KPMG Pharma Bulletin Issue #12, 2016 (December)
KPMG Pharma Bulletin Issue #12, 2016 (December)
- Ministry for Industry and Trade proposes changes to the Law ‘On Circulation of Pharmaceuticals’ to simplify contract manufacturing
- Federal Anti-Trust Service clarified the rules for amending information of a registered essential drug
- Ministry of Healthcare developed a pack of documents for implementing the law ‘On Biomedical Cellular Products’
- Parliamentaries suggest to exempt procurements by public pharmacies of the Federal Law 44-FZ requirements
- Requirements adopted to the package and completeness of pharmaceuticals for medical use, to be observed during production, sale and transfer by manufactures
- Government considers expanding the list of medical devices subject to restrictions in public procurement
The 2017 List of Essential and Vitally Important Drugs for medical use is fully identical to the one effective during 2016.
The corresponding Decree #2885-p was signed by the Prime Minister on 28.12.2016.
The Ministry of Healthcare has published Минздрав the draft Federal Law “On Amendments to Part 2 of the Russian Tax Code Relating to Imposing and Payment of Stamp Duties in Area of Circulation of Pharmaceuticals for Medical Use”, setting out the list of stamp duties payable for the Ministry’s activities related to registration of pharmaceuticals intended for circulation in the EEU common market.
According to the draft law, the following duty rates are supposed to be reset:
− RUB 325K for expert examination of a drug and examination of the expected use vs. potential risk, while registration of pharmaceuticals intended for circulation in the EEU market, of for the assessment of the expert report upon such an examination;
− RUB 45K for expert examination of the quality of the pharmaceutical and examination of the expected use vs. potential risk, while registration of pharmaceuticals with reliably tested medical use and intended for circulation in the EEU market, of for the assessment of the expert report upon such an examination;
− RUB 145K for confirming the registration of a pharmaceutical intended for circulation in the EEU market;
− RUB 75K for introducing changes to documents included into a registration dossier if such changes require an expert examination in part of the pharmaceutical’s quality and (or) correlation of the expected use vs. potential risk, or for the assessment of the expert report upon such an examination;
− RUB 5K for introducing changes to documents included into a registration dossier if such changes do not require an expert examination of the pharmaceuticals for medical use;
− RUB 75K for updating the registration dossier for a pharmaceutical in accordance with the EEU requirements;
− RUB 10K for issuance of a registration dossier for a pharmaceutical.
Ministry for Industry and Trade proposes changes to the Law ‘On Circulation of Pharmaceuticals’ to simplify contract manufacturing
The Ministry for Industry and Trade Министерством has posted the draft amendments to the Federal Law #61-FZ “On Circulation of Pharmaceuticals” which permit manufacturing of drugs having the same international non-proprietary name (INN) but different trade names.
The currently effective regulations prohibit registration of pharmaceuticals having the same INN and different trade names and manufactured at the same production site. In practice, this requirement restrains development of contract manufacturing projects and restricts the number of production sites which could be used.
The proposed amendments, lifting the said restriction, are supposed to support the development of pharmaceutical contract manufacturing market in Russia and enable Russian producers to manufacture, besides own products, the drugs of other companies.
The Federal Anti-Trust Service of Russia believes that, in case of changing the completeness of a pharmaceutical without changing its quantity in the secondary (consumer) package, registration of the ex-factory price and economic analysis by the Anti-Trust Service are not required to be repeated. The said changes shall be introduced by the Ministry of Healthcare within one calendar month.
The Russian Ministry of Healthcare developed several draft orders regulating, inter alia, the procedure of submitting documents for state registration of a biomedical cellular product, available ways, terms and timeframes for transporting the biological materials, procedures of state control over the activities in area of biomedical cellular products circulation, and the applicable rates of stamp duties.
The following draft orders have been places for public debates:
− “On approving the procedure for submitting documents which form a registration dossier for a biomedical cellular product and the template application for state registration of a biomedical cellular product”;
− “On approving rules for receiving biological material for manufacturing of biomedical cellular products and procedure for its transfer to the biomedical cellular products manufacturer”;
− “On approving the procedure for recording in medical documentation a person’s will expression on the dissent of post-mortem provision of biological material for biomedical cellular products manufacturing”;
− “On approving transportation rules for biological material, cells for production of cell lines, cell lines, intended for biomedical cellular products manufacturing, and biomedical cellular products manufacturing”;
− “On approving the Resolution on state control over the activities in area of biomedical cellular products circulation";
− “On amendment to Chapter 25-3 of the Russian Tax Code pursuant to the adoption of the Federal Law “On Biomedical Cellular Products”.
A draft law # 54490-7 «On introducing amendments to Article 1 of the Federal Law “On Procurement of Goods, Works, Services by Certain Types of Legal Entities” and to the Federal Law “On Contractual System for Procurement of Goods, Works, Services for State and Municipal Needs” was submitted to the State Duma for consideration.
