Eveline Van Keymeulen
Eveline Van Keymeulen is a partner in Latham & Watkins’ Brussels and Paris offices and a member of the firm’s healthcare and life sciences practice.
Ms Van Keymeulen advises multinational companies and start-ups in the pharmaceutical, biotech, medical devices, cosmetics, and food and beverage sectors on a broad variety of complex European, domestic and cross-border regulatory matters, including clinical trials, product approvals, regulatory incentives, market access, promotion and advertising, post-market obligations, and general compliance matters.
In addition, Ms Van Keymeulen has extensive experience advising on medical cannabis and hemp-based product regulations. She successfully challenged the legality of French hemp regulations in the first case related to cannabidiol (CBD) products before the Court of Justice of the European Union (Case C-663/18, Kanavape). This landmark judgment had a major impact on the development of the European CBD industry.
Ms Van Keymeulen is ranked in Chambers for Life Sciences Regulatory (since 2020) and recognised as a Legal 500 Rising Star / Next Generation Lawyer in Healthcare and Life Sciences (since 2018). She is considered a National and Global Leader by Who’s Who Legal Life Sciences (since 2016) and is further recognised as one of the leading life sciences practitioners in France by Legal Media Group 2021, Best Lawyers 2021 and Euromoney’s Women in Business Law Expert Guide 2021. Ms Van Keymeulen was also recognised as European Advisory Lawyer of the Year (2021) by, and won Impact Deal of the Year at, the prestigious Europe LMG Life Sciences Awards (2021-2022). Clients particularly value her “high level of energy”, and appreciate her for “being extremely flexible and genuinely engaged” as well as having a “can do attitude” while some have even called her a “rockstar”.
Ms Van Keymeulen has authored numerous articles and has been a featured speaker on EU regulatory matters at prominent conferences such as the Pharmaceutical Law Academy in Cambridge. Ms Van Keymeulen also serves on the editorial board of the European Pharmaceutical Law Review. In addition, Ms Van Keymeulen has been quoted in BBC Business Daily, Bloomberg, The Times, Les Echos and other leading international business journals on life sciences regulatory and policy matters.
Practice Area
Panel
- Contributing Author
Qualified Year
- 2007
Experience
- Allen & Overy LLP (2013 - 2020)
- Covington & Burling LLP (2008 - 2013)
Membership
- EUCOPE – The European Confederation of Pharmaceutical Entrepreneurs
- RAPS - Regulatory Affairs Professionals Society
- DIA - Drug Information Association
- Women@Life Sciences
Qualifications
- Brussels Bar (2007)
- New-York Bar (2010)
- Paris Bar (2013)
Education
- Master of Law (Intellectual Property), Université libre de Bruxelles, magna cum laude (2011)
- LLM (Law & Technology), University of California, Berkeley, School of Law (2008)
- Master in European Law, Ghent University School of Law, magna cum laude (2007)
- Master of Law, Ghent University School of Law, magna cum laude (2006)
2 Contributions by Eveline Van Keymeulen
PRACTICE NOTES
EU Clinical Trials Regulation (536/2014): key requirements on authorisation, CTIS, data transparency, safety and ethics, with 2024–2025 updates and implications for UK sponsors
This Practice Note looks at Regulation (EU) 536/2014, the EU Clinical Trials Regulation (CTR), which governs clinical trials in the EU.
It outlines the principal features of the CTR that trial sponsors and pharmaceutical businesses need to understand in practice and keep in view for compliance, and to keep abreast of. Taking effect on 31 January 2022, the CTR applies directly across every EU Member State and the EEA, marking the most significant overhaul of the EU’s clinical trial legal framework since 2001, and is now in force without exception. Its reach is truly global: any interventional study conducted even in part within an EU Member State or the EEA must follow this regime throughout the entire trial life cycle, at all times, from start to finish. Because the UK had exited the EU before it became operative, the CTR does not extend to Great Britain (ie England, Wales and Scotland); however, under the Northern Ireland Protocol, certain provisions apply in Northern Ireland. From 1 January 2025, the ‘Windsor Framework’ took effect, placing Northern Ireland back under the UK Medicines and Healthcare products Regulatory Agency’s regulatory remit for medicinal products, under UK oversight. While the CTR does not affect clinical...
Life Sciences
PRACTICE NOTES
EU pharmaceutical exclusivities and incentives: SPCs, regulatory data and market protection, orphan and paediatric regimes; interactions, key case law, SPC waiver and unitary SPC, and pending legislative reforms
What are pharmaceutical incentives?
In the EU, protection mechanisms and incentives for medicinal products, grouped under the term pharmaceutical incentives (PIs), are in place. PIs comprise legislative measures that give originator pharmaceutical companies (originators) a degree of advantage over companies selling medicines with the same active substance at far lower prices (generic or biosimilar companies)-ranging from market protection (MP), through extensions of patent rights, to several years of market exclusivity for a medicinal product.
Rationale behind PIs
PIs were introduced in the EU to encourage and support originators in discovering and developing new medicinal products. While innovation and discovery typically require considerable time and financial investment, only limited effort is needed to use the knowledge generated afterwards. When a generic or biosimilar company reproduces an invention, it often does not bear the substantial research and development (R&D) costs of creating it and can therefore sell the resulting medicinal product at a price well below the originator’s. The prospect of this may discourage originators, who cannot recover the initial outlay incurred during the R&D process. PIs help originators in maintaining certain benefits and...
Life Sciences
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