More powers for European Parliament in time for ATMP (Advanced Therapies Medicinal Products) implementation?
This article was originally published in Clinica
Executive Summary
The European Parliament looks close to gaining the increased powers it desires - and in time to have an influence on implementation of the proposed Advanced Therapies Medicinal Products (ATMP) Regulation, after the text has been adopted. This ATMP Regulation will cover at least some human tissue engineered products, as well as cell and gene therapy products. MEPs have long complained that they have no further say, once their role in the approval of a Directive or Regulation is over, in how the legislation is implemented by way of technical operating rules through "comitology". This is a task delegated to the Commission, acting on the advice of 248 expert committees, often composed of national civil servants. Council then decides whether to approve the rules.