Read the Conversation
Meeting Highlights:
- Advancements in Digital Healthcare and Regulatory Streamlining: Significant progress in digital health applications, with 58 listed on BfArM's website, primarily for psychiatric conditions. Innovations like the Health Data Lab (launching in 2025) aim to integrate long-term health data from millions of patients, fostering data-driven healthcare and aligning with the European Health Data Space.
- Focus on Innovation and Collaboration: Establishment of a dedicated Department for Innovation Management, providing scientific advice and fostering collaboration with academic centers, SMEs, and Big Pharma. Harmonization efforts with the Paul-Ehrlich-Institut to streamline clinical trial processes and reduce bureaucracy, supporting faster innovation.
- Response to Antibiotic Resistance: Addressing the overuse of antibiotics in both human and veterinary medicine. Promoting antibiotic stewardship and developing reimbursement models to incentivize the development of new antibiotics while preserving their use as last-resort treatments.
- Integration of AI and Digital Tools in Regulatory Processes: Commitment to leveraging artificial intelligence and large language models for regulatory purposes, enhancing efficiency in clinical trials, marketing authorizations, and lifecycle management. Focus on AI-driven advancements in CNS conditions like Alzheimer's and schizophrenia.
- Leadership and Future Outlook: BfArM's role as a trusted and innovation-driven partner in European healthcare, co-chairing initiatives like DARWIN EU and advancing real-world data applications. Dr. Broich emphasizes the transition to a fully data-driven healthcare system within the next 5–10 years, positioning Germany as a leader in digital health transformation.
EF: How has the regulatory landscape evolved over the past two years, and how have your priorities changed?
KB: In comparison, there is a stronger focus on digitalization. We are witnessing a surge in digital health applications while discussions about digital care applications are gaining traction publicly. However, challenges persist, such as drug and medicinal product shortages.
A key concern remains accelerating the pace of innovation. How can we expedite clinical trials in Germany? Additionally, how can we effectively implement the requirements outlined in the Medical Research Act?
This legislation has prompted closer collaboration with the Paul-Ehrlich-Institut. Significant changes are underway, and with the upcoming launch of the Digital Health Data Lab this year, we anticipate a transformative impact on patient care in Germany.
EF: Could you elaborate on how you foster and promote innovation? How do you strike the right balance,
KB: In response to the requirements set forth by the Medical Research Act, BfArM has established a dedicated Department for Innovation Management. This department houses an Innovation Office that provides guidance and scientific advice on a low-request basis, serving as a clear incentive for academic centers, small and medium-sized pharmaceutical companies, and larger pharmaceutical organizations.
The department holds portfolio meetings to identify upcoming innovative products, offering guidance to support their development. For promising innovations, efforts are focused on overcoming regulatory hurdles and ensuring compliance while also introducing stopping rules for products unlikely to succeed.
Looking ahead, this department will play a central role in managing the Special Ethics Committee, which is another key component of the Medical Research Act. This committee is designed to oversee and enhance specialized, innovative clinical trials, such as those conducted during pandemics, platform trials, first-in-human trials, or advanced therapy medicinal products (ATMPs).
Germany has historically been slower in initiating clinical trial recruitment than other countries. To address this, the BfArM has, amongst others, strengthened its Department for Clinical Trials and Governance, fostering closer collaboration with institutions like the Paul-Ehrlich Institute. Steps include harmonizing websites, centralizing requests from industry and stakeholders, and especially creating a single entry point on the BfArM website for applications, including scientific advice. This streamlined process allows for faster processing on all sides, faster decision-making, and better coordination among departments.
Additionally, BfArM has established a Division for Regulatory IT and a Coordination Office. This division is focused on leveraging digital tools and AI to enhance marketing authorizations, clinical trials, and scientific advice. Efforts include developing common IT solutions in collaboration with the Paul-Ehrlich-Institut and ensuring alignment with the European Medicines Agency's systems.
To reduce bureaucracy, BfArM has prioritized essential regulatory requests and moved away from redundant or outdated requirements. Emphasis is placed on rethinking digital transformation from the ground up, avoiding merely replicating analog processes in digital formats. For instance, instead of relying on PDFs, the department is exploring optimized digital tools that can drive efficiency and innovation in the future.
EF: Could you elaborate on the role BfArM plays in shaping Germany's e-health infrastructure? Are there specific therapeutic areas that you believe are particularly well-suited for digital applications?
KB: Germany has been a pioneer in integrating digital healthcare applications into its system, starting with the fast-track procedure for approval, followed by the ability to prescribe and reimburse these applications. Currently, 58 digital health applications are listed on the BfArM website. Most of these focus on psychiatric indications, as cognitive behavioral therapy approaches are relatively straightforward to translate into digital formats.
