Position Paper on the Draft Law on Genetic Testing and the Implementation of this Law Working Group on Regulatory Affairs and Health Policies

Companies that offer applied human genetics services and products are among those represented by BIO Deutschland. These services include forensic DNA analysis, paternity tests, and the analysis of molecular biomarkers such as genetic polymorphism (SNPs) used in applications in pharmacogenetics and preventive medicine (individualised medicine). The fundamental values and aims of these companies will be presented in the position paper and a statement on the Draft Law on Genetic Testing from the point of view of DNA analytics will be given.

The following application areas are involved:

• Genetic analyses used in prognostic and predictive medicine
• Forensic genetic analyses
• Genetic analyses used in parentage determination

The biotechnology companies active in these areas offer their services on a commercial basis, which are subject to established quality criteria and deadlines. These services are also provided by publicly financed institutions such as (forensic) medical university laboratories and the laboratories in the State Bureaux of Investigation. Some specialist medical laboratories and (hospital) doctors claim an exclusive right to conduct these analyses.

Bio Deutschland’s key demands are as follows:

• Genetic tests for potential diseases that have a significant impact on health, as well as antenatal tests, should only be available from a doctor.
• Companies should be allowed to offer the genetic tests used to ascertain the risk of preventable diseases and for so-called lifestyle areas such as sporting performance and the tendency to obesity freely on the private market.
• Laboratories must be licensed to conduct genetic tests.
• The laboratory must be managed by a doctor or scientist with extensive experience in molecular biological analytics.
• Genetic analysis in forensic medicine should increasingly be devolved to commercial companies that have a proven qualification comparable to that of police laboratories.
• Genetic tests used for the determination of parentage (paternity tests) should be allowed to be commissioned without the consent of all parties involved in order to protect the existing family relationships and to prevent additional court or administrative costs. (Please see inter alia the Baden-Württemberg Bundesrat initiative.)