What is the Pharmaceutical Discount Act?
The Pharmaceutical Discount Act refers to the legal framework governing discount agreements between statutory health insurance funds (GKV) and pharmaceutical companies in Germany. The central legal basis is § 130a SGB V (Social Code V).
Historical Development
| Year | Law / Event | Impact |
|---|---|---|
| 2003 | GMG | Introduction of § 130a para. 8 – discount agreements |
| 2007 | GKV-WSG | Pharmacy substitution obligation |
| 2010 | AMNOG | Benefit assessment + reimbursement price negotiation |
| 2017 | CJEU Falk Pharma | Open house not subject to procurement law |
| 2022 | GKV-FinStG | Increased minimum discounts |
| 2023 | ALBVVG | Supply shortage regulations, diversification |
Legal Framework
§ 130a SGB V – Key Provisions:
- Para. 1: Manufacturer discount (mandatory statutory rebate) – currently 7%
- Para. 8: Discount agreements – health insurers can conclude discount contracts
- Para. 3a: Reimbursement amount after AMNOG benefit assessment
§ 129 SGB V – Substitution Obligation:
- Pharmacies must dispense the discounted medication
- Generic substitution rules
Procurement Process for Discount Agreements
Discount agreements above the EU threshold (EUR 143,000) are subject to procurement law (GWB Part 4, VgV). The process includes needs analysis, market analysis, lot formation by active substance, publication on TED, bid preparation, evaluation (price as dominant criterion), and award (typically 1-3 awards per lot).
Supply Security
The ALBVVG (2023) introduced new rules including diversification requirements (minimum two awards per lot), supply and stockpiling obligations, and bonuses for EU-manufactured active substances.
Legal Protection
Pharmaceutical companies have comprehensive legal remedies including complaints to procurement chambers and appeals to Higher Regional Court procurement senates.
Patterno Helps
Patterno-HIT monitors all GKV discount contract tenders and immediately informs pharmaceutical companies about new active substance tenders. Patterno-BID for Pharma automates diff-checking between old and new contract terms and supports margin calculation.