GERMANY Trends and Developments Contributed by: Ulrich Grau, Constanze Püschel and Tobias Volkwein, D+B Lawyers
D+B Lawyers Kurfürstendamm 195 D-10707 Berlin Germany Tel: +49 30 327787 0 Fax: +49 30 327787 77 Email: office@db-law.de Web: www.db-law.de
An Introduction to the German Life Sciences Industry in 2026 Overview of Germany’s healthcare system For more than 100 years, Germany’s healthcare sys- tem has been based on statutory health insurance ( gesetzliche Krankenversicherung or GKV). Today, approximately 74 out of 84 million inhabitants are cov- ered by statutory health insurance, whereas only ten million patients are privately insured. In 2024, statu- tory health insurance funds spent more than EUR300 billion per year on services for their insureds. 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 ser- vices provided. Impact of statutory health insurance In addition to the density and quantity of regulations, life sciences is one of the most complex and rapidly evolving regulatory branches. A particularly significant – almost disruptive – change to the statutory health insurance system occurred in the legislative period between mid-2017 and the end of 2021 when Jens Spahn was Minister of Health. Since 2020, the COV- ID-19 pandemic has emerged as the main catalyst for action by the legislator. While there was a reset by the Minister of Health, Professor Karl Lauterbach, who was appointed at the end of 2021, the pace of change has significantly slowed compared to the pre- vious legislative period. The new Minister of Health, Nina Warken, has been cautious so far. Furthermore, it will be very interesting to see which new legisla- tion will be introduced during her tenure in 2026. One
of her first major projects is a reform of pharmacy law with the draft Pharmacy Care Development Act ( Apothekenversorgung-Weiterentwicklungsgesetz or ApoVWG). This draft had its first reading in the Ger- man Bundestag on 27 February 2026. Digitalisation initiatives and regulatory changes The focus is still on the acceleration of digitalisation, including installing e-health records or e-prescrip- tions. The further development of digital health appli- cations (DiGA) has raised many specific questions since their introduction at the end of 2019, particularly with regard to reimbursement schemes. However, the implementation of the main digitalisation instruments has faced significant resistance in the last few years. Finally, the e-prescription system has been fully applicable since the beginning of 2024. With the adoption of the Health Data Use Act ( Gesundheits- datennutzungsgesetz or GDNG) and the Digital Act ( Digital-Gesetz or DigiG) in February 2024, the Ger- man legislator has taken two further important steps on its digitalisation path. As of October 2025, the German Health Data Lab ( Forschungsdatenzentrum Gesundheit or HDL) at the Federal Institute for Drugs and Medical Devices (BfArM) is officially in operation. With this, Germany has launched a national health data infrastructure, enabling access to real-world data for research purposes. Focus on financial stability and medicinal supply The focus also remains on the financial health of the statutory health insurance system, which has wors- ened in the last few years. At the end of 2022, the
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