What is meant by deliberate release?

The term "deliberate release" of genetically transformed cells refers to their intentional introduction into the environment. They can be expected to have some interaction with the release environment only if the released organisms are considered being able to survive independently, to replicate and to potentially transfer their transformed genetic information to other organisms of the release environment. Similar to the contained use of transformed cells, the process of deliberate release is strictly governed in the EU by Directive 2001/18/EC.

In healthcare biotechnology, this is not possible to happen because the genetic transformation is applied to somatic human cells which cannot survive on their own in the release environment, hence they cannot interact with it in any way. Further, it could be that microorganisms (non-human cells) are being transformed to produce specific proteins which are then formulated for oral or other types of administration to patients. It is noteworthy, that these microorganisms are not capable to survive outside the patient’s body, either, and therefore have no expected effects on the environment.