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Rada adopts law on simplified registration of medicines: what will change for Ukrainians

Kyiv • UNN

 • 66374 views

The Verkhovna Rada has passed a law on simplified drug registration and transparent pricing. The new rules provide for price control of medicines and simplified registration of drugs from the EU, the UK and the US.

Rada adopts law on simplified registration of medicines: what will change for Ukrainians

The Verkhovna Rada has adopted a law on simplified state registration of medicines, MP Yaroslav Zheleznyak said on Wednesday, UNN reports.

Details 

"No. 11493 - changes in approaches to the existing procedures for simplified state registration of medicines that can be procured by the State Enterprise "Medical Procurement of Ukraine - in general," the MP wrote on Telegram.

The bill was supported by 250 MPs.

What changes

The draft law, according to  Mykhailo Radutskyi, chairman of the Verkhovna Rada Committee on National Health, Medical Assistance and Medical Insurance, introduces mechanisms for transparent pricing of medicines, as envisaged by the NSDC decision of February 5 this year.

According to the draft law, the Ministry of Health will enter into the National Price Catalog the declared cost of the manufacturer or importer of medicines, which cannot exceed the price of the three lowest prices in the reference countries of Eastern Europe. "Pharmacies are obliged to have medicines available at one of the three lowest prices," said the MP.

Also, according to him, practices are being introduced that should lead to an actual reduction in purchase prices for medicines: a mechanism for deferring discounts, credit notes, bonuses and other forms of reverse price adjustment may be used by licensees engaged in the production of medicines.

In addition, medicinal products registered by the competent authority in the UK, EU countries or included in the WHO lists will reportedly receive a simplified registration permit in Ukraine. This also applies to drugs included in the US President's plan to fight HIV.

The conclusion of agreements on marketing services for the promotion of medicines is to be allowed exclusively between manufacturers (importers) and a pharmacy (pharmacy chain). The relevant procedure for the provision of services will be approved by the government, and the provision of advertising services outside the places of retail sale of medicines will be prohibited.

Add 

President Volodymyr Zelenskyy previously stated that it was necessary to make a decision to reduce drug prices. The pharmacy business supported the President's statement. He also announced a meeting of the National Security and Defense Council on Wednesday, which will consider the issue of reducing drug prices. 

The Pharmacy Professional Association of Ukraine NGO sent to the Ministry of Health of Ukraine the Declaration of Cooperation on Reducing the Cost of Medicines, which has already been signed by a number of large pharmacy chains.

It sets out the following obligations of all market participants:

  • National manufacturers of medicines reduce the selling prices of their products by a certain percentage compared to the prices as of January 1, 2025.
    • Distributors reduce wholesale prices in proportion to the manufacturer, which will affect the entire logistics network.
      • Pharmacies, for their part, reduce retail prices for medicines, providing the end consumer with a real reduction in the cost of drugs, i.e., they apply a discount on their margin proportional to the manufacturer.

        The memorandum is expected to be signed by leading Ukrainian manufacturers and distributors.

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