Patients have particularly appreciated these applications because they enhance self-esteem and offer flexibility, allowing users to integrate them into their daily schedules. While the business model for digital health applications is becoming more established, there are still challenges. Payers express concerns about the level of evidence required for efficacy, while applicants often feel the regulatory requirements are too stringent. Nevertheless, ongoing discussions with stakeholders, including digital associations, aim to find a balanced approach.
BfArM remains committed to advancing digital health applications and ensuring they have a defined role in the healthcare system. However, digital care applications face greater hurdles. Many applicants report that the current financial model, such as the 50 euro per month limit without preliminary listing, is not viable. BfArM is actively engaging with policymakers and the ministry to address these barriers and create a more attractive system for future applications.
In parallel, BfArM has contributed to broader digital initiatives. Collaborating with health reform efforts, it has worked on classification systems and registries to support hospital reforms. A major milestone is the establishment of a terminology server, developed in partnership with Gematik, as a foundational element for Germany's electronic patient record. This record was recently launched as a pilot in three regions and represents a significant step forward in digital health infrastructure.
Another transformative project is the Health Data Lab, which is set to launch this year. This initiative will integrate data from 74 million individuals covered by statutory health insurance, encompassing long-term and short-term data, hospital and ambulatory care records, prescription data, diagnoses, and disease progression. Over time, this will be supplemented with data from electronic health records, cancer registries, and digital health applications. The latter already have APIs for seamless integration, ensuring comprehensive and interoperable data.
This vast repository of health data holds immense potential for medical research and innovation, aligning with the vision of the European Health Data Space. Germany has actively participated in pilot phases to shape this initiative, ensuring its data are ready to be utilized within the European framework. The recent endorsement of this approach by the Council represents a significant step forward in leveraging health data for improved care and innovation across Europe.
EF: Could you explain how BfArM is addressing the pressing issue of antibiotic resistance? Additionally, how does your approach align with the regulations outlined in the DART 2030 mandate?
KB: Every year, particularly during the autumn and winter seasons, we face recurring issues of antibiotic shortages affecting adults, children, and adolescents. Available sell-in and sell-out data suggest that antibiotics are still being overused and often prescribed too early, which contributes to long-term challenges.
To address this, we are closely collaborating with learned societies to promote proper antibiotic stewardship, emphasizing the importance of educating patients about delaying antibiotic use unless absolutely necessary. This is crucial for preserving their effectiveness over time.
Additionally, we are working in close partnership with veterinary regulators, as a significant portion of antibiotics is used in veterinary medicine, contributing to resistance even more than human usage. Tackling resistance requires a unified approach across both human and veterinary sectors.
Regarding the development of new antibiotics, we are striving to ensure these are preserved as reserve antibiotics. However, there are challenges in incentivizing companies to develop these medicines, particularly because they cannot be reimbursed immediately. Innovative payment models and collaborative efforts with payers are essential to support the development and availability of new antibiotics while ensuring their sensible use.
This is an ongoing effort that will remain a critical focus in the years ahead, as combating antibiotic resistance is essential for safeguarding global health. We are actively collaborating with stakeholders to ensure that information texts for antibiotics are regularly updated to reflect the resistance situation in different regions. This involves analyzing areas with high prescription rates and identifying regions where usage aligns better with established guidelines and regulations.
EF: Reflecting on your time leading BfArM, what accomplishments are you most proud of as President? Additionally, what are your aspirations for the organization's future?
KB: I am truly excited to continue following the developments and strengthening our role as a trusted and open-minded partner in healthcare innovation. My focus has been on fostering European collaborations with organizations like EMA and the European Commission, co-chairing initiatives such as Darwin EU. Looking ahead, a key area of focus will be our new Network Data Steering Committee, where we will discuss the use of AI applications for regulatory purposes. We have already published some papers on this, and for the upcoming year, I am particularly keen to advance these digital enhancements.
One of my priorities is exploring how we can leverage large language models in regulatory science to improve process management and introduce automation. This will help us streamline development times for innovative products, from discovery and development to lifecycle management.
I am confident that in the next 5 to 10 years, our healthcare system will be entirely data-driven, which presents exciting opportunities. As you know, I am a neurologist and psychiatrist by training, and I am especially looking forward to the progress in treating Alzheimer’s disease and other CNS indications like schizophrenia. There are new approaches emerging, informed by what we are learning through artificial intelligence, and this is an area I will be focusing on in the years to come.
