The Rada adopted a bill on the introduction of the "Bolar rule" into Ukrainian legislation
Kyiv • UNN
The Verkhovna Rada has adopted a law introducing the "Bolar rule", which will allow the production of generic drugs before the expiration of the patent of original drugs. This will increase competition and lower prices.
Today, on 15 May, the Verkhovna Rada of Ukraine adopted the draft law ‘On Amendments to Certain Laws of Ukraine on the Implementation of the Bolar Regulation’. It was supported by 265 people's deputies, UNN writes with reference to the session of the Verkhovna Rada and the text of draft law No. 13087, which was published on the official website of the Ukrainian Parliament.
Details
The purpose of the draft law is to overcome the monopoly in the drug market, which is granted to the owners of the patent for original drugs.
The Chairman of the VR Committee on National Health, Medical Assistance and Medical Insurance, Mykhailo Radutskyi, explained that the "Bolar Rule," which operates in EU countries, gives manufacturers the right to start registering and manufacturing generic drugs (analogues of original drugs) before the expiration of the original drug patent.
The draft law stipulates that drugs can be registered the day after the expiration of the patent for the original drug. At the same time, it is prohibited to sell, advertise or commercialize drugs until the expiration of the patent.
The adoption of draft law No. 13087 will increase competition between manufacturers of generic drugs and reduce drug prices for patients. Also, the state's priority is to support domestic producers. We are preparing a draft law for the second reading
Recall
New regulations for the pharmaceutical market came into force in Ukraine on March 1. In particular, on February 14, the Cabinet of Ministers of Ukraine adopted Resolution No. 168 on stabilizing drug prices, which, among other things, provides for the introduction of restrictions on markups on supply and distribution and retail margins for all drugs, not just for certain categories.
However, this document was not согласован with the State Regulatory Service, as required by law. Also, as it turned out, draft resolution No. 168 was not submitted for legal expertise to the Ministry of Justice, as required by the Regulations of the Cabinet of Ministers of Ukraine.