Advice following the European consultation on the authorisation process of GMOs in medical applications
The Ministry of Infrastructure and Water Management has asked COGEM whether an environmental risk assessment is necessary for all clinical gene therapy applications, and whether generic criteria can be drawn up for medical GMOs that require a more or less extensive environmental risk assessment.
The term gene therapy covers a wide range of applications. For some applications of gene therapy, the nature of the GMO and the acquired experience with risk assessments suggest that there is room to simplify and facilitate the authorisation process. COGEM has implemented this by drawing up a number of generic environmental risk assessments. These advices have been converted or are being converted into a set of standard licence conditions (so-called Vergunning onder Vaste Voorwaarden, or VoV) in the Netherlands. This will make it possible to authorise most current gene therapy applications at an accelerated rate without requiring an additional environmental risk assessment.
COGEM notes that it would be advisable for such a system or a comparable one to be introduced throughout the EU, also in the context of harmonising regulations and the authorisation process between member states.
Because of the wide range of potential applications of gene therapy with GMOs, COGEM is of the opinion that it is not possible to draw up generic criteria beforehand, on the basis of which the safety of human health and the environment for all gene therapy applications is ensured. The process by which authorisation is granted should be a learning system, that allows for generic environmental risk assessments to be drawn up for other GMOs in the future, based on the knowledge and experience gained. These could then be incorporated into similar VoVs to speed up and simplify the authorisation process.