Call for more effective EU regulation of clinical trials with ATMPs consisting of or containing GMOs

Advanced Therapy Medicinal Products (ATMPs), such as gene therapies that consist of or contain Genetically Modified Organisms (GMOs), need to comply with the European Union (EU) GMO legislation before they can be used in clinical trials. Complying with GMO requirements is complex, varies across the EU, and is leading to delays in clinical trials with ATMPs. This makes the EU less attractive than other regions for conducting clinical trials with gene therapies. This is detrimental to EU patients since their access to these transformative, potentially curative medicines is delayed.

Despite recent initiatives coordinated by the European Commission (EC) to facilitate and reduce discrepancies across the EU regarding the application of the GMO requirements, it remains particularly difficult to conduct multi-centre clinical trials with ATMPs containing or consisting of GMOs involving several EU Member States. The recent decision to temporarily exempt potential COVID-19 treatments and vaccines from some provisions of the GMO requirements is a clear recognition of such complexities and delays to clinical development.

The Alliance for Regenerative Medicine (ARM), the European Federation of Pharmaceutical Industries and Associations (EFPIA), and the European Association for Bioindustries (EuropaBio), call upon the European Commission, together with national regulatory authorities, to facilitate access to ATMPs containing or consisting of GMOs in the EU. Major simplification and acceleration of the GMO assessment process will make Europe more attractive as a place for clinical development and will allow more rapid European patients’ access to these potentially life-saving medicines. To meet these objectives, it is proposed that an exemption scheme should be implemented for ATMPs undergoing clinical trials.

In the framework of the new EU Pharmaceutical Strategy, we urge the European Commission to use its right of initiative to put forward a legislative proposal to this effect.

Download the file below to read the full Position Paper.