Some drugs at an advanced (or not so advanced) stage of clinical development are not swiftly authorised. On the grounds of avoiding such "failures", the European Medicines Agency (EMA) offers "scientific advice" to drug companies to help them compile their marketing authorisation application (1). A public drug regulatory agency would be expected to set standards for clinical trials, such as which endpoint, method and comparator to use, through transparent, public, detailed written guidelines, not through confidential tailored advice. In 2015, Prescrire and the Medicines in Europe Forum highlighted the risk that this secret, personalised scientific advice, for which the EMA sometimes charges a fee, could undermine the Agency's impartiality and credibility (1). In 2017, the European Ombudsman highlighted the lack of transparency surrounding scientific advice, and publicly asked the director of the EMA to answer a list of questions about the existence of procedures to manage the risk of bias (2). In 2016, the EMA received 582 requests for scientific advice. More than half of the 81 European marketing authorisations (including 27 new active substances) were granted after the pharmaceutical company received scientific advice from the EMA regarding clinical trials, preclinical studies or pharmaceutical quality issues (3).
展开▼
