Tackling legal and regulatory barriers to health and life science innovations

Bringing new medicines and biosolutions from the laboratory to the market is dependent on increasingly complex laws and regulatory processes. The Inter-CeBIL Programme aims to provide insights, knowledge and tools that contribute to a successful, competitive and sustainable innovation ecosystem. 

The development of the Inter-CeBIL Programme has been led by grant holder and principal investigator Professor Timo Minssen from the Centre for Advanced Studies in Biomedical Innovation Law (CeBIL) at the University of Copenhagen, Faculty of Law. The Programme is a continuation of a 5-year Novo Nordisk Foundation-funded Collaborative Research Programme in Biomedical Innovation Law (CeBIL Programme) launched in 2018 which was also led by Professor Minssen. 

The CeBIL Programme’s objective was to contribute to the translation of groundbreaking biomedical research into safe, effective, affordable and accessible therapies by analysing the most significant legal challenges to pharmaceutical innovation and patient care. A holistic and interdisciplinary approach was key to the CeBIL Programme’s success, bringing together scholars from the world’s leading research institutions. These included core partners from Harvard, the Universities of Cambridge and Michigan, and coauthors and advisors affiliated with the Universities of Yale, Oxford, MIT, Stanford, ETH Zurich, INSEAD, the Max Planck Institute and the Technical University of Munich.

“The CeBIL Programme has been a great success: we have engaged with industry, public bodies and legislators, influenced policy, and published a significant number of research papers in top legal and scientific journals,” says Professor Minssen. “With Inter-CeBIL, we now want to build on what we have learnt and shift from this very high-level impact to more applied and tangible effects at the ground level. I feel very humbled and grateful for the continuous trust in our scientifically independent research, and the generous financial support that the Novo Nordisk Foundation has granted us. I also want to express my most heartfelt gratitude for our splendid teamwork with all our CeBIL partners and the support that I received from our Faculty.” 

Informing efforts to tackle challenges in key areas

With the new funding, the Inter-CeBIL Programme aims to support a robust and competitive bioscience innovation ecosystem by investigating the most important factors sensitive to legal and regulatory challenges, including those that are crucial for speeding up regulatory processes that have the potential to create real health impacts for patients, as well as sustainability impact in society.

Inter-CeBIL will expand its research scope and collaboration, welcoming additional core partners from the Technical University of Denmark (DTU), as well as further research fellows and affiliates from top universities around the globe. The Programme will focus on three key areas: 

1. Advanced Medical Computing, Artificial Intelligence (AI) and Quantum Technologies (QT)
2. Pandemic Preparedness and Anti-Microbial Resistance (AMR)
3. Sustainable Innovation and Biosolutions

By testing and translating academic findings into practical applications, Professor Minssen believes that Inter-CeBIL can play an important role in the coordinated efforts that will be necessary to tackle key challenges and grasp opportunities in the health and life sciences, such as in AMR. “The increasing global health threat of AMR has highlighted the vulnerability of our healthcare systems. To be effective, actions on AMR, as well as actions on other biological threats, new digital possibilities, and climate change, will need to be informed by insights and evidence from the social sciences including legal and economic studies – such as those developed under the umbrella of the Inter-CeBIL Programme,” Professor Minssen explains.

A solid foundation for future success

Looking back over the past five years, the CeBIL Programme’s impact has been substantial in terms of research output and outcome, knowledge dissemination, and societal engagement.

“CeBIL has delivered above and beyond,” says Mikkel Skovborg, Senior Vice President for Innovation at the Novo Nordisk Foundation. “On top of the research outputs, Professor Minssen and his partners have achieved a very high level of international engagement, outreach and teaching activities. We look forward to seeing how the Inter-CeBIL Programme will build on these successes in the next 5-year grant period”.

Overview of CeBIL Programme achievements in the period 2018-2022

• Wide range of collaborations including private and public sector, NGOs, international organisations and leading universities.
• Providing expert advice and impact on innovation policies via the World Intellectual Property Organization (WIPO), World Health Organization (WHO), the Organisation for Economic Co-operation and Development (OECD), and the EU and national governments.
• Contributing expertise and sharing knowledge with high-level academic institutions, biotech, pharma and AI companies.
• High level of public engagement involving interest organisations, NGOs, politicians and the general public.
• Heading high-level international AMR network (INAMRSS).
• Delivering high interdisciplinary research output including more than 200 peer-reviewed journal articles and 5 books.
• Contributing to outreach activities, including via social media.

Text prepared by the Novo Nordisk Foundation. Edited by Emil Tarp Vang.