When does the Medicines Act apply to genetic engineering work?

The Genetic Engineering Act (GenTG) applies to genetic engineering facilities and genetic engineering work, to the release of genetically modified organisms (GMOs) and to the placing on the market (market authorisation) of products containing or consisting of GMOs. Use of GMO-containing test products on humans however, of genetic engineering regulations in Germany (Section 2 (3) GenTG). Here, the approval of clinical trials with these investigational medicinal products, which consist of or contain a GMO or a combination of GMOs, is then in § 40 AMG In Germany, the Paul Ehrlich Institute (PEI), as the highest federal authority, is responsible for granting approval. The Federal Office of Consumer Protection and Food Safety (BVL) is involved as a consulting authority in assessing the risk to third parties and the environment and in determining the delimitation of certain activities from the GenTG. It reports on this to the Central Commission for Biological Safety (ZKBS), which in some cases assesses the hazard potential of the GMOs used in an opinion. But which modified organisms or cells fall under these GMO test products?

In 2023, 26 approvals were granted by the PEI in which the BVL was involved. The investigational products were Potential advanced therapy medicinal products (ATMPs) , which mainly comprise lenti- or retrovirally transduced autologous cells, but also Vaccines , oncolytic adenoviruses for the treatment of cancer and recombinant bacteria for the immune-stimulated treatment of diabetes mellitus (ZKBS Activity Report 2023).

Other ATMP test products are Gene therapies such as mRNA-based drugs for tumor immunotherapy based on adeno-associated viral (AAV) vectors or patient-derived autologous cells that are genetically modified ex vivo (e.g. CAR-T cells). somatic cell therapeutics such as allogeneic mesenchymal stem cells and biotechnologically modified Fabric products such as autologous chondrocytes for the treatment of cartilage defects of the knee belong to ATMP (Advanced Therapy Medicinal Products (ATMP): Arrival in Supply, PEI). ATMP also includes induced pluripotent stem cells (iPS cells) manufactured products.

When genetic engineering work is carried out with test products on humans, the distinction between the GenTG and the AMG can be difficult. The AGCT will offer a key topic on 22.01.2025 Refresher course for PL and BBS.