The Alliance for Regenerative Medicine: ARM, EFPIA and EuropaBio Call for Advanced Therapies to be Exempt from EU GMO Legislation
Advanced Therapies
needs
patients
, 2021
Human Gene Therapy.
The European Commission recognized that GMO requirements hinder the conduct of clinical trials in its April 29 study on new genomic techniques and in the 2020 Pharmaceutical Strategy for Europe, when it called for GMO legislation to be fit for purpose for addressing medicines. The original GMO legislation was primarily enacted to protect food consumers and the environment, but Advanced Therapy Medicinal Products (ATMPs) such as gene therapies are affected as an unintended consequence. The uneven application of GMO requirements across EU Member States causes significant clinical trial delays despite findings that gene therapies pose a negligible risk to the environment.