Regulatory framework for medicinal plant seed production: Ukraine and the EU

Abstract

Purpose. To analyze the regulatory framework for medicinal plant seed production in Ukraine and the EU, identify the strengths and weaknesses of the domestic regulatory system, and establish ways to improve it and harmonize it with international standards. Methods. Generally accepted methods of scientific research were used to study and evaluate the current state of regulatory and legal support in the field of medicinal plant seed production in Ukraine and the EU, namely: systematic analysis – to justify the need for research; logical synthesis and generalization – to determine the current situation regarding the issues under study; abstract-logical method – to form conclusions, etc. Results. An analysis of the regulatory framework for medicinal crop seed production in Ukraine and the EU revealed that the domestic framework is founded on various regulatory standards and methodologies that establish the legal conditions necessary for ensuring seed quality. Advantages of the national standardisation and certification system include the existence of foundational legislation, integration of medicinal and essential oil plants with standards, certification procedures, Ukraine's membership in international organisations (UPOV, ISTA, OECD and IPPC) and functioning competent institutions responsible for quality control and state supervision. At the same time, its weaknesses include the fragmented regulatory framework, the primary focus on major crop groups such as cereals, industrial crops and vegetables, and the failure to fully consider the specific characteristics of medicinal plants. This is exacerbated by the lack of specialised standards and a national catalogue of varieties, reducing comprehensiveness and versatility. Other weaknesses include insufficient harmonisation with EU law, low digitisation of procedures and the existence of a shadow seed market. Conclusions. The results of the research show that the domestic regulatory framework for medicinal plant seed production requires systemic changes. Firstly, the regulatory framework must be expanded by developing and approving separate DSTU standards for a larger number of medicinal crops, creating a national catalogue of their varieties, establishing a unified electronic system for recording seeds, certificates and producers, and strengthening control in the areas of phytosanitary risks, certification and sales. It is also necessary to harmonise with European Union legislation and consider the provisions of relevant directives (66/401/EEC, 66/402/EEC, 2002/53/EC, 2002/55/EC and 2008/72/EC), as well as establish rules in accordance with international documents such as the ISTA and OECD Seed Schemes. An important step is to join the EU Common Catalogue to enable the mutual recognition of varieties and implement Regulation (EU) 2016/2031, which aims to prevent the spread of quarantine organisms. It is also advisable to adopt European practices of open and regulated market access for seeds, as well as to introduce modern digital mechanisms into the registration and control processes. These measures will improve the quality of seed material for medicinal crops and increase international competitiveness.