Inquiry about the Infection Protection Act

Permission under Section 44 of the IFSG (German Federal Institute for Infectious Diseases Act) and notification of the commencement of activities with infectious material under Section 49 of the IFSG must always be considered in genetic engineering facilities of safety levels 1 and 2 if the laboratory has only been notified (S1) or registered (S2), or if the corresponding activity in an S2 laboratory has only been notified. In these cases, due to the lack of a concentration effect, the fictitious authorization under the GenTG does not simultaneously include permission under the infection protection law.

A frequently asked question in this context is whether the permit (Section 44 of the IFSG) has nationwide effect, just like the project manager certificate under genetic engineering law. It should be noted that the project manager course is a continuing education course recognized by the state authority (Section 15 (1) No. 3, Section 4 of the GenTSV). Participants in a state-recognized continuing education program are then listed at the state authority level, so that their project manager certificate is also recognized in other federal states.

In contrast, a permit pursuant to Section 44 IFSG is an authorization issued by the locally responsible state authority, usually the health administration. These authorities examine, within their own authority and exercising their discretion, whether the applicant has the expertise for the specific activities applied for and is reliable. Accordingly, the permit is granted based on the specific activity. In this respect, the requirements of Section 44 IFSG are not comparable with those of Sections 15 (1) No. 3 and 4 GenTSV. In this respect, a new permit pursuant to Section 44 IFSG must be applied for for a new activity in another federal state. In individual cases, the locally responsible authority could, within the scope of its discretion, recognize a permit previously granted in another federal state for comparable activities. In this respect, it is always worthwhile to specifically inquire with the newly responsible authority (health authority) if you are changing federal states.

This publication can also be found on the website of the law firm Dr. Kauch .