Inter-CeBIL: Collaborative Research Program in Bioscience Innovation Law

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.

The legal, regulatory, ethical, and policy considerations surrounding advanced medical computing, AI, and QT/QC in the life sciences and medical sectors are complex and multifaceted. They include i) innovation incentives such as patent protection and competition law, ii) regulatory authorization of devices (FDA/EU MDR- Medical Device Regulation 2017/745 (MDR) 2021), DHTs and endpoints (FDA/EMA Drug Development Tools, Biomarker & COA- Clinical Outcome Assessment Qualification Programs for clinical trials, and iii) data protection laws such as the GDPR affecting the design, development, and market deployment of these data-intensive technologies. The interdisciplinary Inter-CeBIL team investigates these issues and propose frameworks to ensure that the technologies are developed and deployed in a way that is safe, effective, and ethically sound while promoting innovation.

Inter-CeBIL contributes to the field of advanced medical computing, AI, and QT by advancing evidence- based legal studies and proposing legal solutions. In particular, the studies in Key Area 1:

1) Investigate the innovation landscape for medical AI and QC.

2) Examine the landscape of incentives commonly used to support the development of AI and QC technologies in the life sciences and medical sectors, including fundamental patent protection questions such as subject-matter eligibility, scope of protection, and sufficiency of disclosure requirements for medical AI and QC inventions.

3) Evaluate and assess the regulatory requirements including data protection (GDPR) considerations for medical AI data and FDA/EU MDR requirements for clearance AI-enabled medical devices.

4) Scrutinise and contribute to the scholarship on legal, regulatory, governance, ethical, societal and policy implications of medical AI/ML (MML) and DHTs with the objective of promoting the beneficial opportunities expected from MML innovations to achieve desirable social outcomes.

5) Inform and advise concrete use cases involving advanced medical computing, AI and QT in the health and life sciences (see Use-Cases).

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.