According to the EU Parliament, "the lack of common rules within the EU gives cause for uncertainties and dangerous grey areas". Therefore, the European Union thinks a legislation on "advanced therapies" is a necessity: this relates to the Commission’s approval of Mikoláik’s report. The approved document, "which amends a directive and a legislation on drugs for advanced therapies and lays down the law in a sphere where the lack of rules often hinders research, aims at creating shared principles, in the attempt to reconcile a high level of safety with the protection of health". According to Mikoláik, "these new regulations will introduce, for the first time, a European regulatory framework for such innovative, specific and complex drugs". On the other hand, the speaker takes care of specifying that "the new legislation will not concern any area in which ethics is involved, such as embryo cells or germ cell therapy". The document is due to be voted in March by the plenary meeting of the European Parliament.
