GERMANY Trends and Developments Contributed by: Ulrich Grau, Constanze Püschel and Tobias Volkwein, D+B Lawyers
Focus on financial stability and medicinal supply The focus is also still on the financial health of the statutory health insurance system, which has worsened in the last few years. At the end of 2022, the legislator therefore introduced a strict law, the GKV Financial Stabilisation Act (the “GKV-Finanzstabilisierungsgesetz” or GKV- FinStG) to stabilise statutory health insurance funding by avoiding a permanent rise in the pre- miums paid by its members. This had a number of impacts, particularly on the lower reimbursement of 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. Influence of EU directives on regulation Additionally, the focus is on the maintenance of a sustainable availability of medicines (specifi- cally, generic), which again is something that has worsened in recent years. At the start of 2023, the legislator therefore published the Drug Deliv- ery Shortage Control and Supply Improvement Act (the “Arzneimittel-Lieferengpassbekämp- fungs-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 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 but also extends to, inter alia, M&A, antitrust and competition, public procurement and data pro- tection.
Evolution of market access and reimbursement
Manufacturers of pharmaceuticals have to deal with frequently amended regulations on market access and reimbursement of their products without losing sight of the fact that prices in Germany are also a relevant reference point for prices in many European countries, as well. The benefit assessment by the Federal Joint Com- mittee (the “Gemeinsamer Bundesausschuss” or G-BA), based on the Act on the Reform of the Market for Medicinal Products (the “Arzneimittel- markt-Neuordnungsgesetz” or AMNOG) has the greatest influence on the reimbursement prices. Impact of legislative changes on pharmaceutical pricing Nevertheless, the GKV-FinStG of 2022 could essentially change the established system, which is mainly based on the benefit of the respective medicinal product as assessed by the G-BA. Instead, the GKV-FinStG widely introduc- es a schematic price corridor system linked to comparator drugs. According to the first evalu- ation at the end of 2023, the legislator currently does not deem it necessary to reconsider its “new approach” , however. One piece of good news is that with the Medical Research Act (the “Medizinforschungsgesetz” or MFG) of 29 October 2024, the legislator at least introduced an exception to this price corridor system in the event that the pharmaceutical company performs – briefly summarised – 5% of its clinical studies in Germany. The Mediz- inforschungsgesetz (MFG) further introduced the opportunity to agree on confidential reim- bursment prices – to avoid negative reference impacts – for the first time after long years of dis- cussion, but with a lot of limiting requirements.
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