In the autumn issue of the European Biotechnology Magazine, BOEHMERT & BOEHMERT patent attorney and partner Dr. Ute Kilger examines the questionable refusal of the European Medicines Agency (EMA) to allow the Spanish biotech company PharmaMAR to market the cancer drug Aplidin\u00ae.The EMA scientific advisory group, which included an expert with a demonstrable conflict of interest, had denied the safety and efficacy of the drug.<\/p>\n
The biotech company filed an appeal against this rejection with the European Court of Justice in October 2018. This was upheld in full in 2020. Estonia and Germany then appealed against the court’s decision, followed by the Netherlands and the EU. An unusual political move that remains a mystery. Dr. Ute Kilger raises the question of how the EMA intends to guarantee the impartiality of its experts in the future and how to deal with the damage caused to PharmaMAR by seven years of litigation and lost ROI.<\/p>\n
The experienced patent attorney also highlights the fact that the approval figures for cancer drugs appear to be falling in Europe, while they are stagnating in the USA and rising sharply in China. This leads to the assumption that the requirements in Europe are too strict compared to other countries or that there is too much bureaucracy. She concludes that Europe does not appear to be the first port of call for new cancer drugs.<\/p>\n