Europese Commissie stelt een versoepeling voor van de GMO regelgeving voor vaccinontwikkeling COVID-19. De versoepeling houdt in dat de beoordeling van van de milieurisico's wordt overgeslagen.
"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 and without a prior environmental risk assessment and/or consent under Directive 2001/18/EC or Directive 2009/41/EC in so far as there is a valid declaration of pandemic by the World Health Organisation, or if COVID-19 is declared an emergency situation in accordance with Decision No 1082/2013/EU and remains so.
In the situation of public health emergency created by the COVID-19 pandemic, there is an overriding interest in protecting human health. Moreover, the intrinsic characteristics of the conduct of clinical trials (i.e. limited number of patients, limited volumes of medicinal products involved and administration in a highly controlled environment), substantially limit any potential environmental exposure. Hospitals routinely deal with hazardous biological substances and protocols exist to ensure safe handling of biological waste in a hospital setting. In this context, the Commission has also adopted guidelines on waste management in the COVID-19 crisis.
It is stressed that an environmental risk assessment for the medicinal products covered by this Regulation will be performed before they become widely available in the Union as part of the marketing authorisation procedure.
In addition, it should be clarified that medicinal products for human use containing or consisting of GMOs intended to treat or prevent COVID-19 can be administered swiftly in the absence of a prior environmental risk assessment and/or consent under Directive 2001/18/EC or Directive 2009/41/EC in the exceptional situations foreseen in Article 5(1) and (2) of Directive 2001/83/EC, and Article 83 of Regulation (EC) No 726/2004. "(bron: Proposal for a Regulation of the European Parliament and of the Council on the conduct of clinical trials with and supply of medicinal products for human use containing or consisting of genetically modified organisms intended to treat or prevent coronavirus disease (COM(2020) 261 final), pagina 2-3)