Unlocking the value of innovative medicines: Insights from the advanced therapy medicinal products (ATMP) innovation systems in Germany and Sweden

Objectives: Generally low uptake in the advanced therapy medicinal products (ATMP) market and difficult patient access has been observed across Europe. The objective is to analyze the key challenges of the ATMP innovation ecosystem around R&D, entrepreneurial activities, framework conditions and legitimacy and to highlight how national level activities can impact on patient access to ATMPs in Sweden and Germany.
Methods: An exploratory case studies approach was applied for analyzing ATMP development and uptake in Sweden and Germany between 2010 and 2021. A mixed methods and multi-level approach was used to collect data, including desktop research and 17 expert interviews.
Results: Germany is performing well and apart from better patients’ engagement has lower barriers for ATMP development and diffusion compared to Sweden. The main hindrances in Sweden include a lack of collaboration between stakeholders in translational research, conservative HTA assessment and lack of innovative payment models. Both countries could benefit from better streamlined regulation on different aspects around clinical trials (i.e. ranging from legislation on genetically modified organisms for gene therapy medicinal products and master file approach for raw materials).
Conclusions: Despite a number of hindrances around ATMP development and uptake, the evidence in terms of technological development on the one side and unmet patient needs on the other side, shows that ATMPs will play an important role in the future of modern healthcare systems. It is clear that further national level collaboration between academic, clinical and industrial players is necessary to overcome the existing hindrances and boost further development of ATMPs in Europe.