Short presentation

Medicine and health are heavily regulated, affected by several different legal frameworks and subject of significant political controversy. Adding the constant development in science and technology makes it a rich area for many different lines of legal and especially interdisciplinary research. At the moment my research is focused on Advanced therapy medicinal products (ATMPs), representation in clinical trials and the revision of the pharmaceutical regulation.

ATMP’s are treatments utilizing genes, cells and tissue as the raw material in medicinal products. ATMPs are often highly personalized treatments and. They have shown great potential and some significant results in e.g. the treatment of cancer. However, manufacturing of ATMP’s can be complex and require highly specialized staff and facilities, while the patient population are often very small. This creates several challenges such as costs, access and the roles of public- and private institutions in development and manufacturing. As PI in the CREATIC project I am responsible for establishing a community of experts on ATMP’s. together with Masaryk University, Frauenhofer IZI and university of Leipzig the goal of CREATIC is to establish a eastern European center of excellence for ATMP’s in Brno, Czech Republic. The project is funded by EU and runs from 2023 – 2028.

Who do we test medicine on before we place it on the market? In the projects REPACT and DePNeP, we explored what data we have on this question, what methods of analysis that could enlighten us and the regulatory framework governing this question. The projects included collaborations with the Danish Medicines Agency dataanalytics center (DAC), The Danish Health Authority and UCPH’s faculties of humanities, social science and law. One of the results was a report on the representation of sexes in clinical trials (published January 2025).

EU are moving towards increased integration of health, which has historically been something left for the many different healthcare systems and priorities of the member states. The last decade has seen some significant new EU regulatory initiatives laying the foundation for this process such as a new clinical trial regulation (2014), GDPR (2016), Medical device regulation (2017), Health Technology assessment regulation (2022) and European health data space regulation (2025). In April 2023, the EU commission proposed a grand revision of the central EU regulations governing the development and placing on the market of medicinal products. The proposal is currently (may 2025) in trilogue negotiations. The many regulatory initiatives are reconfiguring the entire regulatory landscape in EU – both for medicial products and for healthcare in general.     

Current research

Patents and genome editing technologies 

Advanced therapy medicinal products (ATMP)

EU pharmaceutical package

Clinical trial regulation and transparency

Law and Innovation systems

Fields of interest

Intellectual property

Open Innovation

Law and Technology

Philosophy of Law

Interdisciplinarity

Synthetic biology