Coronavirus - Derogation for COVID-19 clinical trials of medicinal products containing or consisting of genetically modified organisms

In the context of the COVID-19 crisis, the European Union adopted a regulation providing for a temporary derogation from European legislation on genetically modified organisms.

In the context of the SARS-CoV-2 pandemic (COVID-19), the European Union (EU) has adopted the Regulation (EU) 2020/1043 of the European Parliament and of the Council of 15 July 2020. This regulation concerns the conduct of clinical trials with and supply of medicinal products for human use containing or consisting of genetically modified organisms (GMOs) for the treatment or prevention of SARS-CoV-2 infection and the provision of these medicinal products.

This regulation provides a temporary derogation from European legislation on GMOs with a twofold objective.

1.    To support the development of safe and effective medicinal products for the treatment or prevention of COVID-19 by facilitating the possibility to conduct clinical trials on medicinal products containing or consisting of GMOs as soon as possible.

2.    To ensure rapid availability of COVID-19 vaccines and treatments in case of emergency.

This Regulation translates into the following provisions (applicable from 18 July 2020).

For clinical trials involving investigational medicinal products for the treatment or prevention of COVID-19 containing or consisting of GMOs, the following aspects will apply.

·         These clinical trials may be initiated in the EU in the absence of an environmental risk assessment or an approval under the GMO legislation (Directive 2001/18/EC on “deliberate release” and Directive 2009/41/EC on “contained use”), when these operations relate to the conduct of a clinical trial authorised in accordance with Directive 2001/20/EC.

·         Sponsors shall take appropriate measures to minimise the likely negative environmental impact of the intentional or unintentional release of the investigational medicinal product into the environment.

·         The sites where the genetic modifications of wild type viruses and related activities take place (“manufacturing activities”) shall remain subject to Directive 2009/41/EC.

Regarding the use of medicinal products for the treatment or prevention of COVID-19 containing or consisting of GMOs in the absence of a marketing authorisation (to meet the specific needs of an individual patient (compassionate use) or to prevent the suspected or confirmed spread of pathogens, toxins, chemical agents or nuclear radiation which could cause harm), the following aspects will apply.

·         The GMO legislation (Directives 2001/18/EC and 2009/41/EC) does not apply in these exceptional cases.

·         An environmental risk assessment will be required prior to the marketing of the medicinal products.

This regulation is temporary, and shall apply as long as the World Health Organisation (WHO) classifies COVID-19 as a pandemic or as long as an implementing decision is applicable by which the European Commission recognises a situation of public health emergency due to COVID-19.

More information

The Research and Development Division of the FAMHP: ct.rd@fagg-afmps.be

The Service Biosafety and Biotechnology (SBB) of Sciensano: contained.use@sciensano.be

Last updated on
30/07/2020