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Portrait ofEllen Gielen

Ellen Gielen


CMS Derks Star Busmann
Atrium - Parnassusweg 737
1077 DG Amsterdam
PO Box 94700
1090 GS Amsterdam
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 is exceedingly knowledgeable and experienced with a hands-on approach."

Chambers Europe, 2024

"Ellen Gielen knows her business inside and out, making it easy to bounce ideas off her quickly and proceed with business in the right direction and legal framework."

Chambers Europe, 2024

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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Awards & Rankings

  • Chambers Europe, 2024, Ranked in Life Sciences
  • The Legal 500 EMEA, 2024, Ellen Gielen is ranked Leading Individual
  • The Legal 500 EMEA, 2024, Ellen Gielen is Recommended
  • Global Top 200 Cannabis Lawyers Directory, 2022/2023, Ellen Gielen is listed
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  • Dutch Law (Company Law), Erasmus University
  • Business Administration, Erasmus University
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Global Life Sciences & Healthcare Forum 2023 – recordings & presentations
We were delighted to bring you this year’s Forum, “Blurring Boundaries - Exploring the convergence of life sciences and law”, from Amsterdam. The theme “Blurring Boundaries - Exploring the convergence of life sciences and law” aimed to:Uncover the latest breakthroughs: Dive into the forefront of life sciences advances, including biotechnology, genetics, pharmaceuticals, and medical devicesAddress the regulatory gap: Engage in interactive workshops to bridge the divide between rapid innovation and the development of legal frame­work­sNav­ig­ate global challenges: Explore the impact of globalisation, ethical considerations, privacy concerns, and societal implications on the life sciences sectorFoster collaboration: Connect with legal and scientific minds, exchange ideas, and build valuable re­la­tion­shipsP­resent­a­tions were delivered by fantastic industry speakers, including Annemiek Verkamman (Managing Director, Hollandbio), Charida Dorder (Member of the Dutch AI Coalition), Wouter Boon (Associate Professor, Utrecht University) and Marc Kaptein (Medical Director, Pfizer), as they shared their expertise, thoughts and insights on how the sector is “Blurring Boundaries”. We were also joined by Simon Neill (Senior Legal Director) at Johnson & John­son and Joep Rijnierse (Senior Medical Director) at Amgen in our workshops. This webpage has been designed to keep you updated on the Forum, our speakers, as well as provide you with the useful resources complementing the theme “Blurring Boundaries - Exploring the convergence of life sciences and law”. You will also find on this page details on how to stay connected with CMS through our upcoming webinar series, On the Pulse Webinar Series 2023 - Autumn (cms. law); free eAlert service, Law-Now; and social media channels.
Blurring Boundaries – Exploring the convergence of life sciences and law
A unique life sciences Forum brought the legal challenges created by the rapid pace of technological advances into sharp focus with sector focused sessions and informative workshops. Experts from across the sector framed the incredible potential from digital and AI and called for the expertise of legal teams to take the ‘’regulatory handbrake’ off innovation that has transformative potential for healthcare systems and patients. CMS’s much-anticipated Global Life Sciences & Healthcare Forum 2023, co-hosted by Ellen Gielen, Roland Wiring and Gertie Lintjens, delivered a wealth of insight and ignited discussion about how regulatory frameworks can be tested and revised without compromising safety, security and compliance. Blurring Boundaries – Exploring the convergence of life sciences and law heard from leading figures from pharmaceutical companies, cutting edge AI enterprises, legal experts and biotech organisations with a strong accent on debate and collaboration. Marc Kaptein, Medical Director, Pfizer, revealed the unchartered territory he and his team had to tread during the pandemic as the company partnered with BioNTech to release a COVID vaccine and maximise its public uptake. In a fascinating talk, he outlined the twists and turns of the inside story of how Pfizer struck a rapid deal with BioNTech by ‘shaking hands’ and then balanced the societal benefits of maximising its vaccination with legal constraints designed to control public promotion.A willingness to break fresh ground legally, politically, scientifically and logistically was an integral part of the success story and he underlined to guests at the Forum, held in Amsterdam, that ‘without blurring boundaries, we would not have got where we are today’. Joep Rijnierse, Senior Medical Director at Amgen, highlighted its pioneering approach to  work closely with patient groups to generate therapy promise across a complete health condition. He said that the company’s medical departments worked with internal and external legal advisers to find ways to manage constraints in the mission to enhance all areas of healthcare delivery to improve systems and outcomes. Legal expertise is critical in shaping the landscape for AI developments and speakers from across the life sciences spectrum underscored the need for regulatory frameworks to evolve at pace. Life sciences is experiencing seismic change and Thibault Helleputte, the Founder and CEO of DNAlytics, revealed that the BioGPT initiative was able to identify medical hypotheses from deep in the data of 15 million papers in PubMed library to give scientists unprecedented R&D leads. The Forum was an opportunity to discuss how legal teams can use their skill and knowledge to ensure that regulatory frameworks did not impede progress and to explore fast and safe pathways for innovations to become working reality. Wouter Boon, Associate Professor in Innovation and Life Sciences at Utrecht University, emphasised the need to place legal aspects at the inception of the innovation process, observing that the sector was ‘highly regulated for all good reasons but it means that radical innovation has a tough job.’The Forum covered an impressive sweep of themes including AI, digital therapeutics, the challenges of multi-jur­is­dic­tion­al online pharmacies, the new EU medicines directive and co-creation with regulators.“We had a great range of speakers who focused on advances and roadblocks across the life sciences sector and provided us all with some innovative and provocative approaches,” said Nick Beckett, Global Co-Head of CMS Life Sciences & Healthcare Sector Group. “It was a fantastic opportunity to discuss, explore and collaborate and the insights and learnings it generated will help us face global challenges in life sciences.“We have to navigate global challenges such as sustainability, poverty, inequality, ageing populations; concerns about privacy with the use of data, concerns about ethics and the use of AI. To do that we need global perspectives and we believe that CMS as a firm, with 80 offices worldwide, is well positioned to navigate issues, foster collaborations and be a vital partner in moving life science innovation forward in the digital age.”
Global Life Sciences & Healthcare Forum 2023
Blurring Boundaries - Exploring the convergence of life sciences and law
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