Earlier this month, we commented on the European Commission proposal for a Regulation accelerating existing procedures for clinical trials where medicinal products containing or consisting of Genetically Modified Organisms (GMOs) are tested for the development of vaccines and therapies to treat COVID-19. The European Commission had proposed that, during the pandemic and by derogation to the GMO regulatory framework, the requirement of a prior environmental risk assessment or consent by the national competent authorities should not apply.
Despite some concerns expressed by EU Member States, Regulation (EU) 2020/1043 has been adopted by the European Parliament and the Council without any amendments through the ordinary legislative procedure. According to Regulation (EU) 2020/1043, prior environmental risk assessments or consents are not required for operations related to the conduct of clinical trials such as packaging and labelling, storage, transport, destruction, disposal, distribution, supply, administration or use of investigational medicinal products for human use containing or consisting of GMOs.
For more information, read our analysis in our previous blog post.