Lawmakers are gearing up for what could be a long and arduous debate over the European Commission’s proposals for revising the EU pharmaceutical legislation. The revision package, consisting of a draft regulation and a draft directive, is wide-ranging and covers a multitude of areas relating to pharmaceutical regulation. First published in April 2023, it was formally presented to the European Parliament in September.
The contentious nature of many of the proposals bodes ill for a smooth journey through the legislative machinery at the European Parliament and the Council of the EU.