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 2025 Overview of Germany’s healthcare system For more than 100 years, Germany’s healthcare system has been based on statutory health insurance ( gesetzliche Krankenversicherung or GKV). Today, approximately 74 out of 84 mil- lion inhabitants are covered by statutory health insurance, whereas only ten million patients are privately insured. In 2024, statutory health insurance funds spent more than EUR300 billion per year on services for their insureds. Statu- tory health insurance funds therefore have an important impact on all stakeholders in the life sciences industry. This leads to a highly regu- lated life sciences sector, with a major emphasis on the cost-benefit ratio of services provided. Impact of statutory health insurance In addition to the density and quantity of regula- tions, life sciences is one of the most complex and rapidly changing regulatory branches. An almost disruptive change to the statutory health insurance system, in particular, was observed in the legislative period between mid-2017 and the end of 2021 when Jens Spahn was Minister of Health. Since 2020, the COVID-19 pandemic situation has emerged as the main catalyst for action by the legislator. While there was a refresh
by the Minister of Health, Professor Karl Lauter- bach, who was installed at the end of 2021, the pace of change has significantly slowed com- pared to the previous legislative period. It will be very interesting to see which new legislation will be introduced with a new government to be formed in spring 2025. Digitalisation initiatives and regulatory changes The focus is still on the acceleration of digi- talisation, including installing e-health records or e-prescriptions. The further development of digital health applications (DiGA) continues to raise a lot of specific questions following their introduction at the end of 2019, particularly with regard to reimbursement schemes. However, the implementation of the main digitalisation instru- ments faced a lot of resistance in the last few years. Finally, the e-prescription system has been fully applicable since the start of 2024. With the adoption of the Health Data Use Act (the “Gesundheitsdatennutzungsgesetz” or GDNG) and the Digital Act (the “Digital-Gesetz” or DigiG) in February 2024, the German legislator took two further important steps on its digitalisation path.
114 CHAMBERS.COM
Powered by FlippingBook