The draft suggests to exclude state and municipal pharmacies from the list of public entities subject to the provisions of the Federal Law dd. April 05, 2013 # 44-FZ “On Contractual System for Procurement of Goods, Works, Services for State and Municipal Needs”.
According to the draft’s developers, procurement in accordance with the law #44-FZ affects the competiveness of the state pharmacies, as the electronic auction procedure takes from 42 up to 60 days, from the date of the purchase order inclusion into the procurement plan till the date of a contract signing. Additionally, the authors of the amendments highlight the risk of suppliers ignoring the auction due to unattractive contract terms.
On December, 14 the deputies of the State Duma denied the draft law “On introducing changes to Article 63 of the Federal Law “On Circulation of Pharmaceuticals”, which proposed printing the maximum retail price for an essential drug on its secondary (consumer) pack.
According to the resolution of the Duma’s Healthcare Safety Committee, the above provision contradicts Article 6 of the Federal Law #61-FZ “On Circulation of Pharmaceuticals” which limits the powers of executive authorities of Russian regions by setting the maximum wholesale and retail mark-ups applicable to the actual ex-factory prices for essential drugs.
The list of medical goods subject to 10% VAT could be extended
The Ministry for Industry and Trade developed a draft Resolution of the Government of Russia “On introducing amendments to the Resolution of the Government dd. September 15, 2008 # 688”. The document is intended to harmonize the classification codes of medical devices subject to 10% VAT when imported to Russia, with the classification codes set by the All-Russia Classifier of Products per Economic Activity Types.
In addition, the list of medical goods subject to 10% VAT on domestic sale i in line with the All-Russia Classifier of Products is also going to be extended.
The developers of the draft expect the proposed changes to work for the benefit of local manufacturers of pharmaceuticals for medical and veterinary use, as well as to expand the pharmaceuticals’ availability.
The Ministry of Healthcare designed a draft Resolution of the Government of Russia “On Specifics of Descriptions of Pharmaceuticals for Medical Use Subject to Public Procurement”. The document is aimed at setting the unified standard for description of pharmaceuticals by the state (municipal) purchasers when preparing the purchase-related documentation.
The Ministry suggests that the purchase order should be focused on the international non-proprietary name (ONN), without indicating in the procurement documentation any requirements or guidelines on the characteristics of pharmaceuticals which could be linked to particular trade names, for example, the pharmaceuticals form (pill, powder, solution), means of the drug administration, dosage.
Exceptions could be permissible only in case when there is no other way to provide a clear description of the required drug, and provided that the description contains the wording “or a substitutable pharmaceutical”.
Requirements adopted to the package and completeness of pharmaceuticals for medical use, to be observed during production, sale and transfer by manufactures
The Russian Ministry for Healthcare issued requirements to the container volume, package and completeness of pharmaceuticals for medical use. On January 11, 2017 the Ministry of Justice registered the corresponding departmental Order # 979н dd. 21.12.2016.
According to the Order, manufacturing of pharmaceuticals for internal use, their sale and transfer by manufacturers could be done in the following containers, and provided that information is available from at least 25 regions of Russia on the use of the pharmaceutical in a way differing from the one set out by the medical use manual or without prescription by a healthcare professional:
|Volume ration of alcoho
||Course dose of the pharmaceutical||Maximum container volume|
|Over 50%||Not more than 75 ml
||Not more than 25 ml
|From 30% tо 50%||Not more than 10 ml
||Not more than 50 ml
|Below 30%||Not more than 200 ml
||Not more than 100 ml
The draft federal law “On Circulation of Medical Devices” is one of the most long-awaited documents for the Russian healthcare industry – its development commenced back in 2012. Besides the Ministry of Healthcare, the work on the draft law is carried out by the Ministry for Industry and Trade, the Federal Service on Surveillance in Area of Healthcare (Roszdravnadzor), the Ministry of Finance, the Federal Anti-Trust Service, as well as industry experts.
According to the Ministry of Healthcare, further work on the draft law will take place on the State Duma Health Safety Committee’s platform, in course of preparing the document to the second reading by the Parliament.
The Government is considering to extend the list of imported medical devices restricted from public procurement to 128 types наименований (excluding those imported medical devices which could be purchased in the commercial segment).
The new list developed by the Ministry for Industry and Trade includes: medical consumables (bandages, antiseptics, tissues, sponges, breath guards); devices for personal use (glucometers); hi-tech medical equipment (defibrillators, certain types of tomographs); prosthetic devices (silicon breast implants).
The Resolution of the Government of Russia #1581 dd. 31.12.2016 amended the list of medical devise eligible for VAT exemption when sold in Russia and imported into Russia and other territories under Russia’s jurisdiction.
Particularly, the list was supplemented by article “medical table balance”; the following article was removed from the list: “materials and components for manufacturing of prosthetic devices (including artificial limbs, prosthetic eyes, ears, nose, palate, teeth, breast, genitals, combined and cosmetic prostheses) as well as the related semi-products”.
The previous Pharma Bulletin issues are accessible our site.
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