New preferences for pharmaceutical manufacturers in Russia may take effect in 2019

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The Russian government finalized a draft decree for regulating the public procurement of medicines. The document will establish new preferences for domestic manufacturers of medicinal products from 2019.

The decree should enter into force on January 1, 2019.

The draft amends the current decree on preferences for Russian manufacturers and companies from the Eurasian Economic Union and proposes to introduce a new type of state support in the form of a price preference set at 25% of the minimum contract price. It will apply only to the companies involved in full-cycle manufacturing of medicines in these countries, from the substance synthesis (active substance of any drug) to packaging. To demonstrate to the customer that the drug was fully manufactured in Russia or EAEU countries, a company will have to obtain the confirmation from the Russian Ministry of Industry and Trade. The procedure for issuing this document is yet to be elaborated.

The current version of decree on preferences includes the principle, that is called “the fifth wheel” in the pharmaceutical industry. It implies that, if two or more Russian manufacturers (regardless of whether they manufacture the substance or purchase it abroad) are participating in the auction, no foreign medicine will be allowed to participate in the tender. There is no this restriction in the new document, but as the same time it does not exclude the “the fifth wheel” clause from the current version.

SOURCE: gmpnews.ru
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