Ellen Gielen

Eellen Gielen is a leading figure in the Dutch Life Sciences & Healthcare sector, known for her deep regulatory expertise and practical, commercially focused advice. As Co‑Head of the Life Sciences & Healthcare group at CMS Netherlands, she supports pharmaceutical, biotech, medtech and digital health companies with mission‑critical regulatory, compliance, commercial and strategic matters at both Dutch and EU level.

She advises clients throughout the lifecycle of medicines and medical devices, including market access, pricing and reimbursement, advertising, promotion and product supply. Her guidance is particularly in demand on MDR/IVDR compliance, digital health models, hospital contracting and cross‑border collaborations. She is recognised for structuring commercial models that enable innovative solutions aligned with regulatory expectations.

A key part of her practice is regulatory litigation, including her prominent role in the reimbursement case for Eli Lilly’s breast cancer medicine Verzenios.

She also has broad experience in the digital pharmaceutical landscape, advising major online pharmacy groups on cross‑border operations, automated dispensing, outsourced activities, telemedicine pathways and GDPR‑compliant digital processes.

2015 - Partner at CMS

1997 - Lawyer at CMS

• Dutch Pharmaceutical Law Association

• Complaints Committee of a BOPZ Institution, an institution governed by the Psychiatric Hospitals Compulsory Admission Act

• Dutch Standardisation Institute (NEN) on MDR and IVDR topics (panel member)

• Appeal Committee of the Royal Dutch Hockey Association (KNHB)

• Expert Guides: A legal roadmap for Cannabis / Advertising of medicines and medical device / Digital health apps and telemedicines.

• On the pulse Podcast: A legal roadmap for Cannabis.

• Stay ahead Life Sciences and Healthcare – monthly update on legal developments.