Joint open letter from COGEM and ZKBS to the European Commission
In a joint open letter to the European Commission, the Committee on Genetic Modification (COGEM) and the German Central Commission for Biological Safety (ZKBS) express their concerns about the authorisation of medicinal products containing so-called self-amplifying mRNAs (samRNAs) or viral replicon particles (VRPs) without undergoing an environmental risk assessment.
Both committees consider that an adequate environmental risk assessment is essential in this respect, both to assess the risks to humans and the environment of replicating molecules and to ensure the trust and acceptance of medicinal products developed using modern biotechnology.
In the letter, the committees also call on the EC to consult with Member States on this issue and to develop guidelines and procedures to assess the potential risks of these new applications.