Ukraine adopts Bolar rule, allowing early registration of generic drugs
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The Verkhovna Rada of Ukraine has passed legislation allowing pharmaceutical companies to register and manufacture generic drugs before the expiration of the patent on the original medicine. On Thursday, May 15, 265 members of parliament voted in favor of draft law No. 13087, according to Yaroslav Zheleznyak from the Holos (Voice) party.

The new law introduces the Bolar Rule into Ukrainian legislation.

This provision permits generic drug developers to conduct research, complete regulatory procedures, and even produce and stockpile medicines prior to patent expiry—though commercial sale and promotion remain prohibited until patent protection officially ends.

This change enables generics to enter the market immediately after the original drug's patent expires, rather than being delayed by years of additional testing and approvals. Without such a rule, original manufacturers effectively retain a de facto monopoly even after the patent term ends.

The Bolar Rule is widely implemented internationally and is reflected in EU Directive 2001/83/EC of the European Parliament and the Council of November 6, 2001.

In Ukraine, steps toward implementing the Bolar Rule began in 2020. Its full adoption was designated a priority by the National Security and Defense Council in February 2025 as part of efforts to lower drug prices and improve public access to medication.

The law will enter into force the day after its official publication.

  • Separately, in March, the Ministry of Health announced plans to tighten control over the sale of nalbuphine, a powerful opioid painkiller associated with potential addiction, following a sharp rise in demand.