The proposal to relax regulation of genetically modified organisms (GMO) would allow GMO-containing COVID-19 candidate vaccines and 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 GMOs and are intended to treat or prevent COVID-19 can start swiftly. 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.”
Presently, two EU directives, 2001/18/EC and 2009/41/EC, encapsulate GMOs in the member states (MS), through a risk assessment process for deliberate release or contained use of GMOs. As clinical trials involve limited and highly controlled exposure to the products being tested, the European Commission (EC) plans to include an environmental risk assessment as part of the marketing authorisation procedure for any products falling under the relaxed GMO regulations. Some vaccines currently in development contain attenuated viruses or live vectors, which may qualify them under EU GMO regulations.
In some member states, a request for authorisation of a clinical trial of a GMO-containing product may be made to a single competent authority (CA), however, in other member states, sponsors must submit multiple parallel requests to several CAs. Therefore, a harmonised approach for all the MSs is deemed necessary to ensure efficient progress in COVID-19 vaccine and therapeutic development. Large-scale, multinational, multi-centre clinical trials have the most promise to speed development of vaccines, and progress should be streamlined to avoid, if possible, navigating different GMO regulations.
The EC proposes that the European Medicines Agency (EMA), should continue to assess environmental impacts of GMO products alongside its quality, safety, and efficacy assessments. Furthermore, written authorisation should still be acquired from the CA in each MS that is hosting a clinical trial site for the GMO product. Good clinical practice, ethical trial conduct, and good manufacturing practice (GMP) are still mandatory.
The EC have cited an overriding interest in protecting human health as the reason for this proposal. However it has been emphasised that the proposal is limited in scope. The proposed relaxation of regulations is for the duration of the pandemic only, for medicinal products intended to prevent or treat COVID-19.
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