In brief
The newly negotiated Coalition Agreement between Germany’s center-right CDU and center-left SPD political parties outlines a healthcare policy agenda with implications for pharma and med-tech companies. Key measures include reinforcing general practitioners as gatekeepers, expanding Hybrid-DRG hospital reimbursement aiming to shift care to outpatient settings, and reintroducing prompt payment “Skonto” discounts for Rx drugs granted to pharmacies. HTA (AMNOG) pricing rules will be maintained, though “guardrails” limiting reimbursement prices may possibly be reconsidered, and personalised therapies may gain marginal relief. Investor-operated medical care centers (MVZ) face stricter transparency rules, while local pharmacies are to receive financial and professional upgrades. The government also commits to rapid digitalisation—mandating electronic health records and standardising data formats—alongside modest regulatory support for medical research, designating pharma and med-tech as a “pilot sector” of the economy.
In more detail:
On March 9, 2025, the leaders of Germany’s center-right and center-left political parties—the conservative CDU and the social-democratic SPD—concluded their confidential negotiations and released a 144-page “Coalition Agreement” (Koalitionsvertrag). While not legally binding or enforceable, the agreement sets the framework for the government’s policy agenda. Much of its content is likely to be codified into law over the coming four years.
We have reviewed the Coalition Agreement with a focus on healthcare policy, identifying key measures with potentially significant implications for pharmaceutical and medical technology companies. These are outlined below, along with an assessment of their likely business impacts. Note of caution: The coalition government has not yet been formally constituted. Although a collapse in the final stages of coalition forming remains a risk, such an outcome currently appears unlikely.
Policy #1: Strengthening the Role of General Practitioners as Gatekeepers for Specialist Care
→ Potential consequence: Reduced prescription volumes for certain pharmaceuticals.
Overview: Around 90% of the German population is covered under statutory health insurance (SHI). According to the new policy, SHI patients will generally be required to consult a general practitioner (GP) before obtaining appointments with specialists (e.g., cardiologists, dermatologists, ENT specialists). Exceptions will apply for direct access to ophthalmologists and OB/GYNs, as well as for SHI patients with certain chronic conditions. SHI organisations will be mandated to ensure timely appointments, even beyond existing appointment solicitation services (Terminservicestellen). Hospital outpatient departments will serve as a fallback to uphold this guarantee.
Potential effects: To date, such a GP gatekeeper system (Primärarztsystem) has only existed on a voluntary contractual basis under GP-centered care models (hausarztzentrierte Versorgung, Sec. 71b SGB V). Pharmacoeconomic studies indicate that gatekeeping models typically lead to reduced healthcare expenditures, particularly on innovative—and often higher-cost—pharmaceuticals that are more frequently prescribed by specialists than by GPs. It remains to be seen whether this effect will be offset by increased use of hospital-based outpatient specialists.
Initial observations: To maintain adequate pharmacotherapeutic standards, it will be essential to strengthen awareness among both GPs and hospital-based specialists of the full range of available pharmaceutical options.
Policy #2: Expansion of Cross-Sectoral Lump-Sum Reimbursement for Invasive Medical Procedures (Hybrid-DRGs)
→ Potential consequence: Lower reimbursement for certain hospital procedures may reduce demand for some medical devices.
Overview: The incoming government aims to accelerate the transition from inpatient to outpatient treatment modalities—a process known as Ambulantisierung. Hospitals performing certain catalogued procedures (e.g., hernia repairs, liver endoscopies, diagnostic laparoscopies, among others) will receive the same lump-sum reimbursement (Hybrid-DRGs) regardless of whether patients are hospitalised or treated on an outpatient, same-day basis. Already to date, some 244 (typically invasive) procedures are covered by Hybrid-DRGs. In the interest of cost savings, hospitals are typically inclined to favor outpatient care where clinically appropriate.
Potential effects: Procedures implying multi-day hospital stays—especially those involving time-intensive or high-cost medical devices—may be medically reorganised to fit into outpatient settings. As a result, demand for certain medical devices may decline.
Initial observations: Med-tech companies potentially affected by this shift should closely monitor developments in Hybrid-DRG implementation. There may be strategic opportunities in optimising devices for outpatient applicability and ease of administration in same-day treatment settings.
