“Delays in clinical trials result in delays of potentially life-saving treatments”

The European Commission is streamlining the rules for clinical trials of medicines consisting of, or containing genetically modified organisms (“GMOs”).  Under the current EU GMO framework, getting authorization for clinical trials of GMO medicines is a long and costly process.  Industry groups have vocally criticized it; and the Commission itself has voiced the need for change.  

The Commission proposes a single, centralized application for clinical trials of GMO medicines.  The sponsor will include a detailed environmental risk assessment with the application.  In turn, the Commission will exempt clinical trials from the scope of many GMO rules.  The new system will be leaner, greener and will get potentially life-saving treatments to patients with less administrative delay.

The changes are part of the EU’s new package of revisions to the bloc’s common pharmaceutical regime, set out in a draft Regulation and a draft Directive, published by the Commission on 26 April 2023.  The new GMO medicines rules are just one part of a range of environment‑focused reforms to EU pharmaceutical law set out in the proposals — for more information, see our post here.