GERMANY Trends and Developments Contributed by: Ulrich Grau, Constanze Püschel and Tobias Volkwein, D+B Lawyers
Adaptations for Advanced Therapy Medicinal Products Furthermore, Regulation 2021/2282 on Health Technology Assessment (the “HTA Regulation” ) by calling for a more collaborative framework in the EU, gets closer to improving business pre- dictability 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 OMPs in 2028 and to cover all centrally authorised medic- inal products in 2030. The European-wide orientation includes huge challenges for the German life sciences industry. On 8 March 2025, the German national imple- menting rules in the Ordinance for the Benefit Assessment of Medicinal Products (the “AM- NutzenV” ) adopted by the Federal Ministry of Health (the “BMG” ), entered into force. Challenges in clinical trials and regulatory simplification In terms of clinical trials, the implementation of the Clinical Trials Regulation (the “CTR” ) and the Clinical Trials Information System (the “CTIS” ), in particular, is still causing many practical issues for the industry. However, the legislator has tak- en a first step to improving the legislative con- ditions to perform clinical studies in Germany. With the MFG, simplifications of the regulatory framework for clinical studies were introduced, eg, the facilitation of the regulatory process for clinical studies affecting the Radiation Protection Law or the shortening of the processing time for the authorisation of mono-national clinical trials with medicinal products. Furthermore, the con- cept of common standard contractual clauses for clinical trial agreements found its way into law for the first time.
Anticipating the EU pharmaceutical law package The “next big thing” for pharmaceutical entre- preneurs at a European level, beyond the further legislative progress of the regulation introducing the European Health Data Space (the “EHDS” ), surely lies in the new EU pharmaceutical law package. On 26 April 2023, the EC presented the following legislative proposals for the revision of the EU medicinal products legislation: • first, a proposal for a Directive of the Euro- pean 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 lay- ing down EU procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency. The proposals intend to repeal several pieces of EU legislation, including 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 inno- vation while reducing the regulatory burden and environmental impact of medicinal products. This will also undoubtedly have a huge impact on the pharmaceutical industry in Germany and the proposals have already been heavily discussed. Not surprisingly, the different Commission and Parliament drafts (2024) affect the appropriate provision of regulatory data protection. Council discussions are currently ongoing. Challenges for medical device manufacturers under the Medical Devices Regulation Manufacturers of medical devices still face the challenge of adapting to the Medical Devices
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