Professional Legal Services

Ukraine as a Regulatory Bridge: Harmonizing GMO Laws Across the EU, US, and UK Approaches

Access to the publication is free of charge. You may download the article in PDF format.
If you experience any issues with the download, please contact us at: office@marsser.com

Publication date: July 4, 2025

Abstract:

Ukraine has been a Party to the Cartagena Protocol on Biosafety since 2002. The adoption of Law No. 1103 in 2007 established the legal framework for the regulation of genetically modified organisms (GMOs) and biotechnology in the country. However, the emergence of an illegal GMO market has revealed significant deficiencies in the existing legislative system.

Following a protracted legislative process, on 23 August 2023, Ukraine enacted Law No. 3339, which repealed the 2007 Law No. 1103 and introduced a new regulatory regime governing the circulation of GMOs and GMO-related products.

This article examines the sixteen-year legislative trajectory that culminated in the adoption of Law No. 3339 and proposes an explanation for the prolonged duration of the lawmaking process.

Keywords: Ukrainian bioengineering, genetically modified organisms (GMO), regulation of genetically modified organisms (GMOs)

Анотація:
Україна є Стороною Картахенського протоколу з біобезпеки з 2002 року. Прийняття Закону № 1103 у 2007 році заклало правові засади для регулювання обігу генетично модифікованих організмів (ГМО) та біотехнологій у державі. Водночас поява нелегального ринку ГМО виявила суттєві недоліки чинної законодавчої системи.
Після тривалого законодавчого процесу 23 серпня 2023 року в Україні було прийнято Закон № 3339, який скасував Закон № 1103 (2007 року) та запровадив нову нормативно-правову модель регулювання обігу ГМО та продукції, що містить або походить з ГМО.
У статті проаналізовано шістнадцятирічну законодавчу еволюцію, що передувала ухваленню Закону № 3339, та запропоновано можливе пояснення тривалості цього процесу нормотворення.

Ключові слова: українська генно-інженерна діяльність, генетично модифіковані організми (ГМО), правове регулювання ГМО

I. Introduction.

On September 12, 2002, Ukraine joined the Cartagena Protocol on Biosafety under the Convention on Biological Diversity (hereinafter referred to as the Cartagena Protocol).[1] This means that Ukraine, like other countries participating in the Cartagena Protocol, has joined in order to contribute to ensuring an adequate level of protection in the field of the safe transfer, handling, and use of living modified organisms resulting from modern biotechnology that may have adverse effects on the conservation and sustainable use of biological diversity, taking into account risks to human health and specifically focusing on transboundary movements.

In order to implement its international obligations, Ukraine has developed a legislative framework for regulating biodiversity and biotechnology, the creation and transportation of genetically modified organisms, and biological and food safety. Ukrainian biotechnology legislation is based on the Law of Ukraine “On the State System of Biological Safety in the Creation, Testing, Transportation and Use of Genetically Modified Organisms” No. 1103 of May 31, 2007 (hereinafter referred to as Law 1103).[2]

Law No. 1103 served as a framework and system-forming act for the entire field of GMO regulation in Ukraine. On 23 August 2023, Ukraine adopted a new framework law entitled “On State Regulation of Genetic Engineering Activities and State Control over the Placement on the Market of Genetically Modified Organisms and Products,” No. 3339 (hereinafter referred to as the “New Law” or “Law No. 3339”), intended to replace Law No. 1103.

The repeal of Law No. 1103 and the full entry into force of Law No. 3339 are to occur gradually over a three-year transitional period. ……

[1] Law of Ukraine “On the accession of Ukraine to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity” Verkhovna Rada of Ukraine, No. 152-IV dated January 29, 2000., https://zakon.rada.gov.ua/laws/show/152-15#Text

[2] Law of Ukraine “On the State System of Biosafety at the Time of Creating, Testing, Transporting, and Using Genetically Modified Organisms” Verkhovna Rada of Ukraine, No. 1103 dated May 31, 2007., https://zakon.rada.gov.ua/laws/show/1103-16#Text