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ARM, EFPIA and EuropaBio Call for Advanced Therapies to be Exempt from EU GMO Legislation
Alliance for Regenerative Medicine, European Federation of Pharmaceutical Industries and Associations, and European Association for Bioindustries Call for
Advanced Therapies
needs
patients
, 2021
The European Commission should exempt advanced therapies from Genetically Modified Organism (GMO) legislation, which hurts Europe’s ability to attract clinical trials and delays patient access to transformative medicines, said the Alliance for Regenerative Medicine (ARM), the European Federation of Pharmaceutical Industries and Associations (EFPIA), and the European Association of Bioindustries (EuropaBio) in a paper published online yesterday in the journal
Human Gene Therapy.
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.