Germany’s federal cabinet has adopted a financing bill that would add new price controls for patent-protected medicines from 2027, while removing two contested AMNOG-era measures.
Germany has moved the draft Statutory Health Insurance Contribution Rate Stabilisation Act into the legislative process, placing pharmaceutical pricing at the centre of a wider attempt to limit statutory health insurance spending growth. The Federal Ministry of Health (Bundesministerium für Gesundheit, BMG) announced the cabinet decision on 29 April 2026, with Federal Minister of Health Nina Warken presenting the package as a basis for stabilising statutory health insurance finances. The draft bill remains a proposal, however, and it must pass through the Bundestag and Bundesrat before it can become law.
BMG guidance states that statutory health insurance expenditure has recently been rising by almost 8% a year, above the growth in contribution-liable income. It projects deficits of €15 billion in 2027, €22 billion in 2028, €32 billion in 2029 and €40 billion in 2030 without reform.
The main medicine measure is a new dynamic manufacturer discount from 1 January 2027. It would apply in addition to the existing 7% general manufacturer discount on reimbursed medicines that are not subject to a reference price. The draft provides that the new discount will apply mainly to patent-protected medicines, while excluding fixed-reference-price medicines, generic-equivalent off-patent products, vaccines covered by a separate discount rule and biosimilars.
For the first half of 2027, the dynamic discount would be set at 3.5%. From 1 July 2027, it would be calculated annually using data from the previous calendar year. BMG guidance estimates that the dynamic discount for patent medicines will reduce statutory health insurance expenditure by around €5.5 billion by 2030.
The bill would also create a new competitive mechanism for therapeutically comparable patent-protected medicines. Health insurers would be able to conclude rebate contracts for defined groups of such medicines. Regional prescribing-control agreements would then set rebate-medicine prescribing quotas for the relevant groups, while allowing deviation where individual medical reasons justify another product.
That proposal extends a generic-style payer tool into parts of the on-patent market. It would not create automatic substitution between patented products, but it would strengthen payer leverage where products can be grouped as therapeutically comparable.
The bill also contains an important concession to industry criticism of the 2022 GKV Financial Stabilisation Act. It would abolish the rules that limited reimbursement-price negotiations according to added benefit and comparator-treatment costs. Those rules were intended to prevent high prices where the added-benefit case was weak, but BMG states that their effect has not been clearly demonstrated. It also acknowledges criticism that fixed statutory ceilings left too little room for individual negotiation.
This change could allow higher negotiated reimbursement amounts in selected AMNOG cases. BMG presents the removal as a restoration of negotiating flexibility, while expecting the associated financial burden to be offset through broader measures. Those include the dynamic manufacturer discount, stronger price competition between therapeutically comparable patent medicines and price-volume rules.
The draft also removes the 20% combination discount for medicines with new active substances used in specified free combinations. BMG’s explanatory text describes the instrument as bureaucratic, prone to disputes and less effective than expected in delivering savings.
The pharmaceutical provisions are therefore not a simple tightening of every price rule. They would remove two disputed industry-facing controls from the 2022 settlement, while introducing a broader claim on patent-protected medicine revenue and a new route to rebate competition before loss of exclusivity. IQWiG’s position and industry responses to the bill will be covered in separate articles.
Source: Federal Ministry of Health, BMG
Links: Bundeskabinett beschließt GKV-Beitragssatzstabilisierungsgesetz (Federal cabinet adopts GKV Contribution Rate Stabilisation Act); Entwurf eines Gesetzes zur Stabilisierung der Beitragssätze in der gesetzlichen Krankenversicherung (Draft act to stabilise contribution rates in statutory health insurance); Fragen und Antworten zum GKV-Beitragssatzstabilisierungsgesetz (Questions and answers on the GKV Contribution Rate Stabilisation Act)
Date: 29 April 2026
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