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Specific Statutory Legislation
The Gene Technology Act
The Gene Technology Act is primarily a piece of safety legislation and is intended to guarantee a high level of safety for human and health and the environment where genetic engineering is used. It regulates among other things:
• Contained use of genetically modified organisms (GMOs).
• The releasing of GMOs and the marketing of products containing GMOs.
• The establishment of the Advisory Board on Biotechnology and Genetic Engineering, which advises authorities and reports on such matters as applications for approval.
The most important legal regulations concerning the application of genetic engineering in medicine are:
• Interference with the human genome is strictly prohibited
• Molecular genetic testing (MGT) may only be carried out on humans by order of a doctor to determine a disease risk or the danger of transmission of a hereditary disease. Furthermore, it is permitted to diagnose a disease and to prepare a therapy and monitor the progress of the therapy. Molecular genetic testing requires the written approval of the affected person and may - in the case of predictive MGT - be carried out only by institutions that are authorized to do so. Furthermore, special consulting and informational service and stricter data protection are provided for.
• Absolute anonymity must be ensured for MGT for scientific purposes. Moreover, the use of MGT data for employment and insurance contracts is expressly prohibited.
• Somatic gene therapy, i.e. the correction of defective genes in individual patients is permitted. However, it must be carried out by a doctor in a hospital approved for this purpose.
The Medical Products Act
The Medical Products Act, which came into force on January 1, 1997, transposes three EU Directives into national law, thus regulating not only the licensing and marketing but also the professional use, maintenance and clinical testing of medical products in Austria. The concept of medical products is a broad one, covering medical equipment such as nuclear resonance scanning and X-ray equipment, medical implants, medical requisites such as syringes and infusion equipment, medical aids for the handicapped (such as wheelchairs and prostheses), in vitro diagnostic agents and medical laboratory equipment, as well as a multitude of medically important products such as contact lenses, spectacles, blood-pressure gauges, hearing aids and bandages.
The Federal Ministry of Health, Family and Youth monitors the safety and effectiveness of medical products and steps in to protect patients if there is an indication that products are deficient or dangerous.
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