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Germany’s 2024 Pharmaceutical Strategy: Revolutionizing Clinical Trials and Digital Healthcare

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Germany’s Pharmaceutical Strategy for 2024 is set to build on the Clinical Trials Regulation (EU) 536/2014, which came into full force on January 31, 2022, harmonizing clinical trial approvals across European Union (EU) member states. The German Federal Government aims to further streamline and accelerate clinical trials for human medicinal products through several national measures.

One significant proposal involves the establishment of a central Federal Ethics Committee, operating as a subdivision of the Federal Institute for Drugs and Medical Devices (BfArM). This committee would be responsible for handling urgent and complex approval procedures, such as clinical trials discussed within the Emergency Task Force of the European Medicines Agency (EMA), highly intricate master protocol studies, and initial human studies for new medicinal products.

Additionally, the Federal Ministry of Health (BMG) intends to collaborate with Germany’s 16 federal states to enhance harmonization in the decisions made by ethics committees established under state law. However, this proposal has faced opposition from the German Medical Association (Bundesärztekammer) and the Working Group of Medical Ethics Committees (Arbeitskreis Medizinischer Ethik-Kommission), who expressed concerns about the independence of ethical evaluations due to the creation of the Federal Ethics Committee at the BfArM.

Efficiency Boost: Germany’s Plans to Streamline Clinical Trials Processes

To expedite contract negotiations between sponsors and trial centers, and consequently facilitate the initiation of clinical trials, the BMG plans to publish practical model contract clauses. While their use won’t be legally mandated, it is expected that the publication will strongly encourage sponsors to consider these clauses, especially if referenced by German trial centers during negotiations or adopted verbatim in clinical trial agreements provided by sponsors.

Another initiative seeks to reduce approval processing times by up to 19 days for purely national clinical trials. This involves the assessment of the intended clinical trial by the competent higher federal authority within 26 days after validating the submitted application documents, with the decision communicated to the sponsor within an additional five days. Furthermore, the approval process for procedures involving radioactive substances or ionizing radiation on trial subjects, currently governed by Sections 31-32 of the German Radiation Protection Act (Strahlenschutzgesetz – StrlSchG), will be integrated into the approval procedure for clinical trials of medicinal products. This integration aims to simplify the process by aligning deadlines with those specified in the Clinical Trials Regulation and reducing duplicate reviews by involved parties.

The German Federal Government plans to reorganize the responsibilities of the two higher federal authorities, BfArM and PEI, aiming to improve coordination and process management for approval procedures and applications for clinical trials, excluding vaccines and blood products. This move aims to create a central point of contact for the pharmaceutical industry and streamline processes related to ethical approval and radiation protection testing.

Additionally, efforts will focus on harmonizing manufacturing authorizations, including the development of interpretation aids for technical guidelines and granting competent state authorities in Germany the power to request assessments by the higher federal authority for Good Manufacturing Practice (GMP) interpretation issues. This initiative may lead to a standardization of decision-making practices among GMP supervisory authorities in Germany. The German Federal Government also commits to intensifying efforts with the European Commission to ensure that Good Manufacturing Practice (GMP) certificates are recognized for manufacturing sites outside the EU and European Economic Area (EEA) under Mutual Recognition Agreements (MRA).

Pharmaceutical Strategy

Germany’s Initiatives for Digital Healthcare and Pharmaceutical Strategy

Recognizing the importance of health data in pharmaceutical research, the German Federal Government plans to further enhance digitalization in the healthcare sector. This includes efforts to reduce barriers to health data access for research purposes and granting pharmaceutical companies access to data from the genome sequencing pilot project, focused on genomic and clinical data in rare and oncological diseases. Plans also involve connecting to the European genome data infrastructure and the European Health Data Space.

To encourage pharmaceutical manufacturing within the EU, the German government intends to reduce bureaucracy and explore investment subsidies and supply security measures. While specific incentives for establishing and promoting more manufacturing sites in Germany are yet to be mentioned in the strategy paper, the BMG and the Federal Ministry of Economics and Climate Protection (Bundesministerium für Wirtschaft und Klimaschutz – BMWK) aim to develop targeted funding instruments, especially for investments in manufacturing facilities for antibiotics and oncological drugs.

Additional subsidies have been announced to enhance supply security under German social law regulations. These measures, originally implemented in the German Drug Supply Shortage Reduction and Supply Improvement Act (Arzneimittel-Lieferengpassbekämpfungs- und Versorgungsverbesserungsgesetz – ALBVVG) in the summer of 2023, will now be extended to cover other medicines, particularly oncological drugs.

In light of the pharmaceutical regulations package presented by the European Commission in April 2023 to revise EU pharmaceutical regulations, the German Federal Government supports regulatory simplification for approval procedures. However, it opposes reductions in data protection. Specifically, it opposes the reduction of data protection duration, which is currently eight years from authorization for all medicinal products, as proposed by the EU.

The German Federal Government also opposes temporary suspension of intellectual property rights, such as a TRIPS waiver (Trade Related Aspects of Intellectual Property Rights), and mandatory technology transfer. Furthermore, the German government is giving special attention to start-ups and small and medium-sized enterprises (SMEs) in the pharmaceutical sector. It plans to offer incentives and tax support for research, development, innovation, transfer, and the establishment of companies, particularly in areas with limited market potential, such as antibiotics, drugs for rare diseases, vaccines, and pandemic prevention drugs.

Germany’s Legislative Initiatives Shaping Pharma Research and Healthcare Financing

The German Growth Opportunities Act (Wachstumschancengesetz), passed in November 2023, expands tax incentives for research. This includes extending eligible expenses to certain material costs and tripling the maximum assessment base to EUR 12 million. SMEs will have the opportunity to apply for a 10% higher funding rate, subject to compatibility with the EU state aid framework.

The reform of reimbursement negotiations for new medicinal products, implemented in autumn 2022 through the German Statutory Health Insurance (SHI) Financial Stabilization Act (GKV-Finanzstabilisierungsgesetz), will undergo further evaluation in 2024. This evaluation aims to assess its impact on supply security and the pharmaceutical production location and determine whether additional measures are necessary to promote investment by pharmaceutical and biotechnology companies in research, development, and production in Germany.

The German Federal Government has also announced new regulations to enable confidential reimbursement contributions. These regulations will be considered in negotiations on auxiliary tax and other reimbursement discussions, to prevent additional expenses and bureaucracy in the German healthcare system. Finally, the German government is committed to reducing bureaucratic requirements and enhancing digitalization in approval processes through the German Bureaucracy Reduction Act IV.

 

Resource: Lexology, January 11, 2024

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