Ukraine will simplify the production of generics – analogs of original medicines
7 May 10:56
The Parliamentary Committee on National Health, Medical Care and Health Insurance proposes that the Parliament vote in the second reading on a bill that introduces the Bolar Rule in Ukrainian legislation and allows the production of generics to begin before the expiration of the patent for the original drug, and registration the day after the expiration of the document. This was announced by the author of the document, the chairman of the relevant Committee, MP from the Servant of the People party Mykhailo Radutskyi, Komersant ukrainskyi reports.
As you know, according to the current regulations, registration and production of generics is allowed only after the expiration of the patent term.
“The adoption of the draft law will increase competition in the pharmaceutical market and reduce prices for patients,” said MP Mykhailo Radutsky.
What does the so-called “Bolar Rule” provide for?
the “Bolar Rule” is a provision that does not recognize the actions of the applicant of a generic medicinal product for conducting trials and state registration of such a medicinal product until the patent expires as an infringement of the patent for an original medicinal product. This rule provides a legal opportunity for applicants of generic medicinal products to conduct studies of therapeutic properties and submit applications for registration of medicinal products.
Under this rule, applicants have the right to obtain certificates of state registration of medicinal products, and the manufacturer has the right to manufacture the medicinal product and store it in the warehouse until the patent expires. The Bolar Rule is limited by the prohibition for applicants of generic medicines to sell, advertise and commercialize medicines until the patent expires.
This mechanism, on the one hand, allows applicants/manufacturers of generic medicines to enter the market in a timely manner and avoid waiting for one to two years for registration of a medicinal product. On the other hand, this mechanism cancels the period of additional and non-statutory monopoly on original medicinal products, during which such medicinal products remained exclusive on the market after the patent expired.
What does the draft law provide for?
The draft law provides for the possibility of submitting an application for registration of generic medicines, production and storage of medicines until the expiration of the patent.
It also establishes a number of safeguards against premature entry of generic drugs into the market, namely
– prohibition of putting into circulation before the expiration of the patent;
– prohibition of any commercialization (advertising, marketing, offering for sale);
– determination of the date of introduction into circulation – not earlier than the next day after the expiration of the patent;
– increased fines for patent infringement.
According to the authors of the draft law, its adoption will help balance the interests of manufacturers of original and generic medicines, expand the range of medicines in pharmacies and increase competition in the Ukrainian pharmaceutical market.
This regulation will result in a gradual reduction in the cost of some medicines, which is one of the priorities in the healthcare sector.
MP Mykhailo Radutskyi said that more than 100 amendments had been submitted by MPs for the second reading.
“It is important that the final text of the document provides for effective safeguards against patent infringement, in particular, significant fines,” emphasized Mykhailo Radutskyi.
It is worth recalling that the National Security and Defense Council of Ukraine’s decision of February 12, 2025, set the adoption of the Bolar Rule as a priority.
“The Bolar Rule is already in place in most EU countries
The fundamental principles and mechanisms for implementing the Bolar Rule are set out in Directive 2001/83/EC of the European Parliament and of the Council of November 6, 2001 on a Community Code for medicinal products for human use.
This Directive stipulates that it is permissible to conduct research and/or use an invention in research conducted for the purpose of preparing and submitting information for the registration of a medicinal product. Provisions on the implementation of the Bolar Rule are contained in the legislation of Switzerland, the United Kingdom, France, Italy, Poland, Germany and a number of other European countries. These provisions entitle applicants for generic medicines to enter the market in a timely manner without infringing the patent rights of patent holders.
