Co author: Jennifer Knoll
Background
The Statutory Health Insurance Contribution Stabilization Act is intended to address the precarious financial situation in the healthcare sector and, in particular, to permanently stabilize the statutory health insurance contribution rate starting in 2027. The goal is to prevent an expected funding shortfall of 38.1 billion euros in 2030.
Against this background, the Federal Ministry of Health presented a draft bill on 16 April 2026, aimed at stabilizing contribution rates in statutory health insurance (BStabG). On 29 April 2026, the Federal Cabinet approved the draft of this law on the stabilization of statutory health insurance contribution rates, thereby implementing more than three-quarters of the total 66 proposed measures.
Specific measures
The key measures included in the legislation that are intended to reduce the costs of statutory health insurance and increase its revenues are as follows:
- In the future, the manufacturer rebate for patented medicinal products will be adjusted dynamically.. This is scheduled to take effect in the second half of 2027. From that point on, adjustments will be made based on a specific comparison of medication expenditures relative to revenue subject to contributions. Excluded from this are fixed-price medicinal products, generics and biosimilars, certain off-patent pediatric medicinal products, reserve antibiotics, and medication critical to supply to public health. Newly introduced medicinal products that were undergoing clinical trials in Germany, or for which the active ingredient is also produced in Germany, as well as medicinal products exempted under the new Section 130a para. 1c of the German Social Code Book V (SGB V), are also exempt from this requirement.
- Health insurance companies may enter into rebate agreements for groups of patent-protected medicinal products that offer a therapeutically comparable effect. The contracts may be exclusive and may be tendered for multiple active ingredients. Contracted physicians should prioritize prescribing the discounted medication, provided there are no medical reasons to the contrary.
- The existing price-volume regulation is to be further developed. Additional discounts are now planned for medicinal products that reach and exceed a legally defined minimum sales volume. If an agreement between the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband) and the pharmaceutical company regarding a price-volume regulation cannot be reached, an automatic, mandatory adjustment of the reimbursement amount will also take effect in the future.
- The price moratorium will be extended until the end of 2030. The so-called expanded price moratorium is also to be shifted from a company-based to an active ingredient-based framework.
- An additional manufacturer's rebate of 7 percent will be introduced for patent-protected vaccines.
- Reimbursement for cannabis flowers will be eliminated entirely, meaning that only standardized extracts and approved finished medicinal products may be prescribed.
- Coverage for homeopathic and anthroposophic medicines will be removed from the standard benefits provided by statutory health insurance companies. Such benefits will also no longer be available under special care agreements.
- The so-called combination rebate and the AMNOG guidelines are being abolished because they did not produce the desired cost savings.
- No regulatory action is planned regarding orphan drugs.
Outlook and Assessment
While the goal of the Contribution Stabilization Act (BStabG) – to stabilize the statutory health insurance (GKV) contribution rate while simultaneously increasing its revenue – is reasonable, pharmaceutical companies have already been contributing significantly to the financing of the statutory health insurance system for many years. It seems questionable whether developing new sources of revenue is an appropriate way to stabilize the statutory health insurance system in the long term. The following measures are particularly problematic:
- One example is the introduction of the dynamic manufacturer rebate, which means that the size of the rebate is unpredictable from the manufacturer’s perspective. This is likely to make cost calculations increasingly difficult for pharmaceutical companies. It is also reasonable to assume that the manufacturer rebate will be significantly higher than the current rate of 7% in the future. Not every pharmaceutical company will then be able to remain profitable.
- The price moratorium, which has been extended yet again, is also leading to a further decoupling of medication prices from the actual production costs of the products and from general inflation-driven price increases. What was once intended as a temporary measure to stabilize the statutory health insurance system as a “special sacrifice” appears to be increasingly establishing itself as a permanent arrangement for the long-term financing of the statutory health insurance system.
- The introduction of a manufacturer rebate on patented vaccines is likely to place a particularly heavy burden on smaller companies and contribute to stifling innovation.
- However, one positive aspect is that no further regulations are planned regarding orphan drugs, which should ensure legal certainty in this sector.
