3584 BH Utrecht
PO Box 85250
3508 AG Utrecht
Ellen Gielen advises companies operating in pharmaceuticals, medical devices, food, cosmetics or related industries, including manufacturers, wholesalers and importers. She advises clients on a wide variety of agreements, including distribution, wholesale, agency, manufacturing and clinical research agreements. In addition, she assists clients in matters relating to marketing authorisations, pricing and reimbursements, pharmacovigilance, advertising and promotion, nutrition and health claims and acquisitions in the pharmaceutical industry. Most of the top 10 pharmaceutical companies and medical device manufacturers are among her customers. In this respect, she is renowned for developing and securing innovative partnership models in the field of "patient support programs" and "hospital solutions".
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.
Ellen is a regular speaker on subjects relating to international agency and distribution agreements. She is a member of the grievance committee of an institution operating under the Psychiatric Hospitals Compulsory Admissions Act (BOPZ). She also speaks in the CMS Life Sciences webinar series about 'Distribution models in Life Science'.
- 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.
Dutch Law (Company Law), Erasmus University
Business Administration, Erasmus University
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)