital drugs. The Ministry for Healthcare will update in a similar way the list of expensive drugs under the nosology program and the drugs provided to cover certain categories of citizens.
The updated list will be submitted to the Government’s consideration by July 15, 2014. At present the EDL approved back in 2011 remains in effect.
Ministry for Industry and Trade announces the first results of the compliance audit on GMP standards
Since the beginning of the year, the Ministry for Industry and Trade has audited 37 pharmaceutical companies from the perspective of compliance with international quality standards (GMP).
Effective January 1, 2014 Russia introduced standards that set a number of requirements to production facilities, equipment and personnel. For example, Russian standards established more than 270 requirements to the production of pharmaceuticals, more than 360 requirements to the production of pharmaceutical substances and more than 800 – to the production of immunobiological drugs and radiopharmaceuticals. The Ministry for Industry and Trade supervises the GMP compliance of the pharmaceutical production. It is planned to monitor 40 companies each year.
At present, the most common violations identified are the lack of an authorized representative who has been duly certified and the failure to keep documents updated.
The Association of Russian Pharmaceutical Producers has announced that approximately 450 drug production licenses have been issued in Russia, while only a half of the companies will be able to successfully pass the GMP compliance audit.
http://www.vedomosti.ru/newspaper/article/688881/slozhnaya-proverka-dlya-tabletok
The Duma supports deferral of decentralization of pharmaceutical procurements under the “7 Nosologies” program
On May 21, the State Duma deputies adopted in a first reading the draft Federal Law “On Amendments to Article 101 of Federal Law No. 323-FZ “On the Fundamentals of Public Healthcare in the Russian Federation”.
The document proposes deferring the transfer of the functions relating to pharmaceutical coverage for the treatment of high-cost diseases included in the Seven Nosologies Program from federal level to the level of constituent subjects of the Russian Federation from January 1, 2015 to January 1, 2018.
The draft law was submitted for consideration on March 14, 2014. According to the note to the document, decentralization of the procurement of pharmaceuticals in the near future would adversely affect the state’s obligations to provide patients with the required pharmaceuticals and would lead to inefficient budget spending, since, in order to procure drugs, each separate region would have to increase the number of tenders at least 83 times. That would complicate the procedure for pharmaceutical coverage and increase their cost.
Ministry for Industry and Trade to develop state import substitution program by autumn
Pursuant to the results of the St. Petersburg International Economic Forum, it has been decided to develop as soon as possible a comprehensive state program on import substitution, inter alia in respect of pharmaceuticals and medical devices of foreign origin.
Import substitution goals are included in virtually all state programs on development of industry sectors up to 2020-2030. By autumn the Ministry for Industry and Trade is supposed to update all the tools available for attainment of these targets and to combine them in a single document covering Russia’s entire industry as a whole.
The plans of the Ministry for Industry and Trade include the launch of production of strategically important goods in Russia by domestic manufacturers within two and a half years, where possible retaining cooperation with foreign countries and partners in areas where national security issues are not paramount. Special support will be provided to foreign companies interested in increasing the level of localization of their products in Russia..
Regulations developed on providing public service on licensing of pharmaceutical activities
On May 21, Rossiyskaya Gazeta published the Order No. 100n/340 of the Ministry for Healthcare and the Ministry for Industry and Trade dated March 5, 2014 “On Invalidating the Regulations on the Procedure for Receiving a Permit (License) for the Industrial Production and Sale of Pharmaceuticals by Pharmaceutical Manufacturers, approved by the Ministry for Healthcare and Medical Industry of the Russian Federation on March 3, 1994.”
The Ministry for Healthcare has developed new administrative regulations on providing public service relating to the licensing of pharmaceutical activities by the executive authorities of the constituent subjects of Russia (with the exception of activities performed by pharmaceutical wholesalers and pharmacies reporting to the federal executive authorities and state academies of science).
The document establishes the deadlines and order of conducting administrative procedures and actions when providing the public service, and also the officials responsible for executing the administrative actions. In addition, the draft determines the list of documents to be used during the public service rendering and the procedure for filing appeals against actions (inaction) and the decisions to be adopted (taken) during the public service provision.
Draft amendments to the Federal Law “On Circulation of Pharmaceuticals” submitted to the Russian Government
The draft federal law on introducing amendments to Federal Law No. 61-FZ “On the Circulation of Pharmaceuticals” and to Part Two of the Tax Code of Russia has been discussed with the professional expert community and submitted to the Government for consideration.
In the opinion of the Ministry of Healthcare, this draft law makes it possible to resolve a number of tasks related to implementation of actions in the Strategy for the Pharmaceutical Coverage of the Population. The draft stipulates the introduction of amendments related to determination of specific aspects in expert appraisals of individual groups of pharmaceuticals and separately, biological, biologically analogous and orphan drugs; the provision of consulting services to applicants; optimization of the duties payable for amendments of registration dossiers by differentiation by type of amendments; harmonization with international legislation regarding the registration dossier formation, and also the implementation of best practice standards on the circulation of pharmaceuticals.
The previous Pharma Bulletin issues are accessible our site.
Prepared for you by KPMG in Russia and the CIS, Healthcare & Pharmaceuticals Sector.
© 2020 KPMG. KPMG refers JSC “KPMG”, “KPMG Tax and Advisory” LLC, companies incorporated under the Laws of the Russian Federation, and KPMG Limited, a company incorporated under The Companies (Guernsey) Law, as amended in 2008.
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