Home / People / Ellen Gielen
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.

more less

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.
more less

Education

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

Memberships

  • 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)
more less

Feed

Show only
14 April 2021
Top rank­ings CMS in Leg­al 500 EMEA 2021
CMS has once again been ranked in the latest edi­tion of The Leg­al 500 Europe, Middle East & Africa (2021). We thank our cli­ents for put­ting their trust in us and re­cog­nising our ex­pert­ise. Our law­yers...
23 March 2021
On the Pulse
Wel­come to ‘On the Pulse’ de­livered by the Glob­al Life Sci­ences & Health­care Sec­tor Group A video/pod­cast series, On the Pulse, brings to­geth­er CMS law­yers and ex­perts to dis­cuss key in­dustry top­ics...
18 March 2021
Top rank­ings CMS in Cham­bers Europe 2021
CMS is once again ranked in the latest edi­tion of the Cham­bers Europe guide. A big thanks to our cli­ents for put­ting their trust in us and re­cog­nising our ex­pert­ise.CMS in the Neth­er­lands is ranked in...
14 December 2020
CMS Ex­pert Guide to di­git­al health apps and telemedi­cine
Fu­ture fa­cing Di­git­isa­tion is ad­van­cing stead­ily. Its pi­on­eer­ing in­nov­a­tions chal­lenge all parties in­volved. One of the most im­port­ant as­pects in this area is the huge po­ten­tial that lies in the di­git­isa­tion...
Comparable
17 June 2020
Pod­cast: Ad­vert­ising of Medi­cines and Med­ic­al Devices
The series brings to­geth­er CMS law­yers and ex­perts to dis­cuss key in­dustry top­ics im­pact­ing, in­nov­at­ing and dis­rupt­ing the life sci­ences & health­care sec­tor.  In Epis­ode #2, Nick Beck­ett (China/Hong...
20 April 2020
CMS Ex­pert Guide to ad­vert­ising of medi­cines and med­ic­al devices
Ad­vert­ising of phar­ma­ceut­ic­als and med­ic­al devices is a chal­len­ging area for the Life Sci­ences and Health­care in­dustry.The leg­al frame­work is con­stantly chan­ging. Due to very few laws on this area, there...
20 April 2020
CMS Ex­pert Guide to can­nabis law and le­gis­la­tion
In re­cent years can­nabis trade and re­lated activ­ity has de­veloped in­to a growth busi­ness area. In the life sci­ences and health­care fields there have been in­creases in the num­bers of pa­tients hav­ing ac­cess...
15 April 2020
Top rank­ings CMS in Leg­al 500 EMEA 2020
The on­line edi­tion of The Leg­al 500 Europe, Middle East & Africa (EMEA) 2020 has been pub­lished. Our law­yers are de­scribed as 'ac­cur­ate, quick, flex­ible and know­ledge­able'. CMS is val­ued for its pres­ence...
20/03/2020
CMS as­sists Dutch com­pany with the sale and dis­tri­bu­tion of ap­proved corona...
There is a great, world­wide need for corona tests. The Dutch CMS Life Sci­ences & Health­care Team has as­sisted a Dutch com­pany with the sale and dis­tri­bu­tion of ap­proved corona tests un­der time-crit­ic­al...
12 March 2020
Top rank­ings CMS in Cham­bers Europe 2020
CMS is once again re­com­men­ded in the latest edi­tion of the Cham­bers Europe guide. Our teams in the Neth­er­lands are re­cog­nised for their sig­ni­fic­ant sec­tor ex­pert­ise, broad of­fer­ings, prag­mat­ic ap­proach...
21 November 2019
CMS Glob­al Life Sci­ences & Health­care For­um 2019
 We have the pleas­ure to cor­di­ally in­vite you to our    on Thursday, 21 Novem­ber 2019, at 09:30 CET in Frank­furt.The For­um will provide in­sights from ex­tern­al ex­perts and CMS spe­cial­ists on four core...
25 June 2019
AI in Life Sci­ences
At CMS, we have many law­yers in many coun­tries think­ing about the in­creas­ing im­pact of AI on the life sci­ences leg­al land­scape. Rather than keep these thoughts to ourselves, we thought we would share...