EU Council moves to facilitate swift COVID-19 vaccine development

On Tuesday, the European Council adopted, by written procedure, a regulation which aims to speed up the development and the deployment of a vaccine against COVID-19 in the European Union.

The act provides for a temporary derogation for clinical trials with such vaccines from the prior environmental risk assessment required in the EU legislation on the deliberate release in the environment and the contained use of genetically-modified organisms (GMOs).

In addition, it clarifies that this temporary derogation also applies when member states allow medicinal products containing or consisting of GMOs intended to treat or prevent COVID-19 to be used in certain exceptional and urgent situations defined in the pharmaceutical legislation. The environmental impact of medicinal products (including vaccines) containing or consisting of GMOs intended to treat or prevent COVID-19 will remain part of the marketing authorization process, respecting the environmental safety requirements set out in the GMO legislation.