On July 17 2020 the European Commission published a regulation that a day later, on 2020, July 18 took effect . Because of this Regulation 2020/1043 parts of the GMO (Genetically Modified Organism ) regulations are derogated in case of clinical trials for COVID-19 . As a result a GMO permit will no longer be required for clinical research into curative or preventive treatment of COVID-19. As a consequent of Regulation 2020/1043 , the earlier Dutch temporary emergency regulation related to license applications for gene therapy to cure or prevent COVID-19 has been repealed.
Regulation 2020/1043 aims to ensure that clinical trials of GMOs intended to cure or to prevent COVID-19, can be started quickly and without prior environmental risk assessment. To this aim the Regulation stipulates that a prior environmental risk assessment (ERA (environmental risk assessment )) and a requesting for a GMO safety authorization for clinical trials with GM-containing medical product to cure or prevent COVID-19 will be no longer required .
Regulation 2020/1043 is into effect directly and takes precedence over existing national regulations. This means that Regulation 2020/1043 has direct consequences for the implementation of the GMO Decree and the GMO Regulation and also. the earlier Dutch temporary emergency regulation related to license applications for gene therapy to cure or prevent COVID-19:
These consequences are:
- An environmental risk assessment (ERA) as referred to in Article 3.6 of the GMO Decree is no longer mandatory for COVID-19 related clinical research.
- Applying for a permit as referred to in Article 3.7 of the GMO Decree for the deliberate release of COVID-19 for the purpose of clinical research is no longer necessary.
- The Dutch temporary emergency regulation related to license applications for gene therapy to cure or prevent COVID-19 that entered into force on March 31, 2020 is no longer valid. As the requirement to apply for a permit has been lifted, there is no longer need for a fast-track procedure and therefore this emergency regulation has been repealed.
It is emphasized once again that this only concerns clinical research and the support activities required for genetically modified medicinal products to cure or prevent COVID-19. The mandatory review by the CCMO (Central Committee on Research involving Human Subjects ) remains in full force for COVID-19 clinical research. GMO regulations also still fully apply for clinical research into other disorders .
Regulation 2020/1043 calls on companies, sponsors and Member States to implement appropriate measures to minimise foreseeable negative environmental impacts resulting from the intended or unintended release of the investigational medicinal product into the environment. It is therefore advised to assess potential environmental risks during the clinical research phase, all the more as an environmental risk assessment will still be mandatory as part of the application for registration of the market authorization.
Regulation 2020/1043 shall apply as long as WHO has declared COVID-19 to be a pandemic or as long as an implementing act by which the Commission recognises a situation of public health emergency due to COVID-19 in accordance with Decision No 1082/2013 / EU applies.