The current public health emergency caused by the COVID-19 pandemic
requires accelerated development of drugs for treatment or vaccines to prevent
coronavirus diseases. Due to the urgency, the Proposal by the European Commission to suspend the
current directives on the conduct of environmental impact assessments in
clinical trials, was adopted in an accelerated procedure.
Public health emergency
Currently, two pieces of legislation regulate the use and release
of genetically modified micro-organisms (GMOs). On the one hand, in the Directive 2009/41/EC on the contained use of genetically
modified micro-organisms, on the other, in Directive 2001/18/EC on the deliberate release into the
environment of genetically modified organisms. They are intended to protect
human health and the environment.
Nevertheless, there is no uniform approach in the EU to the
evaluation and application of the Directives and the specified environmental
risk assessment. According to the Commission proposal, the environmental risk
assessment in the above-mentioned Directives is to be suspended by a regulation
as long as the WHO classifies COVID-19 as a pandemic or a Commission decision
describing a crisis situation due to COVID-19 applies.
Decision in the accelerated procedure
The proposal by the European Commission of 17/06/2020 follows the
intention of coronavirus vaccination strategy to make flexible use of the existing regulatory
framework to accelerate the development, authorisation and availability of
vaccines. We reported in the news 06/2020.
Prior to the vote in the European Parliament, the EPP Group announced an unanimous agreement on the
Commission proposal. A product-related and temporary suspension of the
environmental risk assessment did not increase the chances of finding an
effective vaccine; however, it does reduce the administrative burden and speeds
up the procedure. It was important to adapt the framework conditions for rapid
vaccine development to meet the demand for millions of vaccine doses in Europe
and around the world.
On 10/07/2020, the European Parliament agreed to the Commission proposal by a broad
majority. The Council also agreed to the proposal by written procedure on
14/07/2020. The Regulation will be published in the Official Journal
of the European Union on 17/07/2020 and will enter into force on 18/07/2020.