Law to stabilize the financial situation of statutory health insurances in Germany

The following changes related to the reduction of drug costs are proposed:

• The price moratorium will be prolonged until December 31, 2026.
• The mandatory pharmacy discount ("Apothekenabschlag") will be increased to 2 EUR for a period of two years.
• The free pricing period for innovative drugs which are assessed within the AMNOG process is reduced to six months. The negotiated § 130b SGB V rebate will be valid from the first date of the 7th month – this also applies for renegotiations.
• Waste due to uneconomical package sizes needs to be reflected in the negotiated price in form of a rebate.
• Volume-related aspects, such as volume-based staggers or maximum annual volumes, need to be part of § 130b SGB V price negotiation contracts.
• The maximum annual sales threshold for the loss of the orphan drug privileges within the AMNOG process will be reduced from 50 million EUR to 20 million EUR.
• The mandatory manufacturer rebate ("Herstellerabschlag"), especially for patent protected pharmaceuticals in line with § 130a Abs. 1 S. 1 ("allgemeiner Herstellerabschlag"), will be limited and staggered and determined by the law for pharmaceutical rebates:
  • January 1, 2023: 19%; January 1, 2024: 16%, January 1, 2025: 13%, January 1, 2026: 10%
  • In case of a negotiated "Ablösung" the rebate is consequently reduced by 7% points.
• For newly launched, innovative pharmaceuticals a price reduction of 15% will be introduced for combination products. The G-BA is requested to determine which products are affected and a new framework agreement covering this aspect will be negotiated.
• The value added tax for pharmaceuticals will be reduced to 7% from 2023 onwards (part of a separate law).

These measures are a response to the increased health care expenditures due to the Corona pandemic and are considered to be a preventive action to stabilize contributions by the insured in light of the demographic change, increased salaries for caregivers and expensive innovations which are expected to burden the statutory health insurances in the upcoming years.

We expect that the lobbying power of the pharmaceutical companies and their associations will soften the proposed law. Nevertheless, we recommend to stay ahead of the changes and carefully assess the strategic impact of each measure on the corporate portfolio with a scenario modelling approach.

Source:

Referentenentwurf des Bundesministeriums für Gesundheit, Entwurf eines Gesetzes zur finanziellen Stabilisierung der gesetzlichen Krankenversicherung vom 04.03.2022