Innovation Paper on Promoting Health Research and Economic Location
To meet these challenges and make Germany’s location future-proof, a significantly more intensive transfer of research results into economically sustainable applications is essential. This position paper outlines ways for increased collaboration between academic research and industry. It does not stop at a description of the current state but provides concrete recommendations for action to overcome barriers in the translation and transformation process to not only promote but make collaboration between stakeholders a reality.
Good research takes place both in public and private institutions in Germany. The goal must be to bring research findings more quickly and purposefully into development and provision to ensure medium- to long-term demand-oriented and high-quality patient care, which leverages the potential of increasingly individualized treatment. At the same time, this will strengthen Germany’s competitiveness in a globalized healthcare economy, which in turn will result in future-oriented jobs, positively impacting the social systems.
The initiators of this call are aware that innovations brought into healthcare for the benefit of patients cannot be considered without ensuring sustainable financing, given the financial situation of health insurance. The accompanying scientific evaluation of a process-optimized healthcare system when introducing innovations ("implementation research") therefore requires precise, high-quality, and curated data from healthcare processes regarding recognized validated endpoints.
A system based on transparency, speed, and data quality, built on the latest infrastructure and clear objectives, can foster innovation and investment. The guiding principle is a fully thought-out, data-informed research and healthcare system.
I. Accelerating Knowledge Transfer – From Research to Market Application
The interface between research and development is a critical success factor for innovations in Germany. To realize and accelerate the transfer of research results into market-ready products and services, a more intensive and appreciative collaboration between academic research and industry is necessary. Below are specific measures to strengthen this interface and optimize the knowledge transfer:
1. Strengthening Cooperation Structures
Joint Research Projects
Promote public-private partnership (PPP) projects and joint research projects to leverage synergies and share risks, with a particular focus on small and medium-sized enterprises (SMEs).
Virtual Research Labs
Establish legally compliant and EHDS-compatible digital platforms that facilitate data, knowledge, and resource exchange between research institutions and companies.
Registers and Biobanks
Promote academically led registers and biobanks (provided certain criteria and certifications are met) with access for industry.
Early Intervention
Many innovations in Germany end up in the "Death Valley of Translation" before reaching a maturity level that makes the transfer attractive for industry. Industry and politics, together with researchers, should establish translation centers to improve the translation process.
2. Financial Instruments
Private Venture Capital
Expand venture capital funds specializing in early-stage financing for technology-based companies.
Tax Incentives
Create tax incentives for companies investing in research and development.
Public Funding Programs
Targeted use and possibly expansion of funding programs for technology transfer, especially for small and medium-sized enterprises (SMEs); funding should not be time-limited, geographically restricted, or limited to a specific indication.
Application Patents for Rare Diseases
3. Promoting Entrepreneurship
Entrepreneurship Education
Integrate entrepreneurship skills into the education of scientists.
Mentoring Programs
Set up specific mentoring programs to support scientists in founding companies and protecting their intellectual property.
Startup Culture
Create a vibrant startup culture at universities and research institutions (e.g., competitions and exchange programs between academic research and industry, best practice sharing).
Incubators and Accelerators
Expand and network incubators and accelerators that support young spin-off companies in their development; implement effective communication measures to publicize these structures.
4. Intellectual Property Protection
Awareness of Intellectual Property Protection
Regularly provide basic knowledge about the necessary protection of research results in the training of scientists at universities and other institutions. Strengthen academic intellectual property departments.
Simplified Patent Application
Simplify patent application procedures for research institutions and startups, including approval of indication patents/application patents for rare diseases.
Licensing
Develop flexible licensing models to facilitate the commercialization of research results.
5. Strengthening Networks
Industry Meetings and Conferences
Regular events and exchange formats to network scientists and entrepreneurs with political support (e.g., state ministries), also to identify research-related needs of companies involving patients.
Idea Markets for New Mechanisms and Technologies
Digital Infrastructure
Ensure a powerful and secure IT data infrastructure to use innovative digital technologies, such as AI applications.
Cooperation with Technology Parks
Expand cooperation with technology parks established with researchers to take advantage of the proximity between research and business.
Regional Clusters
Industry-specific regional clusters are interested in developing their environment into leading life-science locations with international appeal. With their respective networks, they promote innovation in the clusters.
II. Making Career Paths More Open: Promoting and Demanding a Scientific and Entrepreneurial Mindset in Researchers
Knowing both sides fosters collaboration and mutual understanding. Therefore, a career should not follow a single path, but should be characterized by permeability, both in education through internships and in later career stages. Internships and transitions within healthcare systems can serve this purpose.
1. Insights into Research Activities in the Private Sector
Company Internships
Researchers should be given opportunities to gain insights into work in companies through "side-steps" alongside their academic career paths. Research companies should be able to set up project- and time-based employment concepts for academic talent, which are recognized as relevant knowledge growth in their careers.
Short/Long Term Assignments (STA/LTA)
Research stays in private industry should be guaranteed to count as academic credits at universities. A structured reintegration of researchers after these STA/LTAs should also be ensured.
Flexible Employment Environment
A flexible environment is beneficial for developing mutual understanding of the respective cultures and needs in scientific and entrepreneurial environments. One example is working in public-private partnership projects. In addition to working in basic research, clinical development, and healthcare research at universities, researchers should receive early exposure to industry-related research and development. Measures should also be taken to facilitate the transition, for example, from civil servants to CEOs of startups without losing pension rights.
