What does a legal fiction actually mean and when exactly does it come into effect?

For S1 and S2 facilities, as well as other S2 operations, such a legal fiction is provided for in Section 12, Paragraph 5a and Paragraph 5 of the GenTG. The regulations regarding legalization differ in the case of notification and registration, so they should be examined separately. In the last AGCT-Gentechnik.report, we reported on legalization in the case of notification. This AGCT-Gentechnik.report focuses on legalization in the case of registration.

1. Rule In this case, in the case of safety level 2, the operator may begin the construction and operation of the genetic engineering facility and the performance of the initial genetic engineering work 45 days after receipt of the notification by the competent authority, or earlier with the latter's consent (Section 12 (5) Sentence 1 GenTG). The expiration of this deadline is deemed consent (ed. note = fictitious) to the construction and operation of the genetic engineering facility and the performance of the genetic engineering work (Section 12 (5) Sentence 2 GenTG). The law considers the construction and the performance of the work to be legal upon expiration of the deadline. A written decision from the licensing authority is not required in these cases, nor is one provided for by law. To the extent that a written decision has been issued by the authority in these cases in practice, the courts have taken a very critical view of such a decision. In the courts' opinion, there is no legal basis for issuing a notice. Furthermore, such a notice cannot simply reinstate existing legal obligations. A decision can only be issued in individual cases if additional provisions must be included that are specific to the specific facility or activity. Only in such a case is a declaratory administrative act by the authority legally conceivable.

2. Exception The deadline is suspended as long as the authority awaits the supplementary documentation or until the required opinion from the commission on the safety classification of the proposed genetic engineering work and the necessary safety measures is available (Section 12 (5) Sentence 3 GenTG). This is different from the notification for S1 facilities. While for a notification for S1 facilities the competent authority must actively "pause" the legality by issuing a prohibition order, the deadline is "suspended" for the registration of an S2 facility if additional documentation is requested and the authority waits for it or until a required opinion from the ZKBS is available. It is certainly not sufficient for the authority to request additional documentation or to request an opinion from the ZKBS without necessity to revoke the legality. In order to request an opinion from the ZKBS, Section 12 (4) GenTG requires that the work is not "comparable" to genetic engineering work that has already been classified by the ZKBS. Comparability is sufficient; identity is not required, which increases the applicant's flexibility. Nevertheless, the wording is more than unfortunate for the applicant, as they cannot independently determine the point in time at which the statement from the ZKBS - the authority - is "available," while the legalizing effect of their investment/work depends on this point in time - and not on the authority's forwarding or a decision by it. It would be required that the ZKBS send the statement to the authority and the applicant at the same time so that the applicant can recognize the start of legality. However, this is not provided for by law. The following idea is likely to be decisive for the subsequent request for documents: Since the legislature assumes legalization by virtue of the law if Form A and other required forms are fully completed and submitted, it cannot be about information that is required beyond this, as this information is then not required by law. However, if the information is required by the forms, the operator is already in control of submitting the application in full, so the fictitious effect remains. If the operator has actually forgotten something, they should submit the documents as quickly as possible – even before the deadline set by the authority expires. Because once the documents are submitted/received, the authority no longer "wait" for further documents, and the legalization effect takes effect again, without the need for approval by the authority or a written decision from the licensing authority.