Policy #3: Judicial Prohibition to Be Abolished—Enabling Up to 3% Cash Discounts for Prompt Payment on Fixed Prices of Rx Medicinal Products
→ Potential consequence: Market shift from wholesaler distribution to direct sales to pharmacies in some indications.
Overview: Following a series of contentious judicial decisions, the German Federal Court of Justice (Bundesgerichtshof, BGH) ruled in February 2024 that prompt payment cash discounts on prescription drug (Rx) prices violated national drug pricing laws. This ruling closed a previously leveraged regulatory gap that had allowed pharmaceutical manufacturers to offer cash discounts for direct sales to pharmacies—such discounts having effectively undercut the statutory uniform price floor for Rx drugs (so-called Abgabepreis des pharmazeutischen Unternehmers – short ApU). These discounts, typically granted in return for immediate payment (within a few days), had been used strategically to promote direct-to-pharmacy distribution channels.
Potential effects: Pharmaceutical manufacturers may once again offer prompt payment cash discounts of up to 3%. According to research conducted by statutory health insurers, the average pharmacy previously benefited from such discounts by approximately €15,000 per year.
Observations: If manufacturers resume offering favorable terms for direct sales, bypassing wholesalers, universal wholesalers may lose market share for certain therapeutic classes or active substances. Pharmaceutical companies may also gain more flexibility in selecting distribution channels.
Policy #4: AMNOG (German HTA) – Further Development of Reimbursement Price “Guardrails” and Focus on Personalised Medicine
→ Potential consequence: Limited pricing relief; possible opportunity for personalised therapies.
Overview: The concept of “guardrails” (Leitplanken) within the AMNOG process was introduced in 2023 to impose structural limitations on the pricing of innovative medicinal products subject to health technology assessment (HTA). These mechanisms include benchmarking new therapies against low-cost comparator treatments, effectively capping reimbursement levels even for novel, patent-protected medicines. The new coalition government has announced its intention to further “develop” AMNOG’s pricing structures including the “guardrails”, alongside particular consideration given to personalised medicine.
Potential effects: Substantial changes to the HTA-AMNOG price-setting framework appear unlikely. Notably, longstanding calls from the pharmaceutical industry to eliminate guardrails altogether have not been addressed. Nor is there any indication that existing cost-containment measures—such as the combination therapy rebate or mixed pricing across indications—will be repealed or mitigated.
However, the reference to “personalised medicine” may hint at a future policy direction that supports more adequate pricing for gene therapies and other individualised treatments. In particular, AMNOG’s structural disadvantages for niche therapies—typically caused by insufficient data on comparators in small patient populations—could potentially be alleviated.
Observations: A fundamental paradigm shift in AMNOG, from a rigid cost-control mechanism toward a more flexible reimbursement framework, is not anticipated. Nevertheless, incremental pricing improvements for selected therapies, especially in the realm of personalised medicine, may materialise.
Policy #5: Investor-Operated Medical Care Centers (MCC) Facing Stricter Regulation
- Potential Consequence: A less favorable environment may emerge for private equity and strategic investors aiming to expand their presence in the outpatient medical care market.
Overview: Medical care centers (MCCs – German: MVZ) are outpatient clinics typically organised as limited liability companies (GmbHs), whose shares are ultimately held by strategic or private equity investors. Medical services are provided by employed physicians. In order to exert control, investors must hold a statutory health insurance (SHI)-licensed hospital as the immediate shareholder of the MCC GmbH. The new government’s policy agenda calls for increased transparency in disclosing the ultimate ownership structures of MCCs and aims to ensure that public reimbursement proceeds remain within the SHI system.
Potential Effects: Legislation may be introduced requiring the disclosure of indirect shareholdings, thereby unveiling cascading ownership structures. The government’s somewhat opaque commitment to preventing the extraction of revenues from the SHI system could result in stricter scrutiny of profit transfer agreements. In addition, geographic expansion of MCC chains may be constrained, and their potential market shares limited.
Observations: While transparency requirements may be relatively straightforward to implement, scaling back the entrenched position of investor-operated MCCs in the outpatient sector may prove challenging. Nonetheless, a considerable degree of legal and regulatory uncertainty persists.
