Jeanne Fabre
Jeanne Fabre is an associate in the Paris office of Latham & Watkins and a member of the firm’s healthcare and life sciences practice. She 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, market access, promotion and advertising, post-market obligations, contracts and general compliance matters.
Ms Fabre has significant experience working in pharmaceutical companies. Since her Master’s in Life Sciences Law, she has worked for more than three years for several companies, both for local affiliates and parent companies. She was seconded for 18 months part-time to a pharmaceutical company specialising in rare diseases, and a further three months for another pharmaceutical company. During that time she advised on a wide range of day-today regulatory topics (such as observational, (former) ATU and post-ATU studies, contractual relationships with service providers, consultancy and pay for performance agreements and pricing and reimbursement topics).
Practice Area
Panel
- Contributing Author
Qualified Year
- 2018 (Paris Bar)
Experience
- Allen & Overy LLP (2018 - 2021 (until Jan 11, 2022))
Membership
- EUCOPE – The European Confederation of Pharmaceutical Entrepreneurs
Qualification
- Paris Bar (2018)
Education
- Paris Bar School (2018)
- University Paris Descartes (Paris V), Master II - Health Products Industries, Salutatorian (2015)
- University Paris-Est Creteil (Paris XII), Master I - Business Law, Magna cum laude (2014)
- University of Poitiers, Bachelor Private Law, Cum Laude (2013)
- Camille Guérin School, Classes préparatoires aux grandes écoles , Hypokhâgne (2010)
2 Contributions by Jeanne Fabre
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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