Analysis of the Draft Law on Amendments to the Criminal Code of Ukraine Regarding the Protection of the Legal Market for Veterinary Medicines Against Counterfeits

A draft law has been registered with the Verkhovna Rada to amend the Criminal Code of Ukraine regarding the protection of the legal market for veterinary drugs from counterfeits. (hereinafter referred to as the “Law”) (Reg. No. 15413 dated July 15, 2026).

The need to adopt this Law stems from the fact that the counterfeiting of veterinary drugs has a direct negative impact not only on the health of animals but also on public health in general (in particular, due to the potential spread of diseases common to both humans and animals; through the food chain, as people consume food products derived from animals, etc.).

This draft law was also developed to implement the Convention on the Counterfeiting of Medical Products and Similar Crimes Threatening Public Health, adopted by the Council of Europe in October 2011 (the so-called Medicrime Convention, hereinafter referred to as the Convention).

In June 2012, the Verkhovna Rada of Ukraine adopted Law of Ukraine No. 4908-VI, which ratified the Convention. At the same time, in 2011 and 2012, amendments were made to the Criminal Code of Ukraine (hereinafter the “CCU”) (see, in this regard, Laws of Ukraine dated September 8, 2011, No. 3718-VI and No. 5065-VI of July 5, 2012), thanks to which intentional acts involving counterfeit medicines were criminalized in Ukraine.

In accordance with the Convention, each Party to the Convention must take the necessary legislative and other measures to establish as criminal offenses under its national law:

1) the intentional manufacture of counterfeit pharmaceuticals, veterinary pharmaceuticals, and their active ingredients (Article 5, paragraph 1, of the Convention);

2) the intentional supply, offer to supply, brokering, trade, storage, import, and export of counterfeit pharmaceuticals, veterinary pharmaceuticals, and their active ingredients (hereinafter referred to as “pharmaceuticals,” “veterinary pharmaceuticals,” and “active ingredients”); (Part 1 of Article 6 of the Convention).

Currently, there is no criminal liability in Ukraine for the counterfeiting of VMD and AS.

The absence of any liability has allowed the phenomenon of counterfeiting veterinary medicines and active ingredients to reach significant proportions in Ukraine (according to estimates by the Veterinary Union of Ukraine, the turnover of counterfeit veterinary medicines on the Ukrainian market last year reached 3.7 billion UAH per year).

According to the draft law, the following amendments are proposed to Article 305 of the Criminal Code of Ukraine (currently, this article pertains to the smuggling of controlled substances and counterfeit pharmaceuticals).

Specifically, the draft law amends Article 305 of the Criminal Code to establish liability for transporting counterfeit veterinary drugs and medicinal products across Ukraine’s customs border without customs control or by concealing them from customs control (i.e., for smuggling):

a) amendments to the first part (which defines the “basic” offense): smuggling the aforementioned counterfeit medicines or substances shall be punishable by imprisonment for a term of 5 to 8 years;

b) amendments to Part 2 (which defines aggravating circumstances): the same acts, if committed repeatedly, or by prior conspiracy by a group of persons, or by a public official abusing their official position, or on a large scale, shall be punishable by imprisonment for a term of 8 to 10 years with confiscation of property;

c) amendments to Part Three (defining particularly aggravating circumstances): the same acts committed by an organized group or on an especially large scale shall be punishable by imprisonment for a term of 10 to 12 years with confiscation of property.

Article 305 of the Criminal Code is also to be supplemented with one additional (new) paragraph in the note, and certain clarifications are to be made to the existing text of the note. Specifically, it is proposed that the existing text of the note be:

a) be supplemented with a reference to counterfeit active pharmaceutical ingredients;

b) be clarified by removing the reference to the fact that the Ministry of Health must establish the definitions of “large” and “exceptionally large” quantities of certain substances and materials must be established by the Ministry of Health jointly with another body that is a central executive authority responsible for formulating state policy regarding the circulation of narcotic drugs, psychotropic substances, their analogs and precursors, and combating their illicit trafficking.