Policy #6: Pharmacies – Comprehensive Measures to Strengthen Local Pharmacies
- Potential Consequence: Pharmacies likely to evolve into more important strategic partners for companies dependent on pharmacy-retail channels
Overview: The government proposes to increase the fixed basic dispensing fee for reimbursable prescription drugs from €8.35 to €9.50 per package, with negotiable surcharges of up to €11 for rural pharmacies. The professional competencies of pharmacists are to be expanded, possibly allowing them to provide certain medical services, particularly in the field of preventive care. Simultaneously, regulations concerning cold-chain standards will be tightened. Third-party investors, including private equity firms, remain prohibited from owning pharmacies, with ownership restricted to licensed individual pharmacists.
Potential Effects: The proposed measures reflect a sustained political skepticism toward large, foreign-based mail-order pharmacies, even though their business model is not being directly challenged. Local pharmacies—of which there are approximately 17,000 in Germany—may assume a more prominent role in delivering low-threshold, direct-to-patient healthcare services, such as monitoring vital signs, offering preventive care, or providing nutritional counselling.
Observations: Pharmacists may become increasingly important partners for pharmaceutical and med-tech companies—within the limits of compliant healthcare professional (HCP) engagement—elevating their status as stakeholders alongside prescribing physicians.
Policy #7: Digitalisation, E-Health, and Health Data – Government Push Toward Digital Transformation
- Potential Consequence: Timeframes for adapting traditional business models may shorten, while the regulatory framework for IT companies expanding into the healthcare sector is likely to become more favorable.
Overview: The new government has pledged to accelerate the digital transformation of the healthcare sector. A key initiative includes making the switch to electronic patient records compulsory. Medical fees for video consultations may be increased, and the implementation of electronic prescriptions for medical aids (i.e., medical devices) expedited. Additionally, data exchange formats for software and IT service providers are to be standardised by 2027. Existing health data registries (beyond the established cancer registry) are supposed to be consolidated under a unified legal framework.
Potential Effects: The priorities align with the European Union’s broader agenda, particularly the European Health Data Space (EHDS), i.e. the EU’s flagship initiative for making health data universally available for secondary use. At the national level, the Health Data Secondary Use Act (Gesundheitsdatenutzungsgsetz), already in force, serves as a complementary legal framework. Multiple IT standardisation projects are underway and actively supported by the German government.
Observations: Businesses must remain alert to the deepening digital transformation reshaping nearly all healthcare processes and services, ranging from telemedicine and e-prescriptions to health apps, AI-powered medical devices, electronic health data, and cloud-based infrastructures. The sector is witnessing the rapid emergence of new market entrants, especially IT and technology companies leveraging their digital expertise to penetrate the healthcare sector.
Policy #8: Pharma and Med-Tech Designated a “Pilot Sector” of the Economy, with a Focus on Medical Research
- Potential Consequence: While the political branding of the sector as a “pilot” or flagship industry signals strong governmental goodwill, actual policy measures appear incremental, with no game-changing policy shifts on the horizon.
Overview: As part of broader industrial policy, the government has reiterated the objective of reshoring the production of critical medicines, referencing the pharmaceutical strategy adopted in December 2023 by the previous administration: New German Pharmaceutical Strategy Promises to Bolster Investment and Innovation, Implicitly Questioning the EU Pharmaceutical Review – Healthcare & Life Sciences Blog. This tags along with the government’s declared intent to reduce bureaucratic barriers in clinical research, although specific legislative or regulatory steps remain undefined. Notably, the mention of CAR-T cell therapy indicates growing political awareness of cell and gene therapies. As a specific measure, the regulatory framework governing biosafety level S1 laboratories is slated for simplification.
Potential Effects: The most effective lever for accelerating medical research would likely be a significant increase in public funding. While the Coalition Agreement references the German Centers for Health Research and certain university clusters, it stops short of making a commitment to financial investments.
Observations: Clinical research may be expected to remain significantly driven by the private sector, i.e. pharmaceutical and med-tech companies. Regulatory improvements, though welcome, appear modest in scope. The potential impact of the already adopted Medical Research Act (Medizinforschungsgesetz) has yet to materialize in tangible outcomes.
