The Evolving Role of the Bolar Exemption in the Romanian Pharmaceutical Industry – Balancing Innovation and Access
February 2025 by Ileana Nicolescu and Jasmine Botiș A cornerstone provision in pharmaceutical law, the Bolar Exemption allows the conduct of studies and trials for the purpose of obtaining regulatory approvals, without infringing the patent or supplementary protection certificate (SPC) holder’s rights. Originating in the United States, it has since been incorporated into European law…
Read more