Supplement to the commentary on biotechnology and genetic engineering published

This question has come into focus since the emergence of medicinal products made from genetically modified organisms (GMOs). Section 2 (3) of the Genetic Engineering Act (GenTG) merely stipulates that the Genetic Engineering Act (GenTG) does not apply to the use of GMOs in humans. However, according to the explanatory memorandum to the law, this exception does not apply to in vitro sub-stages of procedures that may precede or follow the direct use of GMOs in humans (Bundestag Printed Paper 12/5145, p. 11). However, this distinction does not answer all questions regarding the distinction between pharmaceutical law and genetic engineering law. Firstly, this distinction explicitly applies only to human medicinal products, not to veterinary medicinal products. Furthermore, this distinction cannot be found in European law. For this reason, the following commentary includes excerpts from the provisions of European law laying down Union procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency. The Regulation on Advanced Therapy Medicinal Products has also been supplemented. These refer to medicinal products that are medically prescribed as individual preparations for a single patient, are manufactured non-routinely according to specific quality standards, and are administered in a specialised healthcare facility under the professional responsibility of a physician. Certain licensing regulations do not apply to these. They are only considered non-routinely manufactured if they are manufactured and administered on such a small scale that it is not expected that sufficient clinical experience can be gained to comprehensively evaluate the medicinal product, or if they have not yet been manufactured and administered in sufficient numbers to permit the necessary knowledge for a comprehensive evaluation. Such medicinal products are subject to authorisation by the competent higher federal authority. According to this, the higher federal authority decides in consultation with the BVL in the case of novel therapies that consist of a genetically modified organism or a combination of genetically modified organisms or contain other GMOs.