What is meant by contained use?

The term "contained use" refers to any activity involving the genetic transformation of cells that is carried out in closed environment, such as laboratories and hospital rooms, to limit the contact of the transformed cells with the environment and into the general population. Such activities include, for example, the process of genome editing, the use of transformed cells in some clinical trials as part of a gene therapy, as well as the use and storage of transformed cells. It is noteworthy, that the cells of a living organism which have been transformed in a contained environment do not have a life on their own and cannot survive or reproduce. Contained use activities are strictly governed in the EU by Directive 2009/41/EC.

In healthcare biotechnology, transformed somatic cells are not released into the environment (where they cannot survive on their own). They are delivered to a patient.  Therefore, the process of human gene editing is considered “contained use” as it is carried out in a closed laboratory or a hospital room with the purpose to mitigate or cure a genetically-based disease.