Koosje van Lessen Kloeke

Practice Areas

Koosje van Lessen Kloeke (partner) is co-head of Leijnse Artz’s Life Sciences and Healthcare practice group. She specialises in Life Sciences and Healthcare regulation under EU and Dutch law, both contentious and non-contentious. Her practice covers pharmaceuticals, medical devices, biotech, food, cosmetics and healthcare. Koosje has extensive experience representing clients in procedures before regulatory, pricing and reimbursement authorities, competent authorities, and with judicial review proceedings before the Dutch courts. She advises several prominent multinational and national life sciences companies, industry associations and foreign counsel on a broad range of complex European, domestic and cross-border regulatory matters, including product approvals, manufacturing and wholesale, pricing and reimbursement, financial arrangements and managed entry agreements, joint clinical assessment and/or joint negotiations, e.g. in the context of the Beneluxa Initiative on Pharmaceutical Policy, cross-border pharmaceutical care, the regulatory status of borderline products, clinical trials, labelling, advertising, government transparency and data protection issues (in the context of the Dutch Open Government Act (“Woo”)), and contentious matters relating to investigations and enforcement actions by competent authorities in the life sciences and healthcare markets, for example into market launches of products, pharmacy compounding and product advertising.

Koosje regularly writes and speaks on life sciences issues. She is the author of the only comprehensive commentary on the Dutch Medicines Act (Geneesmiddelenwet) (Kluwer, Tekst & Commentaar Gezondheidsrecht). She furthermore is a lecturer at the post-academic course Grotius Healthcare law, “Grotius specialistatieopleiding Gezondheidsrecht” since 2019.

Career

Koosje studied law at the University of Leiden. Koosje joined Leijnse Artz in 2006 and became partner in 2013. She previously worked with the law firm Stibbe. She is admitted to the bar in Rotterdam.

Professional Memberships

Koosje is a member of the Commissie evaluatie regelgeving at ZonMw. Koosje is co-founder and honorary member of the Dutch Pharmaceutical Law Association (“VFenR”). She is also a member of the Vereniging voor Gezondheidsrecht (the Dutch Health Law Association), the Nederlandse Vereniging voor Levensmiddelenrecht (the Dutch Food Law Association), and the VAR (Dutch Administrative Law Association).

Publications

Koosje regularly writes and speaks on life sciences issues. She is the author of the only comprehensive commentary on the Dutch Medicines Act (Geneesmiddelenwet) (Kluwer, Tekst & Commentaar Gezondheidsrecht) as well as the author of the chapter on the key regulations affecting pricing and reimbursement of pharmaceuticals in the Netherlands, in the Global Legal Insights - Pricing & Reimbursement of Global Legal Group (https://www.globallegalinsights.com/practice-areas/pricing-and-reimbursement-laws-and-regulations/netherlands).

Koosje is doing PhD research into the regulation of exempted products under the EU regulatory frameworks for medicinal products (e.g., pharmacy preparations, ATMPs under hospital exemption, named patient and special needs, compassionate use).

Languages Spoken

Dutch, English