Germany: A Life Sciences Overview

For over a century, Germany’s healthcare system has been defined by its statutory health insurance. Nowadays, approximately 74 million out of 84 million inhabitants are covered by statutory health insurance, whereas only 10 million patients are privately insured. By 2024, statutory health insurance funds had spent more than EUR300 billion a year on services for their insured. Statutory health insurance funds therefore have an important impact on all stakeholders in the life sciences industry. This leads to a highly regulated life sciences sector, with a major emphasis on the cost-benefit ratio of services provided.

In addition to the density and quantity of regulations, life sciences is one of the most complex and rapidly changing regulatory branches. Notably, the period between mid-2017 and the end of 2021, during Jens Spahn’s tenure as Minister of Health, witnessed a near-disruptive transformation of the German statutory health insurance system. This trend continued during the COVID-19 pandemic, prompting a new wave of regulatory actions spearheaded by the current Minister of Health, Karl Lauterbach, though significantly slowing down compared to the prior legislative period. The new Minister of Health, Nina Warken, has so far shown reluctance, and 2024 was a relatively quiet year in terms of national legislation in the life sciences field. It will be very interesting to see what new legislation will be introduced under her tenure in 2026.

A key area of focus has been the acceleration of digitalisation in healthcare, such as the implementation of electronic health records and e-prescriptions, as well as the further development of Digital Health Applications (DiGAs). Despite their introduction at the end of 2019, DiGAs continue to raise numerous issues, particularly regarding reimbursement schemes. The roll-out of these digital initiatives met with significant resistance initially. However, by the start of 2024, the e-prescription system had become fully operational. With the Health Data Use Act (Gesundheitsdatennutzungsgesetz – GDNG) and the Digital Act (Digital-Gesetz – DigiG), the German legislature took two further important steps on its digitalisation path in 2024. As of October 2025, the German Health Data Lab (Forschungsdatenzentrum Gesundheit – HDL) at the Federal Institute for Drugs and Medical Devices (BfArM) was officially live. With that, Germany has initiated a national health data infrastructure with real-world data accessible for research purposes.

The financial health of the statutory health insurance system – which has deteriorated in recent years, particularly during the COVID-19 pandemic – is still another area of focus. To address this, the legislature introduced the Financial Stabilisation of the Statutory Health Insurance System Act (GKV-FinStG) at the end of 2022. This law aimed to stabilise the financial situation of the statutory health insurance system by curbing the continual rise in premiums to be paid by members, significantly impacting (among other things) the reimbursement of medicinal products in Germany. With its decisions published on 16 July 2025, the Federal Constitutional Court (Bundesverfassungsgericht) rejected two constitutional complaints against several measures pursuant to the GKV-FinStG. As statutory sick funds are still facing growing deficits, it is somewhat likely that new laws will be introduced in the current legislative period. The government has invited the industry to a new “pharma and medtech dialogue” that started on 12 November 2025, and will probably reveal the main changes for the industry on a national level in 2026.

A further key area of concern has been the maintenance of a sustainable supply of medicines – particularly generic medicines, which has seen a decline in recent years. In response, in early 2023 the legislature introduced the Drug Delivery Shortage Control and Supply Improvement Act (Arzneimittel-Lieferengpassbekämpfungs- und Versorgungsverbesserungsgesetz – ALBVVG).

The regulatory framework for the life sciences industry is also widely influenced by EU Directives and Regulations, especially concerning the marketability of pharmaceuticals and medical devices. All in all, legal advice must cover many areas. This obviously includes legal know-how and expertise on life sciences regulations, and extends to, inter alia, mergers and acquisitions, antitrust and competition, public procurement and data protection.

Current Developments and Challenges for the Industry

Manufacturers of pharmaceuticals must deal with frequently amended regulations on market access and reimbursement of their products, without losing sight of the fact that German prices are also a very relevant reference for prices in many European countries. The benefit assessment by the Federal Joint Committee (G-BA) based on the Act on the Reform of the Market for Medicinal Products (AMNOG) has the greatest influence on reimbursement prices.

