Competition has been strengthened: Ukraine has simplified the production of analogues of original medicines
15 May 14:07
The Verkhovna Rada has adopted a law that introduces the Bolar Rule into Ukrainian legislation and allows the production of generics to begin before the expiration of the patent for the original drug, and registration to begin the day after the expiration of the document. MP Yaroslav Zheleznyak announced the adoption of the law, "Komersant Ukrainian" reports.
Prior to this decision, the current regulations allowed the production of generics only after the patent term expired.
Thus, by adopting the law, 265 MPs voted, as Yaroslav Zheleznyak noted, for “overcoming the monopoly on the drug market, which is granted to the owners of the patent (certificate) for the original drug.”
“The adoption of the draft law will increase competition in the pharmaceutical market and reduce prices for patients,” said MP Mykhailo Radutskyi.
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 are entitled to receive certificates of state registration of medicinal products, and the manufacturer is entitled to manufacture the medicinal product and store it in the warehouse 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 expiration.
There are also caveats for generic manufacturers
The Bolar Rule is limited to prohibiting applicants for generic medicines from selling, advertising and commercializing medicines until the patent expires.
And Ukrainian law establishes effective safeguards against patent infringement, namely
– a ban on putting into circulation before the patent expires;
– prohibition of any commercialization (advertising, marketing, offering for sale);
– determination of the date of putting into circulation – not earlier than the next day after the expiration of the patent;
– increased fines for patent infringement.
It is worth recalling that the decision of the National Security and Defense Council of Ukraine dated February 12, 2025, identified the adoption of the Bolar Rule as a priority.
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.
