Temporary derogation from European environmental legislation for clinical trials of genetically modified organisms for coronavirus disease 2019.
Cytotherapy
; 23(1): 10-11, 2021 01.
Article
in English
| MEDLINE | ID: covidwho-1002742
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
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Clinical Trials as Topic
/
Organisms, Genetically Modified
/
Pandemics
/
COVID-19 Vaccines
/
SARS-CoV-2
/
COVID-19
Type of study:
Observational study
/
Prognostic study
/
Randomized controlled trials
Topics:
Vaccines
Limits:
Humans
Country/Region as subject:
Europa
Language:
English
Journal:
Cytotherapy
Journal subject:
Therapeutics
Year:
2021
Document Type:
Article
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