2/17/2025 8:30:15 AM A Sea Change for Pharma: EU's Urban Wastewater Treatment Directive and its Cost Implications By Marc Martens Kevin Munungu Lungungu A new European directive is set to significantly impact pharmaceutical companies operating within the European Union. Directive (EU)...
1/29/2025 11:15:40 AM First decision on the SPC manufacturing waiver by the Belgian courts By Domien Op de Beeck Camille Vanpeteghem On 23 December 2024, the Brussels enterprise court issued a first decision in Belgium on the so-called “SPC manufacturing waiver”. Under...
10/9/2024 1:41:38 PM Case C-237/22 of the CJEU – Clarification of the concepts of “Significant Benefit” and “Clinical Superiority” By Marc Martens Benedicte Mourisse The CJEU brings clarity, on the concepts of “Significant Benefit” and “Clinical Superiority” with respect to Orphan Medicinal Products...