However, the GKV-FinStG could significantly change the established system, which is mainly based on the benefit of the respective medicinal product as assessed by the G-BA. The GKV-FinStG introduces a broad schematic price corridor system linked to comparator drugs. One piece of good news is that, with the Medical Research Act (Medizinforschungsgesetz – MFG) of 29 October 2024, the legislature at least introduced an exception to this price corridor system in the case where the pharmaceutical company performs (briefly summarised) 5% of its clinical studies in Germany. The MFG further introduced the opportunity to agree on confidential reimbursement prices – to avoid negative reference impacts – for the first time after many years of discussion, though with a lot of limiting requirements.

Furthermore, the upcoming Regulation 2021/2282 on Health Technology Assessment (the “HTA Regulation”) is set to bring significant changes, advocating for a more collaborative framework in the EU to improve business predictability and avoid duplication of work and discrepancies between HTA mechanisms. The HTA Regulation began to apply on 12 January 2025 – starting with cancer medicines and ATMPs, expanding to cover OMPs in 2028, and eventually covering all centrally authorised medicinal products in 2030. The Europe-wide shift presents huge challenges for the German life sciences industry as well as the G-BA. In March 2025, the Federal Ministry of Health (BMG) published the German national implementing rules in the Ordinance for the Benefit Assessment of Medicinal Products (AM-NutzenV). With effect from 18 November 2025, the G-BA adapted its rules of procedure correspondingly.

With regard to clinical trials, the implementation of the Clinical Trials Regulation – especially its Clinical Trials Information System – is still causing many practical issues for the industry. The legislature has however taken a first step towards improving the legislative conditions for performing clinical studies in Germany: with the aforementioned MFG, simplifications were introduced to the regulatory framework for clinical studies – eg, the facilitation of the regulatory process for clinical studies affecting radiation protection law, or the shortening of the processing time for the authorisation of mono-national clinical trials with medicinal products. Further, the concept of common standard contractual clauses for Clinical Trial Agreements found its way into law for the first time in Germany. The respective Ordinance on Standard Contractual Clauses for the Conduct of Clinical Trials applies to contracts concluded after 17 December 2025.

For pharmaceutical entrepreneurs in Europe, one of the most significant upcoming developments – aside from the ongoing legislative process concerning the European Health Data Space – is the new EU pharmaceutical law package. On 26 April 2023, the European Commission presented a legislative proposal for the revision of the EU medicinal products legislation:

• first, a proposal for a Directive of the European Parliament and of the Council on the Union code relating to medicinal products for human use; and
• second, a proposal for a Regulation of the European Parliament and of the Council laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency.

The proposals aim to repeal several EU legal acts, such as Directive 2001/83/EC and Regulation (EC) 726/2004. This revision is part of the implementation of the Pharmaceutical Strategy for Europe, and aims to promote innovation while reducing the regulatory burden and environmental impact of medicinal products. Undoubtedly, this will have a huge impact on the pharmaceutical industry in Germany, and the proposals have already been heavily discussed. Not surprisingly, the different drafts of the Commission and Parliament (2024) in particular affect the appropriate provision of regulatory data protection. In June 2025, the Council agreed on this position, and the related trilogues have since begun.

Manufacturers of medical devices continue to grapple with the challenges posed by the Medical Devices Regulation (MDR), which establishes the regulatory framework for the marketability of their products. This demands an understanding of the new legal requirements and of the implications for the certification process and the design of quality management systems. In Germany, the industry welcomed the news that, following months of discussions, the transitional provisions of the MDR had been extended, providing some respite. However, even with this additional time, preparing for stricter regulations remains a challenge for the industry, and there are many unresolved questions; as such, new proposals for further facilitation in practical terms have already been submitted.