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German health law in English
Social Code Book V

SGB V in English: the statutory health insurance rules that decide reimbursement

Sozialgesetzbuch (SGB) Fünftes Buch – Gesetzliche Krankenversicherung

20 sections · English side by side with the current German text · German text as of 29 October 2026 · translation edited by Alexander Baranov

Book V of the Social Code is the statute of German statutory health insurance, which covers about 90% of the population. For a medicine, device or app, it decides whether insurers pay, through which procedure, and at what price.

We translate the sections that matter for market access. Each section page shows the English and the German side by side, sentence by sentence, with a link to every provision. The German text is copied from the official consolidated version; our English is an unofficial working translation.

General principle

  1. § 12Principle of cost-effectivenessWirtschaftlichkeitsgebot

Medicinal products: entitlement, reference prices, benefit assessment

  1. § 31Medicinal products and dressings; power to issue ordinancesArznei- und Verbandmittel, Verordnungsermächtigung
  2. § 34Excluded medicinal products, remedies and medical aidsAusgeschlossene Arznei-, Heil- und Hilfsmittel
  3. § 35Reference prices (fixed amounts) for medicinal products and dressingsFestbeträge für Arznei- und Verbandmittel
  4. § 35aAssessment of the benefit of medicinal products with new active substances; power to issue ordinancesBewertung des Nutzens von Arzneimitteln mit neuen Wirkstoffen, Verordnungsermächtigung
  5. § 35bCost-benefit assessment of medicinal productsKosten-Nutzen-Bewertung von Arzneimitteln

Medicine prices and pharmacy supply

  1. § 129Framework contract on the supply of medicinal products; power to issue ordinancesRahmenvertrag über die Arzneimittelversorgung, Verordnungsermächtigung
  2. § 130aRebates by pharmaceutical companiesRabatte der pharmazeutischen Unternehmer
  3. § 130bAgreements between the National Association of Statutory Health Insurance Funds and pharmaceutical companies on reimbursement amounts for medicinal productsVereinbarungen zwischen dem Spitzenverband Bund der Krankenkassen und pharmazeutischen Unternehmern über Erstattungsbeträge für Arzneimittel
  4. § 130eRebate agreements for medicinal products with patent-protected active substances having a therapeutically comparable effectRabattverträge für Arzneimittel mit patentgeschützten Wirkstoffen mit therapeutisch vergleichbarer Wirkung

Medical aids

  1. § 33Medical aidsHilfsmittel
  2. § 127ContractsVerträge
  3. § 139Directory of medical aids; quality assurance for medical aidsHilfsmittelverzeichnis, Qualitätssicherung bei Hilfsmitteln

Digital health applications (DiGA)

  1. § 33aDigital health applicationsDigitale Gesundheitsanwendungen
  2. § 134Agreement between the National Association of Statutory Health Insurance Funds and the manufacturers of digital health applications on remuneration amounts; power to issue ordinancesVereinbarung zwischen dem Spitzenverband Bund der Krankenkassen und den Herstellern digitaler Gesundheitsanwendungen über Vergütungsbeträge; Verordnungsermächtigung
  3. § 139eDirectory of digital health applications; power to issue ordinancesVerzeichnis für digitale Gesundheitsanwendungen; Verordnungsermächtigung

New examination and treatment methods

  1. § 135Assessment of examination and treatment methodsBewertung von Untersuchungs- und Behandlungsmethoden
  2. § 137cAssessment of examination and treatment methods in hospitalsBewertung von Untersuchungs- und Behandlungsmethoden im Krankenhaus
  3. § 137eTrial (testing) of examination and treatment methodsErprobung von Untersuchungs- und Behandlungsmethoden
  4. § 137hAssessment of new examination and treatment methods involving high-risk-class medical devicesBewertung neuer Untersuchungs- und Behandlungsmethoden mit Medizinprodukten hoher Risikoklasse

Terminology

GermanIn this translation
Gemeinsamer Bundesausschuss (G-BA)Federal Joint Committee
Spitzenverband Bund der Krankenkassen (GKV-SV)National Association of Statutory Health Insurance Funds
Zusatznutzenadded benefit
zweckmäßige Vergleichstherapieappropriate comparator therapy
Erstattungsbetragreimbursement amount
Festbetragreference price (fixed amount)
Herstellerabschlagmanufacturer’s rebate
Schiedsstellearbitration board
Hilfsmittel / Hilfsmittelverzeichnismedical aids / directory of medical aids
digitale Gesundheitsanwendung (DiGA)digital health application
Untersuchungs- und Behandlungsmethodeexamination and treatment method
Erprobungtrial (testing)
Rahmenvertrag / Rahmenvereinbarungframework contract / framework agreement
sollshall (as a rule; exceptions possible in atypical cases)
More acts coming

Next in the library: the Medicinal Products Act (AMG), the Medical Devices Implementation Act (MPDG), the Healthcare Advertising Act (HWG), the AMNOG ordinance (AM-NutzenV) and the DiGA ordinance (DiGAV). Follow the weekly Regulatory Digest for updates.

Unofficial translation for information only. Only the German text is legally binding. German text: consolidated version from gesetze-im-internet.de, retrieved 29 October 2026, last amended by Article 2 of the Act of 6 October 2026 (BGBl. 2026 I No. 289). Where German statutes use “soll”, “shall” denotes an obligation that admits exceptions in atypical cases. Not legal advice.