Koosje van Lessen Kloeke joined the Institute of Private Law as (part-time) Researcher Law & Life Sciences on 1 May 2023. She is working on a PhD thesis on the regulation of medicinal products exempted from the authorisation requirements under European pharmaceutical legislation.

More information about Koosje van Lessen Kloeke

Koosje graduated from Leiden University in 2000 in constitutional and administrative law. Until 2006, she worked as a lawyer at Stibbe. In 2006, she joined the life sciences and healthcare specialist law firm Leijnse Artz in Rotterdam, where she became partner in 2013. Koosje van Lessen Kloeke joined the Leiden Law School Institute of Private Law as (part-time) Researcher Law & Life Sciences on 1 May 2023, where she is working on a PhD thesis on the regulation of medicinal products exempted from the authorisation requirements under European pharmaceutical legislation. 

Koosje specialises in life sciences and healthcare regulation under European and Dutch law. This includes the regulation of products, such as (human and veterinary) medicinal products, medical devices, health products, food for specific groups, cosmetics and the regulation of healthcare. Koosje focuses mainly on issues related to clinical trials, marketing authorisations and approvals (marketing authorisations, notifications, labelling and products exempted from authorisation requirements), manufacturing and distribution, pricing, funding and reimbursement of care, cross-border healthcare, advertising, nutrition and health claims, demarcation issues between products (e.g. medicinal products vs. food), enforcement and supervision by competent authorities, and government transparency and data protection issues. 

Koosje regularly writes and speaks on life sciences issues. Since 2008 she is the author of the commentary on the Dutch Medicines Act (Geneesmiddelenwet) in Kluwer, Tekst & Commentaar Gezondheidsrecht, and former editor of Teksten wetgeving gezondheidsproducten. She furthermore is a lecturer at the post-academic course Grotius Healthcare law since 2019. Koosje is a member of the Commissie evaluatie regelgeving at ZonMw and co-founder and honorary member of the Dutch Pharmaceutical Law Association (Vereniging Farma en Recht, VFenR). She is also a member of the Dutch Health Law Association (Vereniging voor Gezondheidsrecht, VGR), the Dutch Food Law Association (Nederlandse Vereniging voor Levensmiddelenrecht, NVLR) and the Administrative Law Association (VAR). 

Publications