EU adopts regulation granting temporary derogation for clinical trials with medicinal products against COVID-19
Regulation (EU) 2020/1043 of the European Parliament and of the Council entered into force on 18 July 2020.
The Regulation (EU) 2020/1043 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 (COVID-19) entered into force on 18 July 2020. The Regulation provides for a temporary derogation for such products from certain authorisation requirements, such as a prior environmental risk assessment, of Directives 2001/18/EC and 2009/41/EC on genetically modified organisms (GMOs) for the duration of the COVID-19 pandemic.
This exceptional procedure applies to clinical trials approved in accordance with Directive 2001/20/EC and conducted for the purposes of preventing or treating COVID-19. Member States may temporarily authorise that the procedure be applied to the treatment of individual patients to prevent the spread of pathogenic agents. For compassionate reasons, the procedure may also be applied to the treatment of seriously ill patients in situations where a marketing authorisation has not yet been granted for medicinal products containing or consisting of GMOs intended to treat or prevent COVID-19.
The exceptional procedure applies only to the notification and application procedures laid down in the GMO legislation. In other respects, the normal authorisation procedures for medicinal products containing or consisting of GMOs still apply, together with their ethical reviews. After the COVID-19 pandemic, the authorisation procedures laid down in the Gene Technology Act will apply to medicinal products containing or consisting of GMOs that are intended to treat or prevent COVID-19.