Judicial authorities and the antimonopoly service have put an end to the dispute regarding the legal regulation of medicinal leech supplies. Supervisory bodies confirmed the legitimacy of customers’ requirements classifying this commodity as a medicinal product, which obliges suppliers to hold a corresponding pharmaceutical license.
The Essence of the Conflict
The Regional Office of the Federal Antimonopoly Service (FAS) had to intervene in a dispute that arose during a procurement for medical needs. The Customer established a mandatory requirement for participants in the documentation: possession of a license for pharmaceutical activity or the production of medicinal products.
An entrepreneur planning the supply disagreed with such conditions. He insisted that the “medicinal leech” is not a medicinal product, and the license requirement illegally restricts competition, reports GTRK “Stavropolye”.
Regulator’s Arguments
Specialists of the Stavropol OFAS reviewed the supplier’s complaint and found it unsubstantiated. The agency’s position is based on the current regulatory framework, clarifies the press service of the antimonopoly body:
- The Customer’s documentation was compiled in strict accordance with the Decree of the Government of the Russian Federation.
- In the official Catalog of Goods, Works, and Services (KTRU), the item “medicinal leech” has a code included in the directory of medicinal products (ESKLP).
Court Decisions
The entrepreneur attempted to challenge the conclusions of the antimonopoly service by filing a lawsuit with the arbitration court. However, the courts of the first and appellate instances supported the regulator’s position, recognizing the FAS decision as lawful and justified. Thus, a precedent has been created, legally cementing the status of live medicinal leeches as a medicinal product.
New Rules and Consequences
Now, manufacturers and suppliers of Hirudo medicinalis are required to comply with Good Manufacturing Practice (GMP) standards, undergo state quality control, and follow the rules for the circulation of medicines (registration, labeling, storage).
Experts note that the innovation affects the activities of about 100 bio-factories in Russia. This is a serious challenge for the industry: small players unable to ensure compliance with strict requirements risk leaving the market, according to materials from the legal database “Orlenko and Partners”.
Precedent for Bio-products
The court decision creates an important legal basis for regulating the entire segment of “live” preparations (bacteria, worms, cell products), unifying requirements for them under pharmaceutical standards. Despite rising costs, this provides a chance for full standardization of hirudotherapy, which, according to Ministry of Health recommendations, is used in the treatment of thrombosis, hypertension, and hemorrhoids.
