The new regulations also introduce streamlined approval processes for certain drugs from the EU, the UK, and the US. Below is an overview of the key changes.
1. Key Legislative Changes
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Transparent Pricing and National Price Catalog
- The Ministry of Health will register the declared cost of medicines from manufacturers or importers in a National Price Catalog.
- Drug prices cannot exceed the level of the three lowest reference prices in Eastern Europe.
- Pharmacies must have at least one version of the medicine available at one of those three lowest prices.
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Mechanisms to Reduce Purchase Prices
- New measures such as discount deferrals, credit notes, bonuses, and other forms of reverse price adjustment will be allowed.
- These incentives aim to drive down production and distribution costs, ultimately lowering retail prices for consumers.
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Simplified Registration of Foreign-Approved Drugs
- Medicines already registered by competent authorities in the UK, EU member states, or included on WHO lists will be eligible for streamlined registration in Ukraine.
- This fast-track also applies to drugs covered under the US President’s plan to combat HIV.
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Regulation of Marketing Agreements
- Marketing service agreements for promoting medicines will be restricted to direct contracts between manufacturers (or importers) and a pharmacy/pharmacy chain.
- Advertising services beyond the point of retail sale will be prohibited.
2. Context and Background
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President Zelenskyy’s Call for Action
- President Volodymyr Zelenskyy emphasized the urgency of reducing drug prices and proposed convening the National Security and Defense Council to address the issue. -
Industry Cooperation
- The Pharmacy Professional Association of Ukraine and large pharmacy chains have already signed a Declaration on reducing the cost of medicines, committing to lower prices in tandem with manufacturers and distributors.
- National producers will lower factory prices by a certain percentage compared to January 1, 2025 levels.
- Distributors will adjust wholesale prices proportionally.
- Pharmacies will, in turn, reduce retail prices accordingly, passing the savings on to consumers.
3. Expected Benefits for Ukrainians
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Lower Drug Costs
- The combined effect of price transparency, reference pricing, and reduced mark-ups should make essential medicines more affordable.
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Better Access to Internationally Approved Medications
- Streamlined registration will facilitate faster availability of high-quality foreign drugs, especially those vital for critical or chronic conditions.
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Improved Transparency and Oversight
- National Price Catalog and regulated marketing practices aim to eliminate hidden costs and ensure that patients can easily find and compare medicine prices.
With these reforms, Ukraine moves toward greater alignment with international standards, potentially attracting more global pharmaceutical players while also reducing the financial burden on patients. As the law comes into effect, the Ministry of Health will issue further guidelines detailing how pharmacies, manufacturers, and distributors must comply with the new measures.
