Exemptions from the release and system directive in clinical trials for COVID-19 medicinal products

By Regulation (EU) 2020/1043 of 15 July 2020, the EU has adopted rules on the conduct of clinical trials with human medicinal products containing or consisting of genetically modified organisms (GMOs) for the treatment or reimbursement of coronavirus disease (COVID-19) and their supply. This regulation contains only four articles in total. For all operations related to the conduct of clinical trials, including packaging and labelling, storage, transport, destruction, disposal, distribution, supply, administration or use of investigational medicinal products containing or consisting of GMOs intended for human use, a temporary exemption has been granted.

• not to carry out an environmental impact assessment.
• Approvals from federal authorities (ed. note: member states) are not required for the deliberate release of GMOs. These regulations refer to the EU-regulated authorization for placing medicinal products on the market for the purpose of clinical trials. The manufacture of medicinal products containing GMOs, including investigational medicinal products, is expressly excluded; for these, the requirements of the Release and Systems Directive and the resulting authorization regulations issued by the member states continue to apply. Specifically, this means that COVID vaccines and medicinal products must be developed in a genetic laboratory under the applicable regulations of the member states, and upon leaving the genetic laboratory (release or placing on the market) for the purpose of clinical trials, they are exempt from two procedural elements of the genetic directives (environmental compatibility and consent of the member states). The regulations entered into force immediately after publication in the Official Journal in July 2020. Clinical trials that began before the publication of the new regulation may continue as valid (Article 4 (3) sentence 1 of Regulation (EU) 2020/1043). It is unclear whether subsequent diagnostics must be conducted in a genetic engineering facility. According to the system of the Genetic Engineering Act (GenTG), once ubiquitously available GMOs (released or placed on the market) do not have to be returned to a genetic engineering facility for monitoring, even if the GMO is still present.