GERMANY Trends and Developments Contributed by: Ulrich Grau, Constanze Püschel and Tobias Volkwein, D+B Lawyers
legislator introduced a strict law, the GKV Financial Stabilisation Act ( GKV-Finanzstabilisierungsgesetz or GKV-FinStG) to stabilise funding for statutory health insurance by preventing a permanent rise in the pre- miums paid by its members. This had a number of impacts, particularly on the lower reimbursement rates for medicinal products in Germany. As statutory sick funds are still facing growing deficits, it seems likely that new laws will be introduced in the upcoming legislative period. In its decisions published on 16 July 2025, the Federal Con- stitutional Court ( Bundesverfassungsgericht ) rejected two constitutional complaints against several meas- ures under the GKV-FinStG. However, the govern- ment has invited the industry to a new “pharma and medtech dialogue” that started on 12 November 2025 and is expected to set out the main changes for the industry on national level in 2026. Influence of EU directives on regulation Additionally, the focus is on maintaining the sustain- able availability of medicines (specifically, generics), which has also worsened in recent years. To address this, at the start of 2023, the legislator published the Drug Delivery Shortage Control and Supply Improve- ment Act ( Arzneimittel-Lieferengpassbekämpfungs- und Versorgungsverbesserungsgesetz or ALBVVG). Current developments and challenges for the industry The regulatory framework for the life sciences industry is heavily influenced by EU directives and regulations, especially concerning the marketability of pharma- ceuticals and medical devices. Overall, legal advice must cover many areas. This obviously includes legal know-how and expertise on life sciences regulations but also extends to, inter alia, M&A, antitrust and com- petition, public procurement and data protection. Evolution of market access and reimbursement Pharmaceutical manufacturers have to deal with fre- quently amended regulations on market access and product reimbursement without losing sight of the fact that prices in Germany are also a relevant reference point for pricing in many European countries. The benefit assessment by the Federal Joint Committee ( Gemeinsamer Bundesausschuss or G-BA), based on
the Act on the Reform of the Market for Medicinal Products ( Arzneimittelmarkt-Neuordnungsgesetz or AMNOG), has the greatest influence on the reimburse- ment prices. Impact of legislative changes on pharmaceutical pricing Nevertheless, while the GKV-FinStG of 2022 could have essentially changed the established system, which is mainly based on the benefit assessment of the respective medicinal product by the G-BA, it has yet to do so. Instead, the GKV-FinStG widely intro- duced a schematic price corridor system linked to comparator drugs. However, according to the first evaluation at the end of 2023, the legislator does not currently consider it necessary to revisit this “new approach”. One piece of good news is that with the Medical Research Act ( Medizinforschungsgesetz or MFG) of 29 October 2024, the legislator introduced an excep- tion to this price corridor system for pharmaceutical companies that perform at least 5% of their clinical studies in Germany. The MFG also introduced an opportunity to agree on confidential reimbursement prices (to avoid negative reference impacts) for the first time after years of discussion, but with a number of limiting requirements. Adaptations for Advanced Therapy Medicinal Products (ATMPs) Furthermore, Regulation (EU) 2021/2282 on Health Technology Assessment (the “HTA Regulation”), by establishing a more collaborative framework in the EU, gets closer to improving business predictability and avoiding duplication of work and discrepancies between HTA mechanisms. The HTA Regulation has been applicable since 12 January 2025, starting with cancer medicines and ATMPs. It will expand to cover Orphan Medicinal Products (OMPs) in 2028 and all centrally authorised medicinal products in 2030. The European-wide approach presents huge chal- lenges for the German life sciences industry. In March 2025, the German national implementing rules in the Ordinance for the Benefit Assessment of Medicinal Products (AM-NutzenV), adopted by the Federal Min- istry of Health (BMG), entered into force. With effect
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