Reconsidering Repositioning Incentives: An Empirical Legal Analysis of Market Protection for New Therapeutic Indications journal article Johnathon Liddicoat, Kathleen Liddell, Zoë Fritz European Pharmaceutical Law Review, Volume 5 (2021), Issue 3, Page 110 - 122 In Europe, drugs that are shown to have new therapeutic indications can receive additional market protection. This study analyses all instances this extra protection was awarded up until the end of 2020. This study pioneers a method to analyse what type of new indications receive the extra protection and shows that it was awarded for treating new patient cohorts as often as new medical conditions. No evidence supports granting extra protection for new patient cohorts. Therefore, this paper argues to pare back the circumstances the extra protection is awarded.
Are You AI’S Favourite? EU Legal Implications of Biased AI Systems in Clinical Genetics and Genomics Anastasiya Kiseleva, Paul Quinn
A Case of Unforeseen Adverse Side-Effects? The Ireland/Northern Ireland Protocol and Medicines Regulation George Peretz, Xisca Borrás