Ellen Gielen

Practice Areas

Ellen Gielen is a highly experienced legal expert specializing in regulatory, compliance, and complex contractual matters within the life sciences and healthcare sectors. As head of the Life Sciences & Healthcare group in the Netherlands, she advises leading international pharmaceutical and medical device companies, including Amgen, Boston Scientific, and Johnson & Johnson, on a wide range of legal issues at both the domestic and EU levels.

Her expertise spans various aspects of the life sciences industry, including manufacturing and distribution, pricing and reimbursement, and advertising regulations. Ellen is particularly renowned for her role in developing and securing innovative partnership models, such as patient support programs and hospital solutions. She has a strong litigation background in life sciences matters and is a sought-after speaker and educator, delivering masterclasses on pharmaceutical and medical device law. Her teachings include specialized topics such as contracting with hospitals, sourcing of medicines, advertising and promotion.

Beyond pharmaceuticals and medical devices, Ellen has extensive experience in healthcare law, covering contracts, market regulation, public-private partnerships, medical practice acquisitions, licensing, registration, fee structures, reimbursements, budgeting, and health insurance. Her deep understanding of the regulatory landscape enables her to provide strategic legal guidance to clients navigating complex compliance challenges.

Career

1997 - Lawyer at CMS

2015 - Partner at CMS

Professional Memberships

• 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)

Publications

• 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.