Policy Environment for Cell Therapies in Germany (GCTs)

National and regional policies, strategies and guidance have an important role in supporting the life sciences. They can boost inward investment, drive economic growth, advance research and development and help improve access to medicines.¹⁴¹

In 2022, the German Federal Ministry of Education and Research (BMBF) commissioned the Berlin Institute of Health (BIH) to coordinate the development of a National Strategy for Gene and Cell Therapies (GCTs). The initiative drew from eight expert working groups, with 150 stakeholders from across different sectors. The resulting paper was handed to the German Federal Government in December 2023 to guide the negotiation and finalization of a National GCT Strategy.¹⁴¹

The strategy paper highlights eight “fields of action” to cement Germany’s position as a global leader in GCTs. Each field is presented with strategic objectives and proposed measures to implement (see below).¹⁴² This initiative is effective because it is expert-led, patient-centric and proposes actionable recommendations at every stage of the CAR T-cell therapy journey (spanning topics like R&D and regulation, as well as public awareness and patient support).

Field of Action	Example objective and/or measures
Connecting and supporting stakeholders	Objective to strengthen national GCT networks, with a proposed measure of creating a “CGT network map” to provide a structured overview of relevant stakeholders.
Training and strengthening of skills in the area of GCT	Objective to develop training and professional development programs for junior and senior professionals.
Technology transfer	Objective to improve the conditions for the early recognition and realization of innovative potential of scientific findings, with proposed measure to establish a product development unit focused on GCT that can train, advise and support institutions.
Standards, regulations and regulatory framework	Objective to defragment and standardize competencies and processes in clinical R&D of GCT, and proposed measure to coordinate regulatory procedures and approvals through a central point (the Paul Ehrlich Institute).
Expansion of quality and capacities in the area of GMP production	Objective to increase efficiency and accelerate processes in manufacturing, with proposed measure to create a central national production facility for critical starting materials for GCT.
Research and Development	Objective to improve the structural conditions for technology transfer research and development, with proposed measure to establish flexible funding formats with short lead-in times to cover unmet needs.
Market authorization and transition to healthcare provision	Objective to create flexible care and reimbursement models in the application of GCT, with a proposed measure to maintain the necessary flexibility in the benefit assessment and pricing in the German AMNOG process.
Interaction with society	Object to inform society about GCT by providing reliable and target group-specific information, with a proposed measure to establish a central web-based point of contract for quality-checked information.

Germany: Creating a supportive policy environment for gene and cell therapies