Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the conduct of clinical trials with and supply of medicinal products for human use containing or consisting of genetically modified organisms intended to treat or prevent coronavirus disease
1. The European Commission has proposed a Regulation to ensure that clinical trials with medicinal products for human use that contain or consist of genetically modified organisms (GMOs) and are intended to treat or prevent COVID-19 can start quickly and without a prior environmental risk assessment and/or consent under the current requirements. Currently, there are requirements under Directive 2001/18/EC and Directive 2009/41/EC. The proposed Regulation would apply so long as the current declaration of the pandemic by the World Health Organisation (WHO) remains in place and COVID-19 remains a public health emergency.
2. The EU legislation on GMOs are laid down in Directive 2009/41/EC on the contained use of GMOs (the “contained use Directive”) and Directive 2001/18/EC on the deliberate release into the environment of GMOs (the “deliberate release Directive”). The purpose of the EU legislation on GMOs is to protect both human health and the environment. Regulation of clinical trials is covered under Directive 2001/20/EC without prejudice to the application of the GMO Directives.
3. The objective of the Regulation is to provide a temporary derogation from the EU legislation on GMOs to ensure that clinical trials with investigational medicinal products (IMPs) containing or consisting of GMOs intended to treat or prevent COVID-19 are not delayed.