2. Consulting Offices at Research Institutions
Universities and research institutions should establish mandatory consultation centers that support individuals' willingness to start a business and guide initial steps towards spin-offs. These centers should also support and promote patenting research results and provide concrete steps for rapid development into products and services. Additionally, they should advise on public-private partnerships.
3. Recognition of Achievements
Success in spin-offs should be incorporated into performance evaluations in academia. University rankings should consider successful spin-offs at respective universities, as successful science is not only measured by the number of publications or third-party funding but by "impact," such as the number of successful spin-offs. It is also about inspiring researchers from all over the world to work in Germany.
III. Designing Regulatory Frameworks to Support Innovation
Targeted regulatory frameworks are essential to creating motivating working conditions in academic research and business, as well as developing innovative products and successfully marketing them at scale.
1. Development of Data Usage Regulations in Healthcare
Data Standards
The regulation of the German healthcare system sets national data standards ahead of internationally recognized ones. This results in significant additional work for cross-border projects. With the upcoming establishment of the European Health Data Space (EHDS) as a "data internal market," this situation is untenable. Internationally recognized data standards must be prioritized.
Harmonization of Data Privacy Regulations
In Germany, in addition to the binding EU-wide GDPR, numerous additional laws govern the use of health data on various levels, such as state hospital laws with their own, sometimes conflicting, and often more far-reaching regulations. The GDNG was a step in the right direction, but it is not sufficient to eliminate all barriers for research in Germany. A research data law is still missing. In international competition, Germany is falling behind in the ranking for the conduct of clinical trials, among other reasons because the applicable requirements are not harmonized and impose additional obligations beyond the GDPR. Harmonization therefore appears particularly necessary at the level of the state hospital laws in order to enable data processing procedures to be carried out significantly faster and more efficiently.
Establishing Living Labs
"Sandboxes" are an effective measure to test and adjust the transfer and translation of research results under realistic conditions before requesting approvals and marketing.
Further Development of the Electronic Health Record into a Health Data Ecosystem
The "ePA for everyone" is a significant advancement, and in conjunction with the Health Data Utilization Act and the EHDS, it provides a solid data foundation for future data utilization projects. It is understandable that, in the initial phase, a document-based system is being established. In the further development, the goal must remain the creation of a health data ecosystem with digitally available, structured, and interoperable data, as only then will the available data be usable for research purposes.
2. Market Access for Innovative Products
Processing of Treatment Data
The use of modern, digital-based medical technology generates numerous data, whose processing and use are complex from a regulatory standpoint. A product used in different states must be re-examined in light of the data processing rules of each state. Simplification and clarification will speed up the use of innovative, newly developed technologies.
A Clear Re-regulation of the Equivalence Proof Procedure for a Method
The rules for the market access of new methods or procedures within the statutory health insurance system are very strict. They focus on proving medical benefit through "hard" patient-related endpoints. Digital solutions today can replace established, more invasive methods through simulation based on existing data. These solutions are not necessarily better; they simply achieve the same goal using different, ideally more efficient means. The usual proof of benefit currently represents a significant market entry barrier, which makes new methods more expensive and delays their implementation. This also results in outdated methods in healthcare not facing any competition.
Introduction of an Enabling Principle
Due to an overly security-focused evaluation practice of research projects, applicants are asked for data that exceeds the requirements of other EU member states and is difficult for start-ups and SMEs to manage. As a result, other EU member states often become alternative locations. Establishing an enabling mindset would significantly strengthen Germany's position.
3. Unified Interpretation and Implementation of EU Regulations
Rolling out regulatory frameworks across all Member States
EU regulations in these areas could provide uniform conditions across the 27 member states, offering start-ups and SMEs opportunities for the development and marketing of innovative products and solutions. Clear regulation would provide legal certainty. Any additional national requirements that go beyond the provisions of the respective EU regulation undermine this advantage. Young companies do not have the resources to conduct extensive research into country-specific requirements or to establish separate processes to comply with them, nor can they bear the associated costs. National "gold-plating" leads to slower and more costly research, development, and commercialization processes. Only harmonized rules across the EU Single Market can provide a decisive advantage for innovation and translation.
Harmonization of Vertical and Horizontal Legal Frameworks in the Health Sector
The necessary integration of laws can be exemplified through AI applications in healthcare. The continuous expansion of the use and acceptance of AI applications must progress. A necessary foundation for this is a harmonized conformity assessment procedure for AI systems, in line with the existing Medical Device Regulation (EU Regulation 2017/745; MDR), which avoids bureaucratic overload, capacity bottlenecks, and additional costs caused by the AI Act.
Conclusion
When research, healthcare provision, and sustainable financing are considered together based on data, it is a gain for healthcare and Germany's economic position.
Products and solutions newly developed through research are intended to improve healthcare for people in our country. Increasingly, products based on data usage can be applied in a needs-oriented and targeted manner for specific disease situations. This leads to better treatment outcomes and a more resource-efficient use. This is something that should be the focus.
The task of taking the right regulatory and practical steps is immense. Therefore, as participating associations and institutions, we offer our cooperation, through which we are happy to contribute our expertise and ideas, and together with other stakeholders, plan and coordinate the targeted implementation.
