Regulation 2020/1043 - 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) - Main contents

EN

Official Journal of the European Union

L 231/12

Coronavirus disease (COVID-19) is an infectious disease caused by a newly discovered coronavirus. On 30 January 2020, the World Health Organization (WHO) declared the outbreak a public health emergency of international concern. On 11 March 2020, WHO characterised COVID-19 as a pandemic.

Directive 2001/83/EC (2) and Regulation (EC) No 726/2004 (3) of the European Parliament and of the Council require that applications for authorisation to place a medicinal product on the market, in a Member State or in the Union, be accompanied by a dossier containing the results of clinical trials carried out on the product.

It follows from Directive 2001/20/EC of the European Parliament and of the Council (4) that, before commencing any clinical trial, sponsors are required to request authorisation from the competent authority of the Member State in which the clinical trial is to be conducted. The purpose of the authorisation is to protect the rights, safety and well-being of clinical trial subjects and to ensure the reliability and robustness of the data generated by the clinical trial.

Under Directive 2001/20/EC, the authorisation for a clinical trial is issued without prejudice to the application of Directives 2001/18/EC (5) and 2009/41/EC (6) of the European Parliament and of the Council.

Directive 2001/18/EC provides that a deliberate release into the environment of genetically modified organisms (‘GMOs’) for any purpose other than for placing on the market is subject to a notification to and to written consent by the competent authority of the Member State within whose territory the release is to take place. The notification is to include an environmental risk assessment performed in accordance with Annex II to Directive 2001/18/EC and a technical dossier supplying the information specified in Annex III to that Directive.

Directive 2009/41/EC provides that the risks to human health and the environment associated with the contained use of genetically modified micro-organisms are to be assessed on a case-by-case basis. To that end, that Directive provides that the user is to assess the risks to human health and the environment that the specific type of contained use may pose, using as a minimum the elements of assessment and the procedure set out in Annex III to that Directive.

Clinical trials necessitate the performance of multiple operations, including the manufacture, transport and storage of the investigational medicinal products, packaging and labelling, the administration thereof to clinical trial subjects and subsequent monitoring of the subjects, and the disposal of waste and unused investigational medicinal products. Those operations may fall within the scope of Directive 2001/18/EC or 2009/41/EC in cases where the investigational medicinal product contains or consists of...