Abstract
Attempts to streamline environmental procedures for those products containing or consisting of genetically modified organisms (GMOs) among the European Union (EU) Member States are ongoing but still need to be further developed. These procedures can be complex, resource-intensive and time-consuming. Some candidate vaccines currently under development for COVID-19 include genetically modified viruses, which may be considered GMOs. Given the public health emergency caused by the COVID-19 outbreak, on July 15, 2020, the European Parliament approved a temporary derogation of the European environmental requirements to facilitate that those clinical trials with GMOs intended to treat or prevent COVID-19 can start as soon as possible in Europe. This measure has been very controversial, since it could entail risks to human health and the environment, and could be seen as unfair for other products targeting unmet medical needs. With the adoption of this measure, the bottlenecks and obstacles for the development of innovative GMO-based medicines in the EU that the environmental legislation entails have become even more evident.
Keywords: European Union; environmental monitoring; environmental policy; genetically modified organisms; risk assessment.
【저자키워드】 environmental policy, European Union, environmental monitoring, genetically modified organisms, risk assessment., 【초록키워드】 COVID-19, viruses, Europe, clinical trial, risk, Risk assessment, Medicine, Health, COVID-19 outbreak, public health emergency, adoption, environmental monitoring, genetically modified organisms, Streamline, medical needs, complex, union, candidate vaccine, treat, organism, bottlenecks, member, state, European, Prevent, caused, include, approved, facilitate, time-consuming, bottleneck, 【제목키워드】 coronavirus disease, clinical trial, genetically modified organisms, organism, European, temporary,