Gabriela Maria Lenarczyk

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Gabriela Lenarczyk is a Postdoctoral Fellow at the International Center for Bioscience Innovation Law (Inter-CeBIL). She has an academic and professional background in the field of intellectual property law, with a special focus on pharmaceutical intellectual property, regulatory exclusivities, and the protection of clinical trial data.

Gabriela earned her PhD in Law, Summa Cum Laude, from the Institute of Law Studies of the Polish Academy of Sciences (ILS PAS) in Warsaw, Poland. She also holds a Master of Laws from Jagiellonian University in Kraków, Poland, and has further enhanced her legal education at the London School of Economics and Political Science in the UK.

Her research interests lie at the intersection of intellectual property rights and public health, particularly in how private ordering mechanisms can facilitate open innovation for better access to medicines and environmental sustainability. Recently, Gabriela has been engaged as a Thomas Edison Innovation Law and Policy Fellow at the Center for Intellectual Property x Innovation Policy (C-IP2) at George Mason University in Arlington, US, focusing on the protection of commercially confidential information within regulatory frameworks governing clinical trial data sharing in the EU and the US.

At Inter-CeBIL, she will extend this area of research to explore specifically how the European Health Data Space regulation impacts the clinical trial data ecosystem in the EU, further enriching her contributions to understanding and navigating the intricacies of intellectual property and clinical trial data protection in the health sector.

Gabriela was previously a research associate at the Institute of Law Studies of the Polish Academy of Sciences and has practical experience as an attorney-at-law specializing in medical and clinical negligence claims.

Primary fields of research

Selected publications

1. Accepted/In press

   The European Medicines Agency’s path to greater access to pharmaceutical regulatory data: balancing intellectual property rights and the right to privacy

   Matthews, D. N., Lenarczyk, Gabriela Maria & Zemła-Pacud, Ż., 2024, (Accepted/In press) Kritika: Essays on Intellectual Property.

   Research output: Chapter in Book/Report/Conference proceeding › Book chapter › Research › peer-review

2. Clinical Trial Data Transparency in the EU: Is the New Clinical Trials Regulation a Game-Changer?

   Zemła-Pacud, Ż. & Lenarczyk, Gabriela Maria, 2023, In: IIC International Review of Intellectual Property and Competition Law. 54, 5, p. 732-763 32 p.

   Research output: Contribution to journal › Journal article › Research › peer-review

3. The EU regulatory data protection in the agrochemical industry: Towards a data sharing model in favour of sustainable market play and a sustainable environment

   Zemła-Pacud, Ż. & Lenarczyk, Gabriela Maria, 2023, In: Journal of World Intellectual Property. 26, 3, p. 458-476 19 p.

   Research output: Contribution to journal › Journal article › Research › peer-review

4. Published

   IP and Access to COVID-19 Relevant Medicines – in Search of an Optimal Legal Framework

   Lenarczyk, Gabriela Maria & Zemła-Pacud, Ż., 2020, In: Jagiellonian University Journal of IP Law.

   Research output: Contribution to journal › Journal article › Research › peer-review