Evaluation of the environmental risk assessment procedure according to Directive 2001/18/EC for Gene Modified Organism used as medicinal products

The deliberate release of genetically modified organisms (GMOs) including GMOs used as medicinal products, e.g. gene therapies, into the environment is regulated by directive 2001/18/EC of the European Parliament and of the Council of 12 March2001. An integral part of the directive regulates the provision of information on the GMO and, based on this, the risk management with regard to the environmental effects of such releases. As regulated by this directive, a publicly accessible database is the "GMO Register" of the JOINT RESEARCH CENTER of the EC (http://gmoinfo.jrc.ec.europa.eu/Default.aspx), which contains information about all releases under the guideline. As of 07.11.2016, there were 238 entries of medicinal GMOs” in the "Summary Notification Information Format (SNIF).SNIFs are prepared as a summary document of the confidential environmental risk assessments (ERA) by the respective Sponsors of clinical trials in the EU and evaluated during the clinical trial application by the national competent authorities. They comprise, inter alia, information regarding the GMOs and the parental organism’s nature, release, environmental interactions, monitoring, waste treatment and emergency response plans. We strived to assess information concerning the environmental risk, derived measures and the overall standard of SNIFs concerning compliance with the regulatory requirements. To do so, we picked a homogeneous group of GMOs, namely gene modified Adenovirus, the most frequently used vector in gene therapy trials worldwide. Relevant information were entered into a database and categorized, applying unified vocabulary. Different challenges regarding the information available within the SNIFs were identified by analyzing the database: in several cases mandatory information was not available, e.g. monitoring plans, and in other cases the SNIF documents were misinterpreted, e.g. the connection between replication, dissemination and survivability was interpreted heterogeneously. Although this analysis has been performed using only Adenovirus data, information gaps and inconsistencies are transferable to other species as well. Consequently, it is proposed to specify some parts of the SNIFs in order to make more reliable information transparently available