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Portrait of Ellen Gielen

Ellen Gielen

Partner
Advocaat

CMS
Newtonlaan 203
3584 BH Utrecht
PO Box 85250
3508 AG Utrecht
Netherlands
Languages English, Dutch

Ellen Gielen is head of the Life Sciences group in the Netherlands. She is an expert in regulatory, compliance and complex contractual matters and represents leading international life science companies, like Amgen, Boston Scientific and Johnson & Johnson, on a wide range of pharmaceutical and medical device product issues, including manufacturing & distribution, pricing & reimbursement and advertising, both on domestic and EU level. ​

She is renowned for developing and securing innovative partnership models in the field of "patient support programmes" and "hospital solutions". Ellen is an experienced litigator related to life sciences matters and also teaches a number of pharma law masterclasses at Smelt Academy (a Dutch institute for learning and development in life sciences and health), such as on contracting with hospitals. ​

Ellen also has experience in many areas of healthcare law, in particular relating to contracts, market regulation, partnerships and privatization, medical practice acquisitions, licences, registrations, fees, reimbursements and budgeting and health insurance.

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Ellen Gielen’s in-depth knowledge of health laws is complimented by an outstanding knowledge of the medical/health sector

The Legal500 EMEA, 2022

Clients laud her as an "authority on life science-related topics," adding that she is a "fantastic repository of knowledge."

Chambers Europe, 2022

Broad and in-depth experience on pharmaceutical matters and practical approach to legal and business challenges.

Chambers Europe 2021

‘Ellen Gielen is very focused and delivers practical advise moving our business forward. Has a thorough understanding of the health sector.’

The Legal 500 EMEA, 2020

"Has extensive experience of regulatory regimes."

The Legal 500, 2019

Relevant experience

  • Representing a global cardiovascular company which has its global marketing and sales headquarters in the Netherlands. We have drawn up all their commercial agreements such as distribution agreements, agency agreements, sales agreements and their general terms and conditions. Assisting this client with any issues regarding the termination of such agreements.
  • Acting for a global medical device company in the drafting and negotiating of a cooperation agreement with a hospital in the Netherlands. Focus of this partnership is the provision of services to the hospital which are designed to maximise operational efficiency through effective management and modernisation programmes, thus generating sustainable efficiencies to critical operational departments, so-called hospital solutions. It was the first agreement of its kind in the Netherlands and brought a number of challenges with it, on issues like liability, competition law and regulatory guidelines for medical devices.
  • Acted for a global medical device company. We have drawn up their commercial agreements. We also support this client on regulatory matters. 
  • Acting for a global bio-pharmaceutical company. We support them on a large number of agreements, including all their commercial agreements.
  • Advising a USA based medical device company on regulatory issues for medical device clinical trials.
  • Advises on legal classification, import and distribution of human-derived (engineered) tissue products.
  • Advises on setting up a cross-border internet/mail order pharmacy business.
  • Advises on the set-up of so-called health management services in the Netherlands, including drafting all agreements related to the project. Health management services are pharmaceutical company services which enable them to provide added value to patients, health care providers and health insurance funds to improve patient outcomes and reduce the disease-related burden for all stakeholders. 
  • Advises on the set-up of a subsidiary of a global pharmaceutical company in the Netherlands, which involved assisting them with obtaining the necessary licenses, drafting agreements, such as LSP agreements, service agreements etc.
  • Advises a manufacturer on their new distribution structure, setting up the required network, including the drafting of the new distribution agreements. Assists them, including litigation, in the termination of existing contracts with their distributors.
  • Over the last several years, assisting several clients on their new distribution structure.  The above project is the most recent example of our expertise in this area.
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Memberships & Roles

  • Complaints Committee of a BOPZ Institution, an institution governed by the Psychiatric Hospitals Compulsory Admission Act
  • Dutch Pharmaceutical Law Association
  • Appeal Committee of the Royal Dutch Hockey Association (KNHB)
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Education

  • Dutch Law (Company Law), Erasmus University
  • Business Administration, Erasmus University
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