Federal Office of Public Health — Bundesamt für Gesundheit (BAG)
FOPH / BAG · Switzerland · europe
Swiss federal public-health authority — sets reimbursement scope under KLV including the historic 2017 decision to make hirudotherapy permanently reimbursable when delivered by FMH-credentialed physicians.
Regulatory Profile
- Agency type
- national regulator
- Region
- europe
- Country
- Switzerland
- Leech status
- medical device cleared
- Last ASH review
- 2026-05-25
- Website
- https://www.bag.admin.ch
Relevant Regulation Codes
- Krankenversicherungsgesetz (KVG, SR 832.10)
- Krankenpflege-Leistungsverordnung (KLV, SR 832.112.31), Anhang 1
- Bundesverfassung Art. 118a — Komplementärmedizin
Prescriber Requirements
- FMH-credentialed physician with Fähigkeitsausweis in complementary-medicine speciality is the prerequisite for OKP reimbursement
- Naturheilpraktiker with federal diploma have legal scope but typically not OKP-reimbursed
Supply Chain & GMP
Out of scope — FOPH/BAG sets reimbursement, not product regulation (Swissmedic handles the device side).
Import/Export Rules
Out of scope — Swissmedic handles import authorisation for the device itself.
Reimbursement Context
Hirudotherapy delivered by an FMH-credentialed physician under Anhang 1 KLV is fully OKP-reimbursable as of 2017 — a unique Western status conferred by constitutional anchoring (Art. 118a BV).
Key Regulatory Documents
ASH Editorial Notes
FOPH/BAG is a payer-side regulator paired with Swissmedic on the product-side. ASH presents them as separate entries because the reimbursement decision (2017) is editorially distinct from the device-clearance pathway.
Related Jurisdictions
EMA — European Union
Centralised EU authority for medicinal products — leeches sit on the border between MDR-regulated device and HMPC traditional herbal medicine framework.
European Commission — European Union
EU executive body responsible for the Medical Device Regulation (MDR) — the legal instrument that frames how Member States CE-mark leech products.
MHRA — United Kingdom
Post-Brexit UK regulator — accepts EU CE marks during transition, with UKCA marking now phased in for Great Britain (Northern Ireland follows EU MDR via Windsor Framework).
BfArM — Germany
Germany classifies medicinal leeches as a finished medicinal product (Fertigarzneimittel) — uniquely strict among EU Member States and requires marketing authorisation via BfArM.