Diritto Pubblico Comparato ed Europeo

Sommario

1. On acceptance, societal consensus and legal shaping of gene diagnostic examinations. – 2. Legal Developments: the planned law on gene diagnostic examinations for humans (Gene Diagnostic Law/ Gendiagnostikgesetz). – 2.1. Tissue Law. – 2.2. Stem Cell Law (Stammzellengesetz-StZG). – 2.3. Embryo Protection Law (ESchG). – 2.4. Pre Implantation Diagnostics (PID). – 3. Other Areas. – 3.1. Gene diagnostics in the insurance sector: gene diagnostics prior to closing insurance contracts. – 3.2. Gene Diagnostics in Health Insurances. – 3.3. Gene Diagnostics in the labour and public service law. – 3.4. Family Law – secret paternity tests. – 4. Conclusion.

Abstract

In Germany, the Gene Diagnostics Law was finally passed after a 20-year process of elaboration. The author describes its content and underlines that the Gene Diagnostics Law does not regulate two very important aspects, i.e. the discipline regarding data gathered on the basis of genetic diagnoses and Bio banks. In order to implement the EC directive 2004/23 a new Tissue Law (Gewebegesetz) must provide for a framework to implement the EC quality and safety standards for donating, procuring, testing, processing, conserving, storing and distributing human tissue and cells. At an international level, reforms of the stem cell law and pre-implantation diagnostics are under discussion. The increase application of the latter in other European countries did not lead to an assertion in Germany. The author finally approaches the issue of doctors’ liability. Similarly to what happens in other fields of medicine, the attending (specialist) doctor committing an error in humane diagnostics and consultation procedures may be considered liable. Liability due to a breach of a contract, which has as a goal birth control of a gene-defective child is in the foreground. The author concludes that so far Courts have never ruled on doctors’ liability in cases of predictive genetic testing, and on altruistic donation for research purposes.