European Union regulation proposed for relaxing genetically modified organisms (GMOs) requirements for vaccines under development for SARS-CoV-2, the virus responsible for the novel coronavirus pandemic. The proposed derogation would allow GMO-containing candidate vaccines and coronavirus therapeutics to proceed with clinical trials.

“The policy objective of this proposed regulation is to ensure that clinical trials with medicinal products for human use that contain or consist of GMO’s and are intended to treat or prevent COVID-19 can start swiftly,” said the European Commission (EC) in setting the context of the proposed changes. “It is necessary to adapt the regulatory framework on GMOs so that the conduct of clinical trials with these vaccines can start within the shortest possible timelines,” said the commission, citing an “overriding interest in protecting human health.”

Currently, two directives, 2001/18/EC and 2009/41/EC, set the framework for handling GMOs in the EU member states, with goals of “ensuring a high level of protection of human health and the environment” through a risk assessment process for deliberate release or contained use of GMOS.

However, member states vary in their approaches to the particulars of regulating GMOs, both in general and within the context of clinical trials of medicinal products containing, or consisting of, GMOs. In some member states, a request for authorization to conduct a clinical trial of a GMO-containing product may be made to a single competent authority; in other member states, sponsors must submit multiple parallel requests to several competent authorities. The EC said, “Attempts to streamline the process through informal coordination between Member States’ competent authorities have not borne fruit.”

“A common approach for all the Union Member States is deemed necessary as threats to health arising from the COVID-19 pandemic have, by their nature, transnational implications,” noted the EC. Large-scale, multinational, multi-center clinical trials have the most promise to speed development of vaccines, and progress should not be hindered by the complexities inherent in navigating a heterogenous set of GMO regulations.

The proposed derogation would also allow distribution of medicinal products containing GMOs under a compassionate use exemption of Regulation (EC) No 726/2004.

However, the EC made clear that the proposal is “limited in scope.” The proposed derogation is for the duration of the pandemic only and applies only to medicinal products intended to prevent or treat COVID-19.

For more detail please refer below link:

https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=COM:2020:261:FIN&from=EN