Orphan Drugs, a successful regulation after all? Or just about to experience its pitfalls?

On  December 5, 2018, the General Court ruled in favor of the European Commission in an action brought by Bristol-Myers Squibb Pharma (BMS) against the Commission and the European Medicines Agency (EMA) in the case, T‑329/16, read here. The application in question was made pursuant to Article 263 TFEU for annulment of an act adopted by the Commission removing Elotuzumab from the Community Register of orphan medicinal products for human use and/or of a possible act adopted by the Commission or the EMA determining that Elotuzumab no longer met the criteria for designation as an orphan medicinal product when the marketing authorisation was granted for the medicinal product Empliciti (Elotuzumab) under Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products (OJ 2000 L 18, p. 1). For those  IPKat readers who may not be familiar with the term, an “orphan drug” is a…

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