Last updated: March 18, 2026

A Fragmented Global Landscape

Medicinal leech therapy is practiced on every inhabited continent, yet no two countries regulate it the same way. Some classify leeches as medical devices, others as pharmaceuticals or traditional medicines, and many have no specific regulation at all. This page provides a verified, country-by-country overview based on multi-source research.

Hirudotherapy — the therapeutic application of medicinal leeches — is practiced in more than 40 countries worldwide. From FDA-cleared microsurgery support in the United States to ancient Ayurvedic traditions in India and traditional Chinese medicine formulas spanning millennia, the global landscape of leech therapy is remarkably diverse in its regulatory frameworks, clinical applications, and research activity.

Regulatory Leaders

Seven countries have established formal regulatory frameworks specifically governing the use of medicinal leeches in clinical practice. These frameworks range from medical device classification to traditional medicine integration.

United States

FDA-cleared medical device (510(k) K040187, 2004). Regulatory jurisdiction transferred to CBER (Center for Biologics Evaluation and Research) in December 2024. Off-label use is legal with informed consent under the practice of medicine doctrine. Three companies hold active clearances.

Germany

Registered pharmaceutical product (Arzneimittel). Practiced by both physicians and Heilpraktiker (naturopathic practitioners). Private health insurance may cover treatment. Biebertaler Leech Farm is a major European supplier. Home to landmark RCTs by Michalsen and Andereya.

Russia

Official medical activity since 1995 (Ministry of Health Order No. 142). Licensed practitioners with specialized training programs. Medicinal leeches available in pharmacies. State biofactories for leech production. Most extensive clinical tradition with large observational cohorts across multiple specialties.

India

AYUSH Ministry recognition under traditional medicine frameworks. Jalaukavacharana (leech therapy) is an established Panchakarma procedure. BAMS (Ayurveda) and BUMS (Unani) licensed practitioners. Government AYUSH hospitals provide leech therapy services.

China

Shuizhi (water leech) listed in the Chinese Pharmacopoeia since 1963. Three species officially listed for medicinal use. Over 300 classical formulas incorporate dried or processed leech material. Primarily used in processed/dried form rather than live application.

Turkey

Regulated under the GETAT (Traditional and Complementary Medicine) framework. 84 certified centers and over 26,000 certified professionals. WHO-affiliated hirudotherapy congress scheduled for October 2025. Rapidly growing clinical and research infrastructure.

Canada

Classified as a DRUG (not a medical device, unlike the US). Available only through the Special Access Programme (SAP) for emergency or compassionate use. Health Canada maintains a 24/7 hotline for SAP requests.

Active Research Hubs

Several countries serve as major centers for hirudotherapy research, driving innovation in leech-derived compounds, clinical protocols, and translational science.

Israel

Prof. Kosta Mumcuoglu (Hebrew University / Hadassah Medical Center) — global leader in leech therapy protocols and research. Pioneering microbiota research published in 2025. Significant contributions to standardized clinical methodology.

South Korea

Discovery of Hirunipin-2 antimicrobial peptide (published in Advanced Science, 2025). AI-driven screening of leech-derived compounds for drug development. Emerging as a major center for leech bioactive compound research.

Australia

Hospital microsurgery programs using medicinal leeches (St Vincent's Hospital, Melbourne). Native Australian leech breeding program (Echuca, Victoria). Growing integration of leech therapy in reconstructive surgery.

France

Ricarimpex SAS — original FDA 510(k) clearance holder (K040187, 2004). Aletheya training center for hirudotherapy practitioners. Multiple university theses on medicinal leech biology and applications.

Emerging Markets

A growing number of countries are developing hirudotherapy practices, with increasing research activity, practitioner training, and clinical integration.

Pakistan

Over 60,000 registered hakims (traditional medicine practitioners). Irsal-e-Alaq (leech therapy) practiced within Unani medicine. Approximately 40 educational institutions offering relevant training programs.

Iran

Persian Medicine (Tibb-e Irani) officially recognized by the government. Tehran University faculty actively conducting leech therapy research. WHO Global Summit commitment in 2025 to integrate traditional medicine including hirudotherapy.

Indonesia

IPB University (Bogor Agricultural University) conducting leech research as of 2025. Growing interest in alternative and complementary medicine driving adoption. Tropical climate supporting potential native leech utilization.

Mexico

Dr. Reynoso identified as the primary hirudotherapy practitioner. UNAM (National Autonomous University of Mexico) conducting leech-related research. La Jornada newspaper coverage in November 2025 increasing public awareness.

Azerbaijan

181-patient clinical study published in Turkish Journal of Parasitology (2025). Herba Medical Center providing clinical hirudotherapy services. Contributing to the regional evidence base for leech therapy efficacy.

Limited or No Formal Practice

In several countries, leech use is confined to hospital microsurgery or is absent entirely due to regulatory gaps, species availability, or cultural factors.

United Kingdom

Hospital microsurgery use well-established. Biopharm Leeches (Swansea, Wales) supplies approximately 70% of the world's medicinal leeches. No formal regulation of hirudotherapy as a standalone practice.

Japan

No specific regulation for hirudotherapy. Use limited to hospital microsurgery programs in academic medical centers. Some research interest in leech-derived compounds.

Brazil

No ANVISA (national health regulatory agency) regulation for medicinal leech use. Hirudo medicinalis is not native to Brazil. Species availability barrier limits clinical adoption.

Sub-Saharan Africa

Traditional medicine across the region is predominantly herbal, not leech-based. South Africa is the only sub-Saharan country with documented clinical use, utilizing native Hirudo michaelseni.

South Africa

Only sub-Saharan African country with clinical hirudotherapy use. Native species Hirudo michaelseni available for therapeutic application. Limited but growing practitioner community.

Conservation Status

Species Under Threat

The primary medicinal leech species face significant conservation challenges. Wild populations are declining due to habitat loss, agricultural runoff, and historical over-collection. Sustainable captive breeding is essential for both conservation and continued clinical supply.

Hirudo medicinalis: CITES Appendix II, IUCN Near Threatened, EU Habitats Directive Annex V.
Extinct in Ireland; populations threatened in 15+ European countries.
Wild populations declining globally; captive breeding is now essential for sustainable supply.
Major farms: Biopharm (UK), Biebertaler (Germany), EURO-BION (Poland), and several Russian state bioplants.
Two species are CITES-listed: Hirudo medicinalis and Hirudo verbana.
International trade requires CITES permits; improper sourcing may violate wildlife protection laws.

Global Summary Statistics

Metric	Count
Countries with formal regulation	7
Countries with active clinical use	20+
Countries with research programs	15+
Major leech farming operations	6
CITES-listed species	2 (H. medicinalis, H. verbana)

Global Hirudotherapy: Worldwide Practice, Regulation, and Research