As noted in the explanatory note to the draft law, the rationale for omitting such a provision stems from the fact that, in accordance with the Regulations on the Ministry of Health of Ukraine, approved by Resolution No. 267 of the Cabinet of Ministers of Ukraine dated March 25, 2015, the Ministry of Health is precisely the central executive authority responsible for formulating state policy in the aforementioned sphere of relations.

Consequently, the note to Article 305 of the Criminal Code of Ukraine currently requires the Ministry of Health to define the concepts of “large” and “especially large” quantities of certain substances and materials on its own. This wording of the note indicates the presence of a logical-legal error that makes it impossible to properly implement the note’s provision due to a legal conflict and the presence of a logical paradox (where a government agency must simultaneously play two different roles: submit a draft decision to itself, await a response from itself, and approve the decision in conjunction with itself).

The draft law also proposes the text of yet another (new) clause in the note regarding the definition of “large” and “especially large” quantities for counterfeit medicinal products and their registration certificates —which is analogous to the text of the currently existing note, which provides for the definition of these same terms regarding counterfeit medicines by the central executive authority responsible for shaping state policy in the field of healthcare.

The following amendments are proposed to Article 321-1 of the Criminal Code, which provide for the criminalization of intentional acts involving the production (manufacture) and distribution of counterfeit medicinal products and active pharmaceutical ingredients:

a) amendments to paragraph one (which defines the “basic” offense): intentional acts involving the production (manufacture), purchase, transportation, shipment, or storage for the purpose of sale, as well as the offer for sale or sale of counterfeit veterinary drugs or veterinary medical devices—shall be punishable by imprisonment for a term of 5 to 8 years;

b) changes to Part Two (which defines aggravating circumstances): the same acts committed by a veterinarian or other veterinary medicine specialist – shall be punishable by imprisonment for a term of 8 to 10 years, along with disqualification from holding certain positions or engaging in certain activities for a term of up to 3 years, and confiscation of property.

The draft law also proposes to clarify the wording of Part 4 of Article 321-1 of the Criminal Code (which currently sets forth the conditions for exemption from criminal liability for committing the aforementioned “basic” offense involving counterfeit medicines).

In particular, the draft law proposes to provide for exemption from criminal liability for committing the “basic” offense for persons who voluntarily surrendered all counterfeit medicines, as well as medical devices, have indicated the source of their acquisition (receipt), and have assisted in the investigation of crimes provided for in Part 1 of Article 321-1 of the Criminal Code of Ukraine, provided that the commission of such a crime did not pose a threat to human life or health.

The possibility of exemption from criminal liability shall not apply to acts involving the production (manufacture) of counterfeit VLZ and DR (since this is a more serious offense in terms of its consequences, compared to the distribution of counterfeit medicines and medical devices, and, as practice shows, the organization of the production (manufacture) of counterfeit medicines and medical devices almost never involves just one person).

It should be noted that the amendments to the Criminal Code of Ukraine proposed by the draft law do not provide for any changes to the existing penalties. All of the above sanctions are already in place today. The draft law provides only for the extension of the elements of the crime to new categories of persons (veterinarians and other veterinary medicine specialists), clarifying the existing elements of the offense and supplementing them with a reference to a new subject of the offense (counterfeit veterinary drugs and veterinary medical devices).

In light of the foregoing, it can be concluded that the adoption of the draft law and its practical implementation will have a positive impact on social relations in the fields of public health and veterinary medicine, as well as in the production and distribution of veterinary drugs and veterinary medical devices.

In particular, the adoption of the draft law will make it possible to eliminate the gaps in the current legislation related to the lack of any liability for the production and distribution of counterfeit veterinary drugs and veterinary medical devices; create effective deterrents by introducing strict sanctions; implement Ukraine’s international obligations in practice, which will help strengthen our country’s positive image on the international stage; strengthen the protection of public health, as the public is the ultimate consumer of food products derived from animals; strengthen the protection of animal health and ensure more humane treatment of animals; and strengthen the protection of legitimate businesses and investments in Ukraine.