Verstöße gegen das Gentechnikrecht - Mögliche Folgen für die verantwortlichen Personen im Lichte der neuen Gentechnik-Sicherheitsverordnung (GenTSV)

In Germany genetic engineering is mainly carried out by universities and other research institutions (e. g. the Max-Planck-Institutes) and also by industrial companies. Any violations of the relevant statutes made in context of genetic engineering can be of considerable consequences. This article first examines the roles and responsibilities of people and legal entities involved as stated in the genetic engineering law. Second, it examines to what extent the operator can delegate his/her own responsibilities to other people. The article explains both the role of the persons and/or legal entities responsible under the Genetic Engineering Act, who are the operators or their legal representatives, the Biosafety Officer and the Project Manager, on the one hand, and the role of the »Genetic Engineering Operator Representative«, who is not explicitly defined by the law, on the other hand. This is followed by an account of the possible consequences that the above-mentioned operator or other persons can face, should the genetic engineering regulations be violated. Next the article deals in particular with the fines defined in the Genetic Engineering Act (GenTG) and in the Genetic Engineering Safety Ordinance (GenTSV), which has been in force since March 1st, 2021. It goes on to explain that practical implementation of the regulations can lead to issues in certain individual cases. On the other hand, there are constitutional concerns about certain fines. Finally, the negative implications of the violations for the general reliability (e. g. of an operator or a project manager) are discussed.