Environmental risk assessment temporarily suspended

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.