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Centre for Commercial Law Studies

Regulatory Data Protection: the challenges, opportunities and ongoing reform

When: Thursday, March 14, 2024, 6:00 PM - 8:00 PM
Where: CCLS, Room 3.1, Queen Mary, University of London, 69 Lincoln's Inn Fields London, WC2A

Speaker: Żaneta Zemła – Pacud


Protection of regulatory data is, alongside patents and supplementary protection certificates, an essential element shaping intellectual property protection in the pharmaceutical sector and thus directly impacting access to healthcare innovation. Taken together, the rewards and exclusivities provided in the pharmaceutical regulatory regime represent the longest-lasting form of protection for medicines in almost 60% of cases. As such, they have a direct impact on the much-needed balance in the pharmaceutical market. At the same time, lying at the intersection of IP and pharmaceutical regulation, they are underestimated and greatly under-researched.

The talk presented the rules of regulatory exclusivities and rewards for medicines in Europe, describe the challenges related to regulatory strategies, and discuss the systemic issues of the legal nature of regulatory exclusivities, their limitations and enforceability. Against this background, the talk examined the ongoing reform of pharmaceutical regulation concerning innovative medicines, orphan, and paediatric drugs in the European Union.

The talk was introduced and moderated by Professor Duncan Matthews, Chair in Intellectual Property Law, Director of the Queen Mary Intellectual Property Research Institute (QMIPRI), CCLS, Queen Mary University of London.

Żaneta Zemła – Pacud, PhD, is Assistant Professor at the Institute of Law Studies at the Polish Academy of Sciences (ILS PAS), where she leads the Life Science Legal Lab. She also has led and participated in several domestic and international research projects in the field of biotechnological inventions, AI in patent judiciary, IP in the health sector in Poland, and others. As an external expert, she served WIPO and the PPO projects. Since 2023 she represents the Polish Academy of Sciences in the ALLEA IPR working group. As a visiting researcher, Żaneta carried out her research at the Max Planck Institute (MPI) for Innovation and Competition in Munich and at the LML Centre at the University of Cambridge. At present, she participates in the ongoing international project at Queen Mary University of London on “Lessons from the COVID-19 Pandemic for IP Licensing Practices in Vaccine Production”, funded by the British Academy. Żaneta has published and presented extensively on technology protection, especially in the life sciences. She has taught intellectual property law, patent law, and new technologies at several prominent Polish universities. She has also gained expertise in the Life Science practice as an Of Counsel in Traple Konarski Podrecki, one of the leading Polish law firms. Her present research is centred around the protection of regulatory data.

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