European Commission proposes relaxing GMO regs for COVID-19 vaccines

Regulatory NewsRegulatory News | 18 June 2020 |  By 

A proposal to adjust European Union regulation of genetically modified organisms (GMOs) would relax requirements for vaccines under development for SARS-CoV-2, the virus responsible for the novel coronavirus pandemic. The proposed derogation would allow GMO-containing candidate vaccines and coronavirus 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 GMO's and are intended to treat or prevent COVID-19 can start swiftly,” said the European Commission (EC) in setting the context of the proposed changes. “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,” said the commission, citing an “overriding interest in protecting human health.”
Clinical trials, by their nature, involve limited and highly controlled exposure to the products being tested, pointed out the EC, which said that it plans to include an environmental risk assessment as part of the marketing authorization procedure for any products falling under the relaxed GMO regulations. Some vaccines already in development contain attenuated viruses or live vectors – substances which may fall under European Union (EU) GMO regulations.
Currently, two directives, 2001/18/EC and 2009/41/EC, set the framework for handling GMOs in the EU member states, with goals of “ensuring a high level of protection of human health and the environment” through a risk assessment process for deliberate release or contained use of GMOS.
However, member states vary in their approaches to the particulars of regulating GMOs, both in general and within the context of clinical trials of medicinal products containing, or consisting of, GMOs. In some member states, a request for authorization to conduct a clinical trial of a GMO-containing product may be made to a single competent authority; in other member states, sponsors must submit multiple parallel requests to several competent authorities. “Attempts to streamline the process through informal coordination between Member States’ competent authorities have not borne fruit,” said the EC.  
“A common approach for all the Union Member States is deemed necessary as threats to health arising from the COVID-19 pandemic have, by their nature, transnational implications,” noted the EC. Large-scale, multinational, multi-center clinical trials have the most promise to speed development of vaccines, and progress should not be hindered by the complexities inherent in navigating a heterogenous set of GMO regulations.
Some portions of the directive will continue to be in force in some circumstances, according to the proposed derogation. For example, manufacturing sites where wild-type viruses will actually undergo modification will still be subject to compliance with Directive 2009/41/EC. 
The European Medicines Agency (EMA), in its assessment of any GMO-containing medicinal products, should continue to assess environmental impacts in parallel with its quality, safety, and efficacy assessments, as required by 2001/18/EC. Also, written authorization will still be needed from the competent authority in each member state that is a clinical trial site for a GMO-containing product. Good clinical practice, ethical trial conduct, and good manufacturing practice will, as always, be mandatory, said the EC.
The proposed derogation would also allow distribution of medicinal products containing GMOs under a compassionate use exemption of Regulation (EC) No 726/2004.
However, the EC made clear that the proposal is “limited in scope.” The proposed derogation is for the duration of the pandemic only and applies only to medicinal products intended to prevent or treat COVID-19.


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