International Collaborative Bioscience Innovation & Law (Inter-CeBIL) Programme

The vision of Inter-CeBIL is to become the world-leading research hub in health & life science innovation law by continuing and further expanding our contributions to interdisciplinary high-impact research focused on identifying and tackling legal barriers to health & life science innovation including biomedical R&D and product adoption. Likewise, we will also continue and expand our collaboration with and integration into the innovation eco-system – in the Greater Copenhagen region, nationally as well as in Europe and globally.

It is our primary ambition to support a successful and competitive innovation system. We will therefore play an active and prominent role in relation to health & life science innovation. Particular emphasis will be placed on supporting a robust and competitive biomedical innovation ecosystem by focusing on factors that are:

• sensitive to legal and regulatory challenges,
• crucial for speeding up regulatory processes and building bridges between translational research and innovation, as well as product adoption,
• having the potential to create real health impacts for patients, and that are practically relevant and

We will continuously disseminate our findings and insights by interacting with both private and public decision makers. We will publish policy papers, propose new industry standards, develop new contractual framework tools, participate in public hearings, and provide recommendations to key stakeholders and innovators where relevant. We will do this in close collaboration with our core partners at DTU, Cambridge, and Harvard. We will moreover draw on our extensive international network within both academia, public administration, and industry.

We want to strengthen our collaboration with key decision makers in the Danish medical research and innovation landscape – from academia over industry to interest organisations – with the ambition of becoming the go-to place for well-informed legal research and research-based education, knowledge communication and advice within the area of life science innovation.

We want to consolidate our collaboration with some of the world’s strongest legal and regulatory research groups in the field. Together, we will address the legal and ethical implications of pathbreaking technologies, by showing how to enable these technologies while simultaneously avoiding their perils and unwanted uses.

Our ultimate goal is to help build bridges from drug R&D to product adoption and to contribute with legal research to addressing the grand challenges of our time, such as advances within medical computing, pandemic threats, antimicrobials resistance, and more sustainable medical innovation and drug R&D.

Inter-CeBIL’s mission is to provide solid, research-based support that eases the translation of world-class health & life science research to viable and needed products, effective therapies, and high-quality patient care.

Health and life science innovations must readily and safely reach patients and markets, while simultaneously being developed in responsible, effective, sustainable, and globally competitive ways.

We will focus on three biomedical “grand challenges”:

• Advanced medical computing: Artificial Intelligence (AI) and Quantum technologies (QT),
• Pandemic Preparedness & Anti-Microbial Resistance (AMR),
• Sustainable innovation – eco-systems, drug R&D, drug regulation & data infrastructures,

We will approach and address these challenges in an encompassing and bi-directional manner, where research-based knowledge will flow into industry, and where industrial knowledge will inform our research endeavours.

Inter-CeBIL’s core team possess deep and globally recognized legal expertise in IP law, regulatory sciences, data protection law, competition law, pharmaceutical and medical law as well as expert knowledge of advanced computing. The comprehensive interdisciplinary collaboration of the program, combined with the

unique evidence-based research capabilities of its participants, enable the realization of unique insights into the complex regulatory issues related to the grand’ challenges listed above.

Key to our mission is to operationalise these unique insights to:

• ease and support life science innovation and development,
• provide guidance to help ensure adequate protection of sensitive emergent technologies, such as medical AI, invasive high-risk medical devices, specific applications in synthesis biology and genome- editing, or quantum computing, contribute to the development and implementation of well- calibrated incentives,
• avoid over-regulation that hinders the development of beneficial uses and cripple the safety and competitiveness of the European innovation system (see g. Ben-Menahen et al. 2020), while at the same time making sure that crucial risks of new technologies are appropriately addressed in legislation,
• facilitate that new and safe technologies and therapies are made available to those in need,
• contribute to the development of a sustainable health & life science innovation

Advanced computing is playing an increasingly important role in the life sciences and medical sectors. Algorithms are becoming the fundamental building blocks in a wide range of medical devices, digital health technologies (DHTs), and drug discovery tools (DDTs). The use of advanced computing such as AI/ML and quantum computing (QC) has many potential benefits for the life sciences, drug discovery, and medical sectors.

Key Area 2: Pandemic Preparedness & Anti-Microbial Resistance (AMR)

The COVID-19 pandemic has raised awareness of the urgent need to improve the design of health systems, as well as the practical implementation of new strategies and technical solutions to better prepare for future pandemics. The rapidly evolving and mutating virus, as well as secondary infections linked to COVID-19, demonstrate that these preparations must also consider harms secondary to the pandemic, including the resulting effects on and of antimicrobial resistance (AMR). While drug-resistant infections pose a well-known and severe threat to human and animal health, the COVID-19 pandemic is compounding this already problematic situation (Weldon et al., 2023). The COVID-19 pandemic has placed more focus on the role of IP and trade secrets in improving access and affordability, and scaling-up of manufacturing and supply of vaccines and other health-related technologies. These conversations have stressed the need for further studies on the relationship between IP, innovation, prevention, and access to improve pandemic preparedness. Our research highlights the important interaction between pandemic preparedness and the ongoing fight against AMR.

Inter-CeBIL contributes to improving pandemic preparedness and support the fight against AMR by providing interdisciplinary and evidence- based legal studies and proposing legal solution models for selected key factors, such as by:

• analyzing regulatory and data protection issues regarding surveillance of outbreaks,
• conducting empirical studies on AMR and vaccine innovation landscapes, company profiles and most relevant legal challenges,
• identifying legal issues regarding infection prevention & control,
• examining legal frameworks for push and pull incentives to spur the development of new treatment and technical innovation, such as medical devices, in close collaboration with relevant actors such as the AMR Impact Fond, Novo Holding’s Repair Fond, CARB-X, as well as legislators, regulators and international organizations,
• proposing legal models to incentivize so-called social and behavioural innovation to improve AMR stewardship and conservation,
• proposing legal models and incentives to improve and govern appropriate access to available treatments.

Key Area 3: Sustainable innovation – eco-systems, drug regulation & data infrastructures

Managing an organisation’s innovation strategy increasingly requires careful consideration of legal aspects relating to environmental, social and governance (ESG) issues.

Many regulatory initiatives are emerging for AI and data uses, which are often considered crucial for facilitating Sustainable Development Goals. The regulatory and legal ecosystem has become extremely complex and difficult to navigate with inherent risks for the competitiveness of Danish and European life science and pharmaceutical industry due to factors such as overregulation, regulatory inconsistency, insufficient data access, and lack of interoperability. Building on and expanding our work on legal aspects of sustainable innovation including responsible and greener drug R&D, better access to biomedical data/data-sharing, better governance of platform technologies, and more inclusive clinical trials, we further investigate these issues.

This focus area is broad and flexible, and Inter-CeBIL takes a responsive approach to public debates. We also stay abreast of long-standing high-priority legal questions for the pharmaceutical industry, which require steady reflection for sustained development. Examples include:

• European pharmaceutical legislation review and the impact of the EMA and other regulatory agencies,
• the balance between fair IP protection for originators and timely entry for generics (two current issues being divisional patents, and the impact of ‘patent linkage’ on generic entry),
• fair drug pricing, which takes into account the complex costs of R&D, urgent access needed by patients, wealth-disparities, and the norms and principles of competition law, IP and regulatory price controls,
• strategies for managing product liability in the context of emerging drug development, and personalised medicines,
• the challenges of regulatory burdens (and compliance) in the pharma sector, and policies to alleviate pinch-points,
• data protection regulation involving longitudinal genetic and health research, particularly where health data is transferred across borders and between public and private sector firms.