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Notice of updates !
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KPMG Pharma bulletin, Issue #8, 2012
KPMG Pharma bulletin, Issue #8, 2012
Related content
In this issue:
- The program for pharmaceutical and medical industry development adopted
- Pilot projects on pharmaceuticals insurance to be implemented in 4-6 Russian regions
- Federal Anti-Trust Service to review the prices for pharmaceuticals
- The rules for re-registration of maximum producers’ prices for ED could be changed
- Item-quantitative accounting rules adopted in the first reading
- The retail chains could start selling pharmaceuticals
- Working Group for regulating pharmaceuticals to be created by Eurasian Economic Commission
- Draft resolutions on state tenders
The program for pharmaceutical and medical industry development adopted
The state program “Pharmaceutical and medical industry development” was adopted on 18 October at the Russian Government’s session.
As announced by the Minister for Industry and Trade Denis Manturov, implementing the Program should ensure significant re-shape of the industry: the market share of the local manufacturers would increase up to 50% in the pharmaceutical sector and up to 40% in the medical equipment sector.
Also, the Program provides for a range of measures aimed at localizing the medical equipment production. In particular, the draft resolution of the Government, dedicated to unified regulations for the companies intending to localize their production, was prepared.
Pilot projects on pharmaceuticals insurance to be implemented in 4-6 Russian regions
According to the announcement by the Deputy Minister for Healthcare and Social Development, Igor Kagramanyan, the Strategy for pharmaceutical insurance of the Russian citizens for the period till 2025 should be based on the practical experience of pharmaceuticals insurance implementation in the Russian regions. With this respect, 4-6 regions should be selected for approbation of 3 models of pharmaceutical insurance which are being considered as of today.
Federal Anti-Trust Service to review the prices for pharmaceuticals
In particular, FAS plans to check the retail prices set by the Russian pharmacies. It will compare the local prices for ED with the worldwide ones, for example with those in German and Polish pharmacies.
As per Igor Artemiev, FAS is already aware of two- and threefold overstatement of prices for pharmaceuticals supplied by some companies. The pharmacies which overstate prices would be subject to turnover-based penalties.
The rules for re-registration of maximum producers’ prices for ED could be changed
FAS suggested allowing Russian drug manufacturers to re-register their maximum producers’ prices with account for the cost of production dynamics, rather than for the forecasted inflation.
Besides, FAS proposes to revise the list of reference countries which is stipulated by the Methodology as the basis for benchmarking the prices registered by foreign manufacturers. The Anti-Trust Service proposes either to reduce the list and include only those countries where the level of economy development is close to the Russian one, or to fix the prices subject to registration at the level not exceeding the average-weighted sales price for the product in the reference countries.
In addition, FAS suggests to replace the maximum mark-ups in % to mark-ups denominated in absolute values (in Russian rubles), with differentiation by price groups.
Item-quantitative accounting rules adopted in the first reading
On 31 August the Government of Russia submitted to the State Duma a draft law “On introducing amendments into the Federal law “On circulation of pharmaceuticals” (please refer to KPMG Pharma Bulletin, issue #26).
On 24 October 2012, the draft was adopted by the State Duma in the first reading, in part of item-quantitative accounting of pharmaceuticals.
http://www.duma.gov.ru/systems/law/?number=134007-6&sort=date
The retail chains could start selling pharmaceuticals
The Russian Government is considering the possibility of selling OTC drugs in retail chains; by the 1st of December 2012 the report “Possibilities of selling particular pharmaceuticals in retail chains” should be presented.
This information is released in the Minutes of the session of the state Commission for competition and development of small and mid-sized businesses. The report is to be prepared by the Ministry for Healthcare and Social Development together with the Ministry for Industry and Trade, Ministry for Economic Development, Federal Anti-Trust Service and Federal Tariff Service.
Working Group for regulating pharmaceuticals to be created by Eurasian Economic Commission
In course of the Eurasian Economic Commission (EEC) Board session, it was suggested to create a Working Group for shaping the general approach to regulating circulation of pharmaceuticals within the Customs Union and the United Economic Space, in order to unify the governance of pharmaceuticals circulation in the territory of the member states based on the worldwide practice and the EU documents.
The Working Group will include representatives of the Ministries for Healthcare of the Customs Union member states, of the Russian Ministry for Economic Development and the Ministry for Industry and Trade, of the state authorities controlling pharmaceuticals circulation, of pharmaceutical market players, as well as the members of Russian and international pharmaceuticals manufacturers’ associations.
Draft resolutions on state tenders
To prevent abuses in course of state tenders, the following draft Resolutions were developed by the Russian Government: “On adopting the list of pharmaceuticals for which supply orders are placed according to trade names” and “On establishing the initial (maximum) contract (lot) price exceeding of which precludes combining different pharmaceuticals with INN into one contract (lot)”.
According to the first draft, there will be a list of pharmaceuticals for which supply orders are to be placed according to their trade names. The second draft stipulates that pharmaceuticals with different INN could not be the subject of one contract (lot) if the initial (maximum) price for such contract (lot) exceeds RUB 3 MM.
The same applies to pharmaceuticals with identical INN when their total value under the initial (maximum) contract (lot) price exceeds RUB 3 MM during a calendar quarter.
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